Introduction
Floating under the radar of a series of regulatory changes governing the operation of Critical Access Hospitals ("CAHs") over the last eighteen months was a significant shift in the regulations governing the relationship between the medical staffs of CAHs and general acute care hospitals within the same multi-hospital health system. Effective January 23, 2023, under the Medicare Conditions of Participation ("CoPs")1, and effective June 1, 2023, under The Joint Commission ("TJC") standards, Critical Access Hospitals will now be able to elect to create a single unified and integrated medical staff with other hospitals that are part of the same multi-hospital system, including with general acute care hospitals.2
Background
Prior to the changes to the CoPs and TJC standards, the Centers for Medicare & Medicaid Services ("CMS") guidelines had indicated that hospitals that are paid under a Medicare payment system other than the Hospital Inpatient Prospective Payment System ("IPPS"), which includes CAHs, may jeopardize payment status if they were to unify their medical staff with an IPPS hospital such as a general acute care hospital. In response to a previous public comment, which first appeared in a separate final rule published in 2019, CMS stated the reasoning for not allowing CAHs to create a unified medical staff with a general acute care hospital was that, "a CAH must be separately evaluated for its compliance with the CAH CoPs, which would not include the requirements included in this section of the rule [42 CFR § 482.21] since these are hospital CoPs. It would not be possible to evaluate the CAH's compliance as part of an evaluation of a hospital's compliance."3 In short, CMS's previous perspective was that a CAH's compliance could not be effectively evaluated if its medical staff was unified with the medical staff of a general acute care hospital.
Despite the prior guidance from CMS, enough ambiguity remained in the regulations at the time that many multi-hospital systems with CAHs nonetheless established unified medical staffs that incorporated the CAH medical staff together with the medical staffs of the other general acute care hospitals within the system.
However, in 2022 CMS updated the CoPs governing CAHs to allow CAHs to establish a unified medical staff with other hospitals within the same system, including acute care hospitals thereby bringing the CAH CoPs into alignment with the CoPs governing acute care hospitals.4
The Joint Commission subsequently indicated its support for allowing a CAH in a multi-hospital system to participate in a unified medical staff in written comments sent to CMS on August 29, 2022, responding to the then proposed rules.5 Yet it would take another year before TJC published new standards for CAHs setting out the elements of performance permitting CAHs to participate in a unified medical staff in August 2023. The new CAH standards now align with the existing TJC standards for acute care hospitals.
Legal and Accreditation Standards
Under the new Medicare CoPs and TJC standards a CAH may elect to participate in a unified and integrated medical staff with other separately certified hospitals, CAHs, or Rural Emergency Hospitals (REHs) (collectively "hospitals"), within the same system if certain established conditions are met.
The initial threshold requirement for unification is that the CAH and any other hospitals participating in the unified medical staff must share a single system-wide governing body carrying out the functions delegated to the governing body by CMS and TJC.6 Assuming this initial threshold bar is cleared, the governing body may then vote to approve the adoption of a unified medical staff model, subject to acceptance by the medical staffs of each of the participating hospitals. If the governing body approves the establishment of a unified medical staff, the question of unification then turns to the individual hospital medical staffs.
The medical staffs of each separately certified hospital in the system must then vote by a majority, in accordance with the medical staff bylaws, to either accept or opt-out of the unified and integrated medical staff structure.7 It is recommended as best practice that prior to voting on unification each hospital's medical staff bylaws address the process by which such a vote will occur. CMS has indicated that it expects all hospitals that are part of a multi-hospital system to amend their medical staff bylaws to address the potential of a vote on medical staff unification, even if unification is not being considered at present.
If the CAH and other hospitals elect to establish a single unified medical staff, then unified and integrated medical staff must establish a single set of medical staff bylaws, rules and regulations, and other governing documents that describe the medical staff's processes for self-governance, taking into account the unique characteristics and concerns of each separate hospital, and set forth the functions and responsibilities of the unified medical staff including all essentials elements required of medical staff bylaws under the CoPs and TJC standards such as qualification criteria, credentialing and privileging, peer review, and hearings and appeals.8 The unified and integrated medical staff bylaws must also set out the process by which a member medical staffs may vote to opt out of the unified medical staff and reestablish a separate distinct medical staff.9
In conjunction with the governing documents, the unified medical staff must also put in place policies and procedures to ensure that the localized issues, concerns, and needs of each participating hospital medical staff given due consideration and addressed.10
Implementation Challenges and Considerations
Beyond the essential regulatory and accreditation requirements, establishing and maintaining a unified medical staff raises significant practical challenges and considerations for hospitals that are part of a multi-hospital system.
Addressing the Unique Needs of Each Hospital
For unified medical staffs that include a CAH, the requirement that the unified medical staff be established in a manner that takes into account the unique circumstances of each hospital can be a particular challenge given the different requirements under the Medicare CoPs and TJC standards for CAHs as compared to general acute care hospitals. This is true for any unified medical staff that incorporates multiple hospital types in addition to those with CAHs, such as children's hospitals, rehab hospitals, small rural or community hospitals, and large academic medical centers. Taken together with the requirement that the unified medical staff have in place policies that address the considerations of each separate hospital, health systems must be careful when drafting unified medical staff bylaws and system-wide policies to account for the differences between the requirements and day-to-day functions of a CAH, or other hospital type, as compared to the other general acute care hospitals in the system.
