July 21, 2016

QUESTION:        We have an applicant for appointment and clinical privileges who seems to have an unusual number of malpractice cases in his history.  Do we need to do anything with this information if everything else about the applicant checks out?

ANSWER:            Every application for appointment and reappointment asks applicants about their malpractice history.  But many hospitals don’t know what to do with the information they receive. The Joint Commission requires hospitals to consider “any evidence of an unusual pattern or an excessive number of professional liability actions resulting in a final judgment against the applicant” in granting privileges. But what is “an unusual pattern or an excessive number”?

A physician’s malpractice history cannot be ignored.  Unfortunately, there is no hard and fast rule on what constitutes reasonable due diligence when it comes to reviewing these types of disclosures.  The key is to know what to look for:

  • Not all malpractice claims are created equal, so information should be obtained to understand the nature of the claims.
  • The number of claims may not tell the whole story, but patterns or trends do.
  • Don’t compare apples to oranges – know which states and which specialties are more “at risk” for malpractice claims.
  • There is a big difference between malpractice claims and malpractice verdicts.

To learn more about how to consider an applicant’s malpractice claims history, as well as other hot topics in the world of credentialing, please join LeeAnne Mitchell and Ian Donaldson this fall at The Credentialing Clinic in Las Vegas, Nevada.

July 14, 2016

QUESTION:        We have several ambulatory surgery centers (“ASCs”) in our System.  We recently looked at the bylaws of the ASCs and they are quite antiquated.  Even more of a concern, we learned that the credentialing process in the bylaws is not being followed at the ASCs.  We need to work with the ASCs to change their bylaws, but where do we start?  The medical staff bylaws (and credentials policy) for the hospitals in our System are now all very similar.  Can we incorporate the ASCs into the medical staff bylaws?

ANSWER:           You asked if the ASCs could be incorporated into the medical staff bylaws of the hospitals in your System.  This approach has the appeal of simplicity.  However, given the vast differences in the size, structure, and organization of the medical staffs at the ASCs and the medical staffs at the hospitals, this option seems awkward at best.  There might also be some regulatory issues with this approach.  Specifically, the ASCs are required to have their own medical staffs in some states.  Thus, in order for the medical staffs of the ASCs to function as a part of the medical staffs of the System hospitals, it could be necessary to seek an exception from the Department of Health.

Another option would be to take the medical staff documents that were prepared for the System hospitals’ medical staffs and use them as a starting point for the creation of governance documents for the ASCs.  We recommend this approach for several reasons.  First, this approach would provide an opportunity to update the ASC bylaws to reflect current practices.  Second, this approach would help ensure that the ASC bylaws are well-drafted and in compliance with controlling law.  Third, while the hospital medical staff documents would have to be substantially pared down and streamlined for use by the ASCs, these documents would include key provisions, such as a System Credentials Committee, a Professional Affairs Committee to resolve disputes among the Medical Executive Committees, and language to ensure that decisions at one System facility are applicable at all System facilities, which would facilitate uniformity within the System.

July 7, 2016

QUESTION:        Our state passed a medical marijuana bill, and it’s now ready to be fully implemented.  Should our hospital allow inpatients to use their own therapeutic cannabis?

ANSWER:            As of now, 25 states and Washington, D.C. have legalized marijuana for medical use.  And it would not be surprising if more come on-line.

The first place to start is whether the state law in any way requires a hospital to allow for an inpatient’s individual usage.  That’s highly unlikely, which is why this becomes an area for the development of a hospital policy.

Guidance certainly comes from a likely already existing policy concerning the use by patients of their own medications brought while an inpatient.  Even with that, though, we’ve been asked whether therapeutic marijuana should be treated in a different way than “regular” medications.

In the long run, the answer is no.  Certainly, the medicine brings its own notoriety, cultural and political issues, but the answer is that it is best to review medical marijuana along already established and regular ways.

But because of that notoriety, medical marijuana raises other issues that may or may not be addressed in a traditional “patient’s own prescription usage” policy.  Or if they are, those issues may need to be reviewed again in the context of whether there should be any other answers where therapeutic cannabis is involved.  If the hospital chooses not to allow medical cannabis use in the hospital, how should the patient’s cannabis be handled?  Could the patient keep it in her room?  Should it be locked in the hospital’s patient possessions safe?  Must a family member or friend come as soon as possible to get it out of the hospital and off the hospital’s campus?

