Except as expressly limited, in COMAR 10.67.01.12 the following terms have the meanings indicated. Terms Defined. “ACOG guidelines” means the American College of Obstetricians and Gynecologists' Guidelines for Perinatal Care that specify the recommended periodicity and content of prenatal, perinatal, and postpartum care, and are incorporated by reference in COMAR 10.67.04.01. “Acquired immune deficiency syndrome (AIDS)” has the meaning stated in COMAR 10.52.06.01B. “Action” means: Denial or limited authorization of a requested service, including: The type or level of service; Requirements for medical necessity; Appropriateness; Setting; or Effectiveness of a covered benefit. Reduction, suspension, or termination of a previously authorized service; Denial, in whole or part, of payment for a service, except for administrative denials of unclean claims; Failure to provide services in a timely manner; Failure of an MCO to act within the required time frames; or The denial of an enrollee's request to dispute a financial liability, including: Cost sharing; Copayments; Premiums; Deductibles; Coinsurance; or Other enrollee financial liabilities. “Activities of daily living” means, in the context of COMAR 10.09.69, bathing, feeding, toileting, dressing, and ambulation; “Adjusted clinical group (ACG)” means a method for categorizing individuals into a case mix category based on the diagnoses assigned by their clinicians over a predetermined period of time. Administrative Services Organization. “Administrative services organization (ASO)” means an organization with which the Department contracts to assist in the management of behavioral health services. “Administrative services organization” does not mean an organization that directly provides health care services to waiver-eligible individuals. “Advanced practice nurse” means a nurse practitioner, nurse midwife, nurse anesthetist, or nurse psychotherapist who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, and COMAR 10.27.01 “Aged” has the meaning stated in COMAR 10.09.24.02B. “AIDS payment category” means one of the two payment categories represented as individual rate cells within the rate table set forth in COMAR 10.67.04.19B(4)(b) to which enrollees with AIDS are assigned pursuant to COMAR 10.67.04.19B(2)(c)(ii). “Alcohol abuse” has the meaning stated in Health-General Article, §8-101(e), Annotated Code of Maryland. “Ancillary services” means diagnostic and somatic therapeutic services, including but not limited to radiology, laboratory services, cardiac diagnostics, neurology diagnostics, occupational therapy, physical therapy, durable medical equipment, disposable medical supplies, audiology, speech therapy, and cardiac rehabilitation therapy. “Annual quality assurance (QA) audit” means a systems performance review and a clinical care review. “Appeal” means a request for review of an action. “Applicant” means an entity that seeks approval from the Department to operate as a managed care organization in the Maryland Medicaid Managed Care Program. “Benefits package” means a set of health care services to which an MCO's enrollees are entitled, when the services are medically necessary, and which the MCO delivers to its enrollees either through providers with which it has employment or contractual relationships, or through reimbursement for services provided to the MCO's enrollees. “Blind” means having a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of no greater than 20 degrees. “Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. “Caller abandonment rates” means the percentage of calls terminated by callers without speaking to a live operator. “Caller average hold time” means an average amount of time a call is on hold after being answered. “Caller service level” means the speed of answering the telephone. “Capitation payment” means the sum of money paid in advance on a monthly per capita basis by the Department for a fixed benefit package. “CARF” means the Commission on Accreditation of Rehabilitation Facilities (also known as the Rehabilitation Accreditation Commission), which is an organization that: Establishes quality standards for rehabilitative services; and Determines, in the context of its accreditation process, the extent to which rehabilitative service providers are in compliance with CARF quality standards. “Case management” means, assessing, planning, coordinating, monitoring, and arranging the delivery of medically necessary health-related services. “Case management contractor” means, in the context of COMAR 10.09.69, the Department's designee, or a subcontractor of the designee, which provides case management to participants assigned to it by the Department. “Case manager” means, in the context of COMAR 10.09.69, the individual who: Is employed by the Department's designee or a case management contractor; Is assigned by a case management contractor to manage the care of some or all of the participants assigned to that case management contractor; Participates in the meetings of the interdisciplinary team; Is responsible for the development of an individual's case management plan by the interdisciplinary team; Is responsible for implementing the participant's case management plan; and Is responsible for modifying the case management plan when information regarding a change in the participant's condition or status is received. “CDS license” means the State licensure authorizing a health care practitioner to prescribe controlled dangerous substances. “Certified nursing assistant” means, in the context of COMAR 10.09.69, an individual: Certified as a nursing assistant by the Maryland Board of Nursing; and Who performs nursing tasks delegated by a registered nurse or licensed practical nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland. “Child in State-supervised care” means a waiver-eligible child who is in the care and custody of a State agency pursuant to a court order or a voluntary placement agreement, including, but not limited to, waiver-eligible children: Under the supervision of the Department of Juvenile Services; In kinship or foster care under the Department of Human Services; and In residential treatment centers or psychiatric hospitals for the first 30 days after admission. “Child with a special health care need” means an individual younger than 21 years old, regardless of marital status, suffering from a moderate to severe chronic health condition: With significant potential or actual impact on health and ability to function; Which requires special health care services; and Which is expected to last longer than 6 months. “CHIP Health Services Initiative” means services offered to improve the health of low-income children pursuant to 5 U.S.C. §2105(a)(1)(D)(ii) of the Social Security Act. “Chronic hospital” has the meaning stated in COMAR 10.09.06.01B(4). “Clinical care review” means a review of the quality of clinical health care delivered by an MCO, which is: Required by federal law; and A component of an annual quality assurance (QA) audit. “CMS” means Centers for Medicare and Medicaid Services. “Cold call marketing” means any unsolicited personal contact by the MCO with a potential enrollee for the purpose of marketing. “Collaborative Care Model” means the Psychiatric Collaborative Care Model, a patient-centered, evidence-based approach for integrating physical and behavioral health services in primary care settings that includes: Care coordination and management; Regular, systematic monitoring and treatment using a validated clinical rating scale; Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and Regular, systematic consultation for patients who do not show clinical improvement. “Commissioner” means the Maryland Insurance Commissioner of the Maryland Insurance Administration. “Community-based substance abuse program” means a program that: Is certified by the Office of Health Care Quality (OHCQ); and Provides services in community settings not regulated by the Health Services Cost Review Commission. “Complaint” means an expression of dissatisfaction that results in either an appeal or a grievance. “Contract year” means the period of time to which the Maryland Medicaid Managed Care Program agreement between the Department and an MCO applies. “Core service agency (CSA)” means, in the context of COMAR 10.67.08, the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services. “Corporation” means: An entity formed under and meeting the requirements of Corporations and Associations Article, §2-101 et seq., Annotated Code of Maryland; or A foreign corporation registered with the Maryland Department of Assessments and Taxation. “County” means a county of this State and, unless expressly provided otherwise, Baltimore City. “Credibility adjustment” means an adjustment to the MLR for a partially credible MCO to account for a difference between the actual and target MLRs that may be due to random statistical variation. “Days” means, unless otherwise expressly indicated, calendar days. “DEA license” means the federal license authorizing a health care practitioner to prescribe controlled substances. “Definitive drug test” means drug screening tests that include: The ability to identify individual drugs and distinguish between structural isomers, but not necessarily stereoisomers, using: Gas chromatography or mass spectrometry; and Liquid chromatography or mass spectrometry; Qualitative or quantitative results; All source types for specimen selection; Specimen validity testing, per day, 122 or more drug classes including metabolites, if performed. “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. “Diagnostic evaluation services (DES)” has the meaning stated in COMAR 10.09.32.01B, and includes the services described in COMAR 10.09.32.04A. Direct Medical Education Costs (DME Costs). “Direct medical education costs (DME costs)” means costs associated with providing graduate medical education that are measurable using accounting data. “Direct medical education costs (DME costs)” includes, but is not limited to: Salaries; Supervision costs; and Allocated overhead. “Disabled” has the meaning stated in COMAR 10.09.24.02B. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq. (1981), and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services. “Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in: Placing the patient's health, or with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part. “Emergency services” means those health care services that are provided in a hospital emergency facility after the sudden onset of a medical condition that manifests itself by symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in: Placing the patient's health, or with respect to a pregnant woman, the health of the woman, or her unborn child, in serious jeopardy; Serious impairment to bodily functions; or Serious dysfunction of any bodily organ or part. “Encounter data” means information documenting a service to an enrollee. “Enrollee” has the meaning indicated in Health-General Article, §15-101(b), Annotated Code of Maryland. “EPSDT-certified provider” means a physician or nurse practitioner who is certified by the Department's EPSDT program to provide comprehensive well-child services according to the Department's periodicity schedule and program standards to enrollees younger than 21 years old. “EPSDT comprehensive well-child services” means: All the screening services provided by an EPSDT-certified provider that are required or recommended on the EPSDT periodicity schedule; and Health care services to diagnose, treat, or refer problems or conditions discovered during the comprehensive well-child service. “EPSDT partial or interperiodic well-child service” means: A well-child service provided at times different than those outlined in the EPSDT periodicity schedule; or Any encounter by a health care practitioner necessary to diagnose or identify a condition and recommend a course of treatment. “EPSDT periodicity schedule” means the Departmentally approved list of required or recommended preventive health care services which are to be performed at specified ages. “Evaluations” means, in the context of COMAR 10.09.69, a determination of the health status of a patient in a patient's home or any other appropriate setting by a licensed professional for the purpose of designing an individual plan of care which incorporates the modalities of treatment which will promote optimal functional ability and recuperation. “External quality review organization (EQRO)” means a utilization and quality control peer review entity or a private review agent meeting the requirements of §1902(a)(30) of the Social Security Act, 42 U.S.C. §1396a(a)(30), which performs an independent external review of health care services furnished under a contract under §1903(m) of the Social Security Act, 42 U.S.C. §1396b. “Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. “Federally qualified health center (FQHC)” means a clinic which either: Receives a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c; Meets the requirements for a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c; or Qualifies as a FQHC pursuant to a waiver from the Secretary of the U.S. Department of Health and Human Services of one or more of the requirements for receiving a grant under §329, 330, or 340 of the Public Health Services Act, 42 U.S.C. §254c. “Fiscal year (FY)” means the time period beginning the preceding July 1 and ending on June 30 of the referenced year. “Free-standing birth center” means a free-standing facility not associated with a hospital that provides nurse midwife services under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland. “Full credibility” means a standard for which the experience of an MCO is determined to be sufficient for the calculation of an MLR with a minimal chance that the difference between the actual and target MLR is not statistically significant. “Graduate medical education (GME)” means the training of physician interns and residents after completion of a medical degree program. “Graduate medical education costs (GME costs)” means the amount it costs a hospital to train physician interns and residents after their completion of a medical degree program, including both direct medical education costs and indirect medical education costs. “Grievance” means an expression of dissatisfaction about any matter other than an action, including but not limited to: The quality of care or services provided, and aspects of interpersonal relationships such as rudeness of a provider or employee; Failure to respect the enrollee's rights regardless of whether remedial action is requested; or A dispute over an extension of time proposed by the MCO to make an authorized decision. “HCQIS” means the Health Care Quality Improvement System produced by the Centers for Medicare and Medicaid Services. “Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland. “HealthChoice Financial Monitoring Report (HFMR)” means an annual financial report of an MCO's MMMCP-related activities during a specified calendar year that: Is submitted to the Department by an MCO pursuant to COMAR 10.67.04.15; Serves as a supplemental schedule to an MCO's quarterly and annual reports to the Maryland Insurance Administration; and Includes a completed HFMR form provided by the Department and any supplemental schedules required by the Department. “Health home” means a provider designated to offer enhanced care coordination and management services to individuals affected by, or at risk for, chronic conditions. “Health maintenance organization (HMO)” has the meaning stated in Health-General Article, §19-701, Annotated Code of Maryland. Health Service Needs Information. “Health service needs information” means an instrument to identify new Maryland Medicaid Managed Care Program enrollees who require immediate or specialized health care services. “Health service needs information” does not mean an initial health screen performed by an MCO. “HEDIS” means the Healthcare Effectiveness Data Information Set, a set of indicators of managed care plan performance developed by the National Committee for Quality Assurance. “Hepatitis C” means having one of the following as a primary, secondary, tertiary, or level 4 diagnosis: 070.41 — Acute or Unspecified Hepatitis C with hepatic coma; 070.44 — Chronic Hepatitis C with hepatic coma; 070.51 — Acute or unspecified Hepatitis C without mention of hepatic coma; or 070.54 — Chronic Hepatitis C without mention of hepatic coma. “Hepatitis C plan risk factor” means an MCO-specific risk adjustment factor reflecting the level of risk associated with the proportion of the MCO's HIV/AIDS enrollees who also have Hepatitis C. “HIPAA” means the Health Insurance Portability and Accountability Act, a federal law enacted on August 21, 1996, whose purpose is to improve the efficiency and effectiveness of the health care system by standardizing the electronic exchange of administrative and financial data, provide security requirements for transmitted information, and protect the privacy of identifiable health information. “Historical diagnostic period” means the time period under consideration for the cumulative chronological determination of an enrollee's Hepatitis C status and ending: For the initial rate adjustment period, on June 30 of the calendar year before the rate year; or For the mid-year rate adjustment period, on December 31 of the calendar year before the rate year. “HIV” means infection with the human immunodeficiency virus. “HIV/AIDS” means: Infection with the human immunodeficiency virus; or Acquired immune deficiency syndrome. “HIV/AIDS enrollee” means an enrollee who is infected with HIV or has AIDS and is assigned to an HIV or AIDS payment category. “HIV payment category” means one of the four payment categories represented as individual rate cells within the rate tables set forth in COMAR 10.67.04.19B(4)(a) and (b), to which enrollees with HIV are assigned pursuant to COMAR 10.67.04.19B(1)(c)(ii) or (2)(c)(i). “Home”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53. “Home health agency” means, in the context of COMAR 10.09.69, an agency licensed by the Department in accordance with COMAR 10.07.10. “Home health aide” means, in the context of COMAR 10.09.69, an individual who meets all the conditions of participation specified in: 42 CFR §484.36; and Health Occupations Article, Title 8, Annotated Code of Maryland. “Homeless person” means an individual who, as defined by §340 of the Public Health Services Act, lacks housing, without regard to whether an individual is a member of a family, including an individual: Who is a resident in transitional housing; or Whose primary residence during the night is a supervised public or private facility that provides temporary living accommodations. “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. “HSCRC” means the Health Services Cost Review Commission, an independent agency functioning in the Department with the powers and duties set forth in Health-General Article, §19-201 et seq., Annotated Code of Maryland. “Indirect medical education costs (IME costs)” means costs associated with providing graduate medical education that, although not measurable using accounting data, are subject to assessment by application of a regression analysis methodology that: Estimates teaching hospitals' extra costs attributable to factors including, but not necessarily limited to the: Lower productivity of inexperienced residents, and Adoption of advanced technology; and Controls, where possible, for confounding variables such as differences in: Area labor costs, Uncompensated care, and Case mix. “Individualized education program (IEP)” means a written description of special education and related services developed by a multidisciplinary team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.09. “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.02B. “Individual with a developmental disability” means an individual who, as defined in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq., has a physical or mental impairment arising before the age of 22, except for the sole diagnosis of mental disorder, that substantially limits one or more major life activities, and which may include, but is not limited to, an intellectual disability, specific learning disabilities, head injury, epilepsy, and muscular dystrophy. “Individual with a physical disability” means an individual who, as defined in P.L. 101-330, the Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq., has a physical impairment, either sensory or motor, that substantially limits one or more major life activities, and which may include, but is not limited to, orthopedic impairment, vision, speech, or hearing impairment, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, HIV/AIDS, and tuberculosis. “Initial health screen” means the comprehensive evaluation performed by the PCP, that includes a comprehensive history and physical examination to determine the new enrollee's baseline health status and health needs. “Initial rate adjustment period” has the meaning stated in COMAR 10.67.04.19-3A. “Inmate” means an individual who is serving time for a criminal offense and is confined involuntarily in State or federal prisons, jail, detention centers, or other penal facilities or who has been placed on home detention. Institution for Mental Disease. “Institution for mental disease (IMD)” means a hospital, nursing facility, or other institution of more than 16 beds that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases or substance abuse problems, including medical attention, nursing care, and related health care services. “Institution for mental disease (IMD)” includes the following categories of facilities, if the particular facility has more than 16 beds: Psychiatric hospitals; Residential treatment centers; In the context of admissions of enrollees who are 21 years old or older, intermediate care facilities-alcoholic (ICF-A) facilities; and Residential drug-free treatment programs. “Institution for mental disease” does not include intermediate care facilities-alcoholic (ICF-A) facilities, except in the context of admission of enrollees who are 21 years old or older. “Interdisciplinary team” means, in the context of COMAR 10.09.69, the group convened and conducted by the case manager, consisting of the case manager and relevant service providers, that established the case management plan under the overall direction and coordination of the case manager and in consultation with the participant and, when applicable, the participant's family. “Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID)” means a residential facility providing care and services for individuals with an intellectual disability or developmental disabilities, or both. “Limited English proficiency” means the special need status of potential enrollees and enrollees who do not speak English as their primary language and who have a limited ability to read, write, speak, or understand English, and are therefore eligible to receive language assistance for a particular type of service, benefit, or encounter. “Local access area” means the local geographical area, as identified by the zip code groupings in COMAR 10.67.05.06D, that is located within the relevant MCOs service area and in which the relevant enrollee resides. “Local transportation grantee agency” means the county entity, usually the local health department, that receives transportation grant funds pursuant to COMAR 10.09.19. “Long-term care facility” means a chronic hospital, a chronic rehabilitation hospital, a nursing facility, or a special pediatric hospital. Long-Term Care Services. “Long-term care services” means the medical and support services required by an individual who, due to chronic illness or mental or physical disability, requires long-term care facility services over an extended period of time. “Long-term care services” includes services provided to a patient in a long-term care facility after the 30th day of continuous care following the enrollee's admission to the facility. “Long-term care services” do not include services provided to an enrollee admitted to a long-term care facility for a stay of less than 31 days of continuous care following the enrollee's admission to the facility. “Loss ratio” means the ratio of an MCO's: Net medical expenses plus medical management expenses which: Are quantified according to COMAR 10.67.04.19-4; Relate solely to the MCO's MMMCP line of business; and Are incurred during a specified period; and Net revenues which: Relate solely to the MCO's MMMCP line of business; and Are earned during the same specified period in which the expenses referenced in §B(98)(a) of this regulation are incurred. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Marketing” means any communication, from an MCO to a Medicaid recipient who is not enrolled in that MCO, that can reasonably be interpreted as intended to influence the recipient: To enroll in that particular MCO; or To not enroll in or to disenroll from another MCO. “Marketing materials” means materials that are produced in any medium, by or on behalf of an MCO, that can reasonably be interpreted as intended to market to potential enrollees. “Maryland Children's Health Program” means the State program for uninsured, low-income children with federal matching funds provided under Title XXI of the Social Security Act. “Maryland Medicaid Managed Care Program (MMMCP)” means the Medicaid reform program established in this subtitle, as authorized by Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, and by a §1115 waiver issued by the federal government. “Medicaid” has the meaning stated in COMAR 10.09.24.02. “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. “Medical day care for adults” means a program of medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, due to their degrees of impairment, need health maintenance and restorative services supportive to their community living. “Medical day care for children” means a program of medically supervised health-related services provided in an ambulatory setting to children with complex medical needs who do not require 24-hour inpatient care, but, due to their specialized medical needs, cannot be managed in a typical day care setting. “Medical expense” means costs incurred by an MCO in connection with providing health care services to its enrollees. “Medical loss ratio (MLR)” means a formula that measures the ratio of MCO spending on medical and related benefits compared to revenue, to ensure MCOs are spending a sufficient amount of their premium revenue on medical expenses and other high-impact initiatives. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, the consumer's family, or the provider. “Medically needy” has the meaning stated in COMAR 10.09.24.02. “Medical management expense” means costs incurred by an MCO in connection with outreach and utilization management activities as specified in COMAR 10.67.04.19-4. “Medical necessity” means what is medically necessary. “Medically underserved area” means an area designated by the Health Resources and Services Administration (HRSA) as having shortages of primary care, dental care, or mental health providers. “Medicare” means the federal program that provides benefits to the aged and disabled under Title XVIII of the Social Security Act. “MIA” means the Maryland Insurance Administration. “Mid-year rate adjustment period” has the meaning stated in COMAR 10.67.04.19-4A. “MIEMSS” means the Maryland Institute for Emergency Medical Service Systems. “MLR reporting year” means a period of 12 months consistent with the rating period selected by the Department. “Model Waiver Program” means the Home Care for Disabled Children under a Model Waiver as established in COMAR 10.09.27. “National Diabetes Prevention Program” means an evidence-based diabetes prevention program established by the Centers for Disease Control and Prevention. “Net medical expenses” means an MCO's total medical expenses less reinsurance recoveries. “Net revenues” means an MCO's total revenues less reinsurance premiums. “Network” has the same meaning as “provider panel”, as specified in this regulation. “Network provider” means a provider that is a member of the MCOs provider panel. “No credibility” means a standard for which the experience of an MCO is determined to be insufficient for the calculation of an MLR. “Non-claims costs” means expenses for administrative services other than: Incurred claims; Expenditures on activities that improve health care quality; Licensing and regulatory fees; or Federal and State taxes. “Nursing facility” has the meaning stated in COMAR 10.09.10.01B. Nutritional Counseling. “Nutritional counseling” means, in the context of COMAR 10.09.69, the review of the patient's nutritional status and advice on its improvement when medically necessary. “Nutritional counseling” includes family education provided by either a licensed dietitian or licensed nutritionist. “Nutritional supplements” means, in the context of COMAR 10.09.69, enteral feeding which is either the sole source of nutrition or a supplement which enhances the physical well-being of the patient and is medically indicated. “Ombudsman or ombudsman program” has the meaning stated in Health-General Article, §15-101(g), Annotated Code of Maryland. “Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body. “Out-of-plan provider” means a provider that is neither the employee nor the subcontractor of the enrollee's assigned MCO. “Outreach services” means efforts to contact enrollees and bring them into care, as described in COMAR 10.67.05.03. “Overpayment” means: Any payment made by the Program to a provider in excess of the correct Program payment amount for a service; or Any payment for services under COMAR 10.67.06 made by the Program or an MCO which at the time of payment, or at a subsequent date, is determined to be inappropriate, inaccurate or in excess of the correct amount of the procedural code billed, for reasons including but not limited to: Improper claiming; Lack of medical necessity; Unacceptable practices; Fraud, waste, or abuse; or Provider mistake. “Partial credibility” means a standard for which the experience of an MCO is determined to be sufficient for the calculation of an MLR but with a non-negligible chance that the difference between the actual and target medical loss ratios is statistically significant. “Peer review organization” means an organization qualified by the Centers for Medicare and Medicaid Services in accordance with 42 CFR 462 that reviews health care practitioners, and the health care services they order or furnish, utilizing other practitioners from the same field of practice. “Personal care” has the meaning stated in COMAR 10.09.20.01B. “Plan of care” means, in the context of COMAR 10.09.69, the document which governs a participant's care management, and which: Includes the: Case management assessment report; Interdisciplinary plan of care; and Case management plan; Is composed of the participant's health status and needs for medical, health-related, housing, and social services including, but not limited to: All pertinent diagnoses; Functional status; Type, frequency, and duration of services; Treatment goals for each type of service; Medication; Social support structure; Current service providers; Assigned level of care; Diet; Current living arrangement; and Emergency plan, if appropriate; and Is established in consultation with the interdisciplinary team. “Postpartum” means within 2 months after delivery of a child. “Poststabilization care services” means covered services, related to an emergency medical condition, that are provided after an enrollee is stabilized in order to maintain the stabilized condition, or under the circumstances described in 42 CFR §438.114(e), as amended, to improve or resolve the enrollee's condition. “Potential enrollee” means a Medicaid recipient who is determined eligible for the HealthChoice program but is not yet an enrollee of a specific MCO. “Practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or a state contiguous to Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program. “Preauthorization”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53. “Pregnant” means the period beginning with conception and ending at delivery. “Presumptive drug tests” means drug screening tests that include: Any number of drug classes; Any number of devices; Sample validation; and The use of: Direct optical observation; Instrument assisted direct optical observation; or Instrumented chemistry analyzers. “Primary care” means medical care that addresses a patient's general health needs, including the coordination of the patient's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the enrollee's health records, and referral for medically necessary specialty care. “Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the enrollee, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.67.06. “Primary care residency slots” means, in the context of COMAR 10.67.11, positions in a teaching hospital's residency program occupied after completion of a medical degree program by physicians who have trained in family medicine, internal medicine, pediatrics, or obstetrics and gynecology. “Primary mental health services” means the clinical evaluation and assessment of mental health services needed by an individual and the provision of services or referral for additional services as deemed medically necessary by a primary care provider. “Private duty nursing” means, in the context of COMAR 10.09.69, skilled nursing services for recipients who require more individual and continuous care than is available under the Medicaid State Plan, and which are provided by a registered nurse or a licensed practical nurse, in a recipient's own home or another setting when normal life activities take the recipient outside his or her home. “Program”, unless the context indicates otherwise, has the meaning stated in COMAR 10.09.36.01B. “Progress note” means, in the context of COMAR 10.09.69, a signed and dated written notation by the home care nurse, home health aide, or certified nursing assistant which: Summarizes facts about the care given and the participant's response during a given period of time; Specifically addresses the established goals of treatment; Is consistent with the participant's case management plan; and Is written during the course of care. “Prosthetic device” means an artificial device to replace, in whole or in part, a leg, an arm, an eye, or breast, including surgical brassiere. “Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland. “Provider panel” means that group of providers employed by the MCO or with which the MCO contracts to provide services to the MCO's enrollees under the MCO's health benefit plan, which is at least equivalent to the benefits specified in COMAR 10.67.06. “Public institution” has the meaning stated in COMAR 10.09.24.02. “Quality assurance plan (QAP)” means a document or series of documents that set forth an MCO's strategy for systematically monitoring, evaluating, and improving all facets of MCO operations, including, but not limited to, clinical health care delivery, enrollee assistance and outreach services, and administrative services. “Rare and expensive case management” means the method of health care delivery provided to individuals with rare and expensive conditions. “Rare and expensive condition” means a medical diagnosis or condition identified in COMAR 10.09.69. “Rate adjustment period” has the meaning stated in COMAR 10.67.02.19-4A. “Rate year” has the meaning stated in COMAR 10.67.04.19-4A. “Readily accessible” means electronic information and services which comply with modern accessibility standards such as: Section 508 guidelines; Section 504 of the Rehabilitation Act; or W3C's Web Content Accessibility Guidelines (WCAG) 2.0 AA and successor versions. “Reasonable allowable costs” means costs that are related to the provision of covered Medicaid services and are determined to be allowable in accordance with Medicare principles of reasonable cost reimbursement in 42 CFR 413, subject to the limitations specified in COMAR 10.09.08.05C. “Recipient” or “Program recipient” means an individual who is certified as eligible to receive Medical Assistance benefits, as provided in COMAR 10.09.24. “REM optional services” means, in the context of COMAR 10.09.69, the services which meet the general requirements under Regulation .08 and are listed in Regulations .10 and .11 of that chapter. “School-based health center (SBHC)” means a provider located on school grounds that meets the requirements set forth in COMAR 10.09.76. “Secretary” means the Secretary of Health. “Self-referral services” are the health care services listed in COMAR 10.67.06.28 for which, under specified circumstances, the MCO is required to pay, without any requirement of referral by the PCP or MCO, when the enrollee accesses the service through a provider other than the enrollee's PCP. “Separate CHIP Program” means the program for targeted low-income children established under Title XXI of the Social Security Act. “Service area” means a geographical area, comprised of one or more of Maryland's counties, with each selected county included in its entirety. “Service year” in the context of COMAR 10.67.04.19-4, means the calendar year in which an MCO incurs the expenses reported pursuant to COMAR 10.67.04.15E(5)(c). “Somatic care” means medical care that addresses an individual's physical health care needs. “Special needs population” means a group of recipients who share a special health care need as specified in COMAR 10.67.04.04. “Special rehabilitation hospital” has the meaning stated in Health-General Article, §19-307(a)(iii), Annotated Code of Maryland. “Specialty behavioral health services” means any behavioral health services other than primary behavioral health services. “Specialty care” means health care services that are either outside the PCP's scope of practice or, in the judgment of the PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in. “Specialty care residency slots” means, in the context of COMAR 10.67.11, positions in a teaching hospital's residency program occupied after completion of a medical degree program by physicians who have trained in specialties other than family medicine, internal medicine, pediatrics, or obstetrics and gynecology. “Spend down” means a procedure by which an individual applying for Medical Assistance who is otherwise ineligible due to excess income becomes eligible by deducting incurred medical expenses from excess income. “State fair hearing” means a hearing, conducted by the Office of Administrative Hearings, for the purpose of ensuring the right of recipients to be treated in a fair and unbiased manner in their efforts to resolve disputes with the Department or an MCO. “Subcontract” means a written agreement between an MCO and a third party, under which the third party performs any one or more of the MCO's obligations required by the Department. “Subcontractor” means an individual or entity that has a contract with an MCO that relates directly or indirectly to the performance of the MCOs obligations under its contract with the Department; provided, however, that a contract does not by itself cause an MCOs network provider to be a subcontractor. “Substantial minority” means an ethnic or linguistic group that comprises 5 percent or more of the Medicaid population in the county to be served. “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. “Systems performance review (SPR)” means an assessment, as a component of the quality assurance (QA) audit, of quality assurance operations taking place in the MCO. “Teaching hospital” means a hospital that: Had HSCRC-approved rates for FY 1995 that included an allowance for GME costs; and During the contract year, operates a graduate medical education program that is accredited by the Accreditation Council for Graduate Medical Education. “Temporary Cash Assistance (TCA)” means a form of cash assistance provided, pursuant to Article 88A, §44A et seq., Annotated Code of Maryland, to assistance units which are technically and financially eligible. “Tertiary care” means health care services provided by highly specialized health care providers which are usually diagnostic or therapeutic in nature and often require highly sophisticated technological and support facilities. “Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition. “Waiver-eligible” means an individual who qualifies for enrollment in the Maryland Medicaid Managed Care Program. “Whistleblower” means an individual who exposes any kind of information or activity that alleges any violation of regulation, statute, contract, policy, or unethical behavior that may be indicative of an individual or entity committing fraud, waste, or abuse against the Medicaid program. “Witness”, in the context of COMAR 10.09.69, has the meaning stated in COMAR 10.09.53. Health-General Article, §§15-101 and 15-103(b), Annotated Code of Maryland Effective date: Regulation .01 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulation .01 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .01 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .01 amended as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); amended permanently effective June 29, 1998 (25:13 Md. R. 993) Regulation .01 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000 Regulation .01 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838) Regulation .01 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 2, 2004 (31:2 Md. R. 82) Regulation .01B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .01B amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .01B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .01B amended effective December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180) Regulation .01B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .01B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1612); October 14, 2013 (40:20 Md. R. 1652); October 28, 2013 (40:21 Md. R. 1775); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); March 14, 2016 (43:5 Md. R. 385); August 29, 2016 (43:17 Md. R. 955); April 10, 2017 (44:7 Md. R. 355); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244); August 26, 2019 (46:17 Md. R. 726) Chapter transferred from COMAR 10.09.62 effective November 1, 2019 (46:22 Md. R. 977) Regulation .01B amended effective June 13, 2022 (49:12 Md. R. 641); November 13, 2023 (50:22 Md. R. 974); August 5, 2024 (51:15 Md. R. 707); June 9, 2025 (52:11 Md. R 532) Criteria. Except as provided in §B of this regulation, a Program participant shall be enrolled in the Maryland Medicaid Managed Care Program, described in this chapter, if the participant is eligible for receipt of Medical Assistance benefits by qualifying: As categorically needy or medically needy under COMAR 10.09.24, unless the participant is: 65 years old or older; Newly eligible and 64 1/2 years old or older; Eligible to receive Medicare benefits; Determined medically needy under a spend down; or Otherwise certified for a period of less than 9 months; For the Pregnant Women and Children's Program on or after January 1, 1997; or For the Maryland Children’s Health Program on or after July 1, 1998; or For the Separate CHIP Program and CHIP Health Services Initiative on or after July 1, 2023. A participant is not eligible for the Maryland Medicaid Managed Care Program if the participant: Has been, or is expected to be, continuously institutionalized for more than: 90 successive days in a long-term care facility; or 30 successive days in an institution for mental disease (IMD); Is institutionalized in an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); Is enrolled in: Home Care for Disabled Children under a Model Waiver, pursuant to COMAR 10.09.27; The Family Planning Waiver Program pursuant to COMAR 10.09.58; or The Employed Individuals with Disabilities Program pursuant to COMAR 10.09.41; Is a child receiving adoption subsidy who is covered under the parent's private insurance; Is a child under State supervision receiving adoption subsidy who lives outside of the State; Is a child in an out-of-State placement; or Is an inmate as defined in COMAR 10.67.01.01. The Department shall make available through its website and upon request provide a paper copy of the following: Materials regarding each MCO providing services in the eligible individual’s county of residence including, but not limited to: Information about how to access the provider directory and drug formulary, with instructions for how to request paper copies if needed; A schedule of the benefits offered, including any benefits offered beyond the basic required package described in COMAR 10.67.06; Which, if any, benefits are provided directly by the Department; If applicable, a list of services that the MCO does not provide, reimburse for, or provide coverage of, because of moral or religious objections, and information about where and how to obtain these services; The requirements for each MCO to provide adequate access to covered services, including the network adequacy standards established in COMAR 10.67.05; and Quality and performance indicators for each MCO, including enrollee satisfaction; and Materials about the managed care program, including: The MCO enrollment and disenrollment process; and The basic features of managed care. Any forms necessary to select an MCO; and The toll-free telephone number of the enrollment unit. Only the Department, or its designee, is authorized to enroll individuals into MCOs. A participant found eligible for Maryland Medicaid under 42 U.S.C §1902(a)(10)A(i) shall be assigned to: The MCO the participant chooses at the time of application; or If the participant does not choose, an MCO with available capacity that is accepting new participants in the participant’s service area. Except for a participant found eligible as described in §C of this regulation, a participant, including a child in foster care or kinship care, shall: Have 28 days from the day the Department mails its eligibility notification in which to select an MCO; or Be assigned to an MCO with available capacity that is accepting new participants in the participant’s service area. All Managed Care Program eligible family members who live in the same household shall be assigned to the same MCO. Newborns. A newborn shall be automatically enrolled from birth in its biological mother’s MCO. The MCO is responsible for the newborn’s health care from birth until the newborn enrolls into another MCO. A