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Insight into Government Run Healthcare: Comparative Effectiveness Research

Last Updated: Thu, 01/07/2010 - 5:10pm

After months of fiery debate, name-calling, and other controversial behavior, the United States nears passage of a healthcare bill in the name of “change.” This healthcare bill, however, is not a sure ticket to Utopia. The most obvious problem is that both the House and Senate bills are lengthy to read and disguised in legalese. Meanwhile, as has occurred with other legislation like TARP, even when a legislative bill seems to clearly state one thing, sometimes it is implemented differently. In addition to these fundamental challenges, ABC News reports that the bill still faces the “hurdle” of combining proposals from both the House and Senate. As Congress tries to forge ahead, it is imperative to also place government run healthcare in perspective by examining its other related endeavors.

Judicial Watch initiated an investigation of the healthcare debate by examining current and relevant government programs using documents obtained under the Freedom of Information Act. The first batch of responsive documents pertains to the American Recovery and Reinvestment Act (ARRA) creation of the Federal Coordinating Council (FCC). FCC is tasked with coordinating Comparative Effectiveness Research (CER) across the federal government. The infamous death panel discussion was based partly on CER. A major principle of the healthcare bill is funding more CER, as ARRA funding is slated to expire in 2011.

While the documents are not a complete and thorough depiction of government healthcare, several interesting trends emerge. First, although FCC opened comments on the CER definition and application, its report to the President seemed to cherry pick the comments that favored CER. Some of the more critical comments concerned whether CER would be guided only by cost instead of quality, as well as its real world implementation, the lack of clarity of who is included as a “decision maker” (i.e. loved ones or policy makers), its potential liability, and the one size fits all approach.

In addressing the one size fits all problem, National Alliance on Mental Illness (NAMI) cautioned that the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) resulted in 69% of participants switching to different medications at the end of the trial. The approach did “not reflect best clinical practice which calls for a dialog between a medical professional and consumer that helps determine a best-choice medication based upon treatment goals and risk of side-effects.”   

Another recurring theme addresses “sub-groups.” Many commentators point out that certain populations like minorities, disabled people, or individuals with multiple conditions are often not included in the research and therefore do not benefit.  This discussion provokes the question of whether research will be guided by the greatest need (and how that is determined) or by some other factor. Many of the commentators note that these "sub-groups" should become priority populations for CER. NIH states:


The lack of adequate representation of important patient populations in many research studies presents a major challenge in applying the results of these studies to important populations and sub-groups. In recognition of this fact, the ARRA legislation notes that “research conducted with funds appropriated shall be consistent with Departmental policies related to the inclusion of women and minorities.” This criterion is critically important for ensuring that information gained from comparative effectiveness research improves the quality of care for all Americans.

CER may also distort medical research innovation. Documents from Health Resources and Services Administration (HRSA) show a chart of CER priorities. The chart contains a list of 40 potential CER funding categories, each with approximately 19 responses. The options were “do not fund,” “fund for less than the requested amount,” “fund for the requested amount,” and “fund for greater [than] the requested amount. Topics receiving the majority of “do not fund” responses were “reducing oral health disparities,” “HIV/Aids oral health,” and “orthopedic joint registry.” Meanwhile, the top three “fund for greater” programs were “enhance availability and use of Medicare data,” “Medicaid analytic extract (Max) data repository for,” and “Linked HHS longitudinal claims and clinical data sets.” The chart poses a challenge to healthcare innovation by allowing a council of unelected individuals to determine the nation’s healthcare funding (at least with respect to CER).

These intricacies of the CER documents are a mere sample of how complex the healthcare debate truly is. While the end goal is providing healthcare for everyone, getting there is simply not as easy as signing a bill. While CER is a small program, the same questions of one size fits all, priority populations, and determination of research priorities are also relevant for universal government funded healthcare.

As Judicial Watch continues to investigate the healthcare debate, it will keep the public apprised of new information.

Documents:

Health Resources and Services Administration CER Documents 1

Health Resources and Services Administration CER Documents 2

Health Resources and Services Administration CER Documents 3

Health Resources and Services Administration CER Documents 4




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