March 28, 2024

QUESTION:
Our On-Call Policy requires physicians to have 30 admissions or operating cases at the hospital per year to participate in the on-call schedule.  The Policy also gives discretion to the department chairs, who develop the call schedules, to limit the ability of a particular physician to participate in the schedule for a number of reasons, some of which have nothing to do with the quality of care being provided.  Do these provisions in our Policy pose any legal concerns?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
Yes.  First, conditioning participation in the call schedule on admissions at, or procedures done in, the hospital could be interpreted as conditioning participation on referrals to the hospital.  Such a requirement could present compliance issues with the federal Anti-Kickback Statute.  In Supplemental Compliance Program Guidance for Hospitals, the Department of Health and Human Services Office of Inspector General (“OIG”) cautioned that “conditioning privileges on a particular number of referrals or requiring the performance of a particular number of procedures, beyond volumes necessary to ensure clinical proficiency, potentially raise substantial risks under the [Anti-Kickback] statute.”  Moreover, some state courts have found that participation on the call-coverage roster constitutes a “privilege.”

This issue is something that is on the Department of Justice’s radar as well.  For example, in 2010, a hospital agreed to pay the United States $108 million to settle claims that it violated the Anti-Kickback Statute and the False Claims Act by limiting the opportunity to work at an outpatient cardiology testing unit to cardiologists who referred business to the hospital, giving the cardiologists a percentage of time in the testing unit which corresponded with the gross revenue attributed to the cardiologists’ referrals.  Conditioning participation on the call roster on admissions or performing cases at the hospital presents similar risks.

If compensation is involved in the call coverage arrangements, there is further concern under the Anti-Kickback Statute.  The OIG has warned that under the Anti-Kickback Statute there is “considerable risk” in conditioning compensation for on-call coverage on “doing business at a hospital.”

Finally, giving the department chairs the discretion to limit the ability of a physician to take call poses anticompetitive concerns.  While there may be legitimate reasons to limit the ability of a physician to take call, such as issues with a physician’s quality of care, such decisions should not be made solely by potential competitors in the department.

If you have a quick question about this, e-mail Charlie Chulack at cchulack@hortyspringer.com.

March 21, 2024

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 because it involves actions on appointment and privileges.  Can we still ask for the information?  Should we ask for a letter from her lawyer?  Should the application be held incomplete?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Yes! Credentialers have a legal duty to review all relevant information that has any bearing on the qualifications of an 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, 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 made an application.  The physician argued that he received legal advice that signing the release could compromise his lawsuit against the 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.

If you have a quick question about this, e-mail LeeAnne Mitchell at LMitchell@hortyspringer.com.

March 14, 2024

QUESTION:
Do you have any tips for virtual meetings?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, invest in Zoom!  The pandemic changed a lot of things, one of which was that many meetings became virtual.  While in-person meetings are back, virtual meetings still may be held from time-to-time, so we’ve compiled the following tips:

  • Virtual participants should be required to maintain compliance with all policies relating to confidentiality, data privacy, electronic communications and security. We recommend that all meetings begin with a reminder about confidentiality, privacy and security, and that this be reflected in the minutes.  Quorum and voting requirements apply as if at an in-person meeting.
  • The best practice is to prepare for calls by testing new cameras and microphones before the meeting. Also, minimize outside distractions, such as the dog coming in and out of the picture, hearing the neighbors fighting, or the kid next door testing out the new exhaust on his Dodge Challenger.  You can’t soundproof the walls, but do try to find a secluded, quiet space.
  • Remember that you’re in a professional setting. We’ve all heard the stories about people making dinner, brushing their teeth, etc., while on Zoom.  Avoid that and give the meeting the attention it deserves.
  • Remember that mute is your friend. Keep microphones on mute unless speaking, and always assume that the mic is hot.  Pre-pandemic, there’s the famous story about President Ronald Reagan forgetting that he had a hot mic, and saying “My fellow Americans, I’m pleased to tell you today that I’ve signed legislation that will outlaw Russia forever. We begin bombing in five minutes.”  Then there are the pandemic stories – all members of a San Francisco area school board resigned after they were heard making disparaging comments about parents at a virtual board meeting.  Always assume the mic is hot and the camera is on.
  • Set forth a process for sharing documents, taking into account: How do you control access? (passwords, secure email, etc.); Do you send emails to gmail accounts or only to hospital accounts? Are you going to blind the records?  Prohibit copies?  Which videoconferencing platform is secure for HIPAA and other privacy laws?  Create a list of approved software programs.

Finally, take everything and turn it into a policy to be used whenever a virtual meeting is held.

If you have a quick question about this, e-mail Nick at ncalabrese@hortyspringer.com.

