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New Comparative Effectiveness Bill Enhances Dx, Genomics Focus

NEW YORK (GenomeWeb News) – A bill introduced last week in the Senate that would create an independent institute for comparative effectiveness research includes more emphasis on the role of personalized medicine than last year's version of the bill, according the bill's sponsors, Senators Max Baucus (D – Mont.) and Kent Conrad (D – ND).

Two large differences between the Patient-Centered Outcomes Research Act of 2009 and last year's manifestation of the bill include the addition of language about personalized medicine and genomics, and the requirement that the Centers for Medicare and Medicaid Services has to meet several requirements before allowing the use of research, including that from comparative-effectiveness studies, in making coverage decisions.

The bill includes language specifying research approaches such as "molecularly informed trials" and "genetic and molecular sub-typing." It also includes more emphasis on involvement with the diagnostics community and calls for an expert in genomics to serve on a methodology committee.

With the arrival of this version of the bill, Amy Miller, public policy director of the Personalized Medicine Coalition, told GenomeWeb Daily News that "personalized healthcare has entered the debate about the improvement of quality health care in the United States."

Miller who had advocated adding some of emphasis on genomics and personalized medicine to the bill, said there is a symbiosis between her field and comparative effectiveness.

"CER can do more to promote personalized medicine than any other policy initiative being negotiated right now, if done right," she explained.

Miller said that the addition of the personalized medicine ideas were the result of efforts from different groups from industry and patient advocates. "It was kind of a community coming together and saying it wanted to incorporate new science and not old science" in a comparative effectiveness bill.

Although the PMC is excited about the changes to the bill, Miller would like to see one group in the Patient-Centered Outcomes Research Institute that would offer expertise in genomics, pharmacogenomics, diagnostics, and related fields, such as a committee along the lines of an orphan drug or rare disease committee that focuses on personalized medicine. The PCOR institute would be a non-profit, private entity formed through the Senate bill.

The PCOR institute is expected to cost nearly $600 million over the next five years. The funding will come from the contributions from both public and private payers, which will be made available through a Patient-Centered Outcomes Research Trust Fund, and "amounts from the Medicare Trust Funds phased in to $2 per beneficiary annually, and amounts from a $2 fee per covered life assessed annually on insured and self-insured health plans," according to a statement from the Senate Committee on Finance.

The Association of Molecular Pathology recently said it wants to see more emphasis on genomics and diagnostics in discussions about comparative effectiveness.

"Unfortunately, the value of diagnostics in improving clinical outcomes has not been appreciated adequately in the past; therefore, considering the role of genomics under CER will be critical," AMP President Jan Nowak wrote in a letter to the Federal Coordinating Council for Comparative Effectiveness Research.

The American Recovery and Reinvestment Act of 2009 brought comparative effectiveness into the foreground by including $1.1 billion for studies that could be used to develop more effective healthcare practices and lower healthcare costs.

"Diagnostic tests will most definitely be included in this paradigm, especially when the effectiveness of treatments will vary among different population subgroups," Nowak wrote.

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