- CMS wants to sharply raise the standards for organ procurement organizations to participate in Medicare in a bid to increase availability in the U.S.
- A new rule proposed Tuesday, meant to incentivize these OPOs to actively collect donated organs and improve transplantation rates in their donation service area, would require the country's almost 60 OPOs to meet the donation and transplantation rates of the current top 25% of these groups.
- It's the second major development stemming from a July executive order to overhaul the way kidney care is delivered in the U.S. The American Society of Nephrology praised the changes calling them "long overdue" in a Tuesday morning tweet. Most facets of the rule would not take effect until 2022.
Unlike many of its other healthcare initiatives, the Trump administration's push to revamp American kidney care has broad, bipartisan support. President Donald Trump signed a three-pronged executive order in July directing his agencies to increase preventive care for end-stage renal disease, incentivize home dialysis and kidney transplants and modernize the country's outdated organ recovery and transplant system.
Tuesday's proposed rule is HHS' first move on the latter and a "good logical step, based off the executive order," Bryan Becker, chief medical officer at DaVita Integrated Kidney Care, told Healthcare Dive. "This is good for our patients."
Every day, 20 people die waiting for an organ. Almost 113,000 people are on the organ transplant waitlist — 96,000 on the waiting list for a kidney. The Trump administration wants to double the amount of kidneys available for transplant by 2030, according to the executive order.
OPOs act as nonprofit middlemen between organ donors and recipients. There are currently 58 federally designated OPOs licensed to procure viable organs from hospitals, match them to patients and deliver them to transplant centers.
Federal law requires CMS to inspect OPOs and certify them for Medicare reimbursement based on a set of basic quality and safety regulations, including outcomes and process requirements.
Those metrics are self-reported and based off of measures from 2006, which public health advocates call a distinct, long-term lack of oversight.
CMS wants to overhaul these metrics with Tuesday's proposed rule. The new proposed donation and transplantation rates are meant to encourage OPOs to chase all potential donors, even those who can only donate one organ, and fix an oversight in previous reporting measures that allowed OPOs to count organs used for research as "transplanted," which resulted in some viable organs going unused.
OPOs must meet the current top 25% rates for both donation and transplantation in order to participate in Medicare. CMS will publicize OPO performance and re-review it every year, with potential re-certification every four years.
"An independent, verifiable metric for evaluating OPO performance can be an important tool, helping to identify potential opportunities for growth," Kelly Ranum, president of the Association of Organ Procurement Organizations, said in a statement, saying the association looks forward to working with CMS on implementation of the rule.
CMS estimates if all OPOs met both the donation and transplantation rate measures, the number of yearly transplants in the U.S. would shoot up more than 15%, from 32,000 to 37,000, by 2026.
Right now, roughly 17,000 of those are kidney transplants.
"Many organ procurement organizations do wonderful work, but some aren’t performing nearly as well as they could," HHS Secretary Alex Azar said in a statement. "We’re going to stop looking the other way while lives are lost and hold OPOs accountable."
A related rule from the Health Resources & Services Administration, also released Tuesday, would financially reward living donors by increasing reimbursable expenses to include some non-medical expenses, like lost wages and childcare. HRSA is also considering increasing the income threshold for living donors eligible for reimbursements. Currently, the median household income of subsidy recipients falls below the 40th percentile of U.S. households.
Though kidney care providers welcome the government-backed push, industry is concerned about at least one tenet of the initiative: a proposed mandatory payment model, called ESRD Treatment Choices, or ETC.
The model plans to enroll all U.S. dialysis providers in randomly selected geographic areas spanning half the country to account for about 50% of all adult ESRD beneficiaries. CMS will then adjust Medicare payments based on home dialysis and transplant rates.
Concerns about methodology could derail the payment model — one of them relating to organ transplants. Providers largely don't control organ availability in their area, yet their Medicare payments could be bumped down if their transplant rates are lower than a control group. If both ETC and Tuesday's proposed rule are finalized as drafted, the forecast spike in available organs could help mitigate some of the financial uncertainty for participating providers caused by the payment rule.