newborn, automatically assigned to its biological mother’s MCO, is not eligible to change MCOs for family unity as described in COMAR 10.67.02.06A(1)(b) and (c) during the first 90 days of enrollment. Effective Date of Enrollment. Enrollment in an MCO shall be effective at 12:01 a.m. on the 10th calendar day beginning with the day on which the Department notifies the MCO of the enrollment. Upon the approval of the Department and the MCO, a participant may select an MCO that does not serve the participant’s service area. The Department or its designee shall submit the enrollee's choice of PCP to the enrollee's selected MCO at the time of enrollment. The Department, MCO, or agents of the Department or MCO shall attempt to complete the health service needs information at the time of enrollment. The Department shall transmit any information obtained from health service needs information to the enrollee’s MCO within 5 business days. Upon its receipt and review of the health service needs information, an MCO shall take appropriate action to ensure that a new enrollee, who needs special or immediate health care services, as identified by the health service needs information, receives them in a timely manner. If the Department does not transmit health services needs information for an enrollee to the MCO within 10 days of enrollment, the MCO shall make at least two attempts to conduct an initial screening of the enrollee’s needs, within 90 days of the effective date of enrollment. At least one of these attempts shall be during non-working hours. The Department shall inform an enrollee identified in connection with the health service needs information as having a behavioral health problem that the individual may self-refer to the behavioral health ASO for services as described in COMAR 10.09.59 and 10.09.80. Within 10 days of the notification of enrollment of a new enrollee or within 10 days of any event that requires a change in an existing enrollee's PCP, an MCO shall notify the enrollee of the enrollee's PCP assignment. A Program recipient with no previous affiliation with any of the providers on the MCO's primary care provider panel who: Indicates a preference for a participating PCP during the enrollment process shall be assigned to that PCP unless the MCO documents in writing, for good cause, its inability to assign the enrollee to that PCP; or Fails to make known any preference for a PCP shall be assigned to a PCP whose location satisfies the access standards specified in COMAR 10.67.05.06E. Before changing an enrollee’s PCP, the MCO shall obtain the Department’s approval at least 60 days before the reassignment is effective unless: The PCP has decided to stop practicing; The PCP has terminated the relationship with an enrollee due to the enrollee’s behavior; The change is requested by the enrollee; or The age limits of the PCP's practice no longer meet the needs of the enrollee. Once every 12 months, a Program recipient may elect to: Maintain enrollment with the recipient's current MCO; Enroll in another MCO in the recipient's local access area; or Enroll in an MCO outside the recipient’s local access area, upon the approval of the Department and the MCO. The Department shall notify the enrollee no less than 60 days before the start of each new enrollment period. The Department shall reassign into the same MCO from which the recipient was last enrolled any recipient disenrolled from an MCO who, within 120 days of disenrollment, regains: Eligibility for Medicaid; or Maryland Medicaid Managed Care Program eligibility lost for any of the reasons listed in Regulation .06B of this chapter. The MCO shall assign the recipient to the primary care provider of record at the time of the recipient's disenrollment. A Program participant who has been disenrolled from an MCO because the Department terminated the MCO's contract shall be assigned to another MCO subject to Regulation .02D of this chapter. Enrollee-Initiated Disenrollment for Cause. An enrollee may disenroll from an MCO and enroll into another MCO if: The enrollee moves to a county that is not served by the enrollee's present MCO; The family members are enrolled in different MCOs and the adult enrollee requests that other family members be enrolled in one of the MCOs in which another family member is currently enrolled; The enrollee requests enrollment into the MCO that contracts with the PCP of any other family member who is not a HealthChoice enrollee; The enrollee moves or becomes homeless, creating a transportation hardship that may be resolved by enrollment into another MCO serving the enrollee's new local access areas; The enrollee requests a change of MCO within 90 days after the termination of the enrollee's primary care provider's (PCP's) contract if the PCP's contract with the enrollee's MCO, MCO's medical management group, or its subcontractors is terminating for the following reasons: By the MCO for reasons other than the quality of care or the PCP's failure to comply with contractual requirements related to quality assurance activities; or The MCO's reduction of PCP's reimbursement to the extent that the reduction in rate is greater than the actual change in capitation paid to the MCO by the Department, and the MCO and PCP's inability to negotiate a mutually acceptable rate; The enrollee is automatically assigned to an MCO or it is the enrollee's initial enrollment in an MCO as follows: Only one request during the first 90 days of automatic assignment or initial enrollment into an MCO; and The enrollee is not hospitalized at the time of the request; The MCO terminates its contract with the Department in which case: The MCO shall provide written notice to the recipient at least 60 days before the date on which the MCO will exit the HealthChoice Program; The MCO shall include in the notice the name and provider number of the PCP assigned to the recipient and the telephone number of the enrollment broker; The Department shall send a notice to every enrollee of the MCO regarding the MCO's termination of its contract with the Department, at least 30 days before the effective date of the termination of the contract; An enrollee shall have at least 30 days before the effective date of the MCO's contract termination with the Department to choose another MCO, or will be assigned to another MCO; and An enrollee may choose another MCO one additional time within at least 90 days after reenrollment into the new MCO; The MCO is acquired by another entity in which case: The MCO shall provide written notice to the recipient at least 60 days before the date on which the MCO will exit the HealthChoice Program; The MCO shall include in the notice the name and provider number of the PCP assigned to the recipient and the telephone number of the enrollment broker; The Department shall send a notice to every enrollee of the MCO regarding the change in ownership, 30 days before the effective date of the change of ownership; An enrollee shall have 30 days before the change of ownership to disenroll from the MCO into another participating MCO; If an enrollee does not choose to disenroll in accordance with §A(1)(f)(ii) of this regulation, the enrollee will be reenrolled in the newly purchased MCO; and An enrollee may choose another MCO one additional time within at least 90 days after reenrollment in the newly purchased MCO; The MCO does not, because of moral or religious objections, cover the service the enrollee seeks; All of the following apply: The enrollee needs related services to be performed at the same time; Not all related services are available within the network; and The enrollee's PCP or other provider determines that receiving the services separately would subject the enrollee to unnecessary risk; or The Department imposes the intermediate sanction specified in 42 CFR §438.702(a) and (b), as amended. The Department shall provide timely notification to the affected MCO of an enrollee's intention to disenroll under §A of this regulation. The Department shall allow disenrollments, subject to the Department's approval, for other reasons, including but not limited to: Poor quality of care; Lack of access to services covered under the contract; or Access to providers experienced in dealing with the enrollee's health care needs. Enrollees shall make an oral or written request to the Department's enrollment agent for disenrollment. Department-Initiated Disenrollment. The Department shall disenroll from an MCO an enrollee: Subject to the MCO or long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary, who has been continuously institutionalized for a period of more than 90 successive days in a long-term care facility; Upon admission to an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); Determined eligible for rare and expensive case management pursuant to COMAR 10.09.69; Who loses Medicaid eligibility or who changes to an assistance category not eligible for MCO enrollment, subject, however, to Regulation .01 of this chapter; Upon the termination of the contract between the enrollee's MCO and the Department; Who has died; Who has not been validly enrolled in the MCO; Who is 65 years old or older; Who is an inmate of a public institution, including a State operated institution or facility; or Who is eligible to receive Medicare benefits. The Department may disenroll individuals from an MCO which the Maryland Insurance Administration has put into rehabilitation or liquidation pursuant to Health-General Article, §15-102.2, Annotated Code of Maryland. MCO Initiated Disenrollment. An MCO may request disenrollment of an enrollee who has: Moved outside of the MCO's service area; or Become ineligible for continued enrollment for one of the reasons specified in §B of this regulation. An MCO may not request disenrollment as specified in 42 CFR §438.56(b)(2), as amended. Effective Date of Disenrollment. Except as specified in §E(2)—(6) of this regulation, an enrollee's disenrollment is effective on the 10th calendar day after the enrollee selects a new MCO. An enrollee's disenrollment shall take effect: Immediately when the enrollee dies; From the first day of the month following the month that the enrollee lost Medicaid eligibility; On the first day of the month following the month in which the Department receives the required notification, when the enrollee permanently relocates outside of the State; or From the first day of the month following the month in which the Department verifies an enrollee is an inmate. When an enrollee becomes eligible for Medicare, the enrollee’s disenrollment from the MCO is effective on the: First day of the month following the month in which the Program receives notice of Medicare eligibility; or Last day of the month before the month in which the enrollee turns 65 years old. Termination of enrollment resulting from termination of the contract between the Department and an MCO shall be effective on the date the Department terminates the contract. Termination of enrollment resulting from the MCO being placed into rehabilitation or liquidation by the Maryland Insurance Administration shall be effective on the date the Department notifies the MCO of the disenrollment. In the case of an enrollee's death, the Department has the right to recover any capitation payments made on behalf of an enrollee for the period beginning on the date of death. An MCO shall: Make a good faith effort to give written notice to the Department when enrollees have the right to change MCOs under §A(1)(e) of this regulation 90 days before the effective date of the termination; Provide the Department with a list of the affected enrollees in a format specified by the Department; and If applicable, provide the termination survey required under COMAR 10.67.04.17B(4). The Department shall notify enrollees who may change MCOs under §A(1)(e) of this regulation. At the Department’s discretion, an MCO may be required to reimburse the Department for the costs associated with the mailing of the notifications in §G of this regulation. Health-General Article, Annotated Code of Maryland Effective date: Regulations .01—.06 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730);adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01A amended effective April 19, 2010 (37:8 Md. R. 615); March 14, 2016 (43:5 Md. R. 385); August 29, 2016 (43:17 Md. R. 955) Regulation .01B amended effective February 18, 2002 (29:3 Md. R. 220); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1612); October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); May 22, 2017 (44:1 Md. R. 472) Regulation .01C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .01C repealed effective December 20, 2004 (31:25 Md. R. 1790) Regulation.02 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .02 amended effective February 18, 2002 (29:3 Md. R. 220); October 22, 2018 (45:21 Md. R. 973) Regulation .02A amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .02A amended effective June 30, 2008 (35:13 Md. R. 1180); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .02D, E amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .02F amended effective April 28, 2014 (41:8 Md. R. 471) Regulations .02H and .06F amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .02H amended effective February 9, 1998 (25:3 Md. R. 144); February 2, 2004 (31:2 Md. R. 82) Regulation .02I amended effective December 24, 2012 (39:25 Md. R. 1612) Regulation .02L adopted effective June 25, 2001 (28:12 Md. R. 1109) Regulation .03 amended effective October 28, 2013 (40:21 Md. R. 1775); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation.04 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation.04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .04 amended effective December 24, 2012 (39:25 Md. R. 1612) Regulation .04C amended effective October 28, 2013 (40:21 Md. R. 1775) Regulations .05 amended effective February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316) Regulation.05B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05E amended effective October 22, 2018 (45:21 Md. R. 973) Regulation.05F, G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .05G, H adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .05G, H repealed effective April 28, 2014 (41:8 Md. R. 471) Regulation .06 amended effective June 25, 2001 (28:12 Md. R. 1109); February 18, 2002 (29:3 Md. R. 220); December 31, 2018 (45:26 Md. R. 1244) Regulation.06A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .06A, B amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .06A, D amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .06B amended effective February 6, 2012 (39:2 Md. R. 141); October 14, 2013 (40:20 Md. R. 1652); February 26, 2018 (45:4 Md. R. 205) Regulation .06B, F amended as an emergency provision effective January 1, 2001 (28:4 Md. R. 414) Regulation .06B, F amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .06F amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .06F amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .06F amended effective April 9, 2007 (34:7 Md. R. 698); February 16, 2015 (42:3 Md. R. 316) Regulation .06G adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .06G amended effective April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434) Regulation .06H adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .06I adopted effective February 1, 2016 (42:23 Md. R. 1434) Chapter transferred from COMAR 10.09.63 effective November 1, 2019 (46:22 Md. R. 977) Regulation .01 amended effective November 13, 2023 (50:22 Md. R. 974) Regulation .01A amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .06E amended effective November 18, 2019 (46:23 Md. R. 1065) When applying for participation in the Maryland Medicaid Managed Care Program as an MCO, an applicant shall submit an application to the Secretary in the form that the Secretary requires. An applicant may omit from its application any information or documents that it has previously submitted to the Department, if: The information or documents are up to date; and The applicant identifies in its application the information and documents that it has omitted. Except as provided in Regulation .02B of this chapter, an MCO applicant shall include the following information or descriptions in its application: An indication whether the applicant is an operating HMO with a certificate of authority from the Maryland Insurance Administration; A written legal history of the applicant, specific as to dates and parties involved, that includes, but is not limited to: Predecessor corporations; Mergers; Reorganizations; and Changes of ownership; A copy of the articles of incorporation of the applicant, and any amendments to it, certified by the Maryland Department of Assessments and Taxation; A copy of the applicant's current bylaws, certified by the appropriate corporate officer; A written description providing a reason if the applicant has ever defaulted on a contract or otherwise had a contract terminated; If the applicant is an HMO, the most recent annual loss ratio report provided to the Maryland Insurance Administration pursuant to Insurance Article, §5-605, Annotated Code of Maryland; A copy of the applicant's business plan provided to the Maryland Insurance Administration pursuant to Insurance Article, §5-605, Annotated Code of Maryland. Evidence of compliance with Maryland Workers' Compensation Law, as follows: Except as provided in §H(2) of this regulation, the applicant shall submit: The policy number of its Workers' Compensation insurance coverage; and The name of its Workers' Compensation insurance carrier; or If self-insured, the applicant shall submit a certificate of compliance evidencing employee coverage under Workers' Compensation Law, as provided in Labor and Employment Article, Title 9, Annotated Code of Maryland; The names, addresses, and official capacities of the managing employees or other individuals responsible for the conduct of the affairs of the applicant, including concise position descriptions and background, citing education, training, and experience, for, but not limited to, the applicant's: Chief Executive Officer; Chief Medical Officer; Chief Information Officer; Chief Financial Officer; Chief Quality Officer; Clinical Operations Manager; Chief Operating Officer; Marketing Director; Program Integrity Director; Health Equity Director; Chief Compliance Officer; Appeals and Grievances Manager; Provider Relations Manager; Special Needs Coordinator, as defined in COMAR 10.67.04.04; and Newborn Coordinator, as defined in COMAR 10.67.04.27; A full disclosure of the extent and nature of any contracts or arrangements, including any possible conflicts of interest between the applicant and any individual specified in §I of this regulation; The name and address of each person with a 5 percent or more ownership or controlling interest in the applicant or in any subcontractor or supplier in which the applicant has direct or indirect ownership of 5 percent or more, including identifying whether any person named is related to any other named person as either spouse, parent, child, or sibling; A list of any subcontractors or suppliers owned by the applicant, indicating the percent of financial interest held; A history of any subcontractors with whom the applicant has had business transactions totaling more than $25,000 during the 12-month period ending on the date of application; A description of the applicant's corporate and organizational structure, and an organizational chart, with detailed lines of authority indicating the relationships among the board of directors, the administrative component, and the medical and health service delivery component of the applicant including, but not limited to, staff positions responsible for the plan's key management functions enumerated in §I of this regulation; A description of all current contractual relationships between the applicant and subcontractors for administrative/management, health, and marketing services, including the subcontractors' names; A description of any contracts the applicant intends to enter into before beginning operation as an MCO; The name of any person or persons holding an ownership or controlling interest in excess of 5 percent in the applicant, or who is an agent or managing employee of the applicant, who has been subject to a conviction as defined at 42 U.S.C. §1320a-7(i), or a sanction for a Program-related offense; Copies of all standard subcontracts with service and administrative providers who are not salaried employees of the applicant, including identification of any provision in subcontracts which differ from the standard subcontract; A description of the method by which the applicant will accomplish cost avoidance or recovery in the case of third-party liability; and Copies of the applicant’s written Medicaid marketing plan including: A description of how the applicant plans to address the special access provisions in COMAR 10.67.05.01D; and Sample version of all material and communication the applicant would like to distribute to potential enrollees, including but not limited to: Brochures; Fact sheets; and Posters. An applicant that is not a Maryland certified HMO shall include in its application the following information or descriptions: A table labeled “Insurance Coverage”, specifying the applicant's coverage in insurance types including, but not limited to, reinsurance, risk of insolvency, medical malpractice, general liability, and fidelity bond, and detailing the: Carrier; Entity covered; Description of coverage including deductibles, coinsurance, and minimum and maximum benefits; Premium in effect; Any additional policies to cover new risks associated with anticipated MCO functions; and Any other pertinent arrangements; Evidence of the applicant's insurance for general liability and medical malpractice in the minimum amounts of $1,000,000 per loss and $3,000,000 in the aggregate; Evidence that the applicant has on hand sufficient liquid funds or a reasonably adequate cash flow to meet all organizational and administrative expenses incurred or expected to be incurred before commencing operations; An explanation detailing how the applicant would, if approved, protect itself from insolvency; A description of how the applicant would, if approved, limit its financial risk; Document that the applicant has deposited, in a trust account with the State treasury, $100,000 in cash or government securities of the type described in Insurance Article, §5-701(b), Annotated Code of Maryland; A financial statement audited by an independent certified public accountant of the financial condition of the applicant, including: Assets, liabilities, and minimum tangible net equity; A prospective budget and expected cash flow analysis of the applicant for the first 24 months of its anticipated operation demonstrating financial stability based on reasonable assumptions; and Any other financial information required by the Commissioner to adequately conduct financial examination of an applicant; and A power of attorney executed by the applicant appointing the Commissioner and the Commissioner's authorized deputies as the true and lawful attorney of the applicant in and for the State upon which may be served all lawful process in any action, proceeding, or cause of action arising in this State against the applicant regarding the solvency and financial condition of the applicant. An MCO applicant shall include in its application the following information or descriptions: A map or maps showing the county or counties in which the applicant proposes to provide health care services, and the service area boundaries. The name and address of each of the applicant's service delivery sites, and, if applicable, the type of facility licensure of each site, grouped by county; If the applicant is an HMO, the applicant's total prepaid enrollment or client population as of the date of application, with a breakdown by payment source, including Medicare, Medicaid, commercial group, commercial individual, and other enrollment; If the applicant is an HMO, the total of the applicant's current unduplicated fee-for-service patient count, with a breakdown by payment source, including Medicaid, Medicare, commercial group, commercial individual, and other patients (including self-pay); The name and address of each of the applicant's primary and specialty care providers, provided in a format specified by the Department, for distribution to recipients in enrollment packets; The following information, grouped by medical specialty and county, regarding each individual practitioner, including primary care providers and specialists, who will act as a health care provider for the applicant: Name, address, and practice location or locations, including a separate line for each location; State licensure number; Specialty, if applicable, indicating the type of services to be provided on behalf of the applicant; Whether the provider will be a primary care provider; A description of the practitioner's employment relationship to the applicant, including, but not limited to: A salaried employee; A subcontractor; An employee of a subcontractor; or Any other form of contractual or employment relationship; Any restrictions as to age of patients or numbers of enrollees the provider will serve; The procedures for assuring proper credentialing and recredentialing of providers; Documentation that the MCO applicant is able to meet the access standards set forth in COMAR 10.67.05 in each service area the MCO applicant plans to enter; Documentation of any reasons for which they are unable to meet the access requirements of COMAR 10.67.05 in any service area; For each primary care practice location, a specification of: The name, address, and hours of operation; and The staffing at each location, expressed in full-time equivalencies and grouped by medical specialty; and Written protocols detailing how the applicant will provide 24-hour per day, 7-day per week coverage for emergency medical situations, including compliance with MIEMSS protocols and the federal Emergency Medical Treatment and Active Labor Act. The service area in §A(1) of this regulation shall include at least two underserved counties as defined in §C of this regulation. An underserved county is a county in which less than three current MCOs are participating and accepting new enrollments. If there are no underserved counties, applications will not be accepted. An MCO applicant shall include in its application the following information or descriptions: Written evidence of the applicant's preparedness to provide benefits equivalent to the benefit level mandated by the Maryland Medical Assistance Program as described in COMAR 10.67.05; A description of any benefits the applicant proposes to provide in addition to those required by the Maryland Medicaid Managed Care Program, including: Whether there are any limitations on these services; and The name, medical specialty, location, and employment status as enumerated in Regulation .05F(5) of this chapter, of any providers rendering additional services; A copy of the written procedures specifying how an enrollee may select and change primary care providers; A written explanation of the applicant's plan to provide adequate case management and continuity of care, including its policies and procedures concerning: Case management; Making appointments; Appointment no-shows; Follow-up for appointment no-shows who are at-risk patients; and Referral claims and reimbursement for authorized noncontractual and out-of-plan provider services; Documentation of the applicant's preparedness to collaborate with providers of self-referral services, and reimburse at the Department's established fee-for-service rate, for permissible self-referred services as defined in COMAR 10.67.06.28; Documentation of the applicant's preparedness to provide the full range of EPSDT services; Documentation of the applicant’s preparedness to work with the Department’s behavioral health ASO for coordination of somatic care, behavioral health care, and all appropriate drug utilization review. A written explanation of the prospective MCO's plan for providing monthly updates to primary care providers of the enrollees assigned to them; Documentation of the applicant's plan to satisfy statutory requirements that enrollees be notified of due dates for obtaining immunizations, examinations, and other wellness services; Documentation of how the applicant will provide timely access to health care services, including but not limited to: Waiting time for telephone calls to be answered; Obtaining appointments; and Waiting times in practitioners' offices; Documentation of access provisions to address the needs of enrollees who: Do not speak English; Are deaf; or Have one or more physical, mental, or developmental disabilities; The applicant's proposed written utilization management program that specifies, at a minimum, policies and procedures for: Referral processes; Services requiring preauthorization, including mechanisms for ensuring consistent application and requesting provider consultation when appropriate; Criteria for determining medical necessity; Provider responsibilities for utilization management activities; Case management processes; Utilization tracking mechanisms and the determination of over-utilization and under-utilization of health care services; Integration of activities with quality improvement for provider profiling; and Appeals and grievance processes; The applicant's proposal to establish and utilize a consumer advisory board, including: The anticipated composition of the board; Identifying staff responsible for serving board needs; and Proposed mechanisms by which the board will furnish the MCO with regular enrollee input; A written description of the applicant's proposed member services unit, including a consumer services hotline, describing how the applicant will use this: As an information source for enrollees; To respond to enrollees' needs and requests in a timely manner; and To facilitate enrollees' access to needed health care services, including how the hotline will function as a point of entry for complaint resolution and internal grievance procedures; A written Enrollee Outreach Plan that: Describes how the MCO intends to comply with the outreach, quality assurance, and provision of health care services requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland; and To the extent that the materials are relevant to the requirements of §O(1) of this regulation, may incorporate by reference written materials provided by the applicant in response to other elements of its application; and Documentation of any service the MCO elects not to provide, reimburse for, or provide coverage of, because of a moral or religious objection, which shall: Be provided to the Department whenever an MCO adopts the policy during the term of the contract; Be consistent with the provisions of 42 CFR §438.10, as amended; and Be provided to enrollees within 90 days after adopting the policy with respect to any particular service. An MCO applicant shall include in its application the following information or descriptions: A description of the applicant's hiring and subcontracting policies, which shall correspond to the requirements of Insurance Article, §15-112, Annotated Code of Maryland; A blank copy of the provider application form; Documentary assurances that the applicant and its health care providers furnish access on a nondiscriminatory basis, in accordance with State and federal law, to all of their enrollees regardless of gender, race, age, religion, national origin, physical or mental disability, or type of illness or condition; If the applicant is an HMO that will require its panel providers to participate in the MCO, documentation of the mechanism the MCO will use to make an equitable distribution of enrollees among its panel providers so that no provider is assigned a disproportionate number of enrollees; Written evidence of the applicant's organizational capacity to provide special programs adequate to meet the individual needs of all enrollees, including: Outreach; Case management; Home visiting; Disease management; Prevention and wellness education; and All Medicaid-covered services required to comply with State statutes and regulations mandating health and behavioral health services for children in State-supervised care; A written explanation of the applicant's plan for ensuring that each primary and specialty care provider receives a copy of the MCO's Medicaid requirements manual, and any other information necessary to facilitate full compliance with all federal and State Medicaid requirements within 2 weeks after the provider has entered into a contract or has begun employment with the MCO, and updated as necessary thereafter; and A description of the applicant's plan to accommodate the cultural and ethnic diversity of the populations to be served. Effective July 1, 2012, an MCO applicant shall obtain NCQA health plan accreditation within 2 years of their effective date as an MCO. Effective January 1, 2025, an MCO shall obtain NCQA health equity accreditation within 2 years of their effective date as an MCO. An applicant shall include in its application the following information or descriptions: The applicant's proposed quality assurance plan, that contains, at a minimum, all elements specified by Health-General Article, §15-103(b)(9)(i), Annotated Code of Maryland; A description of any written procedures or protocols regarding physician and nursing care practice the applicant intends to use; A description of the applicant's peer review committee structure and process; A copy of the applicant's case management plan; A description of all mechanisms to be used to ensure the quality of any services, including administrative and clinical, that the applicant intends to delegate to subcontractors; The name and a description of the published standards or guidelines for maintenance of medical records the applicant will follow; A description of how providers will be apprised of medical records, utilization review, and case management requirements; A description of the applicant's system for ensuring inclusion in the medical record of reports of health care services or diagnostic testing performed in a referral setting; A written description of the applicant's internal review system for the handling, monitoring, and resolution of provider complaints, grievances, and appeals; Evidence of an adequate system for medical record retention and retrieval that meets, at minimum, all requirements of Health-General Article, §15-103(b)(9)(xiv), Annotated Code of Maryland; Documentary evidence that the applicant requires school-based clinics to provide information concerning health care services provided to their enrollees; A copy of the applicant's practice guidelines used to assist practitioners in approaching health care issues in a systematic, appropriate manner; A copy of the applicant's health education plan; A written description of the applicant's complaint resolution protocol, which shall, at minimum: Include an internal grievance procedure by which an enrollee who is dissatisfied with the applicant or its providers may seek recourse within the applicant; Specify what constitutes a grievance; Provide for prompt resolution of complaints; Require participation in the grievance process by individuals within the MCO who have the authority to require corrective action; Specify how the MCO will handle formal appeals by enrollees; Include a form that enrollees will use when filing a grievance, including foreign language versions for any substantial minorities in the applicant's proposed MCO service area; Identify the steps in the grievance process, and what personnel will be responsible for receiving, processing, monitoring, and responding to grievances; Specify how the enrollee will be informed that the enrollee's grievance is being investigated, and the protocols by which grievances will be resolved; Describe what methods will be used to inform enrollees about the operation of the grievance procedure; and Describe whether manual or automated processes will be used to track enrollees' complaints, determine any patterns of complaints, and report findings to the proposed MCO's quality assurance or quality improvement system; and A copy of the MCO's provider education plan. An MCO applicant shall include in its application the following information or descriptions: A narrative description of the clinical expertise and experience of the MCO's network for special needs populations in a format specified by the Department; Written evidence of the applicant's ability to comply with specific quality access, data, and performance measurements to satisfy the general requirements for all special needs populations specified in COMAR 10.67.04.04; Written evidence, including treatment protocols, of the applicant’s ability to provide the range of clinical and support services specified in COMAR 10.67.04.05—.10 and .13, to ensure appropriate and coordinated services to the following special populations: Children with special health care needs; Individuals with a physical disability; Individuals with a developmental disability; Pregnant and postpartum women; Individuals who are homeless; and Individuals with HIV/AIDS; and Referral protocols that demonstrate the conditions under which PCPs will make the arrangements for children with special health care needs to be referred to MCO specialty care networks and when appropriate the behavioral health ASO for services as described in COMAR 10.09.59 or 10.09.80. An MCO applicant shall include in its application the following information or descriptions: A description of the applicant's management information system, including, but not limited to: Capacities, including: The ability to generate and transmit electronic claims data consistent with the Medicaid Statistical Information System (MSIS) requirements or successor systems; The ability to collect and report data on enrollee and provider characteristics and on all services furnished to enrollees through an encounter data system; The ability to screen the data collected for completeness, logic, and consistency; and The ability to collect and report data from providers in standardized formats using secure information exchanges and technologies utilized for Medicaid quality improvement and care coordination efforts; Software; Characteristics; and Ability to interface with other systems; A description of the applicant's operational procedures for generating service-specific encounter data; Evidence of the applicant's ability to report, on a monthly basis, service-specific encounter data in UB04 or CMS1500 format; A description of the applicant's operational procedures for generating financial reports, including, but not limited to: Annual audits; Annual financial statements; and Quarterly unaudited financial statements; Evidence of the applicant’s ability to collect and report all data necessary to derive indicators for Healthcare Effectiveness Data and Information Set (HEDIS); and A description of the applicant’s procedures for verifying the accuracy and timeliness of reported data, including data from network providers the MCO was compensating on the basis of capitation payments or other payment arrangements that are not fee-for-service. Health-General Article §§15-102 and 15-103, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulations .01—.11 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 repealed effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02C repealed effective April 16, 2012 (39:7 Md. R. 492) Regulation .03F, G amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .03H amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .03T amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .04 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .04F amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .05 amended effective October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434) Regulation .05A amended effective December 27, 2010 (37:26 Md. R. 1787); December 31, 2018 (45:26 Md. R. 1244) Regulation .06 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .06 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .06E amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .06G amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .07A amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .07E amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .08 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .08 adopted effective December 24, 2012 (39:25 Md. R. 1612) Regulation .09 amended effective April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787) Regulation .09G amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .09K amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .10C, D amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .11 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .11C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Chapter transferred from COMAR 10.09.64 effective November 1, 2019 (46:22 Md. R. 977) Regulation .03I amended effective April 28, 2025 (52:8 Md. R. 359) An MCO shall have sufficient provider capacity to provide health care services to Program recipients residing in a geographic region no smaller in size than one county or the City of Baltimore. An MCO shall comply with COMAR 10.09.36. An MCO shall enter a memorandum of understanding with each local health department (LHD) in its service area addressing the method by which the MCO and the LHD will collaborate and communicate on matters of mutual interest and concern, including but not limited to the responsibility of the LHD for contact tracing for sexually transmitted diseases and directly observed therapy for tuberculosis. Assurance Against Insolvency. An MCO shall be actuarially sound. An applicant shall possess an initial surplus in the amount of $1,500,000 as specified in Health-General Article, §15-102.4(a)(2)(ii), Annotated Code of Maryland. If the Commissioner determines and reports to the Secretary that the applicant has an initial surplus that is at least $1,250,000 but less than $1,500,000, before approval the Department shall designate funds in trust sufficient to provide an initial surplus of $1,500,000. If the Commissioner determines and reports to the Secretary that the applicant's initial surplus is less than $1,250,000 before approval the Department may, at its discretion, designate funds in trust in an amount equal to: The sum of the amounts due to the owners of the applicant from the Department for Medicaid services provided on a fee-for-service basis, so long as the owners of the applicant have waived in writing their right to receive Medicaid payments until such time as the Department is permitted to remove its funds from the trust account pursuant to §D(6) of this regulation; or If a financial guarantor with sufficient net worth and an adequate history of generating net income agrees to pay claims against the MCO in the case of insolvency, the difference between $1,250,000 and the applicant's initial surplus. If, in accordance with §D(4) of this regulation, the Department designates funds sufficient to increase the applicants initial surplus to $1,250,000, the Department shall designate $250,000 in trust for the applicant. Funds designated by the Secretary pursuant to §D(3)(5) of this regulation shall remain in trust until such time as the Commissioner has determined that the MCO meets the minimum statutory surplus requirements based on the MCOs annual report submitted pursuant to Insurance Article, §5-605, Annotated Code of Maryland. Before approval of an applicant, the Secretary shall notify the Commissioner whether the Secretary has placed any money in trust under this section. In the event of insolvency, the MCO shall cover continuation of services to enrollees for the duration of the period for which capitation payment has been made. An MCO shall meet the solvency standards established by the State for private HMOs, or be licensed or certified by the State as a risk-bearing entity except if the MCO: Is a public entity; or Is, or is controlled by, one or more federally qualified health centers and meets the solvency standards established by the State for those centers; Has its solvency guaranteed by the State. Health Care Delivery. An MCO shall: Provide the services set forth in COMAR 10.67.06 promptly and continuously, consistent with good medical practice and community professional standards; Conform with and fulfill the requirements of 42 CFR §422.128, as amended, and provide adult enrollees with written information on advance directives which shall: Include a description of applicable State law; and Reflect a change in State law as soon as possible, but not later than 90 days after the effective date of the change. Provide each enrollee within 10 days of notification to the MCO of the enrollees enrollment with a distinctive, durable identification card, clearly indicating the bearer to be a member of the MCO and containing, at a minimum: The enrollee's Medicaid number; The MCO's consumer services hotline telephone number; The Department's enrollee hotline telephone number; and Enrollee's assigned primary care provider's name and telephone number; Provide enrollees, within 30 days before the intended effective date, written notice when there is a significant change in the nature or location of services provided; and Provide on the card required in §E(3) of this regulation, on a separate prescription benefit card, or other technology, prescription billing information that: Complies with the standards set forth in the National Council for Prescription Drug Programs pharmacy ID card prescription benefit card implementation guide at the time of issuance of the card or other technology; or Includes, at a minimum, the following data elements: The name or identifying trademark of the MCO; The name and identification number of the recipient; The telephone number that providers may call for pharmacy benefit assistance; and All electronic transaction routing information and other numbers required by the MCO or its benefit administrator to process a prescription claim electronically. An MCO: Shall comply with the standards in P.L. 101-336, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; May not discriminate against an enrollee on any basis, including, but not limited to, age, sex, race, creed, color, marital status, sexual orientation, gender identity, national origin, physical or mental handicap, health status, or need for health care services; Shall prepare and make available all publications in a manner consistent with COMAR 10.67.05.01A, including, but not limited to: Provider directories; Enrollee handbooks; Health education materials; and Informational brochures. An MCO shall maintain enrollee medical records in compliance with Health-General Article, §4-301 et seq., Annotated Code of Maryland, and the utilization control requirement of 42 CFR Part 456, as amended. An MCO shall permit the enrollment of a waiver-eligible Program recipient who is enrolled by the Department or who selects the MCO, unless the MCO's enrollment meets or exceeds any enrollment limits mutually agreed to by the Department and the MCO. MCO Local Access Area Participation. Effective January 1, 2014, an MCO shall open in all local access areas located within the same county in which the MCO chooses to participate. The MCO shall provide written notification to the Department of the MCO's intent to participate and accept new enrollees in each of the counties by September 15 for the next calendar year. The MCO's decision to accept new enrollees is in effect from January 1 to December 31 unless the Department decides there is adequate justification to waive this requirement, which includes, but is not limited to, a rate cut or an MCO exit from the market. Unless the Department approves a shorter time frame, an MCO that exits the Program during the calendar year shall submit their exit transition plan to the Department 120 days prior to the effective date of the exit. If the MCO has not participated in a county for a period of 12 or more consecutive months, the MCO may participate and accept new enrollees in that county by notifying the Department at least 30 days before accepting new enrollees. An MCO that voluntarily freezes for new enrollments in a county shall remain frozen in that county for the remainder of the calendar year and the following calendar year. If system modifications require longer than 30 days to implement, the effective date may be extended. The MCO shall follow the access standards specified in COMAR 10.67.05.06 and .05-1. In counties where the MCO decides to stop accepting new enrollees, the MCO shall: Continue to accept enrollees who regain eligibility within 120 days of becoming ineligible for the Program; Accept newborns if the mother is an MCO member at the time of birth; and Accept the family members of enrollees enrolled with the MCO before the effective date that the MCO stopped accepting new enrollees. An HMO that is approved as an MCO and that requires its panel providers to participate in an MCO shall submit for review by the Secretary its plan to assure the equitable distribution of enrollees and to ensure that a provider is not assigned a disproportionate number of enrollees, as required by Health-General Article, §15-102.5, Annotated Code of Maryland. An MCO shall comply with the provisions of Insurance Article, §15-112, Annotated Code of Maryland when credentialing providers, and during the credentialing process the MCO: May not discriminate against particular providers that serve high-risk populations or specialize in conditions that require costly treatment; May not employ or contract with providers excluded from participation in federal health care programs under either §1128 or 1128A of the Social Security Act; and Shall give the affected providers written notice of the reason for its decision if the MCO declines to include the providers in its network. The requirements of Regulation .17A(2) of this chapter, or §L(1) of this regulation, may not be construed to: Require an MCO to contract with providers beyond the number necessary to meet the needs of its enrollees; Preclude an MCO from using different reimbursement amounts: For different specialties; or For different practitioners in the same specialty; or Preclude an MCO from establishing measures that are designed to maintain quality of services and control costs, consistent with its responsibilities to enrollees. Disclosure of Provider Incentive Plans. An MCO shall disclose to the Department the information on its provider incentive plans listed in 42 CFR §417.479(h)(1): Prior to approval of its contract or agreement; and Upon the contract's or agreement's anniversary or renewal effective date. An MCO shall include in the disclosures required by §N(1) of this regulation information sufficient for the Department to determine whether the incentive plans meet the requirements of 42 CFR §417.479(d)(g) and, as applicable (i), when there exist compensation arrangements under which payment for designated health services furnished to an individual on the basis of a physician referral would otherwise be denied under §1903(a) of the Social Security Act. When making a referral, an MCO shall use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06. An MCO shall meet all other requirements of applicable State and federal law including but not limited to: Title VI of the Civil Rights Act of 1964; Title IX of the Education Amendments of 1972 regarding education programs and activities; The Age Discrimination Act of 1975; The Rehabilitation Act of 1973; Any laws regarding privacy and confidentiality; Any laws that pertain to enrollee rights; 45 CFR Part 74, as amended, including particular attention to requirements at 45 CFR §§74.42, 74.43, 74.44, 74.48, and 74. 