.05 Limitations.

A. Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered:

(1) Nonlegend drugs;

(2) Medical supplies and durable equipment;

(3) Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered;

(4) Drugs supplied to hospital inpatients;

(5) Drugs and supplies dispensed by the provider with an actual acquisition cost of $0;

(6) Experimental or investigational drugs;

(7) Except where authorized by the Department to be covered under this Regulation, injectables dispensed by a provider for administration by the prescriber;

(8) Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products when administered orally;

(9) Sugar or salt substitutes;

(10) Cosmetics, medicine chest supplies, and sundries including all soaps, all body powders, all body oils or body lotions, cotton balls, adhesive strip bandages, cotton-tipped applicators, suntan products, deodorants, dentifrices, tissues, convenience packages of covered items, hot water bottles, ice caps, heating pads, soft cervical collars;

(11) Alcoholic beverages;

(12) Ostomy supplies;

(13) Those services authorized for payment to a prescriber, hospital, nursing facility, hospital outpatient department, or freestanding clinic;

(14) Oral drugs or injections for central nervous system stimulants, anorexigenics, and any other agents when used for weight control;

(15) Drug products for which federal financial participation is prohibited pursuant to 42 CFR §441.25;

(16) Ovulation stimulants;

(17) Effective January 1, 2006, any Part D drug for individuals who are eligible for Medicare Part D benefits;

(18) Drugs or products used for hair growth or other cosmetic purposes;

(19) Any drug or supply that is covered and reimbursed by the Department under any other chapter of this subtitle; and

(20) Any drug or product the Department determines is not medically necessary.

B. Prescriptions requiring preauthorization according to Regulation .06 of this chapter are not covered unless the required preauthorization has been obtained from the Department or its designee.

C. Limitations on Covered Services.

(1) The allowable cost of ingredients dispensed pursuant to a prescription may not exceed an upper limit as established in Regulation .07, of this chapter.

(2) Refills.

(a) The prescriber shall authorize refills only on the original prescription if the prescriber determines a refill is necessary and appropriate.

(b) The Program may authorize no more than 11 refills, not to exceed other applicable federal and State limitations.

(c) The pharmacy may not automatically refill a prescription unless authorized in writing by the recipient or their designee.

(3) Days Supply.

(a) The total amount dispensed under one prescription order, including refills, is limited to a 360 days supply, not to exceed other applicable federal and State limitations.

(b) Unless otherwise specified, prescriptions shall be limited to a 34 day supply at one time.

(c) Unless otherwise specified, maintenance medication shall be limited to:

(i) A 34-day supply for the initial prescription; and

(ii) Up to a 100-day supply at one time for all subsequent prescriptions.

(d) Prescriptions shall be dispensed at the lower of the quantity prescribed or the maximum days supply allowed at one time unless:

(i) The Program authorizes a reduction of the quantity; or

(ii) The prescription is the final refill for the balance remaining on the total prescription order.

(e) Providers may partially fill a prescription for Schedule II controlled dangerous substances, but the remaining portion of the prescription may not be later filled.

(f) Oral sodium fluoride products used in the prevention of dental caries are limited to an original prescription of up to a 120-day supply with up to two refills, not to exceed a total of a 360-day supply.

(g) Prescriptions for drugs packaged by the manufacturer as an unbreakable unit may be dispensed in increments of appropriate package size.

(h) Whether for an initial or subsequent prescription, contraceptive prescriptions may be dispensed in up to a 12 months supply at one time.

(4) Generic Drugs.

(a) Except as limited by §C(4)(b) and (c) of this regulation, when a drug product is prescribed by its nonproprietary or generic name, a provider shall substitute as follows:

(i) A drug product in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the providerís professional opinion, therapeutically equivalent to the drug as prescribed; or

(ii) A drug product with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the providerís professional opinion, bioequivalent to the drug as prescribed as rated by the U.S. Food and Drug Administration.

