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Medicare News

For Immediate Release: Contact:
Thursday, February 18, 1999 CMS Office of Public Affairs
202-690-6145

For questions about Medicare please call 1-800-MEDICARE or visit www.medicare.gov.

MEDICARE TO COVER LASER PROCEDURE FOR SEVERE ANGINA

Expanding treatment options for Medicare beneficiaries with severe heart-related chest pain known as angina, the Health Care Financing Administration (HCFA) today announced a national decision to cover transmyocardial revascularization (TMR), a laser surgical procedure where tiny holes are made in the heart muscle to help restore blood flow.

After reviewing new medical evidence of TMR's effectiveness in treating severe angina that is unresponsive to standard medical therapy, HCFA will rescind a 1997 national decision denying coverage of TMR. The earlier non-coverage decision reflected a lack of conclusive scientific evidence at the time regarding the effectiveness of TMR for beneficiaries with severe angina. On Aug. 20, 1998, the Food and Drug Administration (FDA) approved the first laser device for use in the TMR procedure.

"As scientific evidence becomes available about the effectiveness of new treatments, HCFA wants to act as quickly as possible to make sure Medicare beneficiaries have access to safe and effective new treatments," said Jeffrey Kang, M.D., HCFA's chief medical officer and director of the Office of Clinical Standards and Quality. "Medicare beneficiaries who suffer from severe heart-related chest pain will now have another treatment option available to them."

Medicare will limit coverage of the procedure to FDA-approved uses of the devices used in TMR. After reviewing the FDA decision and seeking additional medical evidence about the treatment's effectiveness from device manufacturers, HCFA will now cover TMR as a late or last resort treatment for Medicare beneficiaries with severe angina that is unresponsive to standard medical therapy, including drug therapy at the maximum tolerated or safe dosages.

Additionally, the procedure must be performed by properly trained physicians at hospitals with dedicated cardiac care units that document that all personnel have been trained in the procedure and the proper use of the equipment involved.

While most Medicare coverage decisions are made locally by HCFA contractors -- the private companies that by law process and pay Medicare claims -- HCFA makes national coverage decisions that apply nationwide and supersede local policies. HCFA will next issue a coverage instruction, including coding and billing information, to all of its contractors that will specify an effective date when Medicare payment will be available.

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