December 1, 2021

Volume XI, Number 335

Advertisement
Advertisement

November 30, 2021

Subscribe to Latest Legal News and Analysis

November 29, 2021

Subscribe to Latest Legal News and Analysis
Advertisement

Organ Procurement Organization Final Rule Takes Effect

After some implementation delays, the final rule updating Organ Procurement Organization (OPO) performance measures took effect April 1, 2021. The final rule, titled, “Medicare and Medicaid Programs: Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Final Rule,” (OPO Final Rule) creates tougher new quality and transparency requirements for OPOs.

According to the The Centers for Medicare & Medicaid Services (CMS) press release accompanying the Final Rule, the intent of the OPO Final Rule to ensure that OPO performance and outcome measures are more transparent, reliable, and enforceable. The new measures will be implemented during the next OPO survey cycle, which is scheduled to begin in 2022. OPOs will be held accountable for the new outcome measures for recertification purposes in 2026.

Background

OPOs are non-profit organizations that facilitate organ transplantation by recovering and assisting with the distribution of organs from deceased donors. In addition to the medical evaluation and clinical management of potential deceased donors, OPOs arrange for organ recovery and distribution working in close collaboration with donor and transplant hospitals. In addition, OPO staff communicate with donor families at the bedside and provide professional and public education about organ donation.

OPOs are subject to regulations from several federal and state agencies, including the Health Resources and Services Administration (HRSA), which oversees the national U.S. organ transplant system. CMS certifies qualified OPOs and there are currently 58 OPOs, each assigned to its own geographic donation service area (DSA). CMS conducts OPO performance surveys and reviews OPO outcome and process measures. The CMS re-certification process occurs every four years and OPOs that fail to meet Conditions for Coverage, must submit an acceptable plan of correction or risk decertification.

It is critical to maintain the availability of organ recovery services in each DSA. Therefore, CMS does not decertify an OPO without arranging for alternative organ recovery service providers. If an OPO is decertified, regulations provide that the OPO’s DSA is opened to competition from other OPOs. CMS then selects one or more other OPOs in good standing to serve all or part of the decertified OPO’s DSA. The next OPO survey cycle will begin in 2022, when the proposed changes to the OPO measures would take

The OPO Final Rule

Following former President Trump’s Executive Order on Advancing American Kidney Health, CMS issued the OPO Final Rule on November 20, 2020. The Final Rule was set to take effect on February 1, 2021; however, on January 20, 2021, the Biden Administration issued a memo requesting that all rules, guidance, or agency actions which did not take effect prior to January 20, 2021, be delayed to provide agency officials with the opportunity for further review of the issues of fact, law, and policy raised by such rules.

In addition, CMS provided an additional 30-day comment period for the OPO Final Rule. As a result, the initial February 1, 2021 effective date of the rule was delayed to March 30, 2021. Neither CMS nor the Biden Administration issued any further guidance; therefore, the new OPO Final Rule became effective on March 30, 2021.

Key Provisions

Donation Rate Measure

One of the most controversial changes included in the OPO Final Rule is the adoption of a new “Donation Rate Measure.” The new measure assesses the number of organ donors in the OPO’s DSA as a percentage of total inpatient deaths among patients 75 years old or younger with a primary cause of death that is consistent with organ donation. While the measure appears relatively straightforward, CMS intends to determine the total number of inpatient deaths with a primary cause of death that is consistent with organ donation from state death certifications. During the comment period, OPOs raised concerns about the reliability of death certifications, and therefore the validity of the measure. For example, if an individual with an infectious illness that precludes donation dies in a motor vehicle accident, that individual would be considered in the denominator even though organ recovery is contraindicated.

Transplantation Rate Measure

CMS is also changing the OPO transplantation rate to measure to the number of transplanted organs from an OPO’s DSA as a percentage of inpatient deaths among patients 75 years old or younger with a primary cause of death that is consistent with organ donation. OPOs also raised concerns regarding this measure for two primary reasons. First is the concern regarding inpatient death data available on death certification as described above. Second, OPOs try to avoid recovering organs that will not be transplanted, and transplantability is solely within the medical discretion of the transplanting surgeon.

Performance Benchmark

The OPO Final Rule establishes variable performance benchmarks that all OPOs will be encouraged to meet. For the donation and transplantation rates described above, all OPOs will be ranked and the rankings will be made publicly available. The performance benchmark for both measures will be the lowest rate of the top 25 percent of OPOs from the previous 12-month period. OPOs with performance rates that are below the top 25 percent will be required to take action to improve their rates through a quality assurance and performance improvement (QAPI) program.

12-Month Review Periods

Under the OPO Final Rule, CMS will review OPO performance every 12 months throughout the four-year recertification cycle. According to CMS, the more frequent review of OPO performance outcomes will promote continuous quality improvement and best practices. If an OPO does not improve enough to meet the performance expectations before the end of the recertification cycle, the OPO may be de-certified and lose its DSA.

Performance Tiers & Competition

The OPO Final Rule establishes a performance tiering system that triggers decertification, competition, and potential DSA reassignment. At the end of each re-certification cycle (every four years), each OPO will be assigned a tier ranking based on its performance for both the donation rate and transplantation rate measures and its performance on the re-certification survey. The highest performing OPOs that are ranked in the top 25 percent will be assigned to Tier 1 and be automatically recertified for an additional four years. Tier 2 OPOs, OPOs for which performance on both measures exceeds the median but does not reach Tier 1, will not automatically be recertified and will have to compete to retain their DSAs. The lowest performing OPOs (Tier 3) are OPOs that have one or both measures below the median. Tier 3 OPOs will be decertified and will not be able to compete for any other open DSA.

At the end of each 4-year re-certification cycle, DSAs for Tier 2 and Tier 3 OPOs will be opened for competition. Only Tier 1 and Tier 2 OPOs will be able to compete for DSAs. Tier 2 OPOs will need to successfully compete for their DSA or another open DSA in order to be re-certified for another 4 years. All the DSAs for Tier 3 OPOs will be replaced by a better performing OPO and DSAs for Tier 2 OPOs could be replaced by a higher performing OPO. According to CMS, DSA competition will result in DSA reassignment from the lowest performing OPOs to the highest performing.

OPOs also expressed concern regarding the impact of CMS’ decertification and competition strategy. It is unclear what will happen if none of the OPOs seek to assume a struggling OPOs DSA, or how CMS will determine which of the higher performing OPOs should be granted the new DSA. Other implementation question include: What happens to the staff and resources of the de-certified DSA? Does CMS proposed to mandate the transfer of those assets? What happens after multiple decertification and competition cycles? What if the forced consolidation actually reduces performance outcomes?

Implementation Timeline

The current OPO four-year re-certification cycle ends on July 31, 2022. Until that date, OPO performance will be evaluated according to the former outcome measures. On August 1, 2022, CMS will implement the new measures. Thus, full implementation and enforcement of the new measures will occur in July-August of 2026.

© 2021 Foley & Lardner LLPNational Law Review, Volume XI, Number 104
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Maureen F. Kwiecinski Health Care Attorney Foley Lardner
Of Counsel

Maureen F. Kwiecinski is of counsel with Foley & Lardner LLP, based in the firm’s Milwaukee office, where she is a member of the Health Care Industry Team. Maureen counsels health systems, hospitals, medical clinics, blood centers, organ procurement organizations (OPOs) and other health care providers on corporate governance, strategic transactions, and significant investigations and corrective actions; as well as general operational, compliance and regulatory matters. Following a successful career as a registered nurse and health care attorney, Maureen served as the...

414.297.5081
Advertisement
Advertisement
Advertisement