medical staff bylaws

May 6, 2021

Posted on by Courtney Patterson

QUESTION:    “We are in the midst of a review of our Medical Staff Bylaws and one of the Bylaws Committee members said that she heard that we shouldn’t be including our hospital’s Institutional Review Board (“IRB”) in the Bylaws with all of the other medical staff committees. Is that true?”

ANSWER:       Yes.  The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.”  The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46).  Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration in which the agency has taken issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document like the bylaws.  The auditors pointed generally to the regulatory language, that it is an institutional responsibility to maintain an appropriate IRB, not a medical staff responsibility.  As a practical matter, the concern is that (while very unlikely) if the IRB procedures need to be revised because of a regulatory change, the medical staff could refuse to do so, as is contemplated by the amendment process to these rules.  By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action.  Again, while the likelihood of a Medical Executive Committee or a medical staff as a whole acting in such an obstructionist manner is very slim, in the eyes of the audit agencies, it is a valid concern.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board.  There may be substantial overlap of the IRB membership with that of a medical staff committee.  However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

February 4, 2021

Posted on by hortyspringer

QUESTION:        Our Medical Staff Bylaws contain a provision stating that Medical Staff members automatically relinquish their appointment and clinical privileges if they lose their license or fail to meet other threshold eligibility criteria.  Do we have to report such automatic relinquishments to the National Practitioner Data Bank (“NPDB”)?

 

ANSWER:          You do not.  By way of background, we generally recommend that Medical Staff Bylaws documents identify certain events that will lead to the automatic relinquishment of appointment and clinical privileges.  This includes, among other things, failure to meet any threshold eligibility criteria that are required for appointment and clinical privileges.  When a member’s appointment and privileges are automatically relinquished pursuant to such a provision, the action is considered to be “administrative” in nature.  That means there is no “professional review action” as defined by the Health Care Quality Improvement Act, so there is no need for a report to the NPDB.  The latest edition of the NPDB Guidebook includes the following question and answer that addresses this specific situation (See page E-47):

Question:  A hospital automatically revoked a physician’s clinical privileges when the physician lost her license.  Should this action be reported?

Answer:  No. Administrative actions that do not involve a professional review action are not reportable to the NPDB. The revocation of clinical privileges is automatic because the practitioner no longer holds a license.  Regardless of the reason for the State medical board’s licensure action, the hospital’s revocation of privileges was not the result of a professional review action.  Therefore, the hospital’s action should not be reported to the NPDB.

October 15, 2020

Posted on by hortyspringer

QUESTION:        In the Tayefeh v. Kern Medical Center case summarized in this week’s Health Law Express, there was confusion about whether the physician was entitled to a Medical Staff hearing because of his failure to disclose certain unfavorable information and the resulting “termination” of his clinical privileges.  Is there any way that we can make it clear in our Medical Staff Bylaws or Credentials Policy that such an event does not give rise to a hearing?

 

ANSWER:          Yes.  While it is always important to consult requirements under state law, which may address situations when a hearing is required (we saw the California Business and Professions Code come into play in the Tayefeh case), your Medical Staff Bylaws or Credentials Policy (“Bylaws”) should clearly define the consequences for certain events and the circumstances that give rise to a hearing.  In Tayefeh, the physician failed to disclose an “accusation” filed against him by the Medical Board of California.  The Bylaws should spell out the results of failing to disclose information requested on the application and instruct that any misstatement in, or omission from, the application is grounds to stop processing the application. A decision not to process an application for these reasons does not entitle the applicant to a hearing or appeal.

With that in mind, it also makes sense to review your application forms to confirm that the application questions are seeking information that you need to make an informed decision about someone’s qualifications.  For example, the hospital’s application in the Tayefeh case not only sought information on past actions by licensing boards, it also asked for information on pending actions.  Confirm that the questions on the application form are consistent with provisions in the Bylaws with respect to the threshold eligibility criteria that someone must satisfy for eligibility for appointment.  If one of your threshold eligibility criterion requires an applicant to “have a current, unrestricted license to practice that has never been subject to any restrictions, conditions, or probationary terms and have never had a license to practice in any jurisdiction denied, revoked, restricted or suspended by a state licensing agency,” then there should be a corresponding question on the application seeking this information.

