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Medicare Immunosuppressive Drug Coverage for Kidney Transplant Recipients (CRS Report for Congress)

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Release Date July 16, 2013
Report Number R43154
Report Type Report
Authors Scott R. Talaga, Analyst in Health Care Financing
Source Agency Congressional Research Service
Summary:

End-stage renal disease (ESRD) is substantial and permanent loss in kidney function. Persons with ESRD require either a regular course of dialysis treatment (a process that removes harmful waste products from an individual's blood stream) or a kidney transplant to survive. The Medicare program provides coverage for health care services for the vast majority of individuals diagnosed with ESRD, regardless of age. In 2010, roughly 489,000 Medicare beneficiaries received ESRD-related services—less than 1% of the total Medicare population. According to the United States Renal Data System (USRDS), in 2010, Medicare expenditures for the ESRD-related services totaled $32.9 billion, or roughly 6.3% of total Medicare expenditures. The Medicare program consists of four parts: Part A (Hospital Insurance, or HI), Part B (Supplementary Medical Insurance, or SMI), Part C (Medicare Advantage), and Part D (outpatient prescription drug coverage). Under Part A, Medicare-covered ESRD-related services include dialysis treatments upon admission to a hospital, inpatient services in an approved hospital for covered kidney transplants, and the cost of care for the individual donating a kidney. Under Part B, Medicare-covered ESRD-related services include dialysis treatments in a dialysis facility or at home, physicians' services for kidney transplant procedures, and certain prescription drugs—including immunosuppressive drugs (for individuals who received a Medicare-covered transplant). Under Part D, beneficiaries can also enroll in a prescription drug plan to receive coverage for drugs that treat ESRD-related symptoms and any additional outpatient prescription drugs. Coverage of immunosuppressive drugs for individuals whose transplant was not covered by Medicare may be covered under Part D. Individuals who have received a kidney transplant usually require immunosuppressive drugs for the rest of their life to minimize the risk of their immune system rejecting the donor kidney. In 2010, Part B expenditures for immunosuppressive drugs totaled $345 million. Under Part B, Medicare provides payment for immunosuppressive drugs based on manufacturers' reported average sales price (ASP), for each drug, plus a 6% handling and storage payment. Since 2009, the ASP for commonly used immunosuppressive drugs has decreased by over 50%—most likely due to the use of generics. For ESRD beneficiaries, Medicare covers a lifetime of dialysis treatments. For Medicare-eligible individuals with a functioning kidney transplant, Medicare covers the cost of the transplant and 36 months of follow-up care (which includes immunosuppressive medication). According to the USRDS, at the end of 2010, approximately 41% of individuals under the age of 65 who had a functioning kidney transplant and thus no longer required dialysis were not covered by Medicare. Since the 105th Congress, legislation has been introduced in each Congress to provide some form of Medicare coverage for post-transplant recipients who are no longer entitled to Medicare following 36 months of a successful kidney transplant. Individuals who are not covered by Medicare who require immunosuppressive drugs and do not have health insurance may have to pay the cost of immunosuppressive drugs out-of-pocket. In 2014, individuals who are not covered by Medicare and who have a functioning kidney transplant may have greater access to immunosuppressive drug coverage from private health plans due to provisions in the Patient Protection and Affordable Care Act and a recent decline in the price of commonly used immunosuppressive drugs.