# COMAR Title 10 — Maryland Department of Health

## Subtitle 11 — Maternal and Child Health

### Chapter 01 — Identification of Infants

**Authority:** Health-General Article, §§2-104(b), 20-401, and 20-402, Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Subtitle 11 Midwifery effective February 1, 1957; repealed effective July 12, 1987 (14:14 Md. R. 1572)

**Administrative History:** Regulations .01—.03 adopted effective December 25, 1989 (16:25 Md. R. 2710)

**Administrative History:** Chapter revised effective April 6, 2009 (36:7 Md. R. 524)

**Administrative History:** Regulation .02 amended effective March 30, 2026 (53:6 Md. R. 291)

#### Regulation .01 Scope.

*COMAR 10.11.01.01*

These regulations affect all institutions or related facilities, as defined in Regulation .02 of this chapter, that deliver a newborn infant from its mother.

#### Regulation .02 Definitions.

*COMAR 10.11.01.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Born” means the complete expulsion or extraction of a product of human conception from its mother, regardless of the period of gestation, if, after the expulsion or extraction, it breathes or shows any other evidence of life, such as heartbeat, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether or not the umbilical cord is cut or the placenta is attached.

  (2) “Cord blood sampling” means the taking of a sample of a newborn infant's blood from the infant's umbilical cord.

  (3) “Footprinting” means the taking of an ink or other type of impression of the skin patterns located on the sole of the newborn infant's foot.

  (4) “Institution” means:

    (a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland;

    (b) A freestanding birthing center as defined in Health-General Article, §19-1101, Annotated Code of Maryland; or

    (c) Any other facility that delivers an infant from its mother.

  (5) “Secretary” means the Secretary of Health or the Secretary's designee.

#### Regulation .03 Identification of Newborn Infants — Mandatory Procedure.

*COMAR 10.11.01.03*

A. An institution shall perform the infant identification procedures described in this regulation:

  (1) Immediately after the birth of the infant; and

  (2) Before the mother and infant are separated.

B. An individual employed by the institution who attends the birth shall securely attach matching identification bands to the wrists of the mother and infant. An additional matching band may be attached the infant's father or another individual designated by the infant's mother.

C. The matching identification bands shall include:

  (1) The mother's name;

  (2) The same identification number for:

    (a) The infant;

    (b) The mother; and

    (c) If applicable, the father or any other designated person;

  (3) The infant's gender;

  (4) The date and time of birth; and

  (5) Any other information specified by the institution's policy.

D. In the case of multiple births:

  (1) The identification band for each infant shall also include the infant's birth order indicated either alphabetically such as by A, B, C or numerically such as by 1, 2, 3; and

  (2) A band corresponding to each infant shall be attached to the mother.

E. Any unused band shall be:

  (1) Attached to the mother;

  (2) Stapled to the mother's chart; or

  (3) Disposed of in a secure disposal box.

F. An individual employed by the institution shall check the birth record and identification bands for accuracy before the mother or infant leaves the delivery room.

G. Each institution shall implement policies requiring personnel to check to ensure that the identification bands of a mother and her infant match:

  (1) Each time the infant is taken to the mother while at the institution; and

  (2) At the time of the discharge of the mother and infant from the institution.

#### Regulation .04 Identification of Newborn Infants — Additional Procedures Permitted.

*COMAR 10.11.01.04*

A. An institution may perform additional identification procedures on an infant before the infant leaves the delivery room. These methods do not link mother and infant, but may be useful in establishing the identity of an infant, and include:

  (1) Cord blood sampling;

  (2) Footprinting;

  (3) Taking a color photograph of the infant;

  (4) Physically assessing the infant and documenting of any distinguishing features; or

  (5) Another procedure proposed by the institution to the Secretary for approval that provides at least equivalent identification.

B. An institution proposing to the Secretary another procedure to identify newborn infants shall include in the proposal at least the following information:

  (1) Method of collection;

  (2) Methods of storage;

  (3) Specimen labeling;

  (4) Specimen security and chain of custody;

  (5) Testing method, or methods to be used;

  (6) Circumstances for testing;

  (7) Quality assurance of tests;

  (8) Confidentiality issues;

  (9) Protection against unauthorized access; and

  (10) Record and documentation system.

C. Identification of Policies and Procedures. An institution shall:

  (1) Develop policies and methods for conducting each additional infant identification procedure under this regulation, and each procedure shall be documented with at least the following information:

    (a) Mother's name;

    (b) Mother's patient identification number;

    (c) Date of birth;

    (d) Gender of the newborn infant;

    (e) Birth order if a multiple birth; and

  (2) Designate and train personnel responsible for performing newborn infant identification procedures.

D. Verification.

  (1) An institution shall verify that the identification procedure was performed by completing a form supplied by the institution or related facility. Information on the form shall include, but need not be limited to the:

    (a) Type of identification procedures performed;

    (b) Date and time the identification procedure was performed; and

    (c) Name of personnel performing the identification procedure.

  (2) An institution shall enter this form, which lists at least the information required in §D(1)(a), (b), and (c), of this regulation, into the infant's institutional medical record and maintain it as part of the infant's overall institutional record.

E. Retention. An institution shall retain any identifying material (blood sample or footprint) for at least 10 days or until the newborn is discharged, whichever comes later.

### Chapter 02 — Early Hearing Detection and Intervention Program

**Authority:** Health-General Article, §§13-601—13-605, Annotated Code of Maryland

**Administrative History:** Effective date: January 20, 1992 (19:1 Md. R. 32)

**Administrative History:** Regulations .01—.09 repealed and new Regulations .01—.09 adopted effective June 22, 2015 (42:12 Md. R. 762)

**Administrative History:** Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 291)

#### Regulation .01 Purpose.

*COMAR 10.11.02.01*

The Early Hearing Detection and Intervention Program shall provide for the universal hearing screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills. The Program shall identify newborns and infants who have a permanent hearing status that affects speech-language skills as early as possible.

#### Regulation .02 Scope.

*COMAR 10.11.02.02*

This chapter requires the screening of all newborns and infants born in Maryland and follow-up for those who have, or are at risk for developing, a permanent hearing status that affects speech-language skills.

#### Regulation .03 Definitions.

*COMAR 10.11.02.03*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Alternative birthing site” means any site of birth other than a hospital.

  (2) “Appropriate services” mean any necessary audiological, medical, developmental, speech-language, sign language, psychosocial, educational, or intervention services required in the follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills.

  (3) “At risk for developing a permanent hearing status that affects speech-language skills” means an infant identified as having any risk factor listed in Regulation .04 of this chapter.

  (4) “Audiological assessment” means testing to determine status of the auditory mechanism.

  (5) “Audiologist” means an individual licensed to practice audiology by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists.

  (6) “Birthing hospital” means a medical facility licensed by the Department which provides obstetrical services.

  (7) “Department” means the Maryland Department of Health.

  (8) “Department database” means the computer data management system used to gather and maintain program data.

  (9) “Early Hearing Detection and Intervention Advisory Council (Advisory Council)” means the 12-member advisory council appointed by the Secretary to provide advice and consultation to the Department concerning the Early Hearing Detection and Intervention Program.

  (10) “Early intervention system” means the total effort in the State, for children from birth to 5 years of age, to meet the needs of eligible children and the children’s families, including the efforts of the Maryland Early Hearing Detection and Intervention Program.

  (11) “Hearing screening” means behavioral, electrophysiological, or other procedures used to identify newborns and infants in need of diagnostic audiological assessment.

  (12) “Hearing status” means the state of an individual’s ability to perceive sound, based on audiological assessment.

  (13) “Infant” means a Maryland resident who is younger than 1 year old.

  (14) “Infant with a permanent change in hearing status that affects speech-language skills” means an infant who has a status that is an atypical function of the auditory system or any nontransient hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification.

  (15) “Local education agency” means a public board of education and public school system legally constituted to administer and direct education and programs of education in the public elementary or secondary schools, including early childhood from birth through the end of high school or their equivalent, in Baltimore City and the 23 counties in Maryland.

  (16) “Local health department” means the official public health agency of the local political subdivision affiliated with the Department.

  (17) “Maryland Infants and Toddlers Program” means the program within the Maryland State Department of Education’s Division of Special Education/Early Intervention Services that provides early intervention services for children under Part C of the Individuals with Disabilities Education Act.

  (18) “Newborn” means a child up to 29 days old who is born in the State.

  (19) “Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child’s welfare, or a person appointed as the surrogate parent as defined in COMAR 13A.05.01.

  (20) “Primary care provider” means a licensed practitioner who is the primary coordinator of care for the individual, whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services.

  (21) “Program” means the Early Hearing Detection and Intervention Program established by the Secretary that provides for the universal screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills.

  (22) “Referral” means directing the newborn or infant at risk for developing a permanent hearing status that affects speech-language skills and the newborn or infant’s parent or guardian to a professional for diagnostic audiological assessment or other appropriate services, or both.

  (23) “Risk factors” means indicators that are associated with permanent congenital, delayed-onset, or progression to a hearing status that affects speech-language skills in childhood.

  (24) “Secretary” means the Secretary of Health or the Secretary’s designee.

  (25) “Telephone resource line” means toll-free telephone access to the Program inside Maryland through live voice or recorded message that is compatible with telecommunication relay services.

#### Regulation .04 High Risk Factors.

*COMAR 10.11.02.04*

Any of the following high risk factors are considered relevant in determining the possibility of a newborn or infant developing a permanent hearing status that affects speech-language skills under this chapter:

A. Caregiver concern regarding hearing, speech, language, or developmental delay;

B. Family history of a permanent hearing status that affects speech-language skills occurring during childhood;

C. Medical risk factors:

  (1) Neonatal intensive care for more than 5 days;

  (2) Extracorporeal membrane oxygenation;

  (3) Assisted ventilation;

  (4) Hyperbilirubinemia that requires exchange transfusion of the blood;

  (5) Exposure to ototoxic medications, such as gentimycin and tobramycin; and

  (6) Exposure to loop diuretic medications, such as furosemide and lasix;

D. In utero infections, such as cytomegalovirus, herpes, rubella, syphilis, and toxoplasmosis;

E. Craniofacial anomalies;

F. Physical findings associated with a permanent hearing status that affects speech-language skills;

G. Diagnosis of a syndrome associated with a congenital or progressive change in hearing status that affects speech-language skills;

H. Neurodegenerative disorders, including:

  (1) Hunter syndrome; and

  (2) Sensory motor neuropathies, such as Friedrich’s Ataxia and Charcot-Marie-Tooth disease;

I. Culture-positive postnatal infections associated with a permanent change in hearing status that affects speech-language skills, including bacterial and viral meningitis;

J. Head trauma, including basal skull and temporal bone fracture, that require hospitalization; and

K. Chemotherapy.

#### Regulation .05 Model System.

*COMAR 10.11.02.05*

The Department shall establish and maintain a model system to provide for the implementation of an early identification program and follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills and includes the following components:

A. Educational materials;

B. Telephone resource line;

C. Department database to gather and maintain program data;

D. A service referral directory;

E. In-service training of hospitals, local health departments, and local education agencies;

F. Referral to appropriate agency or professional for services;

G. Program monitoring and review;

H. Confidentiality of records and information in accordance with Health-General Article, §§4-101 and 4-301 — 4-309, Annotated Code of Maryland; and

I. Continuum of follow-up which includes:

  (1) Contacting the primary care provider in writing or by telephone to verify the status of the infant;

  (2) Contacting parents or guardians in writing or by telephone to facilitate referral for diagnostic audiological assessment and referral for appropriate services; and

  (3) Interfacing with the single point of entry for the early intervention system.

