March 8, 2018

QUESTION:        We received a subpoena from an attorney requesting the medical records of a patient.  The attorney represents the plaintiff in the case, and the patient is the defendant.  We are not a party to the litigation and want to comply with the subpoena, but we don’t want to violate the Health Insurance Portability and Accountability Act (“HIPAA”) either.  Help!

ANSWER:            The regulations implementing HIPAA (the “HIPAA Privacy Rule”) require that certain conditions be satisfied before a covered entity, in this case a hospital, may disclose medical records in response to a subpoena.  Basically, these regulations require that a hospital receive “satisfactory assurances” that the patient has been notified of the subpoena and that any objections to the subpoena by the patient have been resolved.  Until the hospital receives these “satisfactory assurances,” it is prohibited by federal law from disclosing the medical records.

State law may also help here.  For example, the Pennsylvania Rules of Civil Procedure require a party in a lawsuit to serve a copy of a proposed subpoena on all other parties prior to issuing that subpoena to a third party (the hospital).  Also, the Rules state that a party that intends to serve a subpoena on a third party (the hospital) must file a certificate showing that it has notified other parties in the lawsuit of the subpoena.

So, as required by the HIPAA Privacy Rule, a hospital, or its attorney, should request that the individual who requested the medical records provide the hospital with documentation that indicates that the patient has received notice of the subpoena, has had an opportunity to object to it, and either no objections were filed or all objections have been resolved.  Once the hospital receives that documentation, it will be able to comply with the subpoena.

March 1, 2018

QUESTION:        We have a family physician who recently applied for colonoscopy clinical privileges at our hospital but is ineligible because he does not meet the threshold eligibility criteria for those privileges.  Our criteria require, among other things, all applicants to demonstrate competence through the performance of 140 colonoscopies in the last two years or during their training.  The physician is requesting that we change this criterion, claiming that it is too high and inconsistent with the American Academy of Family Physicians (“AAFP”) guidance on determining competency for colonoscopies.  What should we do?

ANSWER:            First, check your Medical Staff policies to determine how an applicant for clinical privileges who does not satisfy threshold eligibility criteria should be handled.  Medical Staff policies (typically, your Credentials Policy) should explicitly state that “applicants who fail to meet the threshold eligibility criteria will be notified that their applications will not be processed” and that “a determination of ineligibility does not entitle the individual to a hearing and appeal.” This applies to both applications for Medical Staff appointment and clinical privileges.  Thus, the family physician would be ineligible for a grant of clinical privileges to perform colonoscopies based on the hospital’s current threshold eligibility criteria.

However, in this case, there is a wrinkle since the physician is asking for a change in the criterion.  While you are under no obligation to change the criteria, especially if it is based on a thorough review of the literature, the needs of the community where the hospital is located, and is used in conjunction with other patient-safety-oriented criteria, it may be worth looking into the physician’s claims.  In this case, the physician is correct.  In a colonoscopy position paper, the AAFP states as follows:  “[b]ased upon recent studies, the AAFP has determined that the standard of fifty (50) cases as the primary operator be used as a basis for determination of basic competency in [colonoscopy].”  But, as the AAFP paper observes, the American Society for Gastrointestinal Endoscopy (“ASGE”) recommends that a physician perform 140 colonoscopies as a minimum number before competency can be assessed.  Obviously, this higher number favors specialists who perform colonoscopies as a primary part of their practice.  That doesn’t necessarily mean that the number isn’t legitimate.

The recommendations from the various specialty societies when it comes to the number of procedures needed to assess competency aren’t hard and fast rules.  As the ASGE notes:  “[p]erformance of an arbitrary number of procedures does not guarantee competency.  Whenever possible, competence should be determined by objective criteria and direct observation.  The number of supervised procedures necessary to obtain competency will vary tremendously among trainees.”  Of course, this statement from the ASGE implies that some trainees may need to perform more than 140 colonoscopies to guarantee competency (but the opposite may be true as well).  Whatever number your hospital decides on in setting criteria for clinical privileges should be supported by thorough research and sound reasoning.  At a minimum, you should explore what the relevant specialty societies are recommending, acceptable complication rates (and how to incorporate this into the criteria for the clinical privileges), and the type of training needed to support the request.  Other areas of consideration include what hospitals in similar situations require and the needs of the community.  Most importantly, if there is any doubt, criteria should set thresholds which err on the side of caution to protect patients and to ensure that only competent physicians are performing procedures on patients.

February 22, 2018

QUESTION:        Our hospital is looking for creative ways to reduce the on-call burden for our physicians.  We’d like to find more efficient ways to schedule and structure their time, but we don’t want to sacrifice quality.  We’ve heard that some organizations are moving toward community call.  Does CMS permit this?

