The ASN Policy Board presents the October issue of Renal Policy Express.
In This Issue...
- ASN Public Policy Update
ASN Public Policy Board Plans Effort for World Kidney Day 2008.
- Regulatory Issues
Updates including FDA changes for ESA labels, ESRD payment reform, and a GAO report on Kidney Transplant Recipients.
- National Institutes of Health
Lucy Greene Appointed Executive Officer of NIDDK, new NIH grant funding, and Spanish health materials on the NIDDK website.
- Congressional Actions
Learn about the latest legislation and hearings.
- Other
Fistula First Launches New Website
1. Policy Board Update
ASN Public Policy Board Plans Effort for World Kidney Day 2008
World Kidney Day is scheduled for March 13, 2008. Last year, the ASN Policy Board brought 11 nephrologists to Washington, D.C. for a busy day with more than 40 meetings on Capitol Hill.
For 2008, the ASN Public Policy Board plans to increase the organization’s efforts to raise the awareness of kidney disease, to advocate for increased research funding, and to address various regulatory issues that could impact the practice of nephrology by including more ASN members from a larger number of states. Health and appropriations committee members and champions for the importance of kidney disease on the Hill will be the main targets for visits.
We are encouraging interested society members who are willing to make Congressional visits on behalf of the ASN to contact us at 202-416-0646 or policy@asn-online.org. We would also encourage ASN members to become involved by making visits to local Congressional district offices prior to or on World Kidney day. The ASN will provide interested members with materials reflecting our professional advocacy goals. We are also planning to provide a slide set on chronic kidney disease (CKD) to be used for Grand Rounds and local community outreach around the time of World Kidney Day. You will hear more about specific ASN World Kidney Day activities in the coming weeks.
2. Regulatory Issues
FDA Changes ESA Labels
The Food and Drug Administration has announced changes to erythropoietin stimulating agents (ESA) labels. The revised wording indicates that ESAs should be used to maintain a hemoglobin level between 10 and 12 grams per deciliter in patients with chronic kidney failure. The label also provides dosing instructions for non-responsive patients. To view the FDA news release, click here: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01740.html.
Medicare Payment Advisory Committee Discusses ESRD Payment Reform
The Medicare Payment Advisory Committee (MedPAC) held a public meeting on November 8, 2007. A portion of the agenda focused on improving dialysis quality and efficiency. Discussion points related to ESRD payment reform included the extension of Medicare as a Secondary Payor (MSP) and chronic care special needs plans (SNPs). Click here to view a summary prepared for Kidney Care Partners. Paul Smedberg, ASN’s Director, Policy & Public Affairs, attended this meeting.
Government Accountability Office Issues Report on Kidney Transplant Recipients
A Government Accountability Office (GAO) report released in November found that transplant recipients who were under 18 when transplanted but are now adults (transitional recipients) are more likely than their pediatric and adult counterparts to experience a transplant failure and subsequently receive dialysis. The GAO also found that the percentage increase of transplant failures from 1 year to 3 years post transplant for transitional recipients cannot be attributed to an inability to access medications due to a lack of Medicare coverage.
To reach these conclusions, the GAO analyzed United States Renal Data System (USRDS) data from 1997 to 2004 and interviewed officials from pediatric transplant centers. The study, entitled Characteristics of Kidney Transplant Recipients, Frequency of Transplant Failures, and Cost to Medicare (GAO-07-1117) was conducted in response to calls to Congress from the American Society of Pediatric Nephrology (ASPN) and the American Society of Transplantation (AST) asking for further evaluation of post-transplant care in the pediatric and young adult kidney disease populations. Highlights can be seen here: http://www.gao.gov/highlights/d071117high.pdf and the entire report can be viewed here: http://www.gao.gov/new.items/d071117.pdf.
3. National Institutes of Health
Lucy Greene Appointed Executive Officer of NIDDK
Lucy Greene has been appointed executive officer of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK). She will advise the NIDDK director and other senior officials on all phases of administrative management involved in operating the institute in support biomedical research. Dr. Greene has served as the deputy executive officer at NIDDK since April of 2006 and as acting executive director since April 2007. To read the official news release from NIH, please visit: http://www.nih.gov/news/pr/nov2007/niddk-13a.htm.
New NIH Grants Fund Investigators Developing New Technologies
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has announced the award of four grants totaling more than $12 million to support research and development of potentially high-impact, innovative technologies to advance health care. One of the grants was awarded to Shuvo Roy, PhD, a researcher at Cleveland Clinic Lerner College of Medicine. He was awarded $3.2 million over 3 years to develop a miniaturized, implantable, and self-regulating bio-artificial kidney that would replace dialysis machinery. For more information, please visit: http://www.nih.gov/news/pr/oct2007/nibib-04.htm.
NIDDK Website Now Includes Spanish Health Materials and Resources
NIDDK has launched three new portals to feature Spanish health materials and resources on its website. Resources include 40 diabetes-related publications, 10 publications about digestive diseases, and 18 kidney and urologic publications in Spanish. Future additions will include one-page fact sheets. The NIDDK website also links to the Spanish portals for MedlinePlus and the National Kidney Disease Education Program (NKDEP). The new Spanish portal on kidney and urologic diseases is available at: http://www.kidney-espanol.niddk.nih.gov.
4. Congressional Actions
Kidney Care Partners Congressional Briefing
The Kidney Care Partners (KCP) is sponsoring an educational briefing to educate congressional members and staff about the importance of modernizing End Stage Renal Disease (ESRD) policy. The briefing, to be held on Tuesday, December 4, will emphasize improved patient education, quality and prevention initiatives, use of fistulas to improve care and outcomes, standardized training of technicians, annual update for providers and extension of the current period when Medicare is the secondary payer from 30 to 42 months.
The Kidney Care Quality and Education Act of 2007 (S. 691 and H.R. 1193) (KCQA) will be discussed, as well as the community’s perspective on much needed reform during this time of debate on Capitol Hill. ASN is a member of KCP.
The Senate Finance Committee will likely consider KCQA in early December as part of a larger Medicare reform bill.
Labor-Health-Education Appropriations
On November 13, 2007, President Bush vetoed H.R. 3043, the Fiscal Year 2008 appropriations bill for the Departments of Labor, Health and Human Services, and Education. This bill would have increased funding for the National Institutes of Health and the Centers for Disease Control. The ASN, along with many organizations, submitted at letter in support of this legislation, which you can view here.
Two days later, the House of Representatives attempted to override the veto. During the debate, Representative Dave Obey (D-WI), Chairman of the House Appropriations Committee and the Labor-Health-Education Subcommittee, delivered a statement warning of possible outcomes if the override vote failed. You can read that statement here: http://appropriations.house.gov/pdf/LaborHVetoOverrideStatement11-15-07.pdf. Several Republican legislators were influenced by the effort by the bio-medical community (including ASN) that urged them to vote for the override, but the vote fell just short of the two-thirds majority necessary.
Congress returned from the Thanksgiving recess on December 3, 2007. The ASN Policy Board will continue to monitor the situation and keep you informed of the next steps in the appropriations process. We also appreciate the response of the ASN membership to the recent email advocacy alert that was sent out regarding this appropriations bill.
5. Other
Fistula First Launches New Website
The AV Fistula First Breakthrough Coalition (FFBI), of which ASN is a member, has launched a new, more user-friendly website. Click here to view it: http://www.fistulafirst.org.
We hope that you have enjoyed this version of ASN's Renal Policy Express. Please refer any questions or comments regarding this newsletter to policy@asn-online.org.
Paul Smedberg, Director, Policy and Public Affairs
Susan Owens, Senior Policy Coordinator
