January 13, 2022

QUESTION:
We’ve had a question raised about a Medical Staff member who performed a test on a family member without going through the formal patient registration process.  What can we do to educate our medical staff about the risks involved with these kinds of practices?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
We have found it to be helpful to set forth guidelines that remind Medical staff members of the concerns that can arise when a physician treats him or herself, a family member, or others with whom the physician has a close relationship.  A good starting spot is the Standard E-8.19 in the American Medical Association’s Code of Ethics, which speaks to how such actions can compromise professional objectivity and unduly influence medical judgment.  In addition, your state medical board may have guidance on this issue.

Relying on these resources, Medical Staff leaders can then adopt policy language that reinforces the standards of acceptable medical practice in these situations.

December 9, 2021

QUESTION:
Early on during the pandemic, stress got the best of a well-thought-of member of our Medical Staff, resulting in the Leadership Council issuing this physician a letter of reprimand, a copy of which went into his file.  The issue never became a problem again and recently he asked if we could remove the letter from his file, as he is worried this could come back to haunt him if he decides to seek opportunities elsewhere.  Is it okay honor his request?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
While we can understand this individual’s frustrations about having negative information in his file, there are a number of reasons why we recommend thinking twice before removing anything from a practitioner’s confidential file.

First, removing documentation from the file may create insurance coverage issues.  Some hospitals that we work with have been told by their professional liability carriers that removing information from a practitioner’s file would violate the hospital’s condition of coverage because it would hinder the carrier’s ability to defend any claims involving that practitioner.  Another reason we’ve found is that in those rare instances where an MEC does have to take an adverse action against a physician, it is often based on a history or pattern of conduct.  It is extremely difficult to justify such an action if the documentation of these past events is no longer available.  Similarly, removal of such documentation hampers the institutional memory of the hospital, making it more difficult for future Medical Staff leaders to fully understand past issues and the steps that were taken to mend them.

It is a good idea to have access to confidential files policy in place, so your leadership team can anticipate these types of requests and how they will be handled when they come up.  In the meantime, it may be helpful to explain why you can’t honor this particular physician’s request (based on the reasons above), but then invite him to provide a written update or response to the original concern that will be made a part of his file as well.

November 11, 2021

QUESTION:
Last month, our hospital announced a policy requiring individuals who are physically present on the premises to be fully vaccinated with the COVID-19 vaccine.  We understand that this policy applies to advanced practice professionals and members of the Medical Staff, but we are not sure how to enforce it.  Any suggestions would be appreciated.

ANSWER:
The Medical Staff Bylaws and Credentials Policy (“Medical Staff Governance Documents”) probably require members “to abide by the medical staff documents and the policies of the Hospital.”  That’s a start, but you may want more.  Here are some ideas.

We recommend that the Medical Staff Governance Documents include a threshold criterion that requires individuals to “document compliance with immunization and health screening requirements (e.g., TB testing, mandatory vaccines, and infectious agent exposures).”  We also recommend that your documents expressly state: “Failure of an individual to continuously satisfy any of the threshold eligibility criteria will result in the administrative relinquishment of appointment and clinical privileges, unless a waiver is granted.”

If you don’t have that language now, the Medical Executive Committee may be able to add it to your Medical Staff Governance Documents, but you’ll have to check the notice requirements and the amendment process.

Another alternative is to rely on language in your Medical Staff Governance Documents that requires individuals to provide information when it is requested by a medical staff leader.  Specifically, we recommend the following language:  “Failure of an individual to provide information pertaining to an individual’s qualifications for appointment or clinical privileges in response to a written request from any medical staff leader or any other authorized committee will result in the administrative relinquishment of appointment and clinical privileges until the information is provided to the satisfaction of the requesting party.”  Since the hospital policy requires proof of vaccination, we are comfortable using this language to help enforce the hospital policy.

Remember, a relinquishment is administrative in nature and is not considered an adverse professional review action.  Therefore, the individual is not entitled to a hearing and the hospital is not required to report the individual to the National Practitioner Data Bank or the State Board.