ANSWER:             Yes, CMS does permit organizations to adopt so-called “community call” arrangements.  Community call plans can potentially reduce the on-call burden on physicians, can allow hospitals to provide specialty care in a more efficient and reasonable manner, can eliminate the need for duplicative coverage at nearby hospitals, and can increase access to limited resources throughout the region.

CMS permits hospitals to enter into community call plans so long as those plans meet certain defined criteria.  Among other things, the call plan must have a clear delineation of on-call coverage responsibilities (explaining when each participating hospital is responsible for on-call coverage).  It must include a description of the specific geographic area that the plan covers.  Local and regional EMS protocols should include information on the community call arrangements.  In addition, the plan must be annually assessed by each of the participating hospitals.

So long as these criteria (and a handful of others) are met, CMS will generally permit hospitals to engage in the community call arrangement.  CMS has not provided much detail beyond this on what an ideal model should look like — instead, the agency has given hospitals some room to be creative.

The difficulty comes in designing an effective community call plan that is agreeable to all of the participants.   There are a lot of details to consider and resolve.  For example, hospitals may have to reconcile different approaches on paying for call.  In addition, hospitals must be prepared to invest time, effort, money, and personnel in administrating and implementing the call plan.  In some states, the department of health may need to review and approve the call plan.  There are many other topics that should be considered and addressed as well.

February 15, 2018

QUESTION:        Our hospital is employing a lot more physicians than in the past.  When we receive a complaint about the behavior of one of these employed Medical Staff members, we’re not sure if we should review it through the Medical Staff process or through the employment process (i.e., HR policies or the employment agreement).  Or should we use both?

ANSWER:            We recommend that the Medical Staff Professionalism Policy (or Code of Conduct Policy) have a “triage” process.  If a behavioral concern is raised about a Hospital-employed physician, a Medical Staff leader (such as the Chief of Staff) will discuss the concern with a representative of the employer.  The Medical Staff leader and the employer representative then decide which process will be used to review the complaint.

If a decision is made to use the employment process, the Medical Staff process would be held in abeyance.  Critically, though, the employer would keep Medical Staff leaders continually informed of the status and outcome of the review.  If the Medical Staff leaders are unhappy with how the review is being conducted, they can commence their own review under the Professionalism Policy at any time.  On the other hand, if the Medical Staff leaders are satisfied with what the employer is doing, the Medical Staff leaders would essentially adopt that action as their own.  Thus, the Medical Staff is not “punting” or abdicating its responsibilities.  It’s evaluating the actions of the employer, then deciding to either adopt that action as its own or conduct a separate review.

There are several goals to this process.  The first is to avoid a duplication of effort by both the physician under review and those conducting the review.  The second is to use the most effective process to address the concern.  In some cases, the employer will have better tools for dealing with the issue, while in other cases the Medical Staff process will be more effective.  Finally, a triage process can help to avoid inconsistent results that send mixed messages to physicians and create legal risk.

For a more detailed discussion of peer review of hospital-employed physicians, join us in sunny Austin, Texas for The Peer Review Clinic on March 1-3, 2018.

February 8, 2018

QUESTION:        We heard that part of the tax reform law passed in December has a provision imposing an excise tax on tax-exempt organizations that have employees making more than $1,000,000 a year. A couple of our employed physicians fall in that category. Will they be subject to the tax?

ANSWER:            The 2017 tax reform law created new section 4960 of the Internal Revenue Code which will impose a 21% excise tax on compensation in excess of $1,000,000 paid by exempt organizations to their five highest compensated employees.  The tax is payable by the employer, not the employee.  It goes into effect in tax years beginning after December 31, 2017, so if you are on a calendar tax year, it applies to any compensation paid in 2018.  A last minute amendment to the bill exempted compensation paid to physicians, but it only applies to compensation for medical, not administrative, services.  Therefore, if your doctors earn all or most of their money from providing clinical services, the tax would not apply to their compensation.  However, even though compensation for medical services is not covered, it would be wise to review all existing physician compensation arrangements to make sure that medical and administrative compensation is separately accounted for, to avoid arguments later on as to whether the medical services exception applies.

To learn all about the new excise tax on excess compensation paid by exempt organizations, order the CD or MP3 file from the audio conference presented by Henry Casale and Dan Mulholland last month.  Click here to learn more.

 

February 1, 2018

QUESTION:        I saw in last week’s HLE’s Government at Work that the Department of Justice (“DOJ”) has recently issued a memorandum that discusses the dismissal of a qui tam case.  Can the government really do that?  Can you provide more information?

