OPTN Bylaws Rewrite Appendix L: Reviews, Actions, and Due Process John Lake, MD President, OPTN/UNOS Board of Directors Co-chair, Appendix L Substantive Rewrite MPSC Work Group lakex009@umn.edu Sharon L. Shepherd, JD, MSN, RN Compliance Analyst sharon.shepherd@unos.org

What is Appendix L? Appendix L: Reviews, Actions, and Due Process outlines: Rights and responsibilities of OPTN Members Requirement that OPTN Members must comply with OPTN obligations Definition of OPTN obligations Represents a substantive rewrite to the portion of the current Appendix A that deal with reviews of Members by the MPSC. OPTN

OPTN Obligations Members agree to comply with all OPTN obligations. OPTN obligations include all the applicable provisions of the National Organ Transplant Act (NOTA), OPTN Final Rule, OPTN Charter, OPTN Bylaws, and OPTN Policies. OPTN

What is Appendix L? Appendix L: Reviews, Actions, and Due Process outlines: How the OPTN Contractor and the MPSC will review and act on potential violations or non-compliance issues Members’ rights when a potential violation is being reviewed The role of the Secretary of Health and Human Services (HHS) in these reviews OPTN

Why Rewrite Appendix L? OPTN The goals of the rewrite were to: Rewrite in plain language Reorganize the bylaws logically Clarify Members’ rights and responsibilities Clarify OPTN responsibilities and actions Define three possible review pathways for potential violations, including an option that allows for the speedy, agile handling of threats to patient health and public safety There are a number of goals for this rewrite. The plain language piece of the rewrite makes OPTN obligations, responsibilities and actions much clearer and easier to understand. The reorganization enables you to find information more easily. The substantive part of the rewrite is slanted more toward helping Members come into compliance and quality improvement than punishment. OPTN

Why Rewrite Appendix L? OPTN Clarify the period in which the Secretary of HHS should be notified of a potential violation or non-compliance issue Clarify when potential violations will be referred to the Secretary of HHS Clarify when and how the OPTN Contractor will perform special Secretary-directed reviews as permitted under the Final Rule, especially in cases where there is no OPTN policy violation We worked with HRSA to better clarify their role in the review process and their expectations of us. Input from an MPSC workgroup, UNOS Legal, UNOS staff, including policy, DEQ, membership and of course… HRSA. OPTN

Why Rewrite Appendix L? OPTN Add a monitoring tool to aid Members who may need time and assistance to come into compliance Provide increased opportunities to Members for quality improvement OPTN

Current Bylaws Category I : Fast track review for substantial, time sensitive threat to patient health or public safety Category II and III: Defined based on MPSC action Currently, the Bylaws provide for three categories of cases. Category I is a fast track for matters that present a substantial, time sensitive threat to patient health or public safety. This pathway has been maintained in the rewrite with a few modifications. Category II and III are defined based on the action the MPSC would take in the matter. They both follow same path – both are prepared and presented at the next scheduled meeting of the MPSC. OPTN

How Is an Issue Reviewed? MPSC review Letter of Reprimand or recommendation of adverse action (probation or member not in good standing) entitles Member to an interview If after interview, the MPSC recommends an adverse action, then the Member is entitled to a hearing Continued recommendation for an adverse action goes to the Board of Directors for final decision. Currently, the Bylaws provide for three categories of cases. Category I is a fast track for matters that present a substantial, time sensitive threat to patient health or public safety. This pathway has been maintained in the rewrite with a few modifications. Category II and III are defined based on the action the MPSC would take in the matter. They both follow same path – both are prepared and presented at the next scheduled meeting of the MPSC. OPTN

Three New Review Pathways Imminent Threat Review pathway (Former Category I) Expedited Review pathway (New!) Routine Review pathway The new process for review has been divided into three pathways to allow flexibility in the timing of the response to matters based on the severity of the violation and the risk the violation poses. The MPSC Chair may change the review pathway of a potential violation at any time as information is gathered and the assessment of the urgency and severity of the risk to patient health or public safety changes. OPTN

Imminent Threat Review Urgent/severe potential risk to patient health or public safety Request to mitigate the threat w/in 24 hours No interview Adverse action effective immediately Expedited Review Potential risk to patient health or public safety Not immediately urgent; could become so if not addressed quickly Interview is expedited Board review is expedited Routine Review Other pathways not warranted Most cases This slide just gives an overview of the differences in the three review pathways. In the next several slides we will take a closer look at the pathways.

