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.

January 18, 2024

QUESTION:
We are developing a hospital-wide animal visitation policy.  What are some things we need to consider including so that we are compliant with the Americans with Disabilities Act?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
This is a great policy to have.  We all love animals, but it’s important to make sure that you take the necessary steps to identify the proper use of service animals and acceptable visitation rules for therapy animals.  Today, let’s focus on service animals.  Under the ADA, covered entities, like most hospitals, are required to provide reasonable accommodations for people with disabilities.  The service animal rule falls under this requirement.  In other words, places that have a “no animals allowed” policy provide an exception that allows service animals in their facility.

What is a service animal?  Well, it is a dog of any breed that has been trained to work or perform a task for an individual with a disability.  For example, a person with a panic disorder may have a dog that is trained to sense an upcoming panic attack and to help lessen its impact.

When building an animal visitation policy, you want to include a section that considers service animals and sets out general rules for your staff to follow.  For instance, when it is unclear as to whether a dog in your facility is a service animal, your staff may not inquire into the nature of the person’s disability, may not ask for documentation, and may not require that the dog perform its trained task.  Rather, your staff may only ask (1) if the dog is a service animal that is required because of a disability and (2) what work or tasks has the dog been trained to perform.

If the patient requires basic assistance from staff, then staff may be required to accompany the patient while they attend to their service animal (i.e., taking their dog for a walk, but requiring a wheelchair).  Under the ADA, the patient, or service animal handler, bears full responsibility for the dog and must be in control of it at all times.  This includes making arrangements to pass the dog off to family members, or even boarding the dog, in the event that the patient is unable to provide the necessary care.

Make sure to review the ADA regulations governing service animals in detail, and feel free to reach out to Mary Paterni with any additional questions.

January 4, 2024

QUESTION:
Are Medical Staff Professionals protected under the Health Care Quality Improvement Act (“HCQIA”)?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
While it is rare for a Medical Staff Professional to be named individually in a lawsuit brought by a physician subject to a professional review action, the protections under the HCQIA should be available.  The HCQIA’s protections are available for “professional review bodies,” “any person acting as a member or staff to the body,” and “any person who participates with or assists the body with respect to the [professional review] action.”  Typically, Medical Staff Professionals are not appointed as members of professional review bodies, but the immunity under the HCQIA, as noted above, is also available for those who participate or assist the body with respect to a professional review action.  This provision could apply to duties that Medical Staff Professionals perform, including preparing materials for review by, for example, the Medical Executive Committee.  But keep in mind, for the immunity to apply when a professional review action is taken, certain enumerated standards in the law must be met.  The HCQIA also provides immunity from damages for those providing information to professional review bodies regarding the competence or professional conduct of a physician.  Again, this would most likely cover the tasks performed by Medical Staff Professionals if they are playing a supporting role for Medical Staff committees.

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

December 21, 2023

QUESTION:
I have always found the OIG’s past “Compliance Guidance” to be vague and not particularly helpful.  Is there anything more recent that will provide an analytical framework to comply with the Anti-kickback statute?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The Anti-kickback statute is an intent-based statute.  So, the OIG can be forgiven to a certain extent for their “it depends” guidance on compliance with this law.  However, given the fact the Anti‑kickback statute is a criminal statute and that federal health care program claims resulting from a violation of this law will also constitute a violation of the False Claims Act, even the OIG has realized that more definitive guidance is required.

The OIG seems to have heard your plea for help, and has provided the following analytical framework for compliance with the Anti-kickback statute on Pages 12-14 of the November 6, 2023, OIG General Compliance Program Guidance (“GCPG”).

When attempting to identify problematic arrangements under the federal Anti-kickback statute, some relevant inquiries to explore and consider can include the following.  This list of questions is illustrative, not exhaustive, and the answers to these questions alone are not determinative as to whether an arrangement violates the federal Anti-kickback statute.

Key Questions:

(1)        Nature of the relationship between the parties –

        • What degree of influence do the parties have, directly or indirectly, on the generation of federal health care program business for each other?

(2)        Manner in which participants were selected –

        • Were parties selected to participate in an arrangement in whole or in part because of their past or anticipated referrals?

(3)        Manner in which the remuneration is determined –

        • Does the remuneration take into account, either directly or indirectly, the volume or value of business generated?
        • Is the remuneration conditioned in whole or in part on referrals or other business generated between the parties? Is the arrangement itself conditioned, either directly or indirectly, on the volume or value of federal health care program business?  Is there any service provided other than referrals?

(4)        Value of the remuneration.

        • Is the remuneration fair market value in an arm’s-length transaction for legitimate, reasonable, and necessary services that are actually rendered?
        • Is the entity paying an inflated rate to a potential referral source? Is the entity receiving free or below-market-rate items or services from a provider, supplier, or other entity involved in health care business?
        • Is compensation tied, either directly or indirectly, to federal health care program reimbursement?
        • Is the determination of fair market value based upon a reasonable methodology that is uniformly applied and properly documented?

(5)        Nature of items or services provided.

        • Are the items and services actually needed and rendered, commercially reasonable, and necessary to achieve a legitimate business purpose?

(6)        Federal program impact.

        • Does the remuneration have the potential to affect costs to any of the federal health care programs or their beneficiaries?
        • Could the remuneration lead to overutilization or inappropriate utilization?

(7)        Clinical decision making.

        • Does the arrangement or practice have the potential to interfere with, or skew, clinical decision making?
        • Does the arrangement or practice raise patient safety or quality of care concerns?
        • Could the payment structure lead to cherry-picking healthy patients or lemon-dropping patients with chronic or other potentially costly conditions to save on costs?

(8)        Steering.

        • Does the arrangement or practice raise concerns related to steering patients or health care entities to a particular item or service, or steering to a particular health care entity to provide, supply, or furnish items or services?

(9)        Potential conflicts of interest.

        • Would acceptance of the remuneration diminish, or appear to diminish, the objectivity of professional judgment?
        • If the remuneration relates to the dissemination of information, is the information complete, accurate, and not misleading?

(10)      Manner in which the arrangement is documented.

        • Is the arrangement properly and fully documented in writing?
        • Are the parties documenting the items and services they provide? Are the entities monitoring items and services provided?
        • Are arrangements actually conducted according to the terms of the written agreements (when written to comply with the law)?

Is this perfect guidance – No.  But it is a significant improvement over any compliance guidance that the OIG has provided in the past.  In fact, we find the OIG’s New General Compliance Guidance to provide an excellent framework for compliance with the Anti-kickback statute, and a number of other federal laws that affect health care providers.

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

For an in-depth discussion of the OIG’s November 6, 2023, OIG General Compliance Program Guidance, please check out the Horty Springer Health Law Expressions Podcast  “New OIG General Compliance Program Guidance by Dan Mulholland and Henry Casale.”