In this chapter, the following terms have the meanings indicated. Terms Defined. “American Academy of Pediatric Dentists” means the membership organization representing the specialty of pediatric dentistry. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program or its designee. “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other diagnostic and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses in children younger than 21 years old. “EPSDT periodicity schedule” means the State-specified listing of the minimum required and recommended preventive health screening services that are to be performed at specified ages. “EPSDT screen” means the full scope of comprehensive well-child screening procedures, required by the State periodicity schedule that a participant receives at a given age. “EPSDT screening provider” means a physician, nurse practitioner, or physician assistant certified by the Department to provide EPSDT screens. “EPSDT treatment provider” means a health care provider that is enrolled to provide services that are not otherwise covered for individuals 21 years old or older. “EPSDT treatment services” means health care services that are covered for children younger than 21 years old that are not otherwise covered for individuals 21 years old or older. “Environmental lead investigation” means an inspection of the primary dwelling of a participant that results in a report characterizing the hazards associated with identified lead-containing substances. Foster Care Child. “Foster care child” means a participant who is in the care and custody of the Department of Human Services. “Foster care child” includes children who receive kinship care. “Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or another state, to provide health care services. “Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland. “Healthy Kids Program” means the unit within the Maryland Medical Assistance Program that develops guidelines for and monitors EPSDT well-child screening services and certifies EPSDT screening providers. “Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. “Jurisdiction” means a state or the District of Columbia. “Managed Care Organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Participant” means a person younger than 21 years old who is determined eligible for, and is receiving, Medical Assistance benefits as provided in COMAR 10.09.11 or 10.09.24. “Plan of treatment” means a written plan, updated at a minimum of every 6 months for ongoing care, to address identified problems to include: Diagnoses; Treatment goals; Frequency of visits; Duration of treatment; and Prognosis. “Preauthorization” means the approval required from the Department or its designee before services can be rendered. “Preventive services” means primary health care designed to: Promote normal growth and development; and Detect, ameliorate, or delay diseases at an early stage before complications or serious disabilities develop. “Program” means the Maryland Medical Assistance Program. “Screening services” means the EPSDT preventive health care and laboratory procedures required at specified ages by the State periodicity schedule. “Third-party payers” means insurers and other entities obligated either legally or contractually to pay for or to reimburse the participant for service covered in this chapter. “Vaccines for Children Program” means the federal program that provides specific childhood vaccines to health care providers, at no cost, for administration to participants younger than 19 years old. The Audiology, Physical Therapy, and Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual (Maryland Medical Assistance Program, Effective January 1, 2022) is incorporated by reference. EPSDT screening and treatment providers shall meet all of the licensure and certification requirements specified in this or any other applicable chapter of COMAR, statute, or policy for the service that the provider renders. In order for the Program to consider a health care practitioner for certification by the Healthy Kids Program as an EPSDT screening provider, the practitioner shall have a demonstrated history of providing services to children younger than 21 years old and shall also: Be a doctor of medicine or osteopathy who is: Licensed in good standing and legally authorized to practice medicine and surgery in the jurisdiction in which the service is provided; and Board-certified in one of the following: Pediatrics; Family practice; or Internal medicine; or Be a pediatric or family nurse practitioner or a physician assistant who is licensed in good standing and certified to practice in the jurisdiction in which services are provided. A freestanding clinic as defined in COMAR 10.09.08 shall be considered for certification by the Healthy Kids Program as an EPSDT screening provider if the clinic employs or contracts with one or more of the licensed health care practitioners listed in §B of this regulation. Any health care practitioner whose professional services are recognized in §1905(a) of the Social Security Act may apply to the Program to be an EPSDT treatment provider. EPSDT treatment providers that are covered by the Program include: The following provider types that are licensed in good standing to practice in the jurisdiction in which services are provided: Chiropractors; Nurse psychotherapists; Nutritionists or dietitians; Occupational therapists; Professional counselors; Psychologists; Social workers; Speech therapists; or An intermediate care facility that provides at least one of the following: Clinically managed high intensity residential treatment; and Medically monitored intensive inpatient treatment; Lead paint risk assessors who are accredited by the Maryland