Review of Erectile Dysfunction Drugs in the Medicare Part D Program

摘要

Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended Title XVIII of the Social Security Act (the Act) by establishing the Medicare Part D prescription drug benefit. Under Part D, which began January 1, 2006, individuals entitled to benefits under Medicare Part A or enrolled in Medicare Part B may obtain drug coverage. The Centers for Medicare & Medicaid Services (CMS), which administers Medicare, contracts with private prescription drug plans and Medicare Advantage plans (collectively known as sponsors) to offer prescription drug benefits to eligible individuals under Medicare Part D. Every time a beneficiary fills a prescription covered under Part D, the sponsor must submit prescription drug event (PDE) data, including drug cost and payment information, to CMS. Sponsors are required to submit final PDE data within 6 months after the end of the coverage year. Medicare Part D Excluded Drugs. The MMA requires that a drug meet the definition of a Part D drug to be covered by the Part D program. Certain drugs or classes of drugs, or their medical uses, may be excluded from coverage or otherwise restricted under sections 1927(d)(2) or (d)(3) of the Act, except for smoking cessation agents. Effective January 1, 2007, P.L. No. 109-91, section 103, amended section 1860D-2(e)(2)(A) of the Act to exclude from the statutory definition of a Part D drug a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration (FDA). An erectile dysfunction (ED) drug meets the definition of a Part D drug when it is prescribed for medically accepted indications other than sexual or erectile dysfunction (such as pulmonary hypertension) for which the drug has been approved by FDA. OBJECTIVE. Our objective was to determine the extent to which CMS accepted PDE data that sponsors submitted for ED drugs used for the treatment of sexual or erectile dysfunction. SUMMARY OF FINDING. Of approximately $133 billion in gross drug costs included in sponsors PDE data for calendar years (CY) 2007 and 2008, CMS accepted PDE data totaling $3,107,200 in gross drug costs for ED drugs approved only for the treatment of sexual or erectile dysfunction. Pursuant to Federal requirements, Part D should not have covered these drugs.