ASN's Renal Policy Express
- August 2004 -
Publisher: American Society of Nephrology       Email: policy@asn-online.org

Paul's Message

Dear ASN Members:

Clearly, double-digit funding increases for biomedical research have come to an abrupt end. The House Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Subcommittee and full Appropriations Committee marked up their FY 2005 spending bill, which includes a 2.8 percent increase for the National Institutes of Health (NIH). The LHHS subcommittee passed their version of the bill by a vote of 18 to 0 after defeating an amendment by Rep. David Obey (D-WI), the ranking member on the full committee, to provide additional funding for health, education, and labor programs, offset by a reduction in the tax cuts passed in 2001 and 2003 for individuals with annual incomes above $1 million.

For NIH, the bill provides a fiscal year (FY) 2005 funding level of $28.441 billion, an increase of $782 million (2.8 percent) over FY 2004. This is equal to the Administration's FY 2005 request. All institutes and centers – including the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) - are funded at the Administration's requested levels.

Senate Appropriations Committee Chairman Ted Stevens (R-AK) cancelled planned (Senate) subcommittee markups of nine FY 2005 spending bills, including the LHHS bill, after Senate Democrats rejected the chairman's demand that they agree to time limits on floor debate on the bills before the subcommittees or full committee could consider them. It is not known when the Senate will attempt to deliberate and mark up their version of the LHHS Appropriations bill. Given the national election, lack of Senate movement and the dwindling number of legislative days until the end of the FY04-- September 30-- lawmakers in both chambers are making plans for an FY05 omnibus bill. Click here to read the House LHHS Appropriations Bill Summary.

Of primary concern to the ASN™ is the still uncertain outlook for funding for NIH and NIDDK for the 2005 fiscal year, which begins October 1. ASN™ has joined with more than 200 medical and health organizations advocating for a 10 percent increase in NIH funding for FY 2005, and we are pushing for a larger NIH allocation in the Senate bill. Click here to read the letter and the organizations who have signed on.

Despite its current funding concerns, NIH continues to strengthen its public health campaign, through several outlets. The National Kidney Disease Education Program (NKDEP) began its first national effort to call attention to the severity of kidney disease and the importance of testing those at high risk, particularly African Americans. "It's critical that we get in front of this growing epidemic. People's lives don't have to be devastated by kidney failure," said Thomas Hostetter, M.D., director of NKDEP, an initiative of the National Institutes of Health (NIH). That's the aim of NKDEP's “You Have The Power To Prevent Kidney Disease” campaign. It stresses three key messages: 1) know if you are at risk, 2) have your kidneys tested if you are at risk, and 3) kidney failure can be slowed or prevented if detected early. This national effort builds upon pilot education campaigns conducted in Atlanta, Baltimore, Cleveland and Jackson, MS, over the past year. More than 30 public agencies and private organizations were involved in the pilot programs' development and are supporting the initiative's national implementation. Click here to learn more about the ”You Have The Power To Prevent Kidney Disease” campaign.

NIH also recently announced the launch of an expanded health information website. The expanded site now offers links to a wider range of NIH's valuable resources and features colorful images to highlight an intriguing range of useful features. Visitors can still access the popular "A to Z" listing of health topics, browse topics by body location/systems, or use the main "Search" box.

As you can tell, the ASN and our Policy and Public Affairs Committee continue working hard to make sure that medical policy is in the best interest of you and yours patients. As always, please email me, if you have suggestions that enable us to assist you.

Sincerely yours,

Paul C. Smedberg
Director, Policy and Public Affairs


Senate Pay-for-Performance Bill Introduced

On June 23, 2004, Senator Max Baucus (D-MT), a ranking member of the Senate Finance Committee introduced "The Medicare Quality Improvement Act of 2004", which would build on the initiatives included in the Medicare bill to link payment with quality of care in the Medicare program.

Following the recommendations of MedPAC (Medicare Payment Advisory Commission), the bill would establish a pay-for-performance system for Medicare Advantage and End Stage Renal Disease (ESRD) programs. Plans and providers delivering the highest quality care, as well as those who saw improved quality from one year to the next, would receive higher payments than those plans and providers that either were not high-quality or did not improve.

