Stakeholders Criticize Payments, Measures in Mandatory ESRD Model

September 24, 2019 - Dialysis centers, major health systems, and other industry stakeholders are calling on CMS to reconsider a proposed end-stage renal disease (ESRD) model that will put providers at risk for at-home dialysis and kidney transplant rates.

The Trump Administration proposed several models earlier this year to revamp chronic kidney disease care, which affects 37 million patients and more than 726,000 with ESRD, according to the White House. Specifically, the president intends for one of the models – the ESRD Treatment Choices (ETC) Model – to reverse outcomes for patients suffering from ESRD by rewarding providers for at-home dialysis and kidney transplant use.

But adjusting Medicare payments based on at-home dialysis and kidney transplant rates would not improve outcomes for ESRD patients, industry stakeholders told CMS in formal comments on the proposal.

The measures “lack sufficient validity to serve as the basis for the payment incentives,” the Medicare Payment Advisory Commission (MedPAC) stated.

“For both the home dialysis and transplant measures, we have specific concerns about the reliability of the measurement; the comparison-to-control-group benchmarks and scoring method; the risk-adjustment method; and, in certain instances, the alignment of incentives for participants,” the industry experts continued.

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Furthermore, whether an ESRD patient recommended for a kidney transplant actually receives one is beyond the provider’s control, dialysis centers and health systems agreed.

“We strongly support CMS’s decision to undertake new regulatory efforts to increase organ supply, realizing that the main barrier to increasing transplant rates is a lack of available organs, which is entirely out of the control of the dialysis facility,” Lindsey Clemente, senior director of regulatory administration and clinical quality analytics at American Renal Associates, wrote to CMS.

ESRD providers can increase referrals to the transplant waitlist, but those referrals would not be enough to make a “realistic difference” in transplant rates, she continued.

MedPAC reported that only about 10,100 transplants occurred for Medicare beneficiaries in 2017, meaning 7,097 eligible dialysis facilities would have an average transplant rate of less than 1.5 transplants.

“Given dialysis providers have little control over who receives a kidney transplant, a scoring methodology in which 1/3rd of the weight is based on transplant rates is disproportionate and does not accurately reflect dialysis provider efforts or performance,” Fresenius Medical Care’s C.M. Cameron Lynch stated.

READ MORE: 72% of Medical Groups Oppose Mandatory Alternative Payment Models

The senior vice president of government affairs of the organization that provides ongoing dialysis treatment for more than 210,000 patients through a network of more than 2,600 dialysis facilities and 50,000 employees nationwide advised CMS to combine the transplant and home dialysis measures to “maintain visibility and to align support for home dialysis and kidney transplantation.”

The recommendation could help address concerns about the at-home dialysis measure in the ETC model.

CMS plans to increase a managing clinician’s capitated rate for home dialysis patients and the ESRD’s facility’s base rate for home dialysis treatment for the first three performance years. After that, the agency would apply a performance payment adjustment (PPA) to all payments for all dialysis treatments partly based on the provider’s at-home dialysis use.

But not all dialysis centers or health systems can or should provide at-home dialysis treatment, stakeholders overwhelmingly agreed.

“Offering home dialysis services is not always feasible or logical, given the proximity of other providers, the patient population, clinic shifts and available staff, the size of the unit and many other important factors. It would not be cost effective to provide home dialysis services at every single facility within a dialysis organization,” American Renal Associates’ Clemente explained.

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Furthermore, some ESRD providers cannot build at-home dialysis capabilities because of the current legal and market structures. That is the case for Centers for Dialysis Care, the largest non-profit, independent provider of dialysis and related health services in Northeast Ohio.

The ESRD provider is prohibited from establishing new home dialysis programs because the organization has segregated its in-center dialysis clinic operations from its home dialysis programs and the programs have their own separate provider numbers.

“Although CDC owns an equity interest in joint ventured home dialysis programs, the PPA does not set forth the manner in which aggregation of these home dialysis operations into its in-center operations is to occur, if at all, for purposes of the PPA,” Gary Robinson, president and CEO, said in his criticism of the ETC model.

While dialysis providers and health systems called for changes to the at-home dialysis PPA, the American Medical Association (AMA) urged CMS to eliminate the payment adjustment entirely.

“Even under the proposed PPA, most physicians would likely receive no change in their payments under the PPA if they successfully increase the proportion of patients receiving home dialysis because of the way the scoring methodology is defined,” the group’s CEO and executive vice president James L. Madara, MD, wrote.

Instead, Madara called for a change to the “underlying payment system for dialysis” to effectively remove the barriers of providing home dialysis, which include inadequate Medicare reimbursement for the services.

“Physicians do not need an ‘incentive’ to use more home dialysis, they need Medicare payments that are adequate,” he stressed.

In light of quality measure and payment concerns, stakeholders concurred that CMS should delay implementation of the mandatory alternative payment model for ESRD.

“ESRD providers would not be notified of participation until late 2019. As a result, providers would only have a few weeks to prepare for the new model and implement administrative requirements imposed by CMS,” Sanford Health emphasized in its comments.

Like many other stakeholders, the health system urged CMS to delay implementation of the model until late 2020 to give dialysis facilities time to evaluate the final rule and “identify space for home training rooms, recruit and train home dialysis nurses, and develop processes to promote the new program.”

CMS plans to launch the ETC model and other alternative payment models for chronic kidney disease on January 1, 2020.