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)