Department of the Environment in accordance with COMAR 26.16.01.16; Audiologists and hearing aid providers, as specified in COMAR 10.09.51.02; Dentists as specified in COMAR 10.09.05.02; Private duty nurses, as specified in COMAR 10.09.53.02; Residential treatment centers, as specified in COMAR 10.09.29.02; Therapeutic behavioral service providers, as specified in COMAR 10.09.34.02; and Vision care and optical providers, as specified in COMAR 10.09.14.02. Therapeutic nursery service providers, as specified in COMAR 10.21.18.03. In order to qualify as an EPSDT treatment provider, an intermediate care facility shall: Be licensed under COMAR 10.63.03 or certified under COMAR 10.47.02, whichever is appropriate; and If appropriate, provide separate social, residential, dietary, and recreational activities for children and adolescents. In order to receive payments as a Medicaid provider, providers shall meet the following general requirements: All conditions for participation set forth in COMAR 10.09.36; If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; The licensure and provider qualification requirements in Regulation .02 of this chapter; and Verify the licenses and credentials of all professionals employed or contracted by the provider, and keep on file documentation of how that verification was completed. To be certified to participate in the Healthy Kids Program as an EPSDT screening provider, a provider shall agree to: Provide EPSDT comprehensive well-child services as outlined in the EPSDT periodicity schedule and in a manner prescribed by the Department; Provide or arrange for referral, diagnosis, treatment, and follow-up when the screening indicates a need for additional services; Inform the parent or guardian of the next preventive health care visit, and assist with scheduling; Cooperate with Departmental efforts to assure that children receive needed follow-up and treatment services; Conform to the equipment, facilities, and procedural standards set by the Department; Maintain a patient record system that is sufficiently detailed and current to allow another physician who is unfamiliar with the patient to properly continue treatment in the absence of the initial provider; Participate in the Vaccines for Children Program; Permit periodic on-site quality assurance visits by the Department or its designee following a protocol established by the Department to: Assure that the equipment necessary to perform required procedures is available; Review the charts of participants to assure delivery of EPSDT screens; Determine that required procedures are being performed correctly and that appropriate follow-up is provided; and Assess the need for any follow-up provider training, staff training, technical assistance, or in-service training; and Maintain a minimum score of 80 percent on all Healthy Kids Program quality assurance reviews. An MCO that has contracted with the Department shall ensure its enrollees have access to EPSDT comprehensive well-child services in accordance with COMAR 10.67.05.05A(3). The Program covers all medically necessary care, including all health care services to identify and correct physical and mental problems that are covered in the State Plan, or that are allowable under the federal Medicaid program as described in §1905(a) of the Social Security Act. For a foster care child, the Program also covers upon entry to or moving within the foster care system: A brief initial check-up; and A comprehensive EPSDT screen as described in §C of this regulation. The Program covers EPSDT comprehensive well-child services in accordance with the EPSDT periodicity schedule, which includes the following: EPSDT screening services which comprise the following: A comprehensive health and developmental history, including assessment of both physical and mental health and development; Age-appropriate immunizations; Age and risk appropriate laboratory tests, including blood lead levels that are required at specific ages regardless of risk; Comprehensive unclothed physical examination; and Health education and anticipatory guidance; Vision services that comprise: Vision screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; Vision screening and vision services delivered by optometrists and opticians, including eyeglasses, as described in COMAR 10.09.14.04; Hearing services that comprise: Hearing screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; and Hearing screening and hearing aid services, as described in COMAR 10.09.51.04; and Dental services, including: Oral health assessment by the EPSDT screening provider and referral to a dentist; and Dental services, as specified in COMAR 10.09.05.04. Additional Medically Necessary Plan of Treatment Services. The Program also covers the EPSDT treatment services listed in §D(2) of this regulation when the services are: Necessary to identify, correct, or ameliorate defects and physical and mental illnesses and conditions; Rendered in accordance with accepted professional standards; and Delivered in accordance with a plan of treatment. EPSDT services covered under §D of this regulation include: Chiropractic services; Mental health services or behavioral health services, or both, when the diagnosis of a participant is not included under the specialty mental health system, as described in COMAR 10.67.08.02; Nutritional counseling services; Occupational therapy services; Speech therapy services; Medically monitored intensive inpatient treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.14, whichever is applicable; Clinically managed high intensity residential treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable; Environmental lead investigations, as specified in COMAR 26.16.02.04 and .05 