#### Regulation .06 Early Hearing Detection and Intervention Advisory Council.

*COMAR 10.11.02.06*

The Advisory Council shall:

A. Advise the Department on:

  (1) The implementation of an early identification program and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills;

  (2) Setting of standards for the Program including procedures for hearing screening;

  (3) Monitoring and reviewing of the Program; and

  (4) Provision of quality assurance for the Program;

B. Provide consultation to the Department in the development of the Program;

C. Make recommendations for operation of the Program;

D. Provide consultation to the Department in the maintenance of an educational program for families, professionals, and the public integrated with the Maryland Infants and Toddlers Program and local early intervention systems, including existing State and local education agency programs;

E. Review any materials the Department may distribute to the public concerning newborns and infants who have a permanent hearing status that affects speech-language skills;

F. Meet annually with the Secretary or the Secretary’s designee; and

G. Provide consultation to the Department in the adoption of rules and regulations necessary to implement the Program.

#### Regulation .07 Procedures for Birthing Hospitals and Alternative Birthing Sites.

*COMAR 10.11.02.07*

For each infant delivered at the facility or site, birthing hospital staff and, in the cases of alternative birthing sites, the licensed professional attending the birth shall:

A. Within 48 hours of delivery, enter demographic and birth event data into the Department database;

B. Within 48 hours of discharge from care in the Department database:

  (1) Document:

    (a) The hearing screening test results; and

    (b) Any known risk factors; and

  (2) Identify and document:

    (a) The infant’s primary care provider; and

    (b) Any referrals made; and

C. Provide to the family:

  (1) Written documentation of the birth hearing screening results;

  (2) Any identified risk factors; and

  (3) Instructions for any recommended follow-up.

#### Regulation .08 Procedures for Audiologists and Licensed Professionals Conducting Audiological Screening or Evaluations.

*COMAR 10.11.02.08*

A. An audiologist or a licensed professional who performs a hearing screening or audiological diagnostic evaluation on a child younger than 5 years old due to the presence of a risk factor as listed in Regulation .04 of this chapter or in follow-up to the birth hearing screening of a newborn or infant who did not receive or did not pass the birth hearing screening shall:

  (1) Within 2 business days:

    (a) Report the results of the screening or audiological diagnostic evaluation to the Program in the Department database;

    (b) Document recommendations and referrals provided in the Department database; and

    (c) Confirm or update the demographic information of the child or infant in the Department database; and

  (2) Within 7 business days, notify the appropriate early intervention program at the Maryland State Department of Education of any child younger than 5 years old confirmed to have or strongly suspected of having a permanent hearing status of any type or degree as described in §B of this regulation which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification.

B. A child younger than 5 years old is strongly suspected of having a permanent hearing status if evidence or clinical judgment exists which indicates that there is a high probability of a permanent hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills.

#### Regulation .09 Department Procedures.

*COMAR 10.11.02.09*

A. The Program shall:

  (1) Implement the model system;

  (2) Perform duties and responsibilities in accordance with the advice and consultation of the Advisory Council;

  (3) Exercise independent judgment in the day-to-day operations of the Program;

  (4) Develop Program processes in consultation with the Advisory Council;

  (5) Conduct in-service training on Program procedures;

  (6) Maintain a Department database to monitor infants at risk for developing a hearing status that affects speech-language skills;

  (7) Track infants identified as at risk for developing a permanent hearing status that affects speech-language skills for a period of 5 years;

  (8) Maintain a service directory within the Department database;

  (9) Assure operation of the telephone resource line;

  (10) Facilitate referral for diagnostic audiological assessment and early intervention for infants who are at risk for developing a permanent hearing status that affects speech-language skills;

  (11) Maintain records of the audiological assessment reports for infants at risk for developing a permanent hearing status that affects speech-language skills; and

  (12) Interface with the single point of entry of the early intervention system.

B. The Secretary shall establish guidelines for the operation of the Advisory Council.

### Chapter 03 — Children's Medical Services Program

**Authority:** Health-General Article, §15-125, Annotated Code of Maryland

**Administrative History:** Effective date: September 21, 1986 (13:19 Md. R. 2121)

**Administrative History:** Regulations .03, .05, and .12 amended as an emergency provision effective January 1, 1987 (14:2 Md. R. 125); adopted permanently effective March 31, 1987 (14:6 Md. R. 715)

**Administrative History:** Regulation .12 amended effective August 24, 1987 (14:17 Md. R. 1871)

**Administrative History:** Regulations .01—.12 repealed effective November 28, 1988 (15:24 Md. R. 2769)

**Administrative History:** Regulations .01—.18 adopted effective November 28, 1988 (15:24 Md. R. 2769)

**Administrative History:** Chapter revised and recodified from COMAR 10.22.08 to COMAR 10.11.03 effective March 1, 1993 (20:4 Md. R. 371)

**Administrative History:** Regulation .01-1 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulation .02A, B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulations .03 and .08 amended as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855)

**Administrative History:** Regulation .03B amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulation .08C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .08E amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulation .10 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulation .10D-1 adopted effective March 28, 1994 (21:6 Md. R. 467)

**Administrative History:** Regulation .10E—I repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .20C amended effective April 24, 1995 (22:8 Md. R. 596)

**Administrative History:** Regulation .20F repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .21C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .23 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .25D amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .26 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .27 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .28A amended effective March 28, 1994 (21:6 Md. R. 467)

**Administrative History:** Regulation .30 repealed, new Regulations .30 and .31 adopted, and Regulation .31 recodified to Regulation .32 as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855)

**Administrative History:** Regulation .30 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .30 repealed and new Regulation .30 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Regulation .30A amended effective March 28, 1994 (21:6 Md. R. 467); April 24, 1995 (22:8 Md. R. 596)

**Administrative History:** Regulation .31 adopted effective March 28, 1994 (21:6 Md. R. 467)

**Administrative History:** Regulation .31 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825)

**Administrative History:** Regulation .31 repealed and new Regulation .31 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19)

**Administrative History:** Chapter revised effective April 13, 2015 (42:7 Md. R. 568)

**Administrative History:** Regulation .14B amended effective February 27, 2017 (44:4 Md. R. 252)

#### Regulation .01 Incorporation by Reference.

*COMAR 10.11.03.01*

In this chapter, the federal poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services, are incorporated by reference.

#### Regulation .02 Definitions.

*COMAR 10.11.03.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Agency” means a legally incorporated body or governmental unit which provides services to disabled children or their families, or both.

  (2) “Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription.

  (3) “Appeal” means the process by which a child with special health care needs, as defined in §B(9) of this regulation, or the family on the child’s behalf, obtains a review of a decision, action, or lack of action on the part of the CMS Program or one of its designees.

  (4) “Applicant” means a child with special health care needs, as defined in §B(9) of this regulation, or the parent or guardian of a child, for whom a written application has been submitted to the CMS Program for services, but for whom eligibility has not yet been determined.

  (5) “Authorized services” means that care which is approved by the CMS Program for an eligible child.

  (6) “Care coordination services” means services to promote the effective and efficient utilization of resources to assure access to necessary comprehensive services.

  (7) “Care management plan (CMP)” means a written document that lists recommendations for care as specified by a licensed and boarded provider.

  (8) “Children’s Medical Services Program (CMS Program)” means that program which is administered by the Department pursuant to Health-General Article, §15-125, Annotated Code of Maryland, to:

    (a) Provide for specialized medical, surgical, pharmacologic, and related rehabilitative evaluation and treatment services for children with special health care needs younger than 22 years old who:

      (i) Meet the residential, identification, financial, and medical eligibility requirements; and

      (ii) Are uninsured or do not have coverage in their existing health insurance plans that cover certain types of medical care;

    (b) Provide and promote family-centered, community-based, coordinated care for children with special health care needs, and promote development of community-based, culturally competent systems of services for those children and their families throughout the State; and

    (c) Distribute funds to cover specialty diagnostic and treatment services for eligible children with special health care needs in Maryland.

  (9) “Children with special health care needs” means individuals, birth to 22 years old, who have or who are at increased risk for a chronic physical, development, behavioral, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally.

  (10) “Department” means the Maryland Department of Health, the single State agency designated to administer the CMS Program.

  (11) “Disabling condition” means a health-related condition or impairment that may hinder achievement of normal growth and development.

  (12) “Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medical purpose.

  (13) “Durable medical equipment” means equipment which satisfies all of the following requirements:

    (a) It can withstand repeated use;

    (b) It is used to serve a medical purpose; and

    (c) It is appropriate for use in the home.

  (14) “Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services.

  (15) “Financial eligibility guidelines” means the schedule based upon the federal poverty level which is used to determine financial eligibility for the CMS Program.

  (16) “General hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed as a general hospital by the Maryland Department of Health, Division of Licensing and Certification, in accordance with COMAR 10.07.01.

  (17) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland.

  (18) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the services are provided.

  (19) “Income” means any property or service received by a person in cash or in kind which can be applied directly to meet basic needs for food, shelter, and medical expenses.

  (20) “Long-term hospitalization” means an inpatient stay of more than 2 weeks.

  (21) “Medical assistance” has the meaning stated in COMAR 10.09.24.02.

  (22) “Medical care” means medical services and specialized care provided by physicians and allied health professionals in hospitals, convalescent facilities, clinics, private physicians’ offices, in home and other community-based settings. Medical care may include the services rendered by dentists, nurses, medical social workers, childlife specialists, nutritionists, dietitians, psychologists, physical therapists, occupational therapists, speech-language pathologists, audiologists, optometrists, ophthalmologists, technicians, and other pertinent personnel whose services may be needed by those children who are served by the CMS Program.

  (23) “Medically necessary dental care” means reasonable and appropriate diagnosis, treatment, and follow-up care as determined and prescribed by qualified, appropriate health care providers in treating a condition, disease, injury, birth defect, or development malformation to restore facial configuration or function necessary for speech, swallowing, or chewing.

  (24) “Physician specialist” means a:

    (a) Licensed medical doctor who is qualified to practice medicine in a specialty area and who is either board certified or board eligible and who has experience in the care of children; or

    (b) Resident physician under the supervision of a licensed board-certified physician.

  (25) “Preauthorization” means an approval required from the Department or its designee before the provision of services.

  (26) “Provider” means an individual or entity duly licensed or certified to render a health care service or product pursuant to these regulations through an appropriate agreement with the Department, and identified as a CMS Program provider by the issuance of an individual vendor number.

  (27) “Residency” means living in the State voluntarily with the intention of making the State the individual’s permanent home for an indefinite period and not for a temporary purpose.