Finally, your Bylaws should place an obligation on members to notify the Medical Staff Office of any change in information provided as a part of the application and state that a failure to do so may result in administrative relinquishment of appointment and clinical privileges.  This permits the Medical Staff and Hospital to evaluate any changes in an individual’s qualifications, weigh those changes against eligibility criteria, and assess the appropriateness of any applicable consequences under the Bylaws.  Unless state law requires it, an administrative relinquishment of appointment and clinical privileges because of failure to continuously satisfy threshold eligibility criteria does not give rise to a Medical Staff hearing.

October 8, 2020

Posted on by hortyspringer

QUESTION:        Our Medical Staff Bylaws require all bylaws amendments to be accomplished at an officially called, in-person meeting.  As a result, we have been compiling revisions for months (years?) because of the logistics involved in getting this done.  The issue has now come to a head because we have revisions that really have to get into our Bylaws in preparation for an upcoming survey.  Do medical staffs really still vote on bylaws amendments in meetings?  No one shows up for meetings any more — even before the complications created by the current pandemic! Is this still a current practice?  Should it be?

 

ANSWER:           In our experience working with medical staffs across the country, the answer has pretty clearly become no.  While it was traditional for big things — like bylaws amendments and voting on medical staff officers — to occur in in-person medical staff meetings, that tradition has been changing significantly over the past decade.  The negative spin on the move away from in-person voting is that people have stopped showing up for meetings — there just isn’t enough time in the day for all of the patient care issues that have to be addressed to then make time for medical staff citizenship obligations.  However, what we hear most often is the positive side of this coin — which is that by moving away from in-person meetings to take action, which, no matter when they are held (early morning, lunchtime, or late afternoon/evening) will exclude some portion of the medical staff, it is a way to get the input of a much more board cross-section of the medical staff.  The reality is that folks have more time to read an email that includes the proposed amendment and a description of the rationale than they to do attend a meeting.

We have also worked with a number of medical staffs that have opted to “open forum” meetings to discuss proposed bylaws amendments (generally when there is a comprehensive revision process underway), but then conduct the actual vote through email or other electronic ballot — again, attempting to reach as many members of the medical staff as possible.

July 30, 2020

Posted on by hortyspringer

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QUESTION:        We recently received a request, from one of the Physician Assistants in our organization, asking that the Medical Staff Bylaws be amended to allow advanced practice clinicians (Nurse Practitioners, CRNAs, and Physician Assistants) to be members of the Medical Staff and to serve on committees, including the Credentials Committee and the Peer Review Committee.  Can you tell us what you are seeing around the country in these areas?

 

ANSWER:           There has been significant change around the role and responsibilities of advanced practice providers.  We can start with the terms that have been used to describe this group.  In the past, these practitioners were referred to as “physician extenders,” “mid-levels” or “allied health practitioners.”  Now, many organizations use the term “advanced practice professionals” or “advanced practice clinicians.”

Historically, any reference to “physician extenders” or “mid-levels” in the Bylaws was limited to a paragraph or two tucked away at the back of the document.  As the accreditation organizations began to require that these practitioners be credentialed and privileged through the medical staff or related process, many hospitals created parallel policies but still treated allied health practitioners as separate from the Medical Staff.

As advanced practice clinicians have become more integrated into the delivery of care in hospitals and integral to that care, we have seen their roles and responsibilities on the Medical Staff change.  Some Medical Staffs have created an Advanced Practice Clinician Staff that is not a category of the Medical Staff but is included in the Bylaws and addresses the prerogatives and responsibilities of these practitioners.

A small number of Medical Staffs, usually in critical access hospitals, have simply incorporated advanced practice clinicians into their existing Medical Staff categories.  More recently, in Bylaws that we draft, we include an Advanced Practice Clinician Staff as a category of the Medical Staff; however, much like the Courtesy Staff or Consulting Staff, the Advanced Practice Clinician Staff has limited prerogatives and responsibilities.

Another easy step towards inclusion is to allow advanced practice clinicians to be appointed to committees.  This will allow advanced practice clinicians the opportunity to participate in medical staff affairs in a meaningful way and to develop valuable leadership skills.

Since the number of advanced practice clinicians continues to grow, their training continues to evolve,  and their scope of practice continues to expand, creating an Advanced Practice Clinical Committee (staffed by both advanced practice clinicians and physicians) or adding advanced practice clinicians to the Credentials Committee could give your organization a leg up on these challenging issues.

Similarly, since hospitals must evaluate the clinical performance of advanced practice clinicians through the peer review process initially, on an ongoing basis, and when questions are raised, fostering the development of advanced practice clinicians so they can participate in this process makes a lot of sense.  Training advanced practice clinicians to perform case reviews and inviting advanced practice clinicians to serve on the Peer Review Committee are important discussion points.