October 21, 2021

QUESTION:
We are trying to implement care guidelines for hip and knee replacements across the system.  The leadership has agreed on the guidelines generally and is now discussing implementation and enforcement.  They want to monitor the established metrics through the OPPE process and, if a practitioner is outside the metrics, have them automatically referred for FPPE (the matter would be referred to the Medical Staff peer review committee for further review and a determination of what collegial measures, if any, could be taken to get the practitioner into compliance).  If the practitioner remains outside the metrics cutoff after 90 days, the leadership has recommended that the practitioner’s joint replacement privileges be deemed automatically relinquished for failure to comply.  This method of enforcement does seem a whole lot easier than conducting an investigation and going through all of the procedures that are necessary to revoke privileges.  What do you think?

ANSWER:
While it is true that implementing an automatic relinquishment is easier than conducting an investigation, making an adverse professional review recommendation, and/or conducting a hearing and appeal process, not every situation is well suited to automatic relinquishment.

The situations where automatic relinquishment is most appropriate are those that are objectively assessed, require little to no evaluation of the practitioner’s competence or conduct, and tend to be focused on administrative requirements.  For example, failure to comply with documentation requirements, failure to attend a meeting when requested by the Medical Staff leadership, or loss of licensure are all matters that routinely lead to automatic relinquishment within hospitals/medical staffs all across the country.

There are some situations where failure to follow a protocol or guideline could appropriately lead to implementation of automatic relinquishment.  For example, consider the scenario where a hospital and medical staff establish a clinical protocol requiring a practitioner to either comply with the protocol or, alternatively, document contemporaneously in the file the reason why he or she is not following the protocol.  Automatic relinquishment of privileges for failure to comply with the administrative requirement of documenting the reasons for non-compliance would be acceptable, since the evaluation of the matter would be objective (e.g. did the practitioner comply?  If not, was there documentation of why in the chart?).  Further, the relinquishment would be related to an administrative matter (failure to comply with a documentation requirement applicable when not complying with a protocol).

However, if the practitioner were being reviewed because, although he or she was documenting the reasons for not following the protocol, the Medical Staff leadership felt those reasons were not good – that would be a different matter.  That would involve evaluation of the practitioner’s clinical judgment (e.g., the explanations for why the protocol was not followed), which would require subjective evaluation, clinical expertise, and a judgment about the practitioner’s clinical competence and/or conduct. Because of that, the consideration of whether the practitioner was justified in not following the protocol would better lend itself to review under the Medical Staff professional practice evaluation process (which is specifically designed to evaluate performance issues utilizing the expertise of the Medical Staff leaders and, afterwards, implement collegial solutions to help practitioners improve).

The situation you describe sounds like it may be more akin to the latter situation described above, in which case automatic relinquishment would not be the best solution.  It’s true that words like “guidelines” and “metrics” give the initial impression that a matter is being objectively evaluated – and that can lead many to believe that automatic relinquishment is a viable option for all situations involving failure to comply.  Our suggestion is to focus more on the actual metrics that are under consideration.  Is non-compliance with those metrics measured objectively, without the need to consider the explanation of the practitioner (e.g. H&P was on the chart prior to surgery, surgical note was on the chart prior to surgeon leaving the OR)?  If the metrics are “administrative” in nature, like these, then automatic relinquishment may be the right enforcement method.

But, if non-compliance with metrics is measured objectively at first –and then requires subjective evaluation to verify whether non-compliance was justified (e.g. patient was an appropriate candidate for the procedure, diagnostic tests were appropriate, appropriate medications were given), then review through the peer review process may be a better option than resorting to automatic relinquishment.  In your scenario, since the original plan is to refer matters of non-compliance into the FPPE process, it sounds like your guidelines may require subjective evaluation and be less “administrative” and, in turn, less suited to automatic relinquishment.

Of course, as always, the best option is to consult with your in-house or Medical Staff counsel, as the best answer depends on the specific protocols/guidelines you are looking to implement and enforce, as well as the language of your Medical Staff Bylaws and related governance documents.

July 8, 2021

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

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 27, 2021

QUESTION:   “When a hospital receives a peer review incident report on a practitioner, is the medical director of an affiliated physician group practice that employs the practitioner allowed to see the occurrence?”

