Professional associations in nephrology, dialysis providers and patient groups joined recent criticism by the Medicare Payment Advisory Commission in telling CMS Administrator Seema Verma to drop plans to implement the ESRD Treatment Choices model this January.
The agency received 330 responses to the proposed incentive plan before ending the comment period on Sept. 16.
“[Fresenius Medical Care North America] FMCNA is eager to work with HHS to realize the ambitious goals set forth in the executive order,” the company wrote in its comments about the plan. “As a start, the growth rate for home modalities at FMCNA is eight times the growth rate for in-center dialysis. While we would welcome a change in the payment system that prioritized these outcomes, the [ESRD Treatment Choices] ETC model as drafted includes serious methodological flaws that make the model unworkable for providers and will undoubtedly lead to unintended consequences for patients.”
Like MedPAC, Fresenius was critical of the fundamental approach CMS was taking in an effort to increase the number of home dialysis and transplant patients during the next 6 years.
“To grow home dialysis in the best interest of beneficiaries, dialysis providers must be able to plan for investments in resources and capacity. It is clinically irresponsible to set achievement targets that are arbitrary and unsupported by evidence and performance data,” Fresenius wrote. “Setting targets that are reflective of experience in other countries with dissimilar regulatory and payment structures is unrealistic. This is especially true given the high penetration of staff-assisted home dialysis in other countries compared to the near absence of those models in the U.S. due to regulatory restrictions.”
In a joint letter to Verma, the Renal Physicians Association, the American Society of Nephrology and the National Kidney Foundation said the implementation date of January for the ETC was premature.
“We believe the success of all participants in the model would be enhanced by providing more time before commencing the ETC model date for stakeholders to prepare starting April 1, 2020. We also believe the success of the model would be enhanced by using the rulemaking process throughout the life of the model,” according to the letter.
Reduce the size of the demonstration
Others, such as the Rogosin Institute, also said the model should be used for a smaller sample size — about 25% of patients — and a phase-in period should take place.
“To allow organizations to develop the infrastructure necessary to achieve results consistent with the goals of the ETC model, we suggest a phase-in period so that during the first year, a smaller number of facilities and patients are included. ... Increasing the scope of the model in subsequent years to 25% to achieve full statistical power would allow providers to build out their infrastructure and avoid the unintended consequence of depriving patients excluded from the model of the care they need and deserve,” the group wrote.
The expanded growth of home dialysis patients could also leave both staff and patients unprepared for those who move back to in-center care, the American Nephrology Nurses Association (ANNA) noted in its response to the ETC proposed rule.
“ANNA is extremely concerned that the kidney community and dialysis industry is currently unprepared for the increased number of patients that will transition to home therapy under the proposed rule,” the group wrote. “ANNA feels strongly that the current staffing model for in-center dialysis care is insufficient for the number of patients who will fail or experience complications requiring them to leave home therapy and return to in-center care at least temporarily. More importantly, ANNA fears that the proposed payment model and incentive for home dialysis therapy may stimulate the encouragement of both incident and prevalent ESRD patients to choose home dialysis when they may not be clinically appropriate or ready for this modality leading to a high failure rate.”
Harsh criticism from MedPAC
ETC is one of several payment models that CMS is proposing as part of its effort to implement Advancing American Kidney Health, an executive order announced by President Donald J. Trump on July 10. The proposed rule, which would involve more than 200,000 patients on dialysis, offers nephrologists and dialysis providers up to 3% in additional payments if they increase their home dialysis and transplant population.
In a 15-page letter sent Sept. 3 to Verma, MedPAC Chair Francis J. Crosson, MD, said the commissioners had “significant methodological concerns such that we believe CMS should not implement the proposed ESRD Treatment [Choices] ETC model.
“We believe the proposed measurement of home dialysis and kidney transplantation rates in the [performance payment adjustment] PPA lack sufficient validity to serve as the basis for the payment incentives. 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,” Crosson wrote.
MedPAC commissioners were also concerned that the ETC does not measure beneficiary experience.
“Given the ETC model’s potential effect on beneficiaries’ care, we urge CMS to implement a more formal approach to assess beneficiaries’ experiences, such as developing a home dialysis [Consumer Assessment of Healthcare Providers and Systems] CAHPS instrument. Assessing patient experience is a key component in the commission’s principles for measuring quality. These concerns also apply to monitoring the experience of beneficiaries undergoing a transplant,” according to the letter.