Some Medical Staffs have decided to include an advanced practice clinician as a member of the Medical Executive Committee (with or without vote).  Identifying the right person to serve in this role is very important and that’s why it may be worth vesting this power in the Chief of Staff or the Medical Executive Committee.

In addition to serving on committees, advanced practice clinicians can be invited to attend department meetings and meetings of the Medical Staff.   In the organizations that we work with, typically, this participation is without the right to vote.

The bottom line is that these are important issues to discuss because they are not going away.  Before you make any changes to your bylaws, however, be sure to check state law.  Some states, like Pennsylvania, limit the Medical Staff to physicians and dentists, unless an exception is granted by the Department of Health.

Additionally, there are some limitations reflected in the CMS Interpretative Guidelines in terms of the Chief of Staff position; this position must be filled by an MD, DO, or, if permitted by State law, “a doctor of dental surgery, dental medicine, or podiatric medicine.”  With respect to the composition of the Medical Executive Committee, the Interpretative Guidelines say that a majority of the members must be MDs or DOs.

March 12, 2020

Posted on by hortyspringer

QUESTION:        We had an applicant who “forgot” to disclose two hospitals where she practiced in the past when she completed her application form.  We found out about one of them through a National Practitioner Data Bank query and the other when we directed her to correct her application form.  She was very apologetic and said it was an accident because her office manager completed the form.  What do we do with this now that we feel like she wasn’t honest? It seems unlikely that she “forgot” an affiliation where they restricted her privileges.

ANSWER:          Misstatements and omissions on application forms can certainly be very serious and the concerns that your medical staff leaders have are justified. The act of completing a medical staff application form is a practitioner’s very first administrative contact with the hospital.  As an administrative function, we recommend having an administrative response when this type of discrepancy is discovered.  That response should not be an invitation to “correct” the application form, because through the use of such language, it implies to the practitioner that there are no concerns raised by their initial completion of the form or that those concerns are fully resolved by their “correcting” the erroneous information.

Rather, we recommend having medical staff bylaws/credentials policy language that clearly states that the hospital will stop processing an application if a misstatement or omission is discovered – and if it is not discovered until after appointment has been granted, that appointment will be automatically relinquished.  The applicant should be notified of the misstatement or omission and given an opportunity to respond, and then there should be an administrative-level review of that response to determine whether or not to move forward.  The same language should be on the application form release that the individual signs upon completing the application form.  Addressing this issue on an administrative level means avoiding words like “rejection” or “termination” of the application or “denying” the application – which is an action that is only ever taken following a comprehensive review of the application and all supporting materials in its entirety.

February 13, 2020

Posted on by hortyspringer

QUESTION:            We are revising our Medical Staff Bylaws and a question has come up about whether we could add a “years of service” exemption that let’s physicians opt-out of their ED call obligations if they have been on the Medical Staff for more than 20 years. Is this okay under EMTALA?

ANSWER:            It is. CMS recognized the practice of giving age or year’s of service based exemptions in the 2003 Preamble to the updated EMTALA Regulations, stating:

“We understand that some hospitals exempt senior medical staff physicians from being on call. This exemption is typically written into the hospital’s medical staff bylaws or the hospital’s rules and regulations, and recognizes a physician’s active years of service (for example, 20 or more years) or age (for example, 60 years of age or older), or a combination of both. We wish to clarify that providing such exemptions to members of hospitals’ medical staff does not necessarily violate EMTALA. On the contrary, we believe that a hospital is responsible for maintaining an on-call list in a manner that best meets the needs of its patients as long as the exemption does not affect patient care adversely. Thus, CMS allows hospitals flexibility in the utilization of their emergency personnel.” (Emphasis added).

Obviously, the highlighted language indicates that while such exemptions are permissible under EMTALA, the exemptions cannot interfere with a hospital’s ability to maintain adequate on-call services.

Therefore, we recommend the MEC approve any request for such an exemption, since allowing an exemption to take effect automatically could create EMTALA problems, depending on the number of remaining physicians in the specialty.  Furthermore, we also recommend including language that states the MEC can require a physician who was previously given an exemption to return to the call schedule (on a temporary or permanent basis) if the needs of the Hospital change.

November 14, 2019

Posted on by hortyspringer

QUESTION:        Is there any way to ensure that practitioners at our hospital keep patients within the community and don’t unnecessarily transfer them to other facilities for the practitioners’ convenience or profit, without going through all of the rigamarole of summarily suspending the physician and then revoking his appointment and privileges, as in the Patel case that was featured in the “NEW CASES” section of this week’s Health Law Express?

