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ASHP's Zellmer Testifies About Medicare Formulary

Cheryl A. Thompson

William A. Zellmer, deputy executive vice president of the American Society of Health-System Pharmacists, presented comments Friday at the United States Pharmacopeia (USP) public meeting regarding the development of model guidelines for classes and categories of drugs.

USP developed the guidelines on behalf of the Centers for Medicare & Medicaid Services (CMS) as part of the new Medicare Part D prescription drug benefit.

Zellmer expressed ASHP's serious concerns regarding several major elements of the model guidelines, which could have a devastating impact on the quality of patient care, as well as the process in which the guidelines were developed.

The Society's objections include:

  • The potential that the model's disease state approach to classifications will result in lack of prescribing flexibility when model guidelines are implemented.
  • The failure to require drug plans to use the specific subclasses of drugs included in the "Recommended Subdivisions" column of the classification.
  • The potential for significant inequities in access to needed drugs due to the imbalanced structure and category weight of the proposed classification.

    For more information about ASHP's comments, contact Jocelyn Edwards, at 301-657-3000, ext. 1457.

    American Society of Health-System Pharmacists' Presentation at the USP Open Public Meeting Regarding the Development of the Model Guidelines for Categories and Classes of Drugs

    August 27, 2004

    Presented by William A. Zellmer, M.P.H.
    Deputy Executive Vice President
    American Society of Health-System Pharmacists
    7272 Wisconsin Ave.
    Bethesda, MD 20814
    301-657-3000, ext. 1226

    My name is William Zellmer, and I am the Deputy Executive Vice President of the American Society of Health-System Pharmacists (ASHP). Our members practice in hospitals, ambulatory care clinics, home care organizations, and long-term care facilities. Many ASHP members have experience in drug-use policy, including management of formulary systems. ASHP also has many members who are pharmacy clinicians who collaborate with physicians in striving for effective, safe, and affordable use of medicines in patient care.

    ASHP brings three perspectives to the issues being addressed here today. First, we represent the perspective of the developer of consensus-based standards on multiple facets of the medication-use process, including the formulary system; ASHP has been directly involved in formulary issues for over five decades, issuing our first standards on formulary systems in 1951.

    Second, we represent the perspective of a scientific, nonprofit publisher of evidence-based drug information; we have published AHFS Drug Information (originally called the American Hospital Formulary Service) since 1959.

    Finally, we represent the perspective of the developer of a widely recognized pharmacologic-therapeutic classification system for drugs—the AHFS Classification. The AHFS Classification for drugs has been the foundation for organizing drug formularies in institutional and other settings since 1959. The AHFS Classification is far more granular overall than the classification proposed in the Model Guidelines, but its hierarchical structure can be readily collapsed or expanded to meet the specific needs of granularity of any drug plan. We are in the process of examining the categories and classes proposed in the USP draft to assess whether there are significant gaps in comparison to the AHFS Classification; we will include the results of this analysis in our written comments.

    ASHP previously wrote to USP and CMS to express our great disappointment with the process used in developing the Model Guidelines, which marginalized the input and advice of experts like ASHP. We firmly believe that the draft Model Guidelines would have been significantly improved had we and others been provided greater opportunity to participate in a more transparent process.

    At this stage of our analysis, we have three major concerns about the draft model guidelines. First, we have serious questions about the implications of the purported linkage of the model guidelines to disease states. Nothing in the legislative history of the new Medicare law suggests that Congress expected such a major departure from the well-established practice of organizing drug formularies according to the pharmacology and therapeutic uses of medications themselves. The absence of any information on how the 700 disease states that undergird the Model Guidelines will link to the therapeutic categories when drug plans are operationalized makes it impossible to decipher the implications of this approach to drug formulary development. One wonders, for example, if CMS contemplates that eventually the diagnosis or disease entered by the prescriber into a computerized order entry system would have a tight linkage to a specific class or subdivision in the Model Guidelines. If so, this could have a profound effect on the prerogatives of clinicians and the appropriateness of patient care. It is impossible to fully evaluate the model guidelines without having more details about how they are connected to disease states, and how that connection would be used in the real-world operations of drug plans.

    Also troubling is the use of ICD-9 rather than SNOMED CT as the top-most level of the drug classification, particularly since the Department of Health and Human Services has concluded that SNOMED CT is the superior system and will be employed in the uniform data standards for patient medical record information.

    ASHP's second major concern is USP's decision to not require drug plans that follow the Model Guidelines to use the subclasses of drugs included under the "Recommended Subdivisions" column (column 3) of the classification. Instead, USP simply encourages drug plans to consider these subdivisions. By not explicitly requiring drug plans to include these specific subclasses, we are worried that Medicare will not meet one of its major goals, namely, assuring beneficiaries access to the medications they need.

    The subdivision of Cardiovascular Drugs demonstrates the potential problem. For example, in the case of high cholesterol, access could be limited to older, less expensive therapies such as niacin and cholestyramine while excluding newer, more expensive therapies such as the statins. This approach would be contrary to the federal government's guidelines on treating high cholesterol, particularly in geriatric and diabetic patients, and would have devastating consequences on the quality of patient care.

    ASHP's third major concern involves the imbalanced structure and category weight of the proposed drug classification, which will result in inequities in access to needed drugs for certain illnesses. For example, Antivirals are highly subdivided at the "Pharmacologic Class" level, thus ensuring access to at least two drugs from the full spectrum of available classes. By comparison, the highly granular subdivision of drugs used to treat diabetes appears at the "Recommended Subdivisions" level, where adoption by the drug plans would be voluntary. This would have important negative consequences on the management of diabetes in the elderly, where treatment typically follows a stepped-care approach, and access to the full spectrum of available antidiabetic agents is critical for ensuring optimal glucose control and therapeutic benefit. These inequities are unacceptable and should be eliminated by redefining the classes in a more therapeutically balanced fashion. Anything less has the potential of depriving Medicare beneficiaries of needed, preferred, and often safer therapies.

    Let me interject that ASHP members are very concerned about the impact of CMS Medicare formulary policies on the continuity of care, for example, as a Medicare beneficiary moves from the hospital inpatient setting (where drug therapy is governed by the hospital's formulary system) to ambulatory care (where drug therapy will be controlled by the formulary of a drug plan). We will be addressing this issue in our response to CMS's proposed regulations on the drug benefit.

    Thank you for the opportunity to comment on this significant component of the new Medicare prescription drug benefit. ASHP is willing to collaborate with all interested parties in an open and fully engaged process to move this initiative forward in a manner that best serves the Medicare population.