#### Regulation .03 Covered Services.

*COMAR 10.11.03.03*

A. The CMS Program shall authorize covered services when a CMP has been approved.

B. The CMP shall:

  (1) Include:

    (a) All diagnoses or suspected diagnoses;

    (b) Service requested or provided;

    (c) Specific reason for the service request;

    (d) Evaluation or treatment findings;

    (e) Follow-up plans related to the service provided by the CMS Program;

    (f) Source of primary health care; and

  (2) Be reviewed and approved by the CMS Program.

C. The CMS Program may request further information from the provider in order to:

  (1) Support the information required in §B(1) of this regulation;

  (2) Assure that all services are coordinated with other services the child is receiving through the CMS Program or other programs; and

  (3) Assure that the needs of the family are addressed in relation to meeting the medical and developmental needs of the child.

D. CMS Program eligible services shall include:

  (1) Specialty clinics;

  (2) Private office care including, but not limited to, the following:

    (a) Allergy/Immunology;

    (b) Audiology and hearing;

    (c) Cardiology;

    (d) Craniofacial;

    (e) Cystic fibrosis;

    (f) Developmental pediatrics;

    (g) Endocrine;

    (h) Gastroenterology;

    (i) Genetics;

    (j) Hematology;

    (k) Infectious disease;

    (l) Nephrology;

    (m) Neurology;

    (n) Neurosurgery;

    (o) Oncology;

    (p) Ophthalmology, optometry, and vision;

    (q) Orthopedics;

    (r) Otolaryngology;

    (s) Physical medicine;

    (t) Plastic surgery;

    (u) Pulmonology;

    (v) Rheumatology;

    (w) Speech-language pathology;

    (x) Surgery; and

    (y) Urology.

  (3) Primary physician care arranged at the discretion of the CMS Program to assure access for needed specialty diagnostic evaluation, treatment, and care coordination services;

  (4) Inpatient hospital care services, which are provided by Medical Assistance affiliated hospitals; and

  (5) Professional evaluation and treatment services, which may include, but are not limited to, the following:

    (a) Audiology;

    (b) Family training and counseling regarding medical and rehabilitation needs;

    (c) Genetic counseling;

    (d) Nursing;

    (e) Nutrition;

    (f) Occupational therapy;

    (g) Physical therapy; or

    (h) Speech-language pathology.

E. Specialized activities to facilitate a special treatment program may include, but are not limited to, the following:

  (1) Equipment to provide:

    (a) Life support;

    (b) Mobility;

    (c) Stimulation; and

    (d) Aid in activities of daily living;

  (2) Orthoses to correct or prevent orthopedic disabilities, including prescription shoes and their modifications;

  (3) Prostheses to replace a missing part or to enhance the applicant's functional performance;

  (4) Formula and medication to correct metabolic and physiologic errors;

  (5) Supplies of durable and disposable items to facilitate management of specific disorders;

  (6) Approved therapies involving specific treatment as authorized by appropriate CMS Program professional staff to cure functional deficiencies;

  (7) Life sustaining medications;

  (8) Dental services provided for children with disabling conditions; and

  (9) Hearing aids and augmentative devices to improve communication.

#### Regulation .04 Rights and Responsibilities.

*COMAR 10.11.03.04*

A. Applicant.

  (1) The applicant shall furnish factual information regarding the applicant’s eligibility, and shall keep the CMS Program informed of any change in demographic, financial, medical, or insurance coverage status.

  (2) An eligible applicant shall use only Medical Assistance approved providers.

  (3) An applicant shall complete a Medical Assistance application when the applicant is considered potentially eligible.

B. CMS Program.

  (1) An applicant who meets eligibility criteria as set forth in this chapter shall have access to approved services within the budgetary limitations of the CMS Program.

  (2) The CMS Program may purchase health insurance benefits for an eligible child when all of the following conditions are met:

    (a) The cost of this expense is less than the cost of directly purchasing the child’s medical care;

    (b) The policyholder is unable to pay for the health insurance policy due to:

      (i) An increase in insurance cost;

      (ii) A change in employment;

      (iii) Loss of income;

      (iv) An increase in health-related expenses; or

      (v) The policyholder’s eligibility to purchase health insurance benefits in accordance with the Consolidated Omnibus Budget Reconciliations Act of 1985, P.L. 99-272;

    (c) The health insurance policy is issued directly from:

      (i) An authorized insurer;

      (ii) A nonprofit health services plan;

      (iii) A health maintenance organization;

      (iv) A self-insured health benefit plan; or

      (v) The employer of the family member whose health insurance provides coverage for the eligible child; and

    (d) Payment is for premiums that can be costed out as related to the applicant only.

  (3) The CMS Program may pay copays, deductibles, and coinsurance costs when the CMS Program is purchasing the health insurance benefits.

  (4) The CMS Program shall comply with the requirements of:

    (a) Title VI of the Civil Rights Act of 1964 as amended;

    (b) The Age Discrimination Act of 1975 as amended;

    (c) Section 504 of the Rehabilitation Act of 1973 as amended; and

    (d) The Americans with Disabilities Act of 1989.

  (5) The CMS Program shall determine financial assistance based on the income and allowable deductions.

  (6) The CMS Program shall provide full financial assistance for authorized services when the income is equal to or less than that which is allowable in accordance with the financial eligibility levels described in Regulation .05A(4) of this chapter.

  (7) The CMS Program shall provide full CMS Program eligible service to the extent that medical assistance for this service is not covered under Title XIX.

#### Regulation .05 General Eligibility Criteria.

*COMAR 10.11.03.05*

A. To be eligible for the CMS Program’s services, an applicant shall:

  (1) Submit a completed, signed, and dated CMS Program application;

  (2) Provide documentation of:

    (a) State residency, as this program is not meant to cover those whose sole purpose in coming to Maryland is to obtain medical care or coverage; and

    (b) Being younger than 22 years old;

  (3) Provide a form of identification for the applicant and the applicant’s parents or guardians if the applicant is less than 18 years old;

  (4) Have income that does not exceed:

    (a) 200 percent of the federal poverty level; or

    (b) 250 percent of the federal poverty level, if the applicant is eligible for a medical deduction under Regulation .07D of this chapter; and

  (5) Have an eligible medical condition as set forth in Regulation .06 of this chapter.

B. The age eligibility referred to in §A(2)(b) of this regulation may be extended 3 years beyond the 22nd birthday if the CMP:

  (1) Confirms that current treatment of the condition should be continued in order to prevent a significant disruption in the provision of necessary services; and

  (2) Documents that the applicant is without third-party insurance or entitlement coverage.

#### Regulation .06 Medical Eligibility.

*COMAR 10.11.03.06*

A. Children with special health care needs may be eligible for services covered by the CMS Program.

B. Chronic medical conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Chronic asthma;

  (2) Chronic renal disease;

  (3) Cystic fibrosis;

  (4) Diabetes and other endocrine disorders;

  (5) Hemophilia;

  (6) Immune deficiencies;

  (7) Juvenile rheumatoid arthritis;

  (8) Leukemia and other childhood cancers;

  (9) Phenylketonuria and other inborn errors of metabolism; and

  (10) Sickle cell anemia and other chronic anemia.

C. Other medical and surgical conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Biliary atresia;

  (2) Bronchopulmonary dysplasia;

  (3) Tracheal esophogeal fistula; and

  (4) Ulcerative colitis.

D. Neurodevelopmental conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Brain tumors;

  (2) Cerebral palsy and other central nervous system disorders;

  (3) Certain high risk neonates;

  (4) Closed head injury with residual defects;

  (5) Down's syndrome and other genetic and chromosomal anomalies;

  (6) Hydrocephalus;

  (7) Medical aspects of learning disabilities and attention deficit disorders;

  (8) Medical aspects of intellectual disability and developmental delay;

  (9) Muscular atrophies and dystrophies;

  (10) Spina bifida, myelomeningocele, and the spinal cord dysfunctions;

  (11) Other neurologic damage;

  (12) Peripheral neuromuscular disease; and

  (13) Seizure disorder.

E. Orthopedic conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Chronic conditions resulting from trauma;

  (2) Chronic infections of bones and joints;

  (3) Club foot and other foot deformities;

  (4) Congenital developmental hip conditions such as congenital hip dislocation;

  (5) Limb deficiencies and length discrepancies;

  (6) Skeletal dysplasias and other forms of dwarfism; and

  (7) Spinal column defects and deformities.

F. Cardiac conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Arrhythmias;

  (2) Congenital heart defects;

  (3) Hypertension; and

  (4) Rheumatic heart disease.

G. Craniofacial and dental conditions which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Cleft lip and palate, orofacial defects;

  (2) Handicapping malocclusions; and

  (3) Medically necessary dental care related to eligible medical conditions.

H. Vision, hearing and speech-language conditions, which may render an applicant medically eligible include, but are not limited to, the following:

  (1) Amblyopia;

  (2) Cataract;

  (3) Cholesteatoma;

  (4) Chronic otitis media;

  (5) Conductive and sensory-neural hearing loss;

  (6) Otosclerosis;

  (7) Speech-language disorders;

  (8) Strabismus; and

  (9) Velopharyngeal incompetence.

I. The following are excluded from CMS Program medically eligible services:

  (1) Well child care;

  (2) Mental health;

  (3) Emergency care; and

  (4) Urgent care.

J. Care excluded from CMS Program medically eligible conditions unless the services are medically necessary due to the underlying chronic condition includes:

  (1) Dermatology;

  (2) Gynecology; and

  (3) Dental services.

#### Regulation .07 Financial Eligibility.

*COMAR 10.11.03.07*

A. An applicant's financial eligibility is based upon the composition and income of the family unit.

B. Family Unit. A family unit consists of one or more of the following members residing in the same household:

  (1) The applicant;

  (2) The natural or adoptive parents, stepparents, or legal guardian if the applicant is unmarried;

  (3) The unmarried natural or adoptive siblings of the applicant who are younger than 22 years old;

  (4) The lawful spouse of the applicant; or

  (5) Other individuals who are not included in this regulation and who are dependents for federal income tax purposes.

C. Income.

  (1) For the purpose of determining financial eligibility, the CMS Program shall treat the income of members of the family unit listed in §B of this regulation as the sole source for determining an applicant’s eligibility.

  (2) The CMS Program shall determine the family’s income from the following sources:

    (a) Wages, including sick or severance pay;

    (b) Commissions and fees;

    (c) Salaries and tips;

    (d) Profit from self-employment, including income from the operation of a farm;

    (e) The earned income tax credit (EITC);

    (f) Social Security benefits;

    (g) Veterans' Administration benefits;

    (h) Workers' Compensation benefits;

    (i) Black Lung or Agent Orange benefits;

    (j) Railroad Retirement;

    (k) Government, private, or company pensions and annuities;

    (l) Unemployment insurance benefits;

    (m) Payments from oil or mineral rights (leases);

    (n) Government payments on land;

    (o) Insurance benefits paid directly to an applicant;

    (p) Trust funds;

    (q) Individual retirement accounts (IRAs);

    (r) Keough plans;

    (s) Military allotments;

    (t) Alimony or court-ordered and voluntary child support payments received from an absent spouse, or an absent natural or adoptive parent;

    (u) Loan repayments made to the applicant or family member including, but not limited to, mortgage payments;

    (v) Lump-sum benefits or other amounts of income received on a one-time-only basis;

    (w) Profit from rental income;

    (x) Cash assistance received from non-governmental social service agencies greater than the amount allowed by Medical Assistance;

    (y) Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act; and

    (z) Any subsidy covering basic needs for food or shelter.

