Hill Day 2012: ASN Leaders Put Kidney Disease in Legislative Spotlight

The ASN Council, Public Policy Board, and Board of Advisors met with legislators on Capitol Hill as part of the biannual Board of Advisors meeting on April 26, 2012. The second annual ASN Hill Day provided ASN leaders an opportunity to talk directly with lawmakers and House and Senate staff about issues of importance to ASN and the kidney care community. ASN leaders met with more than 50 congressional offices, including more than a half-dozen meetings with senators and representatives themselves, and were divided into four teams to discuss one of the following issues. 1) National Institutes of Health (NIH) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funding and investigation of kidney health disparities, including a bill (S.2163) recently introduced by Sen. Kent Conrad (D-ND) that promotes research regarding disparities and access to care. 2) Support for legislation to extend lifetime coverage of immunosuppressive drugs for kidney transplant recipients (S.1454/H.R.2969). 3) ASN’s efforts to increase interaction between the nephrology community and the U.S. Food and Drug Administration (FDA). 4)A complex set of issues and upcoming changes related to the Medicare end stage renal disease (ESRD) program and the practice of nephrology.

ASN leaders met not only with senators and representatives from their home states and districts, but also with key members of congressional committees with jurisdiction over the issues ASN discussed, either from an “authorizing” perspective (meaning that the committee can tell a certain program or agency what it is allowed to, or must, do) or from an “appropriations” perspective (meaning that the committee is in charge of determining how much funding an agency or a program receives).

This Policy Update gives an in-depth description of the issues for ASN Hill Day 2012, and includes an article from members of the ASN Transplant Advisory Group that illustrates why advocating for legislation to extend lifetime coverage of immunosuppressive drugs was—and continues to be—a top ASN policy priority.

As noted above, ASN’s collaboration with the FDA is one of the society’s top policy priorities in 2012. Several ASN leaders discussed this priority with members of Congress who oversee the FDA. Although ASN is still in the early stages of outlining this collaborative initiative with the FDA to protect kidney health, the society received positive feedback about its goals from members in both the House and Senate. Stay tuned to Kidney News for more details about this vitally important initiative in the coming months.

ASN Addresses NIH Research, Health Disparities, and S.2163

During office meetings with House and Senate appropriators and other lawmakers, ASN leaders discussed the importance of supporting the NIH, which in turn supports innovative kidney disease research that will improve patient care, cut costs, and preserve the investigator pipeline. The bottom line—funding NIH is a smart investment because NIH research generates jobs, stimulates the economy, and enables life-saving medical advancements.

ASN leaders spoke about the public health importance and economic benefits of kidney disease research. ASN supports the work of Congress to reduce the federal debt in a socially and fiscally responsible manner, which is why we urge continued investments in medical research. Publicly funded research supports one of every 500 full-time jobs in the United States, and every dollar invested in medical research generates $2.60 of economic activity. Furthermore, according to a 2010 study, research funding also generated 487,900 new jobs nationally and produced more than $68 billion in new economic activity in the United States.

Most developed countries are dramatically increasing their budgets for medical research. China in particular is ramping up investments in this arena. Currently, the United States is the world leader and can attract the best and brightest investigators from across the globe, but in order to maintain this position it is critical to protect medical research funding. Without this investment, the ability to sustain a pipeline of researchers from this country and abroad—and their future contributions to improving patient care and treatment and possible cures—will be lost.

Consequently, ASN leaders asked the House and Senate offices they met with for their support of $32 billion for the NIH and specifically $2.03 billion for the NIDDK in the fiscal year 2013 budget—the minimum investment necessary to avoid further loss of promising research and allow NIH’s and NIDDK’s budgets to keep pace with the rising cost of conducting biomedical research.

ASN leaders also explained the importance of health disparities research and requested support for the Kidney Disease Equitable Access, Prevention, and Research Act of 2012 (S.2163). Research has helped physicians understand some of the reasons why many minority populations are at higher risk for kidney disease, but without support for additional research we cannot move forward to address and resolve disparities in kidney care.

Sen. Kent Conrad (D-ND) introduced S.2163 to help resolve inequities in kidney disease health policy by addressing barriers to transportation, patient education, and access to insurance. For example, S.2163 would provide key education for Medicare beneficiaries with stage V chronic kidney disease (CKD) through medical and clinical staff at dialysis facilities. Senate bill 2163 would also allow individuals with kidney failure to maintain their private insurance by extending the Medicare Secondary Payer period from 30 to 42 months after they quality for Medicare, which would achieve important savings for the Medicare program.

