Health reforms set comparative-research goals

The situation has generated enthusiasm on the campaign trail for developing objective information on the effectiveness of medical treatments and therapies in real-world settings. Sen. John McCain says publicizing information on treatment options and developing national standards for measuring outcomes can address the rising cost of U.S. healthcare. Sen. Barack Obama sees comparative-effectiveness research on drugs, devices and procedures as necessary to reduce the "considerable waste in our healthcare system."

COSTS AND COVERAGE

Pharmaceutical companies and medical device makers fear that comparative research will be used primarily to deny coverage and support a "cheapest is best" approach. Manufacturers insist that if the FDA approves a product as safe and effective, payers should not use comparative data to deny coverage.

The prospect that more effective use of medical technology could save billions is driving the debate. It makes no sense to establish best treatment processes and not look at them in making coverage determinations, says Karen Ignagni, president of America's Health Insurance Plans (AHIP). Insurers might not deny coverage based on comparative-effectiveness analysis, but they might put a more costly drug that lacks a clear advantage in a higher formulary tier.

Experts believe that research can help ensure that coverage decisions reflect treatment value if studies are based on objective scientific standards. The Medicare Payment Advisory Commission (MedPAC) recommended in its June 2007 annual report that Congress establish an independent entity to sponsor "credible research on comparative effectiveness of healthcare services." An Institute of Medicine committee also issued a report backing a national comparative-effectiveness assessment program to develop standards and processes for synthesizing available evidence on clinical effectiveness.

These assessments are building support in Congress for a quasi-governmental comparative-effectiveness research organization, distinct from the Agency for Healthcare Research and Quality (AHRQ). This agency has expanded its comparative-effectiveness research portfolio in recent years to support coverage and treatment decisions by Medicare and other public health programs. Many advocates believe that an independent research organization would be less subject to political control. At the same time, a central research entity could reduce duplicative efforts by insurers and private groups developing their own comparative-effectiveness data. AHRQ has about $15 million to spend in this area, much less than envisioned.

As the debate continues, policy makers are discussing key issues such as who would control and pay for the comparative-effectiveness operation, what treatments it would evaluate, and what standards would provide a basis for analyses. As the program develops, it's clear that cost management will be central to its success.

Jill Wechsler, a veteran reporter, has been covering Capitol Hill since 1994.