Hello and welcome to the latest 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 about the ASN Public Policy Board's advocacy efforts for World Kidney Day.
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Regulatory Issues
Read about the FDA's recent warning for Erythropoiesis-Stimulating Agents.
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NIH/Research Related Issues
This section details Fiscal Year 2008 Appropriations, the NIH Director's New Innovator Award, and the National Kidney and Urologic Diseases Information Clearinghouse Coordinating Panel Meeting.
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Other Congressional Actions
This section provides updates on current nephrology-related and budgetary legislation.
1. Policy Board Update
World Kidney Day Update
On March 8, 2007, The ASN Policy Board brought 11 nephrologists to Washington, D.C. in recognition of World Kidney Day. These physicians attended more than 40 meetings on both the House and Senate sides of Congress in an effort to raise the awareness of kidney disease as a public health issue and to stress the need for an increase in funding for research. They were accompanied by patient representatives from the National Kidney Foundation and DaVita Patient Citizens. The shared message of the doctors and patients seemed to resonate well with Congressional offices and committee staff.
On behalf of the ASN Policy Board, we would like to extend our thanks to the following ASN participants: Peter Aronson, Tomas Berl, Chip Brosius, Eric Cohen, Tom Coffman, Lance Dworkin, Tom Hostetter, John Stokes, Lynda Szczech, and Don Wesson. They are to be commended for their enthusiasm and informed effort.
In conjunction with the Hill visits, the ASN released print and radio press releases around the country. The audio news release, recorded by ASN President Dr. Bill Henrich, was especially effective as it was picked up by more than 3,000 stations, reaching more than 10 million listeners.
You can read the national print press release here.
2. Regulatory Issues
FDA Revises Product Labeling For Erythropoiesis-Stimulating Agents (ESAs)
The U.S. Food and Drug Administration (FDA) has issued a Black Boxed Warning for ESAs. Black Boxed Warnings are used by the FDA on drug labels to warn users of serious risks that can happen when using a drug product. This particular warning was issued because of recent studies that showed an increased risk of death, blood clots, strokes, and heart attacks in patients with CKD (not on dialysis) who used ESAs to treat anemia.
The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). The revisions include modifications to the dosing instructions, updated warnings, and a new boxed warning that advises physicians to monitor hemoglobin and to adjust the ESA dose to maintain the lowest heomoglobin level needed to avoid the need for blood transfusions.
You can read the complete press release from the FDA here.
In light of these new warnings, the Centers for Medicare & Medicaid Services (CMS) is reviewing its Medicare policies relating to the administration of ESAs, including its Erythropoietin (EPO) monitoring policy for patients with ESRD, and who are dialyzed in renal facilities. The current Medicare benefit policy is consistent with the National Kidney Foundation and current kidney disease industry guidelines to maintain a target hemoglobin level in the range of 10 g/dl to 12 g/dl (grams per deciliter). CMS initiates a payment reduction if the hemoglobin exceeds 13 g/dl unless the provider provides information with the claim that the dosage has already been reduced.
The ASN will continue to monitor this issue with the rest of the renal community. You can read our statement here.
The response from the National Kidney Foundation may be of interest to you as well, due to its patient focus. You can read their response here.
3. NIH/Research Related Issues
Fiscal Year (FY) 2008 Appropriations
The ASN joined with other medical organizations in support of a FY 2008 increase of at least 6.7% over the FY 2007 Joint Resolution level for the National Institutes of Health. Letters stating this request were submitted to the Labor, Health and Human Services, and Education and Related Agencies Appropriations Subcommittee in mid-March. An increase of 6.7% would restore the funding lost to NIH since 2003.
Reps. Markey (D-MA), Reichert (R-WA), Schakowsky (D-IL), Shays (R-CT), Smith (R-NJ), and Waxman (D-CA) circulated a bipartisan “Dear Colleague” letter seeking congressional sign-ons for a letter to House Appropriations Chair David Obey (D-WI) and Ranking Member Jerry Lewis (R-CA) in support of a 6.7% increase in NIH funding for each of the next three years.
You can read that letter here.
The Subcommittee held a hearing on NIH funding on March 19, 2007. You can read a summary of that hearing here. It was attended by Susan Owens from the ASN staff and the summary was provided by Jon Retzlaff, Director of Legislative Relations for the Federation of American Societies for Experimental Biology (FASEB) and a member of the Ad Hoc Group for Medical Research Executive Committee. Paul Smedberg, ASN Director, Policy & Public Affairs, also serves on this committee.
