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Pink Sheet- House Comparativeness Effectiveness Bill includes “Physician Out” Clause

Pink Sheet- House Comparativeness Effectiveness Bill includes “Physician Out” Clause

By Cathy Kelly, A group of moderate House Democrats introduced legislation on Comparative Effectiveness Research May 19th that includes new language aimed specifically at limiting the influence of CER on physician prescribing.

Introduced by Rep. Kurt Schrader, Ore., the bill is modeled on the comparative effectiveness legislation introduced in the last Congress by Sens. Max Baucus, D- Mont., and Kent Conrad, D- N.D.  

Like that legislation, H.R. 2502 would establish a non- governmental institute responsible for managing and guiding health research programs to evaluate and compare the implications and outcomes of two more health care strategies.

The House legislation also adopts the provisions of the Baucus/ Conrad bill barring the CER institute from “mandating coverage, reimbursement or other policies for any public or private payer.”

But it adds something more, designed to further ensure that CER findings will not restrict access to medical products.

In a so called “physician out” clause, the bill states that no CER reports or findings “shall be construed to prevent the physician and patient to ultimately determine what is best for the patient involved given the individual circumstances of different patients.”


Partnership To Improve Patient Care

The bill is endorsed by the Partnership to Improve Care, a CER legislative policy group formed in November 2008 with support from the Pharmaceutical Research and Manufactures Association, Biotechnology Industry Organization, Advanced Medical Technology Association and patient and advocacy groups.

PIPC Chairman and former California Democratic Rep. Tony Coelho participated in a May 19 conference call along with the bill’s sponsors to discuss the legislation.

During the call, Coelho emphasized the importance of making prescribing decisions on a “case- by- case” basis. Schrader also highlighted the bill’s intent to discourage a “one size fits all” approach to comparative effectiveness research, a theme that has been strongly promoted by the pharma industry in discussions on CER policy.

“There is recognition in the bill” that “people are different genetically” and “respond differently to medicine,” Schrader pointed out. In that way, it supports the concept of personalized medicine.

The bill represents a departure from the comparative effectiveness research provisions in the American Recovery and Reinvestment Act in that it envisions the CER institute as a private entity.

The institute would be governed by a board including representatives from HHS, the National Institutes of health, CMS, and other federal agencies, as well as physicians, patients, insurers, methodologies and disseminate the finds.

A 10- Year Funding Plan

The bill also provides for 10- year funding for CER, building on the 1-1 billion allocated for researching best health care practices by the ARRA.

The funding would be provided by the Medicare Trust Fund and private payers. Based on an analysis by Avalere Health, funding could total approximately $100 mil. in 2010 and $200 million per year from 2011 to 2020.

The bill is cosponsored by 11 members of the centrist “New Democrats” and is viewed as a starting point for House legislation on CE. “I don’t expect this is the final version; this is a legislative process, after all,” Schrader said.

He added the CE legislation is expected is expected ultimately to be incorporated in a broad health reform bill. Key House leaders have not tipped their hand on how they will address this high profile issue, but this proposal from a group of moderates suggests the independent entity option will at least get some exposure during the legislative process.

In the Senate, Baucus is also planning to propose “pro- patient safeguards” in the new legislation on CE research, according to his staff ( The Pink Sheet DAILY, May 13, 2009.) One such provision could bar CMS from automatically linking research findings to coverage or reimbursement decisions, an approach included in an “option paper” on healthcare delivery reform released recently by the Senate finance Committee (“ The Pink Sheet, May 4, 2009, p.30).