ANSWER:      This is a question that we receive quite frequently and one in which most hospitals are having to answer because they are part of a system with affiliated groups that employ physicians practicing at one or more hospitals within the system.  The bottom line is that information sharing among relevant entities within a system is an important part of credentialing, privileging, and peer review.  Information sharing ensures patient safety and the quality of care across the system.  However, before any information sharing occurs, there should be a process outlined in your Medical Staff policies so that you don’t inadvertently violate your state’s peer review privilege.

While the details of the process for information sharing in your policies is too detailed to fully outline in an answer to the Question of the Week, below are some important points you should consider addressing in your Peer Review Policy.

If the practitioner involved is employed by the hospital, the Peer Review Committee (or “Professional Practice Evaluation Committee” or “Committee for Professional Enhancement” depending on the terminology you use) may notify an appropriate hospital representative with employment responsibilities (such as the medical director of the group) of the review of the incident report and request assistance in addressing the matter.

Whether notification occurs may depend on the circumstances underlying the incident report and the contemplated intervention by the Peer Review Committee.  For example, the medical director of the group should generally be notified when the concern is more significant and an intervention such as a Performance Improvement Plan/Voluntary Enhancement Plan is being considered.  On the other hand, if a practitioner simply receives an educational letter (e.g., on the need to round daily on patients and record progress notes consistent with the Medical Staff Rules and Regulations), the Peer Review Committee may choose not to notify the group.

Nonetheless, if the group is notified, a representative may be invited to attend meetings of the Peer Review Committee, participate in discussions and deliberations, and participate in any interventions to make sure that the group and Peer Review Committee are on the same page.

You want to make sure you consult your state’s peer review statute because it could affect the way that this process is structured and carried out.  Some state laws specifically address the sharing of peer review information with physician group practices while others are silent.  You also want to be mindful of the fact that some state courts have interpreted peer review statutes to limit what you can do with peer review information.  For example, in a case called Yedidag v. Roswell Clinic Corporation, the New Mexico Supreme Court concluded that “the acquisition and use of confidential peer review information for purposes of employee discipline is not a statutorily permissible use of peer review information.”

Finally, it is helpful also to have an Information Sharing Policy in place that, among other things, spells out the rationale for the Policy, the types of information sharing that will occur, the entities that will be subject to the Policy, and an explicit statement that the Policy has been drafted to comply with the state peer review law and is not intended to waive any applicable peer review privilege.

August 20, 2020

QUESTION:        Do quorum requirements apply when a Medical Staff committee or department takes action via “ballot” rather than by holding a meeting?  Our Bylaws language authorizes us to take action by email, written, and electronic balloting, which our committees have been relying on more often in light of the COVID crisis.

We are hoping to hold our annual meeting this September via Zoom meeting and, for the sake of keeping that meeting as short and efficient as possible, move all action on Bylaws and policy amendments out of the meeting, to be conducted instead by electronic ballot.  Before we do that, we want to make sure we aren’t going to have to receive a majority reply in order to satisfy our quorum.  I don’t think we could achieve a majority response.

 

ANSWER:          For the most part, the way a Medical Staff provides notice of its meeting, the quorum requirements that apply, and its procedures for voting on matters are all entirely within its discretion.  So, the best answer about whether quorum requirements apply to votes taken by ballot is:  Check your Bylaws and other governance documents. 

It’s common for Medical Staff Bylaws to include language addressing how meetings are held, whether members can participate in meetings via telephone or electronic connection, what constitutes a quorum, and the number of votes necessary to pass a particular action.  Sometimes, when such provisions have been updated piece meal over the years to address action without a meeting (such as by ballot voting), the connection may not have been made about whether the quorum requirements (traditionally defined as a certain percent of members present at a meeting) apply to votes taken by ballot.

If, after consulting the Bylaws, you find that your documents solve the problem — great!  But, if not, maybe you can use the upcoming meeting as an opportunity to revise your quorum/meeting provisions to specifically address the matter.  One option for solving your dilemma would be to make “Quorum” a defined term within all of your Medical Staff documents.  Consider the following definition as a starting point:

“QUORUM” means, unless specifically stated otherwise, those Medical Staff Members with the prerogative to vote and who are either (a) the voting members Present (but not fewer than two members) at any regular or special meeting of the Medical Staff, department, division, committee, or other body, or (b) the voting members of the Medical Staff or any department, division, committee, or other body, as applicable, who return a response to a vote presented via mail, facsimile, e-mail, hand delivery, website posting, or telephone.  Exceptions to this general definition of Quorum (e.g. those members Present or returning a vote) exists as follows:

