After years of advocacy from the American Society of Nephrology (ASN) and other members of the kidney community, the Department of Health and Human Services (HHS) and members of Congress are expressing very similar viewpoints to those of ASN and the broader kidney community on some of the major issues confronting the 40 million men, women, and children facing kidney diseases in the United States.
In May 2019, both the administration and members of Congress demonstrated their commitment to change in two critical areas: immunosuppressive coverage and innovation in the kidney space. Building on a speech HHS Secretary Alex Azar gave outlining the department’s plans to tackle many aspects of kidney health policy, HHS is expected to unveil an HHS-wide kidney strategy. Among other things, it is anticipated the strategy will include an announcement from the Centers for Medicare and Medicaid Innovation (CMMI) regarding a new kidney care model for testing—for which ASN’s Quality Committee and Policy and Advocacy Committee have been recommending elements for inclusion.
Extending immunosuppressive coverage
When ASN and other kidney community stakeholders met with HHS Secretary Azar in February 2019, one of the topics the society highlighted was the need for better data from HHS regarding the likely number of transplant patients who would utilize lifetime immunosuppressive drug coverage were Congress to pass legislation extending it past 36 months.
On May 10, 2019, the Office of the Assistant Secretary for Planning and Evaluation within HHS released an analysis demonstrating that extending Medicare coverage specifically for immunosuppressive drugs for more than 3 years posttransplant would save Medicare at a minimum $73 million over the course of 10 years (1).
“Providing limited Medicare coverage for only immunosuppressive drugs could result in savings associated with preventing reversion to dialysis and may have the added benefit of supporting transplant recipients in deciding to transition off Social Security Disability Insurance and Medicare,” according to the report. “This may enable transplant recipients to return to the labor market and possibly enroll in private health insurance coverage, since they may be less concerned about losing coverage for their immunosuppressive drugs. Although these additional savings are not incorporated into the current analysis, given a recent study indicating that a little over 60% of individuals under age 65 who receive a kidney transplant currently continue to be enrolled in Medicare past 36 months, such savings could be substantial.”
Kidney News Online reported in March 2019 in the article “Extending coverage for immunosuppressant drugs” that in a House Appropriations subcommittee hearing Secretary Azar previewed the analysis in response to a question from kidney care champion Rep. Jaime Herrera-Beutler (R-WA-03), who highlighted that “oftentimes we see people who lose their transplants get back on dialysis, because Medicare won’t cover it. And the cost and quality of life issues are ridiculous: it’s a lose-lose.”
ASN President Mark E. Rosenberg, MD, FASN, responded to Secretary Azar’s preview in March saying, “ASN has been advocating for Congress to extend this life-saving coverage for years. In fact, last month, representatives from ASN and other kidney community stakeholders discussed with Secretary Azar and other HHS leadership how helpful obtaining data regarding the potential cost or savings of extending immunosuppressive coverage beyond the three-year window would be.” ASN Policy will continue advocating for Congress to extend the coverage.
Spurring innovation
ASN has been actively advocating for multiple pathways that could spur innovation throughout its existence. Keystone moments include former ASN President Sharon M. Moe, MD, FASN, testifying before a 2014 House Subcommittee on Research and Technology hearing on the use of prizes to spur innovation and technology breakthroughs, the creation of the Kidney Health Initiative (KHI) in 2012, and the formation of the 2018 Kidney Innovation Accelerator (KidneyX), a public-private partnership between HHS and ASN to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. Like immunosuppressive coverage, many of these efforts also came full circle in May.
KidneyX hosted its inaugural Summit in Washington, DC, April 29–30. The summit was overbooked with members of Congress, the administration, and the kidney community—patients, healthcare professionals, innovators, and investors. Attendees spoke about their sense that kidney issues were receiving unprecedented levels of support, signifying a turning tide in kidney care and hopes that KidneyX could serve as a catalyst for innovation.
The Administration
Ed Simcox, JD, Chief Technology Officer at HHS, and ASN President Mark E. Rosenberg, MD, FASN, kicked off the Summit and announced the 15 finalists for the KidneyX Redesign Dialysis Phase I prize competition. (Abstracts from the 15 finalists may be viewed on KidneyX.org.)
“Being present at the KidneyX Summit was the most exciting and energizing experience I have had as a nephrologist. I could palpably sense the excitement, hunger, and momentum for developing new treatments for kidney diseases,” said Dr. Rosenberg. “There was remarkable alignment of scientists, innovators, policymakers, industry, care providers, professional societies, and patients. I left the Summit knowing that we can and will make progress in the prevention and treatment of kidney diseases.”
HHS Deputy Secretary Eric Hargan, JD, set the tone for Summit attendees declaring that kidney patients deserved more treatment options and applauded the efforts of KidneyX. Mr. Hargan went on to outline that policy changes are needed in addition to new technologies. “Patients with kidney failure deserve more options for treatment…. Today’s policies bias providers toward center-based dialysis and in particular payment incentives probably encourage dialysis [centers] to attract and retain patients rather than allow for the most appropriate mode of care,” suggesting that more home dialysis and transplant care is needed. Mr. Hargan was followed by Adam Boehler, Deputy Administrator of the Centers for Medicare & Medicaid Services (CMS) and Director of CMMI, participating in a “fireside chat” during which he discussed how payment policy can help spur innovation. Mr. Boehler is directly overseeing the development of the comprehensive kidney care model referenced earlier.
Members of Congress
The bipartisan, bicameral enthusiasm for KidneyX was on full display at the Summit. Sen. Todd Young (R-IN) provided the Senate’s perspective and noted that he will continue to champion KidneyX in the Senate. Congressional Kidney Caucus Co-Chairs Rep. Suzan DelBene (D-WA) and Rep. Larry Bucshon, MD (R-IN) highlighted the need for innovation in the kidney space as well as delivered a remarkable show of support by gathering the signatures of 57 members of the House of Representatives in support of $25 million for KidneyX in the fiscal year (FY) 2020 Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations bill.
Owing to the support of these and other key congressional champions like Rep. Terri Sewell (D-AL), and the advocacy efforts of ASN and other kidney organizations, John R. Sedor, MD, FASN, KidneyX Chair, made a surprise and welcomed announcement at the Summit that the House Appropriations Committee included $10 million for KidneyX in the FY 2020 LHHS bill. ASN will continue to engage the broader kidney community to work to ensure that KidneyX receives federal funding in FY2020.
“The excitement and energy in the room was palpable. The interest in KidneyX is tangible proof of the hunger in the community for disruptive change in how we diagnose and manage kidney diseases,” said Dr. Sedor. “Our patients are waiting for KidneyX to foster innovation from the bench to the bedside.”
Redesign Dialysis Phase II, the second phase of KidneyX’s inaugural prize competition, was announced at the Summit. Phase II asks innovators to develop and demonstrate prototype solutions and will award $500,000 to up to three finalists.
The Patient Access to ESRD New Innovative Devices Act (H.R. 2710)
Also introduced in May 2019, the Patient Access to ESRD New Innovative Devices Act calls for the Secretary of HHS to make changes to the Medicare payment bundle for dialysis to “allow a pathway for innovation in new medical devices that improve dialysis treatment and outcomes.” H.R. 2710 was introduced by Reps. Danny Davis (D-IL) and Trey Hollingsworth (R-IN).
The bill and an accompanying regulatory outreach effort have been a top policy priority of ASN for years. ASN’s letter of support states, “Your important and timely legislation would increase to the House sponsors of the bill patient access to new products that may increase their quality of life or help bring better value to the healthcare system by creating a pathway for new and innovative devices for kidney failure to be reimbursed by Medicare in the bundle.”
