The ASN Policy Board presents the May issue of Renal Policy Express.
In This Issue...
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Policy Board Update
Listen to the ASN's radio spot and view pictures from World Kidney Day.
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Regulatory Issues
Read about new guidelines for clinical trials, an update for anemia management, quality of life measures, new standards for transplant centers, and the status of drug negotiation legislation.
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NIH/Research Related Issues
Learn about Griffin Rodgers, MD, newly named Director of the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) and read his testimony from a recent Senate subcommittee meeting.
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Other
Outlined here are recent studies regarding EPO dosages, the Stem Cell Research Enhancement Act of 2007, and a Morbidity and Mortality Weekly Report examining Chronic Kidney Disease.
1. Policy Board Update
World Kidney Day Update
As we mentioned previously, 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. 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 listen to this radio spot here.
You can view pictures from World Kidney Day on the ASN website, here.
2. Regulatory Issues
Medicare Proposes Revised Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) announced on April 10th its proposed revisions to the Clinical Trial Policy national coverage determination (NCD). The revisions were proposed by the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) and reviewed by a federal panel led by the Agency for Healthcare Research and Quality (AHRQ). The federal panel also included representatives from CMS, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH).
The proposed revisions include:
- Renaming the policy as the Clinical Research Policy;
- Adding FDA post-approval studies and coverage with evidence development (CED) to studies that would qualify under this policy;
- Requiring all studies to be registered on the NIH ClinicalTrials.gov website before enrollment begins; and
- Requiring studies to publish their results.
You can read more about the proposed changes here.
The proposed NCD will have a 30-day comment period after which CMS will review all the public comments and suggestions received and incorporate them into a final NCD. This final version will be published no later than sixty days after the end of the comment period. The revised policy will be effective with the publication of the final NCD.
NKF Work Group Releases Draft Update
The National Kidney Foundation—Kidney Disease Outcomes Quality Initiative™ (KDOQI™) work group, after reviewing new information about anemia management in chronic kidney disease (CKD), issued a draft update to its 2006 Clinical Practice Guidelines on Anemia and CKD. The draft is being sent to over 1000 stakeholders for review and comment, prior to being finalized and published.
A key aspect of the new update is that the work group was able to clarify key aspects of a Hemoglobin (Hb) target for patients receiving Erythropoiesis Stimulating Agent (ESA) therapy. In the new statements, the work group recommends what factors should be considered in selecting a Hb target and states that the selected Hb target should generally be in the range 11.0 to 12.0 g/dL. The Workgroup points out that because of natural fluctuations, actual Hb results will vary widely from Hb targets.
The NKF Press release describing the draft guideline can be read here.
Kidney Care Quality Alliance Submits Guidelines
On April 11, the Kidney Care Quality Alliance submitted the final adult clinical and quality of life measures to the National Quality Forum for endorsement as part of its National Voluntary Consensus process for ESRD measures. This submission marks an important milestone for the kidney care community. The Kidney Care Quality Alliance appreciates everyone's help and support in making this achievement possible.
Bundled ESRD Payment Raised
The issue of a bundled payment for ESRD services appeared once again on Capitol Hill. Senate Finance Committee Ranking Member Charles Grassley (R-IA), in a list of amendments to the Medicare Part D drug price negotiation legislation, proposed a bundled payment system for ESRD effective upon enactment. Kidney Care Partners (KCP) reacted quickly to issue a statement in response to the proposed amendment and engaged Members and staff in active discussion on the issue. While the amendment was not considered in Committee, it is indicative of the continued interest in bundling by the Committees of jurisdiction.
You can read the KCP Statement here.
CMS Publishes New Standards for Transplant Centers Serving Medicare Enrollees
A final rule setting forth requirements that organ transplant centers must meet to participate in Medicare was issued by the Centers for Medicare & Medicaid Services on March 22nd. The rule, which affects kidney transplant centers, moves Medicare-covered transplant programs toward an outcome-focused system that reflects clinical experience, resources, and commitment. The centers are required to submit a request for initial approval which must then be renewed every three years. You can view the final rule here.
Drug Price Negotiation Bill Dies in Senate
Although legislation (S.3) that would strike the noninterference clause from the Medicare prescription drug law, clearing the way for the Department of Health and Human Services (HHS) to negotiate Part D drug prices, was approved by the Senate Finance Committee on April 12th, the bill failed when it reached the Senate floor on April 18th. The wording of the bill was not as intense as the House version (H.R.4), passed on January 12, which would require HHS to negotiate drug pricing in certain circumstances. The goal of both of these bills was to create cost savings for Medicare recipients.
3. NIH/Research Related Issues
Griffin P. Rodgers, M.D., Named Director of the NIDDK
Elias A. Zerhouni, M.D., director of the National Institutes of Health, has announced the appointment of Griffin P. Rodgers, M.D., as the director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), effective April 1, 2007.