"Giving healthcare providers a reason to make sure their service is top-notch will save taxpayer dollars in the long run,” Baucus said. "This legislation is a step towards raising the standard of care that Medicare beneficiaries receive."

In addition to establishing new programs for Medicare Advantage and ESRD, the bill calls for a roadmap to creating pay-for-quality programs across all of Medicare.

The Medicare Quality Improvement Act will also allow more resources to be allocated to improve healthcare services in the Medicaid program. The legislation authorizes the hiring of five new personnel to work on quality improvement for Medicaid at the Centers for Medicare and Medicaid. It also looks at ways to improve quality of care and reduce costs for the dual-eligibles - those who are enrolled in both Medicare and Medicaid - many of whom represent the costliest beneficiaries in both programs.


ESRD Modernization Bill Introduced in Senate

Senator Kent Conrad (D-ND) recently introduced the ESRD Modernization Act of 2004 (S. 2614). The ESRD Modernization Act seeks to establish an annual update framework for the ESRD composite rate under the Medicare ESRD program. The bill also directs the Secretary of Health and Human Services (HHS) to establish demonstration projects to: 1) increase public awareness about the factors that lead to chronic kidney disease, how to prevent it, how to treat it, and how to avoid kidney failure; and 2) enhance surveillance systems and expand research to better assess the prevalence and incidence of chronic kidney diseases.

In 1972, Congress committed to providing ESRD patients with coverage for their lifesaving therapy through the Medicare program. In 1983, Congress implemented the first Medicare Prospective Payment System (PPS), known as the “composite rate,” for reimbursing dialysis providers. Medicare's ESRD program continues to play a vital role in ensuring access to high quality, lifesaving therapy for patients with kidney failure. Better care for patients means better quality of life, improved rehabilitation, fewer medications, and fewer hospitalizations.

Congress may act immediately to provide an annual update mechanism for the ESRD composite rate, just as it has done for all other Medicare prospective payment systems. The ESRD composite rate is the only Medicare PPS without an annual update mechanism to adjust for changes in input prices and inflation. MedPAC recommended that Congress provide for such an update in its 2000 annual report.

Congress must ensure the economic stability of the ESRD Program. It is essential that the ESRD program provide the appropriate incentives for continued improvements in the quality of care patients receive. For example, CMS has recognized that the type of dialysis access patients receive dramatically impacts the quality of care. Payment policies should promote the most efficient settings for providing these access procedures and the most effective access for each patient. Equally important is considering how to promote improvements in the quality of care. Click here for more information.

 

CMS EPO Policy Revision Proposed

The Centers for Medicare & Medicaid Services (CMS) announced a draft, revised policy for monitoring erythropoietin (EPO) claims for public comment. The (draft) policy was developed after CMS sought scientific information from the end stage renal disease (ESRD) community in order to develop a permanent evidence-based policy for EPO monitoring. CMS will not issue a final EPO monitoring policy until it reviews the public comments from the ESRD community. The ASN™, through its Policy & Public Affairs Committee, Dialysis Advisory Group and Practicing Nephrologists Advisory Group, will comment on the proposal.

CMS proposes a monitoring policy that considers both hematocrit/hemoglobin levels and EPO dosage levels. The CMS policy seeks to monitor incentives to keep hematocrit/hemoglobin levels in the target range while discouraging excessive dosing of EPO. The policy's goal is to establish a payment for EPO that is based on the best scientific evidence available and works in practice.

Medicare's current policy restricts review of EPO claims to post-payment review based on a 90-day rolling average of claims. Medicare beneficiaries with a rolling average hematocrit level of 37.5 percent or greater may be targeted for further review and potentially may have their claim for EPO reimbursement rejected.

Look for details on the final EPO monitoring policy in the September and October ASN™ Renal Policy Express issues.


Clinical Trials Registry

Several members of Congress and the Director of the National Institutes of Health (NIH) are now expressing support for the establishment of a national registry for all clinical trials and their results. The pace of the discussion has also prompted the Food & Drug Administration (FDA) and several pharmaceutical companies to more aggressively engage in the debate.

The main objective of such a registry is to expand protections for clinical trials participants. The concept for a mandatory registry for listing all trials and sharing of results was started when the American Medical Association (AMA) adopted a position urging the Department of Health and Human Services to develop such a registry. The AMA proposal would require approval by an institutional review board for listing.

