922 METHODS FOR DETERMINING COSTS OF PRESCRIBED MULTIPLE SOURCE DRUGS

922.1 The allowable cost for multiple source drugs designated by the Centers for Medicare and Medicaid Services (CMS) of the United States Department of Health and Human Services and included in its listings issued pursuant to 42 CFR 447.332, shall be the lower of the following:- (a) The upper limit established by CMS, which is determined by multiplying the cost of the lowest cost drug by one hundred and fifty percent (150%); or

- (b) The estimated acquisition cost, as determined by the Medical Assistance Administration based upon information from drug manufacturers and local wholesale price data.922.2 If a drug is unavailable in the local market at a cost at or below the CMS limit described in subsection 922.1 (a), the allowable cost shall be the lowest price, determined by the CMS, at which the drug is available in the local market.922.3 The CMS upper limit for a drug price shall not apply if a physician certifies in his or her own handwriting that a specific brand is medically necessary for a particular patient.922.4 The handwritten phrase 'Medically Necessary' or 'Brand Necessary' shall appear on the face of the prescription form. If the prescription is for a nursing facility resident a handwritten phrase 'Medically Necessary' or 'Brand Necessary' shall be documented in the resident's medical record accompanied by a copy of the physician's order and plan of care.922.5 Neither a dual line prescription form, check-off box on the a prescription form or check off-box on the physician's orders and plan of care shall satisfy the certification requirement.922.6 The Department shall supplement the CMS listing by adding drugs and their prices which, in the judgment of CMS, meet the following requirements:- (a) The formulation of the drug approved by the U.S. Food and Drug Administration (FDA) has been evaluated as therapeutically equivalent in the most current edition of its publication, Approved Drug Products with Therapeutic Equivalence Evaluations (including supplements or in successor publications); and

- (b) At least two (2) suppliers list the drug (which has been classified by the FDA as category 'A' in its publication, Approved Drug Products with Therapeutic Equivalence Evaluations, including supplements or in successor publications) based on listing of drugs which are locally available.922.7 Each pharmacy that participates in the Medicaid program shall be notified in writing by the Department of Health, Medical Assistance Administration (MAA), of the established maximum allowable cost for the selected multiple source drugs listed pursuant to this section.

SOURCE: As Final Rulemaking published at 35 DCR 4011 (May 27, 1988); Final Rulemaking published at 53 DCR 2401 (March 31, 2006).