Author: Courtney Patterson

July 8, 2021

Posted on by Courtney Patterson

QUESTION:
“We have an applicant who is refusing to answer one of the questions on our application form because she says that her lawyer told her it could violate a settlement agreement that she has with another hospital.  We think that information is relevant to her request for appointment at our hospital.  Can we still ask for the information?  Should we ask for a letter from her lawyer?  Should the application be held incomplete?”

ANSWER:
Yes!  Credentialers have a duty to review all of the relevant qualifications of each applicant for Medical Staff appointment and clinical privileges and cannot allow the legal interests of an applicant, in an unrelated matter, to interfere with that duty.  Accordingly, the Medical Staff Bylaws (or related policies) should state very clearly that every applicant bears the burden of submitting a complete application and of producing information deemed adequate by the hospital for a proper evaluation of current competence, professional conduct, character, ethics, and other qualifications – and for resolving any doubts.

A similar issue arose in a 1997 case, Eyring v. East Tennessee Baptist Hospital, 950 S.W.2d 354 (Tenn. Ct. App. 1997), in which a physician applicant refused to sign a release form authorizing a hospital where he had previously practiced to send information to another hospital where he had submitted an application.  The physician argued that he received legal advice that signing the release could compromise his lawsuit against the other hospital, which had revoked his privileges.  The court held that because the physician had not provided the additional information that the hospital requested – regardless of the fact that a settlement agreement was in place – he had not submitted a complete application and, thus, under its Bylaws, the hospital was not required to process his application further.

July 1, 2021

Posted on by Courtney Patterson

QUESTION:   “In reference to the case in this week’s HLE, does EMTALA apply to inpatients?”

ANSWER:      The obligations under EMTALA do not apply to a hospital once a patient is admitted as an inpatient in good faith.

However, the issue in the Harmon case was whether the patient had been formally admitted as an inpatient or simply placed in observation. If it is ultimately determined that the patient had been admitted as an inpatient, then he will no longer have a claim under EMTALA, as the Hospital’s obligation to effectuate an appropriate transfer would have ended prior to his attempt to kill himself by jumping out of the car during the transfer to the other facility.

Conversely, if it is determined the patient was put into observation but not admitted as an inpatient, he will be free to pursue his EMTALA claim. This is because CMS has stated that such action does not end a hospital’s EMTALA obligations. This can be found in the Interpretive Guidelines, which state:

“Individuals who are placed in observation status are not inpatients, even if they occupy a bed overnight. Therefore, placement in an observation status of an individual who came to the hospital’s [emergency department] does not terminate the EMTALA obligations of that hospital or a recipient hospital toward the individual.” (Emphasis added)

TAG A-2411/C-2411, Rev. 191,07-19-19

The court in Harmon cites entries in the patient’s medical record that support both arguments (i.e., that the patient was admitted vs. put into observation), so it declined to make a finding on this factual question at this point in the litigation.

June 24, 2021

Posted on by Courtney Patterson

QUESTION:   “Since the new Stark regulations came out late last year, can we still require our employed physicians to refer patients to our hospital or other providers in our health system?”

ANSWER:       Yes.  The amendment to the Stark regulations set forth a separate section on “directed referrals” at 42 CFR §411.354(d)(4) which permits physician compensation in employment relationships, personal service arrangements and managed care contracts to be conditioned on the physician’s referral of patients to a particular provider, practitioner or supplier as long as the physician is paid fair market value, agreement is in writing and subject to the following exceptions:  (i) the patient expresses a preference for a different provider, practitioner or supplier, (ii) the patient’s insurer determines the provider, practitioner or supplier, or (iii) the  referral is not in the patient’s best medical interests in the Physician’s judgment.  The required referrals must relate solely to the services covered by the contract in question.