ANSWER:            Yes!  Hospital and medical staff leaders can use a number of strategies to help ensure that patients who present to the hospital for treatment do not end up being unnecessarily transferred away to other organizations and/or other communities.  Most organizations’ Medical Staff Bylaws or Credentials Policy includes, as a threshold eligibility criterion for Medical Staff appointment, that an individual live and/or maintain an office within a certain geographic distance of the hospital.  The intent of such requirements is to ensure that practitioners are routinely available to respond to their patients when needed and to participate in medical staff affairs.  Further, it helps to ensure that follow-up, outpatient services are available to patients within the community.

Note that some organizations choose to have a general geographic distance requirement for medical staff membership (e.g., “within 30 miles” or “within 30 minutes driving”) and to also have specialty-specific requirements for those specialties where patient needs may be more urgent or demanding.  For example, it is not uncommon for there to be more stringent geographic requirements (e.g., “within 10 miles” for trauma).  Further, some organizations impose a loose requirement for general medical staff appointment (e.g., “within 50 miles”) but require individuals within certain specialties to be closer to the hospital when serving on call for the emergency department.

In the end, each organization has to choose how to define its geographic requirements, based on the unique nature of the community and the services offered by the hospital’s practitioners.  There’s not a “right” or “wrong” answer with respect to that.  So long as the Bylaws and/or Credentials Policy are appropriately drafted, an individual who fails to meet the geographic distance requirement need not have an application for appointment denied but, rather, can simply be told that he or she has been deemed ineligible to have an application  processed and considered.  Further, so long as those documents call for automatic relinquishment of appointment and privileges when an individual fails to satisfy any eligibility criteria, an individual whose status changes during the course of an appointment term could simply be informed of his or her automatic relinquishment, rather than the Medical Executive Committee and Hospital having to go through the motions (and possible hearing, appeal, and litigation) associated with revocation of appointment and privileges.

Finally, with respect to employed physicians, many organizations require (either in the employment contract or in separate employment policies) that services to be provided within the employer’s facilities unless certain, enumerated circumstances apply (e.g., the patient’s best interest requires transfer to another facility with more specialized capabilities, the patient’s health insurer insists, the patient requests transfer).

July 11, 2019

Posted on by hortyspringer

QUESTION:        Our Medical Staff Bylaws state that once a quorum has been achieved at a meeting, business may continue and all actions taken will be binding.  I presume this means that the Committee can take action even if, during the course of the meeting, members depart or recuse themselves (and leave the meeting).

Recently, we had a quorum for an MEC meeting where three of our 10 members were absent (in other words, we had seven of 10 members present, which was sufficient to satisfy our quorum requirement of 50%).  Three additional members of the Committee recused themselves when a particular physician matter came up for consideration, citing previous involvement in the matter (two of the three physicians who recused themselves had filed complaints against the physician; the other was heavily involved in prior collegial efforts with the physician and practices in the same specialty as an economic competitor).  After the recusals, we had only four of 10 voting members present to consider the matter.

There was disagreement within the remaining members about whether it would be appropriate to proceed — particularly given that serious action (such as a suspension) was being contemplated.  If the Bylaws say the Committee can “go ahead” even when participation drops below a quorum, is there any problem?

ANSWER:            Medical Staff Bylaws (and related documents) serve a very important role of setting guidelines and rules for the conduct of Medical Staff leadership activities and clarifying rights and responsibilities of Medical Staff members.  To that end, it is important to follow the documents whenever possible.  In your case, you did a good job of following the “rules,” established by your Bylaws.  When your meeting was convened, you ensured that you had satisfied the quorum requirement.  Thus, as per the terms of the Bylaws, the MEC was free to proceed in conducting any of the activities that are within its duties (including considering matters of physician peer review and professional review action).

Whether it is a good idea to proceed in a situation such as that which you described is a different matter than whether it is allowed.  And the answer is, “it depends.”

In hospitals that have smaller Medical Staffs and fewer leaders, it can sometimes be difficult to achieve high quorum requirements for meetings.  So, many such Medical Staffs choose to have low quorum requirements (e.g., “whoever is present” or 10%) and meetings are regularly conducted with few people present.  This allows the Medical Staff leadership to get things done, even though only a few people might be actively participating in leadership activities.  In larger hospitals with (presumably) more resources, some Medical Staffs choose more substantial quorum requirements, particularly for Committees that are deemed to have more substantial and important duties – such as the Credentials Committee, Peer Review Committee, and MEC.

