Ardelyx sues CMS about plan to place phosphate binders into ESRD payment bundle
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Key takeaways:
- A CMS proposed rule would place oral phosphate therapies into the Medicare bundled payment for dialysis.
- Ardelyx is the maker of Xphozah, an oral phosphate binder that would be included in the payment bundle.
Ardelyx Inc. is leading a lawsuit against CMS about plans by the agency to include oral-only phosphate-lowering therapies into the End-Stage Renal Disease Prospective Payment System by January 2025.
The company, which manufactures Xphozah (tenapanor), an oral phosphate binder approved in October 2023 by the FDA to treat hyperphosphatemia, is partnering with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum, a health care research, education and advocacy organization, in filing the lawsuit.
“Inclusion of oral-only phosphate lowering therapies (PLTs) within the bundled ESRD [Prospective Payment System] PPS limits patient choice and timely access to important innovations and treatment options for unmet needs,” Ardelyx said in a press release.
When CMS implemented the PPS and payment bundle for dialysis providers in 2011, the agency agreed to delay the inclusion of payment of oral drugs into the bundle until 2014 to gather data on usage. That allowed nephrologists to continue to bill Medicare separately for oral drugs they prescribed to patients on dialysis.
Congress has intervened numerous times on behalf of the kidney community to delay the inclusion of oral drugs until 2025, which is part of the proposed rule CMS released earlier this month to place oral drugs like Xphozah for patients on dialysis into the payment bundle for next year.
Aside from the lawsuit, legislation has been introduced in Congress this year to again delay inclusion of oral drugs into the bundle until 2033.
In a fact sheet on its proposed rule, CMS wrote that inclusion will “increase access to these drugs, as we have seen previously that incorporating Medicare Part D drugs into the ESRD PPS has had a significant positive effect on expanding access to such drugs for beneficiaries who do not have Medicare Part D coverage, with significant positive health equity impacts.”
The lawsuit claims that CMS has violated its statutory and regulatory authority under the Medicare Improvements for Patients and Providers Act (MIPPA), which established the ESRD PPS bundled payment system for dialysis services in 2008, according to the release. The CMS plan to bundle oral-only drugs under the PPS “is inconsistent with MIPPA’s statutory provision and contradicts CMS’s own regulations,” Ardelyx said in the release.
“It is abundantly clear that moving Xphozah and other PLTs into the ESRD PPS will result in the imposition of severe care choice and timely access restrictions for all dialysis patients,” Mike Raab, president and CEO of Ardelyx, said in the release. “The planned move by CMS will continue to create disincentives for the development of new and important medicines that can improve patient health and address unmet needs in an already underserved therapeutic area.
“This lawsuit attempts to stop CMS’s continued harmful statutory overreach and better protect dialysis patients’ choice and timely access to important new therapies,” Raab said.
The AAKP said placing PLTs in the ESRD payment bundle would limit access to the drug. “Phosphorus management is a critical issue for many kidney patients on dialysis, and status quo therapies are highly burdensome to patients and are limited in their effectiveness across the kidney population,” the AAKP said in a press release. “More effective phosphorus management therapies have long been considered an unmet need by both patients and medical professionals.
“CMS's plan to bring oral only drugs into the bundle is not only bad public policy, but also fully inconsistent with applicable law, CMS's own regulations, and its decades long commitment to improve the health of Americans suffering from life-threatening kidney disease,” the AAKP said.
Reference:
Fact Sheet: Calendar Year 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Proposed Rule (CMS-1805-P). https://www.cms.gov/newsroom/fact-sheets/calendar-year-2025-end-stage-renal-disease-esrd-prospective-payment-system-pps-proposed-rule-cms. Published June 27, 2024. Accessed July 22, 2024.
Largest kidney patient group joins lawsuit against Medicare. https://aakp.org/largest-kidney-patient-group-joins-lawsuit-against-medicare/. Published July 18, 2024. Accessed July 22, 2024.
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