The regulations go on to say that neither the existence of the arrangement or the amount of compensation can be contingent on the directed referrals.  However, an established percentage or ratio of the physician’s referrals to the designated providers can be required.  In other words, a directed referral provision in an employed physician’s contact could not provide that the physician’s compensation would be cut if the physician does not refer patients to the hospital, but it could require that a certain percentage of the physician’s patients who require hospitalization are sent to the hospital – subject always to the three exceptions.

But beware!  Although the Stark regulation says that personal services arrangements can contain a directed referral requirement, there is no corresponding directed referral language in the Anti-kickback safe harbors.  The only protection there would be the bona fide employment exception, so requiring independent contractors to refer to the hospital would be risky.

Want to know more about this or other provisions in the new Stark regulations? Contact Dan Mulholland or Henry Casale or call 412-687-7677 to schedule an appointment.

June 17, 2021

Posted on by Courtney Patterson

QUESTION:   “We have a mandatory COVID-19 vaccination program for our employees.  If an employee has an adverse reaction to the vaccination, are we required to record it in our Occupational Safety and Health Administration (“OSHA”) 300 log?”

ANSWER:      No, not at this time, but here’s the background.  On April 20, 2021, in its FAQs, OSHA stated that an adverse reaction would be recordable if the injury or illness was work-related (OSHA’s position was that if the vaccine was mandated by employers, it was work-related), it was a new case, and the illness met one of the recording criteria (days off of work, restricted work, medical treatment beyond first aid, etc.).  However, OSHA has since updated its guidance and has stated that at this time it will no longer require employers to record those events since it might disincentivize employers’ vaccination efforts.  OSHA stated that it won’t enforce the rule until May 2022.

June 10, 2021

Posted on by Courtney Patterson

QUESTION:   “Can our hospital impose a requirement that all Medical Staff members get a COVID-19 vaccine?”

ANSWER:      While we are aware of some hospitals that are considering making COVID-19 vaccination mandatory for their Medical Staffs, most have not yet implemented such a policy.  We should also note that at least one health system is subject to a class action lawsuit filed by 117 of its employees because of its policy requiring employees to be vaccinated against COVID-19. Read about it here.

While the COVID-19 vaccination is proving to be remarkably effective in controlling the spread of the virus, one of the things that is holding some hospitals and health systems back is that the vaccine is currently under emergency use authorization, rather than the full vaccine authorization normally granted by the FDA.  However, at least two pharmaceutical companies are seeking full authorization from the FDA.  On May 7, 2021, Pfizer requested full approval for their COVID-19 vaccine from the FDA.  Moderna followed suit on June 1, 2021.

As noted above in Your Government at Work, the EEOC, in its updated guidance, emphasized that the federal employment equal opportunity laws do not prevent employers from requiring COVID-19 vaccinations, subject to reasonable accommodation provisions and other equal employment considerations.  But, the EEOC also notes that it is beyond its jurisdiction “to discuss the legal implications of [emergency use authorization] or the FDA approach.”

The section of the federal Food, Drug, and Cosmetic Act allowing emergency use authorization requires that individuals to whom a product subject to emergency use authorization is administered are informed of “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”  A reasonable interpretation of this statute would give any individual the right to refuse a vaccine that has only been given emergency use authorization and thus preclude mandates.  A counter-interpretation is that an individual must be informed of the consequences of refusal to accept an emergency use authorization vaccination, such as, for example, automatic relinquishment of clinical privileges.

Nonetheless, if you do decide to move forward with a COVID-19 vaccination requirement, you want to make sure that it is consistent with your Medical Staff Governance Documents and Hospital policies.  There should not be anything to keep you from proceeding, but you will want to confirm this.  You will also want to check if your documents permit you to mandate any vaccines.  If they do, this could set the groundwork for a COVID-19 vaccine requirement.  For example, Medical Staff Bylaws often already require influenza vaccination.  Further, many Bylaws include a threshold eligibility criterion for appointment and privileges stating that an individual must complete all required health screenings and vaccinations prior to providing any patient care at the hospital and any appointment/privileges granted by the Board are conditioned on the individual’s compliance with those requirements.  If you have this threshold eligibility criterion language, it should be broad enough to include a COVID-19 vaccination requirement in a separate policy.

