Organ Procurement Organizations (OPOs) Conditions for Coverage Revisions
CMS-3409-P Proposed Rule
Overview
Today, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would strengthen federal oversight of Organ Procurement Organizations (OPOs), strengthen the framework for upcoming re-certification cycles, and increase the number of viable organs that reach patients in need. This proposal builds on the Trump Administration’s historic reforms that have already driven OPO performance improvement to double the number of high-performing OPOs and reduced underperformers by more than half.
Background
In 2019, President Trump issued Executive Order 13879 “Advancing American Kidney Health,” directing the Secretary to enhance the procurement and utilization of organs available through deceased donation and to establish more transparent, reliable, and enforceable objective metrics for evaluating an OPO’s performance. In response, CMS published the Organ Procurement Organization (OPO) Conditions for Coverage rule in December 2020. In that rule, CMS finalized sweeping reforms that have produced historic results: Between 2021 and 2023, the number of OPOs in the highest performing tier (tier 1) doubled from 15 to 30. During the same time, the number of OPOs in the lowest performing tier (tier 3), those not meeting performance standards, decreased from 24 to 10. These performance improvements resulted in organ donors increasing by 31% and organ transplants increasing by 25% in just four years. The proposed rule would increase accountability, bolster the implementation framework for the upcoming and future re-certification cycles, and reinforce the Administration’s commitment to restoring the public’s trust in the organ procurement and transplant system through safe organ procurement practices and proper allocation protocols.
Key Provisions for Strengthening Quality, Safety, and Oversight
Pancreata used for Islet Cell Research
CMS proposes to remove pancreata used for islet cell research from counting in the transplantation rate outcome measure. Pancreata used for islet cell research would continue to be counted in the donation rate outcome measure to comply with a statutory requirement for counting pancreata used for islet cell research for certification and re-certification purposes. CMS also proposes new record-keeping requirements for research organs, including pancreata used for islet cell research to make sure that OPOs are engaged in legitimate research, including requiring approval documentation from an Institutional Review Board or other formal authorizing body, as appropriate, to improve accountability for these organs.
Appeal Process
CMS proposes modifying the time frames in the appeals cycle to increase efficiency in the process. CMS also proposes to codify a process for discretionary review by the CMS Administrator and clarify the appeals process for OPOs that are decertified based on urgent need. These changes would make sure that OPOs have timely appeal rights for any adverse determinations resulting in enforcement action, such as de-certification.
New Definitions
- Adverse Events: CMS proposes to remove the examples in the definition of “adverse event” and add a revised list of examples to the Quality Assurance and Performance Improvement (QAPI) requirements. This would eliminate any confusion that the list of examples constitutes an exhaustive list of adverse events, so that OPOs continue to identify adverse events by definition, regardless of whether the incident is covered in the examples.
- Unsound Medical Practices: This term is not currently defined but is included as an example of circumstances in which CMS may decertify an OPO based on urgent need. CMS proposes to define “unsound medical practices” as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. These practices would include, but are not limited to, failures in governance; patient or potential donor evaluation and management; and procurement, allocation and transport practices and procedures. This definition would ensure that instances of actions that constitute unsound medical practices are addressed appropriately and that OPOs continue to provide high quality care to patients, potential donors and potential transplant recipients.
- Donor: CMS proposes to revise the definition of the term “donor” to clarify that an individual from whom only the pancreas is procured and used specifically for islet cell research is included in the definition of “donor” for purposes of the donation rate outcome measure. This clarification would ensure consistency and continued compliance with the statutory requirement that pancreata used for islet cell transplantation or research be counted for purposes of certification and re-certification.
- Organ: CMS proposes removing pancreata used for islet cell research from the definition of “organ” and thus the organ transplantation rate outcome measure. Pancreatic islet cell research activity would no longer count as a transplant for purposes of certification and re-certification.
- Medically Complex Donor and Organs: CMS proposes to define the term “medically complex donor” as a donor whose medical history requires special considerations for organ placement. Additionally, we propose to define the term “medically complex organ” as an organ procured from a medically complex donor. These definitions are linked to a proposed new QAPI requirement that would assist OPOs in facilitating appropriate placement and utilization of these organs to increase the pool of organs available for transplantation.