when there is a confirmed elevated blood lead level of the lower of the following values: 3.5 micrograms or greater per deciliter, the current Maryland elevated blood lead level; or The Centers for Disease Control and Prevention blood lead reference value; Private duty nursing services, as specified in COMAR 10.09.53.04; Residential treatment services, as specified in COMAR 10.09.29.04; and Therapeutic behavioral services, as specified in COMAR 10.09.34.03. Any Program limits on services or treatments identified in this regulation are not applicable for individuals younger than 21 years old if it is shown that the treatments or services are medically necessary to correct or ameliorate identified or suspected health problems. The dental covered services specified in COMAR 10.09.05.04, which follow the periodicity schedule issued by the American Academy of Pediatric Dentists, are limited to two dental examinations per participant per 12-month period. Vision services specified in COMAR 10.09.14.04, including eye examinations and eyeglasses or contact lenses, are limited to not more than once a year. Environmental lead investigations: Are limited to the child's primary dwelling; Are limited to one on-site inspection per dwelling; and Do not include testing of any substances sent to a laboratory for analysis. The provider covered by this chapter may not bill the Program for: Services that are: Provided while the participant is in an institution for mental disease, a hospital, or a residential treatment center, as bundled payment for institutional stays includes EPSDT services; Custodial or assist with activities of daily living; Not medically necessary; Beyond the provider's scope of practice; Rendered but not appropriately documented; Part of another service paid for by the State; or Rendered not in person, unless the services are provided in compliance with COMAR 10.09.49 and any subregulatory guidance issued by the Department; Respite services; Completion of forms or reports; Broken or missed appointments; Supplies, equipment, or items that are not medical in nature; or Services that are primarily cosmetic in nature. Preauthorization is required for: Certain audiology and hearing aid services, as specified in COMAR 10.09.51.06; Certain dental services, as specified in COMAR 10.09.05.06; Certain vision services, as specified in COMAR 10.09.14.06; Private duty nursing services, as specified in COMAR 10.09.53.06; Residential treatment services, as specified in COMAR 10.09.29.06; Therapeutic behavioral services, as specified in COMAR 10.09.34.05; and Intermediate Care Facilities, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable. Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04. Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06. Rates for services provided by chiropractors, speech therapists, occupational therapists, and nutritionists covered under this chapter are included in the Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual. Reimbursement of Medically Monitored Intensive Inpatient Treatment Services Provided in an Intermediate Care Facility. The Department may not directly reimburse any State-operated intermediate care facility for participants. The Department shall claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these intermediate care facilities. The Department shall pay the intermediate care facility the lesser of: The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or The provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, up to a maximum of $400 per day. The maximum payment in §D(2)(b) of this regulation will be updated annually by the Centers for Medicare and Medicaid Service’s published federal fiscal year market basket increase percentage relating to hospitals excluded from the prospective payment system. Submitting Cost Reports. Facilities reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413.40, as amended, shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If reports are not received within 3 months and the Department has not granted an extension, the Department shall withhold from the provider a maximum of 10 percent of the current interim payment for the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. There may not be a refund or adjustment for withholding in cost settlement. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. The Department may grant an extension if: The provider makes a written request setting forth the specific reasons for the request; and The Department determines, taking into consideration the totality of the circumstances, that the request is reasonable. If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, and the provider has not received an extension, the Department, in addition to withholding percentages of payment pursuant to §D(3)(a) of this regulation, may impose one or more sanctions as provided for in Regulation .09 of this chapter. If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department, if applicable, shall make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established may not exceed the maximum per diem rates in effect when the facility's costs were last settled. For purposes of §D(3)(a)—(e) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department. Participant’s Contribution. The local department of social services or the State-operated facility’s fiscal agent shall determine the amount the participant has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider. The provider shall collect from the participant that amount as shown available on the designated form. The provider may not collect a total amount, including the participant’s resource and the Department’s payment, which exceeds the provider’s rate established by the