From our experience, hospitals have largely taken a “no own inpatient use” approach.  And it is best to make this clear in a hospital policy or rule, because it’s likely if you’re in one of those 25 states, a patient will ask.

June 30, 2016

QUESTION:        We have a group of surgeons on our staff who are interested in employing a physician assistant.  Wasn’t there a new Stark regulation that will allow our hospital to provide recruitment assistance to the group to assist it with the costs of employing this PA?

ANSWER:           The good news is that, as of January 1, 2016, there is a new Stark exception that will permit a hospital to provide recruitment assistance to a physician group to recruit a nonphysician practitioner.  The bad news is that the exception is limited to groups who provide primary care services or mental health services.  So a surgical group would not qualify for this exception.

Even if the exception did apply, an income guaranty is not permitted.  Rather, the recruitment subsidy cannot exceed 50% of the actual compensation paid to the nonphysician practitioner (including signing bonus and benefits) during the first two years the nonphysician practitioner is employed by the group.

Since the Stark Law only applies to compensation arrangements involving a physician or a physician group, the Stark Law would not apply if the hospital decided to provide assistance, such as educational loan assistance, directly to the nonphysician practitioner.  However, remember the Anti-kickback Statute still applies even if the Stark Law does not.  So, you cannot provide that recruitment assistance if it is intended to induce the nonphysician practitioner (or his/her employer) to refer or otherwise generate business for the hospital.

So while the new Stark nonphysician practitioner recruitment assistance exception is helpful, it is limited both in the types of medical specialists who may receive this recruitment assistance and the type of the recruitment assistance that may be provided.

June 23, 2016

QUESTION:         We’re trying to re-design our peer review process.  One of the biggest obstacles is the perception that any review will be subjective, and depend on the characteristics of the reviewer rather than the quality of care provided.  Is there any way to address this problem?

ANSWER:           Here are a few ways to make the peer review process more objective:

  1. Adopt Evidence-Based Protocols to Define Excellent Care Ahead of Time. Evidence-based protocols should be used to define excellent care.  Once a protocol has been adopted, physicians should still be free to not use it as long as they document their rationale for doing so.  If a physician fails to follow a protocol that has been properly adopted and fails to document a valid reason for doing so, the physician could be sent an “Informational Letter” or given some other form of feedback to encourage compliance.  Physicians who habitually fail to comply with adopted protocols could be evaluated through the peer review process, because the physician’s noncompliance could be a sign that the individual is using outdated or ineffective methods.  The peer review policy should define the threshold number of Informational Letters that will lead to a more focused review.

    A deliberate and transparent process should be used to adopt protocols, with input being sought from all relevant specialties.  The Medical Staff, acting through its designated committees, should begin by identifying a limited number of clinical situations in which there is little doubt about the efficacy of an evidence-based protocol.  Ideally, these would be commonly occurring situations, so that adopted protocols will have the greatest possible impact.  The use of protocols in the peer review process could be expanded over time based on experience.

  1. Build Checks and Balances into the Process.  There should be a committee that engages in active oversight of the peer review process.  This role can be filled by a multi-specialty “Professional Practice Evaluation Committee,” or PPEC.  If the PPEC questions a decision made during the review process or identifies a problematic pattern of decisions made elsewhere in the process, it can seek (or provide) a “second opinion” about the matter.  This additional layer of review will promote consistency between specialties as to how clinical concerns are being addressed.
  1. Manage Conflicts of Interest. Often, peers with the clinical expertise needed to review a case will have a conflict of interest, such as being a competitor or partner of the physician under review.  Such individuals are not necessarily precluded from participating in the review of a case.  For example, a conflict that would disqualify an individual from performing certain roles in the process (e.g., sitting on a hearing panel) would not necessarily prevent the individual from conducting the initial review of a case early in the process.  Peer review policies should explicitly address such issues and outline clear rules as to when individuals with conflicts are precluded from participating in various levels of the review process.  Peer review policies should also make clear that individuals may be recused from the review process if their participation would lead to an undue perception of bias.
  1. Develop Standard Review Forms.  Forms used to document reviews should be detailed enough to prompt reviewers to consider the same, fundamental issues for each case.  However, they should not be so detailed that they overwhelm reviewers or waste their time.  Care should be taken to ask questions in a manner that elicits relevant, candid responses.  For example, a review form might ask if any complications were avoidable, if proper steps were taken to avoid the complication, and if the complication was recognized and managed appropriately.

