Clinical practice figures into Medicare coverage decision

HCFA alleviated fears that scientific evidence would be overemphasized in national Medicare coverage decisions when it approved two new treatments for urinary incontinence.

By Jane Cys, amednews staff. Nov. 13, 2000.

Washington -- Two new national coverage decisions signal a positive shift in the way the Health Care Financing Administration decides which services Medicare will and won't cover, physicians and other industry watchers say.

The agency took clinical guidelines and specialty society opinions into consideration before approving coverage of two new treatments for urinary incontinence. It's input that some in the physician community had feared would be discounted or ignored because HCFA seemed to be placing a heavy emphasis on the need for rigorous scientific evidence.

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"These decisions strike a very well-constructed and well-thought-out balance between the need for evidence and the need to give some credence to clinical opinion," said Grant Bagley, MD, an attorney and partner in the Washington, D.C., law firm of Arnold & Porter. "They also show a flexibility in considering issues on a case-by-case basis."

The new coverage decisions require all Medicare carriers to pay for biofeedback and pelvic floor electrical stimulation. Biofeedback previously was covered at the discretion of local Medicare carriers. Pelvic floor electrical stimulation has not been covered since 1994.

HCFA has been working to improve the process it uses to add new treatments to Medicare's covered benefits. As part of that ongoing effort, the agency created the Medicare Coverage Advisory Committee in 1998 to help it evaluate new therapies.

Learning curve

HCFA asked MCAC in early 1999 to consider whether the scientific evidence on pelvic floor electrical stimulation and biofeedback was adequate to draw conclusions about their effectiveness in treating urinary incontinence.

The panel, after considering the available research, concluded that the scientific evidence was lacking. The wording of HCFA's question seemed to leave little room for MCAC to look beyond the available clinical evidence when evaluating the treatments.

Several MCAC members said during the debate, for example, that they would have voted to cover these therapies if that option had been before them. Others said that more weight should have been given to input from the public, specialty societies and clinical guidelines.

After considering clinical opinions and the scientific evidence, HCFA officials decided to cover both treatments. They also urged researchers to conduct high-quality, rigorously designed studies of the therapies and said that HCFA might look at the coverage policies again within the next three years once more evidence is available.

"I don't think [the agency's decision is] inconsistent with where the panel ended up in their hearts," said Michael Maves, MD, an otolaryngologist who sits on MCAC's executive committee.

The MCAC process and the factors HCFA uses to make coverage decisions are still evolving, Dr. Bagley noted. "As HCFA tries to develop a national coverage process, they're in a learning process. It's inevitable that the pendulum is going to swing back and forth."

Despite the good news, the AMA cautioned that HCFA's coverage policy for clinical trials includes some pitfalls that could hamper efforts to get more clinical research on the urinary incontinence treatments.

The clinical trials policy, for example, fails to outline a role for MCAC. This might make it difficult to integrate trial findings into the process that determines which services Medicare will cover, the AMA noted in a letter to HCFA.

The agency also left open the opportunity for some clinical trials to be deemed "not covered" after the research has already begun. This could result in the government retroactively recouping payments it made for patients enrolled in those trials.

"These policies could prove to be a strong disincentive to clinical researchers who might otherwise be interested in conducting important new clinical trials, including the recommended trials on alternative urinary incontinence treatments," the AMA said in the letter.