Hello and welcome to the most recent edition of Renal Policy Express, sent on behalf of the ASN's Public Policy Board.
In This Issue...
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Policy Board Update
Learn more about the ASN Public Policy Board's advocacy efforts for World Kidney Day.
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Regulatory Issues
ASN provides information on the recent debate surrounding anemia management.
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NIH/Research Related Issue
ASN updates members on congressional passage of the NIH re-authorization bill, NIH Director Zerhouni's appearance at Renal Week, and the new NIH RO1 grant application process.
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Other Congressional Actions
This section addresses final nephrology-related actions of the 109th Congress.
1. Policy Board Update
World Kidney Day
The ASN Public Policy Board is in the process of planning an advocacy effort for World Kidney Day (March 8, 2007). The Board and ASN will be partnering with the National Kidney Foundation to bring physicians and patients together to raise awareness in Congress of kidney disease and its effects on the United States population. The effort will target key committee and caucus members and may include a luncheon for staffers.
You can learn more about World Kidney Day here.
To enhance this effort and similar efforts in the future, the Policy Board is creating a Research Advocacy Toolkit. This useful tool will include fact sheets, brochures, and PowerPoint presentations that can be used when talking to Congress, NIH, CMS, and the media. The ASN is enlisting the help of a marketing firm to help create a cohesive and polished resource for our members. The toolkit will include information on kidney disease research and public health issues related to chronic kidney disease and transplantation.
2. Regulatory Issues
Anemia Management
The results of the CHOIR and CREATE studies, two recent clinical trials published in the New England Journal of Medicine in November, have prompted discussion regarding current guidelines for the prescription of recombinant human erythropoietin (EPO) and the maintenance of hemoglobin levels in dialysis patients.
In the CHOIR study, presented at Renal Week in San Diego, results indicate that kidney disease patients not yet on dialysis targeted to have a hemoglobin level of 13.5 grams per deciliter may have an increased risk for cardiovascular morbidity and death compared to patients targeted to achieve a level of 11.3 grams per deciliter. In the CREATE Trial, also presented at Renal Week, there were no significant differences in cardiovascular outcomes between patients targeted to hemoglobin 10.5-11.5 and patients targeted to 13.0-15.0 grams per deciliter.
The current CMS EPO Monitoring Policy provides full reimbursement for hemoglobin levels up to 13 grams per deciliter, and requires documentation of a reduction in dose for full reimbursement if the hemoglobin is above 13 grams per deciliter.
At a recent House Ways and Means Committee hearing, attended by ASN staff, CMS defended this policy. Leslie Norwalk, Acting Administrator of CMS, explained that the higher hemoglobin monitoring level on CMS' reimbursement policy is necessary to cover variability that can occur from patient to patient and the time (2-6 weeks) that it can take for a hemoglobin level to be corrected through a change in EPO dosage. This policy differs from the current Food & Drug Administration label, which recommends that patients' hemoglobin levels be maintained below 12 grams per deciliter.
The Government Accountability Office (GAO) released a report on December 6, 2006, entitled “End-Stage Renal Disease: Medicare Payments for All ESRD Services, Including Injectable Drugs, Should Be Bundled.” You can read that report here.
The ASN believes that it is essential for the renal community to continue examining all available scientific data to ensure that public policies reflect appropriate anemia management for kidney disease patients. We will continue to work with Congress and CMS to ensure that Medicare policy reflects the best science and ensures the welfare of patients.
3. NIH/Research Related Issues
Congress Passes NIH Re-authorization Bill
In the wee hours of their last morning in session, the 109th Congress passed the “National Institutes of Health Reform Act of 2006.” The bill is now on its way to the President for his signature. It re-authorizes the NIH through 2009.
Key provisions of the bill include an increase in overall funding authorization, the creation of an agency-wide reporting system for NIH research, a scientific management review board to evaluate the structure of NIH at least once every seven years, and a limit on the size of NIH (to 27 institutes and centers).
The bill also establishes a “Common Fund” to promote trans-NIH research. Institutes, centers, and independent investigators can compete for these funds. Moving forward, the amount reserved for the common fund may not be less than the percentage reserved during the previous fiscal year. Once it reaches 5% of the total NIH budget, the Director of the NIH, in consultation with an advisory council, must submit recommendations to Congress on changes to the amount reserved for the common fund.
You can read Dr. Zerhouni's statement regarding this bill here.
Dr. Elias Zerhouni, Director of the National Institutes of Health at Renal Week
The ASN was privileged to have Dr. Zerhouni as a guest speaker during Renal Week. His presentation centered around research at the NIH. You can view his presentation here.
The Policy Board would like to thank everyone who attended this talk. We hope that you found it helpful and informative.
NIH R01 Grant Applications Go Electronic
Beginning with the February 5, 2007 standard receipt date, all Research Project Grant R01 applications must be submitted electronically. Paper applications will no longer be accepted. To ensure a smooth transition, NIH is strongly encouraging all potential principal investigators to contact their central grants offices immediately to learn how their institutions are handling these application form and process changes.
Information on the submission process and additional training and promotional resources are available here.
You can read the press release about this change here.
4. Other Congressional Actions
In another piece of legislation just before the 109th Congress came to a close, an agreement was reached to approve the 2006 Tax Relief and Health Care Act. The legislation will maintain the current level of Medicare physician reimbursement for 2007 and provide a 1.5 percent increase in reimbursement to physicians who report data on quality measures as of July 1, 2006.
And finally, passage of the FY 2007 appropriations bills (which fund the NIH, CDC, AHRQ, and NSF), was deferred until next year. Congress passed a continuing resolution (CR) that will maintain funding for these organizations until February 15, 2007.
For more information on the NIH reauthorization and the physician reimbursement legislation, click here.
And Finally,
We hope that you have enjoyed this version of ASN's Renal Policy Express. Past issues will be archived on the ASN website for your reference. Please refer any questions or comments about material from this newsletter to policy@asn-online.org.
Paul Smedberg , Director, Policy and Public Affairs
Susan Owens, Policy and Public Affairs Coordinator
