Question Of The Week

February 10, 2022

Posted on by Courtney Patterson

QUESTION:
We have a physician who was brought in through a contract with a locum tenens company.  Within the first couple of weeks, he had several horrible outcomes in cases.  We started to review his cases through our peer review process and we are considering a precautionary suspension.  Our CMO just told us that the hospital has instructed the company that the physician can no longer be scheduled at our hospital.  This will result in the termination of his clinical privileges.  Should we suspend his privileges anyway, continue with our peer review process, and then report him to the National Practitioner Data Bank?  We are concerned that he is just going to go someplace else and hurt patients again.

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
We understand the desire to follow your peer review process, especially when there are serious concerns about the clinical care provided by a physician.  The peer review process is, by design, thoughtful, deliberative, and educational with built-in collegial efforts, progressive steps, and, when needed, opportunities for improvement.  As successful as the peer review process can be, it is not well suited to address concerns about physicians who are brought into practice on a temporary basis.

That does not mean you should ignore those concerns.  However, your medical staff may not be in the best position to evaluate, address, and resolve the concerns identified in a physician who is practicing at your hospital on a temporary basis.  In fact, once the hospital has exercised its rights under the contract with the locum company and instructed the company not to schedule the physician again, there is not much left for the medical staff to do through its peer review process.  It difficult to review a physician’s care when the physician is no longer practicing at the hospital and there is no action left to take after the physician’s appointment and privileges have been terminated through the contract with the locum company.

In fact, this is an area where the National Practitioner Data Bank, through its Guidebook, has been very clear.  If a physician’s clinical privileges are terminated as a result of a contract, that termination is not an adverse professional review action and should not be reported to the Data Bank.

If you are concerned that the locum company is going to turn around and place the physician in another hospital, you may want to put the company on notice of your specific concerns.  The company should have a process for evaluating the care and competence of the physicians and other practitioners it is placing.  But be careful what you say to the locum company.  Your communication with the company may not be protected under your bylaws, or state or federal law.

To protect yourself, request the locum company to have the physician sign an authorization and release so that information about the physician’s practice can be shared.  Additionally, if you receive a request from another hospital who is seeking to privilege this physician, you can request an authorization and release before providing any information, including the standard “name, rank, and serial number.”  A request for an authorization should send a message that there are issues that require further review and evaluation.

February 3, 2022

Posted on by Courtney Patterson

QUESTION:
What’s all this I hear about “appropriate use criteria” that Medicare will use to determine payment for outpatient imaging?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The Protecting Access to Medicare Act of 2014 (a/k/a “PAMA”) established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.  Examples of such advanced imaging services include:  CT, PET and MRI scans.  Under this program, at the time a practitioner orders an advanced diagnostic imaging service for a Medicare beneficiary, he/she, or clinical staff acting under his/her direction, will be required to consult a qualified Clinical Decision Support Mechanism.  CDSMs are electronic portals through which appropriate use criteria can be accessed.

The program won’t go into effect until January 1, 2023 or the January 1 after the current public health emergency ends, whichever is later.  And it only applies to services in a physician’s office, hospital outpatient department (including the emergency department), an ambulatory surgical center or an independent diagnostic testing facility and whose claims are paid under the physician fee schedule, hospital outpatient prospective payment system or ambulatory surgical center payment system.  So (at least for now) it does NOT apply in critical access hospitals.

For more information, check out the CMS website.

January 27, 2022

Posted on by Courtney Patterson

QUESTION:
How should our hospital document services provided to patients whose biological gender and gender identity differ?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
Separate fields in the electronic medical record (“EMR”) could be used to properly address patients whose current gender identity does not match their biological sex, with one field capturing birth sex and a second gender identity. Every EMR system may not have this option in its present state, but EMRs certified under the federal Promoting Interoperability Program must have the capacity to record this data.

There is currently no federal rule that mandates hospitals collect information regarding a patient’s gender identity, but gathering both birth sex and gender identity as demographic factors can be helpful to the hospital and patients in several instances.

For example, a patient whose gender identity does not match their biological sex may not have updated legal documentation to reflect their current identity.  In this case, inputting the patient’s gender identity into the EMR in place of sex could result in the patient’s claims getting denied because the information does not align with what is on file with the insurance company.  Additionally, these demographic factors can influence treatment.  For instance, a patient who has a cervix should be offered a cancer screening regardless of gender identity.  By collecting both demographics, hospitals can ensure that claims are approved and allow providers to be aware of potential health problems they may not have otherwise been.

