June 2008 Advocacy Update

Congress Begins Formal Process of Drafting FY 2009 NIH Spending Bill
The U.S. House of Representatives and Senate gave final approval to the fiscal year (FY) 2009 Budget Resolution (S. Con. Res. 70, H. Rept. 110-659) in early June, finalizing the spending framework for the next fiscal year and allowing the House and Senate Appropriations Committees to begin working on spending bills for specific federal programs in earnest. Discretionary health programs, including the National Institutes of Health (NIH), that are funded via the "Function 550" portion of the Budget Resolution will receive $59.7 billion, which is $5.2 billion higher than President Bush's budget. ASH and the health community had advocated $58.556 billion for Function 550 in FY 2009.

While the annual Budget Resolution sets forth a budgetary blueprint, each congressional appropriations subcommittee must determine precise spending levels for federal programs and agencies such as NIH. The House Labor-Health and Human Services (HHS) Appropriations Subcommittee began consideration on June 19 of its version of the FY 2009 spending bill to fund NIH, and the full House Appropriations Committee is tentatively scheduled to consider the bill on June 25. The Senate Labor-HHS Appropriations Subcommittee is tentatively scheduled to consider its version of the bill the week of June 23.

It is widely expected, however, that most of the 12 appropriations bills – including Labor-HHS – will not get completed this year and will be postponed until the next Congress. In the interim, Congress would be forced to enact a continuing resolution (CR) to fund NIH and other federal programs at current FY 2008 levels until after Congress reconvenes in early 2009, when congressional leaders would attempt to negotiate final FY 2009 spending levels with the new presidential administration.

In the meantime, ASH will continue its advocacy efforts on Capitol Hill throughout the FY 2009 appropriations debate and encourages all members to take action to support increased funding for NIH. It is critical to keep research and hematology-related issues on the minds of the Congress.

Senators Continue to Work on Medicare Physician Payment Fix to Pass Legislation Before Cuts Take Effect July 1
Senators continue to move forward with legislation that would avert the scheduled 10.6 percent Medicare physician payment cuts due to be implemented July 1. On June 18, Senate Minority Leader Mitch McConnell (R-KY) asked for unanimous consent for floor consideration of two bills. The first pertained to S. 3118, the legislation introduced last week by Finance Committee ranking member Charles Grassley (R-IA). The second request was to call up and pass a new bill authored by Senator Grassley and advertised as an 18-month extension of S. 2499, the "Medicare, Medicaid, and SCHIP Extension Act of 2007," which passed last December and provided our current six-month 0.5 percent update. Democrats, however, did not grant consent as differences remain concerning how to finance the legislation.

The new bill, called the "Medicare and Medicaid Extension Act of 2008", would extend the current 0.5 percent update through 2008 and provide a 1.1 percent update for 2009. It also includes many of the Medicare-related provisions that enjoy broad support, such as the extension of the physician work GPCI floor. Also of note, this bill does not include the language contained in the previous Grassley legislation that would grant sweeping authority to the Secretary of HHS to establish new budget-neutral quality incentive programs under Medicare. Nor does this legislation contain provisions regarding electronic prescribing or the medical home.

Reports on the status negotiations between party leaders in the Senate are conflicting, although we understand that Senate Finance Committee Chair Max Baucus (D-MT) has initiated conversations with his counterparts in the House about enacting Medicare legislation before July 1. And, as the recent Senate floor discussion indicates, support for an 18-month period of positive updates remains. ASH will continue to keep members apprised of all developments.

ASH Convenes Workshop on Thrombosis Surveillance
On June 12, ASH hosted a landmark Workshop on Thrombosis Surveillance assembling a group of 30 participants, including representatives from relevant federal agencies, patient groups, and the medical and public health communities. Experts from various subspecialties discussed their "front-line" perspective of dealing with venous thromboembolic disorders (VTE) and the group engaged in serious discussions identifying key questions that need to be answered through a surveillance system and scientific approaches that can best answer them. ASH worked closely with the Centers for Disease Control and Prevention (CDC) and the National Heart, Lung, and Blood Institute (NHLBI) in developing the workshop. Leaders from the CDC and NHLBI were among the discussants along with representatives from the National Institute on Aging (NIA), Office of the Surgeon General, and the Federal Aviation Administration (FAA).

Despite the large impact thrombosis has on the population, the United States has not yet developed a national surveillance system for thrombosis. ASH convened the workshop to better understand the scope and scale of the problem, with the ultimate goal of benefiting future research, prevention, and treatment of thrombosis.

Interest in thrombosis is also growing in the U.S. Department of Health and Human Services – the Surgeon General’s Office is expected to issue a "Call to Action" this year stating the U.S. is facing a major public health crisis regarding thrombosis; leadership at the CDC’s National Center on Birth Defects and Developmental Disabilities (NCBDDD) identified thrombosis as one of its top four priorities in 2008. The Society will share a summary of the meeting’s deliberations, key recommendations, and next steps as things move forward with these monumental efforts. The Society will also keep Grassroots Network Members apprised of advocacy opportunities related to these thrombosis initiatives.

