On December 17, 2019, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change outcome performance measures for organ procurement organizations (OPO)s. In addition, the Health Resources and Services Administration (HRSA) simultaneously released a proposed rule that adds new categories of reimbursable expenses in order to incentivize living organ donation. These rules are part of the administration’s efforts to improve kidney health, particularly in relation to the President’s Executive Order on Advancing American Kidney Health.

Comments on the proposed rules are due on February 21, 2020.

CMS Releases Rule Designed to Increase Donation and Transplantation Rates; Proposes NEw Measures to Assess OPO Performance

Organ procurement organizations (OPOs) are involved in the procurement, distribution, and transplantation of human organs, identifying eligible donors and recovering organs in the United States. Stakeholders have noted that existing OPO regulations need improvement, particularly related to outcome measures. CMS notes that the existing outcome measures are not sufficiently objective and transparent and do not properly incentivize best practices.

There are currently 58 OPOs in the U.S. To receive payment under the Medicare or Medicaid program, OPOs must be certified by the Secretary of the Department of Health and Human Services (HHS). The Secretary also is required to establish outcome and process performance measures for OPOs. Currently, OPOs must meet two of three outcome measures. Earlier this year, in the final hospital outpatient department payment rule for calendar year (CY) 2020, CMS finalized a policy to align the definition of “expected donation rate” with the definition used by the Scientific Registry of Transplant Recipients (SRTR) and a policy requiring OPOs meet only one of two outcome measures for the 2022 re-certification cycle only.

In this newly released proposed rule, CMS is proposing to replace the existing outcome measures with two new measures to assess OPO performance. These two measures are referred to as “donation rate” and “organ transplantation rate” and will be effective for CY 2022. They are measured as follows:

• Donation rate: measured as the number of actual deceased donors as a percentage of total inpatient deaths in the donation service area (DSA) among patients 75 years or younger with any cause of death that is not contraindicated to organ donation.
• Organ transplantation rate: measured as the number of organs procured within the DSA and transplanted as a percentage of total inpatient deaths in the DSA among patients 75 years or year with any cause of death not contraindicated to organ donation.

 

CMS believes that donation rate will demonstrate the percentage of possible deceased donors who become actual donors while organ transplantation rate demonstrates the percentage of organs transplanted after procurement. Organs procured for research, but not transplanted are excluded from the definition of organ for the second measure, organ transplantation rate. Donors who had at least one organ transplanted are included in the measurement to encourage pursuing single-organ donors; CMS believes these donors are the greatest opportunity for growth.

Further, the agency believes this combination of measures reflects their view that OPOs should be expanding efforts on converting potential donors into actual donors and successfully place all possible organs for transplantation. The correlated nature of the two measures is also intended to reduce the risk of resources being diverted to focus on one measure instead of address both measures overall.

Performance Benchmark Proposed

OPOs will have to meet a performance benchmark. CMS is proposing that all OPOs will have to at least meet the donation and transplantation rates of the top 25 percent of OPOs; the ranking will be publicly available. A threshold donation rate and organ transplantation rate will be established based on the lowest rate among the top 25 percent during the 12-month period prior to the period being evaluated. OPOs that are below the performance benchmark will be required to improve their rates through a quality assurance performance improvement (QAPI) program. The agency believes this will lead to greater oversight, transparency, and accountability while encouraging better performance.

CMS is seeking comment on whether performance should be solely based on performance of the top 25 percent of OPOs or whether a different percentile or different criteria should be used.

CMS Proposes Assessment Based on 12-Months of Data

OPOs are currently re-certified on a four-year cycle and assessed based on 36 months of data analysis. CMS believes that waiting 36 months to assess and take action on OPO performance could result in lost opportunities for viable organ donation, so it is proposing changes to this.

Under the proposed rule, outcome measures would be assessed at least every year and be based on data from the most recent 12 months of data from state death certificates. OPOs that have rates statistically significantly less than the threshold established by the top 25 percent will undertake improvement activities through their QAPI program.

While assessments will occur at least every year, no OPO will be de-certified until the end of the re-certification cycle, except in cases of urgent need. De-certification would be based on the most recent prior 12 months of data at the last assessment cycle before re-certification.

CMS expects to begin calculating outcome measures before the beginning of the next re-certification cycle in 2022.

CMS Seeks Comment on Additional Topics

CMS is seeking comments on their proposals as well as comments on the following topics:

• Inclusion of an assessment of organ transplantation rates by type of organ transplanted in OPO outcomes measures;
• Criterion used to assess OPO performance, including the proposal to assess performance relative to the top 25 percent; using a state level or different criterion; and the appropriate statistical approach;
• Impacts of using the two proposes measures; and
• Compliance burdens if the two proposed measures are finalized.

HRSA Proposes New Categories of Reimbursable Expenses after Living Organ Donation

HRSA has also released a proposed rule, entitled “Removing Financial Disincentives to Living Organ Donation.” The rule relates to current language around reimbursement for “incidental non-medical expenses” of live organ donors. HRSA has an established “Reimbursement of Travel and Subsistence Expenses toward Living Donation” program, which is currently operated through the National Living Donor Assistance Center (NLDAC). This program providers reimbursement for up to $6,000 in expense, including travel, lodging, meals, and incidental expenditures related to donor evaluation or other donation related medical procedures.

HRSA believes that there are many potential living organ donors who would like to donate an organ to a family member or friend but are unable to because of the loss of income from the loss of work due to transplant surgery recovery time. To combat this, HRSA is proposing to formally add lost wages and child-care and elder-care expenses incurred by primary caregivers as reimbursable expenses for living organ donors.