Comparative effectiveness research continues to have traction in Congress. The issue has been flagged as a priority item for inclusion in the Senate Finance Committee forthcoming package of Medicare and other health care provisions, according to a top health aide to committee Chairman Max Baucus, D-Mont.

The House version of the State Children's Health Insurance Program reauthorization included a provision to establish a Center for Comparative Effectiveness Research, plus a number of Medicare and Medicaid drug proposals (¹ Also see "Benzodiazepine Coverage Among Medicare Provisions In Child Health Bill" - Pink Sheet, 30 July, 2007., p. 18). Those provisions were shorn from SCHIP in order to ensure its passage before Sept. 30, but legislative leaders agreed to work expeditiously on a Medicare bill. Priorities of the Finance Committee will be key in indicating areas of possible agreement with the House.

Finance Committee Senior Majority Health Policy Advisor Shawn Bishop was noncommittal on the likely details of the Senate comparative effectiveness provision.

Describing comparative effectiveness as a "buzz word" that has taken hold in Washington, Bishop said it "appears to be an activity that needs to be funded by the federal government in order for providers, patients and even payers to make better decisions about what health care works and what health care doesn't."

She commented on the Senate outlook during a Sept. 25 appearance at the America's Health Insurance Plans' annual Medicare Conference.

Bishop added: "We are going to be making some kind of an effort, and I can't say what the scope or the scale is going to be because there are no decisions [that have been reached yet] on funding comparative effectiveness research."

At minimum, Baucus is looking to pull together the framework of a comparative effectiveness research program "that would be what we would basically rely on as a nation," Bishop said. "I don't know if we are going to be able to put the entire framework in place."

Bishop identified some key topics related to comparative effectiveness research that still need to be ironed out.

"There are a lot of issues surrounding CE research, like who does it," Bishop said. "Do we create a whole new agency or do we give the activities to [the National Institutes of Health] or [HHS' Agency for Healthcare Research and Quality]? So there are lots of decisions that still need to be worked out and I can't guarantee that we're going to have all the answers by the time we need to have them this fall, but I know we are going to do something in that area, so you should all look for something this year."

Baucus' interest in comparative effectiveness is not a surprise. The committee chairman included language to expand comparative effectiveness research and give resulting data a more explicit role in Medicare Part D formulary reviews in unsuccessful legislation that would have given HHS authority to negotiate Part D drug prices directly with manufacturers (² Also see "Medicare Bill Could Spur Interest In Drug Comparative Effectiveness Studies" - Pink Sheet, 30 April, 2007., p. 20).

Other top priorities for the Senate package are blocking scheduled cuts, Medicare physician payments and addressing concerns about marketing of Medicare Advantage plans.

Uncertainty About Six Protected Classes

Asked about Baucus' interest specifically in Medicare Part D provisions, Bishop said, "We are thinking about providing coverage for benzodiazepines and maybe barbiturates."

The House SCHIP bill contained a provision to lift the current statutory ban on Medicare Part D payment for benzodiazepines. Some Part D plans offer, and bear the full cost of, benzodiazepines as part of a competitive strategy (³ Also see "Part D Enrollees Like Stability, Low Premiums, Analysis Of 2007 Plan Choices Finds" - Pink Sheet, 23 July, 2007., p. 26).

One Part D program that the Finance Committee is struggling with is whether to require by statute that Medicare plans cover "all or substantially all" drugs in six categories - antidepressants, antipsychotics, anticonvulsants, antiretrovirals, antineoplastics and immunosuppressants. CMS now requires that via agency guidance, but can add or delete protected categories.

"There is going to be a lot of pressure on the six protected classes," Bishop said. "There is lots of interest on the Senate Finance Committee from members from both sides of the aisle on codifying the six protected classes."

Committee member John Kerry, D-Mass., has identified codifying the six protected classes as one of his priorities for any upcoming Medicare package, a staffer said.

Another committee member, Gordon Smith, R-Ore., floated a proposal on this matter during the committee's markup of the Part D negotiation bill.

"As you know, the House codified those six protected classes forever and they got a zero score for it," Bishop noted. "So it makes it really difficult for us to say no to a policy like that."

However, she added that it might be hard to bring this policy forward "because I don't necessarily want to set up a situation where we have codification of drug classes that may be evolving over time. So that means that [Sen. Baucus] and [the Finance Committee] would be in a position where we would be deciding potentially what classes are in and what classes are out. We don't necessarily want to be doing that."

Other Part D areas identified as priorities included making adjustments to the asset test for individuals eligible for the low-income subsidy and ensuring pharmacies are paid in a timely manner.

"If we could afford to eliminate [the asset test], we would," Bishop said. "That barrier just needs to go away. We want to make it easier for people to get the low-income subsidy and basically be funded through the doughnut hole. How far we are able to go is just going to depend on what the whole package looks like."

- Gregory Twachtman (g.twachtman@elsevier.com)

Baucus Flags Comparative Effectiveness As Priority For Senate Medicare Bill

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