The Future is Now for Kidney Care

New Care Model, Potential for Expanded Coverage of Immunosuppressant Drugs on Horizon

David L. White
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Members of Congress and regulators are keenly focused on kidney healthcare and the policies around it. With more than 40 million people in the United States living with kidney diseases and 700,000 Americans with kidney failure, Medicare costs topped more than $114 billion in managing kidney diseases in 2016, which accounts for 23% of all Medicare spending. With such a growing burden both on patients and their families and on taxpayers, the pressure is on policymakers to realign the incentives and priorities to achieve better outcomes.

A new vision for kidney care

Department of Health and Human Services (HHS) Secretary Alex M. Azar, II, is developing a kidney strategy to realign incentives and cut across silos in kidney care that have defied truly integrated kidney healthcare. In a speech last month, he outlined the approach, indicating it focused on preventing kidney diseases by catalyzing innovation in healthcare delivery and therapeutics, expanding alternatives to in-center dialysis, and increasing the availability of organs for kidney transplantation.

“Today, I want to lay out what it would look like to pay for kidney health, rather than kidney disease—and pay for Americans with kidney disease to actually get good outcomes, rather than the endless, life-consuming procedures that you all know so well,” he said.

ASN leadership and staff have been meeting with HHS to advocate for a comprehensive, cross-cutting care approach for the model currently under development. ASN President Mark E. Rosenberg, MD, FASN, commented that “ASN commends the Secretary and this administration for acknowledging that the current state of care for kidney patients is unacceptable and that complex barriers inhibit innovation—and for developing a visionary strategy to change that reality.”

Secretary Azar’s speech was followed by a public discussion of the yet-to-be-released model with Adam Boehler, Deputy Administrator for CMS and Director at the Center for Medicare and Medicaid Innovation (CMMI) which is developing the model and will oversee its testing. Boehler spoke about CMMI’s intention to test a kidney model that includes late-stage kidney diseases (stages 4 and 5), kidney failure, and transplantation, saying that the current state of kidney care “is an area that cannot remain static.”

He noted that the rate of home dialysis in the United States is 11% while it is around 75% in Hong Kong. He also noted that the transplant rate for kidneys is approximately 20% while laying out ambitious goals for the very near future. Boehler said he would like to see 80% of patients with kidney failure either on home dialysis or receiving a kidney transplant by 2025. Both Secretary Azar and Deputy Administrator Boehler expressed confidence these goals are obtainable with a realignment of the incentives currently in place, especially with regard to payment/reimbursement policies.

A new future for patient data

To realign incentives and follow patients throughout their care, especially for patients with chronic conditions, patients need greater access to their own data to share with the many caregivers they interact with along their journey. As such, CMS has issued a long-awaited proposed rule aimed at enhancing interoperability and increasing patient access to health information. The rule is one of a set of two rules; the other was issued by the HHS Office of the National Coordinator (ONC). Some of the highlights are:

  • ■ ADTs and Facilities

  • Requires hospitals, including psychiatric and critical access hospitals, to send an electronic notification when a patient is admitted, discharged, or transferred (ADT). The CMS proposed rules mention dialysis facilities once in the context of their eligibility to be included in models that will be tested by CMMI.

  • ■ Trusted Exchange Networks

  • Requires other private and public payers to participate in a trusted exchange network with the capacity for patients, providers, and insurers to access secure patient records, transmit them across EHRs, and provide a messaging and notification platform.

  • ■ Mobile Apps

  • Uses standardized Application Programming Interfaces (APIs) to allow patients and healthcare providers the opportunity to use third-party software (like a mobile app) to access secure information in a standardized format.

  • ■ Information Blocking

  • Prohibits “information blocking,”—the practice of withholding data or intentionally limiting compatibility or interoperability of health information.

CMS proposes requiring compliance in two stages by January 1, 2020, and by July 1, 2020.

A new day for a long-awaited change for kidney transplant recipients

In keeping with his new look at kidney healthcare, Secretary Azar also signaled a potentially huge change in immunosuppressant drug coverage in March 2019. One week after his keynote speech on kidney healthcare, Secretary Azar revealed that a preliminary HHS Office of the Actuary analysis indicates that the savings generated by averting dialysis would be greater than the cost required to extend coverage for immunosuppressant drugs beyond the current three-year limit. While noting that any potential savings would be “specific to the design of any actual policy,” the secretary underscored that HHS is “very focused on ways we can incentivize toward transplantation.”

The preliminary analysis from the Office of the Actuary that points toward potential savings is significant news. For years, one of the chief challenges to passing legislation that extends lifetime Medicare coverage of immunosuppressant drugs for kidney transplant patients has been a concern regarding the cost of the legislation. This has been a policy priority for ASN for many years.