  (3) If an individual in the family unit has recently resumed employment, the Program shall determine income for a 12-month period by averaging actual income for 6 months preceding resumption of employment and projected income for 6 months following resumption of employment.

  (4) If additional CMS Program services are requested 6 months after resuming employment, the CMS Program may re-determine financial eligibility based on current income.

D. Medical Deductions. The applicant may deduct the following from the applicant’s income:

  (1) Loan payments related to medical or medically related emergency debt;

  (2) Payment to a hospital or other health care provider for a member of the family unit not covered by other third-party insurance entitlements, or the Program; and

  (3) Payments for health insurance for a member of the family unit.

E. Effective Dates for Financial Eligibility.

  (1) The CMS Program shall establish financial eligibility for a 12-month period from the date a completed application is received by the CMS Program.

  (2) Exceptions to the 12-month financial eligibility period are:

    (a) If financial eligibility was determined by averaging the previous 6 months, financial eligibility shall be reconsidered after 6 months;

    (b) When an eligible applicant enrolled in the CMS Program informs the CMS Program of changes in family size, income, or expense, the CMS Program may reconsider eligibility as soon as possible if financial assistance is being given, or when the next request for services is made.

  (3) Those receiving CMS Program financial assistance shall notify the CMS Program within 10 business days of any changes in circumstance which could affect continuing financial eligibility.

#### Regulation .08 Application Process.

*COMAR 10.11.03.08*

A. The CMS Program shall make applications available to, but which are not limited to, the following agencies:

  (1) Local health department;

  (2) Admitting, social services, or business office of a participating hospital;

  (3) Cooperating agencies; and

  (4) An applicant, upon request.

B. Completion of Application.

  (1) An applicant, the applicant's parent, guardian, or representative shall submit a complete, signed application approved by the Program.

  (2) A parent of any age, or an authorized representative of the applicant who is 18 years old or older, shall complete and sign the application for an unmarried applicant younger than 18 years old.

  (3) A representative of a public or private agency, which may include a foster parent, shall complete and sign the application for a child in custody of the agency.

  (4) An applicant shall provide financial information for each employed member of the family unit as specified in Regulation .07A of this chapter.

  (5) An applicant shall provide documents verifying residency, identification, income, and medical conditions or suspected medical conditions.

  (6) The CMS Program shall make reasonable accommodations to assure that appropriate assistance is provided to those who are disabled or who are unable to speak or write English.

#### Regulation .09 Disposition of Application.

*COMAR 10.11.03.09*

A. General.

  (1) The CMS Program professional staff shall:

    (a) Review individual applications;

    (b) Determine CMS Program eligibility and services to be approved for payment by the CMS Program within 30 calendar days of receipt of the complete application;

    (c) Verify the information provided by an applicant which may include an interview:

      (i) With the applicant if the applicant is 18 years old or older, or with the applicant’s parent or guardian; and

      (ii) Which is held at a mutually convenient place and time for all parties.

  (2) If additional information is needed to determine eligibility or service needed, the Program shall:

    (a) Return the application within 15 business days of receipt; and

    (b) Advise an applicant in writing of needed documentation.

  (3) Within 30 calendar days of receipt of the completed application by the CMS Program the CMS Program shall send a written decision regarding Program eligibility to the applicant.

  (4) For renewal applications, the CMS Program shall notify an applicant in writing at least 30 calendar days before the date on which the applicant shall reapply.

B. Eligible Applicant.

  (1) An eligible applicant shall receive a letter from the CMS Program which includes, at a minimum, the following information:

    (a) The effective dates of CMS Program eligibility;

    (b) The name of the provider; and

    (c) The service to be covered by the CMS Program.

C. Ineligible Applicant.

  (1) An applicant is ineligible when the applicant does not:

    (a) Provide requested information sufficient to determine eligibility;

    (b) Complete, sign, and date the application; or

    (c) Complete an application for Medical Assistance when the applicant is potentially eligible for services covered by Medical Assistance.

  (2) An applicant determined ineligible shall receive a letter from the CMS Program informing the applicant of the reasons for the determination.

  (3) An applicant determined to be ineligible shall be advised of the right to appeal the determination in accordance with the procedures set forth in §D of this regulation.

D. Appeal Rights.

  (1) Providers filing appeals of administrative decisions made in connection with these regulations shall do so in accordance with Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.

  (2) An applicant or eligible individual, or other authorized representative has a right to a meeting or informal conference with CMS staff responsible for a decision reflected in any notice of determination issued in this chapter.

#### Regulation .10 Record Retention and Confidentiality.

*COMAR 10.11.03.10*

A. Records.

  (1) A provider shall:

    (a) Retain and reproduce, upon request for a minimum of 6 years, records and reports required by the Department for the administration of services; and

    (b) Be responsible for maintaining patient records for services that it provides in accordance with the approved Department retention schedule.

  (2) Records referred to in §A(1) of this regulation include:

    (a) Documentation of personal interviews;

    (b) Diagnosis and treatment recommendations;

    (c) Records of professional visits and consultations;

    (d) Consultant notes which shall be appropriately initialed or signed;

    (e) Medical and laboratory data, including X-rays; and

    (f) Other data as may be required by applicable federal and State regulations.

B. Confidentiality. A provider shall assure that the release of information from an eligible applicant's record is handled in accordance with Health-General Article, §§4-301—4-309, Annotated Code of Maryland, COMAR 10.03.02, and other State and federal laws and regulations governing the confidentiality of records.

#### Regulation .11 General Conditions of Provider Participation.

*COMAR 10.11.03.11*

A. A provider of services which are covered by the CMS Program shall comply with the following general requirements:

  (1) For fee for service reimbursement, be approved by Medical Assistance in writing as a Medical Assistance provider;

  (2) For copay and deductible reimbursement, be a participating provider with the insurance plan purchased by the CMS Program for the family;

  (3) Request preauthorization on the forms designated by the CMS Program;

  (4) Adhere to administrative procedures that are established by the CMS Program for the specific treatment services; and

  (5) Maintain adequate records, including prescriptions, for a minimum of 6 years, and make them available upon request to the Department or the Department's designee.

B. The approval referenced in §A(1) of this regulation shall specify, at a minimum, the following:

  (1) Approved services which may be provided; and

  (2) Duration of approval status.

#### Regulation .12 Conditions of Hospital Participation.

*COMAR 10.11.03.12*

A hospital shall:

A. Comply with all relevant State and federal requirements related to the provision of health services and the receipt of funds;

B. Be licensed by the Department pursuant to the Hospital and Related Institutions subtitle, Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital, and be licensed, as may be required, by other applicable State and local laws;

C. Be accredited by the Joint Commission for Accreditation of Hospitals; and

D. Provide the following services:

  (1) A physician specialist who is qualified in the area of need for which a recipient is hospitalized, and who shall supervise and be involved in:

    (a) The ongoing care of a child; and

    (b) Directing the development of the CMP and other appropriate care plans;

  (2) Pediatric physician supervision on a full-time or part-time basis to assist with:

    (a) Diagnostic evaluations;

    (b) Care planning and treatment; and

    (c) Coordination with others involved in the development of the CMP;

  (3) Nursing services provided by a qualified nurse who has academic preparation and work experience in the care of children, including the specialty area of the condition to be treated;

  (4) Surgical services, which shall have, as a minimum:

    (a) Anesthesiologists trained and experienced in the management of pediatric patients; and

    (b) An appropriate recovery area which is staffed by personnel qualified in pediatrics and equipped with appropriate types and sizes of supplies and equipment;

  (5) Available consultation in other specialty areas for the cases being treated;

  (6) Other specialized support services, which shall include, but not be limited to, the following as appropriate:

    (a) Audiology;

    (b) Nutrition;

    (c) Occupational therapy;

    (d) Physical therapy;

    (e) Psychiatry;

    (f) Psychology;

    (g) Social work services; and

    (h) Speech-language pathology;

  (7) An ongoing inpatient educational program for school-age children, which is approved by the State Department of Education, when long-term hospitalization is required;

  (8) Discharge planning procedures designed to maximize a child's recovery and rehabilitation, which shall include the following:

    (a) Predischarge planning activities to include all appropriate staff and representatives of other agencies involved or indicated;

    (b) Parental counseling regarding a child's medical and social needs after the child's release; and

    (c) Medical care planning resulting from input of the professionals concerned with a child's treatment;

  (9) A discharge summary, which shall include as a minimum, the following:

    (a) Medications, primary and secondary diagnoses, hospital course, procedures performed, and complications;

    (b) Special equipment and other home care needs; and

    (c) Follow-up plans including special transportation needs, if applicable;

  (10) A separate area for a child, with provisions made for a parent or guardian to stay 24 hours, and nonrestrictive visiting hours for a parent or guardian;

  (11) Suitable recreational facilities for children;

  (12) Facilities to isolate children with communicable diseases or other conditions requiring isolation or separation;

  (13) Access to appropriate clinical laboratory facilities providing specialized diagnostic and treatment equipment, including radiological and nuclear medicine equipment; and

  (14) Outpatient facilities to provide follow-up care.

#### Regulation .13 General Billing Procedures.

*COMAR 10.11.03.13*

A. A provider shall accept payment at the Medical Assistance rate as payment in full.

B. A provider shall submit:

  (1) Requests for payment on the form designated by the CMS Program; and

  (2) Completed reports and attachments as requested by the CMS Program.

C. A provider may not bill the CMS Program for:

  (1) Completion of forms and reports;

  (2) Broken or missed appointments;

  (3) Professional services rendered by mail or telephone; and

  (4) Services which are provided at no charge to the general public.

D. The CMS Program shall:

  (1) Make no direct payment to the family;

  (2) Pay any claim for services provided on different dates and submitted on a single form, and only if it is received by the CMS Program within 12 months of the earliest date of service; and

  (3) Pay a claim which is rejected for payment due to improper completion or incomplete information, only if it is properly completed, resubmitted, and received by the CMS Program within the original 12-month period or within 60 calendar days of rejection, whichever is later.

E. The CMS Program reserves the right to return to the provider, before payment, all:

  (1) Invoices not properly signed, completed, and accompanied by properly completed forms as required by the Department, to include any necessary preauthorization forms; and

  (2) Claims not properly completed.

F. If payment is denied by the CMS Program due to late billing, the provider may not seek payment from the child’s family.

#### Regulation .14 Billing Procedures for Physician Office Services.

*COMAR 10.11.03.14*

A. A physician shall:

  (1) Comply with all procedures listed in Regulation .13 of this chapter;

  (2) Charge the CMS Program the usual and customary charge to the general public for similar services; and

  (3) Bill the CMS Program as specified by the CMS Program.

