Clinical pharmacology of the appeals and exception process: the interface of the patient, physician, and insurance company to assure appropriate care under Medicare Part D

Personalized medicine considers factors unique and specific to each patient to make clinical decisions, including selecting pharmacotherapy. Drug formularies, including those available to enrollees in Medicare Part D, are based on group characteristics and financial considerations. Consequently, an appeal of a formulary's preferred drug selection may be necessary to ensure the best care of the patient. Consideration of basic principles of clinical pharmacology can be used to decide whether an exemption should be considered and to document specific reasons for the request.     

Medicaid formularies: a critical review of the literature.

Studies on the impact of restricted Medicaid formularies were reviewed to assess whether other drugs on the formulary were substituted for restricted drugs, the cost of the substitutes, whether the substitutes were therapeutically appropriate, whether restricted drugs continued to be prescribed, what incremental administrative costs accompanied restrictions, what indirect costs occurred and how the cost-effectiveness of pharmaceuticals impinged on the total cost of illness. The assumption that restriction of specific drugs results in savings in the drug costs proportional to prior usage was shown to be questionable, numerous studies found alternate formulary drugs to the restricted drugs being prescribed, or patients were paying out-of-pocket for denied drugs. There was a tendency for alternate drugs to be more expensive. Little information exists as to the incremental administrative costs of restricted formularies or the therapeutic appropriateness of substituted drugs. One study suggests that major shifts in costs occur due to restrictive formularies through substitution of more expensive services such as hospitalization in lieu of pharmaceuticals. It is concluded that restricting formularies leads to dynamic changes in the total Medicaid program of a complex and often costly nature. Plans to implement formulary restrictions require considerable careful thought.     

How do seniors respond to 100% cost-sharing for prescription drugs? Quality of the evidence underlying opinions about the Medicare Part D coverage gap

Popular press coverage of the Medicare Part D coverage gap is based largely on research conducted using retrospective analyses of administrative claims data. These datasets are incomplete because they lack information about methods of obtaining medication that are commonly used by seniors, including free samples, generic drug discount programs, over-the-counter substitution, and patient assistance programs. As a result, evidence about the effects of 100% cost sharing on seniors is limited and suboptimal. Although the current deficit of information about the coverage gap is not entirely unexpected because the Medicare Part D program is relatively new, reliance on claims-based analyses to inform questions that claims data cannot possibly address accurately has tended to mislead and politicize rather than produce constructive policy guidance. Numerous important health policy questions remain unaddressed. These questions are becoming especially important as optimal approaches to providing health care to seniors are the subject of an increasingly vigorous debate.     

Medicaid's transition into managed care. Real or imaginary?

Medicaid provides health coverage for America's poorest citizens. The number of persons enrolled in Medicaid represents 15% of America's population. The percentage of the Medicaid population in managed-care organisations has risen from 8% in 1990 to 50% in 1996. However, only 8% of the Medicaid programme expenditures on pharmaceuticals is directed to the 50% of the Medicaid population in managed care. Furthermore, more than half of this 8% occurs in loosely organised managed-care organisations that do not have formularies or other significant restrictions on pharmaceutical utilisation generally found in health maintenance organisations. The reason that a larger proportion of Medicaid programme expenditures does not occur in managed-care organisations relates to the difficulty of enrolling the elderly and disabled in such organisations. Barring significant new Federal legislative changes, less than 24% of Medicaid programme expenditures will be in managed-care organisations by the year 2000. Medicaid's transition into managed care is therefore more imaginary than real when one focuses on expenditures.     

Estimating the cost of the Medicare Pharmacist Services Coverage Act of 2001

BACKGROUND: In recent years considerable attention has focused on pharmacists' professional evolution toward patient care-oriented practice. The Pharmacist Provider Coalition (PPC), established in 2000, seeks recognition and payment for pharmacists' patient care services. Concerted effort by the PPC on this issue resulted in the introduction of the Medicare Pharmacist Services Coverage Act of 2001, which would have amended Title XVIII of the Social Security Act to create new types of covered services under Medicare and recognize pharmacist practitioners as providers. However, the legislation was not passed by the 107th Congress. STUDY OBJECTIVES: The PPC engaged The Moran Company to measure the potential net cost to the United States government of the Medicare Pharmacist Services Coverage Act of 2001, and to perform this measurement in a manner that is consistent with the cost-projection methods used by the Congressional Budget Office (CBO). DESIGN: The model is anchored to the 10-year projection of revenues and spending within the federal government developed annually by the CBO. It examines the anticipated magnitude and cost of patient care services with respect to chronic disease and pharmaceutical therapy management, in both facility and nonfacility settings. RESULTS: The methodology yields a final cost estimate of 427 million dollars in 2004, the first year of implementation, and a 10-year estimate of 13 billion dollars. CONCLUSIONS: Recognition of pharmacists as providers of selected drug therapy management services under Medicare will have a considerable financial impact. It is instructive, however, to view the 10-year cost estimate of 13 billion dollars for pharmaceutical therapy management in light of the CBO's projected 1.5 trillion dollars estimate, over the same time frame, for drug spending among the Medicare population.