Two Proposed Rules Aim to Increase Organ Donation in the U.S.
On December 17, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the Conditions for Coverage that Organ Procurement Organizations (“OPOs”) must satisfy in order for organ procurement costs to be paid by Medicare and Medicaid (the “OPO Proposed Rule”). Simultaneously, the Health Resources and Services Administration (“HRSA”) issued a Notice of Proposed Rulemaking (“NPRM”) to expand reimbursement for expenses incurred by living organ donors to include lost wages and childcare and elder-care expenses (the “HRSA NPRM”). Together, the proposals fulfill the mandate of President Trump’s Executive Order 13879 of July 10, 2019 titled Advancing American Kidney Health, which is aimed at increasing organs (specifically kidneys) available for transplant and thus saving lives. Key changes proposed by the OPO Proposed Rule and HRSA NPRM are outlined below, together with our thoughts on which aspects of the proposals are likely to attract the most attention.
The OPO Proposed Rule was published in the Federal Register on December 23, 2019 with comments due on February 21, 2020. The HRSA NPRM was published in the Federal Register on December 20, 2019 with comments due on February 18, 2020.
OPO Proposed Rule
OPOs are non-profit organizations responsible for working with hospitals to identify eligible deceased donors, obtaining authorization and testing donors for medical suitability, recovering organs, allocating organs to patients, and delivering them to transplant centers. Each OPO is assigned to one of 58 geographically-based “donation service areas” (“DSAs”). The OPO Proposed Rule is intended to increase the procurement and utilization of organs available through deceased donation by changing the metrics used and process for evaluating and certifying OPOs for participation in Medicare and Medicaid.
Proposed New Metrics. Under the OPO Proposed Rule, the three existing metrics for OPO performance would be replaced with two new metrics commencing with the 2022 – 2026 recertification cycle: (1) “donation rate” and (2) “organ transplantation rate.” Together, the metrics would attempt to capture an OPO’s success in procuring donors and utilizing organs.
The “donation rate” would be calculated as the number of “donors” as a percentage of “donor potential.”
- “Donors” (the numerator) is defined as deceased individuals from whom at least one vascularized organ (heart, liver, lung, kidney, pancreas, or intestine) is transplanted. An individual also would be considered a donor if only the pancreas is procured and is used for research or islet cell transplantation. The number of donors already is reported by OPOs to United Network for Organ Sharing and is verified by transplant hospitals.
- “Donor potential” (the denominator) is defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an “absolute contraindication to organ donation.” This number will be drawn from existing Detailed Multiple Cause of Death (“MCOD”) files. MCOD files contain information derived from state death certificates including location of death (hospital, hospice, home, etc.) and immediate and contributing causes of death. The causes of death reported in state death certificates are assigned one or more ICD-10 codes in the MCOD files. Causes that would be an “absolute contraindication to organ donation” are proposed to include certain communicable diseases (HIV and Meningococcal, for example), malignancies, coagulation defects, and metabolic disorders. CMS declined to include additional “risk adjustments” (other than age over 75 and causes of death that are an “absolute contraindication to organ donation”), but is collecting comments on “whether such adjustments are necessary to reflect donor demographic characteristics (race, gender, age, disease condition) or DSA characteristics (number of ICU beds or level I and II trauma centers).”
The “organ transplantation rate” would be defined as the number of “organs transplanted” as a percentage of “donor potential.”
- “Organs transplanted” (the numerator) is the number of organs transplanted from donors in the DSA, which already is reported by OPOs and is verified by transplant hospitals, although the OPO Proposed Rule clarifies how the number of organs transplanted should be calculated. Notably, the numerator would exclude organs used for research purposes (with the exception of pancreata that are procured for research or islet cell transplantation).
- “Donor potential” (the denominator) is exactly the same as the denominator in the “donation rate” metric.
According to CMS, it chose the combination of these two measures to reflect its view that OPOs should be “expanding their efforts on both converting potential donors into actual donors and successfully placing all possible organs for transplantation.” CMS’s commentary in the OPO Proposed Rule suggests that it views (1) increasing single-organ transplants and (2) decreasing the number of discarded organs that are of “transplant quality” as two of the most important steps to increasing organ availability, with the “donation rate” metric addressing (1) and the “organ transplantation rate” metric addressing (2).
Certification Process. By law, CMS conducts recertification inspections of OPOs for compliance with requirements and performance standards every four years as a condition of Medicare and Medicaid participation. Under the OPO Proposed Rule, if an OPO’s outcome measures (its “donation rate” and “organ transplantation rate”) at the final assessment prior to the end of the re-certification cycle fall below the top 25 percent of all OPOs’ performance measures, the OPO would be de-certified. The performance of the top 25 percent would be established by determining the lowest outcome measure rates achieved by the top 15 OPOs in the calendar year preceding the next certification cycle.