B. The CMS Program shall:

  (1) Use the fee schedule contained in the Maryland Medical Assistance Program’s Professional Services Provider Manual and Fee Schedule, which is incorporated by reference in COMAR 10.09.02.07D;

  (2) Pay for covered services that are the lower of the:

    (a) Physician’s customary charge; or

    (b) Department's fee schedule;

  (3) Reimburse the provider for:

    (a) Dispensed drugs at rates established by COMAR 10.09.03; and

    (b) Injectable drugs at rates promulgated by the Professional Services Provider Manual and Fee Schedule referenced in §B(1) of this regulation.

C. The CMS Program reserves the right to negotiate and establish a different fee for the physician or the group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital’s cost.

#### Regulation .15 Billing Procedures for Medically Necessary Dental Services.

*COMAR 10.11.03.15*

A. A dentist shall comply with all procedures listed in Regulation .13 of this chapter.

B. The CMS Program shall:

  (1) Cover approved diagnostic, restorative, and preventive treatment as described in the CMP; and

  (2) Preauthorize estimates of costs.

#### Regulation .16 Billing Procedures for Orthodontic Services.

*COMAR 10.11.03.16*

A. An orthodontist shall comply with all procedures listed in Regulation .13 of this chapter.

B. The CMS Program shall:

  (1) Reimburse for correction of the full permanent dentition; and

  (2) Give special consideration to services for children with malocclusions in the mixed dentition associated with cleft palates or other craniofacial deformities

C. The CMS Program may not reimburse for preliminary visits to the orthodontist.

D. The provider may not charge the patient, parent, or guardian for orthodontic treatment, including retention visits.

#### Regulation .17 Billing Procedures for Durable Goods and Equipment.

*COMAR 10.11.03.17*

A. The durable goods and equipment providers shall comply with all procedures listed in Regulation .13 of this chapter.

B. A provider shall charge the CMS Program the usual and customary charge to the general public for similar durable goods and equipment.

C. The CMS Program shall:

  (1) Pay for covered services which are the least expensive, except for those described in §B of this regulation;

  (2) Determine, based upon expected duration of medical needs, whether durable medical equipment will be purchased or rented; and

  (3) Pay for repairs to purchased durable medical equipment and disposable medical supplies according to the Medical Assistance reimbursement rate for charges.

D. The ownership of equipment shall remain with the CMS Program and shall be recovered at the option of the CMS Program.

#### Regulation .18 Billing Procedures for Pharmacy Services.

*COMAR 10.11.03.18*

A. A pharmacy provider shall comply with all procedures listed in Regulation .13 of this chapter.

B. A pharmacy provider shall:

  (1) Upon request, produce records to verify any charge to the CMS Program; and

  (2) Charge the CMS Program the usual and customary charge to the general public for similar prescriptions.

C. Determination of allowable cost for multiple source drugs designated by the Centers for Medicare and Medicaid Services of the Department of Health and Human Services or for each drug listed in the formulary allowable cost shall be the lowest of the maximum allowable cost.

D. Payment for covered services to a pharmacy shall be made as follows:

  (1) Payment for formulary drug preparation shall be the:

    (a) Least expensive available; or

    (b) Allowable cost according to the State Title XIX Agency;

  (2) Payment for over-the-counter drugs is not covered except in extenuating circumstances at the discretion of the CMS Program.

#### Regulation .19 Billing Procedures for Hospitals.

*COMAR 10.11.03.19*

A. All hospitals shall comply with the following procedures:

  (1) Hospitals located in Maryland that participate in the CMS Program shall charge and be reimbursed at the Medical Assistance rates approved by the Health Services Cost Review Commission;

  (2) The CMS Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital;

  (3) The CMS Program may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item;

  (4) The contractual physicians' salaries shall be included in the room and board rate or the appropriate ancillary service;

  (5) When a patient is discharged from one general hospital and is admitted to another general hospital and 24 hours have not elapsed between the discharge and admission, the CMS Program shall pay only for those medically necessary days, with the payment for the patient’s hospitalization being apportioned between the two hospitals;

  (6) The CMS Program shall be contacted regarding exceptions or extenuating circumstances relating to admissions and discharges if the patient returns the same day before the hospital patient count;

  (7) All nonemergency inpatient hospital admissions require preadmission approval by the CMS Program;

  (8) Authorization is required by the CMS Program or its designee for more than one preoperative inpatient day; and

  (9) The CMS Program may not reimburse for hospital admissions where a child has been discharged due to cancellation of planned surgery or treatment. The hospital may not bill the family for these charges.

B. In addition, all out-of-state providers shall:

  (1) Participate in Title XVIII of the Social Security Act;

  (2) Have in effect a utilization review plan applicable to all patients who receive Medical Assistance under Title XIX of the Social Security Act and which meets the requirements of the Social Security Act, §186(k), unless a waiver has been granted by the Secretary of Health and Human Services; and

  (3) Meet additional conditions for participation and comply with the requirements specified in Regulation .11 of this chapter.

C. All hospital services shall be reimbursed at the Medical Assistance rate.

#### Regulation .20 Cause for Suspension or Removal and Imposition of Sanctions.

*COMAR 10.11.03.20*

A. If the Department determines that a provider, vendor, agent or employee of the provider, vendor, or a person with an ownership interest in the provider or vendor has failed to comply with these regulations, or applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party:

  (1) Suspension from the CMS Program;

  (2) Withholding of payment from the CMS Program;

  (3) Removal from the CMS Program; and

  (4) Disqualification from future participation in the CMS Program, either as a provider or vendor providing services for which CMS Program payment may be claimed.

B. If the Secretary of the United States Department of Health and Human Services suspends or removes a provider from participation in Medicare or Medical Assistance, the Department shall take similar action.

#### Regulation .21 Funding Availability.

*COMAR 10.11.03.21*

Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland.

### Chapter 04 — Lead Poisoning Screening Program

**Authority:** Education Article, §7-403; Environment Article, §6-303; and Health-General Article, §18-106; Annotated Code of Maryland

**Administrative History:** Effective date: May 12, 2003 (30:9 Md. R. 614)

**Administrative History:** Regulation .02B amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)

**Administrative History:** Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087)

**Administrative History:** Regulation .03 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)

**Administrative History:** Regulation .04 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)

**Administrative History:** Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486); March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087)

**Administrative History:** Regulation .05 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)

**Administrative History:** Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 407)

**Administrative History:** Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407)

**Administrative History:** Regulation .06A amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845)

#### Regulation .01 Purpose.

*COMAR 10.11.04.01*

The purpose of this chapter is to set forth requirements for conducting lead poisoning risk assessments, blood tests for lead poisoning of minor children, and the reporting of blood lead analysis in accordance with applicable State law.

#### Regulation .02 Definitions.

*COMAR 10.11.04.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Administer a blood test for lead poisoning” means to:

    (a) Draw a blood specimen, by either venous or capillary methodology, and:

      (i) Send the specimen to a medical laboratory for blood lead analysis; or

      (ii) Conduct a blood lead analysis at a health care provider's office subject to licensing, certification, and approval by the Laboratories Administration of the Department; or

    (b) Order a blood specimen to be drawn by a third-party health care provider, by either venous or capillary methodology, and sent to a medical laboratory for blood lead analysis.

  (2) “At-risk area” means any geographic area within the State that has been designated by the Department as at-risk for lead exposure in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning.

  (3) “Blood lead analysis” means the analysis and determination by a medical laboratory of the blood lead level in a blood specimen.

  (3-1) “Blood lead reference value” means a blood lead level of 3.5 micrograms per deciliter.

  (4) “CDC” means the federal Centers for Disease Control and Prevention.

  (5) “Child” means an individual younger than 18 years old.

  (6) Repealed.

  (7) “Department” means the Maryland Department of Health.

  (8) Repealed.

  (9) “EPSDT” means the Early and Periodic Screening Diagnosis and Treatment program governed by COMAR 10.09.23.

  (10) “Health care provider” means a person who is licensed, certified, or otherwise authorized to provide health care services under the Health Occupations Article, Annotated Code of Maryland.

  (11) Repealed.

  (12) “Immunization registry” means an immunization registry established and maintained by the Department.

  (13) “Lead exposure risk questionnaire” means the set of questions used to determine an individual's risk for lead exposure and lead poisoning, as approved by the Department and based on the recommendations from the CDC.

  (14) Repealed.

  (15) “Medical laboratory” means a licensed medical laboratory as defined by Health-General Article, §17-201(b), Annotated Code of Maryland.

  (16) “Nonprimary care” means health care that:

    (a) Is given or recommended by a health care provider that is not the individual's primary care provider; and

    (b) Includes but is not limited to episodic health care for acute illness or injury or health care that is given in an emergency room or other urgent care setting.

  (17) Prekindergarten Program.

    (a) “Prekindergarten program” means a public educational or public early intervention program that enrolls or serves children below the level of kindergarten.

    (b) “Prekindergarten program” includes:

      (i) Programs that operate within a school and those that operate outside of a school;

      (ii) Preschool special education programs governed by COMAR 13A.05.01;

      (iii) Extended Elementary Education Programs governed by COMAR 13A.06.02.01;

      (iv) Local Infant and Toddler Programs as defined in COMAR 13A.13.01;

      (v) Head Start and Early Head Start Programs as authorized under the Head Start Act, 42 U.S.C. §9801 et seq.;

      (vi) Judith P. Hoyer Early Child Care and Education Centers established by Education Article, 5-217, Annotated Code of Maryland; and

      (vii) Any other educational or early intervention program as determined by the Department.

  (18) “Primary care” means health care that:

    (a) Is continuous, comprehensive and coordinated;

    (b) Emphasizes prevention of illness and injury; and

    (c) Includes but is not limited to the following services;

      (i) Age appropriate screenings;

      (ii) Diagnosis and treatment of acute and chronic disorders;

      (iii) Growth and developmental assessments;

      (iv) Health care supervision;

      (v) Immunizations;

      (vi) Patient and parent health and psychosocial counseling;

      (vii) Physical examinations; and

      (viii) Referrals to specialty health care providers.

  (19) “Primary care provider” means a health care provider that provides primary care.

  (20) “Targeting Plan” means the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning developed by the Department that includes but is not limited to:

    (a) Methodology for determining levels of risk for childhood lead poisoning;

    (b) Maps of the State designating at-risk areas;

    (c) Zip code and census tract lists indicating each zip code and census tract's designated level of risk; and

    (d) Recommendations regarding the prevention of childhood lead poisoning.

  (21) “12-month visit” means a well-child evaluation by a health care provider that occurs when a child is between 12 months old and 14 months old.

  (22) “24-month visit” means a well-child evaluation by a health care provider that occurs when the child is between 24 months old and 26 months old.

  (23) “Well-child evaluation” means a periodic primary care assessment of a child by a primary care provider in accordance with the:

    (a) American Academy of Pediatrics' guidelines; or

    (b) Periodicity schedule established under EPSDT requirements.

#### Regulation .03 Administration of Lead Exposure Risk Questionnaire.

*COMAR 10.11.04.03*

A primary care provider for a child shall complete a lead exposure risk questionnaire:

A. During the 12-month visit and again during the 24-month visit if the child does not reside in an at-risk area;

B. If the child does not reside in an at-risk area and is 24 months old or older and younger than 6 years old, and the provider does not have documentation that a blood test for lead poisoning or a lead exposure risk questionnaire has been previously administered to, or completed on behalf of, the child;

C. At each well-child check for a child who is 6 months old or older and younger than 6 years old, and resides in an at-risk area; and

D. In accordance with the EPSDT requirements for a child insured under the Maryland Medicaid program regardless of the child's area of residence.

