April 1, 2021

QUESTION:       I’m supposed to take minutes of meetings I attend, but I don’t know what to include, what not to include, etc., and everyone I ask has a different view.  Help!

ANSWER:           We’re not sure either so we can’t help you at all.  APRIL FOOLS!  We’ve reviewed minutes that could have fit on a 5 by 7 inch index card, and others that are as thick as a phone book (if those even exist anymore).  Here are the “Do’s” for taking minutes:

    1. DO – write down the name of the committee that’s meeting.
    2. DO – write down the date of the meeting.
    3. DO- list who’s in attendance, and who’s absent.
    4. DO – list if there are any guests or visitors at the meeting.
    5. DO – note the time the meeting was called to order, who called it to order, and the time it was adjourned.
    6. DO – note whether it’s a regular or special meeting of the committee.
    7. DO – note that if it’s a special meeting, that notice was given to the committee members, and the way notice was given (mail, e-mail, personal delivery, etc.).
    8. DO – note whether a quorum was present (this eliminates the argument that the action of the committee wasn’t valid because of the lack of a quorum).
    9. DO – note whether the previous minutes were read and approved.
    10. DO – note the result of the votes, for example, 7 – 1 to suspend the physician’s privileges. This is the most important “Do” since the vote is the      committee’s action.  If the result of the vote is written down in black and white at the time it’s taken, there is little room to argue in the future that it was inaccurate.

…and here are the “Don’ts:”

    1. Don’t record the details of any discussion. This is the most important “Don’t”.  Sometimes, in the heat of the moment, someone may say something that they don’t mean.  Or that can be misinterpreted.  Or that was meant as a joke, but looks sinister in black and white.  If it’s recorded in the minutes, it’s there forever, and may turn up again.  There isn’t really a need to record the details of a discussion.  What’s important is the vote, the committee’s action. But, with every rule, there’s an exception.  The exception here is “Do put details of a discussion in if it helps” and it helps when a committee makes an adverse recommendation against a physician.  In that case, the minutes could be your best friend.  The details would allow the committee to record the objective reasons for taking action – physician was disruptive on this date, this date and this date and did this and this and this.  The reasons can be explained, but, comments shouldn’t be attributed to any one individual.
    2. Don’t record how each member voted, unless a committee member wants his/her vote recorded. There’s also an exception to this rule.  When a committee’s going to make an adverse recommendation and a competing physician is on the committee, the minutes should reflect that the conflict of interest principles were followed (Dr. Jones fully answered the committee’s questions, left the room prior to the vote, the vote was taken, and Dr. Jones returned to the room).
    3. Don’t record who made a motion and who seconded them.
    4. Don’t record who said what to someone else.
    5. Don’t record personal remarks unrelated to the committee’s business. For example, when discussion is regarding revocation of privileges, don’t record “Dr. Jones said that Dr. Smith pranked him on April Fools’ Day by telling him that the Health Law Express was ending.”  The only thing that’s relevant is Dr. Smith’s competence.  So record “The committee recommended that Dr. Smith’s surgical privileges be revoked because of competence concerns.”

For more about the “Do’s” and “Don’ts” as well as: confidentiality, the peer review privilege, and how to lose it; what goes in (and what, if ever, can come out of) a practitioner’s confidential file, and; sharing files with a practitioner or within a health care system, tune in to the Grand Rounds Audioconference “Medical Staff Documentation – How to Keep It Confidential” on May 4, 2021.

March 25, 2021

QUESTION:       Can our professional practice evaluation/peer review committee use e-mail to communicate with physicians about the review of clinical or behavioral concerns?

ANSWER:           Yes.  Physician leaders have told us that they prefer communicating via e-mail (both internally and with the physician under review) because it’s quick and less formal than regular mail.  The lack of formality can help to reduce anxiety on the part of the recipient and convey the message that the PPE/peer review process is meant to be educational, not punitive.  In contrast, using certified mail sends the message that the Hospital is anticipating a confrontation and that lawyers will soon be involved.

Using e-mail to discuss PPE/peer review matters would not, on its own, waive the peer review privilege under state law.  However, there are several best practices that should be adopted:

    • All e-mails should include a standard convention, such as “Confidential PPE/Peer Review Communication” in the subject line.
    • E-mail should not be sent to non-Hospital accounts unless the e-mail merely directs recipients to check their Hospital e-mail.
    • If the e-mail contains any Protected Health Information (as that term is defined by the HIPAA Privacy Rule), the e-mail must comply with the Hospital’s HIPAA policies. Often, this will require that the e-mail be encrypted.
    • If an e-mail includes a deadline for a response (for example, a request for input or to attend a meeting), the Hospital may want to send a text message or call the physician to say that the e-mail is being sent. The goal is to ensure the physician is aware of the e-mail so the deadline is not missed.  However, the Hospital’s policy should also make clear that failure to send a text message or make a phone call is not an excuse for the physician to miss a deadline.

