August 8, 2024

QUESTION:
We are part of a ten-hospital system.  Each hospital medical staff has its own bylaws, policies, and rules and regulations.  While we have tried to make them consistent over time, there are still a lot of differences in our documents, including in nomenclature, appointment criteria, and the process for suspensions, investigations, and hearings.  Any suggestions??

OUR ANSWER FROM HORTYSPRINGER ATTORNEY SUSAN LAPENTA:
If it helps, you should know, you are not alone.  Most health systems grew through acquisition, one hospital at a time.  Each new hospital had its own medical staff which had their own governing documents which, of course, the medical staff was reticent to change.

At the same time, working with, maintaining, and updating multiple sets of medical staff governing documents is a herculean task.  It also creates the undesired but inevitable opportunity for the documents to become more divergent and even conflicting with time.

That is why many health systems are moving in the direction of rewriting their medical staff governing documents with a focus on the core objectives of consistency and uniformity.  The rewriting often starts with the development of template documents.  While the medical staff bylaws must live at the local level to comply with accreditation standards, starting from the same template document will result in the bylaws being almost identical throughout the system.

When it comes to other medical staff documents, you have more flexibility.  We advocate for the development and adoption of medical staff policies that live at the system level but that are implemented locally by each medical staff.  These policies typically include a system credentials policy, peer review policy, professionalism policy, and practitioner health policy.  The end result is that instead of there being different policies at each hospital medical staff, there is a single system.

An undertaking like this requires commitment, engagement, strong physician leadership, and an ability to “think outside the box.” But the rewards are long lasting.  If you are looking for a mantra to jump start your medical staff bylaws revision project, we offer the sage guidance from a system CMO:  “Our goal, across the system, is to make our medical staff documents as standardized as possible and as unique as necessary.”

If you have a quick question about this, e-mail Susan Lapenta at slapenta@hortyspringer.com.

August 1, 2024

QUESTION:
Our Medical Staff Bylaws allow the MEC or Board to be represented by a lawyer at a medical staff hearing only if the practitioner who requested the hearing is also planning to be represented by a lawyer. We recently went through a hearing where this caused some issues, because the physician who was the chair of the MEC at the time the Committee made its adverse recommendation was not available to present the MEC’s case at the hearing. No one else wanted to step up to advocate the MEC’s position at the hearing. Since the practitioner did not choose to be represented by his lawyer, we had to scramble to find someone to represent the MEC at the hearing. We wish we could have used our lawyer. Is there a better way to handle this?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
There is a better way to handle this! You will be glad to know that neither the Medicare Conditions of Participation for Hospitals nor the accreditation standards prohibit hospitals or their medical staffs from being represented by a lawyer at a hearing, even if the practitioner is not represented. Additionally, the Health Care Quality Improvement Act (“HCQIA”), which grants a safe harbor for immunity for the hospital and those who engage in peer review activities on behalf of the hospital, does not prohibit the hospital or its MEC from having legal representation. The HCQIA does require you to permit the physician who requested the hearing to have legal representation at the hearing, and to provide notice to the physician of that (and other) rights to which he is entitled at the hearing. But if the physician fails to take advantage of those rights – including the right to be represented – there is no obligation on the part of the hospital or MEC to make the same sacrifice. So, it is completely within your discretion to amend the Medical Staff Bylaws to make representation at hearings a right of both parties (without regard to whether the opposing party decides to be represented). Of course, you should always check with your counsel first, so that any applicable state laws and regulations can be consulted (just in case those include more stringent hearing provisions).

While you are free to (and probably should) adopt Bylaws language that provides for a universal right to legal representation at medical staff hearings, you should consider a different course of action when conducting professional review activities that are part of the collegial, progressive steps of the peer review/professional practice evaluation processes. We have long recommended that the peer review process be conducted as it was originally intended: peer-to-peer, without the meddling of legal counsel. After all, the whole point of “peer” review has always been to ensure that those who have the clinical expertise and ethical/professional obligations of the medical profession are at the forefront of reviewing their colleagues’ work and assisting with continuous performance improvement. Lawyers play no role in this process. Having lawyers present at collegial conversations and interventions can only hamper conversation and increase defensiveness. It is sure to stifle the process.

