The ASN Policy Board presents the August issue of Renal Policy Express.
In This Issue...
- Regulatory Issues
Updates on anemia management and the use of erythropoeisis-stimulating agents (ESAs) and recent draft policies released by the Centers for Medicare & Medicaid Services (CMS).
- National Institutes of Health/Appropriations Update
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NIH asks for input on their peer review process, and we provide a summary of the latest actions regarding the 2008 Appropriations Bills.
- Congressional Actions
In this section, you can read about the State Children's Health Insurance Program (SCHIP) legislation that has been proposed in Congress. The House version includes ESRD provisions.
1.Regulatory Issues
FDA to Hold Meeting in September to Examine Anemia Drugs
The U.S. Food and Drug Administration (FDA) announced in the July 20, 2007 Federal Register that a joint meeting of the its renal and cardiovascular drug safety advisory committees will be held on September 11, 2007 to “discuss updated information on the risks and benefits of erythropoeisis-stimulating agents (ESA) when used in the treatment of anemia due to chronic renal failure.,” which the ASN will attend. The advisory committee scrutiny follows a March 2007 public health advisory that included adding a “black boxed” label warning on the risks of serious side effects with aggressive dosing of ESAs.
The ASN also attended a meeting with the FDA on April 26, 2007 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 black boxed warning. At this meeting, the renal community emphasized the fact that cancer patients and kidney disease patients have different needs and therefore their anemia treatment should be managed differently.
Medicare Has Announced Modifications to Its Claims Monitoring Policy for ESAs
The Centers for Medicare & Medicaid Services (CMS) has announced that it is strengthening its ESA Monitory Policy (EMP) for claims for ESAs used to treat anemia in Medicare beneficiaries who are receiving dialysis treatment for ESRD. These modifications are a results of several publications and the FDA black boxed warning and will provide greater restrictions on the dosage amounts of ESAs for which payment is made for patients with levels that rise above 13 g/dL. You can view the revised policy here. Public comments will be accepted until August 19, 2007.
Dr. Stuart Linas Makes Presentation at MedCAC Meeting
Dr. Stuart Linas, Chair of ASN's Hypertension Advisory Group, was recently asked to make a presentation at the summer meeting of the Medicare Evidence Development Coverage Advisory Committee (MedCAC) due to his expertise. Specifically, Dr. Linas was asked to present a review of an American Journal of Nephrology article: “Controversies in Renal Artery Stenosis” (2007;27:212-220). The meeting was held in Baltimore, MD and was additionally attended by Paul Smedberg, Director, Policy & Public Affairs for ASN.
CMS Releases Physician Fee Schedule for 2008
In early July, CMS released the “Medicare Program; Proposed Revisions to Payment Policies Under the Physician Fee Schedule, and Other Part B Payment Policies for Calendar Year (CY) 2008.” ASN staff worked to summarize the sections of the 900-page document that were most applicable to our membership and circulated those summaries to the Practicing Nephrologists and Dialysis Advisory Groups as well as the members of the Public Policy Board to receive their input. This feedback will be used to shape the ASN's submitted comments to CMS, due August 31, 2007. You can view the entire document here, under downloads (CMS-1385-P). ASN staff also attended a CMS briefing on the physician fee schedule that was held at the American Medical Association on July 24, 2007. Congress is currently considering legislation that will eliminate cuts for physicians in future years.
CMS Announces a Clinical Trials Determination and Alters Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) has announced the reopening of its clinical trail policy national coverage determination and has issued a proposed decision memorandum for public comment. CMS said that its proposal clarifies the standards that CMS believes are important to prevent safety and good outcomes. The two changes to the Clinical Trial Policy are:
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A clarification that Medicare will provide reimbursement for items and services used for a clinical research trial “if they would be covered outside of the clinical research trial” and
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The adoption of a “Coverage with Evidence” clause to provide Medicare payment for items and services in clinical research trials for which there is “some evidence of significant medical benefit, but for which there is insufficient evidence to support a ‘reasonable and necessary; determination” as long as the clinical trial meets requirements stated in the national coverage determination.
CMS plan to make a final determination and issue a final decision memorandum by October 19, 2007.
2.National Institutes of Health/Appropriations Update
NIH Establishes Working Groups to Examine Peer Review — Seeks Input from Research Community
National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., recently announced the formation of two working groups — one external, the other internal — to examine the NIH peer review process, with the goal of maximizing its effectiveness.
“Peer review is such a fundamental and critical part of the research process, that it requires our constant vigilance,” said Director Zerhouni. “With the increasing breadth and complexity of science, along with the increased number of research grant applications, we need to take a comprehensive look at our review process, and make the necessary changes to strengthen it for applicants and reviewers alike.”