Of course, there are times when it’s more appropriate to use a formal letter.  If a physician has not responded to prior collegial efforts, a letter may help to convey the seriousness of the matter.  Also, the applicable Medical Staff policy should always be checked to ensure it does not require correspondence to be sent via certified mail or some other form of “Special Notice.”  This is typically the case where a matter has progressed to a formal Investigation or a Medical Staff hearing is under way.

March 18, 2021

QUESTION:       I noticed that the first case in this week’s HLE discussed a Residency Assistance Agreement.  Does the Stark law permit a hospital to enter into such an agreement?  What are the practical and legal risks associated with such an agreement?

ANSWER:           Yes.  The Stark law permits hospitals to enter into a wide range of physician recruitment arrangements, either with the recruit or with a group that will employ the recruit.  A properly drafted recruitment agreement will comply with the Stark law, the Medicare anti-kickback statute and the IRS pronouncements on physician recruitment.

One unique form of recruitment agreement is to assist a physician financially during their residency program.  Such an agreement can be structured to comply with all legal requirements.  However, residency programs can last anywhere from three to seven years (as in the case discussed this week) and you are requiring a physician who is just beginning this training to make commitments that will extend for years after the training program has been completed.  As a result, inherent in this type of recruitment agreement are certain practical risks that often give rise to litigation.

A resident assistance agreement is typically an annual payment (usually a loan) that will be paid while the resident is in training but will then be forgiven if the physician returns and practices in the geographic area served by the hospital in the specialty described in the agreement for a certain period of time.

The situation in the case is not unusual.  There the physician entered into a five-year general surgery residency program.  The hospital agreed to pay her $25,000/year during the residency program.  While not stated in the case, this payment is typically a loan.  The physician agreed to return to the geographic area served by the hospital after the completion of the residency program, practice general surgery for a certain period of time (four years in the case) and if the physician practices in the manner described in the agreement for the full four years, the entire principal and interest will be forgiven.  Straightforward right – Not so fast.

Residents can change their mind – that is what happened in the case described in this week’s HLE.  There the physician wanted to pursue additional fellowship training as a thoracic surgeon.  However, not all hospitals need, or can support, such a subspecialist.  Besides, that is not what the hospital bargained for – they wanted a general surgeon.  Apparently, the hospital did not want to prevent the physician from obtaining the additional thoracic training but did not discuss the effect of her doing so on her commitment to the hospital.  Nor did they amend the agreement at the end of the general surgery residency program to address the change in circumstances.

So, they had an agreement that did not address the additional training.  As such, per its terms, the agreement stated that the physician would be in default if she did not practice general surgery for at least four years.  Apparently, that was not the physician’s understanding and she did not want to practice general surgery after obtaining additional training as a thoracic surgeon.  The result of this misunderstanding was litigation – which is still ongoing.  No general surgeon and legal fees-not the result that either party bargained for when they entered into the agreement.

Another issue that often arises in this kind of arrangement that often leads to litigation is how will the physician practice once they return.  If an employee what will their salary be and how will that salary be determined so far in the future?  If they are not offered employment by the health system, where will they practice and again under what terms?  The reality is that the physician has no idea of their market value before they start training but often become acutely aware as headhunters contact them as the training period ends – that complicates these employment-related issues.

We have also seen instances where a physician gets married during the residency program and their spouse either cannot find a job or does not want to live in the committed area.  Other issues arise if the hospital is sold, if demographic shifts have occurred so that the hospital can no longer support the physician’s specialty (even if the physician did not change or obtain additional training), or if unforeseen circumstances arise such as COVID.

Adding to this problem is that the amount of interest that accrues over the period of a lengthy residency program can be significant and can approach the amount of the principal – another fact that the physician did not realize when they signed the agreement.

So, what is a hospital to do?  Despite these issues, we continue to believe that a residency training assistance agreement is an excellent means for a hospital to recruit a new physician. It allows the hospital to recruit a physician in a needed service, although that need won’t be addressed until after the residency program is over.  It also allows the resident to concentrate on their training, eliminating the need to worry about whether there will be a position at the end of their training program.  It also assists the resident financially at a time when they often need the assistance.  But you need to appreciate the unique risks presented by this type of agreement, have an agreement that anticipates as many of those risks as possible, and if changes do occur during the course of the relationship, make sure that you memorialize those changes and their effect on the terms of the agreement in writing.

March 11, 2021

QUESTION:       Not to be political, but as I hear the reports of alleged sexual harassment by Governor Cuomo, I’m reminded of the allegations that have repeatedly been made about one of our interventional cardiologists, who also happens to be the department chief and former chief of staff.  While there are calls for the Governor’s resignation, our offender in chief continues to practice unrestrained.  Is there a different standard applied to, or more tolerance for, sexual harassment in medicine?

