On September 18, 2020, the Centers for Medicare & Medicaid Services (CMS) released its long-awaited Specialty Care Models to Improve Quality of Care and Reduce Expenditures final rule (link) and the Health Resources and Services Administration (HRSA) released its Removing Financial Disincentives to Living Organ Donation final rule (link) and updated guidelines (link). These rules implement various specialty care models and revise the following policies:
- Implements the new mandatory ESRD Treatment Choices (ETC) payment model
- Adjusts payments to clinicians who receive the monthly capitation payment (MCP)
- Adjusts payments for ESRD facilities that are selected to participate in the Model
- Encourages the use of transplantation and home therapies
- Will cover the care of approximately 30 percent of adult ESRD patients[1]
- Model will last from January 1, 2021 to June 30, 2027
- Implements the new mandatory Radiology Oncology (RO) model
- Includes prospective, episode-based payments that are site-neutral, modality agnostic, and tied to quality for providers of radiotherapy treatment
- Will cover approximately 30 percent of radiotherapy episodes nationally[2]
- Model will last from January 1, 2021 to December 31, 2025
- Expands program eligibility and scope of reimbursable expenses for living organ donors
Over the past year, the Administration has taken various actions to help fulfill its vision of an improved health care system for people suffering from kidney disease. In July 2019, the White House issued an Executive Order on Advancing American Kidney Health[3] with an accompanying report that included actionable goals.[4] Additionally, since 2014, Congress and HHS have explored ways to test models for radiotherapy that simplify payment, reduce potential abuse, and improve care coordination and quality.
CMS Begins New Mandatory ESRD Model January 1, 2021
CMS finalized its ESRD Treatment Choices (ETC) model, which is an alternate payment model for the care of patients with chronic kidney disease (CKD). CMS notes that about 20 percent of total Medicare costs are related to persons with CKD and believes that this model will both reduce costs and improve patient outcomes. The ETC model builds upon the Comprehensive ESRD Care (CEC) Model ending in 2020 and it incorporates design elements from other CMS models (e.g., Direct Contracting). Additionally, the new model is supplemented by four other voluntary models: Kidney Care First (KCF) for nephrology practices and Comprehensive Kidney Care Contracting (CKCC) with its three distinct payment options.
The ETC model goes into effect on January 1, 2021 and will be mandatory for dialysis facilities and managing clinicians in randomly selected geographic areas across all 50 states and the District of Columbia that represent about 30 percent of the adult ESRD population.[5] CMS states that the model is required for certain providers in order to minimize selection effect and allow any resulting data to be broadly representative of the country and informative for potential future policy-making.
The ETC model is focused on encouraging home hemodialysis and kidney transplants and its aim is for providers to invest in care coordination programs that will increase patient choice, reduce Medicare expenditures, and improve outcomes. The ETC model includes two payment adjustments:
- Home Dialysis Payment Adjustment (HDPA), will be a positive adjustment on certain home dialysis and home dialysis-related claims during the initial 3 years of the model and
- Performance Payment Adjustment (PPA), will be a positive or negative adjustment on dialysis and dialysis-related Medicare payments, for both home dialysis and in-center dialysis, based on ESRD facilities’ and Managing Clinicians’ rates of home dialysis, and of kidney transplant waitlisting and living donor transplantation, among attributed beneficiaries during the applicable model year (MY).
These adjustments will be made to the adjusted ESRD PPS per treatment base rate under the ESRD PPS for selected ESRD facilities and to the MCP for selected Managing Clinicians. Greater positive and negative adjustments for Model participants will be phased in over the duration of the Model.
CMS Begins New Mandatory RO Model January 1, 2021
CMS also finalized its Radiation Oncology (RO) model, which tests whether prospective episode-based payments to physician group practices (PGPs), hospital outpatient departments (HOPDs), and free-standing radiation therapy (RT) centers will reduce Medicare expenditures while preserving quality of care. The RO model is mandatory for all RT providers and suppliers within selected geographic areas that cover approximately 30 percent of episodes. The RO model begins January 1, 2021 and lasts for 5 years.
The RO model includes prospective payments for certain RT services furnished during a 90-day episode for the treatment of certain types of cancers and for certain beneficiaries. Other model details include:
- Includes 16 cancer types under the following criteria: commonly treated with radiation, make up the majority of all incidence of cancer types, and have demonstrated pricing stability;
- Includes beneficiaries with a diagnosis of at least one of the cancer types included in the RO Model and who receive RT services from a participating provider or supplier in one of the selected CBSAs;
- Episode payments are prospectively in the RO Model, meaning that half of the episode payment amount is paid when the episode is initiated, and the second half is paid when the episode ends;
- Payments are for select RT services furnished during an RO episode and will be split into two components – the professional component (PC) and the technical component (TC);
- Payments are site-neutral; and
- Incorporates withhold for quality, which can be earned back based on reporting and performance.
The RO model qualifies as an Advanced Alternate Payment Model (APM) and a MIPS APM under the Quality Payment Program (QPP).
HHS Expands Eligibility for Living Donor Reimbursement and Will Now Reimburse Incidental Non-Medical Expenses
Though HHS has reimbursed certain living donor medical expenses for over 20 years, this rule signifies the first time that the Secretary has determined that certain “incidental non-medical expenses” are appropriate for reimbursement (e.g., lost wages and child and elder care). These expenses are reimbursed through the Living Organ Donation Reimbursement Program that is administered by the National Living Donor Assistance Center (NDLAC).[6]
Congress specifically authorizes reimbursement for “incidental non-medical expenses” incurred by living organ donors but up to now, HHS has not used this authority as it is an historically sensitive issue. HHS regularly evaluates and adjusts expense reimbursement so as to remove disincentives without creating incentives that may encourage persons to become living donors in order to generate income.
The HRSA final rule and accompanying guidelines implements Section 8 of the Advancing American Kidney Health Executive Order (E.O. 13879), which directs HHS to propose a regulation allowing living organ donors to be reimbursed for related lost wages, child-care expenses, and elder-care expenses. In the final rule and accompanying guideline, HRSA implements or updates the following policies:
- Increases the household income eligibility threshold to 350 percent of the HHS Poverty Guidelines (from the current threshold of 300 percent) for living organ donors and organ recipients;
- Clarifies the use of the existing preference categories in relation to the proposed household income eligibility threshold; and
- Clarifies that travel and subsistence expenses incurred by non-directed living organ donors qualify as reimbursable expenses under the Program.
In the final rule, none of the commenters opposed HRSA’s proposals and most commenters proposed further expansion of the Program.
[1] Areas selected for participation: https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model
[2] Areas selected for participation: https://innovation.cms.gov/innovation-models/radiation-oncology-model
[3] https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/
[4] https://aspe.hhs.gov/system/files/pdf/262046/AdvancingAmericanKidneyHealth.pdf
[5] This is scaled-back from the proposed 50% of the adult ESRD population that was in the proposed rule.