Chapter 06. Maryland AIDS Drug Assistance Program: Pharmacy Services

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

“Department” means the Maryland Department of Health.

“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.

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

“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.

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

“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.

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

“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.

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

“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.

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

“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.

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

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

The appropriate agency in the state in which the pharmacy is located.

Licensed; and

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

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;

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;

Maintain records in accordance with standards established by Medical Assistance;

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

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

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.

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

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

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

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

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

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

Suspend the pharmacy from MADAP;

Withhold payment to the pharmacy; or

Both.

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

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.

The effective date of the proposed action;

The reason for the proposed action; and

The pharmacy’s right to appeal the proposed action.

Recipient; or

Recipient’s parent or legal guardian;

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

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