CMS-FDA COMPARATIVE EFFECTIVENESS INITIATIVE THREATENED

The future of the Centers for Medicare & Medicaid Services' (CMS) plan to share prescription drug plan data with the FDA in an effort to base Medicare reimbursement on product comparisons is in doubt as the agency determines whether it has the legal authority to share this information, an industry source says.

The CMS has been working with the FDA to develop this new program as a means to ensure the most effective products are covered by Medicare's Part D plan. While CMS Administrator Mark McClellan, the program's primary advocate, is leaving in October, that is not the reason why the program is in trouble, the source said.

The agency's plan is in jeopardy because of concerns that it does not have the authority under the Medicare Rx Law to share the information, the source, who believes the plan is "dead," said.

The CMS is worried that, while the law gives it the authority to use Part D data for payment purposes, it may not be able to use this information to make comparisons between competing drugs. The CMS is also unsure whether it is able to provide the FDA this data for postmarket surveillance, as it originally planned.

This development is positive for industry, which has opposed such comparative effectiveness studies. But companies are concerned that the CMS may get Congress involved to clarify its authority, leading to a stronger program that would be more difficult to challenge, the source said.

Industry has been opposed to comparative analysis, arguing that this approach could limit access to some medical therapies by making cost a major factor in recommending certain treatments. PhRMA, the Biotechnology Industry Organization and other groups have also said that comparative effectiveness will reduce doctors' discretion to choose remedies.

But other healthcare stakeholders believe the program will move forward. It is a "fairly safe assumption" that the initiative will begin, Marissa Schlaifer, director of pharmacy affairs, Healthcare Distribution Management Association, said. This program is "almost an obligation they have to the healthcare of the country." (http://www.fdanews.com/did/5_192/)