Coalition of Senators Voice Concerns Over Liver Distribution Policy Changes – On January 22, 2019, twenty-two (22) Senators sent a bipartisan letter to HHS (the Letter) to voice their concerns over a change in the national liver distribution policy adopted on December 3, 2018 (Revised Policy), by the board of directors of the Organ Procurement and Transplant Network (OPTN) and the United Network for Organ Sharing (UNOS) (the OPTN/UNOS Board).
The OPTN/UNOS Board is the governing body that oversees and participates in developing policies for operating the OPTN to provide equitable organ allocation to patients registered on the national waiting list. The 41 elected member OPTN/UNOS Board includes transplant surgeons, transplant recipients, and organ donors. According to the OPTN news release announcing the Revised Policy, the Revised Policy was adopted “to establish greater consistency in the geographic areas used to match liver transplant candidates with available organs from deceased donors and reduce geographic differences in liver transplant access.” The news release further explained that the Revised Policy “will replace fixed, irregular local and regional geographic boundaries historically used to match liver candidates based on the donor location.” Opponents of the prior policy, which divided the country into 11 geographical regions, claimed that it created a priority system that distributed livers to candidates who are not necessarily the neediest candidates, but nonetheless receive the liver because of geographic disparities in the availability of organs.
The Revised Policy, described in detail here, prioritizes liver offers for most deceased adult donors to candidates with the highest medical urgency listed at transplant hospitals within 500 nautical miles of the donor hospital. It also provides special rules for livers from certain donor categories, including deceased donors under the age of 18 to give priority to pediatric transplant candidates listed at any transplant hospital within 500 nautical miles of the donor hospital.
The Senators assert in the Letter that, by adopting the Revised Policy, HHS and the OPTN/UNOS Board “ignored the impact of socio-economic factors and local organ procurement efforts that help ensure successful liver transplants.” One concern articulated by Senator Roy Blunt (R-MO) is that transplant hospitals in areas with rural and low-income populations could see patients waiting longer for a liver match under the Revised Policy and losing livers donated in their state. The Letter also criticizes the Revised Policy because it “does not appear to give any weight to locations that have been successful in reducing their waitlist through aggressive organ procurement or through adopting innovative transplant techniques.” The Letter requests that HHS provide responses to numerous questions about the Revised Policy by February 15, 2019.
Reporter, Kristin Roshelli, Houston, +1 713 751 3263, firstname.lastname@example.org.
ACO Application Period Now Open for July 1, 2019 Start Date for MSSP Participation – The application period is now open for ACOs that desire to participate in the Medicare Shared Savings Program (MSSP) under either the BASIC or ENHANCED Tracks with a start date of July 1, 2019. Applications may be submitted until February 19, 2019, at 12:00 p.m. (noon) ET. Sample applications and more information are available here, but ACOs must apply to the MSSP using the online ACO Management System (ACO-MS), which is available here.
King and Spalding to Host a Life Sciences & Healthcare Roundtable on January 31, 2019: What’s Next for the ACA after Texas v. U.S.? – The District Court for the Northern District of Texas recently issued a ruling declaring the Patient Protection and Affordable Care Act (ACA) unconstitutional in its entirety. The court did not enjoin any of the ACA’s provisions, and the Trump administration has announced that the ACA will remain in effect while appeals are pending. Nonetheless, the decision creates uncertainty in the U.S. healthcare system. This webinar will:
- Provide a background on the ACA, with a focus on the individual mandate, leading to the decision in Texas v. U.S.;
- Analyze the district court’s reasoning in finding the ACA unconstitutional, including its finding that the individual mandate is not severable from the rest of the ACA’s provisions;
- Discuss the potential healthcare reform provisions put in place by the ACA that could be in jeopardy because of this ruling;
- Describe the potential outcomes on appeal; and
- Explore the likelihood that Congress will respond legislatively, beyond requesting permission to intervene in the case, to “defend the validity of the ACA.”
The roundtable will be held as a webinar on January 31, 2019, from 1:00 P.M. ET to 2:00 P.M. ET. There is no charge to attend. Click here to register.
28th Annual King & Spalding Health Law & Policy Forum – Please join us on March 18, 2019, for a one-day conference at the St. Regis Hotel in Atlanta focusing on the latest legal and political developments affecting the healthcare industry. The keynote speaker will be Dr. Sanjay Gupta. A multiple Emmy® award winning chief medical correspondent for CNN, Gupta is a high-profile practicing neurosurgeon who plays an integral role in CNN’s reporting on health and medical news for all of CNN’s shows domestically and internationally and contributes to CNN.com. King & Spalding partner Sally Yates will be the featured speaker. Yates is the former Deputy Attorney General and Acting Attorney General of the United States. For registration information, please click here.