For this reason, we have always recommended that Bylaws documents and peer review policies state that no lawyers are allowed (both for the peer reviewers and for those subject to the review process) at these types of meetings. Your policy might allow for rare exceptions to this general rule, where requested by the practitioner subject to review and for good reason, but only if the exception is agreed to by the committee/body conducting the peer review activity. Further, we recommend that such exceptions rarely be made. Importantly, however, if an exception is made to allow the practitioner to bring a lawyer to a meeting, the peer review body should also be granted the same exception (allowing its legal counsel to be present, if it so desired).

In sum, at a medical staff hearing, the practitioner will always be entitled to be represented by counsel if he or she wishes. Therefore, the MEC and Board are not in any way compromising the interests of the physician if the Bylaws provide them with the unqualified right to utilize counsel for representation at the hearing (regardless of whether the physician chooses to have legal representation). By contrast, in routine peer review activities at the Hospital, the practitioner will almost never be entitled to be represented by counsel and, in turn, it would be unfair to allow the MEC and Board to utilize legal representation at meetings that are held pursuant to that process – unless an exception has been made to the general rule, permitting the practitioner to bring counsel to a meeting.

If you have a quick question about this, e-mail Rachel Remaley at rremaley@hortyspringer.com

July 25, 2024

QUESTION:
We are confused about whether an applicant for Medical Staff appointment and clinical privileges is entitled to a hearing because of his failure to disclose certain unfavorable information and our decision to not process his application.  The physician claims that he is entitled to a hearing.  How should we handle this?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK
While it is always important to consult requirements under state law, which may address situations when a hearing is required, your Medical Staff Bylaws or Credentials Policy (“Bylaws”) should clearly define the consequences for certain events and the circumstances that give rise to a hearing.  For example, if the physician failed to disclose an “accusation” filed against him by the state licensing board and such information is requested on the application, the Bylaws should spell out the results of failing to disclose such information requested on the application.  Specifically, the Bylaws should state that any misstatement in, or omission from, the application is grounds to stop processing the application. A decision not to process an application for these reasons should not entitle the applicant to a hearing or appeal (and this should be clear in your Bylaws).

With that in mind, it also makes sense to review your application forms to confirm that the application questions are seeking information that you need to make an informed decision about someone’s qualifications.  For example, your application should not only seek information on past actions by licensing boards, it also should ask for information on pending actions.  Confirm that the questions on the application form are consistent with provisions in the Bylaws with respect to the threshold eligibility criteria that someone must satisfy for eligibility for appointment.  If one of your threshold eligibility criteria requires an applicant to “have a current, unrestricted license to practice that has never been subject to any restrictions, conditions, or probationary terms and have never had a license to practice in any jurisdiction denied, revoked, restricted or suspended by a state licensing agency,” then there should be a corresponding question on the application seeking this information.

Finally, your Bylaws should place an obligation on members to notify the Medical Staff Office of any change in information provided as a part of the application and state that a failure to do so may result in administrative relinquishment of appointment and clinical privileges.  This permits the Medical Staff and Hospital to evaluate any changes in an individual’s qualifications, weigh those changes against eligibility criteria, and assess the appropriateness of any applicable consequences under the Bylaws.  Unless state law requires it, an automatic relinquishment of appointment and clinical privileges because of failure to continuously satisfy threshold eligibility criteria does not give rise to a Medical Staff hearing.