53(a) and (b), and Appendix A; and Section 1557 of the Affordable Care Act. An MCO shall meet all program integrity requirements as set forth in COMAR 10.67.07. The following applies to the Department's Health Home Program as described in COMAR 10.09.33: The MCO may not provide services that duplicate the CMS reimbursed health home services for members participating in the State's Health Home Program; The State shall inform the MCO of members assigned to the State's Health Home Program so that the MCO can prepare to coordinate care with the health homes; The MCO shall provide a point of contact for the health homes to the State who shall share with all the enrolled health homes; The MCO shall make referrals to the health homes of members who meet the criteria for enrollment in the program; To facilitate this process, the State shall provide information to the MCO on all the enrolled health homes in the MCO's service areas; and The MCO shall assist the health homes as necessary in accessing somatic care services for health home recipients. An MCO shall have a continuous, systematic program designed to monitor, measure, evaluate, and improve the quality of health care services delivered to enrollees including individuals with special health care needs. At a minimum, the MCO shall: Comply with all applicable federal and State laws and regulations; Comply with all access and quality standards and levels of performance established by the Department including all standards for individuals with special health care needs in Regulations.04—.10 of this chapter; and Be able to provide the Department with timely accurate information in areas including but not limited to: Provider networks; Utilization of services; and Identification and management of individuals with special health care needs, including but not limited to: Enrollees with HIV; Pregnant women; Enrollees with disabilities; Adult enrollees with diabetes; Pediatric enrollees with asthma; and Children with special health care needs. An MCO shall participate in all quality assessment activities required by the Department to determine if the MCO is providing medically necessary enrollee health care. These activities include, but are not limited to: A Systems Performance Review (SPR) performed by an external quality review organization hired by the Department to assess an MCO’s structure and operations in order to determine its ability to provide health care to its enrollees as follows: The SPR shall include, but not be limited to: MCO's Quality Assessment and Improvement program; Enrollee rights; Access and availability of services; Care management; Enrollee outreach; Utilization management and review; and MCO organization, operations, and financial management; The results of the SPR shall be reported in draft to the MCOs for comment; MCO shall submit all comments and any required corrective action within 45 days of receipt of draft report; and The Department shall issue a final report of the SPR results; The annual collection, validation, and evaluation of the latest approved version of the Healthcare Effectiveness Data and Information Set (HEDIS) in order to assess the access to and quality of services provided, in addition to any additional performance measures specified by the Department or CMS; The annual collection and evaluation of a set of performance measures with targets as determined by the Department as follows: The composition of the core performance measures is listed in §B(3)(d)—(f) of this regulation; Each year before the audit period begins, the Department shall identify and obtain public input on all measures to be collected as well as the target for each; In accordance with COMAR 10.67.10, MCOs may receive financial or other types of incentives or disincentives based on performance measure results; Effective January 1, 2017, the core performance measures are: Adolescent well care visits; Adult Body Mass Index (BMI) assessment; Ambulatory care for Supplemental Security Income (SSI) adults; Ambulatory care for Supplemental Security Income (SSI) children; Breast cancer screening; Childhood immunizations — Combo 3; Comprehensive diabetes care — HbA1c testing; Controlling high blood pressure; Immunization for adolescents; Lead screening for children 12—23 months old; Asthma medication ratio; Postpartum care; and Well child visits, 3—6 years old; Effective January 1, 2019, the core performance measures are: Adolescent well care visits; Ambulatory care for SSI adults; Ambulatory care for SSI children; Asthma medication ratio; Breast cancer screening; Comprehensive diabetes care — HbA1c control (<8.0%); Controlling high blood pressure; Lead screening for children 12 through 23 months old; and Well child visits in the first 15 months of life; Effective January 1, 2021, the core performance measures are: Adolescent well care visits; Ambulatory care for SSI adults; Ambulatory care for SSI children; Asthma medication ratio; Breast cancer screening; Comprehensive diabetes care — HbA1c control (<8.0%); Controlling high blood pressure; Lead screening for children 12 through 23 months old; Postpartum care; and Well child visits in the first 15 months of life; Starting with the 2019 performance measures, the Department shall implement the following methodology for imposing penalties and incentives: There shall be three levels of performance; Performance shall be evaluated separately for each measure, and each measure shall have equal weight; On any of the measures in §B(3)(f)(i)—(ix) of this regulation for which the MCO does not meet the minimum target, as determined by the Department, a penalty of 1/9 of 1 percent of the total capitation amount paid to the MCO during the measurement year shall be collected; The total amount of the penalties as described in §B(3)(h)(iii) of this regulation may not exceed 1 percent of the total capitation amount paid to the MCO during the same measurement year; On any of the measures in §B(3)(f) of this regulation for which the MCO meets or exceeds the incentive target, as determined by the Department, the MCO shall be paid an incentive payment of up to 1/9 of 1 percent of the total capitation paid to the MCO during that measurement year; The total amount of the incentive payments as described in §B(3)(h)(v) of this regulation paid to the MCOs each year may not exceed the total amount of the penalties as described in §B(3)(g)(iii) of this regulation collected from the MCOs in that same year, plus any additional funds allocated to the Department for a quality initiative; and Any funds remaining after the payment of the incentives due under §B(3)(h)(v) of this regulation shall be distributed to the MCOs receiving the four highest normalized scores for Value Based Purchasing for all ten performance measures at a rate calculated by multiplying each MCO’s adjusted enrollment as of December 31 of the measurement year by a per enrollee amount; Starting with the 2021 performance measures, the Department shall implement the following methodology for imposing penalties and incentives: There shall be three levels of performance; Performance shall be evaluated separately for each measure, and each measure shall have equal weight; On any of the measures in §B(3)(f) of this regulation for which the MCO does not meet the minimum target, as determined by the Department, a penalty of 1/10 of 1 percent of the total capitation amount paid to the MCO during the measurement year shall be collected if the conditions in §B(3)(h)(iv) of this regulation do not apply; If the Department’s actuary determines that the MCO’s total capitation amount for the measurement year does not meet the actuarial soundness definition described in 42 CFR §438.4 after collection of the total penalty amount described in §B(3)(h)(iii) of this regulation, the Department’s actuary shall calculate the maximum penalty the Department shall apply that results in the MCO’s total capitation for the measurement year remaining actuarially sound; If the MCO’s penalty amount is reduced as described in §B(3)(h)(iv) of this regulation, the Department may impose any of the additional sanctions described in COMAR 10.67.10; The total amount of the penalties as described in §B(3)(h)(iii) of this regulation may not exceed 1 percent of the total capitation amount paid to the MCO during the same measurement year; On any of the measures in §B(3)(f) of this regulation for which the MCO meets or exceeds the incentive target, as determined by the Department, the MCO shall be paid an incentive payment of up to 1/10 of 1 percent of the total capitation paid to the MCO during that measurement year; The total amount of the incentive payments as described in §B(3)(h)(vii) of this regulation shall be paid to the MCOs with total amount of the penalties as described in §B(3)(h)(iii) of this regulation collected from the MCOs in that same year, plus additional reserves in the HealthChoice Performance Incentive Fund if the total amount of the penalties collected is insufficient to pay the total amount of the incentive payments; 40 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be distributed to the MCOs earning net incentives with the four highest normalized scores, at a rate calculated by multiplying each MCO’s adjusted enrollment as of December 31 of the measurement year by a per-enrollee amount; MCOs earning net disincentives are ineligible to receive the funds described in §B(3)(h)(ix) of this regulation; 25 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be distributed to the MCOs that the Department determines have demonstrated performance improvement in the measurement year, provided that the MCOs use the funding to target performance improvement in areas defined by the Department; 25 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be retained for health improvement programs under the Maryland Medicaid Managed Care Program; 10 percent of any funds remaining after the payment of the incentives due under §B(3)(h)(vii) of this regulation shall be used to establish a reserve in the HealthChoice Performance Incentive Fund, to be used in any calendar year when the amount of penalties collected is insufficient to pay incentives earned by MCOs; and If the amount in the HealthChoice Performance Incentive Fund exceeds $5,000,000, the Department shall equally allocate the remaining 10 percent of funds for use in §B(3)(h)(ix)—(xii); The adjusted enrollment amount in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation shall be calculated by: Multiplying four times the enrollment of the MCO with the highest normalized score; Multiplying three times the enrollment of the MCO with the second highest normalized score; Multiplying two times the enrollment of the MCO with the third highest normalized score; and Using the actual enrollment of the MCO with the fourth highest normalized score; The per enrollee amount in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation shall be calculated by dividing the sum of the calculations in §B(3)(i)(i)—(iv) of this regulation into the funds remaining as described in §§B(3)(g)(vii) and B(3)(h)(ix) of this regulation; and The methodology described in §B(3)(a)—(j) of this regulation shall remain in effect through December 31, 2021; An annual enrollee satisfaction survey using the latest version of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey tool, conducted by an NCQA-certified CAHPS vendor; An annual Maryland Healthy Kids audit in order to determine the quality of the clinical care provided to all children younger than 21 years old enrolled in the HealthChoice Program as follows: The audit shall include a review of a sample of medical records from each provider reviewed during the calendar year to assess clinical care; The results of the audit that are below minimum EPSDT standards may result in corrective action required by both the provider and the MCO; and The Department shall issue a final report of the audit results; Performance improvement projects to be conducted by the MCOs that focus on clinical or nonclinical areas as determined by the Department or CMS and include the following: Measurement of performance using objective quality indicators; Implementation of system interventions to achieve improvement in quality; Evaluation of effectiveness of interventions; Planning and initiation of activities to sustain improvement; and Reporting of results to the Department or CMS; and Validation and evaluation of MCO provider networks to ensure compliance with the network adequacy and access standards set forth in COMAR 10.67.05. If an MCO is assessed as deficient in accordance with federal and State standards, the MCO shall submit a plan of corrective action to the Department. An MCO shall provide the Department a copy of its most recent NCQA accreditation, including: Accreditation status, survey type, and level; Accreditation results, including: Recommended actions or improvements; Corrective action plans; and Summaries of findings; and Expiration date of the accreditation. The Department shall award a defined amount of funding annually to MCOs based on the county of residence of their members and the socioeconomic disadvantage index described in this regulation. Socioeconomic Disadvantage Index. The Department shall calculate a ranking for each service area in Maryland in accordance with the following domains: Community safety; Food security; Housing security; and Transportation access. The Department shall select component measures and calculate rankings that aggregate to the domains defined in §B of this regulation. Rankings shall range from first to twenty-fourth, with first being the lowest ranking for socioeconomic disadvantage and twenty-fourth being the highest ranking for socioeconomic disadvantage. Each service area shall be assigned a single summary score by calculating the equal-weighted average across each service area’s domain rankings. The Department shall award available equity funding to MCOs serving members in Maryland service areas based on the following criteria: Allocation of equity funding shall be made proportionally to the MCO’s membership in the service areas at the top quartile of the socioeconomic disadvantage index. Funding for each calendar year shall be determined based on available funding in the Department’s budget and specified in the annual HealthChoice Managed Care Organization Agreement. The annual allocation for HealthChoice Health Equity Incentive Program shall be funded outside of managed care capitation rates. Incentive funds awarded under the HealthChoice Health Equity Incentive Program are not appealable under 10.67.10. Effective January 1, 2022, the Department shall establish the HealthChoice Population Health Incentive Program (PHIP). An MCO may be eligible for an incentive payment for the following performance measures: Ambulatory care visits for Supplemental Security Income (SSI) adults; Ambulatory care visits for Supplemental Security Income (SSI) children; HEDIS asthma medication ratio; Hemoglobin A1c control for patients with diabetes — poor control (>9.0%); Lead screening measures: Lead screening measure for children 1223 months old; and HEDIS lead screening in children; HEDIS postpartum care; HEDIS risk of continued opioid use >=31 days covered; and HEDIS timeliness of prenatal care. Each measure identified in §B of this regulation shall be valued equally at a proportional share of available incentive funds, except for measures §B(5)(a) and (b), which are each valued at half of the available incentive funds relative to one of the other measures. There shall be two rounds of potential incentive payments an MCO may earn. Subject to budget approval, total PHIP funding shall be determined prior to the measurement year and included in the MCO contract. All PHIP payments shall be funded independently from and outside of MCO capitation payments during a given calendar year. Each MCO shall be eligible for no more than 1 percent of the plan's measurement year capitation payments, excluding supplemental payments outside of capitation, as total payment from round one and round two. If the Department determines that the score for any measure identified in §B of this regulation may not be comparable to the previous year's score due to alterations in measure specifications or other factors, the Department may exclude the measure from the PHIP and adjust the incentive valuation in accordance with the remaining performance measures. Round One Incentives. An MCO may earn two types of incentives in round one: A performance incentive payment; and An improvement incentive payment. If an MCO does not report a performance measure or an MCO has a performance score of 0 percent, then the MCO is awarded no performance or improvement incentive payments for this measure. Performance Incentive Payments for Round One. Performance incentive payments shall be based on the following categories for each performance measure: Superlative performance, meaning the performance measure's score is at or above the 90th percentile of HEDIS Medicaid performance nationwide during the measurement year, or estimated 90th percentile among Maryland HealthChoice MCO performance for non-HEDIS performance measures; Very strong performance, meaning the performance measure's score is between the 75th and 89th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 75th and 89th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures; or Strong performance, meaning the performance measure's score is between the 50th and 74th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 50th and 74th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures. Payments for round one performance incentives shall be allocated as follows: For superlative performance, an MCO may earn 100 percent of the incentive allocation for the performance measure; For very strong performance, an MCO may earn 66.6 percent of the incentive allocation for the performance measure; For strong performance, an MCO may earn 33.3 percent of the incentive allocation for the performance measure; and Any MCO earning a performance measure score below the 50th percentile of HEDIS Medicaid performance nationwide during the measurement year on a HEDIS-based measure, or below the calculated 50th percentile among Maryland HealthChoice MCO performance for a non-HEDIS measure, shall be ineligible for a round one performance incentive payment. Round One Improvement Incentive Payments. An MCO may earn an improvement incentive payment of 33.3 percent of the incentive allocation for any performance measure if the following conditions are met: The MCO demonstrates improvement of at least 0.5 percentage points in the measure compared to the previous measurement year; and The performance measure score is at or above the 50th percentile of HEDIS Medicaid performance nationwide on a HEDIS-based measure, or the 50th percentile of Maryland HealthChoice MCO performance for a non-HEDIS measure. An MCO earning a superlative performance incentive payment for a performance measure is ineligible for an improvement incentive payment for the same measure. For any performance measures in which a lower score indicates stronger performance, year-over-year improvement is demonstrated by a reduction in the score for that measure. If an MCO is missing or zero-valued for a performance measure in the previous year, then no improvement incentive will be awarded in the measurement year. Round Two Incentive Payments. An MCO may qualify for payments under round two if the following conditions are met: The MCO earned above 80 percent of possible round one incentives; and The MCO did not have penalties applied during the measurement year for failure to meet the HEDIS MCO Performance Monitoring Policy included in the MCO contract. Any remaining funds that were unallocated during round one may be awarded to eligible MCOs in round two for a maximum incentive award of up to 1 percent of its total capitation payment during the PHIP measurement year, excluding supplemental payments outside of capitation. If any remaining funds that were unallocated during round one are not sufficient to settle all qualifying MCOs up to 1 percent of capitation in round two, then the leftover funds will be awarded proportionally among qualifying MCOs based on enrollment. If additional funds remain after both round one and round two, the Department may, within its discretion, allocate the funding as follows: Make additional payments to MCOs that are below 1 percent of capitation based on improvement or performance; or Place remaining funds into a nonlapsing pool. Effective measurement year 2025, an MCO with penalties under the HEDIS MCO Performance Monitoring Policy included in the HealthChoice MCO Agreement shall be excluded from all rounds of PHIP for that measurement year. Incentives awarded under this regulation and exclusion from PHIP participation are not appealable under COMAR 10.67.10.. An MCO shall provide health care services to enrollees who are members of special needs populations. Special needs populations consist of the following non-mutually exclusive populations: Children with special health care needs; Individuals with a physical disability; Individuals with a developmental disability; Pregnant and postpartum women; Individuals who are homeless; Individuals with HIV/AIDS; and Children in State-supervised care. General Requirements for Special Needs Populations. An MCO shall demonstrate that its pediatric and adult primary care providers (PCPs) and specialists are clinically qualified based upon generally accepted community standards to provide or arrange for the provision of appropriate health care services to individuals who are members of a special needs population. The MCO shall submit to the Department referral protocols that demonstrate the conditions under which PCPs will make the arrangements for referrals to specialty care networks. Clinical qualifications are to be determined through the MCO's credentialing and recredentialing processes, including a review of the provider's medical education, special training, and work history and experience. Specialty and subspecialty providers shall: Have experience in treating individuals within a special needs population; Have experience in interdisciplinary medical management; and Understand the relationship between somatic and behavioral health care issues and interventions. The MCO shall demonstrate the use of a primary care system of care delivery which includes a comprehensive plan of care for an enrollee who is a member of a special needs population and which uses a coordinated and continuous case management approach, involving the enrollee and, as appropriate, the enrollee's family, guardian, or caregiver, in all aspects of care, including primary, acute, tertiary, and home care. To meet the commitment outlined in §C(4) of this regulation, an MCO shall: Provide case management services to adult and pediatric enrollees as appropriate; Have the capacity to perform home visits as part of the ongoing case management program and have the ability to respond to urgent care needs while in the enrollee's home; Ensure that, if warranted, a case manager is assigned to an enrollee at the time of the initial health screen by the MCO; Ensure that the PCP, who may also be the specialist, shall be the admitting or referring provider for all hospital admissions; Ensure that it will: Collaborate with inpatient facilities in facilitating preadmission and discharge planning, and Communicate all post-discharge home and community arrangements to the enrollee, the PCP, and, as appropriate, the enrollee's family, guardian, and caregiver; Document the plan of care and treatment modalities provided to enrollees in special populations, assuring that the plan of care: Is updated at least annually, when the enrollee’s circumstances or needs change significantly, or at the enrollee’s request; and Involves the enrollee and, as appropriate, the enrollee's family, guardian, and caregiver in care decisions; and Be familiar with community and social support providers for the special populations. An MCO shall make documented outreach efforts to contact and educate enrollees who fail to appear for appointments or who have been noncompliant with a regimen of care. These efforts may include, but may not be limited to, notification: By mail; By telephone; By email; By text messaging; and Through face-to-face contact. Referral to Local Health Department. An MCO shall make a written referral, or ensure that the enrollee's provider makes a written referral, to the local health department (LHD) for the county in which an enrollee resides, for assistance in bringing into care an enrollee for whom the MCO has been unsuccessful in its documented out-reach efforts pursuant to §C(6) of this regulation, within 10 business days of whichever first occurs: The third consecutive missed appointment; or The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care. The MCO may not include information about an enrollee's HIV status on the form used to refer an enrollee to the local health department. An MCO shall subject its decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested, for an enrollee who is a member of special needs population to utilization review that includes review by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease. An MCO shall identify a special needs coordinator, who shall: Serve as a point of contact for health care services information and referral for members of special needs populations; Be skilled in communications with, and sensitive to the unique needs of, members of special needs populations, their families, guardians, and caregivers; Participate on the MCO's consumer advisory board, pursuant to Regulation .12 of this chapter, as a representative of special needs populations; Serve as a resource to MCO providers and enrollees on the requirements of P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; and Maintain a log of each denial of treatment and the outcome of the utilization review conducted pursuant to §C(8) of this regulation. An MCO shall have mechanisms in place to allow enrollees with special health care needs to access a specialist directly as appropriate for the enrollee’s condition and identified needs. An MCO shall meet the standards set forth in this regulation for treating children with special health care needs. The Department shall maintain a record of the complaints received through the Department's enrollee and provider hotlines which involve the denial of care for children and review these complaint logs as part of its quality assurance system. An MCO shall demonstrate that its therapies provider network is adequate by demonstrating its: Providers' pediatric specialties; Collaboration with schools that provide IEP or IFSP services to its enrollees, where available; and Provision of family-focused services and development of family-focused plans of care. An MCO shall provide case management services to children with special health care needs as appropriate. For complex cases involving multiple medical interventions or social services, or both, a multidisciplinary team shall be used to review and develop the plan of care for special health care needs children. An MCO shall provide coordinated care for special health care needs children in State-supervised care. An MCO shall refer child victims of alleged abuse, neglect, or sexual offense to an appropriate provider capable of: Determining if the alleged abuse, neglect, or sexual offense occurred; Determining if medical intervention is needed; and Ensuring the preservation of evidence. An MCO shall ensure coordination with the Department’s Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program. An MCO shall establish protocols for effecting medically necessary service referrals to specialty care providers for children with special health care needs. The service referrals referenced in §H of this regulation shall: Include services intended to improve or preserve the continuing health and quality of life for children with special health care needs, regardless of the ability of the services to effect permanent cure; and Be made when the child is: Identified as being at risk of a developmental delay by the developmental screen required by EPSDT; Experiencing a delay of 25 percent or more in any developmental area as measured by appropriate diagnostic instruments and procedures; Manifesting atypical development or behavior; or Diagnosed with a physical or mental condition that has a high probability of resulting in developmental delay. An MCO shall provide durable medical equipment to a special needs child in a timely manner. When a child, who is an MCO enrollee, is diagnosed with a special health care need requiring a plan of care which includes specialty services, and that health care need was undiagnosed at the time of enrollment, the parent or guardian of that child may request approval from the MCO for a specific out-of-network specialty provider to provide those services when the MCO does not have a local in-network specialty provider with the same professional training and expertise who is reasonably available and provides the same service and modality, subject to the following provisions: If the MCO denies the request for an out-of-network provider referral, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05; If at any time the MCO decides to terminate or reduce services provided by the approved out-of-network provider, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05; The MCO shall continue to cover the services of the out-of-network provider during the course of the appeal until such time as the Office of Administrative Hearings issues its decision. An MCO shall meet the standards set forth in this regulation for treating an individual with a physical disability. An MCO shall demonstrate that its providers for durable medical equipment and assistive technology provide the appropriate services and are clinically qualified to provide these services to the individual with a physical disability. Before placement of an individual with a physical disability into an intermediate or long-term care facility, an MCO shall: Recommend that an individual with a physical disability be transferred to an intermediate or long-term care facility only after assessing the needs of the individual and the ability of the MCO to meet these needs in the community as supplemented by other Medicaid services; Conduct a second opinion review of the case, performed by the MCO's medical director, before a transfer to an intermediate care facility or a long-term care facility is implemented; and If the MCO's medical director determines that the transfer to an intermediate or long- term care facility is medically necessary and that the expected stay will be greater than 30 days, obtain approval from the Department before making the transfer. An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with a physical disability. An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with physical disabilities. An MCO shall meet the standards set forth in this regulation for treating an individual with a developmental disability. An MCO shall ensure that its case managers have experience or training related to developmental disabilities. An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with developmental disabilities. An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with developmental disabilities. An MCO shall meet the standards set forth in this regulation for treating pregnant and postpartum women. An MCO shall ensure access to prenatal care for pregnant women and postpartum care for postpartum women by: Scheduling an appointment for the first prenatal visit and seeing the woman within 10 days of request; Scheduling an appointment for a postpartum woman and seeing the woman within 10 days of request: Arranging for an adequate network of providers including obstetricians, gynecologists, perinatologists, neonatologists, anesthesiologists, and advanced practice nurses who are capable of addressing complex maternal and infant health issues; and Linking a pregnant woman with a pediatric provider before delivery. An MCO shall ensure that prenatal providers: Complete a prenatal risk assessment, using an instrument approved by the Department, at the first prenatal visit; and Within 10 days of completing the prenatal risk assessment, forward this instrument to the local health department in the jurisdiction in which the pregnant enrollee lives. The Department may not include questions about a woman's HIV infection status on the prenatal risk assessment instrument. An MCO shall refer pregnant and postpartum women with a substance use disorder to the behavioral health ASO for substance use treatment within 24 hours of request. An MCO shall refer pregnant and postpartum women, infants, and children younger than 5 years old to the WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) Program, and shall provide to WIC necessary medical information to determine WIC nutritional eligibility. An MCO shall follow, at a minimum, the American College of Obstetricians and Gynecologists (ACOG) guidelines for pregnant and postpartum women. An MCO shall provide risk-related medical and nonmedical preventive treatment services, including nutrition counseling by licensed nutritionists or dietitians and smoking cessation education and treatment for pregnant and postpartum women. An MCO shall provide HIV counseling, including a risk assessment and information about possible transmission of HIV to the fetus. An MCO shall offer its pregnant and postpartum enrollees voluntary HIV counseling and testing following the requirements of COMAR 10.67.06. An MCO shall arrange for the appropriate emergency transfer of pregnant women, newborns, and infants to tertiary care centers. An MCO's initial health screen shall attempt to identify homeless individuals and link them to the appropriate provider of services. An MCO shall meet the standards set forth in this regulation for treating individuals with HIV/AIDS. HIV/AIDS Specialist. An MCO shall allow an enrollee with HIV/AIDS to choose an HIV/AIDS specialist for treatment and coordination of primary and specialty care. To qualify as an HIV/AIDS specialist, a health care provider shall be board certified in the field of infectious diseases by a member board of the American Board of Medical Specialties or: Hold a current, valid, unrevoked, and unsuspended Maryland license or certification as a: Doctor of medicine; Doctor of osteopathy; Nurse practitioner; or Physician's assistant being supervised by a medical doctor; Have provided direct, continuous, ongoing care for at least 20 patients with HIV over the past 2 years; and Have completed one of the following requirements: If a medical doctor, certified physician's assistant being supervised by a medical doctor, or doctor of osteopathy, at least 30 hours of HIV-related continuing medical education category I credits over the past 2 years; If a nurse practitioner, at least 30 hours of HIV-related continuing education units over the past 2 years; If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, an accredited training program over the past year; or If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, has completed the American Academy of HIV Medicine (AAHIVM) credentialing examination. AIDS Case Management Services. An MCO shall ensure that an enrollee with HIV/AIDS receives case management services that: Link the enrollee with the full range of available benefits; Link the enrollee with any additional needed services including: Mental health services; Substance abuse services; Medical services; Social services; Financial services; Counseling services; Educational services; Housing services; and Other required support services; Ensure timely and coordinated access to medically necessary levels of care that support continuity of care across the continuum of service providers; Are performed by licensed physicians, physician assistants, advanced practice nurses, registered nurses, social workers, or other individuals who are appropriately trained, experienced, and supervised by a licensed practitioner; and Include, but are not limited to: Initial and ongoing assessment of the enrollee's needs and personal support systems, including the MCO offering an enrollee one face-to-face meeting during the initial assessment and documenting the enrollee's acceptance or declination of the face to face meeting; Development of a comprehensive, individualized service plan, using a multidisciplinary approach; Coordination of the services required to implement the plan; Periodic reevaluation and adaptation of the plan as necessary over the life of the enrollee; Development of an outreach system for the enrollee and family by which the case manager and primary care provider track services received, clinical outcomes, and the need for additional follow-up; and Serving as an effective enrollee advocate to resolve differences between the enrollee and providers of care pertaining to the course or content of therapeutic interventions. An enrollee diagnosed with HIV/AIDS shall be offered case management services by the MCO at any time after diagnosis. An enrollee who has previously refused these services may request case management from the MCO at any time. Diagnostic Evaluation Service (DES) Assessment. An MCO shall offer a diagnostic evaluation service (DES) assessment annually and document the enrollee's acceptance or declination. The DES shall consist of a comprehensive medical and psychosocial assessment. A DES provider shall use assessment and care plan forms used by the Department for adult and pediatric assessments. An individual shall select a DES provider from an approved list of sites, and may select a DES provider which is not part of the individual's MCO if so desired. An MCO and other qualified institutions may become DES providers as provided in COMAR 10.09.32.03C. An individual with HIV/AIDS who has a substance use disorder shall be referred to the behavioral health ASO for substance abuse treatment within 24 hours of request. Clinical Trials. An MCO may refer enrollees who are individuals with HIV/AIDS to facilities or organizations that can provide the enrollees' access to clinical trials. An MCO shall provide enrollees with HIV/AIDS access to clinical trials in accordance with COMAR 10.67.06.26-1. An MCO shall establish a consumer advisory board to facilitate the receipt of input from enrollees. The consumer advisory board membership shall: Consist of enrollees and enrollees' family members, guardians, or caregivers; and Be comprised of no less than one third representation from the MCO’s special needs populations, or their representatives and the MCO’s special needs coordinator. The consumer advisory board shall meet at least 6 times a year. An MCO shall provide or arrange to provide all Medicaid-covered services required to comply with State statutes and regulations mandating health and mental health services for children in State-supervised care. An MCO shall ensure the continuity and coordination of care, provided locally to the extent the services are available, to an enrollee who is a child in State-supervised care. An enrollee who is a child in State-supervised care who moves shall be disenrolled from the recipient's MCO and enrolled in an alternative MCO if the recipient's current MCO does not serve the geographic region to which the child has been relocated. An MCO shall expedite a change of providers within its provider panel upon the move of an enrollee who is a child in State-supervised care to a new geographic area served by the MCO. On request of the responsible State or local agency, a child in State-supervised care may be disenrolled from the current MCO and enrolled in an MCO serving the group facility in which the child resides, members of the foster care family, or other children in foster care placement with the child. Enrollee Self-Referral. An MCO shall permit the self-referral of a child in State-supervised care to an EPSDT certified provider for an initial examination, including a mental health screen, and shall pay for all portions of the examination except for the mental health screen, which shall be paid for by the Specialty Mental Health System. Coordination with Responsible Agency. An MCO shall appoint a liaison to coordinate services to a child in State-supervised care with the responsible State or local agencies. An MCO is responsible for providing medically necessary primary behavioral health services to their enrollees. An enrollee may self-refer to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. If an enrollee’s primary care physician determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the primary care physician shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. If an MCO determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the MCO shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. An MCO shall cooperate with the behavioral health ASO in developing referral procedures and protocols. An MCO shall notify the Department immediately when it has knowledge of an enrollee's death. Encounter Data. An MCO shall submit encounter data reflecting 100 percent of provider-enrollee encounters, in