# COMAR Title 10 — Maryland Department of Health

## Subtitle 18 — Human Immunodeficiency Virus (HIV) Infection and Acquired Immunodeficiency Syndrome (AIDS)

### Chapter 06 — Maryland AIDS Drug Assistance Program: Pharmacy Services

**Authority:** Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland

**Administrative History:** Effective date:

**Administrative History:** Regulations .01—.12 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180)

**Administrative History:** Regulation .01B amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .04 repealed and new Regulation .04 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04B amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)

**Administrative History:** Regulation .04C adopted effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .04-1 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04-2 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485)

**Administrative History:** Regulation .04-2 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .04-2 amended effective September 15, 2014 (41:18 Md. R. 1010)

**Administrative History:** Regulation .05A amended as an emergency provision effective February 20, 2007 (34:7 Md. R. 694); amended permanently effective June 18, 2007 (34:12 Md. R. 1067)

**Administrative History:** Regulation .05B amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561)

**Administrative History:** Regulation .06A amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207)

**Administrative History:** Regulation .06A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Regulation .12A amended effective March 16, 2015 (42:5 Md. R. 486)

**Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408)

**Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .02 amended effective January 19, 2026 (53:1 Md. R. 20)

**Administrative History:** Regulation .03A amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04-1 amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .04-2 repealed effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488), October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .08 amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .09A amended effective May 20, 2019 (46:10 Md. R. 488)

**Administrative History:** Regulation .10 amended effective October 14, 2024 (51:20 Md. R. 899)

**Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488)

#### Regulation .01 Definitions.

*COMAR 10.18.06.01*

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

B. Terms Defined.

  (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus.

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

  (3) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04 of this chapter.

  (4) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

  (5) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice.

  (6) “Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS.

  (7) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in Regulation .04 of this chapter for enrolled recipients.

  (8) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02.

  (9) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter.

  (10) “Pharmacist” means an individual registered and licensed to practice pharmacy in the state where the prescription is filled.

  (11) “Pharmacy” means an establishment or institution registered and licensed to dispense U.S. Food and Drug Administration-approved drugs or other products to the public in the state in which the establishment or institution is located.

  (12) “Preauthorization” means an approval required before the dispensing of the prescription.

  (13) “Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product not excluded from the open formulary.

  (14) “Recipient” means an individual who is enrolled in MADAP.

#### Regulation .02 Permit and License Requirements.

*COMAR 10.18.06.02*

A. To qualify for participation in MADAP, a pharmacy shall first obtain a permit from:

  (1) The State Board of Pharmacy, pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or

  (2) The appropriate agency in the state in which the pharmacy is located.

B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19.

C. To qualify for participation in MADAP, a health care practitioner shall be:

  (1) Licensed; and

  (2) Legally authorized to practice medicine in accordance with applicable state and federal laws.

#### Regulation .03 Conditions for Participation.

*COMAR 10.18.06.03*

A. To participate in MADAP, a pharmacy shall:

  (1) Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department;

  (2) Accept payment by the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family;

  (3) Maintain records in accordance with standards established by Medical Assistance;

  (4) Maintain prescriptions for a minimum of 5 years and make them available for inspection, upon request, to the Department or its designee;

  (5) Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and

  (6) Bill the recipient’s third-party insurance payer in accordance with the payer’s requirements in order to reduce the cost to be paid by the Department.

B. A pharmacy may not:

  (1) Knowingly employ a person who has been disqualified from Medical Assistance; or

  (2) Place a restriction on a recipient’s right to select a pharmacy of the recipient’s choice.

#### Regulation .04 Covered Services.

*COMAR 10.18.06.04*

A. The recipient shall obtain a prescription for each drug or other product ordered for the recipient.

B. The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for the recipient.

#### Regulation .04-1 Formulary.

*COMAR 10.18.06.04-1*

The Department shall:

A. Maintain a list of drugs and other products excluded from the open formulary; and

B. Make available electronically the list of drugs and other products excluded from the open formulary.

#### Regulation .05 Limitations on Covered Services.

*COMAR 10.18.06.05*

A. A pharmacist may not dispense more than a 100-day supply of a prescribed drug or other product.

B. The Department may not pay for:

  (1) A drug or other product prescribed as part of a recipient’s care in a correctional institution, inpatient hospital, nursing home, or long-term care setting; or

  (2) Drugs or other products excluded from the open formulary, unless the Department grants the recipient preauthorization.

#### Regulation .06 Preauthorization Requirement.

*COMAR 10.18.06.06*

A pharmacist shall obtain preauthorization for each prescription or refill before dispensing a drug or other product marked as restricted.

#### Regulation .07 Payment Procedures.

*COMAR 10.18.06.07*

A. Except as provided in §§B and C of this regulation, the Department shall pay a pharmacy in accordance with the procedures of the Medical Assistance Pharmacy Services Program set forth at COMAR 10.09.03.07.

B. If the Department or the recipient tells the pharmacy that the recipient has or may have third-party insurance coverage to offset some or all of the cost for services provided under MADAP, the pharmacy shall:

  (1) Bill the third-party payer the pharmacy’s usual and customary charge for the services provided; and

  (2) Bill the Department for the difference between the pharmacy’s usual and customary charge and the anticipated third-party receipts.

C. If the recipient has third-party insurance coverage, the Department shall pay the pharmacy the difference between the pharmacy’s usual and customary charge and the anticipated third-party insurance receipts, not to exceed the amount permitted under COMAR 10.09.03.07F and G.

D. The Department shall make payments related to MADAP in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009, and any subsequent modifications to the Act.

#### Regulation .08 Recovery and Reimbursement.

*COMAR 10.18.06.08*

The Department shall follow the same procedures for recovery and reimbursement as the Medical Assistance Program in COMAR 10.09.03.08.

#### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions.

*COMAR 10.18.06.09*

A. If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may:

  (1) Suspend the pharmacy from MADAP;

  (2) Withhold payment to the pharmacy; or

  (3) Both.

B. Removal of a pharmacy or a pharmacy’s employee from Medical Assistance shall result in removal from MADAP.

C. The Department:

  (1) May consult with the State Board of Pharmacy regarding the actions of a pharmacy, such as:

    (a) A breach of confidentiality;

    (b) Refusal of service; or

    (c) Discrimination; and

  (2) Shall consider the findings and recommendations of the State Board of Pharmacy when deciding on the imposition of a sanction as stated in §A of this regulation.

D. The Department shall give the pharmacy written notice of the Department’s intention to impose sanctions referred to in §A of this regulation, including:

  (1) The effective date of the proposed action;

  (2) The reason for the proposed action; and

  (3) The pharmacy’s right to appeal the proposed action.

E. A pharmacy voluntarily withdrawing from MADAP or removed or suspended from MADAP according to this regulation shall notify a recipient that the pharmacy is no longer a MADAP pharmacy.

#### Regulation .10 Appeal Procedures.

*COMAR 10.18.06.10*

A pharmacy filing an appeal shall do so in accordance with the Medical Assistance Program as set forth at COMAR 10.09.03.10.

#### Regulation .11 Confidentiality.

*COMAR 10.18.06.11*

Unless otherwise authorized by law, the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on a recipient without written consent of the:

  (1) Recipient; or

  (2) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

  (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

  (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

#### Regulation .12 Availability of Funding and Program Termination.

*COMAR 10.18.06.12*

A. If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination.

B. If MADAP is terminated, the Department shall provide benefits for each current recipient in accordance with COMAR 10.18.05.09B.