At the 2014 Legal Issues Affecting Academic Medical Centers Organ Allocation Meets the Judicial System: Thoughts on the Sarah Murnaghan Lung Allocation Case Teaching Hospitals and Academic Medical Centers Practice Group Mid-Year Luncheon At the 2014 Legal Issues Affecting Academic Medical Centers January 26, 2013  12:00-1:20 pm Eastern Presenter: Stephen G. Harvey, Steve Harvey Law LLC, Philadelphia , PA, steve@steveharveylaw.com

Sarah Javier

Organ Allocation 101 Organ Procurement and Transplantation Network (“OPTN”) runs organ allocation in the U.S. Congress created OPTN with the National Organ Transplant Act of 1984 (“NOTA”). NOTA provides that OPTN must “assist organ procurement organizations [(“OPOs”)] in the nationwide distribution of organs equitably among transplant patients.” (emphasis added) NOTA also provides that the secretary of HHS “shall establish procedures for receiving and considering critical comments about the OPTN.” United Network for Organ Sharing (“UNOS”) operates OPTN. UNOS /OPTN set policies for organ allocation and run UNet℠ computer system for organ matching and management of transplant data.

OPTN Final Rule, 42 C.F.R. § 121 Promulgated by HHS in 1999 “mandate[d] development of organ allocation policies based on medical necessity rather than waiting time.” “intended to bring about…allocation policies that make most effective use of organs, especially by making them available whenever feasible to the most medically urgent patients who are appropriate candidates for transplantation.”  

Lung Allocation Score In 2004 the OPTN developed and in 2005 implemented the Lung Allocation Score (“LAS”), as the primary determinant of priority on the waiting list for lungs.  LAS is “a calculation of illness severity and projected post transplant survival that was intended to place the sickest candidates with the best chance of survival at the top of the waiting list.” 

42 C.F.R. § 121.4(d) provides: Any interested individual or entity may submit to the Secretary in writing critical comments related to the manner in which the OPTN is carrying out its duties or Secretarial policies regarding the OPTN. Any such comments shall include a statement of the basis for the comments. The Secretary will seek, as appropriate, the comments of the OPTN on the issues raised in the comments related to OPTN policies or practices. Policies or practices that are the subject of critical comments remain in effect during the Secretary's review, unless the Secretary directs otherwise based on possible risk to the health of patients or to public safety.

Sarah

Javier

Judge moves Sarah Murnaghan onto adult lung list June 06, 2013 Judge moves Sarah Murnaghan onto adult lung list

June 10, 2013 Vote Allows Children Under 12 Seeking Lung Transplant to Have Case Reviewed WASHINGTON — Officials with the national Organ Procurement and Transplantation Network voted in an emergency meeting on Monday to create a new avenue for children seeking lung transplants after two families filed lawsuits challenging the rules. The families of Sarah Murnaghan, 10, of Newtown Square, Pa., and Javier Acosta, 11, of New York City, sued last week in the hope of changing a rule that keeps children under 12 from qualifying for adult lungs unless eligible adolescent and adult patients in the same geographic region have turned them down. Judge Michael M. Baylson of Federal District Court in Philadelphia ordered the Department of Health and Human Services, which oversees the transplant network, to at least temporarily put Sarah and Javier, patients at Children’s Hospital of Philadelphia, on the adult waiting list.

U.S. OPEN

Sarah Murnaghan Post-Surgery

Javier Acosta Post-Surgery