In addition to the recertification assessment, the OPO Proposed Rule proposes a review of OPO performance every 12 months to provide ongoing feedback and allow for ongoing performance improvement. If an OPO falls below the top 25 percent on an annual basis, CMS would require the OPO to revise its quality assurance and performance improvement program.
According to CMS, the new process is “designed to drive OPOs to perform optimally by motivating them to pursue every organ, every time, rather than setting standards at or near the current average performance.” However, CMS also is collecting comments on the viability of this approach, rather than using an absolute, statistically derived value based on the geometric mean or median.
It appears that CMS has recognized that by requiring all OPOs to meet the performance of the top-performing OPOs (according to the new metrics), de-certifications and certain consolidation will necessarily occur. To that end, CMS is collecting comments on current regulations related to assigning an open DSA in the case where no OPO applies to compete for that open area or in the case where CMS selects an OPO to take over the entire open DSA, but the OPO refuses to do so. CMS also is soliciting comments on minimizing disruption caused by decertification.
Analysis. CMS’s transition to utilizing independently reported data to calculate performance metrics responds to criticism that existing standards are unreliable because they are self-determined and self-reported and also supports CMS’s stated goal of reducing reporting burdens. On the other hand, these independently reported data would not capture differences among DSAs with regard to viability of organs for transplantation based on cause or circumstance of death (beyond what state death certificates can reflect, such as whether the donor died while on a ventilator) or based on the age of the donor (under 75 years of age). In determining whether to adopt or revise the proposed metrics, CMS will need to ensure that the final metrics strike the right balance between being sufficiently objective but also sufficiently “risk adjusted” to accurately assess OPO performance and drive meaningful and positive change.
Additionally, we expect that there will be significant feedback on the proposed revisions to the recertification process. Given that the proposed performance metrics measure factors that are outside of an OPO’s control and may vary regionally, performance evaluation based on relative performance may be problematic. In the OPO Proposed Rule, CMS acknowledged that the proposed measures do not account for certain regional differences (“for example, states without motorcycle helmet laws have higher rates of accidents that create potential donor”), but CMS also stated that it believes “the untapped donor and organ potential is sufficiently large in every DSA so that every OPO has both potential donors, organs, and transplant recipients to exceed its current performance level.” However, under CMS’s proposed recertification standard, across the board improvement in OPO performance could still result in decertification of up to three-quarters of OPOs. Given the high potential for disruption in the organ donation system with the risk that donation rates could go down, we expect to see changes in the final rule on how best to implement and enforce the new performance metrics.
Simultaneous with the issuance of the OPO Proposed Rule, which seeks to increase organs available from deceased donors, HRSA issued a NPRM intended to increase living organ donation by removing financial barriers through the expansion of categories of donor expenses that are eligible for reimbursement. Living organ donor transplants made up 19 percent of the total transplants performed in 2018, and deceased organ donor transplants made up the remaining 81 percent. Living organ donation is primarily for kidney and liver transplant candidates, and can help to reduce the number of individuals on the deceased donor organ waiting list. Previously, Congress authorized the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) to reimburse travel and subsistence expenses for certain eligible living organ donors and individuals who accompany them. These expenses include travel to appointments, lodging, and meals. Congress also authorized the Secretary to issue regulations to provide for reimbursement of “incidental non-medical expenses” incurred by certain living organ donors, but before this NPRM, no regulatory action had been taken.
Under the HRSA NPRM, HRSA proposes to define “incidental non-medical expenses” (which expenses would be eligible for reimbursement) to include lost wages, childcare expenses, and elder-care expenses that are incurred by the living donor. HRSA also is proposing revisions to the reimbursement program’s eligibility guidelines that would raise the income limit of living donors eligible for reimbursement.
Analysis. We expect that there will be wide support for HRSA’s NPRM and likely some debate about whether the proposal could go further to contribute to an increase in living donors without resulting in undue influence or creating inappropriate financial incentives for donors to take a non-trivial medical risk.
 Dep’t of Health & Human Servs, Ctrs. for Medicare & Medicaid Servs., Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization, 84 Fed. Reg. 70628 (hereinafter referred to as “OPO Proposed Rule”).
 Dep’t of Health & Human Servs, Health Resources and Servs Admin., Removing Financial Disincentives to Living Organ Donation, 84 Fed. Reg. 70139 (hereinafter referred to as the “HRSA NPRM”).
 OPO Proposed Rule at 70631.
 Id. at 70707.
 Id. at 70631.
 Id. at 70632.
 Id. at 70634.
 Id. at 70707
 Id. at 70631.
 Id. at 70631, 70640.
 Id. at 70638.
 Id. at 70628, 70635.
 Id. at 70692.
 Id. at 70636.
 Id. at 70630, 70696.
 Id. at 70696.
 Id. at 70647 (emphasis added).
 See Optn.transplant.hrsa.gov.
 HRSA NPRM at 70145.