The Imminent Threat Review Pathway Former Category I – NOT new! Extremely egregious or urgent and severe risks to patient health or public safety Very, very few cases will continue through the Imminent Threat Review Pathway Exact language from Bylaws: “An Imminent Threat Review will be conducted when the MPSC Chair determines that there is a potential violation of OPTN obligations that may pose an urgent and severe risk to patient health or public safety. We would expect these cases to be rare but if there is a case that rises to this level, this pathway allows the OPTN to act swiftly to alleviate the risk.” Because of the urgency and severity of these cases, the due process rights provided to a Member have been altered to allow the OPTN to move swiftly. Much of the details of this pathway mirror the current category I process. Initially, the Chair makes a determination that a situation poses an urgent and severe risk to patient health or public safety. At the time of this determination, the Chair decides what action the Member could take to mitigate this threat such as ceasing transplants for a period of time and whether that action would be sufficient to remove the case from the imminent threat review pathway. If the matter continues in the imminent threat review pathway, an imminent threat review committee, a subcommittee of the MPSC, will review and recommend an action. To accommodate the need for swift action, the member is not entitled to an interview. Instead, the Executive Committee will review the recommendation of the imminent threat review committee. If the Executive Committee takes an adverse action, it will take effect prior to the offer of a hearing. These alterations to due process currently exist in the Bylaws for Category I reviews. The rewritten Bylaws flesh out this process to provide clarity as well as adding the provision for the Member to mitigate the threat. OPTN

The Imminent Threat Review Pathway MPSC Chair will determine what action the Member needs to take to mitigate the threat to patient health and public safety Executive Director may then request that the Member take the determined action immediately (within 24 hours) If threat is mitigated, the potential violation may then proceed through the Expedited or Routine Review pathway Exact language from Bylaws: “An Imminent Threat Review will be conducted when the MPSC Chair determines that there is a potential violation of OPTN obligations that may pose an urgent and severe risk to patient health or public safety. We would expect these cases to be rare but if there is a case that rises to this level, this pathway allows the OPTN to act swiftly to alleviate the risk.” Because of the urgency and severity of these cases, the due process rights provided to a Member have been altered to allow the OPTN to move swiftly. Much of the details of this pathway mirror the current category I process. Initially, the Chair makes a determination that a situation poses an urgent and severe risk to patient health or public safety. At the time of this determination, the Chair decides what action the Member could take to mitigate this threat such as ceasing transplants for a period of time and whether that action would be sufficient to remove the case from the imminent threat review pathway. If the matter continues in the imminent threat review pathway, an imminent threat review committee, a subcommittee of the MPSC, will review and recommend an action. To accommodate the need for swift action, the member is not entitled to an interview. Instead, the Executive Committee will review the recommendation of the imminent threat review committee. If the Executive Committee takes an adverse action, it will take effect prior to the offer of a hearing. These alterations to due process currently exist in the Bylaws for Category I reviews. The rewritten Bylaws flesh out this process to provide clarity as well as adding the provision for the Member to mitigate the threat. OPTN

