Question Of The Week

February 2, 2023

Posted on by Courtney Patterson

QUESTION:
We have a physician who has been working his way through our peer review process with very little sustained success.  Recently, there were several significant clinical events that caused Medical Staff Leaders to escalate the matter to the Medical Executive Committee which decided to commence an investigation.

Our question is “do we have to re-do all the great work done by our Peer Review Committee, or can we use that as part of our investigation?”

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
This is an excellent question and one that we hear quite frequently.  We know from experience Medical Staff Leaders will be able to address and resolve most issues that come to their attention, whether they are of a clinical or behavioral nature, using collegial and progressive steps.  However, every once in a while, a practitioner can’t or won’t change and Medical Staff Leaders will need to escalate concerns to the Medical Executive Committee for a formal, capital “I” investigation.

The procedure for conducting an investigation is laid out in your credentials policy, bylaws or investigation manual.  Once you get to an investigation, the stakes are high for everyone, so it is very important to follow the procedures outlined in your documents.

It is also important that the investigation is thorough, fair, and objective.  However, that does not mean that you have to re-do all the work done by the Peer Review Committee.  That would simply make no sense.  The Medical Executive Committee, or more likely an investigating committee appointed by the Medical Executive Committee, should have access to any documents that it deems relevant, including documents from the practitioner’s credentials file and quality file.  The investigating committee can and should review and rely on informational and educational letters along with letters of awareness, and letters of counsel or guidance.  It can and should review and rely on prior performance improvement plans (aka voluntary enhancement plans).  The investigating committee can and should rely on case reviews and reports from external experts.

If you have worked your professional practice evaluation process, once you get to the investigation phase, you may have already done most of the heavy lifting.  The role of the investigating committee may be primarily to pull together all prior progressive actions that had been taken and consider potential patterns and trends.  Additionally, the investigating committee may want to conduct interviews of individuals with relevant information including staff, the department chair and members of the Peer Review Committee.  Critically, even if your governing documents don’t expressly require it, the investigating committee will want to provide the subject physician with notice of the concerns that have been identified and an opportunity to discuss, explain or refute those concerns.

So, the bottom line is you can and should consider information reviewed by and generated for the Peer Review Committee at part of an investigation.  But you should also use the investigation to answer any outstanding questions and to meet with the subject physician.

January 26, 2023

Posted on by Courtney Patterson

QUESTION:
From time to time, patients in our emergency department will leave without being seen (“LWBS”). Can we get in trouble under the EMTALA law when that happens?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY JOHN WIECZOREK:
Generally no, as long as you document the event correctly. Here is what the CMS Interpretive Guidelines for EMTALA say about LWBS:

If a screening examination reveals an emergency medical condition (EMC) and the individual is told to wait for treatment, but the individual leaves the hospital, the hospital did not “dump” the individual unless:

  • The individual left the emergency department based on a “suggestion” by the hospital;
  • The individual’s condition was an emergency, but the hospital was operating beyond its capacity and did not attempt to transfer the individual to another facility; or
  • If an individual leaves a hospital Against Medical Advice (AMA) or LWBS, on his or her own free will (no coercion or suggestion), the hospital is not in violation of EMTALA.

The Guidelines tell the surveyors to look for this:

In cases where an individual (or person acting on the individual’s behalf) withdrew the initial request for a medical screening examination (MSE) and/or treatment for an EMC and demanded his or her transfer, or demanded to leave the hospital, look for a signed informed refusal of examination and treatment form by either the individual or a person acting on the individual’s behalf. Hospital personnel must inform the individual (or person acting on his or her behalf) of the risks and benefits associated with the transfer or the patient’s refusal to seek further care. If the individual (or person acting on the individual’s behalf) refused to sign the consent form, look for documentation by the hospital personnel that states that the individual refused to sign the form. The fact that an individual has not signed the form is not, however, automatically a violation of the screening requirement. Hospitals must, under the regulations, use their best efforts to obtain a signature from an individual refusing further care.

So as long as you follow these guidelines, you should be OK.  But make sure your ED staff understand these rules.

January 19, 2023

Posted on by Courtney Patterson

QUESTION:
Some of our residents have shown an interest in moonlighting at our hospital. Is that something we would be able to offer them?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Yes, absolutely! However, there are some parameters the hospital should be aware of when deciding what type of services residents can provide while moonlighting.

