April 18, 2019

QUESTION:        Our Professional Practice Evaluation Committee recently asked a physician to attend one of its meetings to discuss several of his cases that are under review.  The physician says he’ll only attend if his attorney is with him.  Do we have to allow the attorney to attend?

ANSWER:            No.  The best way to address quality or behavioral concerns is for physicians to speak with physicians in a collegial and professional manner.  The presence of an attorney would likely cause committee members to speak less candidly and be concerned that their comments – no matter how accurate and honest – would be viewed as hostile or “defamatory.”  Also, an attorney might try to raise procedural arguments that distract from the substantive concerns being evaluated.

Physicians who are subject to a review are welcome and encouraged to consult with an attorney prior to the meeting if they wish.  They may also ask the attorney to accompany them to the hospital.  However, the attorney should be required to remain outside the meeting room.

We recommend that applicable policies clearly state that no attorneys (neither the hospital’s nor the physicians’) will attend meetings between the physician under review and the reviewing committee (or individuals).  At most, the policies could state that a physician may bring a colleague to such a meeting (such as a partner).  However, in such case, the guest should not be permitted to speak for the physician and should be required to sign a confidentiality agreement.

April 11, 2019

QUESTION:        Can a physician use a hospital’s DEA registration number to administer, dispense or prescribe controlled substances to patients at the hospital?

 

ANSWER:            Yes, physicians who are agents or employed by the hospital may, when acting in the usual course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital by which they are employed.  However, it is required that (1) the dispensing, administering, or prescribing is in the usual course of professional practice; (2) practitioners are authorized to do so by the state in which they practice; (3) the hospital has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state; (4) the practitioner acts only within the scope of employment in the hospital; and (5) the hospital authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized.

As you just read, the criteria for utilizing the hospital’s DEA registration number are very specific, so be sure the hospital and the physician follow and abide by each requirement set forth.  This includes, but is not limited to, that the practitioner is employed by the hospital and that the practitioner is authorized to prescribe, dispense, or administer controlled substances within that state.

April 4, 2019

QUESTION:        Do the Medicare Conditions of Participation place any requirements on the use of standing orders?

 

ANSWER:            Yes, they do.  The Centers for Medicare & Medicaid Services (“CMS”) have established multiple requirements for compliant use of standing orders in the hospital setting.  For example, each standing order must be reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership prior to use.  CMS emphasizes that this should be a “multi-disciplinary collaborative effort.”  Crucially, each standing order must have clearly identified specific criteria that govern when it will be executed.  CMS is very clear:  “Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.”

Note that there is some ambiguity in the term “standing order,” and CMS recognizes this.  Consequently, it is possible that some of your pre-printed and electronic order sets could fall outside the scope of this regulation.

As part of your compliance efforts, we recommend periodically reviewing your policies on standing orders, order sets, and protocols for patient orders to ensure compliance with the Conditions of Participation and with state law.  We also recommend periodic compliance audits of medical records to verify that your policies are being implemented appropriately.

March 28, 2019

QUESTION:        We are finally reviewing our conduct policy after a number of years, and in the policy we define unprofessional conduct with a few broad categories, such as abusive or threatening language, throwing an object, or inappropriate physical contact.  Is this what you recommend?

ANSWER:            First, it is fine to have broad categories, but we recommend that those categories include specific examples.  For instance, “abusive or threatening language” is fine, but it should be further reinforced with examples, such as “abusive or threatening language, e.g., belittling, berating, and/or non-constructive criticism that intimidates, undermines confidence, or implies stupidity or incompetence.”  It could also be language that is “degrading, demeaning, or condescending.”  This makes it clear that “abusive or threatening language” is more than just yelling/screaming, etc.

For example, unprofessional behavior also means:

  • refusal or failure to answer questions regarding patients, return phone calls, or respond when on call for the Emergency Department in a timely manner;
  • intentional misrepresentation to Hospital administration, Medical Staff leaders, or others in an attempt to avoid responsibility for an action taken;
  • retaliating against any individual who may have reported a quality and/or behavior concern regarding a practitioner;
  • repeatedly failing to renew legally-required credentials prior to expiration;
  • inappropriate medical record entries impugning the quality of care being provided by the Hospital, another practitioner, or any other individual;
  • inappropriate access, use, disclosure, or release of confidential patient information.