January 20, 2022

Posted on by jwilbert

QUESTION:

Our hospital has granted clinical privileges to practitioners who work primarily in outpatient facilities which are a part of the same health system as the hospital.  How do we conduct FPPE to confirm competence and OPPE for these practitioners when they have limited to no volume in the hospital, but the hospital wants them to retain their privileges in case it needs them to provide patient care services?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK:

During the COVID-19 pandemic, this is an important question because hospitals are scrambling for methods to cover the clinical needs of an influx of patients when there are community spikes in infections and hospitalizations.  Thus, they may want to have practitioners “at the ready” even though their primary practice location is not in a hospital.

Nonetheless, you do have some options when it comes to these “low volume practitioners.”  To use The Joint Commission terminology, for “focused professional practice evaluation” (or “FPPE”) to confirm competence and “ongoing professional practice evaluation” (or “OPPE”), the hospital can have the low volume practitioner provide one or more of the following types of information:  (1) information from their primary practice location, such as ongoing professional practice evaluation reports, a quality profile, and/or patient satisfaction surveys, (2) detailed reference requests from their primary practice location, (3) detailed peer evaluations from individuals who have directly observed or who are in a regular referral relationship with the practitioner, or (4) medical records of patients treated at the primary practice location so that the hospital may conduct an evaluation of the care provided.

If the low volume practitioner works almost exclusively in outpatient settings, the above information, if part of a general request, may not address their clinical skills in a hospital setting.  But, you can structure the requests so that the information received relates to the clinical privileges that the practitioner has in the hospital.  For example, while not completely analogous, if the primary practice location is an Urgent Care Center for a practitioner seeking or granted clinical privileges in emergency medicine, the information requested could target the performance of histories and physicals, the ordering and interpretation of diagnostic studies, the administration of medications, and the requesting of consultations/making of appropriate referrals.

For those hospitals that are accredited by The Joint Commission, keep in mind the FAQ issued on March 4, 2021, which provides as follows:  “When practitioner activity at the ‘local’ level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges.  The use of supplemental data may NOT be used in lieu of a process to capture local data.”  Thus, The Joint Commission requires that at least some of the data used to confirm competence come from the hospital conducting the evaluation.  The Joint Commission gives hospitals significant flexibility in the type of information collected by the hospital for professional practice evaluation, so you can be creative.

We should mention that for health systems that have outpatient locations operating as departments of the hospital (i.e., as provider-based outpatient departments), then any FPPE or OPPE that was completed in that outpatient setting would be viewed as having occurred “in the hospital.”  In this case, The Joint Commission requirements would be satisfied based on what was done in the outpatient setting.

Another tool to deal with low volume practitioners is to grant an exception that permits them to remain subject to FPPE to confirm competence for the duration of the Practitioner’s appointment term for some or all clinical privileges.  This option may be used because of community need, coverage requirements, the rare nature of a given procedure or treatment, or other relevant factors.  We believe this is a reasonable interpretation of the relevant standards based on the needs of hospitals during the COVID-19 pandemic.

January 13, 2022

Posted on by Courtney Patterson

QUESTION:
We’ve had a question raised about a Medical Staff member who performed a test on a family member without going through the formal patient registration process.  What can we do to educate our medical staff about the risks involved with these kinds of practices?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
We have found it to be helpful to set forth guidelines that remind Medical staff members of the concerns that can arise when a physician treats him or herself, a family member, or others with whom the physician has a close relationship.  A good starting spot is the Standard E-8.19 in the American Medical Association’s Code of Ethics, which speaks to how such actions can compromise professional objectivity and unduly influence medical judgment.  In addition, your state medical board may have guidance on this issue.

Relying on these resources, Medical Staff leaders can then adopt policy language that reinforces the standards of acceptable medical practice in these situations.

