Narrative Review: The U.S. Pharmacopeia and Model Guidelines for Medicare Part D Formularies

19 September 2006 | Volume 145 Issue 6 | Pages 448-453

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 includes a provision directing the Secretary of the U.S. Department of Health and Human Services to request that the U.S. Pharmacopeia (USP) develop a list of categories and classes (the USP Model Guidelines) that can be used by prescription drug plans in developing their formularies for the Part D prescription drug benefit. The Centers for Medicare & Medicaid Services (CMS) used the Model Guidelines and USP's related listing, termed the Formulary Key Drug Types, to evaluate prescription drug plan formularies submitted by prescription drug plan sponsors intending to provide the new Part D benefit. This article recounts how USP's all-volunteer Model Guidelines Expert Committee developed the USP Model Guidelines and Formulary Key Drug Types, working under a cooperative agreement with CMS in response to the Secretary's request. The Model Guidelines and Formulary Key Drug Types are updated annually to reflect advances in evidence-based medicine, thereby offering timely guidance to CMS and to prescription drug plans based on USP's demonstrated expertise in setting standards.

*For members of the USP Model Guidelines Expert Committee and the U.S. Pharmacopeia staff who contributed to this manuscript, see Appendix 1.

Author and Article Information

From the U.S. Pharmacopeia, Rockville, Maryland.

Acknowledgment: The authors thank Stefan Schuber, PhD, Director, Scientific Reports at USP, for editorial assistance with this manuscript.

Grant Support: The CMS and USP entered into Cooperative Agreement No. 18-C-92305/3-01 in support of the development of the Model Guidelines.

Potential Financial Conflicts of Interest: The work of USP's MGEC was carried out according to USP's strict rules regarding conflict of interest. Dr. Braden has been employed by AdvancePCS (now Caremark), which offers a Medicare Part D prescription drug plan, and is employed by Mercy Care of Arizona, a fully qualified Medicare special needs plan. Dr. Finkelstein has provided health economic consulting to pharmaceutical companies through Thomson Medstat Group and has received an educational grant from Merck, both for topics unrelated to this manuscript. Dr. Horn is an employee of Pfizer and holds stock in Johnson & Johnson. Dr. Kirking has consulted for Wyeth and has received grants from Wyeth, AstraZeneca, Merck, and Pfizer. Dr. Westrick served as a consulting medical advisor to PBM from 1997 to 2002 and received honoraria from Pfizer and Interactive Forums in 2004 and 2005.

Requests for Single Reprints: Stefan Schuber, PhD, U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; e-mail, sps{at}usp.org.

Current Author Addresses: Dr. Williams, Ms. King, Ms. Penn, Dr. Perfetto, Ms. Singh, and Mr. Zeruld: U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790.

Dr. Abernethy: National Institute on Aging, 5600 Nathan Shock Drive, Baltimore, MD 21224.

Dr. Bielory: University of Medicine and Dentistry of New Jersey–New Jersey Medical School, 90 Bergen Street, DOC, Suite 4700, Newark, NJ 07103.

Dr. Blum: 25 Spruce Drive, East Hills, NY 11575-2331.

Dr. Braden: 2800 North Central Avenue, Phoenix, AZ 85004.

Dr. Calis: National Institutes of Health, 10 Center Drive (MSC 1196), Building 10, Room 1S-259, Bethesda, MD 20892.

Dr. Campen: Kaiser Permanente Pharmacy Operations, 1800 Harrison Street, 13th Floor, Oakland, CA 94612.

Dr. Finkelstein: MIT Sloan School of Management, 38 Memorial Drive, E56-390, Cambridge, MA 02139-4307.

Dr. Foster: University of Kentucky Medical Center, 907 Rose Street, Suite 231F, Lexington, KY 40536-0082.

Dr. Horn: Pfizer Inc., 235 East 42nd Street, New York, NY 10017.

Dr. Kirking: University of Michigan College of Pharmacy, 428 Church Street, Ann Arbor, MI 48109-1065.

Dr. Murray: University of North Carolina, CB-7360, Beard Hall, Room 205-R, Chapel Hill, NC 27599-7360.

Ms. Rucker: AARP, 601 E Street, NW, B-6 433, Washington, DC 20049.

Dr. Schwartzberg: American Medical Association, 515 North State Street, Chicago, IL 60610.

Dr. Shepherd: University of Texas Health Science Center, 7703 Floyd Curl Drive, 5.102 MCD, Mail Code 6205, San Antonio, TX 78229-3900.

Dr. Strnad: Health Canada, 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, AL 3102C3, Ottawa, Ontario K1A 1B6, Canada.

Dr. West: Northwestern University Feinberg School of Medicine, Department of Dermatology, 675 North St. Clair Street, Suite 19-200, Chicago, IL 60611.

Dr. Westrick: University of Massachusetts Memorial Health Care, One Biotech Park, 365 Plantation Street, Worcester, MA 01605-2376.