The Acting NIDDK Director, Dr. Griffin Rodgers, will be testifying on an NIH panel at a follow-up theme hearing on chronic diseases sometime in April.
With regard to other budgetary issues, the ASN added its name to letters requesting $350 million for the Agency for Healthcare Research and Quality (AHRQ) and $117 million for the National Center for Health Statistics (NCHS). You can view those letters here, and here.
NIH Director Launches Program for Innovative New Investigators
On March 9, 2007, NIH Director Elias A. Zerhouni, MD, announced a special program to fund new investigators who propose highly innovative research projects that could have an exceptionally great impact on biomedical or behavioral science. The NIH Director's New Innovator Award offers grants of up to $1.5 million in direct costs over five years.
The application period for these grants lasts from April 25, 2007 to May 22, 2007. To be eligible, applicants must be new investigators who have not yet obtained an NIH R01 or similar grant. They must hold an independent research position at an institution in the United States and must have received a doctoral degree or completed a medical internship and residency in 1997 or later.
Application instructions are here.
For more information, go here.
ASN Staff Attends NKUDIC Coordinating Panel Meeting
The National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC) Coordinating Panel meets yearly to learn about Clearinghouse programs, provide guidance for upcoming projects, share news about panel members' organizations, and network with representatives from professional and voluntary organizations concerned about kidney and urologic diseases. This year, the meeting was held on March 23, 2007 and was attended by Paul Smedberg and Susan Owens from the ASN staff.
4. Other Congressional Actions
Current Nephrology Legislation
Bills have been introduced by Sen. Blanche Lincoln (D-AR) and Susan Collins (R-ME) (S.432) and Rep. Mark Kirk (R-IL) and Jim McDermott (D-WA) (H.R.1245) to establish a pre-dialysis education benefit. The Senate bill was introduced on January 30, 2007 and the House version of the bill was introduced on February 28, 2007. The goal of these bills is to educate kidney disease patients about dialysis and transplant options prior to complete loss of kidney function, and to help them manage co-morbidities and to prepare for the financial and emotional issues associated with kidney failure. The National Kidney Foundation is the primary organization supporting this bill.
You can read a summary of this legislation here.
The Kidney Care Quality and Education Act, supported by the Kidney Care Partners, includes a provision for a pre-dialysis education benefit, but goes further. This bill also seeks to establish a three-year Continuous Quality Improvement Initiative as well as uniform training for patient care dialysis technicians, and requests that Congress provide an annual update for the dialysis payment based on the CMS ESRD market basket. It was introduced on February 27, 2007.
You can read more about this bill here.
Budget Resolution Update
The total provided for (public health) Function 550/discretionary Budget Authority under the Senate Budget Committee Fiscal Year (FY) 2008 Budget Resolution is $54.815 billion. This is $2.717 billion higher than the final FY 2007 amount of $52.098, an increase of 5.2%. While not the $4 billion, 7.8% increase the broad health community pushed for, it is quite good. It is better than the overall domestic discretionary amount provided in the measure, which is $18 billion over FY 2007 and a 4.2% increase. The overall amount is double the 2.1% Congressional Budget Office inflator for FY 2008.
The budget resolution is the first step in Congress to determine budget allocations for Appropriations Committee consideration.
Legislation to Increase Medicare Resident Caps Is Introduced in House and Senate
The Resident Physician Shortage Reduction Act (S.588/ H.R.1093) would allow teaching hospitals in states that have resident physician to 100,000 population ratios below the national median to be eligible to increase their resident caps, pending an allocation method determined by the Secretary of Health and Human Services. According to the bill's formula, this would affect teaching hospitals in 24 states.
The Secretary is required to take into account whether the hospital will be able to fill the positions over a 3-year period and whether the filled positions would be in primary care, preventative medicine, or geriatrics. The total number of additional cap clots granted could not exceed 24 percent of the number of residents needed to raise that state to the national median. This legislation would allow approximately 1,200 additional cap slots to be added to the national resident limit. Increases in the number of positions eligible for federal funding would be phased in over a 5-year period.
You can read a summary of the bill here and a “Dear Colleague” letter here.
ASN Endorses FOVA's Fiscal Year (FY) 2008 Appropriations Recommendations
For FY 2008, to keep pace with biomedical research inflation, the Friends of VA Medical Care and Health Research coalition (FOVA) has increased its recommendations for the VA Medical and Prosthetics Research Program to $480 million. This is an increase of $68 million over the likely FY 2007 appropriation. In addition, FOVA is calling for a $45 million appropriation in the VA Minor Construction account to improve research facilities. ASN has endorsed these requests.
You can read an explanation for these requests 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
