Sec. 10.67.06.04. Benefits — Pharmacy Services

A. An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act.

B. An MCO shall provide to its enrollees all medically necessary pharmaceutical services and pharmaceutical counseling, including but not limited to:

(1) Legend drugs;

(2) Insulin;

(3) All FDA approved contraceptives;

(4) Hypodermic needles and syringes;

(5) Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home;

(6) Enteric coated aspirin prescribed for the treatment of arthritic conditions;

(7) Nonlegend ferrous sulfate oral preparations;

(8) Nonlegend chewable tablets of any ferrous salt when combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation when the enrollee is younger than 12 years old;

(9) Medical supplies used in the preparation of compounded prescriptions for home intravenous therapy;

(10) Medical supplies or equipment used in the administration or monitoring of medication prescribed or ordered for an enrollee by a qualifying provider as specified in §B of this regulation;

(11) Latex condoms;

(12) Nonlegend ergocalciferol liquid (Vitamin D); and

(13) Emergency contraceptives for female recipients.

C. Except as provided in §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by:

(1) An MCO provider;

(2) An out-of-plan provider, when the pharmacy services are ordered or prescribed in connection with medical care furnished by the provider to the MCO's enrollee:

(a) In response to the enrollee's emergency medical condition; or

(b) Pursuant to the enrollee's self-referral to the provider, when the care delivered qualifies as a permissible self-referred service under Regulation .28 of this chapter; or

(3) A behavioral health provider for drugs not in the behavioral health formulary.

D. An MCO shall provide over-the-counter emergency contraceptives and latex condoms to enrollees without requiring an order from an authorized prescriber.

E. Drug Formulary.

(1) An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program, and include at a minimum:

(a) Covered generic and name brand medications; and

(b) The tier each medication is on.

(2) An MCO shall include in its formulary drugs that are appropriate for medical management, safe, and effective.

(3) An MCO shall expand its formulary, as needed, to include drugs that are equivalent to new drugs approved by the federal Food and Drug Administration, and which are deemed to be appropriate, safe, and efficacious in the medical management of the MCO's enrollees.

(4) An MCO shall include in its formulary the following drugs:

(a) Leuprolide acetate;

(b) Clonidine;

(c) Guanfacine;

(d) Medroxyprogesterone; and

(e) Liothyronine.

(5) To ensure that its formulary drugs are medically necessary, safe, and efficacious, an MCO shall:

(a) Subject its formulary to a review process that is:

(i) Established and conducted by the MCO’s Pharmacy and Therapeutics Committee;

(ii) Approved by the Department; and

(iii) Coordinated with the formulary review process of the Specialty Mental Health Services delivery system; and

(b) Submit its formulary for the review and approval of the Department, based upon the standards set forth in this regulation.

(6) Unless approved by the Department, an MCO may not require or utilize prior authorization or step therapy criteria for coverage of formulary drugs if such prior authorization or step therapy requires a recipient to use a drug that is included in the behavioral health formulary.

F. Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in §G of this regulation.

G. In this regulation, the term “specialty drug” means:

(1) A prescription drug that:

(a) Is prescribed for an individual with a complex, chronic or rare medical condition;

(b) Costs $600 or more for up to a 30-day supply;

(c) Is not typically stocked at retail pharmacies; and

(d) Requires a difficult or unusual process of delivery to the patient in the preparation, handling storage, inventory or distribution of the drug; or

(2) Requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug.

H. If an enrollee subsequently requests to use a retail pharmacy for specialty drugs the MCO may not limit the enrollee to the use of a mail order pharmacy.

I. An MCO shall:

(1) Establish and maintain a drug utilization review program;

(2) Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components:

(a) Formulary management;

(b) Generic substitution;

(c) Therapeutic substitution;

(d) Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act;

(e) Drug use evaluation (DUE);

(f) Disease management; and

(g) Pharmacy and Therapeutic Committee;

(3) Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and

(4) Provide to the Department a detailed description of its drug utilization review program activities on an annual basis.

J. The Department shall:

(1) Review each MCO’s drug utilization review program annually; and

(2) Notify an MCO annually if any of the standards established in §I(2) of this regulation have not been met.

K. For any performance standard identified in §J(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.67.10.01A and B.