Drug coverage in the ESRD payment bundle is a guessing game for dialysis providers
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Support of research and innovation in health care is one of the few areas of bipartisan agreement in Washington, D.C.
But for innovation to spread, government policies must do more than fund research; these policies must also ensure that patients gain easy access to those innovative treatments. Unfortunately, CMS policies might do the opposite in the case of Korsuva, the medication approved and awarded breakthrough status by the FDA in 2021.
Korsuva (difelikepahlin), a kappa-opioid receptor agonist, is the first and only drug to effectively treat chronic kidney disease-associated pruritus (CKD-aP).
CMS and TDAPA
In 2016, CMS introduced the Transitional Drug Add-on Payment Adjustment (TDAPA) to accommodate payment for calcimimetics.1 Until then, Sensipar (cinacalcet), an oral form of calcimimetics, was covered under Medicare Part D. With the introduction of Parsabiv, an IV equivalent of oral cinacalcet, CMS instituted TDAPA to pay separately for these drugs for 2 years at average sales price (ASP).
At the end of the TDAPA period, CMS agreed to add $9.93 to the bundle based on the utilization of the drug and the number of Medicare dialysis treatments during that period.
Under the notion that the calcimimetics did not belong to any of the 11 functional categories, CMS decided to put additional funds into the bundle to help dialysis providers cover the cost of the drug.
Pruritus and ESRD
More than 780,000 Americans have end-stage renal disease. Approximately half a million Americans require regular dialysis treatments or a kidney transplant. 2 In this population, the prevalence of severe pruritus ranges from 12.7% to 25.5%.3 This condition causes severe chronic itching, resulting in difficulty sleeping, depression, poor quality of life (QoL) and early mortality. Often the itching is so intense that patients develop open sores on their skin due to scratching. Consequences of CKD-aP, in turn, leave patients more susceptible to skin and systemic infections.
For patients with ESRD, the development and approval of Korsuva represented an important treatment innovation.
While physicians and patients are grateful to see this treatment approved, tens of thousands of patients with ESRD might not gain full access to this drug due to CMS policies. The problem lies with how CMS reimburses dialysis facilities for medications used to treat CKD-aP.
Payment policy
CMS will reimburse facilities for using Korsuva through TDAPA, which means that CMS will pay dialysis facilities the ASP for at least 2 years.
But CMS is not likely to add more money into the bundle as it did with calcimimetics after the TDAPA period. Why? Because CMS assumes that Korsuva is a replacement for the traditional anti-itching medications, such as antihistamines, which are already included in one of the 11 functional categories of drugs in the original bundled payment systems.
Korsuva will likely cost more than the traditional, although ineffective, anti-itching medications currently included in the bundle. If CMS decides not to put additional money in the bundle after the TDAPA period, financial constraints will reduce the availability of Korsuva to patients with ESRD. Because Korsuva will be included in Medicare Part B and can only be administered intravenously at the end of each dialysis treatment, patients with ESRD would be at the mercy of the dialysis provider to approve and administer this therapy.
Cost vs. patient care
This ambiguity would also pose a moral and ethical dilemma for the treating physician, who may not have the authority to override the policy decisions of the dialysis facility. CKD-aP is a patient-centric concern, affecting QoL (as measured by the kidney disease QoL measurement), quality of sleep and depression (measured by Pittsburgh Sleep Quality Index and Beck’s Depression Inventory, respectively).
No additional funds to the bundle after the TDAPA period means there will likely be no economic incentive to use Korsuva. The uncertainty associated with the TDAPA policy challenges patients with ESRD and their providers and reduces the drive to innovate in this specialty.
TDAPA and its close cousin, Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES), are flawed concepts to encourage innovation in a bundled environment. Without additional funding after the TDAPA and TPNIES period, widespread use of these new drugs and technologies would languish due to the economic burden placed on the dialysis providers. I believe CMS is disingenuous in using TDAPA and TPNIES as a teaser to introduce these drugs and technologies to patients with ESRD with no guarantees that these would be used on an ongoing basis after TDAPA or TPNIES. An alternative suggested and rejected by CMS is using the “AY” modifier as we do with antibiotics administered for infections unrelated to renal dialysis.
Pharmaceutical companies invest significant resources into developing new drugs and treatments with the expectation that – if effective – these treatments will eventually be accessible to patients to improve their QoL. When CMS policies decline to pay for these treatments, it disincentivizes a more significant investment in innovation in these specialties, especially in areas like kidney disease, which have seen little innovation for decades.
Access to new and effective treatments is critical to addressing the racial and socioeconomic disparities in the U.S. health care system. Patients with kidney disease are disproportionately from communities of color. ESRD prevalence is nearly four times higher for Black patients – and 1.3 times higher among Hispanic patients – than for white patients.
CMS policies should seek to close this gap, not exacerbate it. If the Biden administration fails to move CMS policies in a more equitable and innovative direction, it will signal to millions of Americans with kidney disease, primarily those in underrepresented groups, that the status quo is inevitable and their pain is not a priority.
It will also signal to the pharmaceutical industry and health care innovators that their work, while necessary, may be in vain.
- References:
- ESRD PPS Transitional Drug Add-on Payment Adjustment. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/ESRD-Transitional-Drug. Published March 24, 2022. Accessed June 17, 2022.
- Kidney Disease Statistics for the United States, National Institute of Diabetes & Digestive and Kidney Diseases. www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Published September 2021. Accessed June 17, 2022.
- Verduzco HA, et al. Kid. Intl Reports. 2020;doi:10.1016/j.ekir.2020.04.027.
- For more information:
- J. Ganesh Bhat, MD, FASN, is co-principal in Atlantic Dialysis Management Services LLC, and Chancellor and professor emeritus at Xavier University School of Medicine, Oranjestad, Aruba.
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