(a)        for meetings and votes of the Medical Executive Committee, the Credentials Committee, and the Committee on Professional Enhancement, where the Presence (or return of a response, in the case of voting via mail, facsimile, e-mail, hand delivery, website posting, or telephone) of at least __% of the voting committee members will constitute a Quorum; and

(b)        for amendments to the Medical Staff Bylaws that are presented to the Medical Staff via mail, facsimile, e-mail, hand delivery, website posting, or telephone (which require __% of the voting members of the Medical Staff to return a response in order to satisfy the Quorum requirement).

July 9, 2020

QUESTION:        We’ve had some debate over who can order therapeutic diets.  Can you help explain the rules on this issue?

 

ANSWER:            Historically, CMS has restricted the ability to order therapeutic diets to “practitioners responsible for the care of the patient.”  This generally meant physicians.  However, CMS changed its position on this matter in its Final Rule dated May 12, 2014 by revising 42 C.F.R. §482.28(b)(2) to read “All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietician or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dieticians and nutrition professionals.” (Emphasis added.)

This change came about largely in recognition of the fact that registered dietitians are trained to order patient diets independently, without requiring the approval or supervision of a physician.  In order to give hospitals more flexibility in this area, CMS noted that “[i]n order for patients to have access to the timely nutritional care that can be provided by [registered dieticians], a hospital must have the regulatory flexibility either to appoint [registered dieticians] to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital’s appropriate medical staff rules, regulations, and bylaws.”  This means that in order for a dietician to order patient diets independently, clinical privileges must be granted and monitored by the medical staff.

We have not seen any medical staffs elect to make dieticians full members.  Instead, the most common approach we have seen is to adopt a stand-alone policy that states that any requests for ordering privileges would be processed through the Medical Staff process, while the rest of the dietician’s practice would continue to be monitored through HR.

Of course, your state law may still limit a dietician’s scope of practice, so be aware of any restrictions at the state law level.

June 18, 2020

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QUESTION:        Does our Utilization Review Committee have to be a Medical Staff committee, or can it be a Hospital committee?

ANSWER:           In our experience, some hospitals do have a utilization review committee set up as a Medical Staff committee, but many do not.  There is no explicit regulatory requirement or accreditation standard obligating a hospital to have a Medical Staff utilization review committee.  For example, the Centers for Medicare & Medicaid Services (“CMS”) Conditions of Participation for Hospitals require hospitals to have a utilization review plan and a utilization review committee.  The committee, per the Conditions of Participation, has to be a “staff committee of the institution” with at least two physicians as members.  The requirement can be satisfied by “a group outside the institution” such as one established by local medical societies.  CMS includes the utilization review requirements in the Conditions of Participation in a separate section from the medical staff requirements.  The Medical Staff sections of the Conditions of Participation do not even mention utilization review.  Even though the Conditions of Participation note that a utilization review committee has to be a “staff committee,”  this is different from a “medical staff committee.” CMS knows how to signify when something falls under the purview of the medical staff and the fact that CMS left out “medical staff” when describing the requirements for the utilization review committee is significant.  Furthermore, the Conditions of Participation state that the committee has to be a committee of the “institution,” which signifies “hospital” as opposed to Medical Staff.  The fact that the utilization review committee requirement can be satisfied by a “group outside the institution” (that would not be a medical staff committee) also demonstrates that it does not need a medical staff committee.  Keep in mind that if you decide to have the utilization review committee as a hospital committee, we recommend that you confirm that your state does not require that the committee be a medical staff committee.

That being said, we are aware of at least one client who received feedback from the CMS Survey & Certification Group, Division of Acute Care Services that the utilization review committee “must be a committee or subcommittee of the medical staff.”  Nonetheless, this feedback, as noted above, is not consistent with the Conditions of Participation and we are not aware of CMS citing any hospital for having a Hospital utilization review committee.  It is also not consistent with current practice of many hospitals whose utilization review committees are multi-disciplinary hospital committees with membership comprised of both practitioners and administrative personnel such as directors of coordinated care, billing staff, and internal audit staff.