CMS1500 and UB04 format or an alternative format previously approved by the Department. An MCO may use alternative formats including: ASC X12N 837 and NCPDP formats; and ASC X12N 835 format, as appropriate. An MCO shall submit encounter data that identifies the provider who delivers any items or services to enrollees at a frequency and level of detail to be specified by CMS and the Department, including, at a minimum: Enrollee and provider identifying information; Service, procedure, and diagnoses codes; Allowed, paid, enrollee responsibility, and third-party liability amounts; and Service, claims submission, adjudication, and payment dates. An MCO shall report encounter data within 60 calendar days after receipt of the claim from the provider. An MCO shall submit encounter data utilizing a secure on-line data transfer system. Monthly Reports. An MCO shall provide an updated list of the PCP's assigned enrollees to each PCP at least on a monthly basis. An MCO shall participate in the electronic enrollment reconciliation process to identify discrepancies in enrollment data between the Department and the MCO. Quarterly Reports. An MCO shall submit to the Department: Within 30 calendar days of the close of each calendar quarter, quality assurance reports including, but not limited to: Quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; and An analysis of recipient appeal and grievance logs including significant trends or anomalies, what caused the trend or anomaly, and any actions taken to address the trend or anomaly; Within 30 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all pre-service denials or reduction of services or benefits issued by the MCO or MCO subcontractors during the preceding quarter. Within 30 calendar days of the close of each calendar quarter, third-party liability collection activities as described in Regulation .18D of this chapter. In a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter. Not later than 45 days after the end of each quarterly rebate period, drug utilization data necessary for the Department to bill manufacturers for rebates in accordance with §1927(b)(1)(A) of the Social Security Act, that: Include, at a minimum, the following information by National Drug Code of each covered outpatient drug dispensed or covered by the MCO: Total number of units of each dosage form; Total number of units of each dosage strength; and Total number of units of each dosage package size; and Distinguish utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program. Within 10 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all State fair hearing outcomes during the preceding quarter. Annual Reports. Except as provided in §E(5) of this regulation, an MCO shall submit to the Department annually, within 90 days after the end of the calendar year: A summary of the information contained in §D(1)(b) of this regulation; A report of the MCO's consumer advisory board outlining the board's activities and recommendations; A copy of the MCO's drug formulary; Any revisions to the MCOs quality assurance, utilization management, and case management plans; HealthChoice Financial Monitoring Reports (HFMRs), including any supplemental schedules required by the Department: In the format required by the Department; Prepared according to: The criteria, set forth in Regulation .19-5 of this chapter, for allocating MCO costs to HFMR expense categories; and Reporting instructions provided by the Department for the HFMR form and any required supplemental schedules; and Submitted according to the following schedule: Services incurred from January 1 through December 31 of the prior year, reported through March 31 of the current year — due on May 15 of the current year; and Services incurred January 1 through December 31 of the prior year, reported through June 30 of the current year — due on September 1 of the current year; and A detailed description of its drug utilization program activities. Unless the MCO is exempt for good cause, an MCO shall submit to the Department when requested the following reports for its enrollee/member services and provider/authorization/preauthorization lines: Caller abandonment rates; Caller service level rates; and Caller average hold time. If the MCO exits the HealthChoice Program for any reason, including those listed in COMAR 10.67.02.06A(1)(e) and (f): The MCO shall provide the Department with a list of enrollees and the name of each enrollee's PCP, at least 30 days before exiting the program; and On receiving the list provided by the MCO, the Department shall provide the list to: The health benefits exchange to assist and provide outreach to participants in selecting an MCO; and If permitted by State and federal law, the remaining MCOs for linking participants with a PCP. Jurisdictional Reporting to Local Health Departments. The Department shall: Aggregate by jurisdiction the encounter data it receives from MCOs; and Provide to local health departments jurisdiction-specific information based on aggregated encounter data for public health monitoring and assessment. For the purposes of Maryland Medicaid Managed Care Program administration or monitoring MCO performance pursuant to this chapter, the MCO shall supply other information as the Department may from time to time request, given a reasonable period of notice. Nonfederally qualified MCOs shall report a description of certain transactions with parties of interest, as described in §1903(m)(4)(A) of the Social Security Act. Upon request, an MCO whose member has disenrolled shall transfer historical utilization data to the member's new MCO in the time frame and format specified by the Department. Subcontracting Permitted. Consistent with this regulation, an MCO may subcontract services that it is required to provide to its enrollees under COMAR 10.67.06 to a health care provider that is licensed, certified, or otherwise legally authorized to provide those services. An MCO may not discriminate for the participation, reimbursement, or indemnification of any provider who is acting within the scope of the provider's license or certification under applicable State law, solely on the basis of that license or certification. An MCO shall have written agreements with subcontractors that comply with 42 CFR §§438.214 and 455.105, as amended, and include at least the following: A provision that the subcontractor be subject to all of the requirements to which the MCO is subject under its contract with the Department and pursuant to the Department's regulations; A clear description of the services to be performed under the subcontract sufficient to definitively inform the Department which of the MCO's obligations have been subcontracted; A provision for the subcontractor's release to the MCO and to the Department, upon request, of any information necessary for the MCO to perform any of its contractual and regulatory obligations under its contract with the Department, including, but not limited to, its records, reporting, and quality assurance duties; A provision requiring that the subcontractor complies with all State and federal requirements regarding audit, inspection, and evaluation; A provision that copies of the subcontractor's medical records pertaining to the MCO's enrollees shall be furnished to the MCO upon request for transfer to a subsequent provider in the event of a termination of the subcontract; A provision to the effect that no termination of the subcontract shall be effective without prior written notice to the Department; An agreement that the subcontractor will look solely to the MCO for compensation for covered services provided to the MCO's enrollees under the subcontract; An assurance that evidence of the subcontractor's professional liability coverage will be submitted annually to the MCO; A provision that no assignment of the subcontract by the subcontractor is effective without prior written notice to the Department; If the subcontractor is authorized by the MCO to make referrals, a provision requiring the subcontractor to use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06; A provision to the effect that each provision of the subcontract that is required under this section supersede and be controlling over any conflicting terms that appear in the subcontract; A provision for revocation of the delegation of activities or obligations, or specifying other remedies in instances where the Department or the MCO determines that the subcontractor has not performed satisfactorily; A provision stating that the MCO has the right to audit the subcontractor pursuant to 42 CFR §438.230(c)(3)(i) for 10 years from the final date of the contract period or from the date of completion of any audit, whichever is later; and A provision to the effect that all providers and subcontractors are subject to a grievance and appeal system consistent with the requirements of COMAR 10.67.09. An MCO may not subcontract for hospital services with a hospital or an entity related to a hospital unless that hospital is in compliance with COMAR 10.37.12 (fixed price contracting regulations). An MCO may not prohibit or otherwise restrict a health care professional, acting within the lawful scope of practice, from advising or advocating on behalf of an enrollee who is the provider's patient for: The enrollee's health status, medical care, or treatment options, including any alternative treatment that may be self-administered; Any information the enrollee needs in order to decide among all relevant treatment options; The risks, benefits, and consequences of treatment or nontreatment; or The enrollee's right to participate in decisions regarding the enrollee's own health care, including the right to refuse treatment, and to express preferences about future treatment decisions. Subcontractual Relations Reporting Requirements. An MCO shall submit its standard subcontract to the Department for its approval at least 30 days in advance of the MCO entering into any subcontracts covered by this regulation. An MCO shall submit to the Department for its prior approval material modifications to, or deviations from, its approved standard subcontract. An MCO shall submit to the Department a specification of procedures to be followed when reallocating responsibility in the event of a change in obligations in its approved standard subcontract. Network Provider Termination. When an MCO and provider terminate their contract the MCO shall provide the Department with a written notice regarding the termination. If the MCO is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided at the later of: 30 calendar days before the effective date of the termination; or 15 calendar days after receipt or issuance of the termination notice. If the provider is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided within 15 days after the MCO receives the notice from the terminating provider. If 50 to 99 enrollees are affected, the notice shall contain the: Date of termination; Name or names of providers or subcontractors terminating; Number of enrollees affected; and MCO's plan for transitioning enrollees to other providers. If more than 99 enrollees are affected, the MCO shall provide the Department with a Department-approved termination survey. In determining the number of enrollees affected under §B(4)(d) and (e) of this regulation, the MCO shall consider: For PCPs, the number of enrollees assigned to the PCP; and For all other providers, the number of enrollees who are in active treatment or who have had an encounter with the provider in the previous 12 months. Subcontractor Termination. When an MCO terminates a subcontract impacting its operations, covered services, or enrollees, the MCO shall provide the Department with written notice regarding the termination that describes: The dollar amount of the subcontract; The effect of the termination on MCO operations; The effect of the termination on MCO covered services or enrollees; and The MCO’s plan to replace the subcontractor, if applicable. If the termination of the subcontract impacts MCO operations, the notice required in §B(5)(a) of this regulation shall be provided at least 90 days before the effective date of the termination. By entering into a subcontract to provide health care services on behalf of an MCO, the subcontractor becomes subject to all the requirements concerning audits and inspections by the Department and other government agencies that are imposed upon the MCO by statute or regulation, or by its contract with the Department. An MCO shall monitor the performance of its subcontractors, including, but not limited to, the areas of enrollee and provider complaints, access issues, quality assurance activities, record keeping, and reporting requirements. An MCO shall report to the Department any material deviations from required procedures by its subcontractor which, in the MCO's judgment, can be expected to have a significant effect on quality of care, or on enrollees' ability to access care. An MCO is responsible for the identification of, and collection of, moneys owing from responsible third parties liable for the cost of medical care furnished by the MCO to enrollees. Upon request from the Department or the U.S. Department of Health and Human Services, an MCO shall convey any information regarding third-party liability to the Department, to the U.S. Department of Health and Human Services, or to another MCO. The Department shall notify an MCO of any third-party liability identified during the course of eligibility determination. The MCO shall submit to the Department any new or changed third-party information in an automated format on a monthly basis. The Department shall provide the MCOs with any new or changed information on a monthly basis in an automated format. In order to facilitate the Department's and the U.S. Department of Health and Human Services' monitoring of its third-party liability collection activities, an MCO shall: Submit to the Department, on a monthly basis, reports on third-party collections and activities during the month, including but not limited to amounts the MCO has cost-avoided and recovered and current accounts receivable for all third-party liability cases; Submit to the Department, on a quarterly basis and in a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter; Cooperate in site inspections by either the Department or the U.S. Department of Health and Human Services for monitoring purposes; and Submit a detailed report of third-party liability collection activities including, but not limited to, cost avoidance, recovered amounts, and current amounts receivable for cases selected by the Department. When both the Department and an MCO have a right of subrogation, they shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount. For insurance coverage identified by an MCO with a retroactive effective date, an MCO shall comply with Insurance Article, §15-1008, Annotated Code of Maryland. An MCO may not deny a provider’s request for a preauthorization solely because a recipient has, or is thought to have, third-party insurance. The requirement in §I of this regulation may not apply if an MCO has a process in place to ensure that a claim will not be denied for lack of preauthorization if the claim ultimately becomes the MCOs responsibility for one of the following reasons: The recipient does not have third-party insurance; or The service received is a noncovered service under the third-party insurance. If an MCO identifies another party as being responsible for retroactive denial of reimbursement, the MCO shall: Obtain a written statement from the third-party that includes: The name and address of the third party; and Acknowledgment of responsibility for payment of the denied claim by the third party; Send this written statement to the provider seeking reimbursement; and Provide this written statement or a summary report to the Department upon request. Capitation Rate Setting Methodology — Extraction of Graduate Medical Education Costs. Percentage of Teaching Hospitals' Rates Representing GME Costs. The Department, in consultation with the HSCRC, shall: Determine the amount, expressed as a percentage, of payments by the Program that are attributable to GME, based on historic cost and discharge abstract data that: Are specific to each individual teaching hospital; Are specific to Program recipients who would have been MCO-eligible if COMAR 10.67.01—.12 had been in effect at the time the activity reflected in the data occurred; Reflect services that would be, if performed during the contract year to which calculations utilizing a teaching hospital's GME percentage amount relate, included in the mandatory MCO benefits package described in COMAR 10.67.06; and Represent activity in FY 1995; and For any teaching hospital that is not in compliance with the primary care and innovation requirements of COMAR 10.10.67.11, reduce the Program's payments to the hospital deemed to be attributable to GME pursuant to §A(1)(a) of this regulation by the hospital's noncompliance penalty percentage derived in accordance with COMAR 10.67.11.03C. GME Percentage Start-Up Adjustment. To ameliorate the impact on MCOs that historically have experienced low utilization of teaching hospitals, the Department shall, during the first 3 years of separate GME funding, reduce the GME percentage determined in accordance with §A(1) of this regulation in the following amounts: FY 1999 ... 10 percent; FY 2000 ... 6.7 percent; FY 2001 ... 3.3 percent; and FY 2002 and thereafter ... 0 percent. Modifying GME Percentage to Maintain Budget Neutrality. To maintain budget neutrality in the GME funding procedure established pursuant to this regulation and COMAR 10.67.11, the Department may modify the GME percentages established pursuant to §A(1) and (2) of this regulation. The Department may use the modified GME percentage authorized by §A(3)(a) of this regulation to calculate non-GME teaching hospital costs pursuant to §A(4) of this regulation, for the purpose of equalizing: The amount of GME costs to be excluded from capitation rates for the contract year pursuant to §A(4) of this regulation; and The amount of GME allocation payments, determined pursuant to COMAR 10.67.11.03C. Application of the GME percentage modification authorized in §A(3)(a) and (b) of this regulation does not affect the amount of the GME allocation payments made pursuant to COMAR 10.67.11.03C. GME Adjustment in Capitation Rate-Setting Methodology. Before determining the average historic costs assigned to the rate cells set forth in Regulation .19B of this chapter, the Department shall, consistent with §A(1)—(3) of this regulation, deduct, for each rate cell, the dollar amount allocatable to GME contained in the Department's base year payments to teaching hospitals. The deduction referenced in §A(4)(a) of this regulation is calculated as follows: For each payment included in the base year data made by the Program to a teaching hospital in the contract year, the amount of the payment is multiplied by the hospital-specific GME percentage, established pursuant to §A(1)—(3) of this regulation; and The dollar amount attributable to GME that is included in the base year payments, as identified by the procedure described in §A(4)(b)(i) of this regulation, is subtracted from the total amount of the payment to yield the non-GME portion of the payment. Consistent with §A(4) of this regulation, the Department shall use the GME percentage rates calculated pursuant to §A(1)—(3) of this regulation for purposes of: Calculating each teaching hospital's GME allocation payment amounts pursuant to COMAR 10.67.11.03C; Determining the amount of each ACG's average non-GME historic costs for grouping ACGs to make risk adjustment category assignments of the ACGs pursuant to Regulation .19B of this chapter; Determining the amount of each demographic grouping's average non-GME historic costs; and Determining, for each risk adjustment category and demographic grouping, the capitation rates set forth in Regulation .19B of this chapter. The Department shall use, in calculating the capitation rates set forth in Regulation .19B of this chapter, a capitation rate-setting methodology that: Excludes the dollar amount allocatable to GME, consistent with the percentage of GME included in historic payments made by the Program to teaching hospitals that receive GME allocation payments in the contract year, based on calculations that: Are consistent with §A of this regulation; Reflect any modifications made pursuant to §A(2) and (3) of this regulation to the percentage of the Program's historic payments made to teaching hospitals allocable to GME; and Reflect the reduction of hospital-specific GME percentages, by operation of COMAR 10.67.11.03C and §A(1)(b) of this regulation, to decrease the amount of GME allocation payments made, pursuant to COMAR 10.67.11.03B, to teaching hospitals that are not in compliance with the primary care and innovation requirements of COMAR 10.67.11; Reduces historic costs to reflect savings expected to result from a managed care delivery system; Includes a trend factor to account for cost differences between the base year and the contract year; Excludes the dollar amount of historic payments determined, based on an aggregation of individual inpatients' payment data for the base year, to be avoidable by an MCO pursuant to Regulation .22 of this chapter, had the services been furnished during the contract year; and Beginning in FY 2000, takes into account Maryland Medicaid Managed Care Program enrollment of the newly eligible population entering the Program pursuant to the Maryland Children's Health Program. Generally. Payment to an MCO for each enrollee shall be at a fixed capitation rate, as specified in §B(4) of this regulation. An MCO shall be reimbursed at rates set forth in this regulation only for individuals enrolled under the Maryland Medicaid Managed Care Program. The capitation rate paid to an MCO by the Department shall be accepted as payment in full for all benefits provided by the MCO. An MCO shall conform to the Department's computer coding requirements. A capitation payment may not be made to an MCO on behalf of an enrollee for whom capitation payment for the same period has been made to any other MCO having an agreement with the Department. The Department may consider a retroactive capitation payment to an MCO, if the MCO notifies the Department within 9 months of the first missed capitation payment for an enrollee for whom the MCO has not received all appropriate capitation payments. Monies collected by an MCO for third party liability, as described in Regulation .18 of this chapter, are considered when calculating the capitation payments in §B(4) of this regulation. Capitation Rate-Setting Methodology. Families and Children. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through TCA or programs for medically needy families and children, including SOBRA children and Maryland Children's Health Program (MCHP), shall be established as follows: For enrollees eligible under COMAR 10.67.02.01A(1) or (3), and for children eligible under COMAR 10.67.02.01A(2) for whom the Department has sufficient clinical data, the Department shall: Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's past diagnostic record; Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of relatively homogenous resource utilization by ACG assignment; and Assign an enrollee to a risk adjustment category based upon the enrollee's ACG assignment; Except as provided in §B(1)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's: Age, residence, and gender; and Birth weight with respect to an enrollee born after December 31, 2004; and On the basis of the enrollee's residence, the Department shall assign: All SOBRA mothers enrolled pursuant to COMAR 10.67.02.01A(2) to one of the two “SOBRA mother” payment categories set forth in §B(4)(a) of this regulation; and Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(a) of this regulation. Disabled. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled shall be established as follows: Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has sufficient clinical data, the Department shall: Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's diagnostic record; Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of nearly homogenous resource utilization by ACG assignment; and Assign an enrollee to a risk adjustment category (RAC) based upon the enrollee's ACG assignment; and Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's age, residence, and gender; and On the basis of the enrollee's residence, the Department shall assign: Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(b) of this regulation; and Enrollees with AIDS to one of the two AIDS payment categories set forth in §B(4)(b) of this regulation. Supplemental Delivery/Newborn Payments. In addition to the monthly payment specified in §B(4)(a) or (b) of this regulation for an enrollee's payment category, the Department shall pay an MCO one supplemental payment per pregnancy in the amount specified in §B(4)(c) of this regulation, upon delivery of one or more infants without regard to method, timing, or place of delivery. An MCO shall have 12 months from the date of delivery to bill for the supplemental payment. Except to the extent of adjustments required by §D of this regulation or by Regulations .19-1 through 19-3 of this chapter, the Department shall make payments monthly at the rates specified in the following tables: Rate Table for Families and Children Effective January 1, 2020—December 31, 2020. Rate Table for Disabled Individuals Effective January 1, 2020— December 31, 2020. Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2020 December 31, 2020. Rate Table for Childless Adult Population Effective January 1, 2020—December 31, 2020. Rate Table for Families and Children Effective January 1, 2021—December 31, 2021. Rate Table for Disabled Individuals Effective January 1, 2021—December 31, 2021. Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2021—December 31, 2021. Rate Table for Childless Adult Population Effective January 1, 2021—December 31, 2021. Interpretation of Rate Table for Families and Children. The table found at §B(4)(a) of this regulation shows capitation rates for individuals who are: Waiver eligible based on receipt of benefits through TCA or programs for medically needy families and children; SOBRA children; SOBRA mothers; and The Maryland Children's Health Program. Interpretation of Rate Table for Disabled Individuals. The table found at §B(4)(b) of this regulation shows the capitation rates for individuals who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled. Interpretation of Rate Table for Supplemental Payment for Delivery/Newborn. The table found at §B(4)(c) of this regulation shows a supplemental payment made in connection with deliveries of MCO enrollees, regardless of the enrollee's payment category under COMAR 10.67.04.19B(4)(a) or (b). Interpretation of Rate Tables in §B(4) of this regulation. “PMPM” means the per member per month payment rate. Consistent with the terms set forth in Regulation .19-4 of this chapter, the Department may, in consultation with the Commissioner, adjust the capitation payment of an MCO if it determines that the MCO's loss ratio, not including any rebate received by the MCO is less than 85 percent. The Department shall reimburse fee-for-service: The Departmental share for any enrollee participating in the Stop Loss Program pursuant to Regulation .22 of this chapter; and The cost of those services specified in COMAR 10.09.69.06.13 provided to the participant that have been authorized by the participant's case manager in accordance with the participant's plan of care. Interim Rates Adjustments. Under the circumstances described in §D(2) and (3) of this regulation, the Department shall adjust the capitation rates set forth in §B(4)(a), (b), (e), and (f) of this regulation to reflect changes in service costs during the contract year due to an occurrence listed in §D(2) of this regulation. The Department shall adjust the payment rates specified in §B(4)(a)(h) of this regulation to reflect service cost changes that qualify under §D(3) of this regulation and result from: An addition or deletion of services covered under the HealthChoice benefits package; An increase or decrease in Medicaid fee-for-service payment rates or copayments, if the MCOs are obligated to adjust their payment rates to providers as a result of those fee-for-service rate changes; An increase or decrease in the inpatient charge per case as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided; or An increase or decrease in the outpatient charge per visit as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided. The Department shall make an interim rates adjustment if the effect of an occurrence listed in §D(2) of this regulation is sufficient to result in program-wide overpayment or underpayment of at least 0.2 percent because of the difference between: Service cost projections used to develop the rates set forth in §B(4)(a), (b), (e), and (f) of this regulation; and Service costs for the same period, taking into account an occurrence that is listed in §D(2) of this regulation. The Department shall make any interim rate adjustments required by this section in amounts that are proportionate to the overpayments or underpayments described in §D(3) of this regulation. Provider rate adjustments as specified in §D(2)(b) of this regulation may not require the MCOs to pay providers more than the Medicaid fee-for-service rate. The Department shall make supplemental payments to an MCO that reflect increases in MCO provider payments for trauma services described in COMAR 10.25.10. The Department shall make an interim rates adjustment in Calendar Years 2022, 2023, 2024, and 2025 to account for changes in acuity due to alterations in redetermination and enrollment processes related to COVID-19. Interim Rate Adjustment for Calendar Year 2025. The Department shall re-open the capitation rates for interim rate adjustments in Calendar Year 2025 to revisit the following adjustments: Risk adjustment; Trend; Administration; Regional factors; and Relational modeling. To assist with the assessment, MCOs shall provide additional information to the Department upon request, including detailed claims data as well as a year-to-date HealthChoice Financial Monitoring Report for the calendar year. To reflect the higher level of risk associated with providing covered health care services pursuant to COMAR 10.67.06 to HIV/AIDS enrollees who also have Hepatitis C, the Department shall, to the extent provided by this regulation, make MCO-specific adjustments to payments for enrollees in HIV and AIDS payment categories to reflect the proportion of an MCO's HIV/AIDS enrollees who also have Hepatitis C. Identification of HIV/AIDS Enrollees with Hepatitis C. For each MCO, the Department shall consider historical encounter and fee-for-service data for enrollees assigned to HIV and AIDS payment categories: For the initial assessment period, as of June of the calendar year before the rate year; and For the mid-year assessment period, as of December of the calendar year before the rate year. For each MCO, the Department shall determine which of the HIV/AIDS enrollees meeting the criteria set forth in §B(1) of this regulation also have Hepatitis C. The Department shall use encounter and fee-for-service data documenting services provided to the HIV/AIDS enrollees identified in accordance with §B(1) of this regulation for the appropriate historical diagnostic period: For the initial assessment period, through June of the calendar year before the rate year; and For the mid-year assessment period, through December of the calendar year before the rate year. Methodology for Determining MCO-specific HIV and AIDS Case Mix Measures. For each MCO, the Department shall: Based on encounter and fee-for-service data from the appropriate historical diagnostic period, classify the MCO's HIV/AIDS enrollees identified pursuant to §B of this regulation as either: Hepatitis C-infected; or Hepatitis C-uninfected. Average relative value for HIV and AIDS payment categories are as follows: Apply weights reflecting costs associated with Hepatitis C-infected and Hepatitis C-uninfected enrollees in each HIV and AIDS payment category to the MCO-specific distribution of HIV/AIDS enrollees who are Hepatitis C-infected or Hepatitis C-uninfected, as determined pursuant to §C(1) of this regulation; and For each MCO, use the results of the calculations specified in §C(2)(a) of this regulation to separately calculate an average relative value for each of the HIV and AIDS payment categories. To determine an MCO's relative case mix factors, each MCO's relative values determined pursuant to §C(2)(b) of this regulation are divided by the overall average relative value determined pursuant to §C(2)(a) of this regulation. Methodology for MCO-Specific Case Mix-Adjusted HIV and AIDS Rates. For each MCO, the Department shall: Calculate MCO-specific HIV and AIDS relative case mix factors for each HIV and AIDS payment group pursuant to §C(3) of this regulation; Calculate MCO-specific HIV and AIDS rates for the rate adjustment period by multiplying the risk adjustment factor derived pursuant to §D(1) of this regulation by the value specified for each HIV and AIDS payment group for the rate year; and Apply a budget neutrality adjustment to the values derived pursuant to §D(2) of this regulation so that the aggregate of payments to all MCOs pursuant to this regulation are equivalent to the aggregate of all payments that would be due to all MCOs in the absence of this regulation. Case Mix Updates. The Department shall: Update current enrollees' region of residence and enrollment categories by repeating the calculations in §§B—D of this regulation every 6 months using residence and enrollment data as of the enrollment month specified below: For the initial assessment period of each rate year, June of the calendar year before the rate year; and For the mid-year assessment period of each rate year, December of the calendar year before the rate year; and For rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated Hepatitis C-infected and Hepatitis C-uninfected distribution to compute its risk adjusted HIV and AIDS payment rates for each rate adjustment period, as described in §D of this regulation. The Department may grant an adjustment to those MCOs for whom the uniform encounter data adjustment results in completeness factors that are below the Statewide average. The encounter adjustment for each MCO shall be determined for the Family and Children RACs and for the Disabled RACs respectively. Definitions. In this regulation, in addition to the definitions set forth in COMAR 10.67.01, the following terms have the meanings indicated. Terms Defined. “Demographic rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(b) and B(2)(b) of this chapter. “Initial rate adjustment period” means the 6-month period beginning January 1 of the rate year. “Mid-year rate adjustment period” means the 6-month period beginning July 1 of the rate year. “RAC rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(a) and (2)(a) of this chapter. “Rate adjustment period” means a 6-month period within the rate year that includes: The initial rate adjustment period beginning January 1 of the rate year; and The mid-year rate adjustment period beginning July 1 of the rate year. “Rate year” means the calendar year to which the rates calculated pursuant to this regulation apply. “Risk Adjustment Category (RAC)” means a grouping of adjusted clinical groups (ACGs), each of which is associated with a similar level of risk. “Risk assessment cohort” means each of the eight groupings of enrollees, assigned on the basis of their: Program eligibility category, either “families and children”, as specified in Regulation .19B(1) of this chapter, or “disabled”, as specified in Regulation .19B(2) of this chapter; Region of residence category, either in “Baltimore City” or in the “rest of State”; and Age category, either at least 1 year old but younger than 21 years old, or 21 years old or older. “Risk assessment year” means the calendar year 2 years before the rate year. For calculating an adjustment to MCO payment rates reflecting the relative level of risk of providing enrollees assigned to demographic rate cells covered health care services pursuant to COMAR 10.67.06, the Department shall, for each MCO, identify the enrollees to be considered as follows: For each rate adjustment period in the rate year, identify the current demographic enrollees for each MCO who: In the risk assessment year: Were certified eligible for the Program for at least 6 months; Were assigned to a demographic rate cell; and As of June 30, were 1 year old or older; and In the calendar year before the rate year: For the initial rate adjustment period calculation for the rate year 2004, were enrolled in the MCO in March; For the initial rate adjustment period calculation for rate years after 2004, were enrolled in the MCO in June; and For the mid-year rate adjustment period calculation, were enrolled in the MCO in December; Assign each enrollee identified pursuant to §B(1) of this regulation into one of the eight risk assessment cohorts; Make the determinations necessary for the assignments required by §B(2) of this regulation consistent with the following time frames: For an initial rate adjustment period calculation for the rate year 2004: An enrollee's eligibility category and region of residence as of March of the calendar year before the rate year; and An enrollee's age category as of March 31 of the calendar year before the rate year; For an initial rate adjustment period calculation for rate years after 2004: An enrollee's eligibility category and region of residence as of June of the calendar year before the rate year; and An enrollee's age category as of June 30 of the calendar year before the rate year; and For a mid-year rate adjustment period calculation: An enrollee's eligibility category and region of residence as of December of the calendar year before the rate year; and An enrollee's age category as of December 31 of the calendar year before the rate year; and For calculating an MCO's case mix adjustment pursuant to this regulation, disregard any risk assessment cohorts to which fewer than 50 of an MCO's enrollees are assigned pursuant to §B(2) of this regulation. Methodology for Determining MCO-specific RAC Case Mix Measures. For each MCO, the Department shall: Based on encounter and fee-for-service data documenting services delivered during the risk assessment year, determine the diagnoses attributable to an MCO's enrollees identified pursuant to §B of this regulation; Based on diagnoses in the risk assessment year, assign each enrollee identified pursuant to §B of this regulation to the appropriate risk adjustment category (RAC), consistent with the protocol set forth in Regulation .19B(1)(a) and (2)(a) of this chapter; Apply the RAC rates for the appropriate rate adjustment period to the RAC distribution determined pursuant to §C(2) of this regulation; Using the results of the calculations specified in §C(3) of this regulation, calculate an MCO's average RAC rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and To determine an MCO's relative RAC case mix factors, divide each of the MCO's average RAC rates determined in accordance with §C(4) of this regulation by each overall average RAC rate for all MCOs for the same risk assessment cohort. Methodology for Determining MCO-specific Demographic Case Mix Measures. For each MCO, the Department shall: Determine the demographic distribution of its current enrollees as specified in §B of this regulation; Apply the appropriate demographic rates for the rate adjustment period to the demographic distribution as determined pursuant to §D(1) of this regulation; Using the results of the calculations specified in §D(2) of this regulation, calculate the MCO's average demographic rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and To determine an MCO's relative demographic case mix factors, divide each of the MCO's average demographic rates determined pursuant to §D(3) of this regulation by each of the overall average of demographic rates for all MCOs for the same risk assessment cohort. MCO-Specific Case Mix Adjusted Demographic Rates. The Department shall, for each MCO: Calculate MCO-specific risk adjustment factors by dividing, for each risk assessment cohort, the relative RAC case mix factor determined pursuant to §C of this regulation, by the relative demographic case mix factor determined pursuant to §D of this regulation; Modify the MCO-specific risk adjustment factor derived for each risk assessment cohort pursuant to §E(1) of this regulation as follows: Reduce each risk adjustment factor that is higher than 1.1 to 1.1; and Increase each risk adjustment factor that is lower than 0.9 to 0.9; Subject to §E(4) of this regulation, calculate the MCO-specific demographic rates for the rate adjustment period by multiplying the risk adjustment factor for each risk assessment cohort, derived pursuant to §E(1) of this regulation, by the value specified in each demographic rate cell for the rate year; and Apply a budget neutrality adjustment to the values derived in §E(3) of this regulation so that aggregate payments to all MCOs pursuant to this regulation are equivalent to the aggregate payments that would be due to all MCOs in the absence of this regulation. Case Mix Updates. The Department shall: Repeat the calculations described in §§C—E of this regulation every 6 months to update current MCO enrollees' region of residence, age, and enrollment categories as of the calendar year before the rate year, as provided in §B(3) of this regulation; and For the rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated RAC case mix measures and updated demographic case mix measures to compute its demographic rates for the rate adjustment period, as described in §E of this regulation. By September 1 of the second calendar year following the MLR reporting year, each MCO shall provide to the Department a completed MLR Reporting Template, including the MCO attestation and any additional documentation supporting the MLR reporting template. The MLR experienced for each MCO in an MLR reporting year is the ratio of the numerator, as defined in §D of this regulation, to the denominator, as defined in §E of this regulation. An MLR may be increased by a credibility adjustment, in accordance with §G of this regulation. Components of MLR — Numerator. The numerator of an MCO's MLR for an MLR reporting year is the sum of the MCO's incurred claims, the MCO's expenditures for activities that improve health care quality, and fraud prevention activities. Incurred Claims. Incurred claims include the following: Direct claims that the MCO paid to providers, including under capitated contracts with network providers, for services or supplies covered under the contract and services meeting the requirements of 42 CFR §438.3(e) provided to enrollees; Unpaid claims liabilities for the MLR reporting year, including claims reported that are in the process of being adjusted or claims incurred but not reported; Withholds from payments made to network providers; Claims that are recoverable for anticipated coordination of benefits; Claims payments recoveries received because of subrogation; Incurred but not reported claims based on past experience, and modified to reflect current conditions, such as changes in exposure or claim frequency or severity; Changes in other claims-related reserves; and Reserves for contingent benefits and the medical claim portion of lawsuits. An MCO shall deduct the following amounts from incurred claims: Overpayment recoveries received from network providers; and Prescription drug rebates received and accrued. An MCO shall include the following expenditures in incurred claims: The amount of incentive and bonus payments made, or expected to be made, to network providers; and The amount of claims payments recovered through fraud reduction efforts, not to exceed the amount of fraud reduction expenses, and excluding activities specified in §D(3) of this regulation; An MCO may include or deduct the following amounts from incurred claims: Net payments; or Receipts related to State-mandated solvency funds; An MCO shall exclude the following amounts from incurred claims: Non-claims costs; Amounts paid to the State as remittance under §I of this regulation; and Amounts paid to network providers under to 42 CFR §438.6(d). Non-claims costs as described in §D(6)(a) of this regulation include the following: Amounts paid to third-party vendors for secondary network savings; Amounts paid to third-party vendors for network development, administrative fees, claims processing, and utilization management; Amounts paid, including amounts paid to a provider, for professional or administrative services that do not represent compensation or reimbursement for State plan services or services meeting the definition in 42 CFR §438.3(e) and provided to an enrollee; and Fines and penalties assessed by regulatory authorities. Incurred claims paid by one MCO that are later assumed by another MCO shall be reported by the assuming MCO for the entire MLR reporting year, and no incurred claims for that MLR reporting year may be reported by the ceding MCO. An MCO shall include activities that improve health care quality in one of the following categories: An MCO activity that meets the requirements of 45 CFR §158.150(b) and is not excluded under 45 CFR §158.150(c); An MCO activity related to any EQR-related activity as described in 42 CFR §438.358(b) and (c); and Any MCO expenditure that is related to Health Information Technology and meaningful use, meets the requirements placed on issuers found in 45 CFR §158.151, and is not considered incurred claims. Excluding expenses for fraud reduction efforts in §D(4)(b) of this regulation, an MCO shall include expenditures on activities related to fraud prevention as adopted for the private market at 45 CFR part 158. Components of MLR Denominator. The denominator of an MCO's MLR for an MLR reporting year shall equal the adjusted premium revenue. The adjusted premium revenue is the MCO's premium revenue minus the MCO's federal, State, and local taxes and licensing and regulatory fees and is aggregated in accordance with §F of this regulation. Premium revenue includes the following for the MLR reporting year: State capitation