If you have a quick question about this, e-mail Charlie Chulack at cchulack@hortyspringer.com

July 18, 2024

QUESTION:
We asked a physician to attend a Leadership Council (a small group of Medical Staff leaders) meeting to provide input about some recent behavioral concerns we have had about them. The physician agreed, but only if they can bring their attorney. Our policies don’t address a provider’s ability to bring an attorney to meetings like this, so do we have to let the attorney attend the meeting?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR
Nope. In this scenario, you do not have a legal obligation to permit an attorney to attend. The meeting is not a hearing where you would be required to allow the physician’s attorney to be present. It is simply an opportunity for the hospital and physician to get together and discuss the concerns in a collegial manner.

The physician should feel free to consult an attorney, have the attorney accompany them to the hospital, etc., but once the doors shut to that meeting, you do not have an obligation to allow that attorney to be on the other side of them accompanying the physician.

Moving forward, there are some ways you can edit your policies, so you avoid this kind of conundrum in the future. Hospital policies should make it clear that in collegial and educational meetings, like the one you described, no counsel representing the practitioner, medical staff, or hospital will be permitted to be present. Putting something like this in writing gives you a clear place you can point to and say, “sorry our policy doesn’t allow that.”  By not allowing attorneys for any party, it also creates an equal expectation for all parties involved.  And, let’s face it, keeping attorneys out of these collegial/education conversations keeps them just that – collegial and educational. Once you add attorneys to the mix, that heat dial moves up whether you intend it to or not because things just feel more confrontational.

If you have a quick question about this, e-mail Hala Mouzaffar at hmouzaffar@hortyspringer.com.

July 11, 2024

QUESTION:
A physician recently resigned employment with a group that’s affiliated with the hospital.  Is there anything we should consider with respect to the physician’s Medical Staff appointment and privileges?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI
Yes, you’ll want to evaluate whether the physician is still eligible for continued appointment and privileges under the Medical Staff Credentials Policy (or Bylaws).

Malpractice insurance is often provided through employers, so physicians who resign their employment often lose their malpractice coverage.  Most Medical Staff Credentials Policies state that such insurance is a threshold eligibility criterion for appointment and privileges and that physicians will “automatically relinquish” their privileges if they lose their insurance.  (If your Credentials Policy doesn’t say this, it should!)  So, one step is to determine if the physician has acquired new malpractice insurance.

Similarly, Credentials Policies often require physicians to have acceptable coverage arrangements to be eligible for appointment and privileges.  Resignation from a group may mean that those coverage arrangements are no longer in place, so the existence of appropriate coverage should be confirmed with the physician.

Finally, all the other eligibility criteria in the Credentials Policy should be reviewed to determine if the physician’s resignation from employment will cause the physician to be ineligible.  For example, some Credentials Policies require the physician to maintain an office within the hospital’s service area as a condition of being granted appointment and privileges.

On the employment side, a physician’s employment contract may contain an “incident and coterminous” provision saying that the physician’s privileges will automatically be resigned upon termination of the contract.  Similarly, the contract may include a restrictive covenant prohibiting the physician from practicing in a defined geographic area for a certain amount of time after the contract ends.  However, the employer (not the Medical Staff) is responsible for enforcing such contractual provisions.

If you have a quick question about this, e-mail Mary Paterni at mpaterni@hortyspringer.com.

June 27, 2024

QUESTION:
Is there any evidence that offering free trips or other freebies to a physician induces that physician to order the product sold by the person or entity that offered the freebie?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The federal government thinks so and so did the jury in a recent case.

In a qui tam case that was brought against the Cameron-Ehlen Group, Inc., d/b/a Precision Lens (“Precision Lens”), and its owner Paul Ehlen, the qui tam relator, and ultimately the federal government, alleged that Precision Lens and Mr. Ehlen provided kickbacks to ophthalmologists in various forms, including travel and entertainment, to induce those physicians to order Precision Lens’ Intraocular Lens (“IOLs”).

