The Centers for Medicare & Medicaid Services (CMS) finalized a six-year mandatory model to increase access to kidney transplants, the agency announced Nov. 26.
First proposed in May, the Increasing Organ Transplant Access (IOTA) Model will begin July 1, a delayed start compared to the original proposal, and is designed to get more specialists in value-based care.
“The IOTA Model will increase the number of kidney transplants that will not only save lives but will enable people to live longer and healthier ones,” said CMS Administrator Chiquita Brooks-LaSure in a statement.
The CMS hopes the new model will better supply donor kidneys to patients in need as well as cut down the 90,000 people waiting for a transplant. These individuals sometimes wait up to five years to secure a transplant.
There will be 103 kidney transplant hospitals participating in IOTA, representing half of the donation service areas and all kidney transplant hospitals, the CMS said in its news release.
Hospitals that participate in the model will receive a financial incentive to perform more transplants; alternatively, they will be financially punished for not performing enough transplants. They will be judged on number of transplants, rates of accepting organs offered and health outcomes. Numbers of transplants is the most heavily weighted criterium.
Hospitals receive a performance-based payment, refund the CMS or fall within a “neutral zone.” Negative incentives do not begin until year two of the model, a fact sheet (PDF) explains.
Participants will be encouraged to address social determinants of health, such as transportation assistance, to help patients obtain transplants.
After receiving feedback from stakeholders, in which hospitals complained the Jan. 1 timeline was “untenable,” the CMS is raising the performance score upside from $8,000 to $15,000 and is modifying the number of donor transplants that should be performed. A maximum negative payment is still $2,000.
Three quality measures and the health equity payment adjustment were also eliminated. All health equity plans from hospitals are voluntary.
The model is still mandatory and occurring simultaneously with the Health Resources and Services Administration’s overhaul of the Organ Procurement and Transplantation Network.
Americans with chronic kidney disease account for a staggering 24% of annual Medicare costs, and kidney transplantation is considered effective for end-stage renal disease.
In September 2023, the Biden administration signed a law that prohibits UNOS, a nonprofit vendor, from being the sole contractor for the country’s Organ Procurement and Transplantation Network.
Due to the timing of the rule’s finalization, the regulation will be subject to the Congressional Review Act lookback period, which allows President Donald Trump greater leeway to rescind the rule. It is difficult for an agency to reintroduce a similar rule at any point in the future, making any regulation pushed in the lame-duck session as a risky exercise for an outgoing administration.