Author: Courtney Patterson

March 3, 2022

Posted on by Courtney Patterson

QUESTION:
Has The Joint Commission (“TJC”) issued new Elements of Performance (“EPs”) regarding obstetrical/maternity care?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes, TJC issued these new EPs in the early days of the pandemic, so it’s not surprising that these may have received little attention.

The new EPs are under the Provision of Care (“PC”) chapter, at PC.06.01.01 and PC.06.01.03, and were effective July 1, 2020.  TJC’s press release stated that the EPs were implemented because maternal morbidity and mortality was becoming worse, especially in the areas of maternal hemorrhage and severe hypertension/preeclampsia.

The new EPs require assessments regarding hemorrhage and hypertension/preeclampsia risk on admission to labor and delivery and on admission to postpartum.  These EPs also require that the quality improvement committee establish criteria that trigger reviews for such cases, and that the reviews evaluate the effectiveness of the hemorrhage response team.  There are also requirements that education be provided to patients and families regarding signs and symptoms of postpartum hemorrhage and severe hypertension/preeclampsia.

The Medical Executive Committee is also involved, since it is required to assign a multidisciplinary committee the task of developing procedures to manage pregnant and postpartum patients who experience maternal hemorrhage, and for measuring and managing blood pressure to lessen the likelihood of harm relating to maternal severe hypertension and/or preeclampsia.

So, this may be a good time to update your rules and regulations to make sure that these new EPs are covered.

February 24, 2022

Posted on by Courtney Patterson

QUESTION:
Last week we had a 35-week pregnant patient present to our emergency department in active labor.  Her obstetrician was not on our medical staff and the on-call obstetrician was contacted to come in.  In the course of the phone call between the ED physician and the on-call obstetrician, the obstetrician realized that she knew this patient, and she informed the ED physician that she had treated her in the past but had terminated that physician-patient relationship the previous year because the patient had been noncompliant in connection with her previous pregnancy and related complications.  The on-call physician didn’t want to come in to treat the patient because she had gone through a formal process of sending the patient a letter, with the required advance notice, and didn’t want to reestablish that relationship.  Does the on-call physician really have to see a patient in this situation? It seems unfair.

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Unfortunately, yes.  While it’s not a popular answer and it does seem unfair from the perspective of the obstetrician at issue who likely did everything required of her to formally terminate that physician-patient relationship – a process that usually requires written notification with at least 30 days’ advance notice (and sometimes longer in the case of a pregnant patient) – the Emergency Medical Treatment and Active Labor Act (“EMTALA”) requirements trump the fact that the obstetrician terminated the physician-patient relationship.  In this case, the obstetrician is responding to the ED as the on-call physician, and she has to respond.

In the absence of a statute like that in effect in Virginia, which specifically provides that a physician-patient relationship created by a response to the ED by an on-call physician is “deemed terminated” upon the discharge of the patient from the ED or, if the patient is admitted, upon the patient’s discharge from the hospital and the completion of any follow-up care prescribed by the on-call physician, the obstetrician will likely have to go through the advance notice and termination process again.

The situation would be different if this patient presented to the ED and told the ED that the obstetrician was her treating physician.  In that case, when the ED contacted the obstetrician to inform her that one of her patients was in the ED, the obstetrician would have been able to inform the ED that she had terminated the physician-patient relationship, and the ED would then have resorted to contacting the on-call obstetrician.

February 17, 2022

Posted on by Courtney Patterson

QUESTION:
We would like to give our physicians backpacks and laptop cases that include our hospital’s logo with the intent that they use these items when traveling to and from work.  The backpack and laptop case would total $225 per physician.  Does this count as remuneration under Stark?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
The short answer is – yes.  If a hospital provides remuneration to a physician, then the arrangement must satisfy an exception to Stark.  Remuneration is defined broadly under the law, and gifts such as backpacks and laptop cases will likely count as such.  But don’t fret.  The first step is recognizing remuneration.  The second step is finding out whether an exception applies!

There are several exceptions from which we can choose to address these gifts.

First, Stark exceptions offer the most flexibility for gifts offered to employed physicians.  42 C.F.R § 411.357(c).  Most gifts, such as backpacks, that are provided to an employed physician qualify as employee fringe benefits.  Such benefits are covered under the bona fide employment exception under Stark.  If the physicians who are receiving these backpacks and laptop cases are employed, you would not have to record this as a non-monetary compensation under the law.

Assuming that the physicians are not employed, the “non-monetary compensation” exception under Stark allows for compensation in the form of gifts so long as these gifts do not exceed an annually adjusted amount for each Calendar Year.  42 C.F.R. § 411.357(k).  For Calendar Year 2022, the annual non-monetary compensation exception limit is $452.  You can find the annual changes to the compensation amount here.

Please keep in mind that, in order for this exception to count, the hospital must record all items and gifts provided by the hospital to the physician.  In addition, the decision to give such gifts must not be based on, or take into account, the volume or value of referrals or business generated by the referring physician and may not be solicited by the physicians.  It appears that the amount for the backpacks and laptop cases per physician would fit within the non-monetary compensation exception, assuming no other items or gifts were already provided to the physicians that could tip the scale of compensation over the limit.  Just be sure to keep track of the value of all non-monetary compensation provided to each of your physicians for each Calendar Year.

In light of the COVID-19 public health emergency, there is still a blanket waiver in effect for the non-monetary compensation limit that allows remuneration from a hospital to a physician in a form of non-monetary compensation that exceeds the limit for the Calendar Year.  The remuneration covered under the COVID-19 blanket waivers must be solely related to COVID-19 purposes, which may include, but is not limited to, (1) ensuring the ability of health care providers to address the patient and community needs due to the COVID-19 outbreak and (2) ensuring the ability of health care providers to address patient and community needs due to COVID-19.

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 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.