September 15, 2022
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD 21244-8013
Subject: Improving Medicare Beneficiary Access to Chronic Kidney Disease Treatment
Dear Administrator Brooks-LaSure,
On behalf of the undersigned organizations, we write to share our concern about the growing problem of chronic kidney disease (CKD) in our country, particularly in the Medicare beneficiary population. As providers and advocates representing patients impacted by CKD, it is our firm belief that Medicare should build upon its recent efforts and improve beneficiary access to CKD treatments.
CKD is a Key Driver for Medicare Spending
More than half of U.S. adults aged 30 to 64 are expected to develop CKD in their lifetime a devastating condition affecting an estimated 37 million Americans that accounts for more than 20% of total Medicare spending. Further, recent estimates show that Medicare alone currently spends more than $120 billion annually on CKD and end stage renal disease (ESRD). With CKD projected to grow from 15% of the U.S. population to nearly 17% and with more than 90% of patients still undiagnosed, the future cost burden of CKD is enormous.
In 2019, treating Medicare beneficiaries with CKD cost the U.S. taxpayers $87.2 billion, and treating patients with ESRD cost an additional $37.3 to the Medicare program. Hemodialysis care alone, the type used by 90% of patients, costs Medicare an average of $90,000 per patient annually in the U.S., totally $28 billion.
As CKD progresses, the drivers of rising costs are consistent between commercial and Medicare patients. Both Medicare and commercial health plans generally see a cost increase of 80% as CKD progresses to later stages and finally into ESRD.
Barriers Exist that Block Treatments, Waste Money, and Exacerbate Health Disparities
After decades with few options, we now have new testing methods to identify patients with CKD and treatments to preserve their kidney function through early intervention. However, health system roadblocks, particularly in Medicare Advantage and Part D plans, prevent patients – and a disproportionate number of patients of color – from accessing care and treatments. This is particularly distressing given the priority that CMS has placed on CKD and kidney care.
Utilization management strategies and other access barriers used by payers block access to treatments that can reduce kidney failure and the likelihood of dialysis. While these barriers to testing and treatment ultimately hurt the health and well-being of patients the most, the lack of access to CKD management has a significant downstream impact on the broader health system, and on the Medicare program and taxpayers, more specifically.
Even with coverage, payer cost-sharing requirements can serve as an insurmountable barrier to treatment. When health plans do cover newer CKD treatments, many patients are unable to access them due to high cost-sharing requirements imposed on patients by Medicare health plans and PBMs. These burdens greatly exacerbate existing inequities as we see in prescription abandonment rates, with Black patients abandoning treatment at greater rates than white and Hispanic patients at the same out-of-pocket level. In Part D programs, Black patients also have the highest abandonment rate overall.
Improved Access to Better Screening and New Treatments Will Improve Lives and Drive Down Costs
With Medicare as a catalyst, the health system must do more to prevent CKD progression in patients and bridge health equity divides in kidney disease management. This must start with increased screening and greater access to the latest treatment options.
Although diagnosis and treatment for CKD have improved, too few patients are benefitting from these innovations due to general lack of awareness, insufficient health care provider education, inefficient resources, inadequate guideline adherence, and health plan access barriers.
The U.S. Department of Health and Human Services is aware of this problem, which is why the agency has a goal to reduce the incidence of ESRD by 25% by 2030 through improved surveillance and adoption of interventions aimed to reduce the progression of CKD.
Prevention has the potential to save money and lives. If treatment options are not made available by plan sponsors, the costs to patients and the health care system will be significant. Patients with CKD need CMS to provide appropriate course-corrections in the CKD therapeutic area to ensure that plan sponsors reduce barriers to treatments that can improve their health outcomes and quality of life and lower overall system costs.
Advancements in diagnostic testing and treatment cannot begin to stem the tide of the CKD burden in our country if patients cannot access them in the first place. CMS should investigate the current prescribing trends of CKD therapies and provide oversight to ensure Medicare Part D plan sponsors’ use of prior authorization, step therapy, and quantity limits is consistent with best practices. The Biden Administration has made a commitment to ensuring people with Medicare who suffer from CKD have easy access to quality care and treatment options, including the President’s Executive Order on Advancing Racial Equity and Support for Underserved Communities and CMS’ proposed actions that aim to close health equity gaps.
Our groups celebrate these commitments. However, Medicare plan sponsors continue to block access to the latest testing and treatments, which raises additional concerns about the potential for discrimination against marginalized communities facing access disparities and who struggle to navigate coverage exclusions and overly restrictive formularies.
We, the undersigned organizations, are dedicated to improving the health of the patients and communities we serve. We are deeply concerned about the growing challenge of CKD for patients within the Medicare population and its disproportionate impact on our most vulnerable. We know that greater access to CKD testing and treatments has the opportunity to put a stop to this alarming trend.
We stand ready to assist CMS in building upon its recent efforts to improve Medicare beneficiary access to CKD testing and treatment. Please contact Michael Ly, Director of Public Policy at the American Kidney Fund, at [email protected] with any questions.
Alliance for Patient Access
American Kidney Fund
Diabetes Leadership Council
Diabetes Patient Advocacy Coalition
National Kidney Foundation
National Minority Quality Forum
NephCure Kidney International
The diaTribe Foundation
Renal Physicians Association
CC: Erin Richardson, Chief of Staff, Office of the Administrator, CMS
Meena Seshamani, M.D., PhD, Deputy Administrator and Director, Center for Medicare, CMS
LaShawn McIver, M.D., Director, Office of Minority Health, CMS
Emily A. Mace, Rep. Larry Bucshon (R-IN), Congressional Kidney Caucus
Abraham B. Friedman, Rep. Suzan DelBene (D-WA), Congressional Kidney Caucus
Vincent Evans, Rep. Joyce Beatty (D-OH), Executive Director, Congressional Black Caucus
Remmington Belford, Communications Director, Congressional Black Caucus
Liam Taggart Forsythe, Rep. Nanette Diaz Barragán (D-CA), Congressional Hispanic Caucus
Stephanie M. Palencia, Executive Director, Congressional Hispanic Caucus
Rani B. Williams, Rep. Sharice Davids (D-KS), Congressional Native American Caucus
Sofia A. Deiro, Rep. Tom Cole (R-OK), Congressional Native American Caucus
Nisha Ramachandran, Executive Director, Congressional Asian Pacific American Caucus
Elizabeth Lacy Nelson, Rep Judy Chu (D-CA), Congressional Asian Pacific American Caucus
Maria Costigan, Rep. Joe Courtney (D-CT), Congressional Primary Care Caucus
Ian T.A. Whitson, Rep. David Rouzer (R-NC), Congressional Primary Care Caucus
Amber Bivins Ray, Rep. Lisa Blunt Rochester (D-DE), Congressional Primary Care Caucus
Casey R. Quinn, Rep. Brad Wenstrup (R-OH), GOP Doctors Caucus
Hannah D. King, Rep. Andy Harris (R-MD), GOP Doctors Caucus
Jacquelyn A. Incerto, Rep. Michael Burgess (R-TX), GOP Doctors Caucus