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Medicare’s Coverage Policy Relating to Organ Transplantation

Medicare’s Coverage Policy Relating to Organ Transplantation. John Whyte, MD, MPH Centers for Medicare and Medicaid Services Ethics and Policy Conference July, 2001. The Old Structure. Centers for Medicare and Medicaid Services (CMS). New Structure.

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Medicare’s Coverage Policy Relating to Organ Transplantation

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  1. Medicare’s Coverage PolicyRelating to Organ Transplantation John Whyte, MD, MPH Centers for Medicare and Medicaid Services Ethics and Policy Conference July, 2001

  2. The Old Structure

  3. Centers for Medicare and Medicaid Services (CMS)

  4. New Structure

  5. Online Access to HCFA www.hcfa.gov

  6. HCFA’s Authority to Make Coverage Decisions • Section 1862(a)(1)(A) of the SSA restricts all coverage and payment to that which is found “reasonable and necessary” for the treatment of illness or injury • The provision gives the Secretary, HHS, acting through HCFA, the authority to determine the coverage of services under Medicare

  7. Section 1862 (a)(1)(A) • “. . .no payment may be made . . . For expenses incurred for items or services . . [which] are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

  8. Two General Methods by which Coverage Decisions are Made • Medicare contractors may develop coverage policies, known as Local Medical Review Policies (LMRPs) -- www.lmrp.net --> medicarelcd • HCFA may develop national coverage policies • Most new items and services covered by the first process, with about 10% covered by second • Both rely upon evidence of medical effectiveness

  9. Coverage of Services, General • Medicare is a defined benefit program • A service must fall into one of 55 statutorily-defined “benefit categories” as a first step toward coverage

  10. Medicare National Coverage Process 90 DAYS Submission of Formal Request for Review HCFA Reviews for Completeness No benefit category. Unable to consider NO Is Submission complete? Return to Requestor YES HCFA Accepts Request Once HCFA accepts a formal request, it will take 90 days to respond to requestor. HCFA will also announce its decision on the Web. HCFA Responds to Request Request Duplicates Earlier Request where Decision Made. Insufficient evidence to reopen Request Duplicates Pending Request. Requests Combined 60 Days Referral for a Technology Assessment DECISION Referral to MCAC 45 Days National Coverage Decision with Coverage Limitations National Coverage Decision without Coverage Limitations National Noncoverage Decision Issue left to Contractor Discretion Notify Requestor of Estimated Timeframe HCFA Announces Intention to make Decision Via Decision Memorandum 60 Days HCFA Issues National Coverage Decision 180 Days from 1st day of next calendar quarter Payment Change Effective

  11. Medicare Coverage Policies • 1976 - Kidney transplants • 1987 - Heart transplants • 1992 - Liver transplants • 1995 - Lung transplants • 1999 - Liver transplants (expanded) • 1999 - Pancreas transplants • 2000 - Intestinal transplants

  12. Actuarial Data • 1 year actuarial survival standards-- • heart 73% • liver 77% • lung 69% • 2 year survival standards -- • hear 65% • liver 60% • lung 62%

  13. Issues Related to Malignancies

  14. Contact Information jwhyte@cms.hhs.gov 410-786-9668

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