The point is to make the list as specific and exhaustive as possible (but even so, still include language stating “including but not limited to” before the list).  This will help Medical Staff leaders tremendously because those leaders can point to a specific category/example without having to resort to interpretation of the language and trying to convince others that this category does really include that behavior.

Finally, we recommend that these polices be called “professionalism” policies, not “conduct” policies to reinforce that all practitioners conduct themselves in a professional and cooperative manner.

For more on this topic, please sign up for the upcoming
Grand Rounds audio conference
“Professionalism Policy — Key Elements”
on April 2, 2019 from 
1:00 pm to 2:00 pm (Eastern time)
presented by: Lauren Massucci and Phil Zarone

March 21, 2019

QUESTION:        A physician came back from one of your leadership programs and was worried about whether our credentialing process complies with the Americans with Disabilities Act (“ADA”).  I’m confused about why we would need to comply with a law that only applies to employment.  Isn’t credentialing completely separate?

ANSWER:            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, medical staff bylaws requirements.

One way to address concerns about the credentialing process is to change the timing of requesting and/or 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 questionnaire 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 discuss accommodations.

March 14, 2019

QUESTION:        We are part of a five-hospital system.  Many of our physicians practice at multiple hospitals in our system.  We’ve had a couple of occasions lately where one hospital addressed a problem applicant or a problem physician, but the physician just moved to another hospital in our system.  We are separate hospitals and separate medical staffs.  We have an information sharing agreement and that helps, but we’re not sure it’s enough.  Can you help?

 

ANSWER:            You’re off to a good start with an information sharing agreement.  That should allow you to share confidential peer review information between and among your sister organizations.  There is also language you can add to your bylaws or credentials policy (bylaws documents) that can help.  For instance, we recommend threshold eligibility criteria that would render someone ineligible if he or she had staff appointment or privileges “denied, revoked, or terminated” for reasons related to clinical competence or professional conduct at any hospital or health care facility, or had resigned appointment during an investigation, or had an application for appointment not processed due to an omission or misrepresentation.  These threshold eligibility criteria apply not only at appointment and reappointment but during the term of appointment and your bylaws documents should make it clear that failure to satisfy these criteria during appointment will result in an automatic relinquishment.

It is also helpful to have language in your bylaws documents that makes it clear that certain actions, such as a performance improvement plan, automatic relinquishment, or professional review action, when taken at one hospital in the system will be automatically effective at all of the other hospitals in the system.  The bylaws language should allow for a waiver by the Board, upon the recommendation of the appropriate Medical Executive Committee, when it would not be necessary or appropriate for the action to be effective at any given hospital.  This language gives you some wiggle room and some discretion, but it also helps ensure that you are not caught up in redoing peer review efforts, including investigations and hearings, at multiple hospitals in the system.  Fortunately, there is helpful language in the National Practitioner Data Bank Guidebook which makes it clear that administrative actions taken by hospitals in a system based exclusively on the action taken at a sister hospital should not be reported to the NPDB.

March 7, 2019

QUESTION:        The Department of Health and Human Services requires us to take reasonable steps to provide meaningful access to Limited English Proficient (“LEP”) persons.  Can we rely on a patient’s family members or friends to help with this?

ANSWER:            No.  The only exception is if it is an emergency or if the patient specifically requests otherwise.  All entities that receive federal financial assistance from the Department of Health and Human Services (“HHS”) are generally prohibited from requiring patients with limited English proficiency to use family members or friends as interpreters.  HHS acknowledges in its regulatory guidance that there may be times when a patient feels more comfortable having a trusted friend or family member act as interpreter — under these circumstances, you can honor the request.  However, you should consider factors such as competency, confidentiality, privacy, and/or conflicts of interest.

Your legal obligations will vary depending on the size of your organization and the patients you typically encounter.  This area of the law is developing quickly and we expect to see more case law on this topic in the next few years.  In the meantime, we encourage you to review your policies on this matter and have your lawyers assess whether you are in compliance with all federal regulatory obligations.

February 28, 2019

QUESTION:        What’s all this I hear about some new kickback law called EKRA?

