Senate Finance Committee Chairman Max Baucus, D-Mont., is trying to keep comparative effectiveness on track as part of health reform legislation, but options under the panel's consideration demonstrate that the role of cost in the evaluations is still a worry.

The committee's "walkthrough" of options for the addressing the delivery of health care were provisions for creating a permanent structure for comparative effectiveness research of medical products and procedures.

The closed-door walkthrough was held April 29 and followed the committee's earlier public roundtable on health care delivery. A "¹ Description of Policy Options" paper was the starting point for the committee's discussion.

The comparative effectiveness section of the paper emphasizes some of the core provisions of Baucus' comparative effectiveness bill from the previous Congress, S. 3408, such as the proposal for creating an independent public/private-funded institute to oversee the research (² Also see "Comparative Effectiveness Bill Calls For Private Group To Plan Research" - Pink Sheet, 11 August, 2008., p. 19).

The document also lists a second option of supporting comparative effectiveness research through annual appropriations to existing HHS entities, as was done in the recent American Recovery and Reinvestment Act (³ [A#00710070016], p. 25). However, it notes potential problems with this approach: discretionary spending can be inconsistent and unstable and the research agenda could be unduly influenced through the political process.

No "Fast Track" To Coverage Decisions

While S. 3408 said the institute would not be allowed to mandate coverage or reimbursement policies and that its reports and findings should not be construed as recommendations or guidelines in those areas, the options paper builds further on that idea. It says the committee "should consider ways of addressing the need for patient safeguards with respect to the use this type of research, particularly by public programs like Medicare and Medicaid."

It says an option is to set limits on use of the research by HHS. "For example," the paper explains, "Medicare could be allowed to use the findings only in circumstances where the processes by which it uses the information is transparent, relies on all available evidence (not only research from the institute), considers the potential for effects on subpopulations of beneficiaries, and allows for public comment on any draft proposals that use the information."

In this way, the paper suggests, HHS agencies would not be able to create a "fast-track process" for automatically linking findings to coverage or reimbursement decisions.

Toughest Decisions Still Ahead

In a post-walkthrough briefing, it was evident that much work remains before actual bill language is crafted. Baucus made it clear that while senators discussed the options presented, no decisions were made which would be included in the committee's health reform legislation.

Congressional Budget Office Director Doug Elmendorf and Medicare Payment Advisory Commission Executive Director Mark Miller were on hand at the walkthrough to answer questions, but Baucus said, "I must say though that there are still a lot of questions on the minds ... of all senators, myself included."

The committee's ranking Republican member, Charles Grassley of Iowa, added that as the committee discussed the problems with health care delivery, "there was not a lot of disagreement about what is a problem. There might be some disagreement about how to handle it." He said that when it comes time to actually choose which options are proposed in legislation, it "is going to be a little more difficult than just discussing the problems."

The committee has two more roundtables scheduled, each followed by a walkthrough, on the topics of increasing health care coverage and financing health care reforms. Those "next two things we do are going to be a little more difficult, and we may see some more division at that point," Grassley said. The coverage topic will include the controversial issue of creating a government-sponsored health plan to compete with private plans.

Baucus insisted, however, that the committee remains "on schedule" to mark up legislation in June. He noted that one "challenge" is "getting the numbers and the estimates from CBO" on some of the proposals. "That's largely because we've got some new ideas here, with not a lot of data for a lot of the concepts. ... The learning curves for all of this are fairly steep."

- Scott Steinke (s.steinke@elsevier.com)

Senate Options Include Barring CER’s “Fast Track” To Coverage

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