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) and included in its listing shall be the lower of the following:- (a) The Federal Upper Limit (FUL) for multiple source drugs other than those brand name drugs for which a prescriber has certified in writing as 'Medically Necessary' or 'Brand Necessary'; or

- (b) The Maximum Allowable Cost (MAC) established pursuant to §§ 922.3 and 922.4 of this chapter.922.2 The Department of Health Care Finance (DHCF) shall restrict payment to only those drugs supplied from manufacturers that have signed a national agreement, or have an approved existing agreement, as specified in Section 1927(a) of Title XIX of the Social Security Act (42 USC 1396r-8(a)).922.3 The MAC may be established for any drug when two (2) or more A-rated therapeutically equivalent, multiple source drugs with a significant cost difference exist.922.4 The MAC for a drug shall be determined by:- (a) Using comparable drug prices obtained from multiple nationally recognized comprehensive data sources including, but not limited to, pharmacy providers, wholesalers, drug file vendors, and pharmaceutical manufacturers; and

- (b) Reviewing the average wholesale price and the wholesale acquisition cost and applying necessary multipliers to ensure reasonable access by providers to the drug at or below the MAC rate.922.5 The CMS upper limit for a drug price and the MAC shall not apply if a physician certifies in his or her own handwriting that a specific brand is medically necessary for a particular patient.922.6 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 beneficiary, the handwritten phrase 'Medically Necessary' or 'Brand Necessary' shall be documented in the beneficiary's medical record accompanied by a copy of the physician's order and plan of care.922.7 Neither a dual line prescription form, check-off box on the prescription form, nor check off-box on the physician's orders and plan of care shall satisfy the

certification requirement.

922.8 DHCF shall supplement the CMS listing by adding drugs and their prices which 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.

922.9 A pharmacy provider may identify MAC rates by visiting the District’s Pharmacy Benefits Management website at www.dcpbm.com.

SOURCE: Final Rulemaking published at 35 DCR 4011 (May 27, 1988); Final Rulemaking published at 53 DCR 2401 (March 31, 2006); as amended by Final Rulemaking published at 57 DCR 1308 (February 12, 2010).