June 3, 2021

Posted on by Courtney Patterson

QUESTION:   “I know that the Stark law covers a lot of seemingly innocuous activities. But surely Stark does not affect the ability of the MEC to serve food and drinks at an off-site medical staff meeting – Can it???”

ANSWER:      As you may have guessed – the answer is YES.  But, do not despair, there are several ways to comply with the law.

Any time that a hospital provides remuneration to a physician, the arrangement must satisfy an exception to the law.  Unfortunately, the Stark law defines “remuneration” so broadly that any meal or gift that a hospital provides to a physician will be considered to be “remuneration” and so the law will apply.  Once the law applies, you must find an exception that will permit the proposed conduct.

The fact that the meeting will he held off campus will limit the exceptions that might otherwise apply.  But even still, the good news is that the hospital gets to choose the exception that applies and depending on the facts, there are several exceptions from which to choose to address the meals to physicians provided at a committee meeting or at an educational event.  Also, you should be aware of a new Stark exception that became effective on January 19, 2021, that will be very helpful in situations such as what you have described.

Employed Physicians
The Stark law provides the greatest amount of latitude when a hospital provides the meal or other benefit to an employed physician.  Most meals and other medical staff benefits provided to an employed physician should be considered to constitute employment related fringe benefits and are covered by the Stark employment exception.

For the purpose of your question, we will assume that the Physicians who will receive the meals or other medical staff benefits are not Hospital employees – but we wanted to mention the Employment exception in case it can be used to minimize the record keeping that will be required by the exceptions that are described below.

Non-Employed Physicians
When dealing with non-employed physicians, the Stark law divides meals and other medical staff benefits into two categories – (1) non-monetary compensation that may be provided anywhere, have no individual per gift limit, but are subject to an annual cap; and (2) medical staff incidental benefits that must be provided on the hospital campus, have a per item limit but no annual limit.  Depending on the facts, other exceptions may apply as well.  However, the two meal related exceptions work like this:

(1)        Non-Monetary Compensation Exception
The “nonmonetary compensation” exception (42 C.F.R. §411.357(k)) permits compensation in the form of items, meals or gifts (but not cash or cash equivalents) that do not exceed the then applicable limit in any Calendar Year, adjusted for inflation.  When this exception was adopted, this amount was $300/Calendar Year.  However, this amount is annually adjusted for inflation and the annual limit for Calendar Year 2021 is $429.  CMS updates this amount annually, and the current annual limit may be found at http://www.cms.hhs.gov/PhysicianSelfReferral/10-CPI-U-Updates.asp.

Even when indexed to inflation, the $429 maximum in Calendar Year 2021 makes this exception of limited utility.  Furthermore, in order to satisfy this exception, the hospital must track all such items, meals or gifts, the item, meal or gift must not be determined in any manner that takes into account the volume or value of referrals or business generated by the referring physician and may not be solicited by the physicians.  However, there is no requirement that the meal or other benefit be provided on the Hospital’s campus.

In case it is needed, this rule also provides:  (1) no more often than once every three years, a physician who has inadvertently received non-monetary compensation of up to 50% in excess of the then applicable annual limit, may repay the excess within the earlier of the same Calendar Year or 180 days of receipt of the excess, but this exception may be used only once every three years with respect to the same physician.  In addition, a hospital may provide one medical staff function per year for the entire medical staff without regard to any monetary limit.

In order to comply with this exception, the hospital must track the value of all of the nonmonetary compensation that is provided to each physician during each Calendar Year.  However, this can be done by taking the cost of the event and dividing that cost by the number of physicians who attended (you do not need to track what each physician may eat).  Also, this exception does not include any geographic limitation.

