Author: Courtney Patterson

July 20, 2023

Posted on by Courtney Patterson

QUESTION:
I see that you have a new podcast that somehow the Stark and Anti-Kickback Statute (“AKS”) have been amended to address how a hospital can assist a physician suffering from burnout.  What do Stark and the AKS have to do with how a hospital and its medical staff can assist a physician in distress, and how did that happen?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
Thank you for the opportunity to plug our new podcast entitled “Don’t Get Burnout from Your Wellness Program.”  While the podcast will provide more detail, here are the highlights.

The Consolidated Appropriations Act of 2023, which raised the debt limit, added a number of other provisions including a new Stark exception and a new Anti-kickback safe harbor on Physician Wellness Programs.  These new sections of the Social Security Act will allow hospitals and the other named types of facilities to incur the expenses required to send physicians on their medical staff to a Physician Wellness Program as defined in the statute under the conditions stated in the new exception/safe harbor.

We should also mention that a separate section of the Consolidated Appropriations Act directed the OIG to consider a new safe harbor, but don’t be thrown off by the title of this section which references something called “contingency management interventions.”  If you look beyond the title of this Section to its text, you will find that Congress is directing the OIG to consider adopting a new safe harbor on “contingency management compensation.”  There is no guarantee that the OIG will do anything other than consider a new safe harbor.  However, if adopted and if reasonable (which is a BIG IF) this new safe harbor may be helpful in a number of settings.

But I digress, with regard to the Physician Wellness Stark Exception/AKS safe harbor, it is helpful to see Congressional recognition that physicians are suffering from burnout and other behavioral health problems and that a hospital can provide the assistance described in the exception/safe harbor without violating the Stark law or the AKS.  However, as discussed in the podcast, that assistance must be provided in the manner described in the statute, which is not onerous, but does require a certain amount of process, such as having a written policy adopted in advance by the board.

On the other hand – who would have thought that a hospital providing this type of assistance to a member of its medical staff in need of Wellness services raises a concern under Stark or the AKS???

The fact that Congress felt the need to adopt this exception in order for a hospital to provide this type of assistance could be used to raise a question as to whether it violates Stark or the AKS if a hospital pays to send a member of the medical staff away for training or for a medical condition that is not expressly covered by the exception.  Should that occur, it will not be difficult to find another exception that applies – nevertheless don’t be surprised if medical staff practices that were taken for granted in the past are now questioned.

Also keep in mind that there is a broad exception under both laws for an employment relationship.  While the new Stark exception/AKS Safe Harbor could be used for an employed physician, it is not needed in that situation – you could rely on the employment exception to Stark and the AKS bone fide employment statutory exception and safe harbor.

For more insights on what is, and what is not, covered by this new law, check out the podcast referenced below.  If you still have any questions about this issue, please feel free to e-mail me or Dan at Hcasale@hortyspringer.com or Dmulholland@hortyspringer.com.

If you want more detail on compliance with the False Claims Act, AKS, the Stark law, the intersection of medical staff and employment law, and much more, consider joining Dan Mulholland, Henry Casale and our newest faculty member – Hala Mouzaffar – in Phoenix November 16-18, 2023, for our next seminar. 

July 13, 2023

Posted on by Courtney Patterson

QUESTION:
Our Leadership Council is developing a Performance Improvement Plan (“PIP”) for a practitioner at our hospital who does not play well with others.  One member of our leadership team suggested that we send the practitioner out for a mental health evaluation before finalizing the PIP.  Is this advisable?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
As a rule of thumb, we recommend that you stay away from requesting mental health evaluations from practitioners who have failed to meet your Medical Staff’s standards regarding professionalism.  In our experience, such an evaluation only tends to cloud the Leadership Council’s thinking on how best to address the inappropriate behavior that has been identified.  Additionally, a request for an evaluation might give the practitioner a basis for claiming that he or she was discriminated against under the ADA if disciplinary action is ultimately taken.  That is why we believe it is better to focus on the behavior at issue rather than spending too much time and energy trying to identify its cause.

Of course, impairment and “burnout” are real concerns.  So, if there is compelling evidence that suggests that the practitioner is dealing with a legitimate health issue, then an evaluation may be appropriate.  But that should be managed through your process on practitioner impairment, not your Professionalism Policy or Code of Conduct.