 

ANSWER:            Yes, the DOJ has the authority to dismiss a qui tam over the objection of the qui tam relator.  On January 10, 2018, the Director of the DOJ’s Commercial Litigation Branch, Fraud Section, issued a Memorandum to the attorneys in that branch of the DOJ entitled “Factors for Evaluating Dismissal Pursuant to 31 U.S.C. 3730(c)(2)(A)” that discusses when it is appropriate for DOJ attorneys to exercise this authority.

In this Memo, the DOJ recognized that while the number of qui tam cases that have been filed over the past several years has exceeded 600 new cases per year, the number of cases in which the DOJ has intervened has remained relatively the same.  The Memo notes that even in cases in which the DOJ declines to intervene, the DOJ expends considerable resources monitoring the case and in some instances must produce discovery or otherwise participate.  The DOJ is also concerned that qui tam cases that lack merit can generate adverse precedent which could hamstring the DOJ’s ability to enforce the False Claims Act.

Therefore, DOJ attorneys have been advised not only to determine whether to intervene in a qui tam case, but to go a step further and, if certain factors are present, to seek the dismissal of the qui tam claim under 31 U.S.C. §3730(c)(2)(A).

The Memo notes that, historically, the DOJ has seldom invoked this authority.  It also advised DOJ attorneys to be judicious in exercising this authority.  However, the Memo then outlines the factors that the DOJ should consider when deciding whether to dismiss a qui tam claim.  Those factors include qui tam claims that:  are meritless; duplicate pre-existing government investigations; threaten to interfere with agency policy or the administration of its programs; threaten the DOJ’s litigation prerogatives; involve intelligence agencies or military procurement; cause the government’s costs to exceed the expected recovery; or frustrate the government’s efforts to conduct a proper investigation.

The Memo states that the DOJ should consult closely with the affected agency as to whether dismissal is appropriate, advise the relator of the prospect of dismissal, and give the relator the opportunity to voluntarily dismiss the action.  However, if the qui tam relator does not voluntarily dismiss the action, then if any of the factors described in the Memo exist, the DOJ is to exercise its authority to dismiss the qui tam claim, which should be filed at or near the time that the DOJ declines to intervene in the qui tam case.

Click here if you want to see the entire Memo or, if you prefer, please join HortySpringer partners Henry Casale and Dan Mulholland who will be discussing this Memo and other late-breaking fraud and abuse and compliance developments at our Physician-Hospital Contracts Clinic in Austin on March 1-3, 2018.  Click here to learn more about it and register.

January 25, 2018

QUESTION:        Our Medical Staff Bylaws require current board certification in the area in which an individual wants to practice.  Does that mean that recertification and/or maintenance of certification is required?

ANSWER:            Board certification (and particularly recertification and maintenance of certification) have become very contentious issues in recent years.  Not a week goes by that we don’t hear about some controversy surrounding board certification (e.g., state laws prohibiting it as a factor to be considered for health plan participation, issues with applicants who want alternative boards to be accepted by the hospital and its medical staff).  Some argue that certification is an industry-acknowledged stamp of approval with respect to basic competence.  Others argue that recertification and maintenance of certification have become overly bureaucratic, money-making machines and no longer serve as an indicator of quality.  We cannot say who is right.  But, due to the level of contention surrounding this issue, we will repeat our oft-given advice:  be clear in the Bylaws, Credentials Policy, privileging forms and delineation documents, and other relevant policies.  Clarity puts everyone on the same page, lets practitioners know what to expect, and prevents disputes.

In your case, the word “current” has been added to the Bylaws language to clarify the requirements for board certification.  From a plain-language standpoint, the Bylaws cannot be read to require only past certification which has now lapsed – since that would make the word “current” superfluous. It is pretty clear that your Bylaws do, in fact, require that an individual’s board certification be kept up to date.  As you know, different boards require different things of different people in order for them to stay “current.”  Some lucky folks from days gone by were granted lifetime board certification and they will satisfy any requirements for “current” board certification for their entire careers.  Other individuals have time-limited certification and must either recertify, comply with maintenance of certification requirements, or both in order to remain “current.”  To ensure that there are no misunderstandings, if a hospital and its medical staff decide that recertification and maintenance of certification will be required, we recommend that the Bylaws language not only use terminology referring to “current” certification but also specifically note that recertification and maintenance of certification are required, if required by the applicable boards.

Further, because issues surrounding board certification continue to be contentious, we recommend that you consult with counsel when revising the Bylaws or privileging forms to address such issues and that you take care to address not just recertification and maintenance of certification, but also:

  • which boards are acceptable for meeting the requirements;
  • whether subspecialty certification is required;
  • whether it is required to be certified in only one specialty or subspecialty, in those cases where the practitioner seeks privileges in more than one specialty at the hospital; and
  • what happens if a practitioner fails to satisfy the relevant board certification, recertification, or maintenance of certification requirements (e.g., automatic relinquishment of privileges upon notice? ineligibility for reappointment?)

