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.

February 7, 2019

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QUESTION:        When a health care provider obtains a self-query from the National Practitioner Data Bank (“NPDB”), does the self-query indicate how many times a hospital itself has queried that provider?

 

ANSWER:            The short answer is that, in limited circumstances, this information will be included in the self-query for the health care provider.  The NPDB discloses all reports about a health care practitioner to hospitals that submit queries about that practitioner and, as a result, those disclosures are indicated on the self-query.  That information is available to the practitioner and contained in the self-query as part of the disclosure history.  However, if there are no reports to be disclosed about a health care practitioner, the NPDB does not inform the individual of the hospital queries, as no disclosures were made.

Federal law provides that the NPDB collect information and maintain reports on medical malpractice payments, federal and state licensure and certification actions, adverse clinical privileges actions, adverse professional society membership actions, negative actions or findings by private accreditation organizations and peer review organizations, health care-related criminal convictions and civil judgments, exclusions from participation in a federal or state health care program (including Medicare and Medicaid exclusions), and other adjudicated actions or decisions.

The reports maintained by the NPDB are disclosed upon query to hospitals, which are mandated by federal law to submit such queries at the time the health care practitioner applies for a position on its medical staff or clinical privileges at the hospital and every two years for any health care practitioner on its medical staff or with clinical privileges at the hospital.  According to the NPDB, when the hospital submits a query, the NPDB releases only the information it is lawfully allowed to access.  A hospital can query through the NPDB using a one-time query, which allows for a one-time query response for a practitioner, or a continuous query, which allows the hospital to receive a query response and all new or updated report notifications during the year-long enrollment for each practitioner.

Also available through the NPDB is a self-query, which can be submitted by a health care practitioner about his or her own information kept by the NPDB.  The self-query searches to determine if the health care practitioner’s own information provided matches information in reports previously submitted to the NPDB.  The response may show that no matching information was found in the NPDB, or it may show that information about medical malpractice payments, adverse licensure or privileges actions, or judgments and convictions was found, in which case the full report(s) will be provided to that health care practitioner as part of the self-query.

In the instance a health care provider submits a self-query and no matching information or reports are found, the health care provider will not see how many times any hospital has queried that provider.  However, when there are reports returned on a health care provider, the self-query will not necessarily show how many times that provider was queried, but will indicate how and who the reports were disclosed to when that provider was queried.

January 31, 2019

QUESTION:        When a concern is raised about the behavior of a Medical Staff member, we’ve typically referred it to our department chairs. The chairs give it their best shot, but we were wondering if there’s a better way?

ANSWER:            Yes! There are many drawbacks to asking a single individual — regardless of who that person is — to deal with difficult behavioral matters.

First, the department chair is often either a competitor or partner of the physician under review. This can make it difficult for the department chair regardless of whether an actual “conflict of interest” exists.

Also, depending on the size of a department, the department chair may not deal with many behavioral concerns. As a result, the chair never obtains enough experience to become truly comfortable addressing behavioral issues.

Individual department chairs have no built-in opportunity to brainstorm about the issues under review. If they want to seek assistance, they have to find another physician leader and bring that person up to speed.

Thus, we recommend that a core group of physician leaders — referred to as a Leadership Council — handle behavioral concerns. The Leadership Council might be comprised of the Chief of Staff, Chair of the Professional Practice Evaluation/Peer Review Committee, and Chief Medical Officer. The advantages of using a Leadership Council to handle behavioral concerns include:

  • consistency across departments (no more variability based on the personality of individual department chairs);
  • easier to avoid conflicts of interest;
  • permits department chairs to preserve their working relationships with physicians under review;
  • expertise through experience;
  • emphasizes the importance of the issue and enhances the credibility of the physician leadership because a group of leaders – not a single person – is speaking with the physician under review; and
  • problems are discussed by a small group, which promotes the exchange and development of ideas.

For more information on Leadership Councils and other important topics, please join us at Disney’s Yacht and Beach Club Resort in Orlando, FL on March 7-9, 2019 for The Peer Review Clinic.

January 24, 2019

QUESTION:        Is there anything new on physician retention arrangements?