March 7, 2024

QUESTION:
A physician was invited to attend a collegial counseling meeting with the Chief of Staff and CMO, to discuss a recent case where his management of a patient’s care had been called into question.  The physician came to the meeting, but once he learned what we were going to talk about, he refused to proceed unless he could record the meeting on his cell phone.  He said that it was his intention to fully comply with the review, but that he’d been treated unprofessionally at similar, previous meetings and felt that he needed to take steps to protect himself.  What’s the right response to this?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
I’m glad to hear that the physician you are dealing with intends to fully comply with your review process.  That’s a good starting point and may give you room to salvage this process, even though you have experienced an initial setback.  A few tips to consider:

First, it is a good idea to inform a practitioner about the general nature of the issue(s) that will be discussed at a collegial counseling session before the meeting.  In other words, inform the practitioner of the concern in the invitation to the meeting.  In some cases, it may even make sense to inform the physician of the concern and ask for specific information in writing.  This approach gives the practitioner a chance to learn about the concerns, work through initial feelings of surprise and defensiveness, gather thoughts, refresh memories, and prepare a thoughtful response.  And all of those things can set you up for a better (and more effective, in the long run) review process.  Even if you don’t intend to ask for the practitioner’s written comments, letting the practitioner know about the leadership’s concerns prior to a meeting almost always makes sense – so that they can arrive at the meeting fully prepared to discuss the matter at hand.  When would you not give advance notice of your concerns?  It can make sense to withhold that information if the leadership wants to see the practitioner’s reaction when informed about the matter under review (and use that observation to help weigh the practitioner’s credibility).  Also, if the practitioner has a long history of retaliatory behavior – or retaliation is a significant concern for some other reason – you may wish to withhold information about the nature of the matter under review until you get to the meeting itself.  That way, the leadership can give an in-person reminder to the practitioner about the importance of avoiding retaliatory behavior (and even have the practitioner sign an anti-retaliation agreement, if that is deemed necessary).

Even with advance notice of the issues of concern, some practitioners are going to be uncomfortable with the peer review process (after all, if you’ve never been in a leadership position, the process likely feels very foreign, and no one likes to receive criticism).  So, how can you deescalate a situation where the physician feels the need to record the process to protect his rights?  Consider stating in the notice/invitation who will be present at the meeting.  In other words, if the practitioner is being asked to meet with just the Chief of Staff and CMO, say so in the invitation.  And if they are acting on behalf of a committee (e.g., a Leadership Council or MEC), state that as well.  If the committee is one charged with implementing the Medical Staff’s collegial, progressive steps of peer review – and does not manage disciplinary matters – consider stating that as well.  That way, the physician knows early on that he is meeting with a committee for a collegial discussion that is not intended to result in any disciplinary recommendation or action.

Make sure that your Medical Staff Bylaws (or related Medical Staff governance documents/policies) include provisions stating that attorneys are not permitted to be present at any meetings between hospital/medical staff leaders and practitioners, nor are any recordings of such meetings permitted to be made (instead, legal counsel and recordings are permitted only during medical staff hearings and appeals).  Consider informing practitioners of the rules against lawyers/recordings in the invitation to meetings.  Doing so can prevent the physician from spending the time and money to arrange to have a lawyer present, only to find that you have no intention of letting the person into the room.  And, if you have communicated your “no recording” rule to the practitioner prior to the meeting, you won’t have to feel so awkward if you feel that you must ask for mobile phones and/or other recording devices to be left outside the room (to prevent surreptitious recording).  Nor will you have to feel bad canceling the meeting if the physician refuses to proceed without making a recording (or having a lawyer present).

Finally, while the above steps are likely to help avoid misunderstandings and disagreements about the procedures that will be followed, it is important that leaders have enforcement tools they can call upon if necessary.  So, your Medical Staff Bylaws (or related Medical Staff governance documents/policies) should specify that if the physician refuses to attend and participate in the meeting without making a recording, then this will constitute his refusal to attend a mandatory meeting.  Your Bylaws should go on to state that the failure to attend a mandatory meeting will result in the automatic/administrative relinquishment of medical staff membership and all clinical privileges until such time as the practitioner attends a rescheduled meeting.  We would suggest setting a time limit for compliance – for example, by stating that if the practitioner has not resolved the automatic/administrative relinquishment (by attending the meeting) within 30 days, that will be deemed to constitute his automatic resignation of medical staff membership and privileges (meaning that any future request to practice at the hospital would not occur via reinstatement from automatic/administrative relinquishment but would, instead, require an application for initial appointment).  If this all seems like “a big to do” over not attending a meeting, know that the intention of this sort of Bylaws language is to never have to invoke it.  It is reasonable for medical staff leaders to expect that when they volunteer to take on leadership roles (often without any pay) and agree to spend their free time furthering patient safety, quality, and standards of professionalism in the hospital, they have every right to expect that their colleagues will meet them half-way.  And that includes attending meetings when requested and given adequate notice – and also complying with the rules that have been established by the medical staff to promote an informal, peer-led review process.  So, the great hope is that the automatic/administrative relinquishment language can be used, if necessary, to remind practitioners of their obligations to be involved in the review process (in hopes that leaders never have to actually enforce it).