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

June 29, 2023

Posted on by Courtney Patterson

QUESTION:
We are working on revisions to our medical staff bylaws and one of the committee members asked whether our credentialing process complies with the Americans with Disabilities Act (“ADA”).  This led to a long and winding discussion about whether we need to comply with an employment law in this context.  Do we?  Isn’t credentialing completely separate from employment?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
It is true that the ADA is an employment law, so on its face, does not appear to apply to credentialing processes.  It is also true that “typical” credentialing practices would likely violate the ADA – because hospitals have traditionally treated health information being sought from applicants just as they would treat any other information being requested on an application form – references, verifications, licensure matters, etc.  As a result, in the credentialing process, health information is requested and reviewed at a stage that is likely analogous to the “pre-offer” stage under the ADA – the most restrictive stage of employment where employers aren’t yet permitted to request any health information.  (Under the ADA, employers do eventually get to request and consider everything necessary that is related to health.  It is more a question of managing the timing of those requests.)

As you pointed out, though, credentialing IS different from employment, so why should we care if the process is compliant with the ADA – an employment law?  There are several reasons.  First, there are some hospitals that do directly employ physicians, and the ADA is clearly applicable to those relationships.  Second, even if the hospital isn’t the employer, most hospital-affiliated physician groups make employment contingent on the physician obtaining privileges at an affiliated hospital (i.e., successfully completing the credentialing process), and it is unclear whether a court would agree that one arm of a corporate entity can ask questions or seek information that the other arm of the same entity could not yet legally request.  Third, some jurisdictions have expanded the ADA to independent contractor relationships, and finally, there is a trend in court cases today where independent contractor physicians are claiming to be employees even when there are no employment agreements in place, claiming that the hospital exercises sufficient control over them to render them employees (for example, by making them comply with protocols, order sets, taking call, and medical staff bylaws requirements).

One way to address concerns about the credentialing process would be to change the timing of requesting and reviewing health information, asking detailed questions about the health of all applicants but waiting to review that information until after the Credentials Committee has determined that an individual is “otherwise qualified” for the clinical privileges requested on the basis of everything else that is being considered – education, training, experience, etc.  Only after that determination is made should the health information be reviewed.  Due to the sensitivity of that information, we also recommend that only one or two medical staff leaders review that information – reporting to the Credentials Committee that there are no concerns, or that concerns were raised and now the committee needs to review and discuss accommodations.

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

June 22, 2023

Posted on by Courtney Patterson

QUESTION:
We have been reviewing our Rules and Regulations and are having trouble sorting out why there are different rules for verbal orders given by a physician speaking to a nurse practitioner while visiting a patient during rounds, versus a verbal order the physician gives to a floor nurse over the phone, versus verbal orders spoken as part of a dictation by the physician.  Can you help us sort out the rules surrounding the verbal passage of information concerning patient care to other members of the care team?  It seems like some of the rules are more stringent than others and we want to make sure we have got it right.

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
The rules surrounding the oral giving, taking, documenting, and authenticating of medical orders in hospitals are so confusing!  You are not alone if you are baffled by the number of rules and white papers and clarifications that are out there speaking to these issues.  As you continue with your Rules and Regulations review and try to sort these things out, we find it is helpful to consider the following factors, as this tends to help clarify why and how different verbal information is treated differently, depending on the circumstance:

  • Whether the verbal information is being recorded by another individual verbatim, exactly as spoken by the physician/privileged practitioner; and
  • Whether the verbal information is going to be acted upon immediately, before the physician/privileged practitioner has had a chance to review and authenticate the written note.

With those factors in mind, our observation has been that verbal ordering can be divided into three types:

Dictating/Transcribing – With dictation and transcription, an individual or piece of software (though this is generally considered risky due to speech recognition technology errors) takes verbal information from the physician or other privileged practitioner (usually a recording) and transcribes it into a written document, verbatim.  The task is often not contemporaneous with the care provided by the physician (the transcription occurs later, after the physician has dictated the notes and orders).  Further, the note is generally not considered final until the practitioner has reviewed the transcription, made any necessary corrections, and authenticated the document.  There are few formal requirements governing the training of transcriptionists, though most hospitals require a certificate or associate’s degree.