ANSWER:           The short answer is no.  State and federal law require employers to provide employees with a work environment that is free from harassment.  The legal standard for sexual harassment does not vary by industry or profession.  Health care doesn’t get a pass because it’s stressful, the hours are long, or because “it’s the way it’s always been.”  Sexual harassment, in health care or elsewhere, is unacceptable and should not be tolerated.  When an organization learns of alleged sexual harassment, they should investigate it promptly and thoroughly.

All too often sexual harassment goes unreported.  Under certain circumstances, this is because many employees and staff are reluctant to report sexual harassment for fear of being ignored or being retaliated against and because the harasser may be a big admitter and/or a leader.  As a result, sexual harassment, like other forms of disruptive behavior, threatens the integrity of team-based care and undermines the culture of safety by chilling channels of communication.  Therefore, to remedy this problem, organizations should implement mechanisms through which early intervention, bystander reporting, and prompt investigation becomes the norm and not the hesitation.

If the behavior is going to change, leaders in the organization need to stand up and get involved.  In an AMA Moving Medicine Podcast, Reshma Jagsi, MD, PhD, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, talked about the importance of bystander intervention and bystander empowerment and training. According to Dr. Jagsi, “when we see something like this going on, we can speak up.  We can distract, we can remove the victim and, if we’re in positions of power, as many of the people in this room are, we can also report or make sure that that situation is addressed more formally.”

Therefore, for these mechanisms to work, sexual harassment must be viewed not only as an institutional responsibility, but as an ethical obligation.  It is important to train employees and staff to say something if they see something, and it is equally, if not more important for the organization to provide the effective and responsive channels to do so.  In other words, the organization should foster a workplace environment where reporting misconduct is always welcome and where sexual harassment is not.

March 4, 2021

QUESTION:        We are currently doing an update to our medical staff bylaws, and, as part of the process, have been really focusing on how our committees are structured – making sure they’re accurate, updating functions – things we haven’t looked at in a decade.  One of the biggest issues we have is that we have so many committees and it’s the same six people who seem to have to sit on all of them because we just don’t have that many people who are willing to serve any more.  Any suggestions?

ANSWER:           Yes – consolidation!  This is a concern that we hear being raised in hospitals across the country.  Medical Staff members are too busy, over committed, looking for work-life balance – whatever the case may be – and they are not as willing or as able to serve in these medical staff leadership roles as was the case in the past.  A bylaws revision project is a great time to look at each medical staff committee and determine whether the functions being fulfilled necessitate a fully separate committee, or whether the function might become one component of a committee that fulfills multiple functions.  While it used to be typical to see hospitals maintain fully separate committees dedicated to Infection Control, Radiation Safety, Pharmacy & Therapeutics, Performance Improvement, Blood Utilization, Tissue Review – and so on and so on – it is becoming much more commonplace to see, for example, a single “Quality Committee” that performs all of those functions with a member or two who has oversight of each of the specific functions.

The only cautionary note would be to check your state hospital licensing regulations.  While most state regulations speak only generally in terms of the above “functions” being fulfilled in the hospital setting, there are still a handful of state regulations that are more proscriptive and do require separate defined committees to fulfill certain functions, so you would want to be sure that any changes made are in compliance with state requirements.

February 25, 2021

QUESTION:        A physician called requesting a patient transfer to our Hospital.  We would like to start recording these types of calls for patient safety and quality purposes.  Does the hospital have to obtain the callers’ consent prior to recording these communications?

ANSWER:           The hospital’s obligation to get a caller’s consent prior to recording the communication depends on whether the hospital is located in a “one-party consent” or an “all-party consent” state.

One-party consent states allow a person to record so long as they are a party to the communication and consent to the recording.  In this case, the physician making the call does not have to be informed that the call is being recorded since the physician receiving the call has already provided the necessary consent.  The hospital may, as a courtesy, include an automated message at the top of the call that informs the physician making the transfer request that the conversation will be recorded.

On the other hand, states that have adopted “all-party consent” recording laws prohibit the use of devices to record absent the consent of all parties involved in the communication.  Therefore, if you find yourself in an “all-party consent” state, then the hospital will be required to disclose that it is recording the call prior to the start of the conversation.

When deciding whether and how to record patient transfer calls, keep in mind that the hospital is obligated under the HIPAA Privacy Rule to protect patient health information shared during these communications.  Therefore, it is important that the hospital determine how it will record and how it will store these communications.  If, for instance, the hospital decides to contract with another entity to record and store these communications, then the entity will likely be furnishing business associate services.  In this case, it would necessary for the hospital and the entity to enter into a business associate contract to ensure that the entity is safeguarding these communications in a manner appropriate under HIPAA.