payments, developed in accordance with 42 CFR §438.4, to the MCO for all enrollees under a risk contract approved under 42 CFR §438.3(a), excluding payments made under 42 CFR §438.6(d); State-developed, one-time payments, for specific life events of enrollees; Other payments to the MCO approved under 42 CFR §438.6(b)(3); Unpaid cost-sharing amounts that the MCO could have collected from enrollees under the contract, except those amounts the MCO can show it made a reasonable, but unsuccessful, effort to collect; All changes to unearned premium reserves; and Net payments or receipts related to risk sharing mechanisms developed in accordance with 42 CFR §438.5 or 42 CFR §438.6. Federal, State, and Local Taxes and Licensing and Regulatory Fees. Taxes and licensing and regulatory fees for the MLR reporting year include: Statutory assessments to defray the operating expenses of any State or federal department; Examination fees in lieu of premium taxes as specified by State law; Federal taxes and assessments allocated to MCOs excluding federal income taxes on investment income and capital gains and federal employment taxes; State and local taxes and assessments including: Any industrywide (or subset) assessments, other than surcharges on specific claims, paid to the State or locality directly; Guaranty fund assessments; Assessments of State or locality industrial boards or other boards for operating expenses or for benefits to sick employed persons in connection with disability benefit laws or similar taxes levied by states; State or locality income, excise, and business taxes other than premium taxes and State employment and similar taxes and assessments; and State or locality premium taxes plus State or locality taxes based on reserves, if in lieu of premium taxes; and Payments made by an MCO that are otherwise exempt from federal income taxes, for community benefit expenditures as defined in 45 CFR §158.162(c), limited to the highest of either: 3 percent of earned premium; or The highest premium tax rate in the State for which the report is being submitted, multiplied by an MCO's earned premium in the State. The total amount of the denominator for an MCO, which is later assumed by another MCO, shall be reported by the assuming MCO for the entire MLR reporting year and no amount under this section for that year may be reported by the ceding MCO. Allocation of Expense. Each expense shall be included under only one type of expense, unless a portion of the expense fits under the definition of, or criteria for, one type of expense and the remainder fits into a different type of expense, in which case the MCO shall prorate the expense between types of expenses. An MCO shall report on a pro-rata basis any expenditures that benefit multiple contracts or populations, or contracts other than those being reported. Methods Used to Allocate Expenses. An MCO shall base allocation to each category on a generally accepted accounting method that is expected to yield the most accurate results. An MCO shall apportion shared expenses, including expenses under the terms of a management contract, pro rata to the contract incurring the expense. The reporting entity shall bear any expenses that relate solely to its operation and may not apportion its operating expenses to other entities. Credibility Adjustment. An MCO may add a credibility adjustment to a calculated MLR if the MLR reporting year experience has partial credibility. An MCO shall add the credibility adjustment to the reported MLR calculation before calculating any remittances if required by the State as described in §I of this regulation. An MCO may not add a credibility adjustment to a calculated MLR if the MLR reporting year experience has full credibility. If an MCO's experience has no credibility, it is presumed to meet or exceed the MLR calculation standards in this regulation. MCOs shall use the base credibility factors CMS publishes on an annual basis that are developed according to the methodology in 42 CFR §438.8(h)(4). Eligibility Groups. MCOs shall aggregate data for all Medicaid eligibility groups covered under the contract with the Department. MCOs shall report, and the Department shall calculate, an annual MLR as described in this regulation separately for the childless adult population. The Department may require separate reporting and a separate MLR calculation for additional populations. An MCO shall provide a remittance for an MLR reporting year if the MLR for that MLR reporting year does not meet the minimum MLR standard of 85 percent. Newly Contracted MCOs. The Department may exclude an MCO that is newly contracted with the State from the requirements in this section for the first year of the MCO's operation. Newly contracted MCOs shall comply with the requirements in this section during the next MLR reporting year in which the MCO is in business with the State, even if the first year was not a full 12 months. If the Department makes a retroactive change to the capitation payments for an MLR reporting year where the report has already been submitted to the Department, the MCO shall recalculate the MLR for all MLR reporting years affected by the change and submit a new report. MCOs shall attest to the accuracy of the calculation of the MLR in accordance with requirements of this section when submitting its report to the Department. MCOs shall report fraud prevention activities as required by 42 CFR §438.8. Notice and Appeal. Within 30 days of its receipt of the notice of a remittance being due to the Department, an MCO may appeal the remittance as a sanction pursuant to COMAR 10.67.10.02. An MCO's appeal does not stay the obligation of the MCO to remit the amount owed to the Department. MCO Payment for Self-Referred Services. For undisputed claims that are submitted to the MCO within 6 months of the date of service, an MCO shall reimburse out-of-plan providers within 30 days for eligible services performed upon an enrollee who has self-referred: To a school-based health clinic pursuant to COMAR 10.67.06.28B, for services described in COMAR 10.67.07; For family planning services, pursuant to COMAR 10.67.06.28A; For an initial medical examination for an enrollee who is a child in State-supervised care, pursuant to Regulation .13F of this chapter; For one annual diagnostic and evaluation service visit for an enrollee diagnosed with human immunodeficiency virus or acquired immune deficiency syndrome (HIV/AIDS) pursuant to COMAR 10.67.06.28E; For obstetric and gynecologic care provided to a pregnant woman, under the circumstances described in COMAR 10.67.06.28C; and For an initial medical examination of a newborn when the: Examination is performed in a hospital by an on-call physician; and MCO failed to provide for the service before the newborn's discharge from the hospital. An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for school-based services as described in COMAR 10.67.07.03 and family planning services including office visits (CPT codes 9920199205 and 9921199215), preventive medicine office visits (CPT codes 9938399386 and 9939399396), and all FDA-approved contraceptive devices, methods and supplies, at the established Medicaid rates. An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for an initial examination for a child in State-supervised care utilizing the Medicaid payment schedule for the following procedure codes: An MCO shall reimburse out-of-plan providers rendering pregnancy-related services, as described in COMAR 10.67.06.28, at the Medicaid rate. An MCO shall reimburse out-of-plan providers performing the DES for HIV/AIDS at the Medicaid rate. An MCO may require enrollees to utilize in-plan providers for pharmacy and laboratory services ordered by out-of-plan providers of self-referral services, except as provided in §A(7) of this regulation. An MCO shall reimburse out-of-plan providers at the Medicaid rate for medically necessary pharmacy and laboratory services when the pharmacy or laboratory service is provided: In connection with a self-referred service specified in §A(1) of this regulation; and On-site by the out-of-plan provider at the same location that the self-referred service specified in §A(1) of this regulation was delivered to the MCO's enrollee. An MCO shall reimburse out-of-plan providers for renal dialysis services in a Medicare-certified facility, at least the Medicaid rate, regardless of whether or not the MCO's preauthorization was secured. An MCO shall reimburse out-of-plan providers under the circumstances described in COMAR 10.67.06.28G at a rate not less than the fee-for-service Medicaid rate for an initial medical examination of a newborn when the mother's MCO fails to provide for the service before the newborn is discharged from the hospital. An MCO shall reimburse out-of-plan providers at the Medicaid fee-for-service rate for services performed in a free-standing birth center as described in COMAR 10.67.06.28. An MCO shall reimburse out-of-plan doulas at the Medicaid fee-for-service rate for services performed during the prenatal, labor and delivery, and postpartum periods of pregnancy as described in COMAR 10.67.06.28 through December 31, 2025. MCO Payment for Emergency Services Provided at a Hospital. An MCO shall reimburse a hospital emergency facility and provider, which is not required to obtain prior authorization or approval for payment from an MCO in order to obtain reimbursement under this regulation, for: Health care services that meet the definition of emergency services in Health-General Article, §19-701, Annotated Code of Maryland; Medical screening services rendered to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; Medically necessary services if the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility and the medically necessary services are related to the emergency condition; and Medically necessary services that relate to the condition presented and that are provided by the provider in the emergency facility to the enrollee if the MCO fails to provide 24-hour access to a physician. MCO Payment to an Out-of-Network Federally Qualified Health Center for Services Immediately Required Due to an Unforeseen Illness, Injury, or Condition. Effective October 1, 2010, an MCO shall reimburse an out-of-network federally qualified health center (FQHC) for services provided to an enrollee that are immediately required due to an unforeseen illness, injury, or condition if: The FQHC participates in the Medical Assistance Program; The FQHC does not have a contract with the MCO; The services are immediately required due to the enrollee's unforeseen illness, injury, or condition; The emergent services are provided on site at the FQHC; and The FQHC has, before rendering services, verified with the enrollee's primary care provider that the enrollee cannot be seen within a reasonable amount of time based on the severity of the enrollee's condition. An MCO may require that the FQHC provide documentation that the FQHC has obtained the verification required under §C(1)(e) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation. An MCO may require that the FQHC provide documentation that services were required for the reasons identified under §C(1)(c) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation. The rate at which the MCO shall reimburse an out-of-network FQHC for services provided under §C(1) of this regulation shall be the rate identified in COMAR 10.67.04.21. For any reimbursement paid by an MCO under §C of this regulation, the Program shall pay the MCO the difference between the rates identified in COMAR 10.67.04.21 and COMAR 10.09.08.05-1. MCO Payment for Provider Services. An MCO shall pass on to providers any MCO rate adjustment that is specified by the Department for a fee increase. For inpatient services performed in hospitals, an MCO shall pay all providers, regardless of the provider's contracting status, at least the Medicaid fee-for-service rate. The MCO may not be required to pay providers more than the Medicaid fee-for-service rate. Payment for Hospital Services. An MCO shall reimburse Maryland hospital providers on the basis of rates approved by the Maryland Health Services Cost Review Commission (HSCRC). An MCO shall reimburse hospital administrative days at the Medicaid fee-for-service rate. Upon the direction of the Department, an MCO shall reduce payments by 20 percent to a hospital located in a contiguous state or in the District of Columbia for services rendered to its enrollees, if the hospital has failed to supply appropriate discharge data to the Health Services Cost Review Commission. FQHC’s shall be reimbursed under the Alternative Payment System (APS). The Department shall: Pay the MCO a prospective payment based on encounter data; and Reconcile the prospective amount paid to the MCO with the MCO's actual expenditure amount, after receipt of MCO encounter data; and MCOs shall reimburse any contracted FQHC, the FQHC’s rate established in accordance with COMAR 10.09.08.05-1A. For self-referred services described in Regulation .20 of this chapter, the MCO shall pay the FQHC’s usual rate in accordance with §A of this regulation, regardless of the FQHC’s contracted status with the MCO. An MCO shall qualify for protection under the Stop Loss Program if: It was participating in HealthChoice as of April 1, 1999; It was unable to self-insure or obtain a contract with another entity for Stop Loss reinsurance after July 1, 1999; and By July 1, 1999, the MCO requested the Department to continue to provide Stop Loss Protection at a rate determined by the Department. An MCO shall notify the Department that the acute inpatient hospital costs of an enrollee are expected to exceed the Stop Loss limit as soon as it knows that this is likely to occur. Upon confirming eligibility for stop loss protection, the Department shall assume liability for reimbursement of 90 percent of accrued acute inpatient hospital charges according to established Medicaid fee-for-service rates for medically necessary acute inpatient treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year. An MCO shall remain financially liable for reimbursing 10 percent of accrued acute inpatient hospital charges for medically necessary treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year, and shall maintain full responsibility for the provision of health care services to the enrollee. At the beginning of the next calendar year, an MCO shall reassume full financial responsibility and full discretion for developing medical treatment plans for any enrollee who qualified for the Stop Loss Program. The Department's Extended Stop Loss Period. If an inpatient enrollee remains hospitalized at the end of a calendar year and incurs acute hospital costs that exceed the Stop Loss limit into the following calendar year without interruption, the Department's stop loss period shall be extended until the end of that hospitalization. The MCO shall remain financially liable for costs up to the Stop Loss limit for enrollees who remain hospitalized in an acute setting at the end of the calendar year as specified in §§A and D of this regulation until the enrollee is discharged. For calendar year 2001 and beyond, the MCO shall submit the MCO's Stop Loss Reinsurance Plan or Self-Insurance Plan to the Maryland Insurance Administration. If an MCO chooses to have the Department provide its Stop Loss coverage, an adjustment will be made to the capitation amount the MCO is paid. Upon the termination of the provider agreement between the enrollee's MCO and the Department, if an MCO has failed to fulfill its financial liability under this regulation, the Department shall assume responsibility only for costs that exceed the Stop Loss limit as specified in §C of this regulation. An MCO may not have face-to-face or telephone contact with a recipient, or otherwise solicit a recipient who is not an enrollee of the MCO, unless authorized by the Department or the recipient initiates the contact. Subject to prior approval by the Department, an MCO may engage in marketing activities designed to make recipients aware of their availability, as well as any special services they offer. Unless they involve face-to-face solicitation, these marketing activities may involve campaigns using but not limited to: Television; Radio; Newspaper; Informational booths at public events; Billboards and other public displays; Addressee-blind informational mailings, but only when mailed to the MCO's entire service area; Magazines; Airborne marketing displays; or Public conveyances. An MCO may not engage in any cold call marketing, including activities using or involving any of the following mechanisms: Direct marketing; Telephone solicitation; Door to door flyers; Email; Texting; Material or financial incentives of any kind, with the exception of advertising trinkets such as balloons or pens that have an acquisition cost of $5 or less; or Influencing enrollment in conjunction with the sale or offer of private insurance. Standards for Departmental Approval of MCO Advertising. MCO advertising shall: Be based on documented fact; Identify all telephone numbers used that do not belong to the MCOs; Include the statement, “'HealthChoice' is a program of the Maryland Department of Health”; and Be at a fifth grade reading level. MCO advertising may not: Be false or misleading; Ascribe to the MCO unique coverage or services that are otherwise required by State or federal law or regulation; Assert that a recipient shall enroll in the MCO in order to obtain benefits or in order not to lose benefits; or Assert that the MCO is endorsed by CMS, the federal or State government or similar entity. An MCO shall submit to the Department, on an annual basis, a written enrollee outreach plan that: Describes how the MCO intends to comply, in the upcoming year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland; and Provides evidence of the MCO's compliance during the previous year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland. Submission Date. An MCO applicant shall submit its initial enrollee outreach plan, as part of its MCO application, as required by COMAR 10.09.64.06O. An MCO shall submit by December 1 an enrollee outreach plan, including the information specified in §A of this regulation, to be reviewed as part of the triennial audit performed by an external quality review organization (EQRO). For years in which the triennial EQRO audit is not performed, an MCO shall submit by April 30 any changes to the enrollee outreach plan, including the information specified in §A of this regulation. An MCO may terminate its provider agreement with the State as provided in §§B—D of this regulation. The MCO shall provide written notification to the Department of the MCO's intent to terminate the MCO's provider agreement with the State for any given calendar year by the previous October 1. An MCO that has previously terminated the provider agreement with the State and would like to sign a new agreement with the State, shall follow the application process as specified under COMAR 10.67.03. The Department may waive the requirement under §B of this regulation if the Department determines that the circumstances warrant, including but not limited to a reduction in rates outside the normal rate setting process or an MCO exit from the program. An MCO shall identify a newborn coordinator who shall be available to providers during the MCO's business hours as a contact for concerns related to eligibility and provision of services to newborns. The newborn coordinator shall provide services for a newborn: Whose mother is enrolled in the MCO on the date of the newborn's birth; and Who is enrolled or who is autoassigned to the MCO after birth. The newborn coordinator shall: Research and confirm the assignment of an eligible newborn to a managed care organization; Interface with the enrollment agent, the Department, the newborn coordinators of other MCOs, and the provider to resolve any eligibility issues involving multiple MCOs; Facilitate and confirm the selection of a primary care provider for an eligible newborn; Request an MCO ID card for a newborn when necessary; Make retroactive PCP enrollments when necessary; Facilitate the resolution of claims for services provided to an eligible newborn; Provide general guidance to providers and their office staff on newborn-related issues; Coordinate with ancillary care providers to facilitate appropriate delivery of care and payment of claims; and Coordinate and authorize in-network care when the newborn does not yet appear in EVS or the MCO's system, or out-of-network care when the MCO cannot offer an appropriate in-network provider. Health-General Article, §§2-104, 15-101, 15-102.3, and 15-103; Insurance Article, §§15-112, 15-605, and 15-1008; Annotated Code of Maryland Effective date: Regulations .01—.23 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) Regulations .01—.23 adopted effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulations .02C, .04C, .08, .11, .15, .17A, .18, .20B, and .22C amended and Regulation .11-1 adopted as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144); November 1, 1999 (26:22 Md. R. 1692); February 18, 2002 (29:3 Md. R.220) Regulation .02 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .02G amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .02G and H amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .03P amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .03T adopted effective February 18, 2002 (29:3 Md. R.220) Regulation .03 repealed and new Regulation .03 adopted effective December 23, 2002 (29:25 Md. R. 1981) Regulation .04C amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .05 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .05K amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .08 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .10B amended effective February 18, 2002 (29:3 Md. R.220) Regulation .11 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .11 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .11 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. 1838) Regulation .11 amended effective February 18, 2002 (29:3 Md. R.220); December 23, 2002 (29:25 Md. R. 1981) Regulation .11-1 and .11-2 adopted February 9, 1998 (25:3 Md. R. 144) Regulation .11-1 and .11-2E amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulations .11-1 and .11-2 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838) Regulation .15 amended effective February 9, 1998 (25:3 Md. R. 144); December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R.220) Regulation .15B amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .15D, E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .16 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .17A amended effective February 9, 1998 (25:3 Md. R. 144); December 23, 2002 (29:25 Md. R. 1981) Regulation .17B amended effective February 18, 2002 (29:3 Md. R.220) Regulation .18 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .18-1 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) Regulation .18-1 amended effective December 25, 2000 (27:25 Md. R.2281) Regulation .18-1C adopted effective November 1, 1999 (26:22 Md. R. 1692) Regulation .19 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); emergency status extended at 26:1 Md. R. 17, 26:6 Md. R. 480, and 26:8 Md. R. 614; emergency status expired May 1, 1999 Regulation .19 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 Regulation .19 amended effective November 1, 1999 (26:22 Md. R. 1692) Regulation .19 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .19 amended effective December 25, 2000 (27:25 Md. R.2281) Regulation .19 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .19A amended as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931 and 29:4 Md. R. 413 Regulation .19B amended effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .19D amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulations .19-1—.19-3 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulations .19-1—.19-4 adopted effective December 25, 2000 (27:25 Md. R. 2281) Regulations .19-1 and .19-2 repealed and new Regulation .19-1 adopted effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19-1 repealed as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); repealed permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulations .19-3 and .19-4 amended and recodified to be new Regulations .19-2 and .19-3 effective December 24, 2001 (28:25 Md. R. 2190) Regulation .19-3 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .19-3 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .19-4 adopted effective December 23, 2002 (29:25 Md. R. 1981) Regulations .19-5 and.19-6 adopted as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931; emergency status extended at 29:4 Md. R. 413 Regulation .20 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .20 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .20A amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .21 amended effective December 25, 2000 (27:25 Md. R. 2281); December 24, 2001 (28:25 Md. R. 2190); July 7, 2003 (30:13 Md. R. 854) Regulation .22 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 Regulation .22 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .22 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; adopted permanently effective June 25, 2001 (28:12 Md. R. 1109) Regulation .22 amended effective December 24, 2001 (28:25 Md. R. 2190) Regulation .22A amended and F—J adopted effective November 1, 1999 (26:22 Md. R. 1692) Regulation .22C amended effective February 9, 1998 (25:3 Md. R. 144) Regulations .24 and .25 adopted as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .24 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 Regulation .24 amended effective December 25, 2000 (27:25 Md. R.2281); December 23, 2002 (29:25 Md. R. 1981) Regulation .24-1 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000 Regulation .26 adopted effective February 18, 2002 (29:3 Md. R. 220) Regulation .27 adopted effective February 18, 2002 (29:3 Md. R. 220) Chapter revised effective February 2, 2004 (31:2 Md. R. 82) Regulation .01 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .02G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .02G, J, X amended effective November 7, 2016 (43:22 Md. R. 1221) Regulation .02K amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .02O, S amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .02V amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .02Z adopted effective November 5, 2007 (34:22 Md. R. 1977) Regulation .02CC amended effective October 5, 2009 (36:20 Md. R. 1528); March 14, 2016 (43:5 Md. R. 385) Regulation .02DD adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .02EE adopted effective December 24, 2012 (39:25 Md. R. 1613) Regulation .02K, L amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .02FF adopted effective October 28, 2013 (40:21 Md. R. 1775) Regulation .03 amended effective February 12, 2018 (45:3 Md. R. 156) Regulation .03A, B amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .03B amended effective December 19, 2005 (32:25 Md. R. 1941); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180) Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787); February 6, 2012 (39:2 Md. R. 141); December 24, 2012 (39:25 Md. R. 1613); December 12, 2013 (40:24 Md. R. 2017); August 29, 2016 (43:17 Md. R. 955); November 7, 2016 (43:22 Md. R. 1221); December 31, 2018 (45:26 Md. R. 1245) Regulation .04B amended effective April 10, 2006 (33:7 Md. R. 668); February 16, 2015 (42:3 Md. R. 316) Regulation .04C amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205) Regulation .05I amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05G amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .05K amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .06C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .08C, E amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .08I amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .08K amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .08M repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .10C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .10D amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .10E amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .10F amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .11 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .11E amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .11F amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .11G amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .11-1 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .11-2 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .12B amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .12D repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .13F amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .14 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .14A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .15 amended effective February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) Regulation .15B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .15C amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .15D amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .15E amended effective December 19, 2005 (32:25 Md. R. 1941); April 19, 2010 (37:8 Md. R. 615) Regulation .15F amended effective April 10, 2006 (33:7 Md. R. 668) Regulation .15L adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .16 repealed effective November 5, 2007 (34:22 Md. R. 1977) Regulation .17 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .17A amended effective November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180); February 6, 2012 (39:2 Md. R. 141) Regulation .17B amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); February 1, 2016 (42:23 Md. R. 1434) Regulation .18H amended effective November 5, 2007 (34:22 Md. R. 1977) Regulation .18I, J adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .19 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634) Regulation .19 amended as an emergency provision effective April 1, 2005 (32:9 Md. R. 847); amended permanently effective July 18, 2005 (32:14 Md. R. 1276) Regulation .19 amended effective April 15, 2013 (40:7 Md. R. 611) Regulation .19A, B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); amended permanently effective June 16, 2008 (35:12 Md. R. 1120) Regulation .19A amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .19B amended effective December 20, 2004 (31:25 Md. R.1790); December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 669) Regulation .19B amended as an emergency provision effective July 1, 2006 (33:20 Md. R. 1610); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) Regulation .19B amended as an emergency provision effective January 1, 2007 (34:4 Md. R. 396); amended permanently effective April 9, 2007 (34:7 Md. R. 699) Regulation .19B amended as an emergency provision effective September 14, 2007 (34:21 Md. R. 1911); amended permanently effective November 19, 2007 (34:23 Md. R. 2027) Regulation .19B amended effective January 12, 2009 (36:1 Md. R. 21); July 27, 2009 (36:15 Md. R. 1166); January 25, 2010 (37:2 Md. R. 67); June 14, 2010 (37:12 Md. R. 800); December 27, 2010 (37:26 Md. R. 1788); April 4, 2011 (37:8 Md. R. 431); April 30, 2012 (39:8 Md. R. 534); December 10, 2012 (39:24 Md. R. 1577); July 7, 2014 (41:13 Md. R. 752); February 16, 2015 (42:3 Md. R. 316); October 26, 2015 (42:21 Md. R. 1301); May 9, 2016 (43:9 Md. R. 530); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319); August 26, 2019 (46:17 Md. R. 726) Regulation .19D amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 446); amended permanently effective May 24, 2004 (31:10 Md. R. 795) Regulation .19D amended effective June 14, 2010 (37:12 Md. R. 800); October 26, 2015 (42:21 Md. R. 1301); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) Regulation .19-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .19-3 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .19-3 amended effective June 19, 2006 (33:12 Md. R. 997); April 9, 2007 (34:7 Md. R. 698); June 14, 2010 (37:12 Md. R. 800); April 30, 2012 (39:8 Md. R. 534) Regulation .19-3 repealed effective October 28, 2013 (40:21 Md. R. 1775) Regulation .19-3 adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .19-3A, B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .19-3A, B amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .19-3B amended effective December 24, 2012 (39:25 Md. R. 1613); February 3, 2014 (41:2 Md. R. 91) Regulation .19-3C amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .19-3C, D amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .19-5 adopted effective December 19, 2005 (32:25 Md. R. 1941) Regulation .19-5 repealed and new Regulation .19-5 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .19-5F amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .19-5G amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .19-5H amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .20 amended effective August 8, 2011 (38:16 Md. R. 945); February 26, 2018 (45:4 Md. R. 205) Regulation .20A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .20A amended effective April 10, 2006 (33:7 Md. R. 668); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316) Regulation .20A, B amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .20A, D amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .20B, C amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .20C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .20E adopted effective August 29, 2016 (43:17 Md. R. 955) Regulation .21 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .21 amended effective February 16, 2015 (42:3 Md. R. 316) Regulation .21B amended effective June 19, 2006 (33:12 Md. R. 997); April 19, 2010 (37:8 Md. R. 615) Regulation .22 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .22C, D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .23 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .23C amended effective November 7, 2016 (43:22 Md. R. 1221) Regulation .23D amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .23D amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .24 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .24 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .25B amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .28 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .28 amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .28 repealed effective February 26, 2018 (45:4 Md. R. 205) Chapter transferred from COMAR 10.09.65 effective November 1, 2019 (46:22 Md. R. 977) Regulation .03B amended effective April 19, 2021 (48:8 Md. R. 309) Regulation .15D amended effective May 18, 2020 (47:10 Md. R. 515) Regulation .25B amended effective May 18, 2020 (47:10 Md. R. 515) Regulation .27C amended effective May 18, 2020 (47:10 Md. R. 515) Chapter revised effective October 18, 2021 (48:21 Md. R. 889) Regulation .03-1 repealed and new Regulation .03-1 adopted effective June 24, 2024 (51:12 Md. R. 620) Regulation .03-2B amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .03-2L adopted effective June 24, 2024 (51:12 Md. R. 620) Regulation .03-2L repealed and new Regulation .03-2 adopted effective April 28, 2025 (52:8 Md. R. 359) Regulation .03-2M adopted effective April 28, 2025 (52:8 Md. R. 359) Regulation .15E amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .17B amended effective June 13, 2022 (49:12 Md. R. 641) Regulation .18K adopted effective April 28, 2025 (52:8 Md. R. 359) Regulation .19 amended effective April 4, 2022 (49:7 Md. R. 468) Regulation .19B, D amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .19D amended effective April 28, 2025 (52:8 Md. R. 359) Regulation .19E adopted effective April 28, 2025 (52:8 Md. R. 359) Regulation .19-4A amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .19-4M, N amended effective June 13, 2022 (49:12 Md. R. 641) Regulation .20A, C amended effective June 24, 2024 (51:12 Md. R. 618) An MCO shall provide access to health care services and information in a manner that addresses the individualized needs of its enrollees, regardless of gender, sexual orientation, or gender identity, including, but not limited to, the delivery of services and information to enrollees: In a culturally sensitive manner; At an appropriate reading comprehension level; In the prevalent non-English languages identified by the State; and In a manner that accommodates individuals with disabilities consistent with the requirements of the Americans with Disabilities Act of 1990, P.L. 101-330, 42 U.S.C. §12101 et seq., and regulations promulgated under it. Special Access. An MCO shall notify enrollees of the following services and make them available free of charge to the enrollee: Written materials in the prevalent non-English languages identified by the State; Written materials in alternative formats; Oral interpretation services in all non-English languages; and Auxiliary aids and services, such as: Teletypewriter/Telecommunication Device for the Deaf (TTY/TDD); and American Sign Language. An MCO shall include taglines in the prevalent non-English languages identified by the State with its written materials critical to obtaining services that: Explain the availability of written translation or oral interpretation to understand the information provided; and Provide the toll-free and TTY/TDD telephone number of the MCO’s customer service unit. Written Materials. An MCO shall provide all its written materials in the following manner: Using language and a format that is easily understood; In a font size no smaller than 12 point; Available in alternative formats and through the provision of auxiliary aids and services; and Available in an appropriate manner that takes into consideration the special needs of enrollees or potential enrollees with disabilities or limited English proficiency. An MCO may provide enrollee information electronically so long as all of the following requirements are met: The format is readily accessible; The information is placed in a location on the MCO’s website that is prominent and readily accessible; The information is provided in an electronic form which can be electronically retained and printed; The information is consistent with the content and language requirements of this section; The enrollee is informed that the information is available in paper form without charge upon request; and Should the enrollee request it, the MCO provides the information in paper form within 5 business days. An MCO shall inform and educate its enrollees about: Basic information about the MCO; The availability of health care services and how to access them; The definitions of managed care terminology in accordance with 42 CFR 438.10(c)(4)(i); and Enrollee's rights and responsibilities in the MCO, and that the exercise of those rights does not adversely affect the way the MCO, its providers, or the Department treats the enrollee. An MCO shall, at the time of enrollment, and anytime upon request, furnish each enrollee with a copy of the MCOs enrollee handbook that includes all language in the template provided by the Department and the following current information: The enrollee's rights and responsibilities in the MCO as described in 42 CFR §438.100(b)(1), as amended; Information on how to access urgent care and emergency care services, including: What constitutes an emergency medical condition and emergency services; The following facts: Prior authorization is not required for these services; and The enrollee has a right to use any hospital or other setting for emergency care; The services included in the MCO's benefits package, including optional benefits provided by the MCO; How and where to access any benefits provided by the State, including any cost sharing, and how transportation is provided; The amount, duration, and scope of benefits available in sufficient detail to ensure that enrollees understand the benefits to which they are entitled; The availability of behavioral health services that are not included in the MCOs benefits package, and how to access these services; Information on the availability of self-referral services as well as any restrictions on the enrollee's freedom of choice among network providers; Information about how enrollees may obtain benefits from out-of-network providers; Any policies and procedures necessary to facilitate accessing needed services in compliance with the Maryland Medicaid Managed Care Program, including any requirements for service authorizations or referrals for specialty care and for other benefits not furnished by the enrollee's primary care provider; Information about the availability of EPSDT, prenatal care, family planning, and other wellness services, including education programs; A statement that the MCO cannot require an enrollee to obtain a referral before choosing a family planning provider; The process of selecting and changing the enrollee's primary care provider; A description of any benefits the MCO offers in addition to those required by the Maryland Medicaid Managed Care Program, including applicable terms and conditions for accessing those benefits; Information on how to access auxiliary aids and services, including additional information in alternative formats or languages; The toll-free telephone number for member services, medical management, and any other unit providing services directly to enrollees, including: A description of each unit and number; An explanation of how the phone numbers can be used to obtain information and assistance; and An explanation of the MCOs internal grievance procedure. Information regarding the importance of scheduling and maintaining appointments for preventive services; If applicable, a list of services that are not covered by the MCO because of moral or religious objections, and a statement that informs the enrollee that the State will provide information on how and where to obtain these services; The rule pertaining to poststabilization care services, as set forth in Regulation .08G of this chapter; Appeal, grievance, and fair hearing procedures and time frames that include the following: The right to a State fair hearing, including the method for obtaining a hearing and the rules that govern representation at the hearing; The right to file appeals and grievances; The requirements and time frames for filing an appeal or grievance; The availability of assistance in the filing process; The toll-free numbers that the enrollee may use to file an appeal or grievance by phone; The fact that, if requested by the enrollee, the benefits will continue if the enrollee files an appeal or a request for a State fair hearing within the time frames specified for filing; and That the enrollee may be required to pay the cost of the services furnished while the appeal is pending, if the final decision is adverse to the enrollee; Any appeal rights the State chooses to make available to providers; Advanced directives as set forth in 42 CFR §438.3(j)(1), as amended; Information on how to report suspected fraud or abuse; Additional information that is available upon request, including the following: Information on the structure and operation of the MCO; and Physician incentive plans. Information on how to access or obtain the MCOs provider directory. Provider Directory. An MCO shall provide enrollees with information regarding their provider networks including: Its primary care service locations; A listing of the MCOs hospital providers, of both inpatient and outpatient services, in the enrollee's county, their addresses, and services provided; A listing of the MCOs pharmacy providers in the enrollee's county and their addresses; and A listing of the individual practitioners who are the MCOs primary and specialty care providers in the enrollee's county, grouped by medical specialty, giving: Name; Address; Practice location or locations; Telephone number or numbers; Website URL, as appropriate; Any group affiliation, as appropriate; Cultural and linguistic capabilities, including languages offered by the provider or a skilled medical interpreter at the provider’s offices, American Sign Language interpretation; An indication of whether the provider's office or facility has accommodations for physical disabilities, including offices, exam room or rooms and equipment; An indication of whether or not the provider is accepting new patients; An indication of the age range of patients accepted or whether there is no age limit; and If applicable, how access to the provider is otherwise limited. Upon request by an enrollee, an MCO shall furnish a paper copy of the provider directory. An MCO shall notify all enrollees of their right to request and obtain the information listed in §§B and C of this regulation at least once a year. The Department may consider the information listed in §§B and C of this regulation to be provided if the MCO: Mails a printed copy of the information to the enrollee's mailing address; Provides the information by email after obtaining the enrollee's agreement to receive the information by email; Posts the information on the MCOs website and advises the enrollee in paper or electronic form that the information is available on the internet and includes the applicable internet address, provided that enrollees with disabilities who cannot access this information online are provided auxiliary aids and services upon request at no cost; or Provides the information by any other method that can reasonably be expected to result in the enrollee receiving that information. An MCO shall update its online provider directory no later than 30 days after the MCO receives updated provider information. An MCO shall update its paper directory: Monthly if the MCO does not have a mobile-enabled electronic directory; or Quarterly if the MCO has a mobile-enabled electronic directory. An MCO shall make provider directories available on its website in a machine-readable file and format as specified by the Secretary for the U.S. Department of Health and Human Services. An MCO is responsible for delivering needed health care services even when the enrollee is difficult to reach or misses appointments. The assistance of local health departments in contacting and bringing into care enrollees who are difficult to reach or miss appointments is available for the specific categories of enrollees identified in this regulation, but only after the MCO has made documented attempts to contact and bring into care