(2)        Medical Staff Incidental Benefits
The other meal/gift related exception that applies to non-employed physicians is the “Medical Staff Incidental Benefits” exception (§411.357(m)).  While it is helpful that CMS has recognized that the Stark regulations should include an exception that recognizes a number of traditional relationships between a hospital and the physicians who are appointed to its medical staff, this exception is still relatively narrow and has a number of requirements, including the requirements that the item or services be offered to all staff members practicing in the same specialty without regard to the volume or value of their referrals to the hospital, provided only during periods when the medical staff members are making rounds or are engaged in other activities that benefit the hospital or its patients, used by the medical staff member “on the hospital’s campus,” be reasonably related to the delivery of medical services at the hospital, and not intended to induce referrals.

Also, the compensation must be of low value.  Originally, each item was valued at $25 or less, and subject to the same inflation adjustment used in the non-monetary compensation exception.  In Calendar Year 2021 this amount has been adjusted to $37 per occurrence.  Future updates can be found at the same area of the CMS website as the update for non-monetary compensation.  However, there is no annual limit and so there is not the same need for the per physician records to be maintained as there is for the above-described exception – but the hospital should keep records of the incidental benefits provided and their costs.

This is the so-called “free lunch exception.”  Therefore, assuming that all of the requirements to the exception are met, a hospital may provide free meals, free parking or any other “on campus” incidental benefit that it normally provides to all members of its medical staff practicing in the same specialty without fear that that benefit will be construed as a prohibited compensation arrangement, so long as each individual benefit (i.e., each meal) is less than $37 in 2021 even if the aggregate value of all of the benefits provided to a physician over the course of a year exceeds  $429 in Calendar Year 2021.  That said, based on the facts that you have provided (i.e., the off-campus location of the meeting), this exception will not apply.

(3)        Compliance Training Exception
There is a broad exception that permits a hospital to provide compliance training to a physician or to a physician’s staff, so long as the training is “held in the local community or service area” 42 C.F.R. §411.357(o) Compliance training is defined in this exception and is pretty broad – so it should apply to a medical staff committee meetings and most medical staff educational meetings. While the exception will permit the hospital to provide the training and CME so long as compliance training is the primary purpose of the program, this exception does not address serving food at the training.  While this exception should protect the training itself that you have described, we do not recommend relying on this exception to serve food at any such program.

(4)        Limited Remuneration to a Physician Exception – Added January 19, 2021
A new exception that became effective on January 19, 2021 will apply to a number of situations, including the one that you have described if none of the other exceptions apply. It does not require a written agreement, is very broad and permits a payment of up to $5,000 per Calendar Year per physician (with the $5,000/Calendar Year limit to be indexed to inflation in the same manner as the two exceptions described above).

Since this exception is new there is no case law interpreting.  However, it does not require a written agreement and is very broad.  While it has the disadvantage of requiring the hospital to track the amount paid to each physician each year (we recommend that you determine the amount/physician in the same manner described above), it will, in our opinion, cover the training that you described and much more.

We recommend relying on this exception first and should the $5,000/Calendar Year limit be exhausted then you may rely on the nonmonetary exception described above for the balance of the then applicable annual benefit.

May 27, 2021

Posted on by Courtney Patterson

QUESTION:   “When a hospital receives a peer review incident report on a practitioner, is the medical director of an affiliated physician group practice that employs the practitioner allowed to see the occurrence?”

ANSWER:      This is a question that we receive quite frequently and one in which most hospitals are having to answer because they are part of a system with affiliated groups that employ physicians practicing at one or more hospitals within the system.  The bottom line is that information sharing among relevant entities within a system is an important part of credentialing, privileging, and peer review.  Information sharing ensures patient safety and the quality of care across the system.  However, before any information sharing occurs, there should be a process outlined in your Medical Staff policies so that you don’t inadvertently violate your state’s peer review privilege.

