1. 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

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 v 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 v 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) v “...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 v Medicare contractors may develop coverage policies, known as Local Medical Review Policies (LMRPs) -- www.lmrp.net --> medicarelcd v HCFA may develop national coverage policies v Most new items and services covered by the first process, with about 10% covered by second v Both rely upon evidence of medical effectiveness

9. Coverage of Services, General v 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 45 Days Submission of Formal Request for Review Is Submission complete? HCFA Accepts Request HCFA Responds to 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. 90 DAYS HCFA Reviews for Completeness Return to Requestor Request Duplicates Pending Request. Requests Combined NO YES 60 Days DECISION Payment Change Effective 180 Days from 1st day of next calendar quarter HCFA Issues National Coverage Decision HCFA Announces Intention to make Decision Via Decision Memorandum Notify Requestor of Estimated Timeframe Request Duplicates Earlier Request where Decision Made. Insufficient evidence to reopen Referral for a Technology Assessment National Coverage Decision without Coverage Limitations National Coverage Decision with Coverage Limitations Issue left to Contractor Discretion National Noncoverage Decision 60 Days Referral to MCAC No benefit category. Unable to consider

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

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

13. Issues Related to Malignancies

14. Contact Information jwhyte@cms.hhs.gov410-786-9668