NIH Announces Plan to Implement Peer Review Enhancements
NIH Director, Elias Zerhouni, MD, recently announced a plan to implement recommended enhancements to the NIH peer review process following a year-long examination of current peer review processes.

The details of the implementation plan were presented to Dr. Zerhouni at a June 6 meeting of the NIH's Advisory Committee to the Director (ACD). The plan addresses four major priority areas identified by a Working Group of the Advisory Committee to the NIH Director via comments submitted by the biomedical research community:

• Engage the Best Reviewers: Increase flexibility of service, formally acknowledge reviewer efforts, further compensate time and effort, and enhance and standardize training.
  
  
• Improve Quality and Transparency of Reviews: Shorten and redesign applications to highlight impact and to allow alignment of the application, review, and summary statement with five explicit review criteria, and modify the rating system.
  
  
• Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages:
  
  
  • Support a minimum number of early stage investigators and investigators new to NIH, and emphasize retrospective accomplishments of experienced investigators.
    
    
  • Encourage and expand the Transformative Research Pathway.
    
    
  • Create a new investigator-initiated Transformative R01 Award program funded within the NIH Roadmap with an intended commitment of a minimum of $250 million over five years.
    
    
  • Continue the commitment of – and possibly expand the use of – the Pioneer, EUREKA, and New Innovator Awards. NIH will invest at least $750 million in these three programs over the next five years.
    
    
  • Reduce the burden of multiple rounds of resubmission for the same application, especially for highly meritorious applications.
    
    
• Develop a Permanent Process for Continuous Review of Peer Review.

This "implementation phase" of the peer review enhancement process is expected to be carried out over the next 18 months. An ad hoc Peer Review Task Force, chaired by NIH Deputy Director, Raynard S. Kington, MD, will be formed to develop detailed plans and oversee initial implementation, and a new entity will be formed within the Division of Program Coordination, Planning and Strategic Initiatives to oversee Continuous Review of Peer Review. Dr. Zerhouni also announced a commitment by NIH to spend $1 billion over the next five years on investigator-initiated high-risk, high-impact transformative research as part of this implementation process

The announcement of the implementation plan is the culmination of a year-long review of the peer review process that sought the input of the biomedical research community "regarding NIH's support of the biomedical and behavioral research, including peer review, with the goal of examining the current system to optimize its efficiency and effectiveness." ASH submitted comments to NIH last year offering the Society's support of the peer review process and support of ways to encourage senior investigators to serve on study sections and ways to make the entire process less burdensome. ASH also submitted comments to NIH in March in response to the Final Draft of the NIH 2007-2008 Peer Review Self-Study, which marked "the end of the diagnostic phase of the peer review enhancement effort."

Additional information about enhancing peer review at NIH is available on the NIH Web site.

NIDDK to Host Workshop on Erythropoietin (EpoR) Expression and Function in Non-Hematopoietic Tissues
A two-day Workshop on Erythropoietin (EpoR) Expression and Function in Non-Hematopoietic Tissues, sponsored by the Hematology Program of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), will be held in Bethesda, Maryland, at the Doubletree Bethesda Hotel Meeting Center on September 8 and 9, 2008. This workshop will address evolving insights into the distribution and function of EpoR in non-hematopoietic tissues. The workshop will summarize clinical observations of non-hematopoietic erythropoietin (Epo) effects in patients with renal failure and solid tumors, and it will review experimental and clinical findings of Epo effects on the development, growth, and function of vascular endothelial cells, neoplasias, and cardiovascular and neural tissues. The program will include presentations by both invited speakers and speakers selected from submitted abstracts, together with poster presentations.

This workshop is designed to promote interactions and discussion among workshop participants and to define key unanswered questions and highlight priorities and directions for future research. A limited number of travel grants will be made available to registrants whose abstracts are selected for oral presentations at the workshop. Space will be limited, and so early registration is encouraged. Registrants who submit abstracts for presentation will be given preference if the number of registrants exceeds available space.

Individuals who wish to attend this workshop are invited to contact Amy Amerson of the Scientific Consulting Group at 301-670-4990 or via e-mail at aamerson@scgcorp.com. Additional information on the workshop may also be found on the NIDDK Web site.

House Passes Bill to Extend Visa Waiver Program
The U.S. House of Representatives passed legislation (H.R. 5571) in late May to reauthorize the Conrad State 30 J-1 visa waiver program, which directs foreign medical graduates to underserved areas within the United States, until June 1, 2013. The current authorization for the program expired on June 1, 2008.

In addition to extending authorization for the program, H.R. 5571 would also increase from five to 10 the number of "flex slots", which states can use to place non-primary care international medical graduates in facilities outside of federally designated health profession shortage areas, as long as the facilities serve patients who live in an underserved area.

A Senate bill (S. 2672) has also been introduced to reauthorize the Conrad State 30 J-1 visa waiver program permanently. The Senate bill also includes a number of reforms, such as a green card exemption to increase the number of physicians training and practicing in underserved areas. The Senate has not yet scheduled any action on either S. 2672 or H.R. 5571.