If you have a quick question about this, e-mail Rachel Remaley at rremaley@hortyspringer.com.

February 29, 2024

QUESTION:
Since the COVID-19 waiver that paused certified registered nurse anesthetist (“CRNA”) supervision requirements expired in May 2023, our facility has been scrambling to find anesthesiologists to supervise our CRNAs.  Is there anything we can do?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Historically, CMS has required CRNAs to be under the supervision of a practitioner when administering anesthesia.  Given the nature of their work, most facilities required CRNAs to be under the supervision of an anesthesiologist.  As recruiting providers is becoming increasingly difficult, many facilities are running into the same problem that they do not have enough anesthesiologists to adequately supervise their CRNAs.

If your state has not yet joined the 24 states that have elected to opt out of CMS’s CRNA supervision requirements, Medicare has long had flexibility built into the Medicare Conditions of Participation (“COPs”) that may help ease your burden.  The COPs allow CRNAs to provide anesthesia, if they practice in an opt‑out state or in any other state, so long as the CRNA is under the supervision of the “operating practitioner or an anesthesiologist” who is immediately available.  According to CMS Interpretive Guidelines, in the case of procedures, an operating practitioner may include the surgeon performing the procedure.

While surgeons may be an alternative to help fill your need for supervising physicians, we would not consider this an open and shut problem.  Using surgeons as supervising physicians opens the door to several key conversations that still need to take place, both with legal counsel and internally.  For instance, does state law also allow surgeons to supervise CRNAs; is there any additional liability incurred by the surgeons for supervising the CRNAs; and will the surgeons agree to act as supervising physicians?

If you have a quick question about this, e-mail Hala Mouzaffar at hmouzaffar@hortyspringer.com.

February 22, 2024

QUESTION:
I heard that a private equity firm is interested in acquiring a local physician practice.  Could that be accurate?  Has the OIG or any other government enforcement agency said anything one way or the other about the entry of private equity into the health care market?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
Subject to a state’s corporate practice law, there may not be anything unlawful about a private equity firm acquiring an ownership interest in a physician practice or other health care provider.  However, in order to give you an idea of what the OIG thinks of private equity, in its November 6, 2023, General Compliance Program Guidance, the OIG included a section V entitled “Other Compliance Considerations” in which the OIG recognized that the health care sector is seeing an increasing number of new entrants, including technology companies, new investors, and organizations providing non-traditional services in health care settings.  OIG then warned these new entrants that they need to become familiar with the unique regulations and business constraints that apply in the health care industry, as well as the range of Federal and State government agencies that regulate health care and enforce fraud and abuse laws.  OIG also repeated its oft‑stated concern that these new entrants into the health care market need to be aware that “business practices that are common in other sectors create compliance risk in health care, including potential criminal, civil, and administrative liability.”

With regard to private equity, the OIG stated:

The growing prominence of private equity and other forms of private investment in health care raises concerns about the impact of ownership incentives (e.g., return on investment) on the delivery of high quality, efficient health care.  Health care entities, including their investors and governing bodies, should carefully scrutinize their operations and incentive structures to ensure compliance with the Federal fraud and abuse laws and that they are delivering high quality, safe care for patients.  An understanding of the laws applicable to the health care industry and the role of an effective compliance program is particularly important for investors that provide management services or a significant amount of operational oversight for and control in a health care entity.

So, the OIG is not saying that private equity investment in health care providers is prohibited.  The OIG is, however, saying that if private equity wants to invest in health care, they need to know the rules, and that the OIG intends to make sure that they follow them.

If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.

If you want to learn more about the OIG, the Anti-Kickback Statute, the Stark Law, the False Claims Act, and much more, check out our latest episode of the “Kickback Chronicles” podcast and also join us at the Hospital-Physician Contracts and Compliance Clinic Seminar in Las Vegas from November 14-16, 2024!

February 15, 2024

QUESTION:
We recently received a complaint that a Medical Staff member may have been inappropriately accessing medical records.  Do we handle this as a Medical Staff matter or should we refer this to our HIPAA Privacy Officer?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
Given the Privacy Officer is responsible for implementing the hospital’s HIPAA policies, they should be made aware of any potential violations by a Medical Staff member.  In addition, Privacy Officers have significant experience investigating and responding to privacy violations and they will understand the law’s regulatory requirements, including if breach notifications are required.

At the same time, there are good reasons for using the Medical Staff process to review HIPAA complaints involving physicians:

  • Physicians may be more likely to listen to other physicians.
  • Hospital licensing regulations generally require the Medical Staff to review the actions of its members.
  • The Medical Staff process is protected by a statutory peer review privilege, which results in confidentiality and candid discussion.
  • Violations of HIPAA (or any regulation) may include a behavioral component that will be of interest to the Medical Staff leadership.