Dr. Rodgers, who was appointed Deputy Director of NIDDK in January 2001, is currently Acting Director of NIDDK and also serves as chief of NIDDK's Clinical and Molecular Hematology Branch, which he has headed since 1998.
He received his undergraduate, graduate, and medical degrees from Brown University in Providence, R.I. He performed his residency and chief residency in internal medicine at Barnes Hospital and the Washington University School of Medicine in St. Louis. His fellowship training in hematology/oncology was in a joint program of the NIH with George Washignton University and the Washington Veterans Administration Medical Center. He also holds a master's degree in business administration from Johns Hopkins University.
You can read the entire NIH Press Release here.
NIDDK Director Testifies at Senate Labor-HHS Appropriations Committee Hearing
On Friday, April 20, 2007, the Senate Labor-Health and Human Services Appropriations Committee, chaired by Senator Tom Harkin of Iowa, held a theme hearing on chronic diseases. Griffin P. Rodgers, M.D., Director of the NIDDK, testified as a member of a National Institutes of Health panel. His written testimony touched on the leverage of prior investments, developing partnerships within NIH, genomics, and the improvement of care for people with chronic diseases. You can read his written testimony here.
The panel also included Drs. Richard Hodes, Steve Katz, and Betsy Nabel, Directors of the National Institute on Aging, the National Institute of Arthritis & Musculoskeletal and Skin Diseases, and the National Heart, Lung, and Blood Institute, respectively.
4. Other
Recent Study Explores EPO Dosages
A recent study published in the Journal of the American Medical Association (JAMA) found that some for-profit dialysis facilities appear to give patients larger doses of Amgen's anti-anemia drug Epogen (EPO) than nonprofit centers. The 2004 study was conducted by researchers from Bethesda, MD-based Medical Technology and Practice Patterns Institute. The researchers used the U.S. Renal Data System to identify 159,522 ESRD patients, and developed models to estimate the average epoetin dose and dose adjustment by profit, chain, and affiliation status.
The investigators found that for-profit chains, on average, increased epoetin doses three times more than nonprofit centers for patients with hematocrit levels of less than 33 percent, and also increased the doses among patients with hematocrit levels in the recommended target of 33 percent to 36 percent, according to the JAMA study.
This study was mentioned by several major media outlets. The primary focus of most publications, according to Schmidt Public Affairs, focused on the following three areas:
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Risks associated with high dosages of Epogen and the Medicare payment structure that reimburses for treatments as well as for use of Epogen;
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Increased use of Epogen by for-profit dialysis centers as compared to nonprofit centers based on JAMA 's case study of almost 160,000 dialysis patients in 2004;
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How Epogen accounts for nearly 25% of the profits of large dialysis centers such as DaVita and Fresnius.
In response, Congressman Pete Stark composed a Dear Colleague letter to all House Members on Thursday, April 19th, encouraging Members to adjust Medicare's reimbursement policy for Epogen.
The study, entitled “Dialysis Facility Ownership and Epoetin Dosing in Patients Receiving Hemodialysis,” can be accessed via JAMA.
Stem Cell Research Enhancement Act of 2007 Passed by Senate
The Senate passed the Stem Cell Research Enhancement Act of 2007 (S.5) on April 11, 2007 by a Yea-Nay vote of 63-34. The vote would fell short of the majority needed to override a promised veto from President Bush.
The Stem Cell Research Enhancement Act of 2007 would amend the Public Health Service Act to require the Secretary of Health and Human Services to conduct and support research that utilizes human embryonic stem cells, regardless of the date on which the stem cells were derived from a human embryo. It limits such research with ethical requirements that: require stem cells from human embryos to be from in vitro fertilization clinics and in excess of the needs of the individuals seeking treatment, forbid implementation of the embryos in a woman, and require written informed consent from individual donors and forbid them from receiving financial or other inducements.
The Morbidity and Mortality Weekly Report Examines Chronic Kidney Disease
The March 2nd Morbidity and Mortality Weekly Report (MMWR) examined the prevalence of chronic kidney disease (CKD) through an analysis of National Health and Nutrition Examination Survey (NHANES) data from 1999-2004. The analysis showed that 16.8% of the U.S. population aged 20 years or older had CKD in those years—an increase from the 14.5% in 1988-1994. CKD prevalence was greater among older persons and among persons with diabetes, cardiovascular disease, and hypertension than among people without these conditions. The study also found that Mexican Americans and non-Hispanic blacks had greater prevalence of CKD than non-Hispanic whites. The report stressed the need for activities aimed at preventing CKD and its progression, such as control of high blood pressure. You can read the entire report here.
The MMWR is prepared by the Centers for Disease Control and Prevention (CDC).
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
