Pharmacy & Therapeutics - March 2008 - (Page 145) OPINION Failures of Medicare Part D Delivery and Recommendations for Improvement Walter L. Way, RPh, MD, and Fred S. Mayer, RPh, MPH OVERVIEW In 2005, an editorial in P&T clearly articulated problems with the then-new Medicare Part D prescription drug benefits program.1 The editorial noted the severe limitations that were expected to be imposed on both physicians and on patients regarding prescription drug product choices. P&T suggested that this approach, which was supported by health insurance plans, would pave the way for even greater restrictions on access to prescription medications than the restrictions that were then in effect. The editorial’s caution relating to increasing restrictions on access to prescription medications has been borne out by the numerous difficulties encountered by Part D beneficiaries. The typical problem involves patients who cannot continue using one or more of their prescribed drugs because the agents are not on the Part D formulary. We view these new limitations on access to care as a direct result of Part D formularies that are created with cursory regard to medical concerns and are subject to minimal outside review either before or after implementation. In addition to providing limited access to pharmaceutical care, congressional estimates suggest that the current drug selection and delivery system under Medicare Part D overspent by nearly $15 billion in 2007 alone.2 Unlike traditional Medicare, which is administered by the Centers for Medicare and Medicaid Services (CMS) under uniform standards, Part D uses private insurers to provide prescription drug coverage to beneficiaries. Insurers typically contract with outside pharmacy benefit managers (PBMs) to administer prescription drug plans. Each Part D prescription drug plan is permitted to create its own formulary, a process that is typically delegated to the PBM that administers the drug plan. The P&T editorial1 explained how guidelines were being developed under contract between the U.S. Pharmacopeia (USP) and CMS to guide insurers and PBMs, thereby ensuring appropriate access to prescription drugs. The CMS review of plan formularies under the Medicare Modernization Act (MMA) of 2003 was intended to ensure that drug benefit plans offered a broad selection of pharmaceutical agents that reflected the best practices in medicine and in pharmacy.3 Physicians and pharmacists, in particular, expected these for- mularies and benefits to include a full range of treatment options then in use by prescription drug plans. Mandates imposed by the MMA included a requirement that Part D was to provide the most clinically appropriate medications at the lowest achievable cost for all Part D beneficiaries. The MMA also required CMS to acknowledge the specific needs of individuals who were already stabilized with specific drug regimens (e.g., enrollees with HIV infection and AIDS, mental illness, and other cognitive disorders). CMS was also obligated to identify patients who were eligible for prescription drug benefits under both Medicare and Medicaid, the socalled “dual eligible” population. These dual eligibles were (and continue to be) at increased risk for reduced access to appropriate pharmaceutical care. Dual eligibles were automatically enrolled in Part D prescription drug programs by CMS on a random basis. Neither the dual eligibles themselves nor the prescription plans selected to administer their Part D benefits were informed of the impact that the randomly selected plan and its formulary could have on each patient’s pre-existing drug coverage, continuing drug treatment options, and state of health. In this article, we examine the barriers to prescription drug access that have arisen under the Medicare Part D prescription drug program since its implementation in 2006. In our view, PBMs play a key role in both the decreased level of pharmaceutical access and excessive costs under Part D. INTRODUCTION Evidence-based medicine describes the use of clinical trials and other objective clinical data in the evaluation of medical care and the design of treatment guidelines. The same process, the measured evaluation of objective clinical evidence, can be used to describe the approach that P&T committees traditionally take in their deliberations, which are designed to reach the best decisions concerning drug safety, efficacy, adverse effects, and interactions. Cost is also a factor in the P&T decision-making process— but only after a drug’s safety, efficacy, effectiveness, side-effect profile, and potential interactions have been considered. Drugs that survive this exhaustive evaluation may be added to the formulary. Although the P&T process was created for inpatient care and evolved in the institutional setting, the method has been widely adopted by health systems and third-party payers to control the delivery of care in outpatient and community settings. We strongly believe that the displacement of traditional P&T committees and their accompanying formularies, as encouraged by Medicare Part D, has adversely affected the Disclosure: The authors have no commercial or financial relationships to report in regard to this article. Dr. Way is Professor Emeritus of Anesthesia and Pharmacology at the University of California, San Francisco. He is currently Medical Director, and Mr. Mayer is Chief Executive Officer, both at Pharmacists Planning Service, Inc., in San Rafael, California. Accepted for publication February 15, 2008. Vol. 33 No. 3 • March 2008 • P&T® 145
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.