 

ANSWER:            Unfortunately, no.  However, we have asked both the OIG and CMS to consider updating their respective positions on physician retention arrangements in response to the OIG’s and CMS’s requests for information on whether the Antikickback Statute and/or the Stark Law are creating barriers to improving quality care and achieving clinical and/or financial integration.

We urged CMS to consider changes to its exception for physician retention arrangements, 42 C.F.R. § 411.357(t), that will permit any hospital, regardless of its location, to use this exception and not limit this exception to instances where there is a firm, written recruitment offer.

There is no rational basis or business justification to continue to limit this exception to hospitals that are located in a rural area or HPSA (42 C.F.R. § 411.357(t)(3)(i)(A)) or where the physician’s patients reside in a medically underserved area or are members of a medically underserved population (42 C.F.R. § 411.357(t)(3)(i)(B)).

In our experience, hospitals, regardless of their location, would benefit from the ability to assist a physician in an existing independent practice to remain independent.  We are aware of clients that have been approached by a group of physicians who want to remain independent.  However, between the charity care they provide, their Medicaid patient population, and the amounts that were being paid to the physicians by Medicaid, Medicare and other third-party payors for their professional services, the group could not generate a sufficient amount of professional reimbursement to allow the group to compensate the physicians at a reasonable fair market rate and precluded the group from expanding the practice even though there was a need for additional physician services.

The hospital could have employed the physicians.  However, the physicians preferred to remain independent and the hospital determined that it would lose more money if the hospital employed the physicians than it would if the hospital provided a guarantee-like payment that would allow the physicians to remain independent.  While such a compensation arrangement might be able to be structured to comply with the Anti-Kickback Statute, there is no safe harbor that will protect such a retention arrangement.  Of greater concern is that currently there is no exception to the Stark Law that would permit this type of retention assistance in most hospitals.

One of the other problems with the Stark retention exception is that a hospital must wait until a physician has a written offer from a third party before it can offer retention assistance.  42 C.F.R. §411.357(t)(2).  By the time a physician has such a firm, written offer, he/she has often decided to leave the area and the permitted retention benefit is of little practical benefit.  We urged CMS to change the exception so that any hospital will be permitted to be proactive and has the ability to offer retention assistance to independent practicing physicians as long as the hospital has a good faith belief that the community served by the hospital would benefit from retention assistance, the amount of the financial assistance is reasonable, and the compensation arrangement complies with the other requirements set forth in this exception.

Whether CMS or the OIG listens to these concerns remains to be seen.

January 17, 2019

QUESTION:       We recently learned that the medical board investigated one of our medical staff members after a patient called the hospital to request a copy of her medical records and, while doing so, informed our patient experience liaison that she had filed a complaint with the state board.  A little fact-gathering revealed that the board’s investigation was closed.  The practitioner showed us a letter from the board thanking him for his cooperation and informing him that the board was unable to substantiate the complaint.  What comes next for the hospital?  Do we just make a copy of the letter and put it in the practitioner’s file?  Since he was exonerated, do we even need to do that?

 

ANSWER:           It’s disappointing to learn AFTER THE FACT that one of your doctors has been under investigation by the state board, CMS, or any other government agency.  Many hospital and medical staff leaders may be hesitant to make “a big deal” about a failure to notify in a situation where, as here, the member provides evidence showing that the investigation went nowhere.

But, as usual, how you respond to information about the state board’s investigation of a medical staff member should depend on what your Medical Staff Bylaws and related documents say.  Do they require members to notify you if they are under investigation?  When?  Within a certain time frame?  Is failure to notify excused when the underlying matter has been closed with no “adverse” action by the regulatory body?  Obviously, it does not serve the interest of patient safety to require notification of investigations only after the outcome is known to the member, since such a policy would prevent the hospital and medical staff leadership from taking precautionary steps to protect patients, the hospital, and other practitioners during the pendency of the investigation (if such precautions were determined to be necessary).

At this point, it makes sense to at least obtain a copy of the letter the physician produced to evidence the fact that the investigation was closed.  Note that the closure of an investigation by the board due to lack of substantiating evidence is not equivalent to exoneration.  Therefore, hospital and medical staff leaders should at least consider whether any additional information should be requested from the physician (e.g., correspondence between the physician and/or his attorney and the state board regarding this matter) or directly from the state board.

