Congressional Action on Organ Transplant

Congress began their consideration of bill H.R. 2544, known as “Securing the U.S. Organ Procurement and Transplantation Network,” on April 10, 2023, when it was introduced in the House.  This happens to be nineteen days after HRSA announced their initiative (detailed below).  Since then, it has moved through subcommittees and committees until it was placed on the Congressional calendar for July 25, 2023.  As stated in the previous installment, this bill has the potential to remove the United Network of Organ Sharing (UNOS) from its current oversight role in the organ allocation process.

Tonight, July 25, 2023, at 6:07 p.m., Bill H.R. 2544 passed by a majority vote in Congress.  They are reserving five legislative days to revise and extend remarks.  The bill will now proceed to the Senate.

Another bill, H.R. 3935, known as “Securing Growth and Robust Leadership in American Aviation Act” also affects organ transplantation.  Section 834 requires the Secretary of the Department of Transportation (DOT), to convene a working group to develop best practices for the transportation of an organ in the cabin of an aircraft.

Action by the House, taken on July 20, 2023, promises to review and possibly reverse a practice established in the wake of the attacks of Sept. 11, 2001. Before then, organs were transported within a commercial flight’s cabin, under supervision of the aircrew. The attacks prompted significant changes to airport protocols.  As a result, organs now travel in the cargo hold.

While not a common occurrence, any delays increase the risk that an organ cannot be transplanted. The post September 11 relegation of organs to the cargo hold created challenges regarding cargo hours and cargo lock-out times – the cut-off time for receiving shipments before the scheduled departure of an aircraft. Not all airlines accept cargo, which limits options for transporting organs by air, especially to areas served by smaller, regional airports.  The Senate provision would require the FAA to establish regulations ensuring that donor organs transported via commercial flight can once again travel in the plane’s cabin, as opposed to traveling in cargo.  This bill has passed the House and is on route to the Senate.

The recent interest from Congress in organ transplantation was sparked by Executive Order 13879 – “Advancing American Kidney Health,” dated July 10, 2019.  Executive Order 13879—Advancing American Kidney Health | The American Presidency Project (ucsb.edu)

It states, in part:

Sec. 2. Policy. It is the policy of the United States to:

(a) prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care;

(b) increase patient choice through affordable alternative treatments for ESRD by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys; and

(c) increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.

Sec. 7. Increasing Utilization of Available Organs. (a) Within 90 days of the date of this order, the Secretary shall propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance.

(b) Within 180 days of the date of this order, the Secretary shall streamline and expedite the process of kidney matching and delivery to reduce the discard rate. Removing process inefficiencies in matching and delivery that result in delayed acceptance by transplant centers will reduce the detrimental effects on organ quality of prolonged time with reduced or cut-off blood supply.

On March 22, 2023, the Health Resources and Services Administration (HRSA) announced a Modernization Initiative to strengthen accountability and transparency in the Organ Procurement and Transplantation Network (OPTN).  Organ Procurement and Transplantation Network Modernization Initiative | HRSA  

HRSA’s planned approach and timelines for the first year of the multi-year modernization process focuses on design, implementation, and oversight, including contract solicitations that will be released Fall 2023 and Spring 2024. In addition, HRSA continues to pursue legislative changes and increased funding included in the President’s Fiscal Year 2024 budget to implement and advance the Modernization Initiative.

HRSA will support two significant multi-vendor solicitations between now and Spring 2024 – with the first solicitation to be issued this Fall 2023. This action will be followed by a Spring 2024 solicitation to further the next generation OPTN. 

There are multiple changes coming to the world of organ transplantation in the coming one to two years.  Only time will tell if these changes will be for better or worse.