medical staff bylaws

July 29, 2021

Posted on by Courtney Patterson

QUESTION:
“We are in the process of reviewing our Medical Staff Bylaws after a long period of neglect. While going over the provisions related to Medical Staff hearings, a Bylaws Committee member suggested that if a practitioner is under precautionary suspension, the hearing should be held within 10 days of the practitioner’s request. Ten days seems like a short time for us to prepare for a hearing. But, a few of the doctors on the committee really felt like it would be most fair to a practitioner whose livelihood is “on hold” to have the hearing occur in the most expedited way possible. What do you think?”

ANSWER:
It’s noble to consider the impact of a precautionary suspension on the practitioner who is affected, but holding a hearing within 10 days of a practitioner’s request will be almost impossible for you to manage, from a practical standpoint. Here’s why:

  • Thirty days is the minimum time you must give the practitioner to decide whether to request a hearing under the Health Care Quality Improvement Act (which provides certain immunities from liability to peer reviewers). Therefore, most organizations’ Medical Staff Bylaws and related documents, like the Medical Staff Credentials Policy, are drafted to give a practitioner 30 days to request a hearing.

Because the practitioner has 30 days to make the request, the hospital never really knows when the practitioner’s request will be received.  The request could come on day one or it could come at the close of business on day 30.  That’s a big window!

This matters because the Bylaws language your Committee member suggested states that you will hold a hearing within 10 days OF THE PRACTITIONER’S REQUEST.  If you don’t know when the practitioner’s request will come in, it will be very difficult to prepare (for example, recruiting hearing panel members who are available to serve).

  • Adding to the complexity here is the fact that the Health Care Quality Improvement Act requires, as a condition of immunity, that the practitioner be given at least 30 days to prepare for the hearing after being provided NOTICE OF THE HEARING. That is, you must give the practitioner 30 days to prepare after you send the notice that includes the time, date, and details of the hearing itself (this is different than the first notice, which tells the practitioner that he or she is entitled to request a hearing).

If a practitioner is subject to a precautionary suspension at the time, he or she may consent to have the hearing held in a shorter timeframe (e.g., 10 days) – but until you obtain the practitioner’s consent, you will not know whether you will be able to hold the hearing within 10 days of the practitioner’s request or, alternatively, after 30 (or more) days.  Again, this lack of knowledge regarding when the hearing may or may not occur will make it incredibly difficult for you to find a hearing panel and schedule the hearing – tasks that are essential to tackle if you are planning to hold a hearing within a 10-day timeframe.

WHAT THIS ADDS UP TO:  Imagine yourself, as a leader, approaching colleagues to see if they would be willing to sit on a hearing panel (which likely would mean giving up at least a couple of evenings and perhaps a couple of working days) – and then telling them that you are not sure when you will need them to do this, but think it will be sometime in the next one to 60 or so days!  It’s difficult enough to recruit a hearing panel member without this level of uncertainty in scheduling.

So, if we can agree that holding a hearing 10 days after the practitioner requests it is not practical, what options exist to provide some expedited assurance of fairness to a practitioner who is subject to precautionary suspension?

  • First, make sure you are considering precautionary suspensions separately from other adverse professional review actions. Try not to lump them all together.  That way, you can expedite the process for reviewing the precautionary suspension (e.g., deciding whether there continues to be an imminent risk to the health or safety of an individual) and, if possible, lift the suspension pending continued inquiry into the underlying matter or work with the practitioner to look for less restrictive alternatives (such as having the precautionary suspension apply to some, but not all, privileges held by the practitioner).
  • Second, in the case of precautionary suspension, provide expedited procedures that are “fair under the circumstances.” These procedures should be outlined in the Medical Staff Bylaws (or related documents, such as the Medical Staff Credentials Policy).  Consider requiring that the MEC meet to review the precautionary suspension within an expedited timeframe (e.g., no more than five or 10 days after the suspension is put in place) to decide whether it should be continued pending further review.  Include an opportunity for the practitioner to meet with the Committee to discuss the concerns and offer input (including suggesting any less restrictive alternatives that might be employed to address the concerns while the review continues – for example, strict compliance with patient selection criteria, the use of a consult/second opinion, etc.).
  • After the above review is conducted, the leadership will determine whether to keep the precautionary suspension in place pending further review. In that case, the Medical Staff leadership should be diligent in proceeding with the review of the underlying matter so that there is not unnecessary delay that prolongs the precautionary suspension period.
  • Finally, if anything changes in the interim, or additional facts are brought to light through the review of the matter, and that changes the assessment of whether an imminent risk exists – it is appropriate for the MEC to revisit the issue and lift the precautionary suspension as soon as plausible.