The two new NIH working groups will seek input from the scientific community, including investigators, scientific and medical societies, grantee institutions, voluntary health organizations, and from within NIH. At a recent NIH-sponsored meeting to discuss this issue, participants recommended a number of ways to address these challenges of peer review at NIH.
To read a summary of the meeting from the Alliance of Academic Internal Medicine (AAIM), please click here.
The ASN's Basic Science and Clinical Research Committees will respond (on behalf of the Society) to NIH's Request for Information (RFI). We also strongly encourage our members to respond to the NIH request on ways to improve the peer review system. For detailed information and access to the comment form, please visit NIH's RFI Web-site.
To read about the NIH Director's Advisory Committee click here.
Appropriations Update
The Fiscal Year (FY) 2008 House Labor, Health and Human Services, and Education bill passed in the House of Representatives with a vote of 276 to 140. Fifty-three Republications voted for the bill; one Democrat voted against it. Fifteen Members did not vote. House Appropriations Chairman Obey met with representatives of nearly 200 health, education and workforce groups (including the ASN) on August 2, 2007, to express thanks for our efforts and to urge continued work to support he Labor-HHS-Education bills.
The bill will have an uphill battle in the Senate after the August recess. With the looming veto threat, expectation of another supplemental funding request in September for the Iraq war, and the likely need to respond to a key report on the progress of the Iraq war and the recent surge effort that will be issued in September, Majority Leader Reid has expressed doubt as to whether time can be devoted to the Labor-HHS-Education bill. It is possible that it will be wrapped up into either a giant omnibus appropriations bill or a mini-bus made up of two or three separate bills.
The National Center for Research Resources Solicits Input for Strategic Plan
The National Center for Research Resources (NCRR) is soliciting comments regarding its new Strategic Plan to cover the 5-year period from 2009-2013. NCRR strives to ensure that the agency remains responsive to the emerging needs of biomedical researchers. The new plan will provide a framework to strengthen and integrate NCRR's matrix of research programs. Comments must be submitted by August 24, 2007. You can provide your input here.
Op-Ed in Washington Post Addresses Lack of Research Scientists
A recent opinion piece in the Washington Post discussed the impact that the lack of increases to the NIH budget is starting to have on the recruitment of research scientists. You can read the article here.
3.Congressional Actions
State Children's Health Insurance Program (SCHIP) Legislation
SCHIP, a state-federal partnership that covers about 6 million children from low-income families that are not poor enough for to qualify for Medicaid, is scheduled to expire on September 30, 2007 if congressional action is not taken. Both the Senate and House of Representatives are expected to pass legislation to expand this program.
In the Senate, a broad bipartisan plan to expand the State Children's Health Insurance Program (SCHIP) with funding from an increase in the cigarette tax was approved by the Senate Finance Committee on Tuesday, July 10, 2007 (S 1893). Under the agreement, funds for the program would increase by $35 billion over five years and would be paid for with a 61-cent increase in the 39-cent federal cigarette tax. At this point, for the bill to be brought to the Senate floor, supporters will have to win a cloture vote.
The House version of the SCHIP bill (HR 3162) is dubbed the “Children's Health and Medicare Protection (CHAMP) Act.” It includes three major components: a $50 billion expansion of the SCHIP, a provision to avert the scheduled 10 percent cut in Medicare rates for physicians in 2008, and other Medicare provisions, such as an increase in reimbursement rates for rural health providers in 2008 and more generous subsidies to low-income beneficiaries. It also has ESRD provisions including education initiatives, training for dialysis technicians, an adjustment in payments for ESAs for large dialysis organizations, the development of an ESRD bundling system, and a mandate for a report by the Health and Human Services Office of the Inspector General on anemia management dosing guidelines. The bill also calls for cuts to Medicare's ESRD benefit. Kidney Care Partners (KCP) has composed a press release speaking against these cuts, which you can read here.
Costs would be offset by cuts to Medicare Advantage and a 45-cent increase in the cigarette tax. The ASN has joined the AARP and AMA in support of the bill. You can read a summary of the bill here.
The House Ways and Means Committee approved the bill on July 27, 2007. The legislation was then sent to the Energy and Commerce Committee, where voting was blocked by Republicans. The committee's chairman, John D. Dingell (D-MI), ultimately gave up and left the bill to be discharged by a parliamentary tactic.
Even if the bill is passed in both the House and Senate and agreed upon in a conference committee, President Bush has threatened to veto the bill based on the large financial cost. Some House Republicans have also echoed a Bush criticism that SCHIP's expansion is a step toward Democrats' ultimate goal of a system of socialized medicine.
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