The NIH believes the federal government is likely to require the reporting of positive and negative results in such a registry. Senator Edward Kennedy (D-MA), a strong supporter of a registry, is inclined to reintroduce a bill authoring such a program at the NIH or FDA.

Response to the proposed clinical trials registry is mixed and several researchers and organizations have raised important questions and concerns . Despite these concerns, key health and research organization leaders believe that a registry would be a significant step toward strengthening the reliability and credibility of clinical research and ultimately would improve patient outcomes and medical care.


McClellan Appoints Norwalk Deputy Administrator of CMS

Centers for Medicare & Medicaid Services (CMS) Administrator Mark B. McClellan announced several senior-level appointments within the health care agency, including promoting Leslie V. Norwalk to deputy administrator.

McClellan said that Norwalk will help implement the new Medicare prescription drug law and help on such issues as Program Integrity activities. She also will be a liaison with other agencies in the Department of Health and Human Services (DHHS) and work with Congress, McClellan said.

Norwalk has been acting deputy administrator since January 2003; before that she was a counselor to then-agency administrator Thomas A. Scully.


NIH Seeks to Reform Ethics Rules, As More Problems are Uncovered

In light of questionable consulting deals at the National Institutes of Health, NIH Director Elias Zerhouni told the House Energy and Commerce Oversight and Investigations Subcommittee that he plans to "completely overhaul" the agency's ethics program. At the hearing, lawmakers criticized the status quo, saying that too many consulting deals involving NIH officials are escaping public scrutiny.

The proposed changes in NIH ethics rules would not have any impact on employees involved in academic activities and would not totally eliminate outside activities with private companies. However, the new system would set strict limits on the amount of hours and form of compensation for such activities. Dr. Zerhouni's ten-step ethics overhaul was well-received by subcommittee members. If the new rules take hold, NIH could end up with some of the tightest ethical standards in the federal government.

Under the changes proposed, industry and nonprofit consulting deals would be banned for senior NIH officials and employees involved in decisions on grant funding and contracts. Other employees could continue their outside consulting activities but new restrictions would apply. Any consulting arrangement would have to be cleared by an NIH ethics advisory committee created in November 2003 as well as a division-level ethics counselor. A final NIH ethics rule proposal by Dr. Zerhouni is expected in the coming months.


First National Coordinator's Report on Health Information Technology

The nation's first strategic framework report on a 10-year initiative to develop electronic health records and other uses of health information technology was released on Wednesday, July 21, at the Secretarial Summit on Health Information Technology. Health & Human Services (HHS) Secretary Tommy G. Thompson and National Coordinator for Health Information Technology David. J. Brailer, M.D., Ph. D. unveiled the report, which provided goals as well as action items and issues to be addressed toward achieving President Bush's goal of electronic health records for Americans within a decade. Dr. Brailer was appointed by the President in May 2004 to the new position of National Coordinator to help accelerate development of health information technology. In his executive order creating the new office, the President also called for a report on a strategic plan for widespread adoption of health information technology. Click here to view the HHS announcement.


DNC & RNC Proposed Plarform Language Urging the Strengthening of the Continuum of Federal Public Health Activities Includes Kidney Disease

The Coalition for Health Funding (CHF) - the oldest, most broadly based alliance of national health organizations focused on federal health discretionary spending – submitted proposed language to the Democratic and Republican Platform Committees urging support of federal public health activities. For the first time the proposed platform language includes kidney disease. ASN™ is an active member of the CHF and supports many of its initiatives. Click here to read the letter.


CAKS Letter on Physicians' Referrals to Health Care Entities

The Council of American Kidney Societies (CAKS) contacted CMS Administrator Mark McClellan, M.D., Ph.D., to express concern regarding a provision included in the Medicare Program on Physicians' Referrals to Health Care Entities With Which They Have a Relationship – Phase II. Specifically, CAKS raised concerns about the establishment of safe harbor methodologies for determining dialysis facility medical director fees. CAKS believes that this provision (and others) could potentially have harmful consequences for nephrology as a specialty and the kidney patient population in general. Click here to read the entire letter.

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