 

January 18, 2018


QUESTION:       
Our Active Staff category requires members to take emergency call.  In many specialties, we struggle with finding physicians willing to take their fair share of call.  In orthopedics, however, we have a group based primarily at another hospital outside our system who own their own diagnostic facilities, to which they end up referring many patients from our ED for services we can provide.  A few patients have expressed concerns about why they were sent to another facility.  A few patients have reported that the orthopedic surgeon said the other facility was much better and newer, with no wait time.  What can we do?


ANSWER:           
The purpose of the emergency call obligations connected to Active Staff appointment and privileges is to enable the hospital to comply with EMTALA and provide care to patients who come to the hospital’s ED, not to provide a source of referrals of patients to facilities owned by on-call specialists.  If a patient needs an X-ray, in order to evaluate and stabilize an emergency medical condition, the patient should not be sent elsewhere (unless the patient specifically so requests) because that could implicate EMTALA.  Follow-up care not needed to treat or stabilize the condition that brought the patient to the ED could be provided elsewhere, and patients can choose where to receive follow-up care.  However, on-call specialists should not be marketing their facilities by in essence disparaging the hospital’s services.  (Of course, if patients are choosing to receive tests and other services elsewhere, upgrading facilities and adding staff to minimize wait times is a good idea, if feasible.)  Some hospitals limit call in some specialties to physicians who are under contract (or employed).  The Board can determine how call will be handled in different specialties.  Call is a responsibility, not a right or a “privilege.”  (It should not be included on delineation forms as a privilege.)  So long as departments don’t vote (which could give rise to conspiracy allegations), the Board and MEC would be free to establish how the hospital will satisfy its EMTALA obligations.

January 11, 2018

QUESTION:        Our Medical Staff Services Department is reviewing an application for a physician who has been recruited by the Medical Center as an employee. The physician does not meet all of the eligibility criteria in the Medical Staff Credentials Policy, but we understand the contract has already been signed.  What should we do?

ANSWER:            Unfortunately, this is an all-too-common problem. “Credentialing 101” says that an application from a candidate who does not satisfy the Medical Staff’s threshold eligibility criteria should never be processed – even in an employment situation.  So, hopefully, the contract contains a provision that states the contract is conditional upon the physician being appointed to the Medical Staff and obtaining clinical privileges in the relevant specialty.

To avoid this situation in the future, organizations should strive for coordination between their Medical Staff Services Department and their recruiters.  This means educating recruiters about the minimum qualifications set forth in the Medical Staff Credentials Policy, as well as giving your recruiters a list of “red flags” that will slow an application up during the credentialing process (e.g., gaps in experience, negative references, etc.)

To make sure your Medical Staff leaders have the knowledge and tools that they need to manage difficult issues like this, please join Barbara Blackmond and Ian Donaldson at The Complete Course for Medical Staff Leaders.

January 4, 2018

QUESTION:        In the past, our reappointment process has been rather perfunctory.  The names of physicians and other practitioners who are up for reappointment get put on a list which is approved by the Credentials Committee, passed on to the Medical Executive Committee, and then forwarded to the Board in a consent agenda.  What steps can we take to make our reappointment process more meaningful?

ANSWER:            This is a great question.  Many hospitals are like yours and muddle through the reappointment process without getting a lot of bang for their effort.

The reappointment process, which includes the renewal of appointment and clinical privileges, is an important opportunity to review and confirm that a practitioner satisfies all of the core competencies.  To make the reappointment process more meaningful, you must have data.  The ongoing professional practice evaluation reports that you generate for all practitioners will provide a good starting point since they evaluate competence in a variety of areas throughout the appointment term.

You should also review and consider any licensure or disciplinary action, as well as any malpractice claims, settlements, or judgments that occurred during the previous reappointment term.  Of course, you should be receiving notice of and reviewing all of these events as they occur, but the reappointment is a good time to verify that the review has taken place.

It is also important that you review the clinical privileges that a practitioner is requesting at reappointment.  If a practitioner has not satisfied volume requirements for a privilege or has not exercised a privilege that is volume?sensitive, the practitioner may be ineligible to seek the privilege or may be required to provide additional evidence of current clinical competence before having the privilege renewed.

And it is important to consider your other quality data at reappointment.  Make sure the Credentials Committee, Medical Executive Committee and Board are aware of any peer review actions, including informational and educational letters, collegial interventions and performance improvement plans.  While these activities may not affect the final reappointment decision, they may warrant that the practitioner receive a different letter at reappointment which reflects clinical or behavioral matters that are being reviewed and addressed through the peer review process.