Leading up to Hill Day, ASN laid the groundwork on the medical research advocacy front, including collaborating with the American Society of Pediatric Nephrology (ASPN) to send a letter supporting kidney disease research to both the House and Senate appropriations committees that was signed by numerous other members of the kidney community, representing patients, providers, and industry. ASN has received positive feedback regarding the letter, including a request from the office of Rep. Jeff Flake (R-AZ), who sits on the House Ways and Means Appropriations health subcommittee (which has significant influence over the NIH budget) to discuss kidney disease research and the NIDDK budget in particular. While this is a difficult time for Congress to make spending-related decisions, the importance of kidney disease research is squarely on the radar screens of those members with influence.

ASN and ASPN are deeply grateful for the support of the Congressional Kidney Caucus, which submitted language for inclusion in the report the House Appropriations Committee submits to the full House of Representatives highlighting the importance of kidney disease research across the NIH and directed at patients of all ages. This report is vitally important, as it explains to Congress the reasons for including the spending proposals in appropriations bills. In addition, ASN and ASPN worked with the caucus to include a specific funding recommendation of $2.03 billion for the NIDDK budget—the first time a specific budget level has been supported by the kidney community.

ASN has taken a number of other steps such as joining more than 165 organizations in sending a letter urging Congress to support $32 billion in funding for NIH, involving the ASN membership in a petition-signing campaign urging the White House to support more funding for NIH, joining more than 900 organizations in sending a letter urging Congress to avert cuts to the overall Health and Human Services budget, and aunching an ASN membership email campaign to urge their members of Congress to support more research funding for NIH. Contact your member at http://capwiz.com/asn/home/.

 

ASN is grateful to the society’s leaders for helping make Hill Day 2012 a success, and the society will continue to engage lawmakers and their offices in the months to come as the budget process plays out and other pieces of legislation important to the kidney community move forward.

Helping Congress Understand the Evolving Practice Environment in Nephrology

Congress made a commitment to save the lives of people with kidney failure by establishing the Medicare ESRD program in 1972, a program that covers all citizens experiencing kidney failure, regardless of age. This essential government program and the kidney professionals who implement it are at the forefront of the innovations, system transformations, and pioneering changes that will affect other areas of health care.

A key goal of ASN Hill Day was informing those lawmakers with oversight of the Medicare ESRD program, or those with a history of commitment to kidney disease and the Medicare ESRD program, of the implications these profound reforms could have for patients and physicians. In order for ASN to achieve success in this area, it is crucial to gain the support of lawmakers who understand the complexity of these changes, who will support kidney professionals’ effort to enact change that focuses on improving care for a vulnerable population, and who will allow time to assess efforts to reduce costs and measure the quality of care.

ASN representatives discussed four key components of the “evolving practice environment in nephrology.”

First is the ongoing process of implementing the Medicare Improvements for Patients and Providers Act (MIPPA), including bundled payments for dialysis care. At the heart of ASN’s message was the principle that Congress should avoid future Medicare payment changes until recently enacted MIPPA changes are fully implemented. Meaningful cost reductions will succeed only if patient care remains uncompromised. Evaluating the success of the program’s experience with bundled payment systems and pay-for-performance quality programs will serve as a model for needed changes to other areas of health care.

Second, it is important for Congress to understand the complexity of addressing the measures and programs related to improving the quality of health care. Because nephrology professionals provide care to a highly vulnerable patient population, achieving this goal requires consistent, evidence based evaluations of the quality of care provided. Promoting the use of the same measures across programs is crucial to facilitate consistent care, reduce unnecessary reporting burdens, and prevent costly data duplication. ASN is dedicated to helping develop and ensure the consistency of quality metrics that fulfill these essential standards.

Third, ASN discussed the society’s principles related to the potential development of integrated care delivery models. Foremost among these principles (available in full at http://asn-online.org) is preservation of the patient-physician relationship. ASN’s advocates addressed the very real potential that such pilot or demonstration programs could pave the way to dramatic improvements in kidney care, but cautioned that establishing successful ones requires careful consideration of the potential effects on a vulnerable patient population.

The fourth component of ASN’s message was the vital need to repeal the flawed sustainable growth rate and replace it with a sensible alternative. Addressing this fundamentally defective formula is key to ensuring that patients maintain access to care, and that physicians can count on the Medicare program to provide payments that accurately reflect the cost of care.

