Trump administration finalizes rules as part of Advancing American Kidney Health initiative
The Trump administration recently released final rules that aim to encourage greater use of home dialysis and transplantation among Medicare beneficiaries and remove financial barriers to living organ donation. Final rules are regulations that have gone through a review process, including public comment; AKF’s comment on these regulations can be found here. These final rules are part of the administration’s Advancing American Kidney Health initiative, which was launched last year with three main objectives: increase efforts to prevent, detect and slow the progression of kidney disease; provide kidney disease patients with more options for treatment; and deliver more organs for transplant.
End-Stage Renal Disease Treatment Choices (ETC) Model final rule
What is the ETC Model?
The ETC Model final rule will test whether adjusting certain Medicare payments to dialysis clinics and physicians (i.e. nephrologists) will encourage more use of home dialysis and kidney transplantation, support beneficiaries’ treatment modality choice, reduce Medicare costs and preserve or enhance the quality of care. The ETC Model is a mandatory payment model, and the Centers for Medicare and Medicaid Services (CMS) will randomly select dialysis clinics and physicians to participate based on their geographic locations. The total number of selected dialysis clinics and physicians will represent approximately 30% of adult ESRD beneficiaries in all 50 states and the District of Columbia.
What will the ETC Model do?
The ETC Model will implement two payment adjustments to dialysis clinics and physicians participating in the model:
- The Home Dialysis Payment Adjustment is a positive payment adjustment on certain home dialysis and home dialysis-related claims during the first three years of the new payment model.
- The Performance Payment Adjustment (PPA) is a positive or negative adjustment based on the rates of home dialysis and transplant for participating dialysis centers and physicians.
How will the ETC Model affect Medicare beneficiaries?
For Medicare beneficiaries receiving care from ETC Model participants, all current protections afforded under the Medicare program will still apply. Beneficiaries who receive care from an ETC Model participant will not be able to opt-out of the payment adjustments for their dialysis clinics and physicians, but they will still have the general Medicare protections of freedom of treatment choice and access to medically necessary covered services. ETC Model participants will also be required to notify patients of their participation in the ETC Model by prominently displaying informational materials wherever beneficiaries receive care.
It is important to note that the payment adjustments to dialysis centers and physicians in the ETC Model will not affect beneficiaries’ deductibles and coinsurance. Patients should not see any personal financial impact from these payment adjustments. CMS intends to closely monitor the ETC Model to ensure that it is implemented safely and appropriately, that the quality of patient care is not impacted, and that adequate patient and program integrity safeguards are in place.
The final rule will also aim to increase the number of beneficiaries who receive the Kidney Disease Education (KDE) benefit. Under existing federal regulation, the KDE benefit is currently available to Medicare beneficiaries with stage 4 kidney disease, and it allows providers to give up to six 1-hour educational sessions on choice of treatment, the management of comorbidities and other relevant topics. The current percentage of eligible beneficiaries who have been provided the KDE benefit is less than 2%. Under the new rule, CMS will now allow beneficiaries with stage 5 kidney disease and those in the first six months of starting dialysis to receive the KDE benefit. CMS will also expand the list of providers who can give KDE services to include social workers and renal dietitians.
Removing financial barriers to living organ donation
The Health Resources and Services Administration (HRSA), which is part of the U.S. Department of Health and Human Services (HHS), released two final rules related to living organ donation that aim to reduce the number of individuals on the transplant waitlist and increase the availability of organs available for transplant:
- HRSA funds a program that provides reimbursements for low-income living organ donors who lack other forms of financial support to help cover the costs of travel, lodging, meals and other costs related to donating an organ. The first final rule from HRSA allows for more expenses to be reimbursed, including lost wages and child care and elder care expenses incurred by a primary caregiver.
- HRSA’s second final rule increases household income eligibility for reimbursement to 350% of the poverty level (up from 300%) for living organ donors and organ recipients. The final rule also describes exceptions to this income eligibility threshold for individuals who can demonstrate financial hardship.