By way of example, imagine a practitioner was precautionarily suspended after the Hospital learned he had been arrested for harassment of an individual who used to be his patient and who claimed that he continued to stalk her following the end of their relationship.  If you later learned from the police that the charges had been dropped after the patient recanted her story and attested to the fact that their relationship was consensual, the MEC might consider immediately lifting the precautionary suspension (on the basis that the concern of imminent risk has been eliminated), even though it would want to continue its underlying review of the matter (on the basis that a consensual sexual relationship with a patient is nevertheless a concern and ethics violation, even if it does not give rise to a concern of imminent risk).

July 8, 2021

Posted on by Courtney Patterson

QUESTION:
“We have an applicant who is refusing to answer one of the questions on our application form because she says that her lawyer told her it could violate a settlement agreement that she has with another hospital.  We think that information is relevant to her request for appointment at our hospital.  Can we still ask for the information?  Should we ask for a letter from her lawyer?  Should the application be held incomplete?”

ANSWER:
Yes!  Credentialers have a duty to review all of the relevant qualifications of each applicant for Medical Staff appointment and clinical privileges and cannot allow the legal interests of an applicant, in an unrelated matter, to interfere with that duty.  Accordingly, the Medical Staff Bylaws (or related policies) should state very clearly that every applicant bears the burden of submitting a complete application and of producing information deemed adequate by the hospital for a proper evaluation of current competence, professional conduct, character, ethics, and other qualifications – and for resolving any doubts.

A similar issue arose in a 1997 case, Eyring v. East Tennessee Baptist Hospital, 950 S.W.2d 354 (Tenn. Ct. App. 1997), in which a physician applicant refused to sign a release form authorizing a hospital where he had previously practiced to send information to another hospital where he had submitted an application.  The physician argued that he received legal advice that signing the release could compromise his lawsuit against the other hospital, which had revoked his privileges.  The court held that because the physician had not provided the additional information that the hospital requested – regardless of the fact that a settlement agreement was in place – he had not submitted a complete application and, thus, under its Bylaws, the hospital was not required to process his application further.

June 10, 2021

Posted on by Courtney Patterson

QUESTION:   “Can our hospital impose a requirement that all Medical Staff members get a COVID-19 vaccine?”

ANSWER:      While we are aware of some hospitals that are considering making COVID-19 vaccination mandatory for their Medical Staffs, most have not yet implemented such a policy.  We should also note that at least one health system is subject to a class action lawsuit filed by 117 of its employees because of its policy requiring employees to be vaccinated against COVID-19. Read about it here.

While the COVID-19 vaccination is proving to be remarkably effective in controlling the spread of the virus, one of the things that is holding some hospitals and health systems back is that the vaccine is currently under emergency use authorization, rather than the full vaccine authorization normally granted by the FDA.  However, at least two pharmaceutical companies are seeking full authorization from the FDA.  On May 7, 2021, Pfizer requested full approval for their COVID-19 vaccine from the FDA.  Moderna followed suit on June 1, 2021.

As noted above in Your Government at Work, the EEOC, in its updated guidance, emphasized that the federal employment equal opportunity laws do not prevent employers from requiring COVID-19 vaccinations, subject to reasonable accommodation provisions and other equal employment considerations.  But, the EEOC also notes that it is beyond its jurisdiction “to discuss the legal implications of [emergency use authorization] or the FDA approach.”

The section of the federal Food, Drug, and Cosmetic Act allowing emergency use authorization requires that individuals to whom a product subject to emergency use authorization is administered are informed of “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”  A reasonable interpretation of this statute would give any individual the right to refuse a vaccine that has only been given emergency use authorization and thus preclude mandates.  A counter-interpretation is that an individual must be informed of the consequences of refusal to accept an emergency use authorization vaccination, such as, for example, automatic relinquishment of clinical privileges.

Nonetheless, if you do decide to move forward with a COVID-19 vaccination requirement, you want to make sure that it is consistent with your Medical Staff Governance Documents and Hospital policies.  There should not be anything to keep you from proceeding, but you will want to confirm this.  You will also want to check if your documents permit you to mandate any vaccines.  If they do, this could set the groundwork for a COVID-19 vaccine requirement.  For example, Medical Staff Bylaws often already require influenza vaccination.  Further, many Bylaws include a threshold eligibility criterion for appointment and privileges stating that an individual must complete all required health screenings and vaccinations prior to providing any patient care at the hospital and any appointment/privileges granted by the Board are conditioned on the individual’s compliance with those requirements.  If you have this threshold eligibility criterion language, it should be broad enough to include a COVID-19 vaccination requirement in a separate policy.

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.