#### Regulation .04 Blood Tests for Lead Poisoning.

*COMAR 10.11.04.04*

A. A primary care provider for a child who resides, or who is known to have previously resided, in an at-risk area shall administer a blood test for lead poisoning during the 12-month visit and again during the 24-month visit.

B. A primary care provider for a child who is 24 months old or older and younger than 6 years old who resides, or who is known to have previously resided, in an at-risk area as defined in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning, shall administer a blood test for lead poisoning if the:

  (1) Child has not previously received a blood test for lead poisoning;

  (2) Child's parent or guardian fails to provide documentation that the child has previously received a blood test for lead poisoning; or

  (3) Provider is unable to obtain the results of a previous blood lead analysis.

C. A primary care provider for a child shall administer a blood test for lead poisoning to a child if:

  (1) An affirmative answer, or a response indicating that the parent or guardian does not know the answer, is given for any question on a lead exposure risk questionnaire that is completed for the child pursuant to Regulation .03 of this chapter; or

  (2) The child's parent or guardian requests that the child receive a blood test for lead poisoning regardless of the child's age or area of residence.

D. If a child is insured under Maryland's Medicaid program, the child's primary care provider shall administer a blood test for lead poisoning to the child at the 12-month visit and again at the 24-month visit in accordance with EPSDT requirements regardless of the child's area of residence.

E. A primary care provider shall administer a blood test for lead poisoning, by venous methodology, if the results of a capillary blood test for lead poisoning indicate a blood lead level that exceeds the blood lead reference level.

F. For each blood test for lead poisoning administered by a health care provider, the provider shall provide on the lab order form the information for blood lead reporting that is required under Environment Article, §6-303, Annotated Code of Maryland, to the medical laboratory that:

  (1) Draws the blood specimen; or

  (2) Performs the blood lead analysis.

G. Physician offices and other point-of-care laboratories shall comply with the requirements under COMAR 10.10.03.02B(36) and C.

H. Bona Fide Religious Beliefs — At Risk.

  (1) If the parent or guardian of a child refuses to consent to a blood test for lead poisoning due to the parent or guardian's stated bona fide religious beliefs and practices, a primary care provider shall:

    (a) Counsel the parent or guardian that the blood test for lead poisoning is required by law due to the fact that their child is at risk for having a blood lead level that exceeds the blood lead reference level; and

    (b) Complete a lead exposure risk questionnaire for the child in the presence of the child and the child's parent or guardian.

  (2) If an affirmative response to the questionnaire under §H(1)(b) of this regulation, or a response indicating that the parent or guardian does not know the answer, is entered for any question on the lead exposure risk questionnaire for the child, the provider shall:

    (a) Further counsel the parent or guardian regarding the risks of lead poisoning, including the potential physical, behavioral, developmental, and intellectual effects, and again request the parent or guardian to consent to a blood test for lead poisoning;

    (b) Document in the child's medical record any continued refusal by the parent or guardian to consent to a blood test for lead poisoning despite counseling, and the grounds for the parent or guardian's refusal;

    (c) Write and sign an order for a blood test for lead poisoning on a medical laboratory order form; and

    (d) Give the child's parent or guardian the completed order for the medical laboratory to draw a blood specimen for blood lead analysis.

  (3) If all the responses to the lead exposure risk questionnaire are negative, the provider shall:

    (a) Follow procedures set forth in §H(2)(b) of this regulation; and

    (b) Complete a form issued by the Department indicating that the questionnaire was completed.

I. Repealed.

J. This regulation does not limit the duties of the child's health care provider, with respect to any child who resides or has previously resided in an at-risk area, under any other provision of the law.

K. A health care provider giving nonprimary care to a child may, but is not required to, administer a blood test for lead poisoning, even if a blood test for lead poisoning is not medically indicated.

#### Regulation .05 Documentation Requirements on Entry into a Prekindergarten Program, Kindergarten Program, or First Grade.

*COMAR 10.11.04.05*

A. The parent or guardian of a child who currently resides, or has previously resided, in an at-risk area shall provide to the administrator of the child’s school or program, or the administrator’s designee, certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, on first entry into a:

  (1) Maryland public prekindergarten program; or

  (2) Maryland public school system at the level of prekindergarten, kindergarten or first grade.

B. An electronic report of the child’s blood lead analysis from a health care provider to the administrator of the child’s school or program, or the administrator’s designee, may serve as an acceptable alternative to the documentation required in §A of this regulation.

C. A health care provider shall:

  (1) Document and certify by signature the dates of the blood lead analysis administered to a child pursuant to Regulation .04A of this chapter on a form developed by the Department; and

  (2) Upon request by the child’s public school or program administrator, or the administrator’s designee, for a child who resides or has previously resided in an at-risk area, provide to the school or program the certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, in order to facilitate the Department’s public health surveillance activities relating to lead poisoning.

D. The child’s parent or guardian shall provide certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, administered in connection with the 12-month visit and 24-month visit to a Maryland public prekindergarten program not later than:

  (1) 20 calendar days from the 12-month visit or 24-month visit; or

  (2) 20 calendar days from first entry into the program or system.

E. Pursuant to Regulation .04A of this chapter, if the child’s first blood test for lead poisoning was administered after the child is 24 months old, then only certified documentation of the most recent blood lead analysis is required to be reported pursuant to §C of this regulation.

F. Pursuant to Regulation .04A of this chapter, if a child has more than two blood tests for lead poisoning done between the ages of 12 months and 24 months, then only certified documentation of the two most recent blood lead analyses shall be reported.

G. The information sent to or received by a program or school pursuant to §A of this regulation shall be recorded and certified by a health care provider’s signature on a form issued by the Department that includes the following:

  (1) Name of the child;

  (2) Date and result of the blood lead analysis; and

  (3) The signature of the:

    (a) Child's primary care provider or designee; or

    (b) School health professional or designee that transcribed the information onto the form issued by the Department.

H. If a child is not required to receive a blood test for lead poisoning pursuant to Regulation .04A or B of this chapter, then the child's parent or guardian shall provide to the administrator of the child's school or program, or the administrator's designee, on a form issued by the Department, documentation that the child does not reside and has never resided in an at-risk area.

I. If a parent or guardian does not consent to a blood test for lead poisoning pursuant to Regulation .04H of this chapter, the child’s parent or guardian shall:

  (1) Take their child to a primary care provider for the provider to complete a lead poisoning risk assessment questionnaire; and

  (2) Submit to the administrator of the child's school or program, or the administrator's designee, a written, signed statement of exemption on a form issued by the Department.

J. Notice Required.

  (1) The program or school shall give notice in accordance with §J(2) of this regulation to the parent or guardian of a child who resides or has resided in an at-risk area who does not provide:

    (a) The certified documentation of the child’s blood lead analysis, as specified in §G of this regulation; or

    (b) A signed statement of exemption.

  (2) The notice required under this section shall state that the parent or guardian is required by law to provide the information under §J(1) of this regulation at the time of enrollment.

#### Regulation .06 Blood Lead Analysis Reporting Requirements.

*COMAR 10.11.04.06*

A. Notwithstanding §B of this regulation, a medical laboratory shall report, to the Department of the Environment, the information required under Environment Article, §6-303, Annotated Code of Maryland.

B. A medical laboratory that performs blood lead analysis shall report the results of all blood tests for lead poisoning, performed pursuant to Regulation .04 of this chapter for a child who resides in Baltimore City, to the Commissioner of the Baltimore City Health Department in accordance with Article-Health, §4-607, Baltimore City Revised Code.

C. The Commissioner of the Baltimore City Health Department may report the information received under §B of this regulation to the Baltimore Immunization Registry Program.

D. The Department may report the results of blood lead analysis to an immunization registry developed by the Department.

E. The Department of the Environment may report the results of blood lead analysis to an immunization registry developed by the Department.

### Chapter 05 — Child Death Review Case Reporting System

**Authority:** Health-General Article, §§2-104(b) and 5-704, Annotated Code of Maryland

**Administrative History:** Effective date: April 6, 2009 (36:7 Md R. 524)

#### Regulation .01 Purpose.

*COMAR 10.11.05.01*

The purpose of this chapter is to clarify the authority of State and local child fatality review teams in Maryland to participate in certain national child death review case reporting systems as a means to enhance the CFR teams' ability to more effectively carry out its purpose of:

A. Developing an understanding of the causes and incidence of child deaths;

B. Developing plans for and implementing changes within the agencies represented on the child fatality review teams to prevent child deaths; and

C. Advising the Governor, the General Assembly, and the public on changes to law, policy, and practice to prevent child deaths.

#### Regulation .02 Scope.

*COMAR 10.11.05.02*

A. This chapter controls the drafting and implementation of data use agreements between the State child fatality review team and other public or private organizations or entities in order to assure that Maryland's State and local child fatality review teams are able to participate in and utilize recognized, appropriate national child death review case reporting systems in a secure manner that comports with applicable laws governing the confidentiality of child death information.

B. This chapter governs the:

  (1) Maintenance of confidential child death review case data;

  (2) Participation of State and local child fatality review teams in national child death review reporting systems; and

  (3) Aggregation and reporting of de-identified child death data in the administration of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland.

#### Regulation .03 Definitions.

*COMAR 10.11.05.03*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Child death review (CDR) case reporting system” means a national standardized, web-based reporting system for the confidential collection, analysis, aggregation, and reporting of child death data that is maintained and operated by a national center for child death review (NCCDR).

  (2) “Data use agreement” means a contract between the Department and a NCCDR that establishes the terms and conditions for the State and local CFR teams' participation in a child death review case reporting system.

  (3) “Department” means the Maryland Department of Health.

  (4) “Local child fatality review (CFR) team” means a multidisciplinary and multiagency review team established by a county under Health-General Article, §5-705, Annotated Code of Maryland.

  (5) “National center for child death review (NCCDR)” means a public, private, nonprofit, or governmental organization or entity that is:

    (a) Funded or otherwise recognized by the United States Department of Health and Human Services (DHHS); and

    (b) Responsible for:

      (i) Developing a CDR case reporting system;

      (ii) Training and serving as a liaison to State agencies participating in the system; and

      (iii) Disseminating national child death review data generated by the system.

  (6) “State Child Fatality Review (CFR) Team” means the State-level multidisciplinary and multiagency review team established under Health-General Article, §5-702, Annotated Code of Maryland.

#### Regulation .04 Data Use Agreement.

*COMAR 10.11.05.04*

A. The Department may enter into a data use agreement with a NCCDR to participate in the NCCDR's case reporting system.

B. The purpose of the data use agreement is to establish the terms and conditions for:

  (1) The confidential submission, collection, storage, and analysis of data obtained from the child death case reviews submitted by Maryland's State and local CFR teams; and

  (2) The reporting, aggregation, and dissemination of de-identified child death review data generated by the CDR case reporting system.

