By Surabhi Dangi-Garimella, PhD

Medicare’s Proposed Rule for the End-Stage Renal Disease (ESRD) Payment Model for Calendar Year 2022 was published on July 9, 2021. Established in 2011, this payment ‘bundle’ provides an adjusted payment to an ESRD facility for each dialysis treatment that a patient receives at the facility or at a beneficiary’s home, along with certain other services. However, the new adjustments may create access barriers for patients.

The ESRD bundle includes payment for drugs, lab services, supplies, and capital-related costs for maintenance dialysis. Additionally, there is provision for high-cost outliers who may experience variations in their condition that need additional care. An add-on payment adjustment for new drugs or biologicals and for new types of dialysis equipment has been built into the calculation, and $10 have been added to the CY 2021 bundled payment base rate to cover the cost of calcimimetics for all ESRD patients—a cost that was earlier billed separately.

A Focus on Health Equity

One in three Americans are at risk for kidney disease, and among those, minority populations are particularly vulnerable because kidney disease can develop as a result of certain underlying chronic conditions that minorities are more prone to, including hypertension, diabetes, and obesity. Black populations are at a four-times greater risk of developing kidney disease while Hispanics are 1.3-times more likely to develop kidney disease compared to whites. Inequitable access to healthcare services can lead to rapid development and progression of kidney disease among minority populations, many of whom may not even be aware of their underlying health condition or its association with kidney failure.

Certain changes to the 2021 payment model have, for the first time, focused on health equity. CMS has offered participants the opportunity to address health disparities—they can improve their scores by reducing transplant rates and increasing home dialysis, especially among patients from low socioeconomic backgrounds, many of whom are from minority populations.

  • A Health Equity Incentive has been added for facilities that can improve home dialysis and transplantation rates among dual eligible beneficiaries (Medicare + Medicaid) or those eligible for low-income-subsidy (LIS)
  • Benchmarks would be adjusted for those who serve a high volume of dual-eligible and LIS dialysis patients, so that they don’t face negative financial consequences

However, advocacy organizations are unhappy with the step therapy approach being followed by certain centers around the use of calcimimetics. The National Hispanic Medical Association (NHMA) has called on CMS to review the fail-first/step therapy policy being followed by several dialysis organizations. Not all ESRD patients need calcimimetics—only those who have hormonal imbalance that can cause hyperparathyroidism and lead to calcium deposits in vital organs need them. Among those who need this treatment, however, some may specifically need an intravenous infusion because they are intolerant to the oral drugs. Others may have failed to respond to oral calcimimetics. 

According to NHMA, implementing step therapy in patients who have failed to respond or are intolerant to oral calcimimetics can be detrimental to patient health. The organization has called on CMS to to develop necessary quality measures for secondary hyperthyroidism to monitor the impact of this protocol change on patient care.

 

Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.