USP 's Part D draft guidelines provoke myriad objections


USP holds meeting in Baltimore to discuss the establishment of a formulary for Medicare Part D



USP's Part D draft guidelines provoke myriad objections

The United States Pharmacopeia presented its draft guidelines for drug plans' formularies under the Medicare Part D prescription benefit at a public meeting in Baltimore last month. Attended by several hundred participants, the meeting saw a host of demands made on USP to make its proposed drug groupings either more or less specific, depending on the viewpoints of the commenters. Overall, managed care groups wanted a more limited drug list to contain costs, while drugmakers wanted more medications covered.

The level of that specificity, after the guidelines are approved by the Centers for Medicare & Medicaid Services, will help determine how many drugs and which drugs the plans are mandated to have on their lists for coverage, in addition to those drugs they choose to cover.

William A. Zellmer, deputy executive VP of ASHP, said the guidelines as proposed could have a "devastating impact on the quality of patient care" by not requiring coverage of some important drugs and causing a lack of prescribing flexibility, among other problems.

Rick I. Smith, senior VP of the Pharmaceutical Research and Manufacturers of America, said the model "would neither afford patients access to a very broad range of medicines they use and need nor protect seniors and disabled persons against cherry-picking by prescription drug plans."

On the other hand, Judy A. Cahill, CEBS, executive director, Academy of Managed Care Pharmacy, said the USP classes provide the scope necessary to have appropriate medications on a formulary: "An excessive number of therapeutic classes that must each contain an individual drug or drugs increases the number of drugs that must be subject to negotiation."

The Baltimore gathering was one step in USP's yearlong guideline development process, which the legislation specifically asked USP to take on. The recommended guidelines are to go to CMS for approval in December. When the Part D prescription program starts, the drug plans may use the guidelines in creating their formularies and CMS may use them in approving those formularies.

The critical force behind the work—and the cause of controversy—is the law's requirement, as interpreted by CMS, that all plans cover at least two drugs within each of the "classifications." Thus the more classifications the guidelines divide drugs into, the more groups of drugs each formulary must include. The USP guidelines are to be "voluntary." However, CMS will evaluate all the formularies to ensure their therapeutic classifications do not "substantially discourage enrollment by certain Part D-eligible individuals." And if a plan conforms to the guidelines, CMS must accept its basic therapeutic classification. Each plan's formulary would also have to pass muster in other ways.

The USP-recommended guidelines, adapted from the ICD-9 disease classification system, start with 43 therapeutic categories. Under those categories are 138 pharmacologic classes, based on mechanism of action. For instance, the therapeutic category of cardiovascular medications includes 11 pharmacologic classes. One of the cardiovascular classes, for instance, is "beta-blockers/related."

However, in a step not anticipated in the legislation, USP added a "third column" of 135 recommended subdivisions. Under USP's configuration, that third column would significantly increase the number of drugs a plan must offer. For example, under "beta-blockers/related" the third column lists three subdivisions: nonselective, cardioselective, and alpha-beta blockers.

At the close of the meeting, Roger L. Williams, M.D., USP CEO and chair of the model guidelines expert committee, emphasized that the committee is saying drug plans should be required to offer at least one drug from each of those "third-column" subdivisions. This was something that apparently was misunderstood by many speakers during the public comment segment.

In a press briefing after the meeting, Williams said, "We're saying in the third column, of course you must have a statin or more than one statin. Of course, you must have an SSRI [selective serotonin-reuptake inhibitor] or more than one." He called the third column, "a scientifically needed column to express the science aspect of the pharmacology of the drug." He also indicated that in time it might become apparent that further subdivisions are needed. On the other hand, he acknowledged that because the third column of subdivisions is not written into the legislation, CMS could decide not to include it in the regulations, and, if it is included, it might be challenged in a lawsuit.

In coming weeks, USP will fill out the guidelines by putting in all approved, Medicare Part D-available drugs where they fit.

USP has the draft guidelines on its Web site, It will accept written comments through Sept. 17 at: Lynn Lang, United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852. Instructions for submitting comments electronically, which is preferred, are on the Web site.

Kathryn Foxhall

The author is a writer based in the Washington, D.C., area.


Kathryn Foxhall. USP 's Part D draft guidelines provoke myriad objections.

Drug Topics

Sep. 13, 2004;148:18.

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