As you are probably aware, CMS requires that the services residents provide to inpatients related to their Graduate Medical Education (“GME”) program be billed as GME payments.  These services cannot be billed as physician services.

This also used to be true for inpatient services provided by residents, not related to their GME.  However, in March 2020, CMS issued a new rule that, among other things, changed the language in 42 C.F.R. § 415.208 that lays out the rules for moonlighting. This new rule established that services provided by residents to inpatients at a resident’s home institution, not related to their GME, were covered as physician services and payable under the physician fee schedule if three criteria were met and documented in the medical record:

(i)         The services must be identifiable physician services and meet the conditions for payment,

(ii)        The resident must be fully licensed to practice in the State, and

(iii)       The services performed must be able to be separately identified from those services that are required as part of the approved GME program.

So, while you can offer residents a range of options for moonlighting, it is important to keep in mind the billing consequences for the types of services the resident is providing.

Also, remember that moonlighting residents would need to be granted clinical privileges to provide services outside of their residency program.  Because moonlighting residents have usually not completed a residency program, they are typically not eligible for clinical privileges as Medical Staff members.  Instead, moonlighting residents are often granted privileges as a category of “Licensed Independent Practitioner.”  Be sure to consult your Medical Staff Bylaws and related documents to see how they treat moonlighting residents.

January 12, 2023

Posted on by jwilbert

QUESTION:
We have a contract with a Patient Safety Organization (“PSO”) and are concerned by the Garcia case summarized in this week’s Health Law Express.  Is there anything that we can do to enhance the eligibility of information we are generating for protection under the Patient Safety and Quality Improvement Act (“PSQIA”)?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK:
Information becomes Patient Safety Work Product (“PSWP”) when it is collected as a part of a provider’s Patient Safety Evaluation System (“PSES”).  Therefore, it makes sense for health care providers that have an agreement with a PSO (or who are considering one) to draft a robust PSES Policy that specifically identifies information that is being collected as a part of its PSES.  The policy should also state that the information is being collected “solely” for reporting to a PSO and constitutes PSWP.  However, before identifying information to include in the PSES, a health care provider should review any applicable laws and regulations that define information collection and reporting obligations.  For example, Pennsylvania requires healthcare entities to report patient safety events to the state.  Under HHS Guidance (and most of the case law on the subject), such information would not be considered PSWP because it is not developed “solely” for reporting to a PSO – it is also being developed for reporting to the state.  The court in Garcia goes one step further, holding that a contractual obligation to generate patient safety information renders that information ineligible for protection as PSWP under the PSQIA. As noted above, this is an incredibly narrow interpretation of the privilege under the PSQIA and sees no support in the PSQIA regulations (although it is consistent with another recent case from a federal court in Oregon – Dence v. Wellpath).  The court appears to indicate that the contract’s reference to accreditation standards provides another reason the mortality review was generated, further removing it from the PSQIA protection.  However, the PSQIA regulations contain a PSWP disclosure exception for “voluntary disclosure[s] to an accrediting body.”  This suggests that information could qualify as PSWP and still be shared with an accreditation entity, such as The Joint Commission, to demonstrate that a health care provider is meeting accreditation standards.  Thus, the court’s reliance on obligations created by accreditation standards as a justification for certain information not being eligible to become PSWP is puzzling.  Nevertheless, development of a PSES is a tricky task, and a health care provider should review its information generation and reporting obligations to assist in defining its PSES and what qualifies as PSWP.

January 5, 2023

Posted on by Courtney Patterson

QUESTION:
There is a lot of confusion amongst members of our Medical Staff about the relationship between Medical Staff appointment and clinical privileges.  For example, it is common to hear individuals refer to “Active Staff Privileges.” How can we help educate our Medical Staff on the difference between Medical Staff appointment and clinical privileges?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
Many people confuse or intertwine these two concepts, even though they are separate and distinct.  As such, it is important that your bylaws recognize appointment and clinical privileges as distinct concepts.

Appointment relates to an individual’s membership on the Medical Staff (i.e., that they are recognized as being “on the team”).  With this membership comes certain rights and responsibilities, like voting, serving on committees, etc.