This is why we recommend that the Medical Staff’s professionalism policy or code of conduct include a provision describing how individuals responsible for other hospital policies (such as the HIPAA Privacy Officer or the Corporate Compliance Officer) will be notified of concerns that involve their area of responsibility.  This allows for coordination between the Medical Staff leadership and the individual responsible for the other policy.

If you have a quick question about this, e-mail Ian Donaldson at idonaldson@hortyspringer.com.

February 8, 2024

QUESTION:
This question was raised by a registrant at our Complete Course for Medical Staff Leaders last week – should we notify Medical Staff members immediately, as soon as a case “falls out” in our peer review process?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
No!  There are so many different indicators that hospitals track – some required by Medicare, some by accreditation standards, some based upon specialty-specific evidence-based medicine – and the mere fact that a case “tripped” one of these many indicators does not mean that there are specific concerns that need to be addressed.  We hear that Medical Staff members already tend to view the peer review process as something that can feel more punitive than performance improvement based, and if we start sending letters out to individuals the minute that a case has met a specific indicator, we risk making that perception even worse.  Professional practice evaluation/peer review policies should clearly state that cases that make their way into the process can be closed at the earliest, most initial stage of review, and that practitioners need to be notified of cases only once questions or concerns about the care provided by the practitioner have been identified.

If you have a quick question about this, e-mail LeeAnne Mitchell at LMitchell@hortyspringer.com.

February 1, 2024

QUESTION:
Recently, we have had several physicians on our medical staff refuse to consult on a case because the patient was covered by Medicaid.  The patient had been admitted to the hospital, so we knew it wasn’t an EMTALA issue, but they still needed to be seen by a specialist.  Have you seen this at other hospitals, and do you have any suggestions on how to handle this?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
Perhaps not surprisingly, this issue has come up before.  In an effort to address it, we recommend including language in your Medical Staff Governance Documents to make it clear that, not only do physicians have an obligation to see all patients in the ED, but they also have an obligation to respond to requests for consult (regardless of the patient’s payor status) when they are on call.

For instance, you might spell out in the Bylaws that Active Staff members have a responsibility to serve on the ED on-call schedule, and to “accept inpatient consultations, when on call for the ED.”  Similar language could be added to the Bylaws with respect to other staff categories.

Additionally, the threshold criteria for appointment and clinical privileges could require individuals to “agree to fulfill all responsibilities regarding inpatients, including responding to requests for consult when serving on the ED on‑call schedule.”  The basic responsibilities and requirements of appointment should also include an agreement “to provide emergency call coverage, consultations, and care for unassigned patients.”  This language will help ensure appropriate coverage not only for the ED but also for inpatients who require specialty consultations.

If you have a quick question about this, e-mail Susan Lapenta at slapenta@hortyspringer.com.

January 25, 2024

QUESTION:
Our hospital wants to require employees to submit documentation to Human Resources of their COVID-19 and flu vaccination status.  One employee complained that this is a HIPAA violation.  Is it?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
No.  A hospital is acting in its role as an employer (not a covered entity/health care provider) when it asks employees to answer questions or provide documentation about their vaccination status.  Hospitals store such information in the employee’s employment record, not in the employee’s medical record.

HIPAA specifically excludes employment records from the definition of “Protected Health Information.”  The relevant definition states:  “Protected health information excludes individually identifiable health information…[i]n employment records held by a covered entity in its role as employer.”  45 C.F.R. § 160.103.

Thus, information that a hospital obtains when it asks an employee about vaccination status isn’t covered by HIPAA.  It follows that HIPAA isn’t violated if the hospital then discloses that information to managers and supervisors so they can enforce the hospital’s policies.

Although HIPAA doesn’t apply, the Americans with Disabilities Act (“ADA”) does govern information that a hospital holds in its role as an employer.  The regulations implementing the ADA state that information “regarding the medical condition or history of any employee shall be collected and maintained on separate forms and in separate medical files and be treated as a confidential medical record, except that:  (A) Supervisors and managers may be informed regarding necessary restrictions on the work or duties of the employee and necessary accommodations.”  29 C.F.R. § 1630.14.

It’s important to recognize that in some cases a hospital could hold information about vaccination status in its role as a covered entity/health care provider under HIPAA.  For example, a hospital might conduct a clinic by which it gives flu shots to members of the community.  HIPAA would apply to that information, because it was created by the hospital in its role as a provider of health care services.  Thus, the hospital could not disclose those vaccination records to a local third-party employer unless the individual signs a HIPAA authorization.

If you have a question about this issue, please e-mail Phil Zarone at pzarone@hortyspringer.com.