#### Regulation .05 National Center for Child Death Review's Duties.

*COMAR 10.11.05.05*

The data use agreement with the NCCDR shall:

A. Assure that the State and local CFR teams have full access to and use of the CDR reporting system for the purposes of collecting, analyzing, aggregating, and reporting on child death review data;

B. Facilitate the comparison of aggregate, de-identified child death data within and among the State and local CFR teams; and

C. Require that the NCCDR acts as a fiduciary agent of the State and local CFR teams in carrying out their responsibilities under this chapter.

#### Regulation .06 Electronic Data Transmittal.

*COMAR 10.11.05.06*

Staff of the State or local CFR team shall first de-identify or remove information which would allow identification of an individual from any CFR team reports filed with, or information electronically transmitted by staff to, the NCCDR.

#### Regulation .07 Confidentiality of Data.

*COMAR 10.11.05.07*

If any personally identifying child fatality review information or record is acquired by the NCCDR or its staff, that information or record is confidential and subject to the same confidentiality and discovery protections set forth in Health-General Article, §5-709, Annotated Code of Maryland, that apply to the State and local CFR teams.

#### Regulation .08 Terms and Construction of a Data Use Agreement.

*COMAR 10.11.05.08*

Any data use agreement entered into by the State CFR Team and a NCCDR shall:

A. Incorporate by reference and be construed in accordance with the provisions of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland, and this chapter; and

B. Be coexecuted by:

  (1) The Secretary or the Secretary's designee; and

  (2) The chairperson of the State CFR Team.

### Chapter 06 — Morbidity, Mortality, and Quality Review Committee — Pregnancy and Childhood

**Authority:** Health-General Article, §18-107, Annotated Code of Maryland

**Administrative History:** Effective date: September 21, 2009 (36:19 Md R. 1436)

**Administrative History:** Regulation .02B amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .03 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .05B amended effective March 14, 2016 (43:5 Md. R. 385)

**Administrative History:** Regulation .06 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .07 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .08 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .09 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .10 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .11 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .12 amended effective April 23, 2018 (45:8 Md. R. 421)

**Administrative History:** Regulation .13 amended effective April 23, 2018 (45:8 Md. R. 421)

#### Regulation .01 Scope.

*COMAR 10.11.06.01*

This chapter does not apply to the review of a fetal death that is the result of a voluntary or therapeutic termination of pregnancy.

#### Regulation .02 Definitions.

*COMAR 10.11.06.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Committee” means the Morbidity, Mortality, and Quality Review Committee established within the Department.

  (2) “Department” means the Maryland Department of Health.

  (3) “Jurisdiction” means a political subdivision of the State, including the 23 counties and Baltimore City.

  (4) “Early childhood” means the period in which an individual is younger than 6 years old.

  (5) “Fetal and infant mortality review (FIMR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team established by a health officer or health officers of a group of jurisdictions.

  (6) “Fetal death” has the meaning stated in Health-General Article, §4-201, Annotated Code of Maryland.

  (7) “Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland.

  (8) “Health officer” has the meaning stated in Health-General Article, §1-101, Annotated Code of Maryland.

  (9) “Infant death” means death occurring to an individual who is younger than 1 year old.

  (10) “Maryland Perinatal System Standards” means the hospital perinatal program standards established by the Perinatal Clinical Advisory Committee of the Department.

  (11) “Morbidity, mortality, and quality review (MMQR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team, or entity established to review cases associated with pregnancy, childbirth, infancy, or early childhood in order to make improvements in systems of care, including:

    (a) A fetal and infant mortality review team; or

    (b) Another multidisciplinary and multiagency review team or other entity established for a jurisdiction that addresses an aspect of morbidity, mortality, or quality of care associated with pregnancy, childbirth, infancy, or early childhood.

  (12) “Perinatal center” means a hospital that offers obstetric or neonatal services, or both.

  (13) “Secretary” means the Secretary of Health.

  (14) “Transport” means the transfer of a patient to another health care facility.

#### Regulation .03 Incorporation by Reference.

*COMAR 10.11.06.03*

The Maryland Perinatal System Standards (Perinatal Clinical Advisory Committee, June 2014) is incorporated by reference.

#### Regulation .04 Morbidity, Mortality, and Quality Review Committee.

*COMAR 10.11.06.04*

There is a Morbidity, Mortality, and Quality Review Committee established within the Department.

#### Regulation .05 Membership.

*COMAR 10.11.06.05*

A. The Committee shall be:

  (1) A State-level multidisciplinary and multiagency review Committee within the Department; and

  (2) Composed of at least 26 members as described in §§B and C of this regulation.

B. Ex Officio Members. The Committee shall include the following ex officio members or their designees:

  (1) The Secretary of the Maryland Department of Health;

  (2) The Secretary of Human Services;

  (3) The Deputy Secretary of the Health Care Financing Administration;

  (4) The Director of the Vital Statistics Administration;

  (5) The Director of the Prevention and Health Promotion Administration;

  (6) The Director of the Behavioral Health Administration;

  (7) The Director of the Maternal and Child Health Bureau;

  (8) The Chief Medical Examiner;

  (9) The Director of the Office of Minority Health and Health Disparities;

  (10) The Director of the Office of Health Care Quality;

  (11) The Executive Director of the Maryland Health Care Commission;

  (12) The Executive Director of the Maryland Institute for Emergency Medical Services Systems;

  (13) The Executive Director of the Medical and Chirurgical Faculty of Maryland;

  (14) The President of the Maryland Hospital Association;

  (15) The President of the Maryland Chapter of the American Academy of Pediatrics;

  (16) The Chair of the Maryland Section of the American College of Obstetricians and Gynecologists;

  (17) One representative from the University of Maryland School of Medicine;

  (18) One representative from the Johns Hopkins School of Medicine;

  (19) Three representatives from the Maryland Association of County Health Officers;

  (20) The Chair of the Maryland State Child Fatality Review Team; and

  (21) The Chair of the Maryland Maternal Mortality Review Committee.

C. Appointed Members.

  (1) The Secretary shall appoint one Committee member that is a certified nurse midwife from a list of qualified individuals submitted by professional nursing organizations that represent licensed registered nurses in Maryland.

  (2) The Secretary may appoint up to five other Committee members and may appoint additional members who are individuals with an interest and expertise in pregnancy, childbirth, infancy, or early childhood or other related disciplines as considered necessary by the Secretary to carry out the Committee’s responsibilities.

  (3) Appointed Committee members shall serve at the pleasure of the Secretary.

D. Designation of Representatives. An ex officio member described under §B of this regulation may designate another individual to represent the member on the Committee from the member’s:

  (1) Agency;

  (2) Department;

  (3) Office; or

  (4) Organization.

E. Invitees. The Secretary may invite representatives from other agencies and organizations, and individuals involved in the prevention or reduction of morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood, to attend a Committee meeting if the representative has information that may be necessary to inform the Committee.

F. Term of Appointment. Appointed members shall serve for a term of 3 years.

G. Staffing. The Committee may employ staff in accordance with the State budget.

H. Expenses. Members of the Committee shall serve without compensation, but may be reimbursed for reasonable expenses incurred in the performance of their duties:

  (1) In accordance with the standard State travel regulations; and

  (2) As provided in the State budget.

I. Chairperson. The Secretary or the Secretary's designee shall serve as Chairperson of the Committee.

#### Regulation .06 Committee Duties.

*COMAR 10.11.06.06*

A. To achieve its purpose, the Committee shall:

  (1) Provide consultation to FIMR teams and other MMQR teams;

  (2) Conduct confidential and anonymous case reviews of morbidity and mortality associated with pregnancy, childbirth, infancy, and early childhood;

  (3) Undertake annual statistical analysis of the incidence and cause of morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;

  (4) Monitor hospital compliance with the Maryland Perinatal System Standards by:

    (a) Reviewing documents requested of the hospital in writing or by conducting on-site reviews, or by both; and

    (b) Making recommendations to improve or facilitate compliance; and

  (5) Determine factors contributing to morbidity and mortality, and make recommendations for strategies to prevent and reduce morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood throughout the State, including recommendations for changes to law, policy, or practice to prevent and reduce morbidity and mortality and improve the system of care.

B. The Committee may:

  (1) Evaluate the continued effectiveness and efficiency of the Statewide morbidity, mortality, and quality review process associated with pregnancy, childbirth, infancy, and early childhood and make or recommend appropriate changes as necessary;

  (2) Establish special panels or ad hoc subcommittees of the Committee as necessary to carry out the duties of the Committee;

  (3) Analyze data and review reports or other information from:

    (a) FIMR teams;

    (b) Other MMQR teams; or

    (c) Other entities which are established for the purpose of addressing an aspect of morbidity, mortality, or quality reviews associated with pregnancy, childbirth, infancy, or early childhood;

  (4) Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood;

  (5) Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care;

  (6) Review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties; and

  (7) Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort.

#### Regulation .07 Local Teams — Establishment and Purpose.

*COMAR 10.11.06.07*

A. A jurisdiction shall have a multidisciplinary and multiagency FIMR team or other MMQR team.

B. The purpose of a FIMR team is to facilitate the reduction of fetal and infant deaths by:

  (1) Conducting confidential case reviews of fetal and infant deaths including the examination of available medical and healthcare information involving fetal and infant mortality; and

  (2) Based on the findings of the case reviews conducted under §B(1) of this regulation:

    (a) Determining factors contributing to fetal and infant deaths;

    (b) Developing recommendations to reduce factors contributing to fetal and infant deaths;

    (c) Recommending strategies to improve the system of care in an effort to prevent or reduce fetal and infant deaths; and

    (d) Informing the Committee of changes that affect fetal and infant deaths in:

      (i) Local law;

      (ii) Policy; or

      (iii) Practices.

C. A FIMR team shall:

  (1) Analyze fetal and infant deaths to determine contributing system factors; and

  (2) Make recommendations for systems change as appropriate.

D. A FIMR team may:

  (1) Evaluate the continued effectiveness and efficiency of the local fetal and infant mortality review process and make appropriate changes; and

  (2) Establish protocols in compliance with State statutes and regulations, as applicable, for:

    (a) Data collection;

    (b) Analysis; and

    (c) Reporting.

#### Regulation .08 FIMR Teams — Membership.

*COMAR 10.11.06.08*

A. Members of a FIMR team shall be appointed by the local health officer of the jurisdiction or be jointly appointed by the health officers of the jurisdictions comprising the multi-jurisdiction local team.

B. A FIMR team shall appoint a chairman from among its membership.

C. A FIMR team shall be multidisciplinary and include professionals and representatives of agencies that provide services or community resources for families in the community and community representatives.

D. A FIMR team shall include at least one representative from:

  (1) Public health programs, such as:

    (a) Maternal and child health;

    (b) Substance abuse; or

    (c) Mental health;

  (2) Health care provider specialties, such as:

    (a) Obstetrics;

    (b) Pediatrics;

    (c) Social work;

    (d) Nursing; or

    (e) Nurse midwifery; and

  (3) Hospitals, such as hospital administrators, or professionals with expertise in perinatal services or quality improvement.

