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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

Medicare’s Coverage PolicyRelating to Organ Transplantation

John Whyte, MD, MPH

Centers for Medicare and Medicaid Services

Ethics and Policy Conference

July, 2001

Hcfa s authority to make coverage decisions
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

Section 1862 a 1 a
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.”

Two general methods by which coverage decisions are made
Two General Methods by which Coverage Decisions are Made

  • Medicare contractors may develop coverage policies, known as Local Medical Review Policies (LMRPs) -- --> 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

Coverage of services general
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

Medicare National Coverage Process


Submission of Formal Request for Review

HCFA Reviews for Completeness

No benefit category. Unable to consider


Is Submission complete?

Return to Requestor


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


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

Medicare coverage policies
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

Actuarial data
Actuarial Data

  • 1 year actuarial survival standards--

    • heart 73%

    • liver 77%

    • lung 69%

  • 2 year survival standards --

    • hear 65%

    • liver 60%

    • lung 62%

Contact information
Contact Information