February 18, 2021

QUESTION:        We entered into an exclusive contract with an anesthesia group, and were wondering whether we can require the anesthesiologists and other group personnel to submit to drug and alcohol testing?

ANSWER:           Yes – as long as testing is addressed in the contract.  Since exclusive contracts are usually between the hospital and the group – and not with the individual physicians of the group – only the group itself is actually bound by any requirements set forth in the contract.  Therefore, it’s important that the contract language state that each of the group’s physicians, as a condition of providing services at the hospital under the contract, shall be free from the influence or presence of alcohol or drugs and that this shall be enforced by the group, which shall conduct testing of its physicians at the time of conditional offer of employment, following a reasonable suspicion of use or abuse, and upon return to work after a leave of absence for drug or alcohol treatment.  This approach can be reinforced by requiring every physician of the group to sign an agreement to be bound by all the terms of the hospital’s contract with the group (and the contract should state that the group will require each physician to sign such a statement as a condition of employment).  Also, a hospital and its medical staff can achieve a similar result by having drug and alcohol testing requirements in the bylaws or another medical staff policy.  Since a group’s physicians would have to be appointed to the medical staff and granted clinical privileges in order to practice at the hospital, the group’s physicians would have to comply with any requirements in the bylaws or other policies, including those for drug and alcohol testing.

February 11, 2021

QUESTION:        I hear that the new Stark regulations have a way that Stark violations can be corrected without penalty.  Is that so?

ANSWER:           Yes, within limits.  CMS has now given hospitals and doctors a new way to correct noncompliance with the Stark law without having to make a self-disclosure.  The regulations, which became effective on January 19, 2021, contain a new regulation at 42 CFR §411.357(h) that allows parties to a compensation arrangement to reconcile all discrepancies while a contract is in effect or up to 90 days after it terminates so long as after the reconciliation the arrangement fully complies with all elements of the applicable exception.

For example:  say a hospital contract with a medical director calls for payment at $140 per hour but the doctor is paid $150 per hour.  If $150 still is within FMV range, all that is necessary is to reflect that in amendment going forward.  If the amount actually paid exceeds fair market value, the contract can be amended to recoup payments in excess of FMV via an offset against amounts due in the future (e.g., a payroll deduction) while the relationship is in effect, but the entire amount of the excess must be recouped within 90 days after the contract ends.

CMS also said that not every error will cause a financial relationship to be out of compliance with Stark nor must every mistake or error be corrected in order to maintain compliance.  Administrative and operational errors that are identified and rectified in a timely manner will not cause a relationship to be out of compliance.  In addition, CMS said that not all transfers of remuneration create compensation arrangements.  Examples include mistaken payments that are never identified, theft, use of office space not in lease, use of equipment beyond the expiration of the lease term or slight deviation from written agreement such as a one-time incorrect rental payment.

This new option is a great alternative to resorting to the Stark self-disclosure protocol.  To learn more about it, stay tuned for an upcoming Health Law Expressions podcast, where Horty Springer attorneys Josh Hodges and Dan Mulholland will discuss this new rule, or e-mail them at jhodges@hortyspringer.com or dmulholland@hortyspringer.com.

 

September 17, 2020

QUESTION:        Some big drug companies sent letters to our hospital saying that they would stop selling us 340B drugs unless we participate in the 340B “ESP” program and give them specific claims information.  Is this legal?

 

ANSWER:          There is some question as to whether drug companies can condition the sale of 340B to submitting this kind of information.  The letters we have seen cite concerns about duplicate discounts between the Medicaid and the 340B program. These requests also raise serious questions about whether the disclosure of claims information would comply with HIPAA unless the protected health information is de-identified – which is easier said than done – or the drug companies sign business associate agreements – which is unlikely. The American Hospital Association recently sent a letter to the Secretary of HHS in opposition to these requests. Some of the requests set a deadline of October 1 for compliance, but it is doubtful that the matter will be resolved by then.  Stay tuned for further developments.  For more information, contact Henry Casale at hcasale@hortyspringer.com or 412-687-7677.

August 22, 2019

QUESTION:        Should we use a separate form to obtain informed consent for the administration of anesthesia?

ANSWER:           The answer may vary depending on state law.  As a general rule, most states will give you discretion on how to structure your informed consent forms.  If you wanted, you potentially could place all relevant information onto a single form.  However, our research shows that the trend nationwide is to utilize a separate form for this purpose.  It tends to be more convenient and efficient.  Similarly, most organizations will also employ a separate form for blood transfusions.

Be aware that it is crucial to document informed consent appropriately.  If you have any questions about the design of your informed consent forms, or about the process outlined in your policies, we strongly encourage you to reach out to your hospital counsel.  It is vital to have up-to-date documents that comply with all applicable laws and that meet the needs of your institution.