E. A FIMR team may include representatives from other agencies or community organizations involved with the prevention or reduction of fetal and infant deaths.

#### Regulation .09 MMQR Teams — General.

*COMAR 10.11.06.09*

MMQR teams may:

A. Inform the Committee of changes that affect morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood in:

  (1) Local law;

  (2) Policy; or

  (3) Practice; and

B. Provide the Committee with requested reports and other information so that the Committee may perform its duties.

#### Regulation .10 Types of Committee Reviews.

*COMAR 10.11.06.10*

The Committee may conduct morbidity, mortality, and quality reviews associated with pregnancy, childbirth, infancy, and early childhood, including but not limited to reviews of the following:

A. Individual cases or clusters of cases of morbidity or mortality;

B. Maternal or neonatal transport to or from perinatal centers; and

C. Aggregate or hospital-specific cases of mortality or morbidity associated with pregnancy, childbirth, infancy, or early childhood.

#### Regulation .11 Access to Records and Information.

*COMAR 10.11.06.11*

A. A health care provider, hospital, HIPAA (Health Insurance Portability and Accountability Act of 1996) business associate, or other related entity shall, on written request of the Committee, FIMR team, other MMQR team, or their staff, provide access to records concerning:

  (1) Prepregnancy, prenatal, and postpartum care of the mother;

  (2) Somatic, dental, and behavioral health of the mother;

  (3) The health care provided by:

    (a) A health care provider;

    (b) A health care facility; or

    (c) Emergency medical services;

  (4) Emergency medical services system data on maternal and neonatal transport;

  (5) State vital records data related to morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood; and

  (6) Documentation relevant to the purpose and duties of the Committee, FIMR team, or other MMQR team that is maintained by a State or local government agency, including:

    (a) Medical examiner investigative information; and

    (b) Law enforcement investigative information, including police reports.

B. The Committee, FIMR team, or other MMQR team shall assign staff to abstract information from patient medical records and other sources of information to which the Committee, FIMR teams, or other MMQR teams are entitled under §A of this regulation.

C. Information abstracted under §B of this regulation shall be de-identified by the abstractor to remove information that would permit the identification of an individual health care recipient before the information may be used to carry out the purpose and duties of the Committee, FIMR team, or other MMQR team.

#### Regulation .12 Meetings.

*COMAR 10.11.06.12*

A. The Committee shall meet at least semiannually.

B. FIMR teams shall meet at least quarterly.

C. A meeting of the Committee, FIMR teams, or other MMQR teams shall be closed to the public and is not subject to General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland, when the Committee, local FIMR team, or other MMQR team is reviewing cases of pregnancy, childbirth, infancy, or early childhood.

D. The Committee, FIMR team, or other MMQR team may invite an individual who is not a member to attend a Committee, FIMR team, or other MMQR team meeting if:

  (1) The attendance is approved in advance by the Committee, FIMR team, or other MMQR team chairperson;

  (2) Participation of the invited individual is intended to assist the Committee, FIMR team, or other MMQR team in carrying out its duties; and

  (3) Invitees in attendance abide by the same confidentiality and nondisclosure requirements which govern the Committee, FIMR team, and other MMQR team members.

#### Regulation .13 Confidentiality of Records and Information.

*COMAR 10.11.06.13*

A. The following shall be held confidential and may not be released to a person except as provided in this chapter:

  (1) Records and information received by the Committee, FIMR team, or other MMQR team;

  (2) Documents produced in the case review process; and

  (3) Minutes of meetings of the Committee, FIMR team, or other MMQR team.

B. Information and records obtained by the Committee, a FIMR team, or other MMQR team are exempt from disclosure under General Provisions Article, Title 4, Annotated Code of Maryland.

C. The Committee, a FIMR team, or other MMQR team may not discuss, disclose, or use information for purposes other than as necessary to carry out the Committee’s, FIMR team’s, or other MMQR team’s duties and purposes under this chapter.

D. Information that is disclosed to the public by the Committee, FIMR team, or other MMQR team shall be de-identified and may not contain information that would permit the identification of an individual, a health care provider, or a health care facility.

E. The Committee, a FIMR team, or other MMQR team may release specific findings that relate to aggregate data as well as recommendations made by the Committee, FIMR team, or other MMQR team to prevent and reduce morbidity and mortality, and this information shall be public record.

F. The Committee, FIMR team, other MMQR team, or their staff shall maintain the confidentiality of information used or addressed at meetings.

G. A person in attendance at a meeting of the Committee, a FIMR team, or other MMQR team may not testify or be required to testify as to what transpired at that part of the meeting that is closed under General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland.

H. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees may not be questioned in a civil or criminal proceeding regarding information presented at or opinions formed as a result of a closed Committee, FIMR team, or other MMQR team meeting.

I. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees, may testify in a civil or criminal proceeding to information that is:

  (1) Obtained independent of the Committee, FIMR team, or other MMQR team; and

  (2) Publicly available, except as otherwise provided by law.

J. Information, documents, and records of the Committee, a FIMR team, or other MMQR team are not subject, in a civil or criminal proceeding, to:

  (1) Subpoena;

  (2) Discovery; or

  (3) Introduction as evidence.

K. Information, documents, and records obtained by the Committee, a FIMR team, or other MMQR team that are available from other sources may be subject, as provided by applicable law, to:

  (1) Subpoena;

  (2) Discovery; or

  (3) Introduction into evidence.

L. A person may not be held liable for civil damages or subject to a criminal or disciplinary action for good faith efforts made to comply with the provisions of this chapter.

### Chapter 07 — Prohibition of Sale of Baby Bumper Pads

**Authority:** Health-General Article, §22-501 et seq., Annotated Code of Maryland

**Administrative History:** Effective date: November 26, 2012 (39:23 Md R. 1532)

#### Regulation .01 Definitions.

*COMAR 10.11.07.01*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “ASTM Standards” means the standard consumer safety performance specifications for infant bedding and related accessories set by the American Society for Testing and Materials (ASTM).

  (2) “Baby bumper pads” means a pad or pads of non-mesh material resting directly above the mattress in a crib, running the circumference of the crib or along the length of any of the interior sides of the crib, and intended to be used until the age that an infant pulls to stand.

  (3) “Department” means the Maryland Department of Health.

  (4) “Hazardous material” has the meaning stated in Health-General Article, §22-501, Annotated Code of Maryland.

#### Regulation .02 General Provisions.

*COMAR 10.11.07.02*

A. Baby bumper pads are hereby declared to be a hazardous material and may not be shipped or sold to a purchaser in Maryland beginning June 21, 2013.

B. ASTM Standards.

  (1) After notification that ASTM has adopted a new voluntary standard for baby bumper pads, the Secretary may provide an opportunity for public comment on whether the new ASTM Standards should replace the prohibition contained in §A of this regulation.

  (2) Within 60 days after the close of public comment, the Secretary may issue an order permitting the sale of baby bumper pads that comply with the new ASTM Standards if the Secretary determines that such bumper pads are not a danger to the public health and safety.

C. The Secretary may issue an order suspending this chapter for covered baby bumper pads if the Consumer Product Safety Commission affirmatively finds that the benefits of certain baby bumper pads exceed the risks.

#### Regulation .03 Violations.

*COMAR 10.11.07.03*

A. A notice of violation will be issued by the Department to any person found to have shipped or sold a baby bumper pad to a purchaser in Maryland after June 21, 2013.

B. A person who, after being issued a notice of violation, ships or sells a baby bumper pad to a purchaser in Maryland shall be subject to a civil fine of not more than $500 for each baby bumper pad shipped or sold in violation of this subtitle.

### Chapter 08 — Sensitive Health Services

**Authority:** Health-General Article, §4-302.5 Annotated Code of Maryland

**Administrative History:** Effective date: September 16, 2024 (51:18 Md. R. 809)

**Administrative History:** Regulation .01B amended effective May 11, 2026 (53:9 Md. R. 413)

**Administrative History:** Regulation .02B amended effective May 11, 2026 (53:9 Md. R. 413)

**Administrative History:** Regulation .04B amended effective May 11, 2026 (53:9 Md. R. 413)

**Administrative History:** Regulation .06 recodified to Regulation .07 effective May 11, 2026 (53:9 Md. R. 413)

**Administrative History:** Regulation .06 adopted effective May 11, 2026 (53:9 Md. R. 413)

#### Regulation .01 Purpose.

*COMAR 10.11.08.01*

This chapter:

A. Defines:

  (1) Mifepristone data;

  (2) Health information exchange;

  (3) Electronic health network; and

  (4) Protected Health Care Commission;

B. Lists the:

  (1) Mifepristone data, and diagnosis, procedure, and related codes for abortion care that are subject to the restrictions on the disclosure of health care information; and

  (2) Diagnosis, procedure, and related codes for gender-affirming treatment that are subject to the restrictions on the disclosure of health care information;

C. Describes to whom these restrictions apply; and

D. Sets forth the restrictions on data.

#### Regulation .02 Definitions.

*COMAR 10.11.08.02*

A. In this chapter, the following terms have the meaning indicated.

B. Terms Defined.

  (1) “Electronic health network” has the meaning stated in COMAR 10.25.09.02.

  (2) “Gender-affirming treatment” has the meaning stated in Health-General Article, §15-151, Annotated Code of Maryland.

  (3) “Health information exchange” has the meaning stated in COMAR 10.25.18.02.

  (4) “Mifepristone data” means all medication or related codes pertaining to mifepristone use during any stage of pregnancy, and excludes any codes pertaining to the use of mifepristone for Cushing’s syndrome.

  (5) “Protected Health Care Commission” means the group established under Health-General Article, §4-310, Annotated Code of Maryland.

  (6) “Secretary” means the Secretary of the Maryland Department of Health.

#### Regulation .03 Abortion Care Codes.

*COMAR 10.11.08.03*

A health information exchange and an electronic health network shall restrict the disclosure of the abortion care medical diagnosis codes and current procedural terminology (CPT) codes listed in the tables below.

A. List of Medical Diagnosis Codes.

B. List of the Current Procedural Terminology (CPT®) Codes.

#### Regulation .04 Mifepristone Data Codes.

*COMAR 10.11.08.04*

A health information exchange and an electronic health network shall restrict the disclosure of mifepristone data Healthcare Common Procedure Coding System (HCPCS) codes and medication codes listed in the tables below.

A. List of Healthcare Common Procedure Coding System ( HCPCS) Level 2 Codes.

B. List of Medication Codes.

#### Regulation .05 Restrictions on Disclosure of Mifepristone Data.

*COMAR 10.11.08.05*

Data is restricted in accordance with COMAR 10.25.18 and COMAR 10.25.07.

#### Regulation .06 Gender-Affirming Treatment Codes.

*COMAR 10.11.08.06*

A. A health information exchange and an electronic health network shall restrict the disclosure of the gender-affirming treatment medical diagnosis codes and current procedural terminology (CPT) codes listed in §B below.

B. List of Medical Diagnosis Codes.

#### Regulation .07 Sensitive Health Services.

*COMAR 10.11.08.07*

The Secretary shall determine what sensitive health services are subject to restriction under this chapter based on the recommendations of the Protected Health Care Commission.