June 16, 2016

QUESTION:         We’ve been hearing about a new federal law called the Defend Trade Secrets Act of 2016.  What is it and how does it apply to hospitals?

ANSWER:            The Defend Trade Secrets Act of 2016 (“DTSA”) was signed into federal law in May 2016 by President Obama.  The DTSA allows private companies to sue in federal court when their trade secrets have been “misappropriated” (basically, stolen).  The DTSA was passed since it is believed that the theft of trade secrets has caused trillions of dollars of losses to the U.S. economy.

Certain disclosures of trade secrets are permitted and give the employee/contractor that disclosed the trade secret immunity – clearly, these provisions mean to protect “whistleblowers.”  Also, if an employee/contractor files a lawsuit for retaliation for reporting a suspected violation of law, the employee/contractor may disclose the trade secret subject to certain conditions.

So, how does this apply to hospitals?  Courts have ruled that the compensation/bonus formula in a contract is a trade secret.  The DTSA requires a notice of immunity from liability for all individual employees/contractors in any contract which governs the use of a trade secret or other confidential information.  This immunity applies to those employees/contractors who disclose trade secrets in a government investigation, provided that the disclosure is in accordance with the DTSA.

Therefore, we recommend a notice provision for all physician employment contracts and personal services contracts, since those contracts contain compensation/bonus formulas.  Even if a hospital does not believe that its contracts contain trade secrets, we recommend adding a notice provision “just in case.”  In lieu of a notice provision, a hospital could provide a cross-reference in the contract to a hospital policy.  In any event, we recommend that a hospital consult with counsel to develop a notice provision, policy, or both.

June 9, 2016

QUESTION:        We need some guidance regarding whether an applicant satisfies our threshold criteria for appointment and privileges.  Specifically, our criteria require that an applicant has not had his or her appointment or clinical privileges revoked at any other health care facility.

We have an applicant who checked “yes” on the application form with respect to whether his appointment and privileges have been revoked at any other facility.  He included a narrative explanation, stating that he disagreed with the other hospital’s decision to revoke his privileges and has instituted a lawsuit to challenge the hospital’s “unjustified and bad faith” action.  The applicant says he has obtained a preliminary injunction/ temporary restraining order preventing the hospital from “interfering with” his clinical privileges pending the outcome of the litigation.

Does the fact that the matter is being contested in litigation mean that the applicant satisfies our criteria until such time as the litigation is resolved?

Does the fact that the court has granted a preliminary injunction/TRO mean that the revocation is “on hold” – and, in turn, the applicant satisfies our criteria until such time as the litigation is resolved?

We really don’t want to get stuck in the middle of a contentious matter.

ANSWER:            Your situation is a real doozy!  As anyone who has been involved in a revocation of appointment and privileges knows – it’s a big, big deal.  Now that you are on notice of the other hospital’s decision to revoke this applicant’s privileges, it would not be prudent to throw caution to the wind and appoint the individual simply because he claims that the revocation was unfair and is in the process of being contested.  That would not satisfy your duty, as credentialers, to protect the patients of your healthcare community.

Since another hospital’s board has taken the action of revoking this individual’s clinical privileges, that individual fails to satisfy your threshold criteria.  You may be thinking, “But wait!  The applicant says the matter is contested.  And the courts have granted him an injunction.  Is it fair to apply the criteria to exclude this individual, given the circumstances?”

The answer to those concerns is:  What is fair and appropriate is what is best for patients.

In this case, another hospital has decided to revoke the physician’s appointment and privileges, thus rendering him ineligible.  The fact that the physician contests the matter is irrelevant to whether the physician satisfies your criteria.  If his challenge is successful, at that time, he will become eligible under your criteria.  And if his challenge is unsuccessful, then he will remain ineligible.  But, it is not within your power to resolve the matter and there is no reason you need to get in the middle of things.  Standing firm regarding this individual’s ineligibility is a good position to be in – and the right way to protect patients.

