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Bowing to legal pressure brought by a patient in desperate need of a lung transplant, the U.S. Department of Health and Human Services recently approved a new policy for determining transplant eligibility.

The attorneys for the plaintiff, Miriam Holman, who suffers from an incurable form of pulmonary hypertension and was potentially days away from dying, hailed the policy change by HHS as a win for their client and others in similar need.

“This is a complete victory for Ms. Holman and for all lung transplant candidates across the country because it opens up the availability of lungs based on medical priority and not on some arbitrary geographic boundary,” said Boies Schiller Flexner partner Motty Shulman, who represents Holman in the case. “Now we are just hopeful that Ms. Holman can find the matching lung that she needs.”

The suit, Holman v. United States Department of Health and Human Services, 17-cv-09041, was brought against HHS on Nov. 20 in the U.S. District Court for the Southern District of New York. Holman's legal team sought an emergency temporary restraining order to, in effect, force the department to override its transplant allocation policy in an effort to get Holman at the top of the list.

Holman's counsel argued that HHS's distribution policy, which prioritizes candidates based on geography rather than need, was arbitrary and discriminatory toward the most needy patients.

“Miriam may soon die and every hour that she has a fair chance to be considered for new lungs outside the arbitrarily-drawn [donation service areas] in which she is located may save her life,” her counsel argued in its TRO and preliminary motion. “That is why this motion is being brought on an immediate, emergency basis.”

U.S. District Judge Laura Taylor Swain of the Southern District of New York denied Holman's motion the same day, while ordering HHS to alert the court by Nov. 28 “as to whether and to what extent the policy will be changed, and a timetable for the implementation of any change(s).”

The following day Holman filed an interlocutory appeal with the U.S. Court of Appeals for the Second Circuit, arguing that the higher court should intercede given the dire circumstances facing the appellant.

“Given Miriam's precarious medical condition, absent a lung transplant, she is likely to die before a final order in this matter,” Holman's counsel argued. “Thus, the district court's denial of Miriam's motion for a temporary restraining order is in effect a final order and this court should exercise its authority to grant the injunctive relief the district court denied.”

As it had at the district court level, the government opposed the motion, arguing the plaintiff was asking to “have the courts rewrite the national policy for allocating lungs for transplant without the agency's expertise, or indeed without any factual or administrative record.”

“While plaintiff's situation is undeniably urgent and sympathetic, the policy change she seeks by TRO would not necessarily lead to her receiving the lungs she needs, and it may well make other potential lung recipients, who are not before the court, worse off, with potentially life-threatening consequences,” assistant U.S. attorneys for the U.S. Attorney's Office for the Southern District of New York argued.

After speaking with the parties, Chief Judge Robert Katzmann issued an order that HHS should report by Nov. 24 on an expedited review of its organ allocation policy.

According to a letter from HHS, the department's Health Resources and Services Administration Administrator, George Sigounas, had on Nov. 21 directed the Organ Procurement and Transplantation Network to conduct an emergency review of its lung allocation policy. The network's executive committee recommended an immediate temporary policy be changed to one that “applies a reasonable geographic constraint in a way that is rational, consistent and promotes increased equity among candidates.”

A 250 nautical mile circle from the donor hospital was implemented, allowing for greater access to transplants for those in need. A later review will determine if the change should be made permanent.

On Monday, the U.S. Attorney's Office alerted Katzmann that HHS had expected the interim implementation of the recommended changes to be effective as of Nov. 25. Later that day, Holman voluntarily withdrew her appeal.

A request for comment from HHS was passed on to the Health Resources and Services Administration. A spokesman for HRSA directed requests for comment to the United Network for Organ Sharing, which serves as the Organ Procurement and Transplantation Network under HRSA. A spokesperson for UNOS could not be reached for comment.