Scribes – With the recording of medical information by scribes, a qualified individual (the scribe) generally listens to verbal information given by the privileged practitioner, decides which pieces of information are most pertinent, and then, contemporaneously with that patient encounter, records the information in the EMR, to assist the privileged practitioner in generating a complete record for medical and billing purposes.  Note that scribes are not transcribing verbatim information but, rather, are listening and recording information so that they can accurately fill in necessary EMR data points (e.g., diagnosis, medications, orders for diagnostic tests, requests for consultation, prescriptions to be given at discharge).  Therefore, after the scribe records the relevant information, it is expected that the privileged practitioner will review and authenticate the relevant note.  The Joint Commission requires scribes working in hospitals to have a certain level of training (to ensure they are familiar with the EMR, understand HIPAA, are familiar with medical and billing information, etc.).  But scribes are not required to be licensed or certified health care practitioners (though hospitals often establish such requirements for scribes and, in addition, establish specified procedures for vetting the qualifications of scribes prior to providing them authorization to provide scribe services in the hospital setting).

Verbal Orders – Finally, we come to verbal orders.  Like scribes, those who take verbal orders are recording the information contemporaneously with when the physician or licensed practitioner is speaking.  However, unlike scribes, when a verbal order is being recorded, it is generally expected that the order will be recorded exactly as spoken (verbatim).  That is because the order is generally expected to be acted upon immediately and, in turn, it is essential that the order be correct when recorded.  It is for this same reason that there is usually a limited, defined subset of individuals who are authorized to take verbal orders (as outlined by hospital policy) and the process of taking a verbal order is subject to greater regulation (the read-back requirement and expedited authentication – usually 24-72 hours after the verbal order is given, depending on state law).  Hospitals have some discretion to determine who may accept verbal orders.  Many allow other physicians, PAs, NPs, and nurses to accept verbal orders related to any matter related to their patient’s care.  More limited practitioners (respiratory therapists, clinical pharmacists, etc.) are often limited to taking verbal orders within their specific medical area of practice.

As you can see, there really are a variety of ways that information is generated orally, but ultimately reduced to writing, in the hospital setting.  Hopefully, this brief explanation helps to make sense of why particular rules, regulations, and policies may treat different types of verbal information differently. Good luck!

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

June 15, 2023

Posted on by Courtney Patterson

QUESTION:
What are the laws/regulations around listing providers on a hospital directory? We’re revamping our provider directory, and have heard there are certain requirements for listing a provider in a directory.  Can we limit the providers listed to just those who are employed by us?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The OIG has long had a safe harbor for “referral services.”  The regulation, at 42 CFR §1001.952(f), reads as follows:

Referral services.  As used in section 1128B of the Act, “remuneration” does not include any payment or exchange of anything of value between an individual or entity (“participant”) and another entity serving as a referral service (“referral service”), as long as all of the following four standards are met –

(1)        The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation.

(2)        Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants and is based only on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs.

(3)        The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge.

(4)        The referral service makes the following five disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service –

(i)         The manner in which it selects the group of participants in the referral service to which it could make a referral;

(ii)        Whether the participant has paid a fee to the referral service;

(iii)       The manner in which it selects a particular participant from this group for that person;

(iv)       The nature of the relationship between the referral service and the group of participants to whom it could make the referral; and

(v)        The nature of any restrictions that would exclude such an individual or entity from continuing as a participant.

Based on this, it would be OK to only list your employed providers in the directory. Just make sure that the list clearly discloses that only employed physicians are listed.

If you have a quick question about this, e-mail Dan Mulholland at DMulholland@hortyspringer.com.

June 8, 2023

Posted on by Courtney Patterson

QUESTION:
An independent member of our Medical Staff has a long history of unprofessional conduct.  Our Leadership Council addressed various complaints using progressive steps under the Professionalism Policy, such as educational letters and collegial meetings.  We even tried sending the physician to an on-site educational course on behavior with no success.  Before we refer him to the Medical Executive Committee for its review under the Bylaws, are there any other options we could try?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
Yes.  A “personal code of conduct” might be successful where other efforts have failed.  A personal code of conduct outlines specific expectations for behavior and, more importantly, specific consequences for failing to meet those expectations.

With respect to expectations, a personal code of conduct may simply require compliance with the standards for behavior set forth in the Professionalism Policy.  (To assist with enforcement of the personal code of conduct, it’s very helpful if the Professionalism Policy includes specific examples of inappropriate behavior.)  Additional expectations might include periodic mentoring meetings with Medical Staff leaders, 360 reviews, or additional training.

