Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Sign up for our Compliance newsletter
You must correct or enter the following before you can sign up:
Thank You!
Law360 (June 29, 2020, 5:44 PM EDT) --
 |
| Melodie Hengerer |
Despite guidance from Centers for Medicare & Medicaid Services identifying transplants as procedures that should not be postponed, transplant rates remained low until very recently. Rates are now close to prepandemic levels, but there are still approximately 114,000 patients remaining on the organ transplant wait list, and calls for a systemic overhaul continue.
Prior to the pandemic, the need to increase the national organ transplantation rate was the subject of significant political and regulatory attention. Last summer, President Donald Trump issued an executive order spotlighting the importance of organ donation and transplants. The order required the establishment of new rules for evaluating organ procurement organization, or OPO, performance.
CMS subsequently proposed a new rule including a provision for measuring OPO success, not only by the number of organs procured, but by the number of organs which are actually transplanted.
Many comments to the proposed rule emphasized that donation begins in hospitals but noted that the proposed rule barely recognizes the hospital as a donation and transplant partner, even though there have long been conditions of participation for donor hospitals.
Other comments stressed that the manner in which the hospital manages the donor family and intakes the potential donor referral can be critical to whether the patient becomes a donor.
Still others highlighted the need for hospitals to focus on best practices to help improve the number of available organs.
In addition to the proposed rule, there has also been considerable congressional pressure to investigate alleged failures in the organ donation and transplant system.
By way of example, in December 2019, the Senate Finance Committee sent a letter to the U.S. Department of Health and Human Services requesting a "comprehensive examination of the adequacy of the organ procurement and transplantation system in the United States."
In February this year, the committee sent a letter to the United Network for Organ Sharing, the nonprofit organization which manages the nation's organ transplant system, requesting detailed information about UNOS and OPO practices and finances.
While the government's current focus seems to be on improving OPO performance, given the request for comprehensive examination of the system, a review of the hospitals' role in the process is likely not far behind.
Moreover, because CMS requires all hospitals receiving any type of federal reimbursement to comply with CMS' conditions of participation for hospitals regarding organ, tissue and eye donation, virtually all hospitals could be impacted. Accordingly, hospitals should take a proactive approach to ensuring regulatory compliance and best practices.
Importantly, the logical first step in increasing the number of available organs is to identify potential organ donors, and the conditions of participation squarely place this responsibility on hospitals. The conditions of participation require that each hospital enter into an agreement with its designated OPO under which the hospital must timely notify the OPO of individuals whose death is imminent or who have died in the hospital.
Absent any waivers from CMS, hospitals retain this obligation to refer potential donors, even in the face of challenges related to, or derivative of, COVID-19.
In anticipation of additional scrutiny, hospitals should review their agreement with their federally designated OPO to ensure the OPO is quickly able to perform its analysis of a potential donor's clinical suitability and allowed to begin immediate interpersonal discussions about authorization with the potential donor's family.
More specifically, hospitals may wish to focus on the agreed-upon definition of "imminent death" within the agreement to ensure that, in practice, the referral process honors the time constraints of the OPO and the need for the hospital to continue treatment until death is declared or until the patient's family has made the decision to withdraw supportive measures.
Elimination of missed opportunities for donation is critical. Facilitation of the interpersonal interaction between highly trained OPO staff and family members of deceased potential donors is essential to increasing authorization for donation and, in turn, the number of organs available for transplant. Hospitals should implement best practices in this regard so that connecting OPOs with the families is of paramount importance.
Streamlining OPO access to required information is another way that hospitals can improve best practices regarding organ donation and transplant. From a clinical suitability perspective, an OPO's timely access to the potential donor's medical record is essential to maximizing the number of available organs. Comprehensive and timely access to the potential donor's medical record is also paramount to ensuring patient safety.
An exception within the Health Insurance Portability and Accountability Act allows the OPO access to potential donor medical records without requiring patient or surrogate authorization and without first confirming authorization to donation. Hospitals should educate information technology staff on this exception and work with them to ensure that OPOs are granted easy on-site and remote access to medical records.
Ultimately, whatever actions hospitals choose to take, they should understand the significance of the comprehensive focus of the government's review of the organ donation and transplant system. Any assessment of internal best practices should consider the important initial role hospitals play in maximizing the number of organs available for transplant and in contributing to patient safety.
Melodie Hengerer is of counsel at Baker Donelson Bearman Caldwell & Berkowitz PC.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
For a reprint of this article, please contact reprints@law360.com.