 

ANSWER:            The Eliminating Kickbacks in Recovery Act (“EKRA”) was enacted on October 24, 2018.  It was part of broader federal legislation to address the opioid crisis.  It generally prohibits knowingly soliciting, receiving, offering or paying remuneration to induce referrals to or in exchange for an individual using the services of a recovery home, clinical treatment facility, or laboratory.  Violations are punishable by up to 10 years in prison and a $200,000 fine.  It applies to any laboratory that fits the CLIA definition, including hospital and physician office labs.  There is an exception for payments made to employees, but it is narrower than the employment exception in the Anti-Kickback Statute since it does not apply to any volume or value-based payments.

For more information about EKRA and other laws that can affect hospital-physician contracts, come to our Physician-Hospital Contracts Clinic in New Orleans on April 11-13. Click here for more information!

February 21, 2019

QUESTION:        A physician on our medical staff has made numerous inappropriate entries into the EMR.  These include critiques of other physicians, the hospital, and its staff.  We have approached the physician several times to inform him that a patient’s medical record is not an appropriate forum for these comments, but he claims he has the First Amendment right to put whatever he wants to in the records, and continues to do so.  What can we do?

 

ANSWER:            The regulatory and accreditation requirements set forth by the Joint Commission and both federal and state law make it clear that they require the medical record to document objective clinical information relative to an individual patient’s medical condition that will enable a patient’s caregivers to provide the appropriate patient care.  Entering comments in a patient’s medical record that are critical of the hospital or of other individuals are inappropriate editorial statements, which do not advance the care of a patient.  In addition, they clearly create and increase legal risks to the hospital and to all individuals involved in the care of the patient.

A physician who has a complaint or concern regarding an administrative policy, the hospital’s utilization practices, or the care provided by any other individual should be advised that the medical record is not the proper forum for that issue and should be directed to register those concerns through appropriate medical staff or administrative channels.  Most times, providing this education and counseling to the physician is sufficient to resolve the concerns.  If not, however, the physician should be advised that continuing disregard of the policy concerning the proper content of medical records will be referred for review under the Medical Staff Professionalism Policy.

February 14, 2019

QUESTION:        In one of the cases in this week’s Health Law Express, the hospital was required to give physicians a hearing for failing to provide data — is that generally an event that would give rise to a hearing?

ANSWER:            Good catch!  The court in Blaine v. North Brevard County Hospital District did indeed require the hospital to give the plaintiff physicians a hearing.  According to the court, under the medical staff bylaws, the hospital was required to give the physicians a hearing before their request for reappointment and renewal of clinical privileges could be denied for failing to provide “patient data.”  The “patient data” appeared to be related to the hospital’s cancer program and necessary for accreditation purposes.

The court did not cite the bylaws provision that led to its determination that the physicians were entitled to a hearing or specify whether the “patient data” was related to the physicians’ qualifications.  Nonetheless, your Bylaws (or Credentials Policy) should contain language stating that an individual does not have a right to a hearing when that individual fails to provide information pertaining to his or her qualifications for appointment or clinical privileges.

Assuming the “patient data” requested by the hospital in the Blaine case was related to the physicians’ qualifications for appointment or clinical privileges, a Bylaws provision instructing that failure to provide this information results in “automatic relinquishment” of appointment and clinical privileges until the information is provided is critical.  There are often times that the hospital and medical staff need information which the individual controls to allow them to make an informed decision on the individual’s qualifications.  For example, the hospital may need to evaluate a physician’s ability to return to practice from a leave of absence for substance dependence rehabilitation.  If the physician refuses to sign a release allowing the hospital to communicate with the rehab entity about the physician’s prognosis and any limitations on the physician’s practice, this would hamstring the hospital’s ability to confirm whether the physician is able to safely return to practice.

The Bylaws should also clearly set out the actions which are grounds for a hearing and the actions not grounds for a hearing, with automatic relinquishment of appointment and privileges falling into the latter category.  If an individual fails to provide information that is relevant to his or her qualifications pursuant to a request by an authorized medical staff leader or committee, the only issue is whether the individual did or did not provide the information.  A hearing is not necessary to make such an administrative determination.

For more information on these difficult types of credentialing issues and good Bylaws language, join Susan Lapenta and Charlie Chulack on March 7?9 in Orlando, Florida for Credentialing for Excellence.