Key Provisions for Incentivizing Fair and Equitable Competition to Increase Organ Donation and Transplantation
OPO Designation
To incentivize robust competition for historically low-performing donation service areas (DSAs), CMS proposes to clarify all aspects related to OPO designation and establish a framework that would enable OPOs to manage DSAs separately.
- During re-certification, CMS would evaluate each OPO’s DSAs separately on the outcome measures and remove the OPO’s designation to under-performing (tier 3) DSAs. Additionally, an OPO with tier 3 performance in all of its DSAs will be decertified.
- An OPO would remain certified if it has at least one DSA that met the outcome measure standards (tier 1 or 2) and met all other requirements for certification.
- CMS proposes that OPOs that have acquired a new DSA through competition or are assigned a DSA by CMS would be provided additional time before being held accountable to the outcome measures in the new DSA for re-certification purposes. This would provide a longer timeframe for the OPO, which may be necessary for the outcome measure data to adequately reflect the OPO’s performance in the new DSA.
- CMS proposes that following a change of control, ownership, or service area (CHOW), if data is unavailable to assess the outcome measures in an affected DSA at the time of re-certification, CMS would provide additional time before holding the OPO accountable for the outcome measures in its new DSA for re-certification purposes.
- Additionally, CMS proposes to clarify rare instances when CMS may forgo competition and temporarily designate an OPO to a DSA.
Non-renewal of Tier 2 OPO Agreements
CMS proposes to clarify that OPOs with tier 2 DSAs would be re-certified (if it met all requirements for certification) but must compete to retain their tier 2 DSA or obtain another DSA. If unsuccessful in competition, the OPO would not be designated to any DSA but would still be eligible to compete or otherwise be selected for designation to an open DSA throughout the next 4-year re-certification cycle. If the OPO is not successful in obtaining a DSA by the end of the re-certification cycle, the OPO would be de-certified at that time.
Requirements for Certification
CMS proposes to remove the regulatory requirement that limits certification to OPOs recertified between 2002-2005. Removing this requirement would eliminate a regulatory barrier that prevents the Secretary from implementing a process for the certification of new OPOs. CMS is soliciting public comment on considerations to inform future rulemaking on a new process to certify new OPOs.
Comment Solicitation and Discussion on Emerging Topics
CMS includes several discussions within this proposed rule to address certain emerging issues related to patient safety and public trust as well as soliciting public comment for potential future regulatory requirements. Addressing conflicts of interest in organ and tissue procurement is vital to ensuring ethical conduct. CMS is soliciting public comment on areas where conflicts may exist and how they may be addressed. CMS is also including a comment solicitation on automated electronic referrals from donor hospitals to OPOs as a follow-up to the CMS Health IT Request for Information and to explore any recent developments in this area and gather information that may be helpful in potentially developing future requirements. Lastly, CMS provides an overview of Federal organ allocation requirements to address recent concerns related to an increase in organ allocation out of sequence (AOOS), which reflects a deviation from allocation policy and may only occur if necessary to prevent organ wastage due to discards. CMS clarifies expectations for regulatory and policy compliance necessary for maintaining public trust.
CMS also discusses alternative approaches to the proposed policies on Designation of an OPO to More Than One Service Area and Non-Renewal of Agreement.
- For OPO Designation: CMS proposes to allow OPOs to choose to merge their DSAs or keep them separate. As an alternative to the proposed policy, CMS considered two approaches: 1) Requiring OPOs to maintain separate DSAs, or 2) Allowing OPOs to choose whether to consolidate or keep their DSAs separate with prior CMS approval.
- For Non-Renewal of Agreement: CMS proposes that when an OPO voluntarily terminates its agreement, or the OPO ceases to furnish organ procurement services, it would no longer be designated to any DSAs. CMS considered an alternative approach that would allow OPOs to selectively withdraw from any one of their DSAs without such withdrawal being considered a voluntary termination of the OPO's agreement.
CMS is soliciting public comments on the benefits, risks, and potential unintended consequences of these alternative approaches.
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