The need to address local issues also creates a knock-on administrative challenge, as the policies must provide a clear mechanism for issues local to an individual hospital's medical staff to be brought before unified medical staff leadership and for underlying concerns, the review process, and its outcome to be properly documented. This additional administrative burden can add strain on the medical staff office and necessitates greater logistical planning at the outset to avoid complications or gaps in the implementation of the unified medical staff policies.
When the unified medical staff consists of multiple types of hospitals, a one-size-fits-all approach to policies and standards may not always be workable. For example, policies that might apply to a children's hospital may not be applicable or function in the same way at a general acute care hospital and vice-versa. Certain policies and procedures, for example call coverage, consultations, and emergency care policies, may continue to require implementation at the individual hospital level despite medical staff unification to appropriately take into account the different needs, challenges, and patient populations of each hospital. For best practices, each policy should clearly identify hospitals and facilities to which it applies.
Managing Peer Review Activities
The requirement that the medical staff bylaws, rules and regulations, and policies and procedures take into account the unique needs and circumstances of the individual hospital may also have implications for routine peer review functions such as ongoing professional practice evaluation ("OPPE") and routine focused professional practice evaluation ("FPPE") upon the grant of initial clinical privileges.
The practical logistics of medical staff unification will also require significant consideration to be tied to the process for managing peer review among and across the hospitals. The unified medical staff will need to determine whether peer review will continue to be managed locally, centralized, or if some form of hybrid approach will be used. Centralizing peer review activities can provide great benefits to the unified medical staff by improving consistency in the application of rules and requirements and ensure that clinical standards are uniformly upheld across the system hospitals. However, where hospitals choose to centralize peer review efforts, the transition to a single centralized or hybrid process poses unique challenges with regard managing the practical transition from the individual hospital's peer review efforts. Failure to properly manage the transfer of peer review activities and ongoing hearings during the transition to a unified medical staff creates a risk of important deadlines or procedural steps being missed or delayed, which in turn has the potential to result in a meaningful increase in liability exposure to the hospital and the health system. Considerable forethought must be placed into the process for handing-off any peer review files from the individual hospitals, with particular consideration given to ensuring a smooth transition of any ongoing corrective actions, investigations, or hearings and appeals. Policies and procedures similarly need to be put in place to address the potential transfer back to the individual hospitals in the event that any one hospital's medical staff later chooses to opt-out of the unified medical staff.
In addition to managing the transfer of ongoing peer review activities at the time of the creation or dissolution of a unified medical staff, new peer review actions taken up under a unified medical staff present unique challenges as well. The unified medical staff must strike an appropriate balance between centralizing the peer review process across the system hospitals while ensuring that local expertise is not lost, the central peer review committee is not too remote from the care provided, and a bottleneck is not created. An option to consider is the creation of an intermediate step in the peer review process whereby a local or regional peer review committee assesses a matter first before sending a report and recommendation to a centralized peer review committee. Additionally, careful coordination across the hospitals must be maintained to ensure that an action taken at one hospital is consistently applied at all of the other hospitals participating in the unified medical staff. For example, if a practitioner's clinical privileges are summarily suspended at one hospital, processes need to be in place to ensure all other hospitals within the unified medical staff are promptly notified of the suspension and able to implement it uniformly across the system. Clear communication and well-defined procedures are essential to the effective and consistent management of peer review activities throughout a unified medical staff.
Granting of Clinical Privileges
Another important practical consideration for health systems and hospitals in establishing a unified medical staff is how clinical privileges will be granted. The Joint Commission does not require privileges to be granted on a site-by-site basis, permitting a system-wide grant of clinical privileges for multi-campus organizations. Indeed, one of the core benefits of participating in a unified medical staff is the ability to have a single credentialing and privileging process with the option to grant clinical privileges to provide care across the system, which in turn allows practitioners to move seamlessly between facilities and ensure specialty care is available at all of hospitals across the system. However, unified medical staffs must continue to evaluate the appropriate range of clinical privileges granted to each practitioner on a case-by-case basis so as not to fall afoul of other TJC standards. Under MS.06.01.01, prior to granting clinical privileges, the medical staff must determine that the resources necessary to support the requested privilege are available. Not every hospital within a unified medical staff will have the same equipment, staffing, space, and other resources. Practitioners should only be granted privileges at multiple facilities to the extent those privileges can be safely and effectively exercised.
If any of the hospitals within the unified medical staff have entered into exclusive arrangement for any specific service lines this will need to be taken into consideration in a determination whether a certain non-aligned practitioner may be granted clinical privileges at such hospital. Some exclusive arrangements may need to be renegotiated after medical staff unification to effectively manage the service line across the unified medical staff and ensure consistent care throughout the system, particularly if separate hospitals within the unified medical staff have competing exclusive arrangements.