Department. The provider shall show to the Department sums collected from the participant. Reimbursement for environmental lead investigation is $333.29 per inspection. Reimbursement for services covered in Regulation .04 of this chapter shall be the lower of the provider's charge for the service, or the Program's fee schedule. Regardless of whether the participant has other third-party insurance coverage, EPSDT screening providers shall bill the Program directly for the following components of an EPSDT screen: Comprehensive unclothed physical examinations; Immunizations when the vaccine is not covered by the Vaccines for Children Program; Vaccine administration; and Objective screenings for: Developmental assessment; Hearing; and Vision. Upon submission of a claim for a EPSDT screening component, as described in §A of this regulation, the Department shall pursue third-party reimbursement when appropriate. Recovery and reimbursement for all other services in the chapter are set forth in COMAR 10.09.36.07. Cause for suspension or removal and impositions of sanctions are as set forth in COMAR 10.09.36.08. If during a quality assessment, the Department staff determines that the provider does not meet the standards established by the Department, the Department may decertify the provider as an EPSDT screening provider. Appeal procedures are as set forth in COMAR 10.09.36.09. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland Effective date: January 1, 1983 (9:25 Md. R. 2483) Regulation .01 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .01B amended effective March 12, 1984 (11:5 Md. R. 463); October 1, 1985 (12:19 Md. R. 1849) Regulation .04A amended effective September 10, 1984 (11:18 Md. R. 1584) Regulation .04B amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .05 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .05B amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); amended permanently effective May 1, 1983 (10:7 Md. R. 634) Regulation .06 amended effective October 1, 1985 (12:19 Md. R. 1849); March 20, 1989 (16:5 Md. R. 629) Regulation .06A amended effective October 29, 1984 (11:21 Md. R. 1814) Regulation .07 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .07A-1 adopted effective February 13, 1984 (11:3 Md. R. 200) Regulation .07D amended effective October 1, 1985 (12:19 Md. R. 1849) Regulation .08 amended effective March 20, 1989 (16:5 Md. R. 629) Regulation .08F amended and .08G-1 adopted effective September 10, 1984 (11:18 Md. R. 1584) Regulation .08F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulations .08F, J and .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); Regulation .08F, J amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Regulation .09A not amended permanently at this time—emergency status expired October 6, 1991) Regulation .08I amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) Regulation .08J amended effective May 1, 1983 (10:8 Md. R. 725); February 13, 1984 (11:3 Md. R. 200); October 29, 1984 (11:21 Md. R. 1814); October 1, 1985 (12:19 Md. R. 1849) Regulation .08J amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 Regulation .08J amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .08L amended effective October 29, 1984 (11:21 Md. R. 1814) Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974); March 20, 1989 (16:5 Md. R. 629) Table 1 amended effective February 13, 1984 (11:3 Md. R. 200); June 3, 1985 (12:11 Md. R. 1049) Table 2A adopted as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); adopted permanently effective May 1, 1983 (10:7 Md. R. 634) Tables 1, 2, and 2A repealed effective March 20, 1989 (16:5 Md. R. 629) Table 3 recodified as Table 1 effective March 20, 1989 (16:5 Md. R. 629) Chapter revised effective July 19, 1993 (20:14 Md. R. 1169) Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .07A amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .08 amended effective June 21, 2004 (31:12 Md. R. 911) Regulations .01—.13 repealed and new Regulations .01—.12 adopted effective March 22, 2010 (37:6 Md. R. 477) Regulation .01B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .01-1 adopted effective February 27, 2017 (44:4 Md. R. 253) Regulation .01-1 amended effective December 31, 2018 (45:26 Md. R. 1243); August 26, 2019 (46:17 Md. R. 726); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) Regulation .02B, E amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .02E amended effective December 27, 2010 (37:26 Md. R. 1787); August 26, 2019 (46:17 Md. R. 726) Regulation .02F adopted effective December 31, 2018 (45:26 Md. R. 1243) Regulation .03A, B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .03B amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .04D amended effective December 27, 2010 (37:26 Md. R. 1787); October 26, 2015 (42:21 Md. R. 1300); July 3, 2017 (44:13 Md. R. 621); December 31, 2018 (45:26 Md. R. 1243); August 7, 2023 (50:15 Md. R. 681); March 16, 2026 (53:5 Md. R. 243) Regulation .05B amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .05D amended effective August 26, 2019 (46:17 Md. R. 726) Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) Regulation .06G adopted effective February 16, 2015 (42:3 Md. R. 315) Regulation .06G amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .07C amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .07C, E amended effective December 27, 2010 (37:26 Md. R. 1787) Regulation .07D amended effective September 30, 2013 (40:19 Md. R. 1544); February 1, 2016 (43:2 Md. R. 127); September 26, 2016 (43:19 Md. R. 1072); August 7, 2023 (50:15 Md. R. 681) Regulation .08A amended effective August 7, 2023 (50:15 Md. R. 681) Regulation .12 repealed effective October 27, 2014 (41:21 Md. R. 1259)