Society Voices Concerns about CER Provision in Stimulus Package
The U.S. House of Representatives approved the stimulus package on January 28, 2009 by a 244-188 vote. The House language regarding comparative effectiveness research (CER) has been criticized for not providing safeguard against using CER data to restrict coverage.
The Heart Rhythm Society wrote a letter to Rep. Nancy Pelosi (D-CA), Speaker of the House; Rep. John Boehner (R-OH), House Republican Leader; Sen. Harry Reid (D-NV), Senate Majority Leader and Sen. Mitch McConnell (R-KY), Senate Minority Leader urging them to ensure that any comparative effectiveness research provision (CER) included in the economic stimulus package establish a legislative framework that is strong and patient‐centered. The Society's letter (PDF, 124K) stated that we believe any provisions related to comparative effectiveness should:
- Focus on comparative clinical benefit, rather than cost-effectiveness
- Be conducted through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage
- Ensure that research supports providers in delivering the best possible care to their patients and that to maintain a focus on patient and provider needs, the research entity should not engage in making policy recommendations or coverage decisions
The Senate version of the bill is addressing the cost issue by replacing “comparative effectiveness” with “comparative clinical effectiveness”, which emphasizes clinical effectiveness over cost. This version of the stimulus package is now being debated by the Senate this week and the full Senate will be voting on it in the next week or two.
Once the Senate passes its version, the House and Senate will meet in a conference to reconcile both version of the bill. The goal is to have the reconciled bill on the President’s desk by mid-February.
On Thursday, January 15, 2009, Democratic leaders of the House released the ”American Recovery and Reinvestment Bill of 2009,” commonly referred to as the stimulus package or economic recovery bill.
Among the priorities addressed in the stimulus package are “lowering healthcare costs” and “transforming our economy with science and technology.”
Summary of Healthcare-Related Priorities
Health Information Technology (Health IT)
The proposed language provides $20 billion to jumpstart Health IT, with funds used to test and certify Health IT software, to support the adoption of Health IT by institutions and physicians offices thought grants and to support healthcare professionals training. Approximatly $2 billion will be spend on infrastructure and standards development; the remaining funds are expected to be used as bonus payments to physicians and other providers who adopt Health IT in the care of Medicare, Medicaid and SCHIP patients.
Comparative Effectiveness Research (CER)
The stimulus package includes language creating the Federal Coordinating Council for Comparative Effectiveness Research. This council will coordinate CER and will advise Congress and the President on strategies regarding the infrastructure needs (for CER) within the federal government. The proposed language also provides funds to existing government programs within Agency for Healthcare Research and Quality (AHRQ) that have already initiated CER.
National Institute of Health (NIH)
Improvements to NIH funding include:
- University Research Facilities: The proposed legislation gives $1.5 billion to NIH to support the renovation of university research facilities. The language is limiting the construction work to repairs and renovations rather than new constructions. Funds are awarded through a peer review process.
- NIH Research: $1.5 billion will be supporting the biomedical research funded by NIH focusing on heart diseases, cancer, Alzheimer's and Parkinson's disease.
- NIH Campus Modernization: The recovery package funds $500 millions to renovate and improve the NIH campus buildings. The funds will be spend on the most urgent campus safety and functional repairs needed as defined in the Renovation and Improvement Strategic plan developed by the NIH Office of Research Facilities.
The House Appropriation Committee will consider the proposed economic recovery bill for debates or amendments thought the mark-up process in the following weeks. Once the language is approved by the House Appropriation Committee, it will be brought to the House floor to be voted on.
If the “American Recovery and Reinvestment Bill of 2009” is passed by the House, it will be sent to the Senate. House Appropriation Chairman David R. Obey (D-WI) is hoping to have this stimulus package on the desk of the President for signature by February 13, 2009.
The Heart Rhythm Society, along with other medical specialty societies, will continue to meet with key Members of Congress and their congressional staff on the range of issues being proposed. Ensuring that comparative effectiveness initiatives involved timely and appropriate review of the research by specialty physicians focusing on clinical effectiveness of the treatments is a chief concerns. The Society will provide updates on further developments with the stimulus package.