The CMS is eying a potentially massive regulatory overhaul for the two big players in organ transplants: the regional contractors that procure and distribute organs for transplant and the transplant centers themselves.
The agency's announcement was embedded in an 800-page hospital regulatory proposal released on Monday night. It came as a sign that the Trump administration will continue working on the highly political and contentious policy issue that is the nation's organ allocation system.
Within its proposed rule, the agency laid out a broad request for comment on "appropriate" reforms the CMS could implement—using Medicaid and Medicare payments to enforce them—throughout organ procurement organizations (OPOs) and transplant centers.
Specifically, the CMS request gets at a common refrain this year among lawmakers critical of the current system: do the current metrics for an OPO's efficacy accurately reflect its performance? If the government introduces new standards, could an OPO do better in procuring more organs?
The CMS specifically asked stakeholders and the public to weigh in on two potential new metrics to make sure all OPOs secure as many transplantable organs as they can.
One would look at the actual deceased donors as a percentage of inpatient hospital deaths of patients aged 75 or younger whose manner of death wouldn't make their organs nonviable.
"We believe that the consistency and quality of this measure could be a significant improvement over the current measures because it relies on independent data to measure true organ donation otential," the CMS said. "While this donation rate might include potential donors in the denominator who would never clinically qualify as organ donors, it does so consistently across all OPOs, which provides a reliable comparative performance measure across all OPO (donor service areas)."
The agency qualified this proposed measure with assurances that "geographic differences" in the manner of deaths across the U.S. and other factors would be considered—a nod to the regional disparities that have made the policy war over liver allocation so bitter. States in the Southeast and Midwest tend to have more livers than northern and western coastal states, where demand for transplants is high.
The agency's other idea for measuring an OPO's success would be to look at the actual number of organs transplanted as a percentage of hospital deaths of patients aged 75 or younger, whose organs could be transplanted.
But beyond these two specific proposals, the agency wants recommendations on any other "empirically based outcome measures" besides what's now laid out in law that could either replace or supplement their current requirements. And officials want to know whether any payment policies for transplant centers are in conflict with those for OPOs.
The CMS' move went largely unnoticed in a rule that included major transparency proposals for hospitals.
But one lawmaker who has been keenly interested in reforming the procurement system took note: Sen. Todd Young (R-Ind.), who earlier this month proposed a bill to require the CMS to establish new metrics for OPOs.
"We applaud CMS in taking this first step to hold OPOs accountable to verifiable metrics," an aide to Young told Modern Healthcare in a statement. "This fits into what we're trying to accomplish in our bill—having verifiable and objective metrics for OPOs."
The aide described Young's bill as a requirement for the CMS to set measures "that are objective, verifiable, and not subject to self-interpretation by OPOs so that there can be meaningful transparency, evaluation, and accountability for OPOs across the country."