January 6, 2022

Posted on by Courtney Patterson

QUESTION:
Our peer review committee is wondering if the name of the physician under review should be redacted so that committee members are not aware of the physician’s identity.  Would this promote a fair review process?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

While at first blush it might seem like a good idea, we do not recommend that the “blinding” of reviews be part of the peer review/professional practice evaluation (“PPE”) process.  Here’s why:

  • This practice could actually create unnecessary legal risk because it makes it more difficult to manage conflicts of interest. If a disqualifying conflict of interest exists between a committee member and the physician under review, the blinding of information might prevent this from being identified early on.  As such, there could be an allegation later that the committee member actually knew the identity of the subject physician but was deliberately not recused.
  • Obtaining input from the physician under review is an essential component of a fair and effective process. While this input is generally written, there are times a meeting is beneficial as well.  While you could probably shield the identity of physicians when they submit written comments, of course it would be impossible to do so for meetings.  Thus, physicians would be treated differently depending on whether a meeting was held or not.
  • If blinding of information is a component of the peer review process but members of the committee determine the identity of the physician in some cases (e.g., because they heard of a certain case or because there is only one physician in a certain subspecialty), it could lead to allegations by an unhappy physician that the committee violated its policy/practice because the committee knew the identity of that individual. It could be alleged this is “proof” that the committee members were biased in their review.
  • It would take a tremendous amount of careful work to attempt to blind reviews consistently and we think it is impractical on a day-to-day basis. It would stress the PPE specialists (i.e., those who support the review process) more than is necessary, distract them from assisting the process in other and better ways, and all for no great gain.
  • Despite everyone’s best efforts, it is exceedingly difficult to do this completely and ensure anonymity. In many cases, committee members will still know the identity of the physician subject to review.
  • There may be times when the committee members want to access a portion of the EHR during deliberations, which would clearly reveal the identity of the physician.

•   Once the case at issue is assessed, it is then critical for the committee members to know the physician’s history, personality, circumstances, etc.  This information will help the committee identify the most appropriate performance improvement tool (e.g., collegial counseling, educational letter, etc.) and who should be involved.

December 16, 2021

Posted on by Courtney Patterson

QUESTION:
Our Medical Executive Committee initiated a formal investigation a few weeks ago – the first one we have done in years.  The investigating committee has met several times and is ready to make its recommendations. The bylaws reference a “report,” but the committee members would rather just come to the MEC meeting and give the findings in person. Is a written report really necessary?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Yes, yes, and YES.  A written report is required not only because your medical staff bylaws require one (which frankly, in a heightened legal process like a formal investigation would be reason enough to ensure a written report is created), but, more importantly, should a matter that led to an investigation result in an adverse recommendation (i.e., revocation of appointment and/or privileges, a restriction of privileges, etc.), the investigating committee report will likely be the most important document that helps to explain the reasoning of the MEC when it made that adverse recommendation.  Most medical staff bylaws permit the MEC to delegate the investigation process to another standing committee or to an ad hoc committee, and they do not require the MEC perform the investigation itself.  The MEC then relies heavily on the fact-finding, conclusions, and recommendations made by the investigating committee.  It is vitally important that such information be reduced to writing in order to create a strong record.

The report should include a summary of the review process (e.g., a list of documents that were reviewed, any individuals who were interviewed, etc.), specific findings and conclusions regarding each concern that was under review, and the investigating committee’s ultimate recommendations.  Capturing that level of detail in a verbal discussion in a (typically) one hour or less meeting, where individuals are asking questions and side discussions often occur, is very difficult.  You really want to have more than a set of minutes to rely upon in explaining the findings that were made.

December 9, 2021

Posted on by Courtney Patterson

QUESTION:
Early on during the pandemic, stress got the best of a well-thought-of member of our Medical Staff, resulting in the Leadership Council issuing this physician a letter of reprimand, a copy of which went into his file.  The issue never became a problem again and recently he asked if we could remove the letter from his file, as he is worried this could come back to haunt him if he decides to seek opportunities elsewhere.  Is it okay honor his request?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
While we can understand this individual’s frustrations about having negative information in his file, there are a number of reasons why we recommend thinking twice before removing anything from a practitioner’s confidential file.

