CMS should keep oral phosphate-lowering therapies outside the dialysis payment bundle
Click Here to Manage Email Alerts
As a nephrologist, it is my mission to promote equal health care access and to end racial disparities in the care of patients with kidney disease.
More than 37 million Americans have chronic kidney disease, and Black people are disproportionately affected, being 4.2 times more likely to develop kidney failure compared with white people.
The General Accounting Office (GAO) recently released a report reviewing plans by CMS to include phosphate-lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (PPS) by 2025. In the report, the GAO wrote the addition of PLTs “may require dialysis organizations to expand their capacity to dispense high volumes of the drugs.”
The GAO also wrote that, “All dialysis organization representatives GAO interviewed anticipate needing to expand their existing capacity to dispense oral drugs. They attributed this need, in part, to the high volume of phosphate binder prescriptions.”
The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
CMS officials told the GAO that it expects that it will be feasible for dialysis organizations to make necessary operational changes and it would assess the adequacy of payments. While the GAO report provides a snapshot of CMS’s plans to include phosphate binders in the bundled payment, it fails to address whether including PLTs in the bundle is the best option for patients living with kidney disease.
Silent disease
One of every seven people in the United States has kidney disease, and most — as high as 90% — do not know they have it. Diabetes and hypertension (two diseases that disproportionately plague the Black community) are the leading causes of kidney disease. Due to the fact these illnesses are often “silent,” the initial presentation of CKD these illnesses cause is often overlooked as well. Most of my patients whom I diagnose with CKD are surprised to hear of the diagnosis.
Kidneys are efficient organs. Not only do these organs filter the blood to get rid of excess toxins, but kidneys also prevent anemia, activate vitamin D, help to control blood pressure and filter out excess electrolytes and minerals like phosphorus. When patients have severe CKD, they are no longer able to filter out the phosphorus in their blood properly, leading to dangerously high levels or hyperphosphatemia.
Fortunately, there are effective prescription PLTs available, including phosphate binder pills, as well as one phosphate blocker that received FDA approval in October 2023. However, if this class of medicines is placed in the ESRD bundle, it may limit patients’ ability to access these treatments.
Bone fractures
When patients with hyperphosphatemia do not have proper access to PLTs, they experience complications such as bone fractures, heart disease, strokes and even death. Finding the right PLT for a patient is an individualized task. What works for one patient may not work for the other. Therefore, it is of the utmost importance as a nephrologist that I have the ability to prescribe the best PLTs for my patients. If PLTs are shifted into the ESRD payment bundle, it will interfere with patient-doctor shared decision-making and move patients like mine to protocol-based treatment. It is also critical that these life-saving medications are affordable for all patients.
Four out of five patients on dialysis have elevated blood phosphorus levels requiring PLTs. Given that Black people make up more than 35% of patients on dialysis (but only 13.2% of the U.S. population), Black people are disproportionately affected.
Additionally, kidney patients of color are far less likely to receive kidney transplants than white patients, leaving them on dialysis for a longer time. Historically underrepresented groups and low-income patients are also more likely to live in food deserts, with a limited ability to obtain low phosphorus-containing foods, especially given that phosphorus is a common additive in processed and packaged foods. Restricting access to PLTs would certainly increase burden on those communities and worsen health disparities.
To give all patients with kidney disease the best access to quality health care and to prevent worsening health inequities, it is imperative that oral PLTs be kept out of the ESRD payment bundle. If PLTs are placed in the PPS, underserved patients will be the most negatively impacted.
The Kidney Patient Act (H.R. 5074), bipartisan federal legislation sponsored by Rep. Earl L. “Buddy” Carter, R-Ga., and now with 10 co-sponsors, would delay the decision by CMS from moving PLTs into the ESRD payment bundle and ensure kidney patients can continue to easily get the medication they need. The legislation needs support from the kidney community.
- References:
- General Accounting Office. CMS plans for Including phosphate binders in the bundled payment. November 2023. GAO-24-106288. Accessed Dec. 14, 2023.
- https://www.congress.gov/bill/118th-congress/house-bill/5074?q=%7B%22search%22%3A%22H.R.+10%22%7D&s=1&r=53. Accessed Dec. 14, 2023.
- For more information:
- Frita McRae Fisher, MD, is the founder and president of Midtown Atlanta Nephrology PC.
Collapse
Read more about
Click Here to Manage Email Alerts