Provided that the Medical Staff Bylaws or Credentials Policy required the physician to notify you of the investigation earlier, it also makes sense to refer this instance of non-compliance into the professional practice evaluation process for further review under the medical staff’s professional practice evaluation policy (or Credentials Policy or other document outlining peer review procedures).  If the practitioner has a long history of failing to comply with the Bylaws and other requirements of hospital and medical staff policies, then a significant response to this event might be appropriate (e.g., a written reprimand or “last chance” performance improvement plan).  If the practitioner is generally compliant and his or her actions indicate that this was mere oversight or a one-time poor decision (e.g., perhaps a conscious decision not to provide notification, but based on the practitioner’s rational embarrassment about being investigated or based on incorrect legal advice telling him he was not required to report), the response may be less substantial (e.g., a collegial conversation).

In cases such as this, a lot depends on the facts.  But, what we know for sure is that ignoring an incident like this is never the right approach.  Consistent application of and reminder of policies – even when done collegially and without a punitive tone – helps to establish the expectations of the hospital and medical staff.

Finally, one could argue that too much of the lip service that is given to the topic of notification revolves around what’s required and what’s not.  Consider including in your policies and/or guidance documents language making it clear that the hospital and medical staff expect all ambiguities to be resolved in the favor of patient safety.  After all, patient safety is the first priority:

Applicants and practitioners are expected at all times to be forthcoming and truthful with respect to their initial and ongoing qualifications for Medical Staff membership and clinical privileges and any concerns that have been raised regarding the same.  The hospital and medical staff agree that complete information is of the utmost importance to the credentialing and professional practice evaluation processes and, in turn, to patient safety.  To that end, when in doubt about whether disclosure is required, applicants and practitioners are expected to err on the side of making a full disclosure to the Hospital and/or Medical Staff leadership, as set forth in the Medical Staff Bylaws and related hospital and medical staff policies.

January 10, 2019

QUESTION:        A brand new member of our Credentials Committee, who is opposed to a request from a physician in a different specialty to apply for a privilege to perform a procedure that member performs himself, has been lobbying other committee members to deny the request and has asked that the request first be referred to his department for a vote.  A written application has not been submitted. The potential applicant did not have residency training in this procedure but, rather, took a short course conducted by an equipment vendor.  The physician requesting the privilege has threatened a lawsuit on antitrust grounds, because he has learned about the lobbying.  How can we manage this situation?

ANSWER:            If your Bylaws or Credentials Policy does not have a section on how to manage requests for privileges that cross specialty lines, consider deferring consideration until such language is adopted and implemented.  It is a best practice to have the Credentials Committee develop eligibility criteria before processing requests (both for new privileges and for practitioners seeking privileges in different specialties).  If current criteria refer to residency training in one specialty, the committee can review possible alternate pathways.  Any physician, including the potential applicant, can submit proposed criteria for education, training and experience.  The committee should also consider how FPPE would work, indications for the procedure, and how call coverage and complications would be handled. How much training is sufficient to demonstrate competence?   A survey of other hospitals would be a helpful step to demonstrate objectivity. Also, a Credentials Committee member who is in an affected specialty has a conflict of interest and should be recused from the process (but he can submit proposed criteria).  It is best if recusal is discussed with the affected member in advance of the meeting. The minutes should reflect that he left the room before final deliberation and vote on the criteria. A conflict of interest should not be viewed as a judgment on the individual’s character but, rather, as a step to protect the integrity of the process.  And, departments should not vote on criteria or specific requests; that is too easily challenged as a conspiracy in restraint of trade. The applicant’s request should not be processed until either new eligibility criteria are adopted by the Credentials Committee, MEC (and Board), or the current criteria are confirmed. A determination of ineligibility is not a “denial.”  (If the Credentials Committee and MEC recommend, and the Board determines to adopt, eligibility criteria with an alternate pathway that would enable this request to be processed, the interested committee member should also recuse himself from the consideration of the application.)

For more information, be sure to join Ian Donaldson and Barbara Blackmond for The Complete Course for Medical Staff Leaders!  You may want to send the new Credentials Committee member to the Complete Course if he has little leadership experience or to our Credentialing for Excellence program if he is otherwise experienced but lacking depth in credentialing!