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Technology approval process under fire

Physicians testify that Medicare beneficiaries aren't getting coverage for new, beneficial technology quickly enough.

By Jane Cys, amednews staff. March 19, 2001.

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Washington -- The process Medicare uses to make coverage and payment decisions for breakthrough medical devices remains lengthy and burdensome despite recent procedural improvements by the Health Care Financing Administration, physicians and others testified at a recent congressional hearing.

Paul Shreve, MD, a diagnostic radiologist from Michigan, cited the 10-year battle to get Medicare coverage for positron emission tomography as an example of a process gone awry.

Years of urging from the medical industry prompted HCFA in late 2000 to expand PET coverage beyond diagnostic evaluation of solitary pulmonary nodules and staging of primary lung cancer. But that action didn't go far enough, Dr. Shreve said.

HCFA's latest coverage decision means Medicare will pay for PET if it's used with six types of cancer: lung, colorectal, lymphoma, melanoma, esophageal, and head and neck. Dr. Shreve noted, however, that the decision doesn't provide coverage for cancers in women, such as breast or ovarian cancer, for which he believes PET is effective.

"How many iterations must we go through with HCFA to get coverage?" said Dr. Shreve, director of the general nuclear imaging section at the University of Michigan Medical Center in Ann Arbor. "HCFA has not established clear standards that new technologies must meet for reimbursement, so decisions can become arbitrary and painfully slow."

Many of the concerns about the coverage process are well founded, acknowledged Jeff Kang, MD, director of HCFA's Office of Clinical Standards and Quality. The agency already has taken steps to improve the coverage process and plans to make further modifications to accommodate recently enacted changes in the law. [...]