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<nobr>Jan 3, 2005</nobr>
ERIC: USP Releases Final Model Drug Guidelines for Medicare Part D
The U.S. Pharmacopeia (USP) released its final model guidelines for drug categories and classes in the new Medicare drug benefit today. The USP guidelines may be found at http://www.usp.org/drugInformation/mmg/. The draft USP guidelines, released in August, contained 43 therapeutic categories and 138 pharmacological classes. The final USP model guidelines contain 41 therapeutic categories and 137 pharmacologic classes. Additionally the final guidelines stress that they contain 146 unique therapeutic categories and pharmacologic classes. The total of 146 (as opposed to 178, the total sum of categories and classes) results from analysis of the pharmacologic class column. Adding the 137 classes to the 9 categories with no associated drug classes yields 146 total categories and classes.
CMS Oversight
The Centers for Medicaid and Medicare Services (CMS) outlined its proposed oversight strategy for the Medicare drug benefit in its recently published draft formulary guidance and proposed regulations. CMS' oversight will involve review of pharmacy and therapeutics committee practices, formulary drug lists and benefit management tools, as well as a straightforward and timely exceptions and appeals process. CMS will soon issue the final regulation and guidance incorporating public comments, including the important contributions from USP. The ERISA Industry Committee submitted comments to the CMS regarding the model drug categories and classes.
USP Action and Background
USP issued its draft formulary guidelines on August 19, 2004. The guidelines contained 43 therapeutic categories and 138 pharmacological classes. Health plans will not be required to adopt the guidelines, but those that do will be considered to have met standards for a drug benefit acceptable to CMS. Formularies not meeting the guidelines will be subject to review by the agency to ensure they do not restrict access to drugs by seniors. Also, CMS has made clear that any guidelines established by the USP are applicable only to Part D benefits.
ERIC Comments
ERIC requested a balance between guidelines that could break the budget and those that place burdensome restrictions on important medications. Further, ERIC stressed that the affordability of the benefit would be threatened if too many drug categories are included in the model set of formulary guidelines. USP should add only categories that are based on pharmaceutical and medical science. Since some pharmacy benefit managers in the commercial market use formularies with as few as 50 categories, the draft did not appear to be flexible. Additionally, ERIC requested that USP not move any additional classes from the recommended subdivisions into the required pharmacological class section.
Further Action Needed
Please review the USP guidelines and send any additional comments to Edwina Rogers at 202-789-1400 or erogers@eric.org. ERIC staff will also review the model guidelines over the next several days and inform ERIC members of their findings.
Edwina Rogers
Vice President, Health Policy
The ERISA Industry Committee
1400 L Street, N.W., Suite 350
Washington, DC 20005
(202) 789-1400
Cell (202) 674-7800
Fax (202) 789-1120
e-mail: erogers@eric.org
www.eric.org
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