June 2, 2016

QUESTION:        A physician on staff is asking to bring his office manager to the hospital to “assist” him when he rounds.  We presume that means the individual will be serving as a scribe, but aren’t really sure.  Should he or she be allowed to accompany the doctor?  If so, should we try to limit the scope of activities he or she can engage in?

ANSWER:            Many organizations are struggling with the issue of physicians wanting to bring office employees with them to the hospital to do certain tasks. Sometimes this includes private scrub personnel.  The body of issues raised will generally depend upon the role that the physician intends for the office personnel to fulfill.

It is appropriate to define threshold qualifications, in terms of education and training, that a physician’s employee or contracted staff would be required to meet to be eligible to apply as an allied health professional.  Private scrubs, for example, could be limited to registered nurses, operating room or surgical technicians, or licensed practical nurses who have been properly trained.  If a physician’s employee does not possess these qualifications, he or she would not be eligible to apply.

With respect to other office personnel who might accompany the physician as a “scribe,” the hospital could require that the physician be physically present with such personnel at all times.  Whether such personnel should be permitted to make entries in records in the presence of the physician is up to the hospital.  Certainly, the physician would have to remain personally responsible for all record entries.

The bottom line is that the hospital has the responsibility and the right to define specifically what physician-directed personnel can and cannot do in the hospital and that the individual should be appropriately authorized before providing any level of treatment or service.  If the individual is an advanced practice registered nurse (i.e., an NP, CNM, CRNA) or a physician assistant, he or she must be credentialed and privileged through the medical staff process per both CMS and accreditation standards. For truly dependent practitioners who do not provide a medical level of care, there is more flexibility.  Some organizations have chosen to handle such personnel through the human resources department, when medical staff office resources are constrained.

May 26, 2016

QUESTION:        Do hospital-employed physicians have a conflict of interest with respect to private practice physicians in matters involving credentialing?  Privileging?  Peer review?

ANSWER:           Some independent physicians may feel that employed physicians should not be involved in leadership positions or that there should be quotas pertaining to the number of employed physicians in these positions for fear that their employment relationships could influence their actions. Legally, there is no support for viewing an employment relationship as a disqualifying factor. And we have rarely seen the type of political pressure from management that independent physicians worry about being brought down on employed physicians.

Of course, if a specific concern is raised about an individual’s participation in any given process, it always makes sense to consider whether an individual’s employment would result in a conflict of interest under the guidelines that have been adopted by the medical staff.  But practically, it seems difficult to imagine a medical staff adopting bylaws documents that exclude employed physicians from serving in leadership positions – or from otherwise participating in credentialing and peer review activities – given the large number of physicians who are now employed by hospitals.

May 19, 2016

QUESTION:        Our hospital is registered with the National Practitioner Data Bank (“NPDB”).  We would like to designate as an authorized agent for NPDB querying purposes a credentials verification organization (“CVO”) with which we have recently started working.  How do we go about doing this?

ANSWER:           The NPDB explicitly permits the practice of eligible entities, including hospitals, designating authorized agents, such as CVOs, to query on their behalf.  However, according to the NPDB Guidebook, an authorized agent must, itself, register with the NPDB and comply with all the registration requirements.  Often, CVOs act as authorized agents for a number of eligible entities.  Nonetheless, the CVO must query the NPDB separately for each eligible entity they represent.  Moreover, the CVO is not permitted to share results of a query for one eligible entity with another eligible entity.

After the CVO registers with the NPDB, your hospital will have to designate the CVO as its authorized agent.  This is a relatively simple process that can be done electronically by accessing this web address:  https://www.npdb.hrsa.gov/hcorg/howToDesignateAnAuthorizedAgent.jsp.  Finally, as a part of designating the CVO as an authorized agent to query the NPDB on behalf of your hospital, you will have to create a written agreement between your hospital and the CVO.  The NPDB Guidebook does not identify any required elements for this written agreement, but the NPDB website provides recommendations for what should be included in the agreement.  According to the NPDB website, the agreement should confirm the following:  (1) the authorized agent is authorized to conduct business in the relevant state; (2) the authorized agent’s facilities are capable of maintaining the security and confidentiality of NPDB reporting and query responses; (3) the authorized agent is prohibited from using querying responses for any purpose other than that for which the disclosure was made; and (4) the agent understands that sanctions can be taken if information is requested, used, or disclosed in violation of NPDB provisions.