June 15, 2017

QUESTION:        What’s this I hear about the penalties for EMTALA violations being doubled?  Haven’t we suffered enough?

ANSWER:            I agree about the suffering, but sorry, that’s not going to affect the doubling of the EMTALA civil monetary penalties.

As difficult as EMTALA can be, until a few months ago, it had actually been years since the federal government issued a new EMTALA regulation, guideline or bulletin.  But that’s not a complaint; EMTALA compliance is difficult enough with the existing rules, let alone any new ones.

So it’s interesting that the Office of Inspector General (the “OIG”) came out in December 2016 with some new regulations.  The OIG revised its regulations concerning penalties, including civil monetary penalties (“CMPs”), that it can impose for EMTALA violations.  These new rules were released in the OIG’s Final Rule concerning Medicare and State Health Care Programs; Fraud and Abuse; and Revisions to the OIG’s CMP Rules.

These new OIG regulations didn’t create new EMTALA responsibilities to be carried out.  Instead, they simply addressed the OIG’s penalty rules.  The most eye-popping of these concern the amount of the CMPs, now adjusted per inflation.

By the Act itself, which went into force in 1986, the OIG can fine hospitals with 100 beds or more and physicians up to $50,000 per EMTALA violation.  Hospitals under 100 beds can be fined $25,000 per violation.

Noting that those figures have never been adjusted for inflation over the past 30-plus years, the OIG adjusted.  Now, hospitals with 100 beds or more and physicians can be fined up to $103,139 per violation.  Hospitals under 100 beds can be fined up to $51,570 per EMTALA violation.

The OIG did not revise the EMTALA-stated penalty amounts themselves; the EMTALA regulations still describe CMPs for $50,000 and $25,000.  This is an inflation-adjusted increase detailed in another HHS-published document regarding CMPs.  (A $50,000 penalty doesn’t get you as much in 2017 as it did back in 1986.)

The OIG has not suddenly become “penalty hungry” when it comes to hospitals, on-call physicians, and other EMTALA matters.  The OIG suggested these clarifications in proposed regulations it issued back in May 2014.  Both the Affordable Care Act and the Medicare Prescription Drug, Improvement and Modernization Act enhanced the OIG’s authority to impose CMPs and to exclude individuals from participating in federal health care programs.  This was the OIG taking advantage of those two statutes to clean up and clarify its EMTALA penalty rules.

As the new CMPs basically double the penalty amount, it’s also important to understand that the OIG’s CMPs apply to each EMTALA violation, and a hospital or a physician can violate EMTALA more than once in the care of a single patient.  It’s not uncommon for an EMTALA wrongdoing to include multiple violations.  With CMPs of now roughly $100,000 per EMTALA violation, a hospital can find itself with the potential for some pretty stiff fines.

June 8, 2017

QUESTION:        Last week we had a 37-week pregnant patient present to our emergency department in active labor.  Her obstetrician was not on our medical staff and the on-call obstetrician was contacted to come in.  In the course of the phone call between the ED physician and the on-call obstetrician, the obstetrician realized that she knew this patient, and she informed the ED physician that she had treated her in the past but had terminated that physician-patient relationship the previous year because the patient had been noncompliant in connection with her previous pregnancy and related complications.  The on-call physician didn’t want to come in to treat the patient because she had gone through a formal process of sending the patient a letter, with the required advance notice, and didn’t want to reestablish that relationship.  Does the on-call physician really have to see a patient in this situation?  It seems unfair.

ANSWER:           Unfortunately, yes.  While it’s not a popular answer and it does seem unfair from the perspective of the obstetrician in your situation who likely did everything required of her to formally terminate that physician-patient relationship – a process that usually requires written notification with at least 30 days’ advance notice (and sometimes longer in the case of a pregnant patient) – the Emergency Medical Treatment and Active Labor Act (“EMTALA”) requirements trump the fact that the obstetrician terminated the physician-patient relationship.  In this case, the obstetrician is responding to the ED as the on-call physician, and she has to respond.