Clinical privileges relate solely to the patient care services an individual has been authorized to provide at the hospital.  They do not relate to an individual’s involvement in Medical Staff affairs and, in turn, are not tied to the individual’s staff category.  In fact, an individual may be a member of the Medical Staff but have no privileges (e.g., “Community Staff”) or could have clinical privileges but no membership on the Medical Staff (e.g., telemedicine providers).

Ensuring your Medical Staff Bylaws documents make this distinction will hopefully help to educate your Medical Staff on this issue.

December 22, 2022

Posted on by jwilbert

QUESTION:

Our hospital has noticed that on-call coverage by other local hospitals has gotten thinner since the pandemic.  If other hospitals adopt lighter on-call schedules, it means more patients are transferred to our hospital and our on-call physicians have more of a burden.  Is it acceptable for these other hospitals to have limited (or zero) on-call requirements for their specialists?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

The Emergency Medical Treatment and Labor Act (“EMTALA”) requires every Medicare-participating hospital with an Emergency Department to have an on‑call schedule.  Specifically, each hospital is required to have “a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition.”  42 C.F.R. §489.20(r)(2).

The Centers for Medicare & Medicaid Services (“CMS”) expects a hospital to provide adequate on-call coverage consistent with the services provided at the hospital and the resources the hospital has available.  If a hospital has physicians on the Medical Staff who routinely provide services in their specialty to patients in the community, the hospital is expected to also provide a reasonable amount of on-call coverage in that specialty.

Prior to 2003, CMS informally operated under the “three‑physician rule.”  This rule stated that if there were three or more specialists on a hospital’s Medical Staff, CMS expected that hospital to provide on-call coverage 24 hours a day, 365 days a year.  In other words, under the three-physician rule, physicians were each expected to provide about 10 days of on-call coverage per month.

In 2003, CMS specifically disavowed the three‑physician rule.  In lieu of the three‑physician rule, CMS said it will use an “all relevant factors” test by which CMS will:

  • consider all relevant factors, including the number of physicians on staff, other demands on these physicians, the frequency with which the hospital’s patients typically require services of on‑call physicians, and the provisions the hospital has made for situations in which a physician in the specialty is not available or the on‑call physician is unable to respond.

CMS has refused to give any firm guidance on the number of days of coverage a hospital must have per physician under the “all relevant factors” test.  Thus, a hospital will only know if its on-call schedule is compliant if, after a complaint and CMS investigation, the hospital is found to be in compliance with EMTALA.

If you have reason to believe that another hospital’s on-call coverage is inadequate or nonexistent, you may want to first gather data to attempt to confirm this is the case.  If the data seem to confirm a problem exists, you might want to arrange a meeting with the other hospital to discuss the issues.  EMTALA allows for hospitals to work together to develop “community call plans” – this might allow all the involved hospitals to make better use of their resources.

There’s certainly no easy solution to on-call problems.  Hopefully, gathering data and communicating will result in better outcomes than any of the alternatives.

December 15, 2022

Posted on by Courtney Patterson

QUESTION:

The Joint Commission’s November 4 FAQ, which stated that the time frame for reappointment/re-privileging would be expanded from two years to three years, noted that additional information would be published at a later date.  Is there any update?  Did TJC make this official?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, TJC made it official.  TJC issued Prepublication Standards for the Hospital Accreditation Program, among others.  The Prepublication Standards revised the Elements of Performance as follows:

MS.06.01.07, Element of Performance 9:  “9.  Privileges are granted for a period not to exceed two years three years or for the period required by law and regulation if shorter.”

MS.07.01.01, Element of Performance 3:  “3.  The organized medical staff uses the criteria in appointing members to the medical staff and appointment does not exceed a period of two years three years or the period required by law and regulation if shorter.”

TJC stated that these Prepublication Standards are “Effective Immediately; February 19, 2023 Release.”

As noted in the November 17 Question of the Week, which commented on the November 4 FAQ, “you should confirm that your state hospital licensing regulations permit a three-year term.  For example, both Idaho and North Carolina regulations require two-year appointment terms.  As the quoted language from the [November 4 FAQ] states, the appointment term may be shorter than three years ‘if required by law or regulation.’  In other words, state hospital law or regulation will control so you want to be sure to check that first.”

