Pharmacy & Therapeutics - March 2008 - (Page 146) Failures of Medicare Part D Delivery drug evaluation, review, and selection process. The result is excessive costs associated with the provision of pharmaceutical care and increasing limitations on access to the most appropriate prescription drug products under Part D. We also believe that the displacement of P&T committees and their formularies was not an inevitable outcome of Part D. The Department of Veterans Affairs (VA) uses a single formulary nationwide, although most VA facilities also have their own locally appointed P&T committees. The VA’s unified approach to formulary design and implementation appears to be effective: Medicare prescription prices are said to be 58% higher than VA prices.4 Good and Valentino described the steps that the VA took in establishing a pharmacy plan that maintains “a generous drug benefit at a very low cost.”5 fees, and, more recently, prescription drugs. The addition of prescription drug coverage to HMO plans is important, because many HMOs manage their drug benefit by contracting with a PBM. The involvement of PBMs is a key development in the delivery of health care. Even though HMO subscribers can take their prescription to a local community pharmacy to be filled, community pharmacies can dispense only a 30-day drug supply under most circumstances. But when an HMO contracts with a PBM to administer HMO drug benefits, patients can typically receive a 90-day supply through contracted dispensing pharmacies such as Next Rx or Caremark. These 90-day prescription fills are typically delivered by mail, a service usually referred to as “mail order.” Patients recognize two advantages from obtaining their medications through a PBM. The cost per dose is less because patients make only one co-payment for a 90-day supply rather than three co-payments for three successive 30-day prescription fills. Second, the patient’s drug supply lasts three times as long and may not require a drugstore visit, saving time, effort, and transportation costs. Each HMO and its related PBM has a P&T committee. The P&T committee and formulary design are typically delegated to the PBM as one of the administrative tasks needed to create and administer a prescription drug benefit. Although organizational designs and responsibilities can vary greatly among PBMs, the membership and deliberations of P&T committees are seldom open to scrutiny by the public or by the HMOs on whose behalf PBMs work. As a practical matter, it is nearly impossible to identify the members of a PBM’s P&T committee, their qualifications, or the precise content of its formulary. This lack of transparency makes it difficult for prescribers and patients to decide which drugs to choose. As an example, if a physician needs to prescribe a drug for a neurological problem, it would be helpful to know which of several potential neurological agents are on the formulary and covered by the patient’s prescription drug benefit. Under the current system, a physician may prescribe the most appropriate pharmacological agent, only to discover that the specific drug is not covered by the patient’s prescription drug plan because it is not on formulary. It could also be helpful to know whether one or more neurologists was on the P&T committee that selected neurological agents for the plan formulary in order to judge the appropriateness of the formulary and the potential need to request special authorization to use a nonformulary agent. EVOLUTION OF P&T COMMITTEES Balu et al. have chronicled the historical origins of P&T committees and their natural outgrowth, the formulary system;6,7 they discuss the many contributions to the concept of P&T committees over the years that evolved into its modern counterpart in the early 1960s. At that time, the P&T committee’s primary purpose was to “maximize rational medication use” and “ensure inventory control.” These committees were organized to guide the medical and pharmacy staff of the institutions that they served. Institutions also had the authority to enforce decisions made by their respective P&T committees. As we watch the evolution of P&T committees to the position that they occupy in the American health care system today, we must remember their original purpose and responsibilities. As health care costs escalated in the final decades of the 20th century, the traditional fee-for-service model gave way to thirdparty providers. Managed care organizations (MCOs) such as Kaiser Permanente and health maintenance organizations (HMOs) such as Blue Cross were created in an attempt to moderate the growth in health care spending by introducing cost as a factor to be considered in selecting a particular treatment or drug regimen. MCOs such as Kaiser provide essentially all of the health care needs of their patient subscribers. Kaiser typically owns the facilities that patients use, including acute-care hospitals, physician offices, satellite clinics, and pharmacies. These facilities are staffed by physicians, nurses, nurse practitioners, pharmacists, medical technicians, and support personnel. Most of these personnel are Kaiser employees, although some specialty services may be outsourced to other health care providers, depending on the needs of the local patient population and the resources available within the organization. Kaiser’s subscribers are covered for all of their medical care, including prescription drugs, for which they pay monthly premiums. The system has provided fine care to its subscribers and has contained costs through effective management strategies. Although Kaiser’s P&T committees and their formularies are generally uniform throughout the entire system, each local patient care unit has its own P&T committee and formulary to address the concerns of its staff.8 Unlike MCOs, HMOs are basically insurance entities that coordinate health care services from independent providers to their subscribers. Services and benefits vary but usually include acute hospitalizations, laboratory procedures, physician PART D RESTRICTIONS Prescribers, patients, and pharmacists have found that the same lack of transparency has become part of Medicare Part D. The Congressional actions that originally established Medicare Part D authorized the USP to create guidelines for Part D P&T committees and formularies.9 The guidelines, P&T committees, and formularies envisioned by Congress and by the USP were expected to be implemented by CMS by the time Part D prescription drug benefits began on January 1, 2006. These USP guidelines were not adopted, because a central P&T committee with a uniform formulary to regulate 146 P&T® • March 2008 • Vol. 33 No. 3
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