The Imminent Threat Review Pathway The Executive Director will provide notice to the Secretary within 24 hours of the MPSC Chair’s determination of an Imminent Threat Review No interview is offered Instead, the Executive Committee reviews the Imminent Threat Review Committee recommendation Any adverse action will become effective immediately, before the Member is offered a hearing Exact language from Bylaws: “An Imminent Threat Review will be conducted when the MPSC Chair determines that there is a potential violation of OPTN obligations that may pose an urgent and severe risk to patient health or public safety. We would expect these cases to be rare but if there is a case that rises to this level, this pathway allows the OPTN to act swiftly to alleviate the risk.” Because of the urgency and severity of these cases, the due process rights provided to a Member have been altered to allow the OPTN to move swiftly. Much of the details of this pathway mirror the current category I process. Initially, the Chair makes a determination that a situation poses an urgent and severe risk to patient health or public safety. At the time of this determination, the Chair decides what action the Member could take to mitigate this threat such as ceasing transplants for a period of time and whether that action would be sufficient to remove the case from the imminent threat review pathway. If the matter continues in the imminent threat review pathway, an imminent threat review committee, a subcommittee of the MPSC, will review and recommend an action. To accommodate the need for swift action, the member is not entitled to an interview. Instead, the Executive Committee will review the recommendation of the imminent threat review committee. If the Executive Committee takes an adverse action, it will take effect prior to the offer of a hearing. These alterations to due process currently exist in the Bylaws for Category I reviews. The rewritten Bylaws flesh out this process to provide clarity as well as adding the provision for the Member to mitigate the threat. OPTN

The Expedited Review Pathway This is a new pathway. Provides an expedited timeframe for review of investigation results by committee. Interview is granted in an expedited manner, either in-person or through teleconference, instead of waiting until the next MPSC meeting. Completion of Hearing Panel report and Board review are both expedited. Exact language from the Bylaws: “An Expedited Review will be conducted when the MPSC Chair determines that there is a potential violation of OPTN obligations that may pose a potential risk to patient health or public safety, which is not immediately urgent but could become urgent or severe if not addressed using an Expedited Review process.” This is a new pathway that will allow the MPSC to review cases in between established meeting times if necessary. All of the rights currently provided to the Member remain in the expedited review pathway. The time periods in between the actions has been shortened. Therefore, if Member is entitled to an interview, the interview may be held prior to the next regularly scheduled MPSC meeting. In addition, the hearing panel report and Board of Director review of the matter are both expedited. OPTN

The Routine Review Pathway A Routine Review will be conducted for any potential violation of OPTN obligations when the MPSC determines that an Expedited Review or an Imminent Threat Review is not warranted. This is the majority of the reviews; the normal review pathway. This review is currently how the majority of cases move through review by the MPSC. Each of the steps of the process occur during a regularly scheduled MPSC meeting, for the most part. The rewrite has simply made the process easier to understand through a reorganization and the use of plain language. OPTN

Secretarial Reviews and Actions Provides an avenue to notify the Secretary within 7 days when there is no violation of OPTN obligations but a threat to patient health and public safety exists. Clarifies that the Secretary may request that the OPTN Contractor perform a special review of a potential violation “in the manner and within the period specified by the Secretary” as provided for in the Final Rule. The requirements of the final rule regarding notice to the Secretary about matters that are not violations of OPTN obligations but pose a threat to patient health or public safety and requests by the Secretary for the OPTN contractor to perform special reviews have been clarified in the proposed bylaw revision. OPTN

Deferred Disposition OPTN If the MPSC is considering a recommendation to impose an adverse action against a Member, the MPSC may vote to delay further consideration of the matter for a Deferred Disposition period. Deferred Disposition is an assessment and improvement period provided to the Member to demonstrate compliance with OPTN obligations. May be offered after the Member has had an interview. Very specific limitations on when this option can be used; looks at Member’s compliance and MPSC review history The other main proposed revision is an option for Deferred Disposition. This option will only be available to the MPSC when it is considering recommending an adverse action, either Probation or Member Not in Good Standing. Deferred Disposition focuses on improvement rather than punishment. Deferred Disposition will result in the delay of further consideration of an adverse action to provide the Member an opportunity to implement improvements that will bring the Member into compliance with OPTN obligations. The MPSC will monitor the Member during this period. Deferred Disposition will only be offered after the Member participates in an interview and there are very specific limitations on the situations where this option can be used. OPTN

Appendix L Schedule OPTN Public Comment Period February 3 through April 6, 2012. Three Live Meeting education sessions: 2/22, 3/9, and 3/13. The substantive rewrite of Appendix L and the entire Bylaws Phase I Plain Language Rewrite will go to the Board for approval in June 2012, but as separate proposals. Subsequent release of the entire “new and improved” OPTN Bylaws. OPTN

Questions? Comments? bylawsrewrite@unos.org You may also send your questions or comments to: bylawsrewrite@unos.org OPTN