D.C. Mun. Regs. tit. 29, r. 29-2708

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 29-2708 - MAXIMUM ALLOWABLE COST FOR PRESCRIBED MULTIPLE SOURCE DRUGS

2708.1

A multiple source drug is a covered outpatient drug for which there is at least one other drug product that is:

(a) Rated as therapeutically equivalent as reported in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" which is available at http://www.accessdata.fda.gov/scripts/cder/ob/;

(b) Pharmaceutically equivalent and bioequivalent, as determined by the FDA; and

(c) Sold or marketed in the United States during the rebate period.

2708.2

Reimbursement for multiple source drugs shall include a professional dispensing fee in the amount of eleven dollars and fifteen cents ($11.15) plus the lesser of:

(a) The Federal Upper Limit ("FUL") of the drug for multiple source drugs, with the exception of the following:

(1) Multiple source drugs that do not have FULs; and

(2) Brand name drugs for which a prescriber has certified in writing as "Dispense as Written" or "Brand Necessary," subject to the requirements set forth under § 2708.3;

(b) The National Average Drug Acquisition Cost ("NADAC") when available, which shall be published online at: https://www.medicaid.gov/medicaid/prescription-drugs/pharmacypricing/index.html [File Link Not Available];

(c) The Wholesale Acquisition Cost ("WAC") plus zero percent (0%), which shall be kept by drug file pricing compendia vendors or drug databases approved by and in use at the federal level;

(d) The pharmacy's usual and customary charges to the general public; or

(e) The District Maximum Allowable Cost ("DMAC ") established pursuant to §§ 2708.4 and 2708.5.

2708.3

Certification of "Dispense as Written" or "Brand Necessary," as described in § 2708.2, shall be subject to the following requirements:

(a) The handwritten phrase "Dispense as Written" or "Brand Necessary" shall appear on the face of the prescription form;

(b) If the prescription is for a nursing facility resident, a handwritten phrase "Dispense as Written" 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; and

(c) A dual line prescription form, a check-off box on the prescription form, and a check-off box on the physician's orders and plan of care shall not satisfy the certification requirement.

2708.4

A DMAC may be established for any drug for which there are two (2) or more A-rated therapeutically equivalent, source drugs with a significant cost difference. The DMAC shall be determined taking into account drug price status (non-rebatable, rebatable), marketplace status (obsolete, regional availability), equivalency rating (A-rated), and relative comparable pricing. Other factors that may be considered are clinical indications of generic substitution, utilization, and availability in the marketplace.

2708.5

The DMAC for multiple source drugs shall be determined as follows:

(a) Multiple drug pricing resources shall be utilized to determine the pricing for multiple source drugs, applying the necessary multipliers to ensure reasonable access by providers to the drug at or below the determined pricing benchmark; and

(b) The resources used to determine DMAC shall be maintained by a vendor under contract with DHCF, and include but are not limited to pharmacy providers, wholesalers, drug file pricing compendia vendors or drug databases approved by and in use at the federal level, and pharmaceutical manufacturers, or any current equivalent pricing benchmark.

2708.6

DHCF shall supplement the CMS listing for DMAC pricing described in § 2708.2(e) 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 Equivale nce 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.

D.C. Mun. Regs. tit. 29, r. 29-2708

Notice of Final Rulemaking published at 59 DCR 2298, 2304 (March 23, 2012); amended by Final Rulemaking published at 65 DCR 7824 (7/27/2018)

Authority: The Director of the Department of Health Care Finance (DHCF), pursuant to the authority set forth in An Act to enable the District of Columbia to receive federal financial assistance under Title XIX of the Social Security Act for a medical assistance program, and for other purposes, approved December 27, 1967 (81 Stat. 774; D.C. Official Code § 1-307.02 (2006 Repl. & 2011 Supp.)) and section 6(6) of the Department of Health Care Finance Establishment Act of 2007, effective February 27, 2008 (D.C. Law 17-109; D.C. Official Code § 7-771.05(6) (2008 Repl.)).