AGS ViewpointUnited States Pharmacopeia Draft Model GuidelinesUnited States Pharmacopeia Draft Model Guideli

As you may know, United States Pharmacopeia (USP), a nonprofit organization with oversight in prescription drug quality and use, was authorized to devise Model Guidelines for the prescription drug plans (PDPs) under the 2003 Medicare Modernization Act (MMA). In this regard, the MMA tapped USP to come up with a list of therapeutic categories and classes to be used in conjunction with the drug benefit under Medicare Part D.

The USP issued draft guidelines late this summer. Most provider, beneficiary, and pharmaceutical organizations responded with a long list of concerns, many of these focusing on nursing home patients. The AGS, in a September 15 letter to USP, echoed many of the concerns expressed by the American Society of Consultant Pharmacists (ASCP) about draft guidelines. “The draft USP Model Guidelines appear to be based on a standard managed care approach to drug benefits, rather than serving the special needs of the Medicare population,” the AGS letter stated.

The draft guidelines have particular implications for the special needs of Medicare beneficiaries receiving long-term care. One group, the Kaiser Family Foundation, expressed concerns in a September report that the MMA does not authorize the creation of prescription drug plans to serve nursing home patients, and contains no requirements for providing greater access to medications used by nursing home residents.

A closer look at the guidelines suggests that those receiving long-term and nursing home care may be discouraged from enrolling in certain drug plans because of the nature of the formulary that shapes them. Of particular concern to several organizations devoted to care for older adults are the limited protections contained in the draft guidelines, as well as other limited administrative protections promulgated by CMS that fail to protect beneficiaries.

Drug classes proposed under the USP guidelines will need to contain a minimum of only two medications. “This is a very limited number of medications,” a letter submitted by the ASCP stated. “Such a limited formulary would require very frequent use of administrative procedures for access to nonformulary medications for these populations.” Long-term care providers would be restricted in their ability to prescribe medications not included on the formulary of the PDP or would have to circumvent the process with special, complex procedures that are no guarantee of access.

AGS also specifically cited the nearly 3.5 million residents of nursing homes and assisted living communities in its letter: “Frail elderly individuals and long-term care residents need access to a wide variety of medications and dosage forms to appropriately manage their multiple chronic conditions and medical problems.” Our main concern is that some medications needed to appropriately treat long-term care and other frail elderly populations will not be included in the formulary and will not be readily available through the formulary override process. CMS will not issue a final rule on Part D until 2005, and the drug benefit itself will not be implemented until 2006. However, the USP guidelines will presumably be finalized sooner.

As always, we at AGS will continue to stay involved at the grassroots level in issues that shape the delivery and quality of care. We encourage you to do the same. Visit https://www.americangeriatrics.org for more information.