First, removing documentation from the file may create insurance coverage issues.  Some hospitals that we work with have been told by their professional liability carriers that removing information from a practitioner’s file would violate the hospital’s condition of coverage because it would hinder the carrier’s ability to defend any claims involving that practitioner.  Another reason we’ve found is that in those rare instances where an MEC does have to take an adverse action against a physician, it is often based on a history or pattern of conduct.  It is extremely difficult to justify such an action if the documentation of these past events is no longer available.  Similarly, removal of such documentation hampers the institutional memory of the hospital, making it more difficult for future Medical Staff leaders to fully understand past issues and the steps that were taken to mend them.

It is a good idea to have access to confidential files policy in place, so your leadership team can anticipate these types of requests and how they will be handled when they come up.  In the meantime, it may be helpful to explain why you can’t honor this particular physician’s request (based on the reasons above), but then invite him to provide a written update or response to the original concern that will be made a part of his file as well.

December 2, 2021

Posted on by Courtney Patterson

QUESTION:
Who should be on our Credentials Committee and what should be the terms of service for the members?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
A Credentials Committee is best composed of experienced leaders, such as past chiefs of staff or other physicians who have had medical staff leadership experience.  Many medical staffs have representation from a variety of specialties to ensure that the Credentials Committee has the expertise necessary to address difficult credentialing and privileging issues.  With the increasing number of advanced practice providers (e.g., nurse practitioners and physician assistants) providing services in hospitals, more and more Medical Staffs are appointing an advanced practice provider to the Credentials Committee as a voting member and for that individual’s input and expertise on the topic of credentialing and privileging these providers.

Service on the Credentials Committee should be the primary medical staff obligation of the members and terms should be at least three years so that committee members have an opportunity to gain some experience and expertise in credentialing.  The terms should also be staggered so that there is always a repository of expertise on the committee.  The Credentials Committee’s primary responsibility is to review and make recommendations on applications for medical staff appointment and clinical privileges.  It can also oversee the development of threshold eligibility criteria for clinical privileges.

For answers to all your credentialing questions, join Lauren Massucci and Charlie Chulack for the Horty, Springer & Mattern seminar “Credentialing for Excellence” on March 10 through 12, 2022 in Savannah, Georgia, or April 7 through 9, 2022 in New Orleans.

November 18, 2021

Posted on by Courtney Patterson

QUESTION:
Our hospital has more than 100 employees.  Do we have to comply with both the OSHA vaccine mandate and the one issued by CMS?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
OSHA has issued two different Emergency Temporary Standards (“ETS”) that are the source of some confusion.  The first was issued on June 21, 2021.  It required that covered health care employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in their workplaces related to the following:  patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting.  The June OSHA ETS encouraged but did not require vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.

In early November, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers (not just health care employers) with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption.  This ETS that was enjoined by the 5th Circuit Court of Appeals this past Friday, and the 5th Circuit  ordered that OSHA take no steps to implement or enforce the ETS until further court order.  CMS said it worked closely with OSHA to ensure that the November regulations of both agencies were complementary.

The FAQs issued with the CMS rule on November 5 contained the following guidance:

Q. Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the upcoming (or new) OSHA Emergency Temporary Standard?

A.  If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.  If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation 11 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.  This rule takes priority above other federal vaccination requirements.  CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.  The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations.  Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.

Hospitals that participate in Medicare subject to the CMS’s Omnibus Staff Vaccination Rule which amended the Conditions of participation, so per this FAQ guidance hospitals are NOT subject to the November ETS which requires weekly testing for those who remain unvaccinated without an eligible exemption.  Therefore, testing is not an alternative for staff who have not been exempted from the CMS vax requirement to comply with the rule.

On the other hand, while testing is not a substitute for vaccinations under the CMS rule, hospitals are allowed to require testing of unvaccinated/exempt workforce members as a mitigation measure.  The CMS FAQs say:  “In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients” but this does not require testing.

CMS explained in the preamble to the regulation:  “we considered requiring daily or weekly testing of unvaccinated individuals.  We have reviewed scientific evidence on testing and found that vaccination is a more effective infection control measure.  As such, we chose not to require such testing for now but welcome comment.  Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.”  86 Fed. Reg. 61614.

However, the September 2020 CMS emergency rule that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19 is still in effect.  The new FAQs say:  “CMS expects continued compliance with this requirement.”

If you have a quick question about this, e-mail Dan Mulholland at dmulholland@hortyspringer.com

Also, listen to HortySpringer’s latest podcast on the CMS vaccine mandate here.