HHS Announces Kidney Care Awareness Campaign, Some Want More

November 06, 2019

HHS has teamed up with the National Kidney Foundation and the American Society of Nephrology on a public awareness initiative about kidney disease that President Donald Trump called for in an executive order. Both stakeholder groups praised the initiative, but some have criticized the administration for not also reforming kidney treatment payment and coverage policies.

Trump’s kidney-care executive order told HHS to launch an awareness initiative to “aid the Secretary’s efforts to educate patients and support programs that promote kidney disease awareness.” The initiative will create proposals for HHS to support research on preventing, treating and slowing the progression of kidney disease; improve kidney transplants; and share information with patients and providers about the causes and consequences of kidney disease.

HHS announced the awareness campaign on Monday (Nov. 4).

Kevin Longino, CEO of National Kidney Foundation, said a third of the public is at risk of developing kidney disease, and it is critical to reach the undiagnosed so kidney disease can be stopped before a patient experiences kidney failure.

“Most Americans who suffer from kidney disease don’t even know it. To raise awareness and provide them with opportunities to improve their health, we look forward to working with nephrologists, other healthcare providers, patients, payors, innovators, and public health professionals inside and outside of government,” HHS Secretary Alex Azar said in a statement.

Azar went on to say the partnership is an early step in Trump’s kidney initiative, and HHS also will reform pay and regulations.

Azar touted the 2020 end-stage renal disease final rule, and said “Americans living with kidney disease deserve access to the latest technology that will improve their health, and HHS is proud to be delivering that as part of our actions under President Trump’s executive order.”

The final rule includes provisions to increase pay for dialysis facilities that use new equipment and drugs, but one lobbyist noted that increase was limited to only two years. After that, the lobbyist said, there will be no incentive to use an innovative product. The lobbyist also raised similar concerns with the add-on payment for new drugs not providing an incentive to use the drugs once the add-on period ends and said the administration is not backing up what it says with funding and action.

John Butler, CEO of Akebia Therapeutics, said he was really happy when the kidney care executive order was signed, but it hasn’t helped get CMS to cover the use of Auryxia to treat iron deficiency anemia in patients with chronic kidney disease who aren’t on dialysis. Akebia has sued CMS over Part D not covering the FDA-approved treatment, a step Butler said the company took after attempts to discuss the issue with CMS provided no clarity on why Part D won’t cover the drug.

“The agency’s decision to deny coverage for Auryxia when used to treat IDA cannot be reconciled with (1) numerous prior decisions by CMS to cover similarly or less-favorably situated products, or (2) CMS’s coverage of Auryxia with respect to its hyperphosphatemia indication. An agency has an obligation to treat similar cases similarly and must offer a reasoned explanation for any departures from past precedents. Here, CMS has done neither,” the company states in a request for the judge to decide in Akebia’s favor.

Butler said CMS’ continued non-coverage of Auryxia is surprising, especially considering the administration's push for innovative kidney care. The drug is one of the few innovative products out there, and CMS won’t pay for it, so that leads to concerns that CMS is not adhering to its commitment with regards to supporting innovation within kidney care, Butler said.

Paul Conway, chair of policy and global affairs and immediate past president of the American Association of Kidney Patients, said it is strange that the administration put out a major executive order on innovation in kidney care while, under the surface, lower-level CMS staff’s decision on Auryxia coverage from CMS runs counter to that. He questioned how CMS could stand by its decision if kidney innovation is a national priority. The executive order is focused on patients and patient choice, but CMS’ coverage decision goes against that, he added. Conway also said he was concerned about the signal the Auryxia coverage decision sends to other companies considering innovative kidney care therapies.

Conway said executive orders and laws are important, but policy often comes down to the civil servants’ and the political appointees’ implementation of those laws and orders. -- Michelle M. Stein (mstein@iwpnews.com)