Comparative Effectiveness Research Under Health Reform, “The Institute”

Filed in Quality Improvement by on March 25, 2010 2 Comments
Image by nick.garrod via Flickr

Image by nick.garrod via Flickr

Bend the cost curve” has been the mantra of many students of health care reform. The Dartmouth Health Atlas has shown that up to 1/3 of care may be unnecessary. But how do we find out what care is unnecessary? One tool that holds promise is comparative effectiveness research.   Now that health reform has been signed into law, there is greater certainty as to the future of comparative effectiveness research (CER). The Stimulus bill had already allocated $1.1 billion dollars to investigate CER. The newest health reform law continues to build on that start. So what about HR 3590, also known as the Patient Protection and Affordable Care Act? Will they ration care? Pull the plug on your grandmother? Get between you and your doctor? To start answering these questions, I will provide a brief overview of CER under the new law, and describe the law’s vision for a new institute for CER research.

Part D of  H.R. 3509 is entitled “Comparative Clinical Effectiveness Research.” Section 1181 of  Part D defines CER as: “research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).” Subparagraph B goes on to describe various services and goods associated with health care.

The Institute
Section (b) of 1181 is where the rubber hits the road. Under this this section, the law creates a nonprofit corporation to be called the “Patient-Centered Research Institute,” known as “the Institute,” which is neither an agency nor establishment of the United States. This is rather interesting, and I did not know that our federal government created such corporations, but I suppose it could be compared to a nonprofit Amtrak.

The Institute will be backed by a Trust Fund created by money transferred from the Medicare Part A and B trust fund. It will receive, for year 2013, an amount equal to 1$ multiplied by the number of individuals entitled to benefits of Medicare Part A or enrolled under Part B. For years 2014 through 2019 the multiplier is $2.

The Purpose and Duties of the Institute
The purpose of the Institute is stated as what amounts to the typical reason for CER: making better health care decisions based on the evidence.

The duties of the institute are listed as:

  1. Identifying and adopting (by majority vote within the Institute) research priorities and establishing research project agenda
  2. Carrying out research project agenda by doing
    1. Systematic reviews of previous (and future) research (often known as meta-analysis), and
    2. Primary research including randomized clinical trials. The primary research the Institute conducts can be subcontracted to other institutions, under certain constraints.
  3. Data collection from various electronic sources like those at the Center for Medicare and Medicaid Services.
  4. Appointing expert advisory panels for clinical trials
  5. Supporting patient and consumer representatives
  6. Establishing a methodology committee to study new ways to measure and conduct CER.
  7. Providing a peer-review process for primary research conducted by the Institute. Notably, if the Institute subcontracts, they can use the peer-review process of the organization to which they contract with.
  8. Release of research findings to clinicians, patients, and the general public. The Institute must also release an annual report.

Governing in the Institute
The Institute will be run by a Board of Governors. The breakdown of the Board of Governors is quite interesting, and possibly telling:

  • The Director of the Agency for Healthcare Research and Quality
  • The Director of the National Institute of Health
  • 17 members appointed by the Comptroller General of the U.S. The 17 members must be composed of:
    • 3 members representing patients and health care consumers.
    • 5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and a representative of a hospital.
    • 3 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits.
    • 3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.
    • 1 member representing quality improvement or independent health service researchers.
    • 2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

This very well may be one of the handouts that the Senate provided Big Pharma and device manufacturers to get them on board. Remember that CER may very well show that a drug that a company has invested hundreds of millions of dollars in turns out to be ineffective when compared to its competitor. Thus, it is not surprising, for the cynics among us, that the Board has at minimum 3 industry reps from pharma and devices while there is a minimum of only 1 doctor. You start to wonder why the AMA supported the bill if physicians are only guaranteed 1/17th of the positions. After all, it is undeniable that physicians will be interacting with the CER data more than anyone, and they have on the ground experience using CER and related decision aids like Clinical Practice Guidelines.

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