an enrollee who is difficult to reach or misses appointments before seeking the assistance of the local health department. Adults. An MCO shall, before referring the enrollee to the local health department, make documented attempts to ensure that follow-up appointments are scheduled in accordance with the enrollee's treatment plan by attempting a variety of contact methods, which may include: Written correspondence; Telephone contact; and Face-to-face contact. If the enrollee, due to impaired cognitive ability or psychosocial problems such as homelessness or other conditions, can be expected to have difficulty understanding the importance of treatment instructions or difficulty navigating the health care system, the MCO shall, after exhausting its best efforts to contact and bring into care the enrollee in accordance with §C(1) of this regulation, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance within 10 business days of whichever first occurs: The third consecutive missed appointment; or The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care. Child Younger than 2 Years Old Needing EPSDT Screening Services. An MCO shall ensure that appointments are scheduled in accordance with the EPSDT periodicity schedule or within 30 days of the MCO's receipt of the health risk assessment, whichever is less. If the enrollee fails to keep the appointment, the MCO shall ensure that a second appointment is scheduled within 30 days. If the enrollee misses the second appointment, a third appointment shall be scheduled within 30 days. For each scheduled appointment, the MCO shall: Provide written notice to the enrollee's parent, guardian, or caretaker of the appointment dates; and Attempt to notify the enrollee's parent, guardian, or caretaker of the appointment dates by telephone. If the enrollee misses the second appointment in a row, after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. After referral to the local health department, the MCO shall continue to work collaboratively with the local health department to bring the enrollee into care until the enrollee comes back into compliance with the EPSDT periodicity schedule. Child Younger than 21 Years Old Needing Follow-up Treatment. An MCO shall ensure that an appointment for follow-up care is scheduled at a time interval appropriate to the enrollee's diagnosed condition. If the enrollee fails to keep the appointment, the MCO shall reschedule the appointment for the enrollee to be seen within 30 days. For each scheduled appointment, the MCO shall: Provide written notice to the enrollee, or to the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by mail; and Attempt to notify the enrollee, or the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by telephone. If the enrollee misses the second consecutive follow-up appointment after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the enrollee into care. Pregnant or Postpartum Woman Needing Prenatal or Postpartum Care. Initial Visit. An MCO shall schedule an initial visit for the pregnant or postpartum enrollee to be seen within 10 days of her request for an appointment. If she fails to appear for the appointment, the MCO shall reschedule in a timely manner appropriate to her medical condition. Follow-Up Appointments. After the enrollee has completed an initial visit that includes a comprehensive history, physical exam, and completion of the Maryland Prenatal Risk Assessment, the MCO shall ensure that appointments are scheduled for the enrollee in compliance with the periodicity schedule of the ACOG guidelines. If the enrollee fails to appear for a scheduled appointment, the MCO shall ensure that the appointment is rescheduled for the enrollee to be seen within 10 days. For each scheduled appointment, the MCO shall: Provide written notice to the enrollee of the appointment dates; and Attempt to notify the enrollee of the appointment dates by telephone. After making the attempts specified in §F(3) of this regulation, if the MCO is unable to bring the enrollee into care within 30 days of the first missed appointment, the MCO shall, within 10 days of the last missed appointment, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the patient into care, until the enrollee comes back in compliance with the ACOG periodicity schedule. An MCO shall develop and make available either electronically or by hard copy to all of its PCP and specialty care providers a Medicaid requirements manual, including periodic updates as appropriate, and shall: Before distribution, file a copy of its manual with the Department for review; Include in its manual the information necessary to facilitate the providers’ full compliance with federal and State Medicaid requirements, including information on: Medicaid statutes and regulations; The benefits package, including optional benefits; Access requirements, which, at a minimum, comply with the requirements of this chapter; Quality requirements, which shall, at a minimum, comply with the requirements of COMAR 10.67.04.03; Continuity of care requirements; Requirements for referral to specialist, ancillary, and other providers as necessary to provide the full range of medically necessary services that are covered by the Maryland Medicaid Managed Care Program; and The MCO’s practice guidelines as described in 42 CFR §438.236. Inform the MCO’s primary and specialty care providers of their responsibility to provide or arrange for medically necessary accessible health care services that are continuous, comprehensive, and coordinated for each enrollee, including: Preventive health services; Primary acute medical care; Chronic medical care; Consultation, referral, and follow-up in areas including medical specialties and child dental care; Referral for ancillary and support-related services including but not limited to: Drug therapies; Diagnostic tests; Medical supplies; Durable medical equipment; and Case management when appropriate for complex conditions; 24-hour per day, 7-day per week provider coverage for medically necessary services; Maintenance of a medical record, including records of referral arrangements and outcomes of those referrals; and Detection of mental health problems or substance use disorder during routine or follow-up screening, to be treated either through the MCO or referred to the behavioral health ASO for services; and Inform the providers of the following enrollee appeal, grievance, and fair hearing procedures and time frames: The enrollee's right to a State fair hearing, how to obtain a hearing, and representation rules at a hearing; The enrollee's right to file appeals and grievances, and the enrollee's requirements and time frames for filing; The availability of assistance in filing; The toll-free numbers to file verbal appeals and grievances; The enrollee's right to request continuation of benefits during an appeal or State fair hearing filing, and that if the MCO action is upheld in a hearing, the enrollee may be liable for the cost of any continued benefits; and The provider's right to appeal, on the enrollee's behalf, the failure of the MCO to cover a service. An MCO shall ensure that its PCP and specialty care providers receive adequate information regarding the Medicaid Program to facilitate full compliance with all federal and State Medicaid requirements. The MCO shall: Ensure that each PCP and specialty care provider receives, at the time they enter into a contract, a copy of the MCO's Medicaid requirements manual, and any other pertinent information; and Provide each PCP and specialty care provider, on an ongoing basis as appropriate, with periodic updates of the materials required to be provided under §B(1) of this regulation. An MCO shall provide to each PCP an updated list of the PCP’s assigned enrollees monthly. Primary Care Provider (PCP). An MCO shall assign each enrollee to a primary care provider who is: Chosen by the enrollee from the MCO's panel of qualified providers; or Chosen by the MCO from its panel of qualified providers if the enrollee has failed to choose a PCP. An enrollee may request a change of PCP at any time if the PCP is within the recipient's current MCO's panel of providers. With respect to enrollees younger than 21 years old, an MCO shall assign the enrollee to a PCP who is certified by the EPSDT program, unless the enrollee or the enrollee's parent, guardian, or caretaker, as appropriate, specifically requests assignment to a PCP who is not EPSDT-certified. If the enrollee’s parent, guardian, or caretaker, as appropriate, chooses a non-EPSDT certified PCP in accordance to §A(3) of this regulation, within 30 days of enrollment, the MCO shall: Notify the parent, guardian, or caretaker, by letter, that a non-EPSDT certified PCP has been chosen; and Include in the notification an explanation of the: EPSDT preventive screening services to which an enrollee is entitled according to the EPSDT periodicity schedule; Importance of accessing the EPSDT preventive screening services; and Process for requesting a change to an EPSDT-certified PCP to obtain preventive screening services. An MCO may include, as appropriate, any of the following practitioners to serve as the primary care provider for an enrollee: General practitioner; Family practitioner; Internist; Pediatrician; OB/GYN; Physician assistant; Certified nurse midwife; Nurse practitioner certified in any of the following areas of specialization: Adult; Pediatric; Geriatric; OB/GYN; School nurse; or Family; and A physician practicing in a specialty area other than those enumerated in §A(5)(b)—(e) of this regulation. The enrollee's designated primary care provider (PCP) is the enrollee's primary coordinator of care. For female enrollees, if the enrollee's PCP is not a women's health specialist, the MCO shall provide direct access, without the need for a referral, to a women's health specialist within the MCO's network for covered services necessary to provide women's routine and preventive health care services. Adequacy of Provider Network. An MCO shall develop and maintain a complete network of adult and pediatric primary care, specialty care, ancillary service, vision, pharmacy, home health, and any other providers adequate to deliver the full scope of benefits as required by this chapter and COMAR 10.67.06. An MCO shall clearly define and specify referral requirements to specialty and other providers. An MCO shall require the PCP to maintain records of referral arrangements, and the feedback and outcomes of those referrals, within each enrollee's medical records. An MCO shall maintain a list of its proposed and existing subcontracts with health care providers who are necessary to fulfill the MCO's service delivery obligations. An MCO shall provide a list of its subcontractor providers to the Department. An MCO shall ensure services are delivered in a culturally competent manner to all enrollees, including enrollees: With limited English proficiency; With diverse cultural and ethnic backgrounds; and Of all genders, sexual orientations, and gender identities. For enrollees with physical or mental disabilities, an MCO shall ensure its network providers provide: Physical access; Reasonable accommodation; and Accessible equipment. Capacity. MCOs shall ensure adequate capacity and services, in compliance with 42 CFR §438.206(b)(1)(i), as amended. The Department shall assess the MCO's provider network and determine its capacity to serve waiver-eligible recipients in each local access area in its service area. Unless the MCO can establish to the Department's satisfaction the adequacy of a higher ratio, the Department shall determine the MCO's capacity with respect to any local access area by assuming that in-plan individual practitioners, based on full-time equivalency, will be assigned no more than the number of enrollees that is consistent with a 200:1 ratio of enrollee to practitioner in the local access area. The Department may not approve an enrollee-to-PCP ratio that is higher than 2,000:1. To ensure compliance with the timely access requirements in Regulation .07 of this chapter, an MCO shall: Establish mechanisms to ensure that network providers comply with access requirements; Monitor regularly to determine compliance; and Take corrective action if there is a failure to comply. Standards and Regions. The Department shall review an MCOs specialty provider network for MCOs overall network as defined in this regulation. Overall Network Standards. An MCO shall meet either the time or distance standard set forth in Regulation .06A of this chapter for core, major, and pediatric specialties. The nine core specialties are: Cardiology; Otolaryngology (ENT); Gastroenterology; Neurology; Oncology; Ophthalmology; Orthopedics; Surgery; and Urology. The 6 major specialties are: Allergy and immunology; Dermatology; Endocrinology; Infectious disease; Nephrology; and Pulmonology. The 4 pediatric subspecialties are: Cardiology; Gastroenterology; Neurology; and Surgery. If the Department determines that an MCO does not meet the requirements specified in §A(2)(b)(d) of this regulation, the MCO may provide additional information to support the adequacy of the MCO's specialty network before any action is taken by the Department. If an MCO fails to meet the requirements established by this regulation, the Department may suspend the automatic assignment to the MCO of recipients who live in the affected local access area. Except as provided in §C of this regulation, an MCO shall develop and maintain a provider network that meets the following time and distance standards: For adult and pediatric primary care, pharmacy, diagnostic laboratory and x-ray, and gynecology: In urban areas, within 15 minutes or 10 miles; In suburban areas, within 30 minutes or 20 miles; and In rural areas, within 40 minutes or 30 miles; For prenatal care, as defined in §B of this regulation: In urban areas, within 15 minutes or 10 miles; In suburban areas, within 30 minutes or 20 miles; and In rural areas, within 90 minutes or 75 miles; For acute inpatient hospitals: In urban areas, within 20 minutes or 10 miles; In suburban areas, within 45 minutes or 30 miles; and In rural areas, within 75 minutes or 60 miles; For core specialty types, as defined in Regulation .05-1A(2)(b) of this chapter: In urban areas, within 30 minutes or 15 miles; In suburban areas, within 60 minutes or 45 miles; and In rural areas, within 90 minutes or 75 miles; For major specialty types, as defined in Regulation .05-1A(2)(c) of this chapter: In urban areas, within 30 minutes or 15 miles; In suburban areas, within 80 minutes or 60 miles; and In rural areas, within 110 minutes or 90 miles; and For pediatric subspecialty types, as defined in Regulation .05-1A(2)(d) of this chapter: In urban areas, within 30 minutes or 15 miles; In suburban areas, within 80 minutes or 60 miles; and In rural areas, within 250 minutes or 200 miles. Prenatal Care Providers. For the purposes of provider network adequacy, prenatal care providers may include, but are not limited to: Obstetricians; Certified nurse midwives; and Family practitioners who provide prenatal care and perform deliveries. If an MCO can otherwise demonstrate to the Department's satisfaction the adequacy of its provider network notwithstanding its inability to meet the requirements of §A of this regulation, the Department may, in its discretion, approve the network if special circumstances exist which, considered along with the overall strength of the MCO's network, establish that the Department's approval of the network will enhance recipients' overall access to quality health care services in the area to be served. Geographical Access: Local Access Areas. For purposes of this regulation: Urban enrollment area includes Baltimore City; Rural enrollment counties include: Allegany; Calvert; Caroline; Cecil; Charles; Dorchester; Frederick; Garrett; Kent; Queen Anne's; Saint Mary's; Somerset; Talbot; Washington; Wicomico; and Worcester; and Suburban enrollment counties include: Baltimore County; Anne Arundel; Carroll; Harford; Howard; Montgomery; and Prince George’s. Appointments. New Enrollees: Initial Appointment. On its receipt and review of the health service needs information of a new enrollee, an MCO shall take appropriate action to ensure that the new enrollee who needs special or immediate health care services, as identified by the health service needs information, receives them in a timely manner. Unless the new enrollee is assigned to a PCP who was the enrollee’s established provider of care immediately before the enrollee’s enrollment, and, consistent with any applicable periodicity schedule, the PCP concludes that no immediate initial appointment is necessary: Unless a shorter time frame otherwise applies, the MCO shall ensure that a new enrollee's initial appointment is scheduled to occur within 90 days of the date of enrollment; Unless the PCP confirms that the enrollee has elected to continue prenatal care with her established provider pursuant to COMAR 10.67.06.28C, the MCO shall ensure that an initial prenatal appointment is scheduled to occur within 10 days of the date that the MCO receives the enrollee's completed health risk assessment, or within 10 days of the enrollee's request for an appointment, whichever is sooner; If the new enrollee is a person requesting family planning services, the MCO shall ensure that an initial appointment is scheduled to occur within 10 days of the date of the enrollee's request for an appointment; or If the new enrollee is identified to be at high risk by the health service needs information form, the MCO shall ensure that an initial appointment is scheduled to occur within 15 business days of the MCO’s receipt of the enrollee’s completed health risk assessment. Required Notice to Enrollees of Wellness Services. An MCO shall notify its enrollees in writing of their due dates for obtaining wellness services, including but not limited to immunizations and examinations, in a timely manner. An MCO shall perform the notice required in §A(2)(a) of this regulation within 90 days of a new enrollee's enrollment. Appointment Guidelines. An MCO shall develop specific guidelines that define how requests for appointments are arranged, which shall include a policy that: On request, all family members needing appointments will be given appointment times that are approximately concurrent or consecutive, whenever practicable, to facilitate the enrollees' transportation to and from their appointments; and When needed, enrollees will be afforded assistance in securing transportation to and from appointments, which shall include, when appropriate, contacting the local transportation grantee agency on behalf of the enrollee for the purpose of securing the enrollee's access to these services. An MCO shall have procedures that result in an interval between the enrollee's request for an appointment and the actual appointment time being consistent with the following standards: When §A(3)(b)(i) of this regulation does not apply, well-child assessments shall be scheduled to be completed within 30 days of the request for an appointment; Initial assessments of pregnant and postpartum women and individuals requesting family planning services shall be scheduled to be completed within 10 business days of the request for an appointment; Individuals requesting urgent care shall be scheduled to be seen within 48 hours of the request; Requests for routine and preventative primary care appointments shall be scheduled to be performed within 30 days of the request; Requests for routine specialist follow-up appointments shall be scheduled to be performed within 30 days of the initial authorization from the enrollee's primary care provider, or sooner as deemed necessary by the primary care provider, whose office staff shall make the appointment directly with the specialist's office; At the discretion of the newborn's PCP, the initial visit for newborns shall be scheduled to be performed within 14 days of discharge from the hospital if no home visit has occurred; If a home visit has been provided, the initial visit for newborns shall be scheduled to be performed, at the discretion of the newborn's PCP, within 30 days of discharge from the hospital; and Requests for regular optometry, lab, and X-ray appointments shall be scheduled to be performed within 30 days of the request, and within 48 hours of the request for urgent care. An MCO shall respond in a timely manner to its enrollees' needs and requests, as follows: If the enrollee arrives early or on time for a scheduled appointment, waiting time to be seen for a regular office visit may not exceed 1 hour after the scheduled appointment time; An MCO representative may not leave an enrollee's telephone call on hold for more than 10 minutes; and An MCO representative shall respond to patient inquiries as to whether or not to use emergency facilities within 30 minutes. Hours of Access for Clinical Services. An MCO shall establish, or require its subcontractors to establish, a reasonable schedule of operating hours during which its service delivery sites are open to the MCO's enrollees as follows: For the MCO's employee and subcontractor providers who are individual practitioners, operating hours shall be at least 20 hours per week and at least 3 days per week; For subcontractors who have contracted with the MCO as a group practice or facility, the operating hours shall be at least 35 hours per week; The distribution of the hours of service shall be consistent with enrollee utilization patterns, but is otherwise at the discretion of the MCO or its subcontractor; and The operating hours may not be less than: The hours of operation offered to commercial enrollees; or The hours of operation offered to Medicaid fee-for-service, if the provider serves only Medicaid enrollees. Hours of Access for Pharmacy Services. An MCO shall establish reasonable hours of access to pharmacy services, including weekend and evening hours, which are equivalent to the hours pharmacy services are generally available in the local access area to the public at large. If the MCO determines that weekend and evening pharmacy hours are not generally available in the local access area, it may request approval from the Department to offer only limited pharmacy hours as specified in §C(2)(c) of this regulation. To seek approval to offer limited pharmacy hours, an MCO shall make its request for approval to the Department, and shall include the following: A specification of the geographical areas where the MCO intends to have limited pharmacy hours; An explanation of why only limited pharmacy hours are available in these areas; and An identification of where its enrollees would have to go to secure prescriptions in the evenings and on weekends. Except as permitted in §C(2)(e) of this regulation, an MCO shall ensure that an enrollee receives at the time the prescription is dispensed to the enrollee any medically necessary disposable medical supplies or durable medical equipment needed by the enrollee to administer or monitor the enrollee's prescriptions. An MCO shall ensure that any disposable supplies or durable medical equipment necessary to administer or monitor an enrollee's prescriptions, if not available at the pharmacy at the time of the dispensing of the prescription, is received in a manner so as not to adversely affect the health of the enrollee, but not later than 24 hours. Clinical Access Outside the MCO's Service Area. Subject to §D(2) of this regulation, an MCO shall be financially responsible for medically necessary emergency services delivered to its enrollees outside of the MCO's service area. With the exception of emergency services, an MCO may require authorization before treatment for services delivered to its enrollees outside of the MCO's service area. If the MCO’s provider network is unable to provide necessary services, covered under the contract, to an enrollee, the MCO shall adequately and timely cover these services out of network for as long as the MCO’s provider network is unable to provide them. The Department may not impose any fines or other sanctions against an MCO for failure to comply with the waiting time standards in §B of this regulation unless there is evidence of a pattern of repeated violations by the MCO. An MCO shall develop and maintain policies and procedures for the adequate provision of emergency services for all its enrollees, including: Instituting and monitoring a system for responding to enrollees' emergency medical conditions, with provisions for immediate attention to and appropriate disposition of emergency calls; and Informing and educating its enrollees in the procedures to be followed in the event of an emergency, whether within or outside of the MCO's service area. An MCO shall provide medically necessary emergency services 24 hours per day, 7 days per week. An MCO shall maintain an emergency telephone service, with a physician on call, for the purpose of rendering medical advice and authorizing care at other facilities when use of the MCO's own facilities is impractical. An MCO may provide emergency services access through adequate and appropriate triage assessments performed by qualified medical professionals. An MCO shall utilize the trauma triage and transfer protocols established through the Maryland Institute for Emergency Medical Services Systems (MIEMSS) as the basis for directing the severely injured enrollee to the most appropriate level designated trauma center. An MCO shall reimburse, within 30 days of invoice, the undisputed claims of hospital emergency facilities and providers for the following services provided to the MCO's enrollees: Emergency services, as defined in COMAR 10.67.01.01B; Medical screening services based on the federal Emergency Medical Treatment and Active Labor Act (EMTALA); If the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility, medically necessary services that are related to the emergency condition, including poststabilization services; and If the MCO fails to provide 24 hour access to a physician, medically necessary services that relate to the condition presented and that are provided by the provider in an emergency facility to the enrollee. Poststabilization Services. The MCO may not require preapproval of, and is financially responsible for, poststabilization services obtained in or outside of the MCO's network and administered to maintain, improve, or resolve the enrollee's stabilized condition if: The MCO does not respond to a request for a preapproval within 1 hour; The MCO cannot be contacted; or The MCO representative and the treating physician cannot reach an agreement concerning the enrollee's care, and an MCO physician is not available for consultation, in which case: The MCO shall give the treating physician the opportunity to consult with an MCO physician; and The treating physician may continue care of the patient until a plan is reached or one of the following criteria is met: An MCO physician with privileges at the treating hospital assumes responsibility for the enrollee's care; An MCO physician assumes responsibility for the enrollee's care through transfer; An MCO representative and the treating physician reach an agreement concerning the enrollee's care; or The enrollee is discharged. An MCO may require that any continuing care be obtained from the MCO's providers or from providers approved by the MCO when the following conditions are satisfied: The enrollee's medical condition is appropriately stabilized and permits transferring responsibility for the enrollee's care, without medically harmful consequences, to these providers; and The transfer is consistent with the requirements of the federal Emergency Medical Treatment and Active Labor Act (EMTALA). An MCO shall comply with the access standards specified in Regulation .06A of this chapter. If an MCO’s service area includes a county that is designated as a medically underserved area and there is only one hospital in the county, the MCO shall include the hospital in its network. Health-General Article, §§2-104, 15-102.1(b)(10), 15-102.3 and 15-103; Insurance Article §§15-112, 15-605, and 15-1008; Annotated Code of Maryland Effective date: Regulations .01—.08 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .01A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); November 7, 2016 (43:22 Md. R. 1221) Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .02 amended effective February 18, 2002 (29:3 Md. R. 220); June 30, 2008 (35:13 Md. R. 1180); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .02B, C amended effective August 29, 2016 (43:17 Md. R. 955) Regulations .03 and .04 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .03 amended effective February 9, 1998 (25:3 Md. R. 144); February 2, 2004 (31:2 Md. R. 82) Regulation .03D amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .04 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .04A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .04A, B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .04A, C amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .04C amended effective December 24, 2012 (39:25 Md. R. 1613) Regulation .05 amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180) Regulation .05A amended effective June 25, 2001 (28:12 Md. R. 1109) Regulation .05A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .05A amended effective February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434) Regulation .05B amended effective April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141) August 29, 2016 (43:17 Md. R. 955); December 31, 2018 (45:26 Md. R. 1244) Regulation .05-1 adopted effective February 2, 2004 (31:2 Md. R. 82) Regulation .05-1 amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .06 amended effective April 28, 2014 (41:8 Md. R. 471); December 31, 2018 (45:26 Md. R. 1244) Regulation .06A amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .06B amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .06E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .06E amended effective April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977) Regulation .07A amended effective February 2, 2004 (31:2 Md. R. 82); April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316) Regulation .07A, D amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .07B, C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .07B, D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07B, C amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .08B, F amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .09 adopted effective March 14, 2016 (43:5 Md. R. 385) Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred from COMAR 10.09.66 effective November 1, 2019 (46:22 Md. R. 977) Regulation .01B amended effective June 13, 2022 (49:12 Md. R. 641) Regulation .02C amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .02G amended effective June 13, 2022 (49:12 Md. R. 641) Regulation .04A amended effective June 13, 2022 (49:12 Md. R. 641) Regulation .05-1A amended effective April 28, 2025 (52:8 Md. R. 359) Regulation .05-1C amended effective October 18, 2021 (48:21 Md. R. 889); April 28, 2025 (52:8 Md. R. 359) Except for non-covered services set forth in Regulation .27 of this chapter and the non-capitated services described in COMAR 10.67.08, an MCO shall provide its enrollees with a benefits package that includes the covered services specified in this chapter when these services are deemed to be medically necessary including services covered under the Maryland Medicaid State Plan in the amount, duration, and scope set forth in the State Plan and in accordance with 42 CFR §440.230. An MCO shall ensure that the services provided are sufficient in amount, duration, or scope to reasonably achieve the purpose for which the services are furnished. An MCO is not required to provide non-covered services even when the service is medically necessary. Any limitations set forth in this chapter on covered services are not applicable to services required by enrollees who are younger than 21 years old when it is shown that the services are medically necessary to correct or lessen health problems detected or suspected by EPSDT screening services, as described in Regulation .20 of this chapter. An MCO may place appropriate limits on a service on the basis of criteria applied under the State plan, such as medical necessity. Cost Sharing and Prohibitions. Except for the following, an MCO may not charge its enrollees any copayments, premiums, or cost sharing: Up to a $3 copayment for brand-name drugs; Up to a $1 copayment for generic drugs; Any other charge up to fee-for-service limits as approved by the Department. An MCO may not: Deny services to an individual who is eligible for services because of the individual's inability to pay the cost sharing; Impose copayments for the following: Family planning services and supplies; Individuals younger than 21 years old; Pregnant women; Institutionalized individuals who are inpatients in long-term care facilities or other institutions; and Emergency services. Arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the enrollee. An MCO shall ensure that all health care services provided under this chapter are performed, to the extent required by law, by an appropriate health care provider who is licensed, certified, or otherwise legally authorized to practice or deliver the services in the state in which the service is provided. An MCO shall provide for a second opinion from a qualified health care professional within the network, or, if necessary, arrange for the enrollee to obtain one outside the MCO network. An MCO shall provide to its enrollees medically necessary primary care services that are provided: By the enrollee's PCP; At the direction of the enrollee's PCP; or With respect to a primary care service that is self-referred pursuant to Regulation .28 of this chapter: By an appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience; or By a clinic that furnishes health care services by or under the direction of a physician. An MCO shall provide to its enrollees medically necessary specialty care services that are outside of the enrollee's PCP's scope of practice, or, in the judgment of the enrollee's PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in and are provided by: A physician or an advanced practice nurse, acting within the scope of the individual's license or certification, training, and experience; A practitioner other than a physician or an advanced practice nurse when the practitioner is in a physician's employ, is under the physician's direct supervision, and performs the service within the scope of the practitioner's license, certification, or other legal authorization, for the purpose of assisting in the provision of the specialty care service; A clinic that furnishes health care services by or under the direction of a physician; or For enrollees who are younger than 21 years old, a doctor of dental medicine or dental surgery, if the services are surgical services that are also typically performed by physicians. Notwithstanding §A(2) of this regulation, specialty care services provided under Regulations .04—.25 of this chapter may include medically necessary diagnostic and treatment services provided by a physician or other appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience. An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act. An MCO shall provide to its enrollees all medically necessary pharmaceutical services and pharmaceutical counseling, including but not limited to: Legend drugs; Insulin; All FDA approved contraceptives; Hypodermic needles and syringes; Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; Enteric coated aspirin prescribed for the treatment of arthritic conditions; Nonlegend ferrous sulfate oral preparations; Nonlegend chewable tablets of any ferrous salt when combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation when the enrollee is younger than 12 years old; Medical supplies used in the preparation of compounded prescriptions for home intravenous therapy; Medical supplies or equipment used in the administration or monitoring of medication prescribed or ordered for an enrollee by a qualifying provider as specified in §B of this regulation; Latex condoms; Nonlegend ergocalciferol liquid (Vitamin D); and Emergency contraceptives for female recipients. Except as provided in §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by: An MCO provider; An out-of-plan provider, when the pharmacy services are ordered or prescribed in connection with medical care furnished by the provider to the MCO's enrollee: In response to the enrollee's emergency medical condition; or Pursuant to the enrollee's self-referral to the provider, when the care delivered qualifies as a permissible self-referred service under Regulation .28 of this chapter; or A behavioral health provider for drugs not in the behavioral health formulary. An MCO shall provide over-the-counter emergency contraceptives and latex condoms to enrollees without requiring an order from an authorized prescriber. An MCO shall provide coverage for the following when performed by a pharmacist: Contraceptive services, as follows: A patient assessment performed at the pharmacist’s practice location in order to determine: Whether to prescribe contraceptives; and Which contraceptive options to prescribe; and If contraceptives are prescribed, a referral: To the participant’s primary care practitioner or reproductive health care practitioner; or If the participant does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services. Administration of: Injectable medications for the treatment of sexually transmitted infection; and Maintenance injectables medications. Drug Formulary. An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program, and include at a minimum: Covered generic and name brand medications; and The tier each medication is on. An MCO shall include in its formulary drugs that are appropriate for medical management, safe, and effective. An MCO shall expand its formulary, as needed, to include drugs that are equivalent to new drugs approved by the federal Food and Drug Administration, and which are deemed to be appropriate, safe, and efficacious in the medical management of the MCO's enrollees. An MCO shall include in its formulary the following drugs: Leuprolide acetate; Clonidine; Guanfacine; Medroxyprogesterone; and Liothyronine. To ensure that its formulary drugs are medically necessary, safe, and efficacious, an MCO shall: Subject its formulary to a review process that is: Established and conducted by the MCOs Pharmacy and Therapeutics Committee; Approved by the Department; and Coordinated with the formulary review process of the Specialty Mental Health Services delivery system; and Submit its formulary for the review and approval of the Department, based upon the standards set forth in this regulation. Unless approved by the Department, an MCO may not require or utilize prior authorization or step therapy criteria for coverage of formulary drugs if such prior authorization or step therapy requires a recipient to use a drug that is included in the behavioral health formulary. Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in §H of this regulation. In this regulation, the term specialty drug means: A prescription drug that: Is prescribed for an individual with a complex, chronic or rare medical condition; Costs $600 or more for up to a 30-day supply; Is not typically stocked at retail pharmacies; and Requires a difficult or unusual process of delivery to the patient in the preparation, handling storage, inventory or distribution of the drug; or Requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug. . If an enrollee subsequently requests to use a retail pharmacy for specialty drugs the MCO may not limit the enrollee to the use of a mail order pharmacy. An MCO shall: Establish and maintain a drug utilization review program; Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components: Formulary management; Generic substitution; Therapeutic substitution; Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act; Drug use evaluation (DUE); Disease management; and Pharmacy and Therapeutic Committee; Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and Provide to the Department a detailed description of its drug utilization review program activities on an annual basis. The Department shall: Review each MCO’s drug utilization review program annually; and Notify an MCO annually if any of the standards established in §J(2) of this regulation have not been met. For any performance standard identified in §K(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.67.10.01A and B. Subject to the conditions specified in §B of this regulation, an MCO shall provide to its enrollees medically necessary home health services, including: Skilled nursing services, including the supervisory visits required by §A(2) of this regulation; Home health aide services, including biweekly supervisory visits by a registered nurse in the recipient's home, every second visit of which includes observations of the delivery of services by the aide to the enrollee; Physical therapy services; Occupational therapy services; Speech pathology services; and Medical supplies that are used during a home health visit. An MCO shall provide the home health services specified in §A of this regulation that are: Certified by the enrollee's PCP or by the enrollee's attending physician to be required on a part-time, intermittent basis; and Rendered in the enrollee's home. An MCO shall provide the following medically necessary habilitation services to enrollees eligible for Medical Assistance under §1902(a)(10)(A)(i)(VIII) of the Social Security Act: Physical therapy; Occupation therapy; and Speech therapy. At a minimum, an MCO shall provide the services in hospital inpatient and outpatient departments and physical therapy in an outpatient community setting. An MCO shall provide to its enrollees medically necessary inpatient hospital services as specified in this regulation. Admission to Long-Term Care Facility. An MCO shall provide to its enrollees medically necessary long-term care facility services for: The first 90 continuous days following the enrollee's admission; and Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department's determination that the admission is medically necessary as specified in §B(2) of this regulation. For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. The Department’s determination as described in §B(2) of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. The Department shall render a determination with respect to the medical necessity of a stay in a long-term care facility as specified in §B of this regulation within 3 business days of receipt of a complete application from the MCO. Childbirth — Length of Stay and Home Visits. Except as provided in §D(2) and (3) of this regulation, the criteria and standards used by an MCO in performing utilization review of hospital services related to maternity and newborn care, including length of stay, shall be in accordance with the medical criteria outlined in the Guidelines for Perinatal Care, which is incorporated by reference in COMAR 10.67.04.01. Unless the enrollee decides, in consultation with her attending provider, that less time is needed for recovery, an MCO shall provide or reimburse the cost of hospitalization including at least the following length of stay for an enrollee recovering from childbirth: 48 hours of inpatient hospitalization care following an uncomplicated vaginal delivery; or 96 hours of inpatient hospitalization care following an uncomplicated cesarean section. If the enrollee elects to be discharged earlier than the length of stay specified in §D(2) of this regulation, the MCO is required to provide a home visit or visits pursuant to Regulation .21B—D of this chapter. In addition to the mother's length of stay required to be afforded by §D(2) of this regulation, whenever a mother is required to remain hospitalized after childbirth for medical reasons and she requests that her newborn remain in the hospital while she is hospitalized, the MCO shall afford the newborn additional hospitalization while the mother remains hospitalized, for up to 4 days. If an enrollee is in the hospital at the time of disenrollment from the MCO, and remains eligible for Medical Assistance, the MCO is responsible for covering the remainder of that hospital admission following disenrollment. An MCO shall provide for a private hospital room when: The enrollee's condition requires a need for isolation; or The enrollee requires admission and only private rooms are available. Payment For Ancillary Services. Effective January 1, 2009, an MCO shall pay for all medically necessary ancillary services provided on inpatient hospital days including those days for which the inpatient hospitalization is otherwise appropriately denied. A denial of an inpatient ancillary service shall be based on the medical necessity of the specific ancillary service. An MCO is not required to pay for ancillary services if the entire hospitalization in §H(1) of this regulation is appropriately denied. Transports between hospitals are covered by the MCO when: A medically necessary covered service is not available at the hospital where an enrollee is being treated; and The enrollee is not being discharged from the sending hospital. An MCO's benefits package shall include medically necessary outpatient hospital services. An MCO shall provide to its enrollees medically necessary transplants. An MCO shall provide to its enrollees medically necessary: Diagnostic services; and Laboratory services, performed by a provider who: Is Clinical Laboratory Improvement Amendments (CLIA) certified; or Has a waiver of a certificate registration along with a CLIA identification number. An MCO shall provide to its enrollees medically necessary services in a chronic hospital, a chronic rehabilitation hospital, or a nursing facility for: The first 90 continuous days following the enrollee's admission; and Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department’s determination that the admission is medically necessary as specified in §C of this regulation. Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. The Department’s determination as described in §C of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. The Department shall render a determination with respect to the medical necessity of a stay in a nursing facility as specified in §C of this regulation within 3 business days of receipt of a complete application from the MCO. A determination by the Department that the admission is medically necessary does not relieve the MCO of the obligation to pay for the admission through the day on which the determination is made. An MCO shall use the Department’s criteria for determining medical necessity for the days described in §A(1) of this regulation. An MCO shall provide to its enrollees medically necessary disposable medical supplies and durable medical equipment, including but not limited to: All supplies and equipment used in the administration or monitoring of prescriptions by the enrollees; Incontinency pants and disposable underpads for medical conditions associated with prolonged urinary or bowel incontinence if necessary to prevent institutionalization or infection; Orthotic devices when medically necessary for use in the MCO enrollee’s home, school, or place of employment; Prosthetic devices once annually when medically necessary: For use in the enrollee’s home, school, or place of employment; or For the purpose of performing physical activities, including running, biking, swimming, strength training, and other activities to maximize the whole-body health and lower or upper limb function of the enrollee; Annual repairs to prosthetic devices covered under §A(4) of this regulation when: Medically necessary; and When the repair’s necessity is not due to misuse; Replacement of prosthetic devices covered under §A(4)of this regulation when medically necessary as follows: Once annually for devices less than 3 years old if the replacement is necessary for the following reasons: Because of a change in the physiological condition of the patient; Unless necessitated by misuse, because of an irreparable change in the condition of the prosthesis or the component of the prosthetic device; or Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device. For devices more than 3 years old subject to §A(4) and (5) of this regulation. Except as required in §C(1), an MCO shall provide preauthorization within 72 hours for DMS/DME services and supplies that require preauthorization by the MCO. An MCO shall provide its enrollees the disposable medical supplies and durable medical equipment in a timely manner so as to not adversely affect the health of the enrollees, in accordance with the following: For medical equipment or supplies, or both, when there is an urgent medical need such as to facilitate hospital discharge or when a potential exists for worsening of enrollee's condition, the MCO shall provide needed items within 24 hours of request; and For all other requests for DMS/DME, the MCO shall provide these items within 7 days from the date of request unless the MCO can document to the Department that justification for additional time is necessary. An MCO is responsible for paying for any durable medical equipment authorized and ordered while the member is active with the MCO if: The delivery of the item occurs within 90 days after the member's termination date from the MCO; and The member remains a Medicaid recipient. An MCO shall provide to its enrollees medically necessary vision care services as specified in this regulation. For enrollees who are 21 years old or older, the MCO is responsible for providing at least one eye examination every 2 years. For its enrollees who are younger than 21 years old, the MCO is responsible for providing medically necessary vision services, including but not limited to: At least one eye examination every year in addition to any vision screen performed as part of an EPSDT screen; Eyeglasses, limited to one pair per year unless lost, stolen, broken, or no longer vision appropriate; and Contact lenses, if medically necessary and if eyeglasses are not efficacious for the condition. An MCO shall provide for its enrollees medically necessary podiatry services. In addition to the services described in §A of this regulation, an MCO shall provide: Diabetes care services specified in COMAR 10.67.06.24; and Routine foot care for enrollees, 21 years old or older with vascular disease affecting the lower extremities. An MCO shall provide to its enrollees medically necessary outpatient rehabilitative services, including but not limited to physical therapy for adult enrollees. An MCO shall provide to its enrollees medically necessary oxygen and related respiratory equipment services. An MCO shall provide to its enrollees medically necessary dialysis services. An MCO shall provide to its enrollees comprehensive family planning services, including but not limited to medically necessary office visits and laboratory tests, all FDA-approved contraceptive devices, methods, and supplies, and voluntary sterilizations. An MCO may place appropriate limits on family planning services for the purpose of utilization control, provided that the services are provided in a manner that protects and enables the enrollee’s freedom to choose the method of family planning to be used consistent with 42 CFR §441.20. An MCO may not apply a copayment or coinsurance requirement for contraceptive drugs or devices. An MCO shall provide coverage for a single dispensing of a supply of prescription contraceptives for a 12-month period. An MCO shall provide, to enrollees younger than 21 years old, medically necessary Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) services, including: EPSDT comprehensive well-child services provided in accordance with the EPSDT periodicity schedule and performed by an EPSDT-certified provider, including: A comprehensive health and developmental history, including an evaluation of both physical and mental health development; A comprehensive unclothed physical exam; Immunizations appropriate to age and health history; Laboratory tests, including blood lead level assessment, as appropriate to age and risk; Health education, including anticipatory guidance; and Vision, hearing, and dental screening; EPSDT partial or interperiodic well-child services; and Health care services that are: Necessary to prevent, treat, or ameliorate physical, mental, or developmental problems or conditions identified by an EPSDT-certified provider or other health professional; Sufficient in amount, duration, and scope to treat the identified condition; and Subject to limitation only on the basis of medical necessity. The health care services described in §A(3) of this regulation shall include, at a minimum, all services described in this chapter, and the following: Chiropractic services; Nutrition counseling services; Private duty nursing services including: An initial assessment and development of a plan of care by a registered nurse; and On-going private duty nursing services delivered by a licensed practical nurse or a registered nurse; and Durable medical equipment. An MCO shall provide referrals for services not covered by Medicaid, but which are furnished at little or no cost to recipients, including appropriate referrals to: The Head Start Program; The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); School Health-Related Special Education Services; Vocational Rehabilitation; and Maternal and Child Health Services located at local health departments. An MCO shall provide to its pregnant and postpartum enrollees medically necessary pregnancy-related services, including: Comprehensive prenatal, perinatal, and postpartum care, including high-risk specialty care when appropriate; Prenatal risk assessment and development of an individualized plan of care that specifies the actions required to address each identified need and is appropriately modified during the course of care; Enriched maternity services, including: Prenatal and postpartum counseling and education; Basic nutritional education; Substance abuse treatment, as provided in Regulation .10 of this chapter; Appropriate referrals to services that may improve the pregnancy outcome, including: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and Healthy Start services; High-risk nutrition counseling services for nutritionally high-risk pregnant women; Appropriate levels of inpatient care, including emergency transfer of pregnant women and newborns to tertiary care centers; Smoking cessation education and treatment; Doula services; and Home visiting services. When an enrollee recovering from childbirth elects to be discharged before 48 hours following a normal vaginal delivery or 96 hours following an uncomplicated cesarean section, the MCO is responsible for providing: One home visit scheduled to occur within 24 hours after discharge; and An additional home visit as may be prescribed by the attending provider. When an enrollee recovering from childbirth and her newborn enrollee remain in the hospital for at least as long as the period of time provided under §B of this regulation, the MCO shall provide a home visit as prescribed by the attending provider. An MCO shall provide for home visits required by §§B and C of this regulation to be performed by a registered nurse and in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child, including: An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse symptoms of the mother; Collection of a blood specimen for newborn screening if not previously completed; Referrals for any medically necessary continuing health care services; and Any other nursing services ordered by the referring provider. An MCO shall provide medically necessary case management services to its qualifying enrollees, as specified in COMAR 10.67.04.10C. An MCO shall include in its benefits package medically necessary hospice care services to enrollees who are terminally ill. The Department shall allow an enrollee to disenroll from an MCO and choose a new MCO if: The enrollee was auto-assigned to the MCO; and The enrollee's hospice provider does not contract with the enrollee's assigned MCO. If an enrollee who is in a hospice that does not contract with the enrollee's MCO and the enrollee will not voluntarily choose a new MCO, the enrollee's current MCO: Shall authorize and pay the out-of-network hospice provider at the established Medicaid rate, to ensure continuity of care; and May not require the hospice care enrollee to change their out-of-network hospice provider to an in-network hospice provider. An MCO shall provide to its qualifying enrollees medically necessary diabetes prevention and care services as specified in this regulation. National Diabetes Prevention Program. In addition to the services included in its usual benefits package, an MCO shall make available to its enrollees who meet the Centers for Disease Control and Prevention (CDC) eligibility criteria defined in §B(2) of this regulation the National Diabetes Prevention Program through a CDC-recognized lifestyle change organization. To be eligible for participation in the National Diabetes Prevention Program, a HealthChoice enrollee: Shall be 18 through 64 years old; Shall be overweight or obese; Shall have an elevated blood glucose level or a history of gestational diabetes mellitus; May not have a previous diagnosis of type 1 or type 2 diabetes prior to enrollment; and May not be currently pregnant. In addition to the services included in its usual benefits package, an MCO shall provide enrollees with a diabetes diagnosis the following medically necessary special diabetes-related services: Diabetes nutrition counseling, consisting of one initial one-on-one session and up to 4 subsequent sessions annually; Diabetes outpatient education; Diabetes-related durable medical equipment, disposable medical supplies, and therapeutic footwear and related services, when ordered as medically necessary, including: Therapeutic footwear, orthopedic shoes, arch supports, orthotic devices, in-shoe supports, elastic support, or examinations for prescription or fitting and related services to prevent or delay a foot amputation that would be highly probable in the absence of the specialized footwear; Blood glucose monitoring supplies; Diagnostic reagent strips and tablets used in testing for ketones and glucose in urine and glucose in blood; Finger-sticking devices used in obtaining blood samples for blood glucose testing; and Blood glucose reflectance meters for home use; Routine foot care; and Vision care consisting of: One ophthalmologic examination per year; and One pair of eyeglasses per year. An MCO shall provide to its enrollees medically necessary blood, blood products, derivatives, components, biologics, and serums to include autologous services, whole blood, red blood cells, platelets, plasma, immunoglobulin, and albumin. An MCO shall provide to its enrollees medically necessary primary mental health services, including appropriate referrals for service to the Department’s behavioral health ASO as described in COMAR 10.09.59. Effective October 1, 2023, MCOs shall provide their enrollees medically necessary primary mental health services, including the Collaborative Care Model, pursuant to COMAR 10.09.64. Subject to the conditions specified in §§B—F of this regulation, an MCO shall provide coverage for cost to an enrollee in an approved clinical trial for: Treatment provided for life-threatening conditions; or Prevention, early detection, and treatment studies on cancer. Clinical trials are deemed to be automatically approved if: The treatment is: Being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trials for cancer; or Being provided in Phase I, Phase II, Phase III, or Phase IV clinical trial for any other life-threatening condition; The treatment is being provided in a clinical trial: Approved by: The National Institutes of Health (NIH); An NIH cooperative group or an NIH center; The Centers for Disease Control and Prevention; The Agency for Healthcare Research and Quality; The Centers for Medicare and Medicaid Services (CMS); The Department of Defense; The Department of Veterans Affairs; or An institutional review board of an institution in the State that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NIH; or Conducted: At National Cancer Institute Centers; Under Investigational New Drug application (IND) reviewed by the Food and Drug Administration (FDA); or As a clinical trial with deemed status through an exemption from having an IND under 21 CFR §312.2(b)(1); The facility and the personnel providing the treatment are capable of doing so by virtue of the facility and the personnel's experience, training, and volume of patients treated to maintain expertise; There is no clearly superior, non-investigational treatment alternative; and The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative. Enrollee cost includes the following: The cost of all medically necessary items and services that are otherwise available to Medicaid beneficiaries such as hospital services, physician services, or diagnostic tests; and The cost of medically necessary items or services required solely for the provision of the following: Investigational item or service such as administration of a noncovered chemotherapeutic agent; The clinically appropriate monitoring of the effects of the item or service; or The prevention, diagnosis, and treatment of complications. Enrollee cost does not include the following: The cost of the investigational item or service itself; The cost of items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the enrollee; The cost of items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; and The cost of non-health care services that an enrollee may be required to receive as a result of the treatment being provided for purposes of the clinical trial. If the enrollee has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the enrollee for, services covered by this regulation, the provider shall seek payment from that source first. The MCO shall authorize the request for participation in an approved clinical trial within 72 hours of the request. An MCO shall provide to an enrollee medically necessary surgery to correct a deformity from disease, trauma, congenital or developmental anomalies, or to restore body functions. An MCO shall provide medically necessary gender-affirming treatment services which include but are not limited to the following: Hormone therapy, hormone blockers, and puberty blockers; Hair alteration for the purposes of altering secondary sex characteristics and surgical site preparation; Alterations to voice, voice therapy, and voice lessons; Alterations to abdomen, chest, trunk, and buttocks; Alterations to the face and neck; Alterations to the genitals and gonads; Laser treatment for scars from gender-affirming treatment; Standard fertility preservation procedures as set forth in Insurance Article, §15-810.1, Annotated Code of Maryland; Revisions to previous treatments and reversal of treatments; Combinations of gender-affirming procedures; and Other treatments as prescribed to suppress the development of endogenous secondary sex characteristics, align the individual’s appearance of physical body with gender identity, and alleviate symptoms of clinically significant distress resulting from gender dysphoria. An MCO may not issue an adverse benefit determination denying or limiting access to gender-affirming treatment unless a health care provider with experience prescribing or delivering gender-affirming treatment has reviewed and confirmed the appropriateness of the adverse benefit determination. An MCO shall provide enrollees medically necessary audiology services as described in COMAR 10.09.51, including: Hearing aids; Cochlear implants; Auditory osseointegrated devices; and Related services. An MCO shall provide its enrollees medically necessary remote patient monitoring services as described in COMAR 10.09.96. An MCO shall provide its enrollees medically necessary mobile integrated health services as described in COMAR 10.09.31. Subject to COMAR 10.09.63, an MCO shall provide coverage for community violence prevention. The benefits or services not required to be provided by an MCO are as follows: Experimental or investigational services, including organ transplants determined by Medicare to be experimental, except when an enrollee is participating in an authorized clinical trial as specified in Regulation .26-1 of this chapter; Any service or treatment that is not medically necessary; Services performed or prescribed under the direction of a person who is not a health care practitioner; Services that are beyond the scope of practice of the health care practitioner performing the service; Transportation services provided through grants to local governments pursuant to COMAR 10.09.19, other than assisting enrollees to access nonemergency transportation services through their local transportation grantee agency; Health-related services and targeted case management services provided to children when the services are: Specified in the enrollee's individualized family service plan (IFSP), or an individualized education program (IEP); and Delivered in the schools or through Children's Medical Services community-based providers; Autopsies; Immunizations required for travel outside the continental United States; Services received while the enrollee is outside the United States; Abortions; Diet and exercise programs for the loss of weight; Prescriptions or injections for central nervous system stimulants and anorectic agents when used for controlling weight; In vitro fertilization, ovum transplants and gamete intrafallopian tube transfer, zygote intrafallopian transfer, or other techniques used in these or similar procedures; Services to reverse a voluntary sterilization procedure; Lifestyle improvements, including smoking cessation, nutrition counseling, or physical fitness programs, unless specifically included as a covered service; Nonmedical ancillary services such as vocational rehabilitation, employment counseling, or educational therapy; Private duty nursing for adults 21 years old and older; Services incurred before the effective date of coverage for an enrollee; Dental or orthodontic care; Piped-in oxygen or oxygen prescribed for standby purposes or on an as-needed basis; and Cosmetic surgery when performed solely to maintain normal physical appearance or enhance beyond average level toward an aesthetic ideal. Enteral nutritional and supplemental vitamins and mineral products when administered orally. An MCO is not required to provide any of the benefits or services which are reimbursed directly by the Department as described in COMAR 10.67.08. An MCO shall be financially responsible for reimbursing, in accordance with COMAR 10.67.04.20, an out-of-plan provider chosen by the participant for the following services: Family planning services specified in COMAR 10.67.04.20A(2), (6), and (7); Services performed by school-based health centers (SBHCs), as provided in COMAR 10.09.76; Pregnancy-related services for women who are pregnant and, at the time of initial enrollment, have received prenatal care during their current pregnancy from an out-of-plan provider, and this pre-enrollment care consists of at least the following: A full prenatal examination; A risk assessment; and Appropriate laboratory services; Initial medical examination for children in State custody when performed by an EPSDT certified provider; One annual diagnostic and evaluation service (DES) visit for any enrollee diagnosed with HIV/AIDS, which the MCO is responsible for facilitating on the enrollee's behalf; Renal dialysis services performed in a Medicare-certified facility; Initial medical examination of a newborn when the: Examination is performed in a hospital by an on-call physician; and MCO failed to provide for the service before the newborn's discharge from the hospital; Emergency services as described in COMAR 10.67.05.08B; Prenatal, intrapartum, and postpartum services performed at a free-standing birth center located in Maryland or a contiguous state; and Doula services, through December 31, 2025. An MCO shall pay undisputed claims of the SBHC for services provided to its participants within 30 days of the MCO's receipt of the invoice. An MCO shall provide SBHCs in its service area with the current information needed to facilitate communication between the SBHC, PCP, and the MCO regarding care provided to the MCO's participant, and to effect reimbursement by the MCO, including: Information concerning the MCO's policies and procedures regarding the provision of pharmacy and laboratory services; Instructions for submitting claims; and Contact information, including names and phone numbers of the following individuals: The MCO representative who serves as an SBHC's contact person for coordination of care; and The student-participant's PCP. An MCO may provide its enrollees with additional health care services that are not required by this chapter. Optional health care services that an applicant intends to include in its benefits package shall be specified, including the terms and conditions for, and limitations to the provision of these services, in the applicant's initial application to the Department, as well as for periodic Departmental review. An MCO's provision of optional services that it has represented to be available to its enrollees is subject to monitoring of complaints and consumer satisfaction surveys, and to random audits. An MCO's provision of additional services that are not required by this regulation may not be taken into account when setting the MCO's capitation rate. Effective January 1, 2015, any changes to the health care services being offered by the MCO under §A of this regulation, including reducing or waiving pharmacy co-pays, shall be effective for an entire calendar year. An MCO shall notify the Department of any changes to their optional services by September 15 for the following calendar year. The Department may waive the requirement under §E of this regulation if the Department determines that the circumstance warrant, including but not limited to a reduction in rates outside the normal rate setting process. An MCO shall provide medically necessary fertility preservation services for the following individuals: Individuals who have iatrogenic infertility; Individuals who are receiving medical treatment that may directly or indirectly cause iatrogenic infertility; or Individuals who are receiving gender-affirming treatment. Fertility preservation services include sperm and oocyte cryopreservation and evaluations, laboratory assessments, medications, and treatments associated with sperm and oocyte cryopreservation. Fertility preservation services do not include the storage of sperm or oocytes. An MCO shall provide to its enrollees medically necessary telemedicine services as described in COMAR 10.09.49. Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland Effective date: Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253) Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255) Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528) Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471) Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141) Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281) Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615) Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316) Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253) Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144) Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668) Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301) Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732) Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316) Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584) Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180) Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220) Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253) Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82) Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221) Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732) Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973) Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973) Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732) Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726) Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316) Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955) Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973) Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775) Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973) Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144) Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947) Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355) Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141) Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981) Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732) Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698) Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775) Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775) Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471) Chapter transferred from COMAR 10.09.67 effective November 1, 2019 (46:22 Md. R. 977) Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337) Regulation .21A amended effective February 21, 2022 (49:4 Md. R. 300) Regulation .26 amended effective August 5, 2024 (51:15 Md. R, 707) Regulation .26-1 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .26-3 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .26-6 adopted effective May 1, 2023 (50:8 Md. R. 337) Regulation .26-7 adopted effective November 13, 2023 (50:22 Md. R. 974) Regulation .27 amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .27A amended effective April 28, 2025 (52:8 Md. R. 359) Regulation .28A amended effective June 24, 2024 (51:12 Md. R. 618) Regulation .30 adopted effective June 24, 2024 (51:12 Md. R. 620) An MCO or its responsible subcontractor shall implement and maintain arrangements or procedures that are designed to detect and prevent fraud, waste, and abuse, which includes a compliance program that has, at a minimum, the following elements: Written policies, procedures, and standards of conduct that include the MCO’s commitment to comply with all applicable: Requirements and standards under the contract; and Federal and State requirements including: Written policies for all employees and those of any contractor or agent that provide detailed information about the False Claims Act and other Federal and State laws described in §1902(a)(68) of the Social Security Act; and Information about rights of employees to be protected as whistleblowers. The designation of a compliance officer, who reports directly to the chief executive officer and the board of directors and is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements of the contract, and at minimum the following staff members: An investigator who is responsible for fraud, waste, and abuse investigations; An auditor who is responsible for identifying potential fraud, waste, and abuse through analysis of claims and related information; and An analyst capable of reviewing data and codes who is responsible for reviewing and researching evidence of potential fraud, waste, and abuse. Staffing and resources located in Maryland to identify and investigate potential fraud, waste, and abuse, which shall be based on criteria determined by the Department that may include but are not limited to: Number of enrollees; Number of claims received on an annual basis; Volume of suspected fraudulent and abusive claims currently being detected; Other factors relating to the vulnerability of the MCO to fraud and abuse; and An assessment of optimal caseload which can be handled by an investigator on an annual basis. The establishment of a regulatory compliance committee, which reports to the board of directors and to the MCO’s senior management level and is charged with overseeing the organization’s compliance program and its compliance with the requirements under the contract; A system for training and educating the compliance officer, the organization’s senior management, and the organization’s employees regarding the federal and State standards and requirements under the contract; Effective lines of communication between the compliance officer and the organization’s employees; Enforcement of standards through well-publicized disciplinary guidelines; Establishment and implementation of procedures and a system with dedicated staff for: Routine internal monitoring and auditing of compliance risks; Prompt response to compliance issues as they are raised; Investigation of potential compliance problems as identified in the course of self-evaluation and audits; Correction of problems, identified under §A(7)(c) of this regulation, promptly and thoroughly, or coordination of suspected criminal acts with law enforcement agencies, to reduce the potential for recurrence; and Ongoing compliance with the requirements under the contract. An MCO shall ensure that a subcontractor is legally qualified to furnish the services provided for in the subcontract. An MCO may not contract with the State unless conflict of interest safeguards at least equal to federal safeguards under section 27 of 41 U.S.C. §423, as amended, are in place. An MCO may not knowingly have a relationship of the type described in §E of this regulation with the following: An individual or entity that is debarred, suspended, or otherwise excluded from: Participating in procurement activities under the Federal Acquisition Regulation; or Participating in non-procurement activities under Executive Order Number 12549, 3 CFR 189 (1986); or An individual or entity who is an affiliate, as defined in 48 CFR §2.101, of a person described in §D(1) of this regulation. The relationships described in §D of this Regulation, are as follows: A director, officer, or partner of the MCO; A subcontractor of the MCO; A person with beneficial ownership of 5 percent or more of the MCO’s equity; or A network provider or person with an employment, consulting or other arrangement with the MCO for the provision of items and services that is significant and material to the MCO’s obligations under its contract with the Department. An MCO may not have a relationship with an individual or entity that is excluded from participation in any Federal health care program under §1128 or 1128A of the Social Security Act. An MCO shall monitor the Department’s correspondence and any database publicizing Department-initiated terminations of providers from the Program. An MCO shall terminate the contract of, or refrain from contracting with, providers terminated or excluded from participation in the Program. An MCO shall suspend payments to a network provider for which the Department has determined that there is a credible allegation of fraud in accordance with 42 CFR §455.23. An MCO shall establish a system to verify, by sampling or other methods, whether services that have been represented to have been delivered by network providers were received by enrollees and shall apply such verification processes at least annually. An MCO shall require and have a mechanism for a network provider to report to the MCO when it has received an overpayment and to: Return the overpayment to the MCO within 60 calendar days after the date on which the overpayment was identified; and Notify the MCO in writing of the reason for the overpayment. Overpayments to Providers and Subcontractors. Overpayments recovered by an MCO, including those recovered due to waste, fraud and abuse, may be retained by the MCO, so long as it is reported to the Department. If the Department, Federal government, or its agents identified the potential fraud, waste, or abuse that leads to recovery of funds paid to an MCO provider, and the MCO did not previously identify and report the provider for potential overpayments, the State shall have the right to recover from the MCO the entire amount of the overpayment. The State shall have the sole right of recovery of an overpayment when the MCO has identified the overpayment and the MCO has not initiated recovery within 90 days after the completion of the MCO’s investigation. The MCO shall have the right to appeal, pursuant to COMAR 10.67.10.02, the Department’s recovery of an overpayment. The Department has the authority to recover any overpayments made to MCOs. An MCO shall ensure that all of its network providers are screened, enrolled, and revalidated by the State as Medicaid providers, in accordance with 42 CFR part 455, subparts B and E. An MCO, its subcontractors, and its subcontractor’s subcontractors shall permit the following organizations or their designees to inspect, evaluate, or audit books, records, contracts, computer or other electronic systems, premises, and facilities that pertain to the MCO’s Medicaid enrollees, and any aspect of services and activities performed, or determination of amounts payable under, the MCO’s contract with the Department: The Department and its agents; The Medicaid Fraud Control Unit of the Office of the Attorney General; The Insurance Fraud Division of the Maryland Insurance Administration; The Centers for Medicare and Medicaid Services; The Inspector General of the Department of Health and Human Services; The Comptroller General; and Other authorized State or federal agencies. The right to inspect, audit, and evaluate shall exist for 10 years from the final date of the contract period or from the completion of any audit, whichever is later, except, if the Department, Centers for Medicare and Medicaid Services, or the Department of Health and Human Services Inspector General determines that there is a reasonable possibility of fraud, or similar risk, those agencies may inspect, audit, and evaluate at any time. Notwithstanding §B of this regulation, the Department has the right to inspect the accuracy, truthfulness, and completeness of the encounter data submitted by, or on behalf of, the MCO. An MCO shall submit to the Department the following: Encounter data in the form and manner described in COMAR 10.67.04.15B, 42 CFR §438.242(c), and 42 CFR §438.818. Data required by the Department in order to certify the actuarial soundness of capitation rates to an MCO, under 42 CFR §438.3, including base data described in 42 CFR §438.5(c) that is generated by the MCO. Data required by the Department to determine compliance of the MCO with the medical loss ratio requirement described in 42 CFR §438.8. Data required by the Department and the Maryland Insurance Administration to determine that the MCO has made adequate provision against the risk of insolvency as required under 42 CFR §438.116. Documentation described in 42 CFR §438.207(b) on which the Department bases its certification that the MCO has complied with the State’s requirements for availability and accessibility of services, including the adequacy of the provider network, as set forth in 42 CFR §438.206. In accordance with §F of this regulation, information on ownership and control described in 42 CFR §455.104 from an MCO and its subcontractors, as governed by 42 CFR §438.230. An annual report of overpayment recoveries as required in 42 CFR §438.608(d)(3). Any other data, documentation, or information relating to the performance of the entity’s obligations under its contract with the Department, or required by the Department or the Secretary of the Department of Health and Human Services. An MCO shall report to the Department any identified inaccuracies in the encounter data reported by the MCO or its subcontractors within 30 days of the date discovered regardless of the effect which the inaccuracy has upon MCO reimbursement. An MCO shall promptly report to the Department’s Office of Inspector General (OIG) any potential fraud, waste, abuse, or information it has received from whistleblowers relating to the integrity of the MCO, its network providers, or its subcontractors. An MCO shall report any potential fraud directly to the Medicaid Fraud Control Unit and the Department’s OIG, including fraud by providers, employees and subcontractors of the MCO, enrollment agents, and enrollees. After reporting any potential fraud, waste, or abuse to the Department’s OIG and to the Medicaid Fraud Control Unit, the MCO may not take the following actions without prior written approval from the State: Contact the subject of the investigation about any matter related to the investigation; Enter into or attempt to negotiate any settlement or agreement regarding the incident; or Accept any monetary or other type of consideration offered by the subject of the investigation in connection with the incident. For complaints of provider fraud and abuse that warrant a preliminary investigation, the MCO’s reports required in §§C and D of this regulation shall include: The number of complaints; The name and identification number of the provider being investigated; The source of the complaint; The type of provider; The nature of the complaint; The approximate dollar amount involved; The legal and administrative disposition of the case; and The method by which the MCO verified that the services being investigated were actually provided to the enrollee. An MCO shall provide to the Department written disclosure of any affiliation prohibited under 42 CFR §438.610 and take action as directed by the Department. An MCO shall provide to the Department written disclosures of information on ownership and control required under 42 CFR §455.104, including: The following information for any individual or corporation with an ownership or control interest in the MCO: For individuals: Name; Address; Date of birth; and Social Security number; and For corporate entities: Name; Applicable primary business address; Every business location and applicable P.O. Box address; and Other tax identification number or any subcontractor in which the MCO has a 5 percent or more interest; Whether the individual or corporation with an ownership or control interest in the MCO: Is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling; or Whether the individual or corporation with an ownership or control interest in any subcontractor in which the MCO has a 5 percent or more interest is related to another person with ownership or control interest in the MCO as a spouse, parent, child, or sibling; The name of any other MCO in which an owner of the MCO has an ownership or control interest; The name, address, date of birth, and Social Security number of any managing employee or agent of the MCO; Disclosures of ownership and control information from MCOs are due at the following times: Upon application; Upon the managed care entity executing the contract with the State; Upon renewal or extension of the contract; and Within 35 days after any change in ownership of the managed care entity. An MCO shall report to the Department all overpayments identified and recovered, specifying the overpayments due to fraud. An MCO shall report third-party liability collection activities as described in COMAR 10.67.04.18. An MCO shall report to the Department the amounts the MCO has cost-avoided and the number of third-party liability cases the MCO has handled. An MCO shall notify the Department promptly when it has knowledge of an enrollee’s change of residence or death. An MCO shall notify the Department promptly when the MCO receives information about a change in a network provider’s circumstances that may affect the network provider’s eligibility to participate in the Program, including the termination of the provider agreement with the MCO. An MCO shall submit all required data, documentation and information in the format specified by the Department. An MCO’s chief executive officer, chief financial officer, or directly-reporting authorized employee shall certify to the best of that individual’s information, knowledge, and belief, that any records, data, or other documents requested under regulations are accurate, complete and truthful. As directed by the Department’s OIG, the MCO shall submit written reports documenting its Program Integrity efforts, including but not limited to: The dollar amount of losses and recoveries attributable to overpayment, abuse, and fraud; and The number of referrals to the Department’s OIG during the prior State fiscal year. Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland Effective date: February 26, 2018 (45:4 Md. R. 205) Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred from COMAR 10.09.68 effective November 1, 2019 (46:22 Md. R. 977) This chapter describes the services that are not the responsibility of the MCOs but are covered by the Department on a fee-for-service basis. An MCO is not responsible for reimbursing for the following substance use disorder services, regardless of diagnosis: Services delivered by a community-based provider as described in COMAR 10.09.80 with the following procedure codes: Substance use disorder services provided to children in an ICF-A with the revenue code 0100, Residential Services, child and adolescent. An MCO is not responsible for reimbursing for the following services performed by free-standing laboratories, regardless of diagnosis: Presumptive drug tests; and Definitive drug tests. An MCO is not responsible for reimbursing for the laboratory services described in §B of this regulation unless billed by a: Primary care provider; or Other somatic care provider. An MCO is not responsible for reimbursing for the following substance use disorder services if the MCO is billed with a primary diagnosis listed in §M of this regulation: Services delivered by an inpatient hospital with the following revenue codes: Services delivered by an outpatient hospital with the following revenue codes: Services delivered by an emergency department with the following revenue codes: An MCO is not responsible for reimbursing for mental health services with a primary diagnosis listed in §N of this regulation when the services are provided by a hospital and the services are the result of the treatment of mental health diagnosis. An MCO shall be responsible for reimbursing for behavioral health services delivered by the participant’s primary care provider. An MCO shall be responsible for reimbursing for somatic services related to gender identity disorder, including gender reassignment surgery. An MCO is not responsible for reimbursing the behavioral poisoning diagnoses listed in §P of this regulation in an emergency department setting. An MCO is not responsible for services billed by specialty mental health providers listed in COMAR 10.09.59 when the bill includes the specialty behavioral health diagnoses listed in §M or N in the primary diagnosis field. An MCO is not responsible for reimbursement of behavioral health crisis services as described in COMAR 10.09.16. An MCO is not responsible for behavioral health medications. An MCO is not responsible for reimbursing for services billed by a physician related to prescribing buprenorphine or Vivitrol when the following conditions are met: The physician delivering buprenorphine has a DATA 2000 waiver; The physician is not the participant’s primary care provider; The primary diagnosis is substance use disorder; The primary reason for the visit is substance use disorder treatment; and The procedure code listed on the claims is one of the following: Table of substance use disorder diagnoses, for dates of service on or after October 1, 2015: Table of mental health diagnoses, for dates of service on or after October 1, 2015: An MCO is not responsible for services billed by a psychiatrist when the claim includes one of the following primary diagnoses: Table of poisoning diagnoses, for dates of service on or after July 1, 2016: An MCO may not be required to provide any of the following benefits or services that are reimbursed directly by the Department: The remaining days of a hospital admission following enrollment in the MCO if the recipient was admitted to the hospital before the date of the recipient's enrollment; Long-term care services except for those outlined in COMAR 10.67.06.07B and COMAR 10.67.06.12A; Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID) services; Personal care services pursuant to COMAR 10.09.20; Medical day care services, for adults and children; The following HIV/AIDS services: Genotypic, phenotypic, or other HIV/AIDS drug resistance testing used in the treatment of HIV/AIDS, if the service is: Rendered by a Department-approved provider; and Medically necessary; and Viral load testing used in treatment of HIV/AIDS. Physical therapy, speech therapy, and occupational therapy services when: The enrollee is younger than 21 years old; and The services are not part of home health services or an inpatient hospital stay; Augmentative communication devices; All dental services including but not limited to outpatient surgery fees for the facility and general anesthesia. Except when a woman has been determined eligible for Medical Assistance benefits under COMAR 10.09.11, an abortion pursuant to COMAR 10.09.02.04G; Emergency transportation; Transportation services provided through grants to local governments pursuant to COMAR 10.09.19; Services provided to members participating in the State's Health Home Program as described in COMAR 10.09.33; Applied behavioral analysis (ABA) services as described in COMAR 10.09.28; and Abortions performed in accordance with Health-General Article, § 15-103, Annotated Code of Maryland. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471) Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621) Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732) Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981) Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775) Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732) Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528) Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487) Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253) Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973) Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301) Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834) Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834) Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) Chapter transferred from COMAR 10.09.70 effective November 1, 2019 (46:22 Md. R. 977) Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1112); November 13, 2023 (50:23 Md. R. 1005) Regulation .03F amended effective May 18, 2020 (47:10 Md. R. 515) Regulation .03I amended effective June 24, 2024 (51:12 Md. R. 620) Regulation .03M, N amended effective March 31, 2025 (52:6 Md. R. 267) Regulation .03O adopted effective March 31, 2025 (52:6 Md. R. 267) An MCO shall: Maintain a member services unit that operates an enrollee services line at least during normal business hours; Operate its enrollee services line as a triage device to handle or properly refer enrollees' questions or complaints; and Provide information in the member handbook about how to use the MCO enrollee services line to obtain information and assistance. An MCO shall have written complaint procedures by which an enrollee who is dissatisfied with the MCO or its network providers, or decisions made by the MCO or a provider, may seek recourse verbally or in writing within the MCO at any time. An MCO shall: Submit its written internal complaint procedures to the Department for its approval; Give enrollees any reasonable assistance in completing forms and taking other procedural steps related to a grievance or appeal in a manner consistent with COMAR 10.67.05.01A; Prepare the document describing the MCO’s internal complaint process: In a culturally sensitive manner; At an appropriate reading comprehension level; and In the prevalent non-English languages, identified by the State; Deliver a copy of the MCO’s complaint procedures to each enrollee: With the MCO’s initial contact with a new enrollee; and At any time upon an enrollee’s request; Maintain an accurate and accessible record of grievances and appeals for monitoring by the State and CMS, which includes, at a minimum: A general description of the reason for the appeal or grievance; The date received; The date of each review or, if applicable, review meeting; Resolution at each level of the appeal or grievance, if applicable; Date of resolution at each level, if applicable; and Name of the enrollee for whom the appeal or grievance was filed; and Provide in its written procedures that an enrollee may file appeals and grievances orally or in writing. An MCO shall submit for Department approval an internal complaint process detailing the procedures for registering and responding to appeals and grievances in a timely fashion, which: Includes a specific standard for grievance decisions, monitored by the MCO for compliance, directing that: The decision time for emergency medically related grievances may not exceed 24 hours; The decision time for nonemergency medically related grievances may not exceed 5 days; and For administrative grievances, the decision time may not exceed 30 days; Includes participation by the provider, if appropriate; Allows participation by the ombudsman, if appropriate; Ensures the participation of individuals within the MCO who have the authority to require corrective action; Requires documentation of the substance of the grievances and steps taken; Includes a procedure for the aggregation and analysis of appeals and grievance data and use of the data for quality improvement; Includes a documented procedure for reporting: Appeals and grievances received by the MCO to: The provider involved; Appropriate quality assurance committees and departments within the MCO; The MCO's consumer advisory board; and The Department as requested; and The quarterly appeal and grievance analysis performed by the MCO as specified in COMAR 10.67.04.15D(1)(b); Includes a documented procedure for written notification of the MCO's determination: To the enrollee who filed the grievance; and To those individuals and entities required to be notified of the grievance pursuant to §C(7) of this regulation; Ensures that decision makers on appeals and grievances: Were not involved in previous levels of decision-making; Are not subordinates of people involved in previous levels of decision-making; Are healthcare professionals with clinical expertise in treating the enrollee’s condition or disease, if any of the following apply: The appeal is a denial based on lack of medical necessity; The grievance is regarding denial of expedited resolution of an appeal; or The appeal or grievance involves clinical issues; and Take into account all comments, documents, records, and other information submitted by the enrollee or their representative, without regard to whether such information was submitted or considered in the initial action. An MCO shall: Acknowledge an enrollee appeal or grievance reported to it by the Department’s complaint resolution unit within 1 business day; Respond to the Department’s request for information regarding disputed nonemergency medical care actions within 3 business days; Provide updates in a time frame specified by the Department; Provide medical records within 5 days of the request; and Provide a corrective action plan upon request and within the time frame specified, but not later than 10 days from the date of the request. An MCO shall have a complaint procedure for providers that is: Documented in writing; Disseminated in writing to all of the MCO's providers at the time they join the MCO's provider panel, and furnished to a provider at any time, upon request; and Linked to the MCO's internal quality assurance program. An MCO shall include in its provider complaint process at least the following elements: Procedures for registering and responding to provider grievances in a timely fashion, including standards for timeliness that recognize the need for expedited determinations in situations that are time-sensitive, that is, when an enrollee's treatment outcome may be significantly affected by the promptness of treatment, as set forth in Regulation .02C(1)(a) and (b) of this chapter apply; Notification to the provider of an MCO's determination that affects the provider or that provider's patient, which includes a description of how to file an internal appeal with the MCO; Documentation of the substance of complaints and steps taken; Procedures to ensure the timely resolution of the complaint and response by the MCO to the provider; Procedures for the termination or withdrawal of a provider from the MCO's provider panel, including: At least 90 days prior notice to the primary care providers in the MCO's provider panel of the MCO's termination of a specialty services provider when the reason for the termination is unrelated to fraud, patient abuse, incompetency, or loss of licensure status; If possible, at least 90 days prior notice to the primary care providers in the MCO's provider panel of a specialty services provider's withdrawal from the MCO's provider panel; and Notices to primary care providers informing them of the enrollee’s right to change MCOs as described in COMAR 10.67.02.06A(1)(e). Mechanisms to aggregate and analyze appeal and grievance data and to use the data for quality improvement; An appeal process which: Is available when the provider's appeal or grievance is not resolved to the provider's satisfaction, or when the MCO acts to reduce, suspend, or terminate provider's privileges with the MCO; Acknowledges receipt of provider appeals within 5 business days of receipt by the MCO; Allows providers 90 business days from the date of a denial to file an initial appeal; Allows providers at least 15 business days from the date of denial to file each subsequent level of appeal; Resolves appeals, regardless of the number of appeal levels allowed by the MCO, within 90 business days of receipt of the initial appeal by the MCO; Pays claim within 30 days of the appeal decision when a claim denial is overturned; Provides at its final level an opportunity for the provider to be heard by the MCO's chief executive officer, or the chief executive officer's designee; Provides timely written notice to the provider of the results of the internal appeal; and Provides for written notice of the substance of the dispute and the result of the internal appeal to appropriate quality assurance committees and departments within the MCO; and A protocol for transmitting provider appeal and grievance reports and aggregate provider grievance and appeal data to the Department when requested. An MCO may not take any punitive action against a provider for utilizing the MCO provider complaint process, for supporting an enrollee's appeal, or for requesting expedited resolution for an enrollee's appeal. An MCO or its pharmacy benefits manager shall resolve pharmacy appeals concerning drug pricing within 21 days of the receipt of a request. For provider disputes involving medical necessity, an MCO shall participate in the IRO process as specified in COMAR 10.67.13. An MCO shall: Acknowledge provider grievances within 3 business days; Provide findings to the Department within 5 days; and Provide a corrective action plan to the Department within 10 days from the date of the request. For certain services to enrollees that require preauthorization the following conditions apply: For standard authorization decisions, the MCO shall make a determination within 2 business days of receipt of necessary clinical information, but not later than 14 calendar days from the date of the initial request so as not to adversely affect the health of the enrollee; For expedited authorization decisions, the MCO shall make a determination and provide notice no later than 72 hours after receipt of the request for service if the provider indicates or the MCO determines that the standard time frame stated in §A(1) of this regulation could jeopardize: The enrollee’s life; The enrollee’s health; or The enrollee’s ability to attain, maintain, or regain maximum function; For all covered outpatient drug authorization decisions, the MCO shall provide notice by telephone or other telecommunication device within 24 hours of a preauthorization request in accordance with section 1927(d)(5)(A) of the Social Security Act; Standard and expedited authorization decisions may be extended up to 14 calendar days, if the following conditions are met: The enrollee or the provider requests an extension; or The MCO justifies to the Department, upon request, a need for additional information and how the extension is in the enrollee’s interest; and If the MCO successfully justifies extending the standard service authorization decision time frame, the MCO shall: Give the enrollee written notice of the reason for the decision to extend the time frame; Inform the enrollee of the right to file a grievance if he or she disagrees with the extension decision; and Issue and carry out the MCO’s determination as expeditiously as the enrollee’s health condition requires but not later than the date the extension expires. Any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested: Shall be made by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease; and May not be based solely on diagnosis, type of illness, or condition. An MCO shall ensure that compensation to individuals or entities that conduct utilization management activities is not structured to provide incentives for the individual or entity to deny, limit, or discontinue medically necessary services to any enrollee. Notices of a decision to deny a standard authorization shall be provided to the enrollee and the requesting provider within 72 hours from the date of determination. An MCO shall give an enrollee written notice of any action within the following time frames: At least 10 days before the action for termination, suspension, or reduction of a previously authorized covered service; The notice period is reduced to 5 days if probable enrollee fraud has been verified; By the date of the action for the following: The MCO has factual information confirming the death of an enrollee; A signed written enrollee statement requesting service termination or giving information requiring termination or reduction of services, where the enrollee understands that this is the result of supplying that information; The enrollee's admission to an institution where they are ineligible for further services; The enrollee's address is unknown and mail directed to the enrollee has no forwarding address; The enrollee has been accepted for Medicaid services by another jurisdiction; The enrollee's physician prescribes a change in the level of medical care; or An adverse determination made with regard to the preadmission screening requirements for nursing facility admissions; and As soon as practicable for nursing facility transfers or discharges when: The safety or health of individuals in the facility would be endangered; The enrollee’s health improves sufficiently to allow a more immediate transfer or discharge; or An immediate transfer or discharge is required by the enrollee’s urgent medical needs; and For denial of payment, at the time of any action affecting the claim. A notice of adverse action shall: Be in writing; Meet the following requirements: Be translated for enrollees who speak prevalent non-English languages; Include language clarifying that oral interpretation is available for all languages and how to access it; Be written in an easily understood language and format that takes into consideration enrollees with special needs; Be available in alternative formats; and Inform enrollees that information is available in alternative formats and how to access those formats; and Contain the following information: The action the MCO has made or intends to make; The reasons for the action, including the right for the enrollee to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the MCO’s action, including: Medical necessity criteria; and Any processes, strategies, or evidentiary standards used in setting coverage limits; The enrollee’s right to request an appeal of the MCO’s action, including information on: Exhausting the MCO’s one level of appeal; and The right to request a State fair hearing; The procedures for exercising the rights described; The circumstances under which an appeal process can be expedited and how to request it; The enrollee’s right to have benefits continue pending resolution of the appeal; How to request that benefits be continued; and The circumstances under which the enrollee may be required to pay the costs of the services. If an MCO does not make an authorization decision within the times specified in §A of this regulation, the untimely decision is considered a denial and thus an adverse action subject to the notice requirements in §§C and E of this regulation. An MCO's appeal process shall: Require that an enrollee, or a provider acting on the enrollee’s behalf, file an appeal within 60 days from the date on the MCO’s notice of action; Include procedures for acknowledging receipt of appeals within 5 business days; Permit an enrollee to request an appeal either orally or in writing; Provide that oral requests for appeal are considered the initiation of the appeal to establish the earliest possible filing date; Provide reasonable opportunity to present evidence and allegations of fact or law, in person as well as in writing, and in the case of expedited appeals, the MCO shall inform the enrollee of the limited time available for the enrollee to present this evidence; Provide the case file upon request to the enrollee and the enrollee's representative, free of charge and sufficiently in advance of the resolution time frame for appeals, which includes: Medical records; Other documents and records; and Any new or additional evidence considered, relied upon, or generated by the MCO in connection with the action. Allow a provider or authorized representative acting on behalf of an enrollee to file an appeal with the enrollee’s written consent; Consider the enrollee, the enrollee's representative, or the estate representative of a deceased enrollee as parties to the appeal; Establish and maintain an expedited review process, when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize the enrollee’s life, physical or mental health, or ability to attain, maintain, or regain maximum function; and Ensure that punitive action is not taken against a provider who requests an expedited resolution or supports an enrollee’s appeal. Resolution. Except for expedited appeals as described in §C, an MCO shall resolve each appeal and provide notice of resolution, as expeditiously as the enrollee’s health condition requires, and unless extended pursuant to §B(2) of this regulation, within 30 days from the day the MCO receives the appeal. The time frames in §B(1) of this regulation may be extended up to 14 calendar days if: The enrollee requests the extension; or The MCO shows, upon the Department's request, that there is a need for additional information and how the delay is in the enrollee's interest. For any extension not requested by the enrollee, the MCO shall: Give the enrollee written notice; and Make reasonable efforts to give the enrollee verbal notice of the reason for the delay. Continuation of Benefits. The MCO shall continue the enrollee’s benefits pending the outcome of the appeal if all of the following occur: The enrollee timely files for continuation of benefits; The appeal is filed timely, meaning on or before the later of the following: Within 10 days of the MCO mailing the notice of action; or The intended effective date of the MCO's proposed action; The appeal involves the termination, suspension, or reduction of a previously authorized service; The services were ordered by an authorized provider; and The authorization period has not expired. If the MCO continues or reinstates the enrollee's benefits while the appeal is pending, the benefits shall continue until one of the following occurs: The enrollee withdraws the appeal; The enrollee fails to request a State fair hearing and continuation of benefits within 10 days after the MCO sends the notice of an adverse resolution to the enrollee’s appeal; or A State fair hearing decision adverse to the enrollee is made. If the MCO or State fair hearing officer reverses a decision to deny, limit, or delay services, the MCO shall authorize or provide the disputed services promptly and as expeditiously as the enrollee’s health condition requires but no later than 72 hours of the date the MCO receives the reversal. Expedited Appeals. An expedited resolution may be approved when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize: The enrollee’s life; The enrollee’s physical or mental health; or The enrollee’s ability to attain, maintain, or regain maximum function. Expedited appeals shall be resolved as expeditiously as the enrollee’s health condition requires but no later than 72 hours after the MCO receives the appeal. If the MCO denies a request for expedited resolution of an appeal, the MCO shall: Transfer the appeal to the standard time frame of not longer than 30 days from the day the MCO receives the appeal with a possible 14-day extension as described in §B(2) of this regulation; and Make reasonable efforts to give the enrollee prompt verbal notice of the denial of expedited resolution and provide a written notice within 2 calendar days. Notification. The MCO shall provide written notice of resolution which includes: The results and date of the appeal resolution; The reasons for the action; For decisions not wholly in the enrollee’s favor: The right to request a State fair hearing; How to request a State fair hearing; The right to continue to receive benefits pending a hearing; How to request the continuation of benefits; and A statement that the enrollee may be liable for the cost of any continued benefits if the MCO's action is upheld in a hearing. For notice of an expedited resolution, in addition to requirements listed in §D(1) of this regulation, the MCO shall also make reasonable efforts to provide oral notice of the decision. If an MCO fails to adhere to the notice and timing requirements, as described in §§A—D of this regulation, the enrollee is deemed to have exhausted the MCO’s appeals process and may initiate a State fair hearing. State Fair Hearing. An enrollee may exercise State fair hearing rights pursuant to the Department’s regulations and State Government Article, §10-201 et seq., Annotated Code of Maryland, subject to the requirements of this regulation. An enrollee may request a State fair hearing for an MCO appeal resolution after first exhausting the MCO’s appeal process by appealing to the Office of Administrative Hearings using the process specified in COMAR 10.01.04. An enrollee shall file for a State fair hearing within 120 days from the date the MCO provides on the written notice of appeal resolution. The parties to an appeal to the Office of Administrative Hearings under this section are the: MCO; Enrollee; and Enrollee’s representative or the personal representative of a deceased enrollee’s estate. The MCO shall provide documentation regarding medical determinations to enrollees and the Office of Administrative Hearings as required by COMAR 10.01.04 and other applicable law. The MCO shall continue the enrollee’s benefits pending the outcome of the State fair hearing if all of the following occur: The enrollee files for continuation of benefits within 10 days of the MCO upholding its action; The State fair hearing request is filed timely, meaning on or before the later of the following: 10 days from the date on the MCO’s notice of appeal resolution; or The intended effective date of the MCO's proposed action; The State fair hearing involves the termination, suspension, or reduction of a previously authorized service; The services were ordered by an authorized provider; and The authorization period has not expired. If the MCO continues or reinstates the enrollee's benefits while the State fair hearing is pending, the benefits shall continue until one of the following occurs: The enrollee withdraws the State fair hearing; or A State fair hearing decision adverse to the enrollee is issued by the Office of Administrative Hearings. The final decision of the Office of Administrative Hearings is appealable to the circuit court, and is governed by State Government Article, §10-201 et seq., Annotated Code of Maryland, and the Maryland Rules. The Department may order an MCO to provide a benefit or service based on its evaluation of the MCO’s action. Health-General Article, §15-103(b)(9)(i)(4), Annotated Code of Maryland Effective date: Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244) Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82) Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615) Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244) Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471) Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180) Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205) Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244) Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred from COMAR 10.09.71 effective November 1, 2019 (46:22 Md. R. 977) Regulation .03D adopted effective May 18, 2020 (47:10 Md. R. 515) Regulation .04A, D amended effective November 18, 2019 (46:23 Md. R. 1065) Regulation .05A amended effective June 13, 2022 (49:12 Md. R. 641) If the Department determines, after a sufficient investigation, that an MCO or any agent or employee of the MCO, or any person with an ownership interest in an MCO, or related party of the MCO, has failed to comply with any applicable law, regulation, or contract term, or for other good cause shown, the Department may impose sanctions on the MCO, including but not limited to: Fines; Suspension of further enrollment; Withholding all or part of the capitation payment; Termination of the current HealthChoice Managed Care Organization Agreement; Disqualification from future participation in the Maryland Medicaid Managed Care Program; Orders to provide a benefit or service to enrollees; and Those outlined in 42 CFR §§438.700—438.708, as amended. Corrective Action. Subject to §B(2) of this regulation, before imposing a sanction pursuant to §A of this regulation, the Department may permit an MCO an opportunity to take corrective action in accordance with a plan approved by the Department. The MCO shall submit a corrective action plan within a time frame specified by the Department. The Department shall comply with notification requirements of CMS at 42 CFR §438.730 for sanction determinations as specified in 42 CFR §438.700(b)(1)—(b)(6). From the decisions set forth in §B(1)—(8) of this regulation, an MCO may exercise the appeal rights set forth in §C of this regulation. The following Department decisions are appealable by the MCO or MCO applicant: Denial of an entity’s completed application to become an MCO; Decision to terminate the MCO's participation in the Maryland Medicaid Managed Care Program; Decision to impose a fine valued at $50,000 or more on the MCO as described in Regulation .01 of this chapter; Order that the MCO is impaired or in “hazardous financial condition”; An adverse decision by the IRO as described in COMAR 10.67.13.08; The denial of a hepatitis C payment as described in COMAR 10.67.04.19; Overpayments recovered by the Department as described in COMAR 10.67.07.01; and Remittances to the Department as described in COMAR 10.67.04.19-5. An MCO may appeal a decision listed in §B of this regulation to the Office of Administrative Hearings as specified in COMAR 10.01.03 and COMAR 10.09.36.09. The parties to an appeal to the Office of Administrative Hearings under §C of this regulation are the Department and the MCO. The enrollee is not a party at this hearing. The following sanctions shall take effect immediately and are not subject to stay during the pendency of an appeal: Any fines imposed; Any full or partial withhold of the capitation payment; Any remittances to the Department as described in COMAR 10.67.04.19-5; or Any overpayments recovered by the Department as described in COMAR 10.67.07.01. All monies collected from the MCOs as a result of the imposition of a financial sanction shall be deposited in the HealthChoice Performance Incentive Fund. This nonlapsing fund shall include all sanctions imposed on the MCOs starting in calendar year 1999. The fund shall be used to provide financial incentive awards to the MCOs that meet or exceed specific performance targets as established by the Department, unless otherwise directed by law. Health-General Article, §15-103(b)(9), Annotated Code of Maryland Effective date: Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244) Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244) Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580) Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244) Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220) Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) Chapter transferred from COMAR 10.09.73 effective November 1, 2019 (46:22 Md. R. 977) Regulation .02B amended effective April 28, 2025 (52:8 Md. R. 359) This chapter applies to teaching hospitals that provide health care services to recipients enrolled in Maryland Medicaid Managed Care Program MCOs. Purpose. GME allocation payments to teaching hospitals are intended to: Reaffirm the Program's historic commitment to preserving graduate medical education at each of the State's teaching hospitals, by maintaining Program payments supporting graduate medical education at levels equivalent to inflation-adjusted FY 1995 expenditures; Promote the training of primary care practitioners; Promote the development of innovative approaches to improve the Program population's access to health care services; and Ameliorate the new funding procedure's impact on MCOs that historically have experienced low utilization of teaching hospitals, by adopting an initial moderate reduction, pursuant to §B(4) of this regulation and COMAR 10.67.05.15, of the amount of GME-allocatable dollars included in teaching hospitals' GME allocation payments during the first 3 years of separate GME funding. GME Allocation Payments to Teaching Hospitals. Beginning in FY 1999, the Department shall, on a quarterly basis, pay each teaching hospital a GME allocation payment, calculated as follows: The Department shall calculate the combined dollar amount of payments made by the Program to teaching hospitals during FY 1995, including only those payments attributable to utilization: Of services that, if delivered during the fiscal year during which the GME allocation payment is made, would be included in the Maryland Medicaid Managed Care Program mandatory benefits package established by COMAR 10.67.06; and By recipients who, if the utilization had occurred during the fiscal year in which the GME allocation payment is made: Would have met the eligibility criteria for the Maryland Medicaid Managed Care Program, pursuant to COMAR 10.67.02.01; and Would not have met the eligibility criteria for the rare and expensive case management program, pursuant to COMAR 10.09.69.03; The amount resulting from the calculation described in §B(1) of this regulation is reduced by the dollar amount of included payments for inpatient hospital services that, if they had been incurred during the fiscal year of the GME allocation payment, would have been subject to avoidance by an MCO pursuant to the stop-loss provisions of COMAR 10.67.04.22; The amount resulting from the calculation described in §B(2) of this regulation is trended forward to adjust for the time differential between the base year (FY 1995) and the contract year; The amount resulting from the calculation described in §B(3) of this regulation is reduced to reflect the managed care discount incorporated into capitation rates pursuant to COMAR 10.67.04.18-1B(2); The amount resulting from the calculation described in §B(4) of this regulation is multiplied by the percentage of Program payments considered, pursuant to COMAR 10.67.04.18-1A(1)—(3), to be attributable to GME; and The amount resulting from the calculation described in §B(5) of this regulation is multiplied by 0.25, to reflect the GME allocation's quarterly payment schedule. Health-General Article, §15-103(b)(18), Annotated Code of Maryland Effective date: Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281) Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692) Chapter revised effective December 24, 2001 (28:25 Md. R. 2190) Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Chapter transferred from COMAR 10.09.74 effective November 1, 2019 (46:22 Md. R. 977) An MCO shall establish a corrective managed care plan that, at minimum, provides for: The identification of an enrollee that has abused MCO pharmacy benefits; and The enrollment of an enrollee that has been determined to have abused MCO pharmacy benefits in the MCO’s corrective managed care plan. Enrollee abuse exists when an enrollee: Has engaged in behaviors identified in COMAR 10.09.24.14-1; or Engages in Medicaid fraud as defined under COMAR 10.09.24.14. An MCO’s corrective managed care plan: Shall cover enrollee abuse of medical assistance pharmacy benefits; and May cover enrollee abuse of nonpharmacy medical assistance benefits. For all benefit abuse covered by an MCO’s corrective managed care plan, the plan shall: Use the criteria as described in Regulation .01B of this regulation to determine if enrollees have abused benefits; Provide for a medical review of the alleged abuse consistent with §C of this regulation; Provide that an enrollee found to have abused benefits will be enrolled in the program for 24 months; Provide that an enrollee who has been enrolled in a 24 month plan and is subsequently found to have abused MCO benefits shall be enrolled in the plan for an additional 36 months; Provide for the MCO to select any participating provider in the MCO that meets the requirements of COMAR 10.67.05.05A to serve as the enrollee’s primary care, specialty care, and pharmacy providers for enrollees in corrective managed care, as appropriate to the type of benefit the enrollee has been found to have abused; Require an enrollee to obtain prescribed drugs only from a single designated pharmacy provider, which may be any pharmacy or any single branch of a pharmacy chain that participates in the MCO and meets the requirements of COMAR 10.67.05.06B and .07C(2) unless the prescription is: Pursuant to an emergency department visit; Pursuant to hospital inpatient treatment; or A specialty drug as defined in COMAR 10.67.06.04; Provide enrollees determined to have abused benefits the ability to suggest primary care, specialty care, or pharmacy providers; Require the MCO to accept the enrollee’s suggestion referenced in §B(7) of this regulation unless the MCO determines that the recipient’s choice of provider would not serve the enrollee’s best interest in achieving appropriate use of the health care systems and benefits available through the MCO; Provide an enrollee determined to have abused benefits 20 days from the date of the notice to present additional documentation to explain the facts that serve as the basis for the MCO’s determination of benefit abuse, consistent with §D of this regulation; Provide for the designation of a new primary care, specialty care, or pharmacy provider if the enrollee moves out of the service area of the current primary care or pharmacy provider; Provide for prompt reporting to the Department the name of any enrollee enrolled in the MCO’s program, the duration of enrollment, or any change in the duration of enrollment; and Be submitted to the Department for review and approval: Within 60 days of the effective date of this regulation; and Before the implementation of any modification. The medical review required in §B(2) of this regulation shall: Be performed by a medical reviewer who is a licensed health care professional; Consider all information that is relevant and available to the MCO, including but not limited to MCO payment records and information secured from any interviews conducted; and Where appropriate, consider records obtained from other sources, including: Providers of medical services; Statistical reports; Outside complaints; Referrals from other agencies; or Any other appropriate sources. If an enrollee provides additional information pursuant to §B(9) of this regulation within 20 days: The effective date of the enrollment provided in the notice shall be tolled pending the MCO’s review of the additional information; The MCO shall consider whether the additional information changes the MCO’s determination regarding the appropriateness of the enrollee’s enrollment in corrective managed care; The MCO shall notify the enrollee of its decision whether the MCO is affirming or reversing its determination to enroll the enrollee in corrective managed care; and If the MCO confirms its determination to enroll the enrollee in corrective managed care, the notice shall: Identify the effective date and duration of that enrollment; and Include an explanation of the enrollee’s right to appeal the determination as described in Regulation .05 of this chapter. An MCO’s corrective managed care plan may include a process for re-considering, at any interval of time, a decision to enroll an enrollee in the MCO’s corrective managed care plan, if the process entitles the enrollee to appeal the decision pursuant to Regulation .05 of this chapter at the same interval of time. The MCO shall provide an enrollee determined to have abused MCO benefits a written notice that includes the following: An explanation of the reason or reasons for the determination that the enrollee abused benefits; A statement that the enrollee has 20 days to provide: Additional information for the MCO to consider before enrollment will become effective; and The address where the additional information shall be sent; A statement that the enrollee will be enrolled in corrective managed care and the effective date and duration of that enrollment; An explanation that the effective date will be tolled pending the MCO's review of any additional information the enrollee provides pursuant to §B of this regulation; A statement that the enrollee may identify a preference for an assigned primary medical care provider, specialty care provider, or pharmacy; and An explanation of the enrollee’s right to appeal the MCO’s determination as described in Regulation .05 of this chapter. Except as provided in §B of this regulation, the effective date of enrollment shall be 20 days from the date of the notice described in Regulation .03A and B of this chapter, whichever is later. If an enrollee determined to have abused benefits appeals the determination, the effective date of the enrollment shall be tolled pending the outcome of the appeal. The duration of an enrollee’s enrollment in a plan may not be altered because of changes in how the individual receives medical assistance, including but not limited to a change in the enrollee’s MCO enrollment. An enrollee shall have 20 days to appeal an MCO’s determination of benefit abuse. Except for the time frame specified in §A of this regulation, an appeal shall be handled as specified in COMAR 10.67.09.05. If the appeal results in a hearing, an MCO shall: Attend the hearing; and Provide justification for enrollment in the program. Health-General Article, §§15-102.1(b)(9) and 15-103, Annotated Code of Maryland Effective date: February 2, 2004 (31:2 Md. R. 82) Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301) Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955) Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred from COMAR 10.09.75 effective November 1, 2019 (46:22 Md. R. 977) This chapter provides for a complaint resolution process for disputes between managed care organizations (MCOs) and providers regarding adverse medical necessity decision made by MCOs. Pursuant to this chapter, providers that receive an adverse medical necessity decision on claims for reimbursement may submit the adverse decision for review by an Independent Review Organization (IRO) designated by the Department. In this chapter, the following terms have the meanings indicated. Terms Defined. “Adverse decision” means a review determination by a managed care organization that a health care service for which a provider seeks reimbursement is not medically necessary. “Affiliate” means a person who, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with another person. “Case record” means documentation submitted to an independent review organization consisting of: A claim and only the supporting documentation, including medical records, originally submitted to a managed care organization by a provider prior to the managed care organization’s adverse decision on the claim; The managed care organization’s adverse decision; and The managed care organization’s written rationale for the adverse decision. “Claim” means a clean claim as defined in COMAR 31.10.11.02. “Complaint” means an appeal of an adverse decision filed with the independent review organization. “Department” means the Maryland Department of Health. “Expert reviewer” means a physician or other appropriate health care provider who contracts with the independent review organization to conduct a review of a managed care organization’s adverse decision. “Health care service” means a health or medical care procedure or service rendered by a provider including: Testing, diagnosis, or treatment of a human disease or dysfunction; Dispensing of drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; or Any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well-being of human beings. “Independent review organization” means an entity that contracts with the Department to conduct independent review of managed care organizations’ adverse decisions. “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medicaid” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for persons. “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland. “Medically necessary” means a health care service that is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with currently accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, the consumer's family, or the provider. “Provider” means any individual or entity that has a valid provider agreement with a Medicaid managed care organization or is a nonparticipating provider rendering covered Medicaid services to the managed care organization’s enrollees. The Department shall procure the services of an IRO to make determinations of medical necessity on provider complaints regarding adverse decisions. An IRO that contracts with the Department shall assure, in accordance with its contract with the Department, the: Timeliness and quality of the reviews; Qualifications and independence of the IRO and expert reviewers; and Confidentiality of medical records and review materials, consistent with federal and State laws. An IRO designated by the Department shall have the authority to conduct the following functions: Obtaining all case information relative to the complaint from the MCO pursuant to time frames established by the Department; Assigning an expert reviewer for review of an adverse decision; Performing conflicts checks relative to the independent review organization and the expert reviewer assigned to review the adverse decision; Communicating procedural rules, as approved by the Department, and other information regarding appeals to the parties; Rendering a timely final decision in accordance with Regulation .06F of this chapter. An IRO or expert reviewer may not be an affiliate or have a financial, familial or professional relationship with any facility, provider, or organization that has filed a complaint. Upon request by the Department, the IRO shall provide to the Department information demonstrating compliance with the requirement in §A of this regulation. The IRO shall ensure that an expert reviewer: Has appropriate clinical expertise in the treatment of the specific medical condition being reviewed and holds a nonrestricted license as a health care provider in the United States; and Has no history of disciplinary investigations, actions, or sanctions, including loss of staff privileges or participation restrictions that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body. Upon request by the Department, the independent review organization shall provide to the Department information demonstrating compliance with the requirements in §A of this regulation. A provider shall exhaust an MCO’s provider appeal process before filing a complaint with the IRO. A provider shall file a complaint with the IRO in the form provided by the IRO not later than 30 calendar days following the date of an MCO’s adverse decision. A review of an adverse decision shall be based on the case record. The IRO shall, after reviewing the case record, issue a final decision as to whether the health care services that are the subject of the complaint were medically necessary. The final decision shall state in writing the factual bases for the decision of the expert reviewer and reference the criteria and standards on which the expert reviewer's decision was based. Final decisions shall be rendered within 45 days of submission of the case record, unless the time period is extended by the Department. In the event that a provider’s complaint is unsuccessful, the provider is responsible for paying to the IRO the case review charge established by the Department. The case review charge established by the Department shall be based on the contract between the Department and the IRO arrived at through a competitive procurement process. An MCO that is determined by the IRO to have improperly denied, either in whole or in part, a provider’s claim on medical necessity grounds is subject to the following: Within 60 calendar days of the date of an adverse decision by an IRO, the MCO shall fully reimburse the provider for claims determined to be medically necessary by the IRO, including any interest owed under Health Insurance Article, §15-1005(f), Annotated Code of Maryland; and Within 60 calendar days of the date of invoice by the IRO, the MCO shall reimburse the IRO the case review charge established by the Department. In the event that the unsuccessful party does not pay the IRO within 60 calendar days of the date of the invoice, the Department shall impose penalties as follows: First delinquency: 17 percent of the invoice amount; Second delinquency: 35 percent of the invoice amount; and Third delinquency: 50 percent of the invoice amount plus: For providers, suspension from using the independent case review services for 1 year; or For MCOs, any sanction set forth in COMAR 10.67.10.01A(1)—(5), as determined by the Department. As a prerequisite for participating in the IRO complaint adjudication process, a provider waives all other administrative and judicial appeal rights and accepts the IRO’s decision as final and binding. An MCO that receives an adverse decision from an independent review organization may file an appeal in accordance with COMAR 10.67.10.02. Health-General Article, §§2-104(b) and 15-103(b), Annotated Code of Maryland Effective date: April 28, 2014 (41:8 Md. R. 471) Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244) Chapter transferred from COMAR 10.09.86 effective November 1, 2019 (46:22 Md. R. 977)