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Science in Donation and Transplant’s Response to HHS Secretary Becerra’s Letter

Science in Donation and Transplant
By Steve Lenox

Science in Donation and Transplant (SID&T), the non-profit devoted to supporting, educating, and advocating on behalf of the interests of members of the donation and transplant communities, has welcomed the input of the Secretary of Health and Human Services Xavier Becerra on the matter the final rule entitled “Medicare and Medicaid Programs: Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations.”

In his November 2 letter to Senator Ron Wyden (D-OR), Secretary Becerra specifically addressed, and ultimately rejected, a proposal by Wyden and 11 of his Congressional colleagues, to accelerate implementation of the 2020 rule.

SID&T was founded on the basis that the Trump Administration rule rejected the premise that the metrics and measures used to credential, license, designate and certify donation and transplant organizations should be evidence-based and based upon sound statistical and demographic projections.

They should also, at all times, be free of political, economic, monetary, or other private influence.

“In his robust and thorough analyses, Secretary Becerra clearly articulates, as we have since our formation, that there is room for improvement within the organ donation and transplantation system, and that positive changes that save lives should begin now,” stated Anthony Pizzutillo, a spokesperson for Science in Donation said. “More importantly, however, he also provides for an opportunity for the 57 OPO’s across the U.S. to create more synergistic alignment within their networks, and among all facets of the donation and transplant process, to save lives.”

“As it stands the rule continues to judge OPO performance in areas they control, organ donation, and areas they don’t, transplant. This begs for greater study of ways to improve alignment and measure OPO and patient success. Concurrently, the potential chaos of the rule’s silence on the criteria which will allow others to take over a de-certified OPO should also be addressed in the coming years.” Pizzutillo added.

Recognizing the need to hear all voices on this matter, SID&T has advocated vociferously for the formation of a task force that will consider the expert knowledge of every facet of the organ donation and transplant system. Secretary Becerra’s announcement, through the letter, that the Department plans to release a request for information (RFI) that would do the same was certainly welcome news.

SID&T believes that this RFI should ultimately be taken a step further and that certified scientists and community stakeholders in organ donation and transplant should lead a National Task Force using a peer-reviewed scientific methodology approach to provide the sound data to develop the necessary metrics for implementing an improved system.  This would be a welcome change from what others offered to CMS during the development of the regulations.

In addition to rightly pointing out that under the new rule OPO’s are expected to begin implementing change for more positive outcomes immediately, Secretary Becerra puts to rest the notion that beginning the process of decertifying these non-profit entities, and thereby potentially leaving large swaths of the nation, namely in already underserved and minority communities, without access to this life saving medicine, makes sense.

Through their advocacy efforts on behalf of those serious about improving outcomes; extensive conversations with medical professionals, patient advocates, and policy makers; and their own thorough review of the current donation and transplant industry, SID&T has continually found that not only the opportunity for, but more importantly desire to, bring positive change to this critical field of medicine about is strong.

Donors and transplant recipients alike deserve a well-aligned, science-based system. Current regulations judge OPO's equally on donations, which they control, and transplants, which they do not. SID&T advocates in concert with leading medical practitioners for enhanced coordination and alignment among organ procurement organizations and transplant centers.

“Secretary Becerra’s letter offers SID&T, and all that are interested in saving lives, not providing data mining and profit driving opportunities, the reassurance that the Biden Administration is serious about making what is already the best organ procurement and transplant system in the world even better,” Pizzutillo said. “There are powerful forces of darkness working against us, yet we stand even more committed to this effort because we know light drives out darkness.”

“With his letter Secretary Becerra has given us light.”