Question Of The Week

February 8, 2024

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by jwilbert

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.”

 

December 14, 2023

Posted on by Courtney Patterson

QUESTION:
Some of the physicians in our department are throwing a holiday party for staff.  It’s been a stressful year, and we are looking for a way to relax and have a little fun together.  We are planning on serving alcoholic beverages.  Is that a problem?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
We appreciate your good intentions, and we don’t want to be the Scrooge who shuts down the party, but you do want to be careful.

We can’t count the number of times we’ve fielded calls from hospitals about work parties that turned into life-altering disasters with referrals to HR, Administration, Medical Executive Committee, Board, and the police.  Go ahead with the party (you might want to clear it with HR) but be careful and consider these practical tips:

  1. Make sure there is lots of food, so no one is drinking on an empty stomach.
  1. Make sure there are plenty of soft drinks, water, and coffee.
  1. Limit high-alcohol-content drinks and stop serving them in time for everyone to sober up for the drive home.
  1. Ask someone to serve as the equivalent of a designated driver to help make sure the drinking doesn’t get out of hand. No one expects the worst, but you should plan ahead.  Remember, calling an Uber is cheaper than the consequences by ten-fold.

Even parties that are held off-site could have serious work implications.  So, have some fun, enjoy yourself and your colleagues, and remember this sage advice: “everything in moderation.”

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

December 7, 2023

Posted on by Courtney Patterson

QUESTION:
I recently finished reading the equivalent of “War and Peace” also known as the minutes of our regular Medical Executive Committee meeting.  Do you have any tips for what to include in minutes?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
We love a good novel, too, and apologies to Mr. Tolstoy, but, meeting minutes don’t have to be akin to a 1,225-page novel set during the Napoleonic Wars.  Here are the Top Ten Tips for what to include in minutes:

  1. DO – write down the name of the committee that’s meeting.
  1. DO – write down the date of the meeting.
  1. DO – list who’s in attendance, and who’s absent.
  1. DO – list if there are any guests or visitors at the meeting.
  1. DO – note the time the meeting was called to order, who called it to order, and the time it was adjourned.
  1. DO – note whether it’s a regular or special meeting of the committee.
  1. DO – note that if it’s a special meeting, that notice was given to the committee members, and the way notice was given.
  1. DO – note whether a quorum was present.
  1. DO – note whether the previous minutes were read and approved.
  1. DO – note the result of the votes, for example, 7‑1

And, here’s a bonus tip that was developed due to the pandemic:

  1. DO – record whether a meeting was a virtual meeting. Also, for this tip, reflect that all participants were reminded of the confidentiality, privacy and security provisions of policies.

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

November 30, 2023

Posted on by Courtney Patterson

QUESTION:
Our hospital is part of a regional system, and while there had been some low-level discussions about whether we may want to have a unified medical staff, the consensus was that we aren’t there yet – however, there is a strong desire for our medical staff processes to become more integrated even if unification isn’t our ultimate outcome.  Are there options short of formally becoming one unified medical staff?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Absolutely!  While one of the main objectives of medical staff unification is consistency in core processes such as credentialing, privileging and peer review – with the goal towards promoting a single standard of care and reducing the administrative burden for the medical staffs and their leaders – many of these benefits can be obtained even in the absence of a unified medical staff.

A good first step is having similar (or identical) policies for credentialing, privileging and peer review at each system hospital that use the same eligibility criteria for appointment and privileges and the same process for evaluating applications among similar types of hospitals.  The same is true for policies governing clinical peer review, professionalism and health.  Consistent bylaws, policies and procedures across the system help the medical staff leaders to do their jobs, and are also helpful for members of the medical staffs who may practice at more than one system hospital to know what the rules are.

Even if a system has the same process for credentialing, privileging and peer review and has adopted the same standards for these activities, there remains the potential for different outcomes when different committees are making decisions.  Steps that the system and its medical staffs can take to address this concern – short of unification – include things such as:

  • Utilizing a central Credentials Verification Office to ensure each medical staff gets the same information about applicants;
  • Utilizing a system (or regional) Credentials Committee, which includes representation from all relevant hospitals, to avoid inconsistent recommendations being made by individual Credentials Committees on practitioners who are applying to more than one system hospital. The same goal can be accomplished in the peer review process by utilizing a system Peer Review Committee – a process that can be even more helpful when system hospitals include much smaller facilities that may have fewer individuals able to serve on such committees; and
  • Incorporating provisions into the medical staff bylaws/credentials policies for each system hospital which state that certain types of significant actions that directly implicate a practitioner’s qualifications to practice – such as performance improvement plans, precautionary suspensions, automatic relinquishments and final actions by the board – become effective immediately at each system hospital where the individual practices, unless the automatic action is waived by the “receiving” hospital’s MEC and the Board.

While these steps don’t achieve the same level of consistency that a unified medical staff would, they are definite steps along the “continuum of integration” that most systems are exploring and implementing.  Also, as the medical staff sees these integration steps in action, they can also help to quell the concerns that are sometimes voiced about possible unification and can be good first steps towards that goal.

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

November 16, 2023

Posted on by Courtney Patterson

QUESTION:
In January, the Federal Trade Commission (“FTC”) issued a proposed rule that would ban almost all noncompete clauses imposed on workers, which includes employees and independent contractors, nationwide.  What’s the status?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
The proposed rule has not been made final yet.  The FTC proposed the rule because it believes that non-competes are a violation of the Federal Trade Commission Act.  The proposed rule would prohibit an employer from: (1) entering into a non-compete with a worker; (2) maintaining a non-compete with a worker; or (3) representing to the worker that the worker is subject to a non-compete.  So, it would ban new non-competes and require that existing non‑competes be rescinded.  Also, the proposed rule would prohibit language that could act as a non-compete clause – a non-disclosure agreement that contains broad language, a provision that workers repay training costs if the worker leaves employment, or other language that bars workers from seeking other employment.

The FTC received over 20,000 public comments on the proposed rule.  Evelyn Wood herself would have had trouble wading through that many comments quickly, so at this point, the best guess is that the FTC will vote on the final rule in the Spring of 2024.  Another best guess is that the proposed rule, even if altered, will pass and become a final rule.  The final best guess is that the final rule will be challenged in court – no guess on how that litigation will turn out!  But, we will keep you updated.

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