While the details of the process for information sharing in your policies is too detailed to fully outline in an answer to the Question of the Week, below are some important points you should consider addressing in your Peer Review Policy.

If the practitioner involved is employed by the hospital, the Peer Review Committee (or “Professional Practice Evaluation Committee” or “Committee for Professional Enhancement” depending on the terminology you use) may notify an appropriate hospital representative with employment responsibilities (such as the medical director of the group) of the review of the incident report and request assistance in addressing the matter.

Whether notification occurs may depend on the circumstances underlying the incident report and the contemplated intervention by the Peer Review Committee.  For example, the medical director of the group should generally be notified when the concern is more significant and an intervention such as a Performance Improvement Plan/Voluntary Enhancement Plan is being considered.  On the other hand, if a practitioner simply receives an educational letter (e.g., on the need to round daily on patients and record progress notes consistent with the Medical Staff Rules and Regulations), the Peer Review Committee may choose not to notify the group.

Nonetheless, if the group is notified, a representative may be invited to attend meetings of the Peer Review Committee, participate in discussions and deliberations, and participate in any interventions to make sure that the group and Peer Review Committee are on the same page.

You want to make sure you consult your state’s peer review statute because it could affect the way that this process is structured and carried out.  Some state laws specifically address the sharing of peer review information with physician group practices while others are silent.  You also want to be mindful of the fact that some state courts have interpreted peer review statutes to limit what you can do with peer review information.  For example, in a case called Yedidag v. Roswell Clinic Corporation, the New Mexico Supreme Court concluded that “the acquisition and use of confidential peer review information for purposes of employee discipline is not a statutorily permissible use of peer review information.”

Finally, it is helpful also to have an Information Sharing Policy in place that, among other things, spells out the rationale for the Policy, the types of information sharing that will occur, the entities that will be subject to the Policy, and an explicit statement that the Policy has been drafted to comply with the state peer review law and is not intended to waive any applicable peer review privilege.

May 20, 2021

Posted on by Courtney Patterson

QUESTION:   “It’s been a long time since we first adopted our bylaws. Some leaders are hoping for a clean slate with a total rewrite, others want to continue to tweak the bylaws we have. What’s the best approach?”

ANSWER:     There is no single right answer to this question but it is a question we get quite a bit.  We have found that if you have done a major revision of your bylaws documents (including your related credentialing, peer review, health and professionalism policies) within the last five years or so, you should be able to tweak the existing documents to reflect any changes in the law and recommended best practices.

Even if it’s been ten years or so since you totally revised your bylaws, you can probably stick with the current documents.  There are a couple of critical qualifications.  First, it’s important that you are starting with an excellent set of bylaws.  This means that the bylaws you have in place are easy to read and follow, the bylaws do not contain lots of internal cross-references (these are almost impossible to keep up-to-date), and the bylaws reflect best practices.  And second, it’s also important that you have been careful, thorough, and diligent in updating the bylaws every two years or so.  In our experience, updating a mediocre set of bylaws only takes you from a bad situation to one that is worse.

If it’s been more than ten years since you’ve done a major overhaul of your bylaws, it’s time to do so.  Just about everything has changed in the medical staff world in the last decade.  Whether it’s the role of APPs, the use of telemedicine, the need for consistency between and among sister hospitals, the focus on collegial efforts and progressive steps in the peer review process, or the non-punitive approach to dealing with health issues, the list of issues that have substantially changed is almost endless.

It’s so important to have modern, up-to-date bylaws, and related policies, to reflect the world in which you are practicing and to provide the necessary tools to solve the challenges you are likely to face.  A major overhaul of your bylaws documents might seem like a daunting task, but we can assure you the time you devote to the project on the front end, will be time well spent.  And you and your colleagues will reap the rewards for many years to come.