The personal code of conduct could then describe the process that will be followed to review the facts if an additional concern is raised about the physician’s behavior.  This fact-finding process may include steps in addition to those set forth in the Professionalism Policy.

The personal code of conduct could then outline the consequences if the Leadership Council determines that there has been a “formal violation.”  The Leadership Council has the flexibility to define these consequences in any reasonable manner.  For example, the first confirmed violation could result in a final letter of warning, the second could result in the physician not exercising his or her clinical privileges for five or 10 days, and the third could result in a referral to the Medical Executive Committee for a formal investigation under the Medical Staff Bylaws.  The personal code of conduct could be indefinite or have a fixed term, and the number of formal violations could be re-set to zero if the physician goes “x” months/years without a violation.

It’s important to include other language in the personal code of conduct, such as a statement that truly egregious behavior can be referred immediately to the Medical Executive Committee.

In our experience, two formal violations are not common and three formal violations are very rare.  As long as the Leadership Council is willing to enforce personal codes of conduct, they can be an effective tool for physician leaders who are attempting to deal with long-term inappropriate behavior.

If you have a quick question about this, e-mail Phil Zarone at PZarone@hortyspringer.com.

May 25, 2023

Posted on by Courtney Patterson

QUESTION:
We had an incident at one of our physician offices a couple of miles from the hospital’s main campus. Someone mentioned there may be some EMTALA concerns. Since the issue didn’t occur in the hospital’s emergency room, there is no cause for concern regarding EMTALA, correct?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
EMTALA may or may not be a concern here – depending on how the physician office operates. EMTALA requires that if an individual comes to a hospital’s emergency department “and a request is made on the individual’s behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital’s emergency department.”

However, just because the incident did not occur in the hospital’s emergency room does not automatically mean that EMTALA was not triggered. EMTALA responsibilities also extend to individuals who present anywhere on a hospital’s campus – not just in the emergency department – and request to be examined or treated for an emergency medical condition or if a prudent person would believe that the individual is suffering from an emergency medical condition. The hospital’s campus includes spaces like the parking lot, sidewalk, driveway, and hospital departments, including any building owned by and within 250 yards of the hospital.

Even if the physician office is several miles away, EMTALA might still apply. EMTALA can also apply to off-site departments or facilities that are deemed to be “dedicated emergency departments” of a hospital.  This would require two things.  First, the office in question would have to be operated as an “outpatient department of the hospital” (i.e., a provider-based entity under 42 C.F.R. §413.65) AND either holds itself out to the public as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; OR provided at least one-third of all of its visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

So while EMTALA is likely not an issue of concern for events that took place in this physician office several miles away, remember that events that occur outside of a hospital’s emergency department may also trigger EMTALA obligations.

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

May 18, 2023

Posted on by Courtney Patterson

QUESTION:
What is a Medicare NCD and why would an NCD be relevant to the delineation of hospital clinical privileges for certain procedures?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
A National Coverage Determination (“NCD”) is a general outline of coverage which is applicable regardless of which Medicare Administrative Contractor (“MAC”) is administering Medicare claims for a particular region.  According to CMS, NCDs are made through an evidence-based process and in some cases are supplemented by outside assistance in order to establish nationwide Medicare payment conditions for the treatment or procedure subject to the NCD.

Medicare does not have the authority to dictate the practice of medicine.  However, the Medicare program does have the authority to define what it will pay for, and under what conditions.  That is where the NCDs (as well as LCDs which are Local Coverage Determinations and are specific to a particular MAC) become relevant to clinical privilege delineations.

For example, the NCD for Percutaneous Left Atrial Appendage Closure (“LAAC”) describes the conditions under which Medicare will pay for LAAC technical and professional services.  Among the requirements of the current NCD, the LAAC must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who satisfies the following criteria:

(1)        Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and

(2)        Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and

(3)        Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a 2-year period.

What happens if you do not use the NCD in your delineation of clinical privileges for an LAAC?  That is not unlawful.  But neither the Hospital’s nor the physician’s claim will be reimbursed by Medicare if the physician who performs the LAAC does not at least satisfy the requirements in the NCD (or any other procedure where an NCD or LCD specifies certain training and/or experience).

