Are Medicare plans complying with CMS regulation?

Area of Science:

• Health Policy
• Pharmaceutical Economics
• Drug Formulary Management

Background:

• The US Centers for Medicare and Medicaid Services (CMS) issued guidance for prescription drug plans (PDPs) to cover 'all or substantially all' drugs in six key therapeutic categories.
• These categories include anticonvulsants, antidepressants, antineoplastics, antipsychotics, HIV/AIDS, and immunosuppressants, deemed medically necessary for Medicare beneficiaries.
• The study examines compliance with this guidance for the 2007 filing year.

Purpose of the Study:

• To assess the extent to which leading prescription drug plans complied with CMS guidance on drug coverage in 2007.
• To identify patterns of noncompliance, including drug exclusions and reimbursement conditions.

Main Methods:

• Utilized databases from the Tufts Center for the Study of Drug Development to identify 201 FDA-approved drugs (1962-2007) in the six specified therapeutic categories.
• Gathered data from 36 prescription drug plans on drug prices, formulary placement, cost-sharing, and reimbursement conditions.
• Leveraged the CMS website's Formulary Finder as the primary source for formulary data.

Main Results:

• Prescription drug plans demonstrated noncompliance with the 'all or substantially all' coverage guidance.
• On average, 17% of drugs across the six categories were not covered, with higher exclusion rates for antineoplastics and immunosuppressants.
• Eighteen percent of covered drugs had reimbursement conditions, most commonly prior authorization (15%), even in unsanctioned categories like HIV/AIDS.

Conclusions:

• The observed noncompliance suggests potential deficiencies in CMS oversight of prescription drug plans.
• Further research is warranted to evaluate the impact of formulary exclusions and restrictions on patient outcomes.