The ASN Policy Board presents the June issue of Renal Policy Express.
In This Issue...
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Policy Board Update
Read about the ASN Public Policy Board's formation of an Anemia Management Working Group.
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Regulatory Issues
This section provides an update on anemia management, Medicare ESRD Payment Reform, and the Physician Quality Reporting Initiative.
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Other Congressional Actions
A brief update on the Fiscal Year 2008 Budget Resolution.
1. Policy Board Update
Formation of Anemia Management Working Group
In response to the current controversy surrounding anemia management and erythropoiesis stimulating agents (ESAs), the ASN Public Policy Board has formed an Anemia Management Working Group. This group will have the ability to respond quickly to new developments and address requests for information from the press and Congress. They will work together to help formulate ASN's position on this issue. The membership of this group includes: Arnie Berns, Joan Blondin, John Burkart, Connie Davis, William Harmon, Jonathan Himmelfarb, Tom Hostetter, Brian Pereira, and Lynda Szczech.
2. Regulatory Issues
Anemia Management
Over the last month, several articles related to anemia management in kidney disease patients have been published by major news outlets. They include the following:
LA Times: “FDA to Assess Anemia Drugs”
New York Times: “Doctors Reap Millions for Anemia Drugs”
New York Times (editorial): “Reforming the FDA”
Wall Street Journal (editorial): “Amgen, J&J Might Face Limits on Anemia Drugs”
Besides the treatment of anemia in kidney disease patients, ESAs are also used to treat anemia in cancer patients. On April 26th, ASN was present at a meeting at which the American Association of Kidney Patients (AAKP), the Renal Physicians Association (RPA), and the National Kidney Foundation (NKF) expressed concerns regarding the FDA's recent block boxed warning and to emphasized the fact that cancer patients and kidney disease patients have different needs and therefore their anemia treatments should be managed differently. The FDA is expected to hold a renal-specific meeting on ESAs in September 2007.
You can read the ASN's statement on the FDA's black boxed warning here.
On May 14th, CMS released a “Proposed Decision Memo for Erythropoiesis Stimulating Agents” (ESAs) for non-renal disease indications (CAG-00383N). While this doesn't apply to kidney disease patients, it still gives the renal community an indication of how CMS is approaching concerns surrounding ESAs. For instance, the memo states that the hemoglobin/hematocrit levels immediately prior to initiation of dosing for the month should be less than 9g/dl in patients without known cardiovascular disease. This proposed national coverage decision (NCD) was made in response to the FDA's black box warning regarding the use of ESA's.
You can view this memo here.
Senator Grassley (R-IA), Ranking Member of the Senate Finance Committee, sent letters to the FDA and Amgen regarding the use of ESAs, which you can view here, as well as a letter to the Center for Medicare & Medicaid Services (CMS), which focused on ESRD and included questions about bundling and quality. You can read that letter here.
Medicare ESRD Payment Reform
Congress has not comprehensively re-examined the Medicare ESRD payment system since its inception in the mid-1980s and there are many issues that could be addressed and reformed. Kidney Care Partners, of which ASN is a member, plans to send a letter to Representatives Stark and Camp, Chairman and Ranking Member, respectively, of the House Ways and Means Subcommittee on Health, expressing interest in working with the committee to address these issues.
The Kidney Care Council (KCC) is a coalition of 11 renal care companies which includes DaVita and Fresenius. This group was formerly called the Renal Leadership Council (RLC). KCC recently released a statement endorsing reforms of the ESRD payment system. You can read their statement here.
Recent articles in Congressional Quarterly Today detailed Chairman Stark's commitment to find ways to cut Medicare to fund other Democratic policy priorities including covering more uninsured children and blocking payment cuts to doctors. The articles stated that Chairman Stark hoped to start talks on a package of Medicare payment cuts after the Memorial Day recess.
Physician Quality Reporting Initiative
On December 20, 2006, the President signed the Tax Relief and Health Care Act of 2006 (TRHCA). Section 101 under Title 1 authorizes the establishment of a physician quality reporting system by CMS. CMS has titled the statutory program the Physician Quality Reporting Initiative (PQRI).
The quality reporting program will begin on July 1, 2007. Doctors who choose to join the effort will be eligible for a 1.5% bonus on all of their Medicare reimbursements for the last six months of the year. To participate, physicians must consult the CMS-approved list of 74 quality measures to decide how many to report and determine how many of their Medicare patients fit into those categories. To be eligible for the bonus, doctors must report on at least three measures and apply each one to at least 80% of the patients who fit the category.
CMS has announced that it will provide additional tools in early June to assist physicians participating in the program. The tools will include a coding manual as well as a link to the American Medical Association (AMA) website for individual coding worksheets for each measure. These AMA developed worksheets will assist physicians and their staff in selecting measures and reporting appropriate codes for the PQRI. We will send out information regarding the worksheets once they have been finalized and posted by CMS.
To learn more about the program click here.
3. NIH/Research Related Issues
The ASN joined with dozens of other medical organizations to advocate for a 6.7% increase in funding for the National Institutes of Health in the Fiscal Year 2008 Appropriations bills. An increase of this size for each of the next three years would restore the purchasing power lost to NIH since 2003.
The ASN, as part of the Coalition for Health Funding, joined with dozens of other medical societies to advocate for this increase. You can read our letter here.
The Washington Times published on editorial on May 4, 2007, entitled “Unhealthy Cuts.” This editorial emphasizes the need to restore NIH to its full funding level. You can read it here.
An article in the May 29th edition of the Washington Post, entitled “Drop in NIH Funding Could Take Toll on Research,” also addressed cuts in funding for medical research. You can read that article here.
4. Other Congressional Actions
Fiscal Year (FY) 2008 Appropriations Update
The FY 2008 budget resolution has been passed by the House and Senate. The conference agreement assumed $54.965 billion for function 550 discretionary, which is $2.9 billion above FY 2007 (+5.5%) and $3.0 billion above the President's budget (+5.8%). Non-defense discretionary is $450 billion excluding supplemental, which is $23 billion above FY 2007 and $21 billion above the President's request. ASN has joined with the larger health community in a request for a 6.7% increase in funding for the National Institutes of Health.
The report is available on the rules website.
The House Appropriations Committee gave formal approval to its 302(B) subcommittee allocations for FY 2008 on Tuesday, June 5th. The Labor, Health and Human Services, and Education Subcommittee received an allocation of $151.5 billion in discretionary funding for the agencies and programs under its jurisdiction. This is an increase of $6.9 billion (4.6%) over FY 2007 levels and $10.6 billion (7.5%) more than the President Bush's FY 2008 budget request. With mandatory funding, the bill totals $607 billion.
The draft FY 2008 spending bill was approved by the subcommittee on Thursday, June 7. Of interest to the ASN, the National Institutes of Health (NIH) will receive $29.65 billion; an increase of $750 million (2.6%) above the current year's funding level and $1.029 billion (3.6%) above the President's request. The Centers for Disease Control (CDC) will receive a total of $6.6 billion, a 4 percent increase of FY 2007 and $366 million more than President Bush's request. The Health Information Service, of which the National Center for Health Statistics is a part, would receive $254 million; a $31 million increase of FY 2007. The bill also increases the amount of the transfer from the NIH to the Global HIV/AIDS fund from $99 million in FY 2007 to $300 million in FY 2008.
Full committee consideration of the bill scheduled for Thursday, June 14. House floor action will tentatively take place the following week.
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
