Patient Choice Limited by CMS Violations of
Legal and Regulatory Authority
CMS Overreach Impacts Timely Access to
Phosphorus Therapy Innovations
WASHINGTON, July 18,
2024 /PRNewswire/ -- The American Association of
Kidney Patients (AAKP), the largest and oldest
independent kidney patient organization in the United States, today issued a formal
statement in regard to a lawsuit it has joined against the Centers
for Medicare and Medicaid Services (CMS), a U.S. Department of
Health and Human Services agency (HHS), responsible for
safeguarding the health of individuals living with chronic kidney
disease (CKD) and kidney failure as well as the interests of
American taxpayers.
The legal action joins AAKP with the National Minority Quality
Forum (NMQF), a Washington, D.C.
based nonprofit research and advocacy organization, and
Ardelyx, a Waltham, Massachusetts
based biopharmaceutical company. The lawsuit targets federal
statutory and regulatory overreach in the form of CMS's decision to
include oral-only phosphate-lowering therapies (PLTs) in the CMS
End-Stage Renal Disease (ESRD) Prospective Payment System (PPS).
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. More effective phosphorus management therapies have
long been considered an unmet need by both patients and medical
professionals.
In 2023, the U.S. Food and Drug Administration (FDA) approved a
safe, new oral therapy for dialysis patients that is viewed by both
patients and medical professionals as being less burdensome and
more effective for many patients. Failure to adequately manage high
serum phosphorus, or hyperphosphatemia, in kidney patients can lead
to severe medical complications, costly medical interventions, and
a markedly higher risk of death from cardiovascular disease. HHS
and CMS officials responsible for kidney patient health have access
to, and are aware of, research studies documenting these risks,
including research data and fact sheets published by the U.S.
National Institutes of Health (NIH).
AAKP FORMAL STATEMENT
"The American Association of Kidney Patients (AAKP) was left
with no choice but to join this lawsuit due to the lack of
responsiveness by federal officials at the Center of Medicare and
Medicaid Services (CMS) to the legitimate, and well known, concerns
and unmet needs of kidney patients in regard to care choice and
timely access to innovations in phosphate lowering therapies. AAKP
has, since 1969, advanced the principles of greater patient care
choice, protection of the patient doctor relationship, and
alignment of regulatory and payment policies to support treatments
that protect patient lives and reduce taxpayer costs associated
with chronic disease and severe illness. Based on our careful
review of CMS's proposed plan to eliminate separate payment under
Medicare Part D for oral only drugs vital to the continued health
of patients on dialysis, we believe the agency has failed to
protect the best interests of the highly diverse kidney patient
population, the medical professionals charged with their care, and
American taxpayers. Further, we believe CMS's plan to pay for oral
only medicines through the ESRD bundled payment system will reduce
patient care choice and timely access to important medications for
dialysis patients, stymie desperately needed innovation, and
exacerbate the very inequities in kidney patient care CMS publicly
claims to be an agency priority. 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."
About the American Association of Kidney Patients (AAKP):
Since 1969, AAKP has been a patient-led organization driving policy
discussions on kidney patient care choice and medical innovations
to improve patient lives and prevent avoidable illness, disability
and death. AAKP advocates played a central role in the
Congressional authorization of Medicare coverage for dialysis and
transplantation (1972), signed by President Richard Nixon (1973), which evolved into the
modern End Stage Renal Disease Program. Over the past decade, AAKP
patient advocates have helped advance the passage of the bipartisan
law modernizing the Organ Procurement and Transplant Network (OPTN)
via greater competition and oversight (2023); lifetime transplant
drug coverage for kidney transplant recipients (2020); the
presidential Executive Order on Advancing American Kidney
Health (2019); new job protections for living organ donors
under the Family Medical Leave Act (FMLA) via the U.S. Department
of Labor (2018); and Congressional legislation allowing
HIV-positive organ transplants for HIV-positive patients (2013).
Follow AAKP on social media at @kidneypatient on Facebook,
@kidneypatients on Twitter, and @kidneypatients on Instagram, and
visit http://www.aakp.org for more information.
MEDIA CONTACT:
Jennifer
Rate
Director
Communications & Digital Operations
jrate@aakp.org
(813) 400-2394
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SOURCE American Association of Kidney Patients