In the absence of a statute like that in effect in Virginia, which specifically provides that a physician-patient relationship created by a response to the ED by an on-call physician is “deemed terminated” upon the discharge of the patient from the ED or, if the patient is admitted, upon the patient’s discharge from the hospital and the completion of any follow-up care prescribed by the on-call physician, the obstetrician will likely have to go through the advance notice and termination process again.

The situation would be different if this patient presented to the ED and told the ED that the obstetrician was her treating physician.  In that case, when the ED contacted the obstetrician to inform her that one of her patients was in the ED, the obstetrician would have been able to inform the ED that she had terminated the physician-patient relationship, and the ED would then have resorted to contacting the on-call obstetrician.

June 1, 2017

QUESTION:        We are concerned about the language in our Medical Staff Bylaws that states that notification to an individual under investigation may be delayed if informing him or her immediately would compromise the investigation or disrupt the operation of the Medical Staff or the Hospital.  Doesn’t a physician under investigation have a right to know immediately when a resolution has been made to conduct an investigation?

ANSWER:            We understand your concern about delaying the notification to the individual. The reality is that, in most cases, the individual will be given notification as soon as possible once the MEC has decided to commence an investigation. However, there may be some situations where Medical Staff leaders are concerned that the individual might take some action (i.e., tamper with evidence or harassment of others involved) that would compromise the investigation or put others at risk of retaliation. In these rare situations, we recommend having Bylaws language that gives the MEC the discretion to delay notifying the individual about the investigation.

May 25, 2017

QUESTION:        The Medical Executive Committee disagrees with the way the Credentials Committee is managing a particular issue that has come before the Credentials Committee for consideration.  Since the MEC has higher authority in the medical staff leadership structure, can it direct the Credentials Committee on how to manage the issue?  Or is the Credentials Committee free to proceed as it sees fit?

ANSWER:            While it is true that the Medical Executive Committee is the “supreme” authority in terms of the medical staff leadership, most medical staffs are structured with built-in checks and balances and roles and responsibilities that are assigned to specified individuals or committees.  While the Medical Executive Committee may exercise oversight over all medical staff activities, that does not mean it can intervene any time that it disagrees with the way that something is being done.  So, if the Credentials Committee is performing assigned functions, it has some discretion to determine how to perform those functions – provided that it abides by the Medical Staff Bylaws and other relevant policies.

The Medical Executive Committee can offer suggestions, but has no authority to intervene with the exercise of the Credentials Committee’s discretion by telling it how to perform its duties (again, unless the Committee is violating the Bylaws or a policy or acting unlawfully).  This does not mean that the MEC is powerless, however.  Remember that the activities of all medical staff committees are subject to oversight of the MEC.  So, if the matter is one in which the Credentials Committee is making a recommendation to the MEC (such as a recommendation for a waiver of threshold criteria, of criteria for new clinical privileges, of criteria for clinical privileges that cross specialty lines, of appointment and privileges for an applicant, etc.), then the MEC can take the opportunity, during its review, to “correct” any mistakes it thinks the Credentials Committee may have made.  That could mean gathering more information, if the MEC feels the Credentials Committee did not do enough to scour an applicant’s background.  It could mean reviewing the matter anew, if it felt the Credentials Committee did not adequately address conflicts of interest during its review.  It could mean talking to an applicant, if it felt the Credentials Committee did not give the applicant ample opportunity to be heard.  The list goes on and on.  The point is, the MEC – as a subsequent level of review – has the opportunity to set right a multitude of perceived wrongs.

On a related matter, when medical staff leaders do not see eye-to-eye about how to manage day-to-day medical staff activities, that can indicate that it’s time for more education about the roles and responsibilities of hospital and medical staff leaders, as well as required credentialing and peer review functions (and the risks of not completing those functions well).  Leaders who are well-informed about the content of their Bylaws, the Credentials Policy, and related Medical Staff policies are likely to be more consistent in how they perform their leadership functions.  All medical staff leaders should also receive education about legal protections for leaders, the risks to legal protection (such as frolic and detour), and ways to maximize legal protections (e.g., through management of conflicts of interest, good documentation, reasonableness when dealing with other practitioners, and following a “patient safety first” rule of thumb).

