The Pink Sheet reports that, “Sen. Max Baucus, D-Mont., is now proposing that CMS or other HHS agencies could not immediately translate results of comparative effectiveness research into health care coverage policies, in CER legislation he introduced June 9.”
The "Patient-Centered Outcomes Research Act of 2009" - stipulates that HHS may use the outcomes of comparative effectiveness research in making coverage decisions "if such use is through an iterative and transparent process which meets the following requirements":
1) "Stakeholders and other individuals have the opportunity to provide informed and relevant information with respect to the [coverage] determination."
2) "Stakeholders and other individuals have the opportunity to review draft proposals of the determination and submit public comments with respect to such draft proposals."
3) "In making the determination, the [HHS] secretary considers (A) all other relevant evidence, studies, and research in addition to such comparative effectiveness research; and (B) evidence and research that demonstrates or suggests a benefit of coverage with respect to specific subpopulation of individuals, even if the evidence and finding from the comparative effectiveness research demonstrates or suggests that, on average, with respect to the general population the benefits of coverage do not exceed the harm."
The bill at strategic spots uses the language "comparative clinical effectiveness" as a means to emphasize that the research itself will not be cost focused, which Baucus noted is key to getting CER into health care reform.
How will comparative effectiveness research generate cost savings without any cost analysis? According to Senator Baucus, cost decisions will be made by patients and providers. "It is up to them. It is not up to an agency to decide."
Decisions to be made by patients and providers (and in that order). Now that's what I call "pay-as-you-go."
And amen … to the Max.