For more information on developing BFB (aka Best Friend Bylaws), join us live for The Complete Course for Medical Staff Leaders in Disney (September 19-21), Phoenix (November 18-20), Naples (January 27-29) or New Orleans (April 7-9).

 

 

May 6, 2021

Posted on by Courtney Patterson

QUESTION:    “We are in the midst of a review of our Medical Staff Bylaws and one of the Bylaws Committee members said that she heard that we shouldn’t be including our hospital’s Institutional Review Board (“IRB”) in the Bylaws with all of the other medical staff committees. Is that true?”

ANSWER:       Yes.  The federal Food and Drug Administration regulations pertaining to IRBs, 21 C.F.R. §56.101 et seq., define an IRB as “any board, committee, or other group formally designated by an institution to review, to approve the initiation of and to conduct periodic review of biomedical research involving human subjects.”  The Department of Health and Human Services’ regulations echo the “institutional” aspect of the formal designation of IRBs (45 C.F.R. Part 46).  Federal regulations require the IRB to be a committee formally designated by a hospital’s Governing Board to review biomedical research involving human subjects at the hospital.

This issue has been gaining momentum lately in research audits performed by both the Office of Human Research Protections and the Food and Drug Administration in which the agency has taken issue with the fact that the institutions included their IRBs as one of several “medical staff committees” that lived in a medical staff governance document like the bylaws.  The auditors pointed generally to the regulatory language, that it is an institutional responsibility to maintain an appropriate IRB, not a medical staff responsibility.  As a practical matter, the concern is that (while very unlikely) if the IRB procedures need to be revised because of a regulatory change, the medical staff could refuse to do so, as is contemplated by the amendment process to these rules.  By comparison, if the IRB is a hospital committee, hospital administration and/or the Board could implement a change on its own action.  Again, while the likelihood of a Medical Executive Committee or a medical staff as a whole acting in such an obstructionist manner is very slim, in the eyes of the audit agencies, it is a valid concern.

Therefore, we recommend that the IRB be created by a Board resolution and thereafter function as a committee of the hospital, rather than the medical staff, with its independent authority derived from the Board.  There may be substantial overlap of the IRB membership with that of a medical staff committee.  However, the IRB should be constituted as a separate committee of the Board in accordance with the membership requirements set forth in the federal regulations.

April 29, 2021

Posted on by Courtney Patterson

QUESTION:    “What is the history of the peer review process in the United States?”

ANSWER:       In the United States, the evolution of the peer review process was pioneered by the American College of Surgeons (“ACOS”).  In 1913, the year of its founding, the ACOS appointed a man named Ernest A. Codman to chair a committee on hospital standardization.  Codman was an outspoken critic of contemporary hospital recordkeeping practices and made public appearances speaking on the importance of adequate medical records, which he believed were essential for studying patient outcomes.

By 1919, the ACOS had created and adopted a document on hospital standardization.  The 1924 version of the ACOS “Minimum Standard” for hospitals is archived and easily accessible online.  In the 1924 Minimum Standard, the ACOS set forth the following mandates:

  1. That membership upon the staff be restricted to physicians and surgeons who are (a) full graduates of medicine in good standing and legally licensed to practice in their respective states or provinces; (b) competent in their respective fields and (c) worthy in character and in matters of professional ethics…
  1. That the staff initiate and, with the approval of the governing board of the hospital, adopt rules, regulations, and policies governing the professional work of the hospital; that these rules, regulations, and policies specifically provide…[t]hat the staff review and analyze at regular intervals their clinical experience in the various departments of the hospital, such as medicine, surgery, obstetrics, and the other specialties; the clinical records of patients, free and pay, to be the basis for such review and analysis.

These efforts by the ACOS continued for several decades until they eventually evolved into the Joint Commission on Accreditation of Hospitals in 1951.  Since its inception, The Joint Commission has promoted and surveyed the use of peer review (sometimes called “medical audits”) on hospital medical staffs.

You can find more information on the website of the American College of Surgeons, available here.