May 18, 2017

QUESTION:        A registrant at our Complete Course for Medical Staff Leaders in New Orleans two weeks ago asked:

Appreciated the suggestion in the case study to hold an application incomplete if there remain questions and concerns, but couldn’t the Credentials Chair or another physician leader suggest that an applicant withdraw the application?

ANSWER:           They could.  However, such a suggestion must be done with care. Suggesting that an applicant withdraw could invite a contention from an applicant’s lawyer that leaders are attempting to talk an applicant out of a “right” to a hearing.  That’s not the case if there has not been a recommendation for “denial,” but dealing with the contention could consume valuable resources.  Instead of appearing to push the applicant to withdraw, it may be better to present the physician with the potential consequences of the options, including withdrawal, appealing a denial recommendation, or allowing the application to remain incomplete.  It is a best practice to have a framework of clear language in the bylaws or credentialing policy (premised on the applicant’s burden), that incomplete applications will not be processed; and any application that remains incomplete after information has been requested, and not fully provided after a stated period of time (30, 45 or 60 days), will be deemed to be withdrawn.  It is easier for someone to simply wait for the expiration of the time period than to have to formally write a letter of withdrawal.  If your documents don’t have that language, you can still use this technique by stating a time period in the letters posing questions and requesting information.  Add additional language to guide future credentialers, next time revisions are considered!

May 11, 2017

QUESTION:        Our hospital is about to sign a letter of intent to merge with a regional health system.  The lawyers want us to also sign a “joint defense agreement.”  What is that and does it make sense to do so?

ANSWER:            A joint defense agreement or “JDA” memorializes the intention and understanding of parties to a prospective merger or acquisition regarding:  (1) particular communications that have been made between them, (2) the contents of such communications, and (3) any other work product containing or referring to such communications shall remain confidential and protected from disclosure to any third party.  The JDA also permits the parties and their respective attorneys to share and exchange information among themselves and with any retained experts or consultants without waiving any privilege that may apply to that information.  It is usually a good idea to have a JDA in any merger transaction.  The courts have recognized that the joint defense and common interest privileges will protect privileged communications between the parties from disclosure.  Given the recent aggressive posture of the FTC and state attorney generals who have challenged numerous health care mergers, a JDA is not only a good idea, it is a critical tool for self-preservation.

May 4, 2017

QUESTION:        We have just received an application for Medical Staff appointment from a physician who has a history of alcohol abuse that caused him to lose his license.  While his license has been reinstated, how should we deal with the fact that at one point in time he lost his license?

ANSWER:            First check your Medical Staff Bylaws.  Many bylaws have threshold eligibility criteria that not only require that an applicant possess a current, unrestricted license, but also require that an applicant have never had his or her license to practice revoked or suspended by any state licensing agency.  Such an eligibility criterion would render this physician ineligible to apply for appointment.

However, that does not end the inquiry.  Most bylaws also have a process that may be followed to obtain a waiver of the threshold eligibility criteria.  If the physician wants to attempt to qualify for a waiver, he or she should be required to request a waiver in writing and provide the MEC with such information as the MEC may require to determine whether granting a waiver is in the best interest of the hospital and the community it serves.

The MEC should be reasonable and keep in mind that past alcohol or drug use is protected by the ADA.  However, that does not alter the fact that the burden remains on the applicant to satisfy the hospital’s eligibility criteria and, if requesting a waiver, to establish a reasonable basis for the requested waiver.  Whether a waiver is granted is discretionary, the burden remains on the applicant, and an application is incomplete and should not be processed unless the waiver has been granted.

April 27, 2017

QUESTION:        Our hospital policies allow almost anyone to order outpatient services, regardless of whether they are a member of the Medical Staff or not.  Is this a problem?

