In a February 9 Wall Street Journal article, staff writer Alicia Mundy mischaracterized a section of H.R. 1 in writing: “The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive 'will no longer be prescribed.' ” But contrary to Mundy's suggestion, neither the House discussion draft in which the quote appears nor the House bill implements federal requirements banning the use of “treatments found to be less effective and in some cases more expensive.” In fact, the section of the bill Mundy referenced establishes a Federal Coordinating Council for Comparative Effectiveness Research and calls for funding to “be used to accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies” and for the Health and Human Services secretary to “consider any recommendations” by the council.

The quote that Mundy ascribes to a “staff report describing the bill” appears in a section of a House Discussion Draft of the legislation regarding “Comparative Effectiveness Research.” The draft language does not state that the bill would implement a federal ban on “treatments found to be less effective and in some cases more expensive” but rather states: “By knowing what works best and presenting this information more broadly to patients and healthcare professionals, those items, procedures, and interventions that are most effective to prevent, control, and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed.” From the draft:

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

HEALTHCARE RESEARCH AND QUALITY

(INCLUDING TRANSFER OF FUNDS)

Comparative Effectiveness Research

Recovery funding: $1.100 billion

The Agency for Healthcare Research and Quality (AHRQ) began a Comparative Effectiveness Research program after passage of the Medicare Modernization Act of 2003 to conduct, support, or synthesize unbiased research about the comparative effectiveness of different healthcare interventions. By knowing what works best and presenting this information more broadly to patients and healthcare professionals, those items, procedures, and interventions that are most effective to prevent, control, and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed. Substantially increasing the Federal investment in comparative effectiveness research has the potential to yield significant payoffs in reducing health care expenditures and improving quality.

Similarly, the corresponding section of the bill provides for no federal ban on treatments, regardless of effectiveness or cost-efficiency:

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

HEALTHCARE RESEARCH AND QUALITY

(INCLUDING TRANSFER OF FUNDS)

For an additional amount for ''Healthcare Research and Quality'' to carry out titles III and IX of the Public Health Service Act, part A of title XI of the Social Security Act, and section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, $700,000,000 for comparative effectiveness research: Provided, That of the amount appropriated in this paragraph, $400,000,000 shall be transferred to the Office of the Director of the National Institutes of Health (''Office of the Director'') to conduct or support comparative effectiveness research: Provided further, That funds transferred to the Office of the Director may be transferred to the national research institutes and national centers of the National Institutes of Health and to the Common Fund established under section 402A(c)(1) of the Public Health Service Act: Provided further, That this transfer authority is in addition to any other transfer authority available to the National Institutes of Health: Provided further, That the provisions of section 1103 of this Act shall not apply to the peer-reviewed grants awarded under this paragraph: Provided further, That the amount set aside from this appropriation pursuant to section 1106 of this Act shall be not more than 1 percent instead of the percentage specified in such section.

In addition, $400,000,000 shall be available for comparative effectiveness research to be allocated at the discretion of the Secretary of Health and Human Services (''Secretary''): Provided, That the funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions; and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009, that includes recommendations on the national priorities for comparative effectiveness research to be conducted or supported with the funds provided in this paragraph and that considers input from stakeholders: Provided further, That the Secretary shall consider any recommendations of the Federal Coordinating Council for Comparative Effectiveness Research established by section 9201 of this Act and any recommendations included in the Institute of Medicine report pursuant to the preceding proviso in designating activities to receive funds provided in this paragraph and may make grants and contracts with appropriate entities, which may include agencies within the Department of Health and Human Services and other governmental agencies, as well as private sector entities, that have demonstrated experience and capacity to achieve the goals of comparative effectiveness research: Provided further, That the Secretary shall publish information on grants and contracts awarded with the funds provided under this heading within a reasonable time of the obligation of funds for such grants and contracts and shall disseminate research findings from such grants and contracts to clinicians, patients, and the general public, as appropriate: Provided further, That, to the extent feasible, the Secretary shall ensure that the recipients of the funds provided by this paragraph offer an opportunity for public comment on the research:

[...]

SEC. 9201. FEDERAL COORDINATING COUNCIL FOR COMPARATIVE EFFECTIVENESS RESEARCH.

(a) ESTABLISHMENT.--There is hereby established a Federal Coordinating Council for Comparative Effectiveness Research (in this section referred to as the ''Council'').

(b) PURPOSE; DUTIES.--The Council shall--

(1) assist the offices and agencies of the Federal Government, including the Departments of Health and Human Services, Veterans Affairs, and Defense, and other Federal departments or agencies, to coordinate the conduct or support of comparative effectiveness and related health services research; and

(2) advise the President and Congress on --

(A) strategies with respect to the infrastructure needs of comparative effectiveness research within the Federal Government;

(B) appropriate organizational expenditures for comparative effectiveness research by relevant Federal departments and agencies; and

(C) opportunities to assure optimum coordination of comparative effectiveness and related health services research conducted or supported by relevant Federal departments and agencies, with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.

[...]

(d) REPORTS.--

(1) INITIAL REPORT.--Not later than June 30, 2009, the Council shall submit to the President and the Congress a report containing information describing Federal activities on comparative effectiveness research and recommendations for additional investments in such research conducted or supported from funds made available for allotment by the Secretary for comparative effectiveness research in this Act.

(2) ANNUAL REPORT.--The Council shall submit to the President and Congress an annual report regarding its activities and recommendations concerning the infrastructure needs, appropriate organizational expenditures and opportunities for better coordination of comparative effectiveness research by relevant Federal departments and agencies.

From the Wall Street Journal article:

The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.

The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.

The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive “will no longer be prescribed.”

A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word “clinical” in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.