If a claim has been submitted for such a procedure by a physician who did not satisfy the NCD or LCD’s criteria, then both the technical and the professional fees paid by the Medicare program for that procedure must be refunded.  Submitting a claim to Medicare in reckless disregard or in deliberate ignorance of Medicare’s conditions of payment constitutes a False Claim.  Keeping the reimbursement for a claim that should not have been submitted to Medicare because it did not satisfy the requirements of an NCD or LCD constitutes a “reverse false claim.”   The penalty for a violation of the False Claims Act is three times the amount of the claim plus a possible per claim penalty of between $13,508-$27,018.

Therefore, a prudent hospital will be aware of Medicare’s conditions of payment, where they exist, and will make their delineation of clinical privileges for an LAAC, or any other procedure where physician qualifications are defined in an NCD or LCD, so that at a minimum, the clinical privileges needed to perform that procedure in the hospital meet or exceed the requirements in any relevant NCD or LCD.

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

If you want to learn more about the False Claims Act, Anti-Kickback Statute, the Stark law, amendments to the regulations of those laws, and much more, consider joining Dan Mulholland and Henry Casale in Phoenix November 16-18, 2023, for our next seminar.  

In the interim, be sure to check out “The Kickback Chronicles” on the Health Law Expressions Podcast featuring Hala Mouzaffar and Henry Casale, so you can learn from the misfortune of others.

May 11, 2023

Posted on by Courtney Patterson

QUESTION:
In the Your Government at Work section of this week’s Health Law Express, it looks like the DEA and SAMHSA are intent on allowing controlled medications to be prescribed through telehealth.  Will other telehealth allowances implemented by the federal government during the Public Health Emergency continue after it ends?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
The short answer is “yes,” with the federal government extending some telehealth flexibilities temporarily and others permanently.  The Consolidated Appropriations Act of 2023 (“CAA”), for example, temporarily extended, through December31, 2024, the expansion of the types of practitioners that could bill Medicare for telehealth services.  This allows physical therapists, occupational therapists, and speech language pathologists to provide, and bill for, telehealth services provided to Medicare patients.  The CSA also temporarily allows: (1) patients to continue to access telehealth services in any geographic area (and not just rural areas), (2) patients to receive telehealth services in their homes rather than requiring travel to a health care facility, and (3) some telehealth visits to be delivered using audio-only technology (but see below for permanent changes for behavioral telehealth patients).

Many of the permanent changes to the rules have to do with behavioral telehealth services.  For example, going forward behavioral health patients can be provided with telehealth services in their homes and do not have to travel to a hospital or other health care facility.  In addition, Federal Qualified Health Centers and Rural Health Centers will qualify as distant sites (the site from where the practitioner providing the telehealth service is located) for behavior telehealth services.  Finally, behavioral health patients will continue to be able to access audio-only behavioral health services.

These extensions reflect a greater acceptance of the utility of telehealth services in the provision of health care to patients.  Don’t be surprised if in the coming years there is an additional loosening of the telehealth rules resulting in an increased use of telehealth for patients.  If you have a quick question about this, e-mail Charlie Chulack at CChulack@hortyspringer.com.

May 4, 2023

Posted on by Courtney Patterson

QUESTION:
We have recently had several applicants who are returning to practice after a significant gap in time.  What kind of policy or practices do you recommend for practitioners who are reentering practice after an extended time off?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
Practitioners may take an extended leave from practice for a variety of reasons, including family obligations, personal health, alternative careers, or retirement. Several resources for physicians returning to practice are available through the AMA and the Federation of State Medical Boards, among others.

From a Medical Staff perspective, one of the eligibility criteria we typically include in our Credentials Policy is that practitioners are not even eligible for privileges unless they can demonstrate clinical activity in their specialty in an acute care hospital setting in the past two years.  Any exception could be considered through the waiver process and might include conditions on their appointment to ensure a safe return to practice.

We have also worked with hospitals to develop a Practitioner Re-Entry Policy that gives the Medical Staff leaders the authority to develop a Re-Entry Plan for any such applicant.  Depending on the circumstances surrounding the practitioner’s absence, such a Re-Entry Plan could include, among other things, a competency evaluation, a refresher course, and/or retraining in order to ensure that the individual’s general and specialty skills are up to date.

The bottom line is that the Medical Staff must confirm the individual’s current clinical competence before putting its stamp of approval on them.