Making the Case for Lifetime Immunosuppressive Drug Coverage

Advocating for legislation to extend lifetime coverage of immunosuppressive drugs (S.1454/H.R.2969) is a cornerstone of ASN’s public policy and Hill Day 2012 messages. ASN leaders met with more than a dozen offices, specifically focusing on members of Congress who supported this bill when it was introduced in the 111th Congress, but who have not signed onto the bill in the 112th Congress (the current session). Here, members of the ASN Transplant Advisory Group Alan Leichtman, MD, David Cohen, MD, and Chair Michelle Josephson, MD, outline the history of this legislation and why it’s the right thing for Congress to do from every perspective, illustrating the many reasons that this issue is at the top of ASN’s public policy priorities.

Transplantation, for nearly all suitable transplant candidates, is the preferable and most cost-effective treatment for ESRD, and typically provides superior longevity, health, and quality of life when compared with dialysis. Median 5-year survival is nearly double for patients following renal transplantation compared with patients who remain on dialysis. For those patients with Medicare coverage from ESRD, Medicare will cover the costs of dialysis indefinitely but only the initial costs of a kidney transplant (1). For most transplant patients Medicare coverage ends after 36 months, leaving many patients unable to pay for the immunosuppressive medications required indefinitely to prevent rejection. Consequently, financial hardship forces many to become non-adherent with their medical regimens—reducing their doses or discontinuing their immunosuppressive medications entirely. Financial hardship-related non-adherence in turn leads to rejection, transplant dysfunction with the associated costs of CKD, and the premature return to dialysis. Once patients return to dialysis they are again covered by Medicare, at minimal estimated costs exceeding $82,000 annually compared with approximately $11,000 to maintain a kidney transplant. It clearly makes neither clinical nor financial sense to pay indefinitely for the less efficacious and more expensive treatment, while denying long-term coverage for the more effective and less costly alternative.

In addition there is a shortage of kidneys, and the deficit in the number of kidneys available for transplantation is exacerbated by the 15 percent of waitlisted patients seeking repeat transplantation. With lifetime immunosuppressive drug coverage, there is little doubt that many transplants would last longer, resulting in fewer patients returning to the waiting list for repeat transplantation, and thus more kidneys would be available for other transplant candidates.

How widespread is this problem? While precise numbers are hard to come by, a survey conducted by the United Network for Organ Sharing and the American Society of Transplantation indicated that 70 percent of kidney transplant programs reported that many of their patients had an extremely serious or very serious problem paying for their medications, and 68 percent reported deaths or graft losses attributable to cost-related immunosuppressive medication non-adherence (2). While extending Medicare coverage for immunosuppressive medications will not entirely solve this problem, it would help a substantial number of these patients.

Federal expenditures for kidney disease currently cost taxpayers more than $30 billion a year, about 6 percent of the Medicare budget. Expanded immunosuppressive medication coverage offers a more cost-effective way for the federal government to manage these expenses. For nearly 10 years the transplant community has lobbied Congress to extend coverage of immunosuppressive medications for kidney transplant recipients for the lifetime of the organ. A bill has been introduced in both the House and Senate to provide for this, and it has broad bipartisan support. The current lead sponsors are the physician Rep. Michael Burgess (R-TX), Rep. Ron Kind (D-WI), Sen. Dick Durbin (D-IL), and Sen. Thad Cochran (R-MS). The current House Ways and Means Committee Chairman Dave Camp (R-MI) was the lead sponsor for many years. ASN will continue to work with a coalition of transplant organizations to keep the patient immunosuppressive medication coverage extension bill at the top of many legislative priority lists. This current policy of paying for a kidney patient’s transplant but not providing the drugs necessary to keep the transplant and the patient alive defies common sense, is life threatening for patients, and costs the federal government untold millions in avoidable expenditures. When will common sense prevail?

Please visit the ASN’s Legislative Action Center (http://capwiz.com/asn/home) and send your members of Congress a message telling them how important this bill is for all patients with kidney disease.

References

1.Gill JS, Tonelli M. Penny wise, pound foolish? Coverage limits on immunosuppression after kidney transplantation. N Engl J Med 2012; 366:586–589.

2.Evans RW, Applegate WH, Briscoe DM, et al. Cost-related immunosuppressive medication nonadherence among kidney transplant recipients. Clin J Am Soc Nephrol 2010; 5:2323–2328.


May 2012 (Vol. 4, Number 5)