Also, stay tuned – Horty, Springer & Mattern plans to do a podcast on the issue and provide additional information.

December 1, 2022

Posted on by Courtney Patterson

QUESTION:
A member of our Medical Staff recently disclosed to the Chief of Staff that they have a prescription to use medical marijuana. How should we handle this?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Rest assured, you are not the only ones that have faced this situation! As the number of states that legalize both medical and recreational marijuana continues to grow, questions related to marijuana use are becoming increasingly common. In general, there are three main things to know before tackling a situation like this:

  1. Marijuana is still illegal at the federal level. Because of that, users of medical marijuana are not entitled to federal protections like those offered by the Americans with Disabilities Act. Instead, all protections and prohibitions are regulated by states, state actors (i.e., a state Board of Medicine), and other committees commissioned by the state.
  1. Every state is handling medical marijuana use and the workplace a little differently. Some states have provided additional protections by doing things like prohibiting discrimination against users of medical marijuana or mandating that employers provide reasonable accommodations for such users. Other states have taken the stance that practitioners should refrain from using medical marijuana, and some states have not addressed the issue at all.
  1. No state requires employers to permit the use of medical marijuana during work or on work property.

With the above in mind, we recommend that hospitals treat this situation like any other where they receive notice that a practitioner may be experiencing a health problem.  The matter should be reviewed under the Practitioner Health Policy or other applicable policy to determine if the underlying cause for the use of medical marijuana affects the practitioner’s ability to safely treat patients. Also, check with counsel to see how your state is addressing this issue.

November 17, 2022

Posted on by Courtney Patterson

QUESTION:
As we can see from The Joint Commission at Work snippet, it looks like The Joint Commission expanded the appointment term for practitioners to three years from two years.  What should we consider if we are interested in moving to three-year appointment terms?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
Per the November 4, 2022 FAQ “How are reappointment/re-privileging dates determined?” The Joint Commission instructed that “[r]eappointment/re-privileging is due no later than three years from the same date from the previous appointment or reappointment, or for a period required by law or regulation if shorter” (emphasis added).  The FAQ notes that “[a]dditional information will be published in the December 2022 Perspectives Newsletter regarding a change to the reprivileging/reappointment time frame.”  Thus, it is not clear if this rule has been finalized, especially since the standards available continue to require a two-year appointment period.  Nonetheless, before you move in the direction of allowing a longer appointment term, you should confirm that your state hospital licensing regulations permit a three-year term.  For example, both Idaho and North Carolina regulations require two-year appointment terms.  As the quoted language from the FAQ above states, the appointment term may be shorter than three years “if required by law or regulation.”  In other words, state hospital law or regulation will control so you want to be sure to check that first.  Also, when The Joint Commission implemented the Ongoing Professional Practice Evaluation (“OPPE”) standard, they considered doing away with the reappointment process.  The Joint Commission’s rationale was that a well‑functioning OPPE process, which requires “ongoing” monitoring of clinical care and other factors, would render reappointment unnecessary.  The Joint Commission never did away with the reappointment process.  However, you should evaluate whether you have a well-functioning OPPE process that catches issues and trends quickly, allowing you to act, intervene, and protect patients.  If not, it may be wise to maintain the shorter reappointment term of two years to take a closer look at practitioners’ clinical practice and professionalism at the Hospital.

Stay tuned – Horty, Springer & Mattern plans to do a podcast on the issue and provide additional information.

November 10, 2022

Posted on by Courtney Patterson

QUESTION:
I hear the new Medicare Hospital Outpatient Payment Rules that were just published by CMS last week created a new breed of cat called a “Rural Emergency Hospital.”  What’s that?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
Rural Emergency Hospitals (“REHs”) are a new provider type established by the Consolidated Appropriations Act, 2021 to address the growing concern over closures of rural hospitals.  The REH designation provides an opportunity for Critical Access Hospitals (“CAHs”) and certain rural hospitals to avert potential closure and continue to provide essential services for the communities they serve.  Conversion to an REH allows the facility to continue providing emergency services, observation care, and, if elected by the REH, additional medical and health outpatient services, that do not exceed an annual per patient average of 24 hours.  The implementation of this new provider type, effective January 1, 2023, is designed to promote equity in health care for those living in rural communities by facilitating access to needed services.

For more information, see the CMS information page here.