While larger quorums can serve some purposes (e.g., giving assurances to Medical Staff members that policy decisions will not be made by individuals, but, instead, by more diverse bodies), they also can have downsides.  Larger quorums can be difficult to achieve – even in larger organizations – if the culture is such that only a small number of individuals are invested in leadership, rather than purely focusing on clinical duties.  Furthermore, even when practitioners are active in leadership, there are times (such as the situation you described) when the circumstances at hand make it difficult to obtain and sustain a significant quorum.

We encourage Hospital and Medical Staff leaders to thoughtfully consider conflict of interest recusal requirements (for example, when drafting PPE policies) that reflect the organization’s culture and resources.  After all, in some organizations, if all who were “involved at a prior level” were required to recuse themselves from any additional consideration of the matter, nearly all members of the MEC might be conflicted out each time a physician conduct matter came before the Committee (since so many of the leaders on the MEC serve as department chairs and officers who handle collegial matters before they ever get to the MEC level).

Further, even when the Bylaws and policies of the organization state that it is acceptable to proceed, we encourage Hospital and Medical Staff leaders to weigh the pros and cons, benefits and risks.  In the situation you described, though the MEC was free to proceed and take action with respect to the peer review matter before it, the MEC might have increased the appearance of fairness by withholding action on the matter until a greater number of MEC members could be present.  After all, although three members were recused and could not participate at this meeting or any future meeting, you described that three members were also absent.  Presuming they were able to attend a future meeting to act on this matter, then the MEC would be able to have seven of 10 members making the decision, instead of just four of 10.  Technically required?  No.  But whenever something as serious as an adverse professional review action is being considered, it makes sense to try to have the determination made by a larger body of individuals, where practical.  It helps if you end up in a Medical Staff hearing (more witnesses to rely on!).  It helps to give the practitioner who is the subject of the action the sense that this is not a personal matter – but rather a matter agreed on by a wide spread of his or her colleagues.

What if the matter is urgent and action cannot wait?  What if patient safety is clearly at risk?  What if you are never able to get more than seven people to attend MEC meetings?  Or the three absent individuals almost never attend?  Those are all things that would have to be considered.  In some situations, it may make sense to proceed with only four of the 10 members present and voting.

But remember, just because the Bylaws say you can does not always mean that you should.

June 20, 2019

Posted on by hortyspringer

QUESTION:              I noted that one of the cases that was in this week’s HLE arose as a result of a hospital granting temporary privileges to an applicant for medical staff appointment.  While we do not routinely grant temporary privileges, they are useful from time to time.  How much risk is there in granting temporary privileges?

 

ANSWER:                 While temporary privileges should not be routinely granted, it is not unusual for a hospital’s medical staff bylaws to state that temporary privileges may be granted to applicants for initial appointment whose complete application is pending review by the Medical Executive Committee and the Board. In order to be “complete” there must be verification of licensure, training or experience, current competence, and an ability to perform the privileges requested. In addition, the bylaws should state that in order to be eligible for temporary privileges, an applicant must (i) have had no current or previously successful challenges to licensure or registration, (ii) have not been subject to involuntary termination of medical staff membership at another organization; and (iii) have not been subject to involuntary limitation, reduction, denial, or loss of clinical privileges.   The bylaws may include other criteria that must be met before temporary privileges are granted.

Additionally, the hospital must query and evaluate information from the National Practitioner Data Bank and check the Office of Inspector General’s List of Excluded Individuals/Entities before temporary (or any privileges) can be granted.  Finally, the grant of temporary privileges should be time limited consistent with the standards of the applicable accreditation organization.  According to The Joint Commission standard “Temporary privileges for applicants for new privileges are granted for no more than 120 days.” 

It is not clear, but it appears from the facts of the case described above, that the hospital’s hospitalist group had such a need for the nocturnist that it wanted to use temporary privileges to rush a candidate through the hospital’s credentialing process.  The temporary privileges were granted and rescinded in 2012, but the litigation did not end until 2019.  In this case, not only did granting temporary privileges fail to fill the nocturnist position, but also caused the hospital years of litigation.

The best way to avoid these kinds of situations and the endless litigation that sometimes ensues is only to grant temporary privileges to applicants after a thorough vetting, after confirmation that there are no red flags and only under the above-described circumstances.