(b) A provider may not substitute a generic drug for a brand name drug under §C(4)(a) of this regulation if:

(i) The prescriber specifically directs otherwise; and

(ii) The prescriber requests and received approval from the Program.

(c) The Department shall only authorize a provider to substitute a drug product under this regulation when there will be a savings in or no increase in cost to the Department.

(5) Copayment for Services Rendered on or after July 1, 2005.

(a) There will be no pharmacy copayment for prescriptions for the following:

(i) Individuals younger than 21 years old;

(ii) Pregnant women;

(iii) Institutionalized individuals who are inpatients in long-term care facilities or other institutions requiring spending all but a minimal amount of income for medical costs;

(iv) Family planning drugs and devices; and

(v) Individuals who are American Indians or Alaskan Natives.

(b) The copayments for prescriptions not excluded from a copayment under §C(5)(a) of this regulation are:

(i) $3 for prescriptions for brand name drugs not on the preferred drug list;

(ii) $1 for prescriptions for generic drugs and brand name drugs on the preferred drug list; and

(iii) $1 for prescriptions for antiretroviral drugs in American Hospital Formulary Service therapeutic class 8:18:08.

(6) Reimbursement may not be made:

(a) For nonlegend enteric coated aspirin tablets in strengths other than 300 to 325 milligrams;

(b) For any other nonlegend aspirin products such as sustained release capsules, buffered tablets, compressed tablets, liquid preparations or combination products in which aspirin is only one of the active ingredients;

(c) For nonlegend ferrous sulfate products in strengths or dosage forms not listed in Regulation .04A(8) of this chapter;

(d) For nonlegend iron products combined with other active ingredients, except for chewable tablets as described in Regulation .04A(9) of this chapter; or

(e) At a reimbursement level which exceeds the maximum allowable cost established by the Program.

(7) Condoms dispensed by pharmacy providers are subject to the following limitations:

(a) The recipient shall present a Medical Assistance card with a current eligibility period;

(b) Only 12 condoms may be dispensed to an individual at one time;

(c) The provider may dispense condoms only to the individual named on the Medical Assistance card;

(d) Natural membrane condoms are not covered; and

(e) Both the recipient receiving the condoms and the provider shall sign the dispensing documentation.

(8) A compounded prescription for intravenous therapy is subject to the following limitations:

(a) The Program may not cover a compounded prescription for intravenous therapy if a premixed, therapeutically equivalent commercial intravenous therapy is available from a commercial source;

(b) The Program may not cover the diluent component of a compounded prescription for intravenous therapy; and

(c) All claims submitted require new prescription numbers.

(9) Prescriptions dispensed to participants residing in nursing facilities are subject to the following limitations:

(a) Claims shall be identified as nursing facilities prescriptions by coding mechanisms determined by the Program;

(b) Credits for unused unit dose medication and any other medication which may legally be returned to pharmacy stock:

(i) Shall be made within 60 days of Program payment;

(ii) May not take into account any professional fee paid by the Program; and

(iii) Shall adjust for leave of absence prescriptions; and

(c) Multiple prescriptions dispensed to a recipient residing in a nursing facility for the same drug product or compounded prescription shall receive only one professional fee per calendar month except for:

(i) Leave of absence prescriptions;

(ii) Prescriptions for intravenous therapy; and

(iii) Prescriptions for Schedule II-V controlled substances.

D. Tamper Resistant Prescriptions.

(1) Prescriptions written on or after April 1, 2008, that do not contain at least one of the tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered.

(2) Prescriptions written on or after October 1, 2008, that do not contain all three tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered.

E. No covered drug or supply identified under Regulation .04 of this chapter shall be reimbursed under Regulation .07 of this chapter if:

(1) Federal financial participation from the Centers for Medicare & Medicaid Services is not available for the drug or supply; or

(2) Prior authorization for the drug or supply is required under Regulation .06 of this chapter but was not obtained.