Voting and Minimum Duration Between Votes
Managing the voting process within a unified medical staff presents its own practical challenges. While the CoPs and TJC standards require that the decision to participate in, or opt-out of, a unified medical staff be approved by a majority, the unified medical staff has a fair degree of flexibility to determine the specifics of the voting process. Broadly, the requirements for voting to opt-in or opt-out of a unified medical staff must be the same as those for amending the medical staff bylaws. For example, the hospital may not require a supermajority to approve opting-out of the unified medical staff unless the same supermajority is required to amend the medical staff bylaws. However, within that, the medical staff has reasonable discretion to determine which members of the medical staff are eligible to vote, the process and timeline by which a vote is taken, and the minimum requirements to request a vote on unification. The bylaws, however, may not require that a petition on a vote to opt-out of the unified medical staff be signed by the same number of voting members as would be required for a successful vote to opt-out.11 Similarly, the bylaws may not establish different criteria for the categories of members entitled to vote on unification than those used for any other type of voting on medical staff matters.12
The governing body of a unified medical staff may also wish to establish a minimum duration between votes to opt-out of the unified medical staff to ensure stability and consistency as much as possible; however, the interval may not be longer than two years to ensure the medical staff's self-governance does not come into question and the medical staff member's rights are not unduly restrained.13 With regard to what constitutes a "majority" required to approve or opt-out of a unified medical staff, the voting provisions of then-current bylaws apply, but similar to approval or amendment of the bylaws, the vote to opt-out of the unified medical staff may not be delegated to the executive committee.
Other Practical Considerations
Each hospital within a unified medical staff must still demonstrate its compliance with the CoPs and adherence to TJC standards individually. As such, unified medical staff's must also be mindful of practical implications of creating a unified medical staff. There is currently no process for a system level certification or accreditation, and each separately certified hospital will continue to be surveyed by CMS and TJC individually. With this in mind, the minutes of the medical executive committee and governing body should clearly specify to which hospital(s) any discussions or actions apply. Additionally, while the medical staff may be integrated as a governing organization, this does not inherently translate to meaning the different departments of each hospital will be functionally integrated in the same way. Integration of departments across hospitals may be an option in some instances, but when such integration is not possible or impractical, close coordination between the individual hospital departments will be critical.
Medical staff unification may have implications for hospital transactions as well. If a health system acquires a new hospital and has elected to utilize a unified medical staff, then the acquired hospital must initiate the process to make the necessary changes to adopt new bylaws and other medical staff governance documents no later than six months after the date of acquisition.14
Other practical concerns such as friction or competition between hospitals, proportional representation of the individual medical staffs, ensuring smaller hospitals within the unified medical staff maintain a meaningful voice in decision making, and allocation of leadership positions must all also be considered when contemplating medical staff unification.
Conclusion
The unification of medical staffs within a multi-hospital system presents a meaningful opportunity for growth, coordination, collaboration, and improvement of patient care. Medical staff unification can provide for greater efficiency and reduced redundancy in the use of resources, improve sharing of information, boost mutual accountability, and improve standardization and consistency in credentialing, peer review, and delivery of patient care across the system. That said, unification also presents unique challenges both in terms of initial implementation and ongoing management of the unified medical staff. The recent changes to the CoPs and TJC standards to allow critical access hospitals to participate in a unified medical staff with other hospital types is a welcome reprieve for those critical access hospitals that had previously been left in the cold and unable to benefit from the advantages of participating in a unified and integrated medical staff. However, any multi-hospital system contemplating or currently operating a unified medical staff would do well to be mindful of the legal requirements and practical challenges posed. As tempting as a single set of standards and documents may be, remember that a one-size-fits-all approach will not be practicable in all instances. When in doubt, seek out guidance from competent legal counsel with solid medical staff expertise to help navigate the potential pitfalls and achieve the optimal potential benefits of creating a unified medical staff.
Footnotes
1. 42 CFR § 485.631(e).
2. The Joint Commission, Critical Access Hospital Accreditation Standards, MS.01.01.05.
3. Available at, https://www.govinfo.gov/content/pkg/FR-2019-09-30/pdf/2019-20736.pdf
4. 87 FR 72308, Nov. 23, 2022.
5. Available at, https://www.jointcommission.org/-/media/tjc/documents/federal-relations-and-public-policy/2022_08_29_tjc-comments_cms_reh-cop-proposed-rule.pdf
6. 42 CFR § 482.12, and TJC LD.01.02.01.
7. 42 CFR § 485.631(e)(1) and CAH MS.01.01.05, EP 1.
8. Id. at 485.631(e)(2) and CAH MS.01.01.05, EPs 2 & 3.
9. CAH MS.01.01.01, EP 37.
10. 42 CFR § 485.631(e)(3) and CAH MS.01.01.05, EP 4.
11. CMS State Operations Manual (SOM), Interpretive Guidelines A-0349, p. 197.
12. Id. at 201.
13. Id. at 198.
14. SOM, Interpretive Guidelines A-0349, p. 197.
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