ANSWER:            This poses compliance issues under the Medicare Conditions of Participation (“CoPs”).  The CoPs only allow outpatient services to be ordered by practitioners who meet certain conditions.  The ordering practitioner must be (1) responsible for the patient, (2) licensed in the state where he or she provides care to the patient, (3) acting within his or her scope of practice under state law, and (4) authorized by state law and policies adopted by the Medical Staff (with approval from the governing body) to order the applicable outpatient services.

Your Medical Staff policies can reflect a determination as to whether practitioners who are not on your Medical Staff are permitted to order outpatient services.  However, these policies must address how you will verify that the referring/ordering practitioner meets the requirements in the CoPs.  You will need to keep documentation to show that you have complied with the CoPs (e.g., documents showing that you checked the ordering practitioner’s license).

If you permit allied health professionals not affiliated with your hospital to order outpatient services, you may have to do a significant amount of work.  Be sure to check their scope of practice to make sure they are permitted to order the service in question.  In addition, be sure to follow the laws of your own state!

You may decide that certain orders should be permitted only by individuals with specific hospital privileges.  The Interpretive Guidelines give the example of requiring practitioners to have hospital privileges before they can place an order for outpatient chemotherapy services.  If you do this, be sure to delineate these terms clearly in your policies.

April 20, 2017

QUESTION OF THE WEEK

QUESTION:        Our current Medical Staff Bylaws state that in order to be eligible for reappointment and renewal of clinical privileges, an individual must have “completed all medical records” during the previous appointment term.  However, even if an individual was compliant 100% of the time, on the date the application was filed, not all of the individual’s medical records would be complete, as some would be outstanding.  How do you resolve that issue?

ANSWER:            We have had several hospitals that we have worked with on Medical Staff Bylaws projects raise the issue that no one is, in fact, compliant with medical records all of the time.  Therefore, no one would truly be eligible for reappointment if eligibility required that an individual have completed all medical records during the previous appointment term.  As referenced in the question, even if an individual was compliant with medical records requirements 100% of the time, on the date the application was filed, not all of the individual’s medical records would be complete (some would be outstanding, but not delinquent).

So, we recommend expanding on the “completed medical records” language by having the Medical Staff Bylaws state that in order to eligible for reappointment, an individual must have:

completed all medical records such that he or she is not delinquent, as per the Medical Staff Rules and Regulations and Hospital policy, at the time he or she submits the application for reappointment or renewal of clinical privileges and, further, was not deemed delinquent (sufficient to result in the relinquishment of privileges) more than _____ time(s) during the prior appointment term.

April 13, 2017

QUESTION:        We are about to begin a medical staff hearing requested by a medical staff member after he was informed that the Medical Executive Committee made a recommendation to the Board that his clinical privileges be revoked for a number of significant clinical concerns.  The physician who requested the hearing is objecting to physicians employed by the hospital’s affiliated group sitting as members of the hearing panel.  Should we grant his objection?

ANSWER:            By itself, employment by the Hospital (or an affiliate of the Hospital) does not preclude an individual from serving on a medical staff hearing panel.  Your medical staff bylaws or credentials policy should explicitly state this.  To maintain eligibility for immunity under the Health Care Quality Improvement Act, a hearing must be held “before a panel of individuals who are not in direct economic competition with the physician involved.”  There may be situations in which an employed physician is in direct economic competition with the physician who requested the hearing, but it is the direct competition that is the disqualifying factor, not the potential hearing panel member’s employment.

That being said, when selecting a hearing panel, the process in your current Medical Staff Bylaws or other applicable policy should be followed.  Ideally, each member of the panel will be selected primarily on the potential member’s ability to be fair and objective.  Any potential conflicts of interest should be managed carefully.  Objections about the composition of the hearing panel should be raised prior to the commencement of the hearing and directed to an appointed presiding officer.  Finally, it is helpful for your policies and procedures to require the resolution of any of the subject physician’s objections, including objections to hearing panel members, during a pre-hearing conference.

For more information on medical staff hearings and appeals, join Susan Lapenta and Charlie Chulack on May 2, 2017 for Horty, Springer & Mattern’s Grand Rounds Audio Conference Series, Medical Staff Bylaws – Hearings, Appeals and Litigation.