Last Updated: 2007-05-28 10:08:05 -0400 (Reuters Health)

By Susan Heavey

WASHINGTON (Reuters) – The U.S. Medicare insurance program said on Friday it did not intend to pay for artificial spinal disc replacement surgery in patients older than 60, including procedures using Synthes Inc.’s ProDisc.

The program, which covers about 43 million people who are disabled or aged 65 and older, said in a draft proposal that it was rejecting coverage of the procedure no matter which disc was used. A final decision is expected in August.

"Many questions remain regarding selection criteria, adverse events, and long-term outcomes for spine surgery in general," Medicare officials said regarding available data.

Last year, the U.S. Centers for Medicare and Medicaid Services that runs the program rejected a similar proposal seeking coverage of Johnson & Johnson’s Charite disc, which was the only such device then-approved in the United States.

Since then, Synthes has received U.S. approval for ProDisc and in November Medicare decided to reconsider its decision, but only for that particular device — not Charite.

Both discs are used to help mitigate back pain and are an alternative to lumbar spinal fusion surgery, in which bone grafts and other devices are used to bind two discs together.

Instead, artificial disc surgery removes the damaged or diseased disc and replaces it with one made from various metals or plastics. Makers say the procedure can help patients maintain mobility, unlike fusion.

A Medicare advisory panel in November told the agency more trials are needed to assess how well fusion worked and said the impact of artificial discs remained unclear.

Still, Medicare said it did not intend to pay for the device, but was seeking public comments before making its decision final.

"We are particularly interested in comments that include evidence we did not review or that assess how we evaluated the evidence included," the agency said.

The wider impact of Medicare’s decision on Synthes was not immediately clear, and officials at Switzerland-based Synthes could not immediately be reached for comment.

Private health insurers often weigh Medicare’s decision when forming their own coverage. But while the agency limited its coverage of J&J’s Charite in older patients, some other providers do cover the device.

Medicare’s proposal may also affect two other device-makers — Medtronic Inc. and Stryker Corp. — that are developing their own discs.

A U.S. Food and Drug Administration advisory panel is set to review Medtronic’s disc in July.

There is no agency-wide coverage policy for younger patients. Instead, their cases can vary and are decided by local Medicare contractors.

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