The unlawful “remuneration” in this case was alleged to consist of Precision Lens and Mr. Ehlen transporting certain physicians who had a history of using Precision Lens’ IOLs to luxury vacation destinations on a private jet – which was typically flown by Mr. Ehlen. The alleged remuneration included multiple trips, high-end skiing, fishing, golfing, hunting, sporting, and entertainment vacations, often to exclusive destinations such as New York City to see a Broadway musical, the College Football National Championship Game in Miami, and the Masters golf tournament in Augusta, Georgia.

Mr. Ehlen claimed that he was personal friends with these physicians and that the trips were gifts from one friend to another.  Mr. Ehlen and Precision Lens argued that the Antikickback Statute (AKS) does not prohibit a friend from providing a gift to another friend, even if the friends happen to do business with each other. Armed with this “friends” defense, Mr. Ehlen and Precision Lens rolled the dice, and risked a jury trial.

Unfortunately for Precision Lens and Mr. Ehlen, the government was able to convince a jury that the various “gifts” that Precision Lens, and its owner, Mr. Ehlen provided to the ophthalmic surgeons constituted unlawful remuneration that was intended to induce the physicians to order Precision Lens’ IOLs in cataract surgeries that were reimbursed by Medicare. It didn’t help that the government was also able to prove that Precision Lens maintained a fund, referred to internally at Precision Lens as a secret fund or slush fund, that was used to finance many of these multiple physician trips.

Another interesting aspect of this case that helps to explain the jury’s verdict was the government’s expert witness.  In order to convince the jury that the intent of the free trips was to induce the physicians to order Precisions Lens’ IOLs rather than IOLs manufactured by another company, the government presented a medical device marketing expert who provided testimony on how companies use gifts and incentives to influence physicians to use their products.  The expert witness provided research that showed that gifts and other incentives trigger the impulse to reciprocate, even if it was just subconsciously, and even at levels disproportionate to the gift.

This expert also testified that although doctors generally claim that their medical decisions are not influenced by the financial benefits they receive from product manufacturers, these benefits do in fact have a strong influence on medical decision making.

Apparently, the jury believed this expert witness along with the other evidence presented by the government because the jury concluded that the free trips were unlawful kickbacks provided to the ophthalmic surgeons with the intent to induce their use of the Precision Lens’ IOLs in cataract surgeries reimbursed by Medicare.  The jury then entered a judgment against Precision Lens and Mr. Ehlen in the amount of $487,048,705.13, which in early 2024 was reduced to a mere $216.7 million.

The OIG and DOJ believe that the fraud and abuse laws level the playing field for all competitors. They argue that a company such as Precision Lens should be competing with the manufacturers of similar products, on price and quality, not by giving the physicians who order their products lavish gifts.  The expert testimony in this case supported this argument.  That expert testimony should be kept in mind any time a referral source considers providing something of value to a referring physician.

If you have a quick question about this, e-mail Henry Casale at hcasale@hortyspringer.com.

If you want to learn more about the OIG, the Anti-Kickback Statute, the Stark Law, the False Claims Act, exclusive agreements, the recent FTC regulations on noncompete agreements, and much more, check out our latest episode of The Kickback Chronicles podcast and also join us at the Hospital-Physician Contracts and Compliance Clinic Seminar in Las Vegas from November 14-16, 2024!

June 20, 2024

QUESTION:
We liked those tips for running an effective meeting that you gave two weeks ago. Do you have any more tips for running an effective meeting?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Sure, let’s get right to them!

The first tip deals with post-meeting tasks.  The meeting attendees should have clear goals and assigned tasks after leaving the meeting.  For example, does research need to be done?  Be clear on the specific issue that is to be researched, how it is to be presented (a memo?  Oral report?), when it is due (one week prior to the next meeting?  At the next meeting?) and to whom the results are to be reported (the chair?  Everyone on the committee?).

The second one deals with how a chair keeps order at a meeting.  By strict adherence to Robert’s Rules of Order?  No!  We recommend that Robert’s Rules be looked to for guidance, but not be binding, and that the chair reserve the power to make all definitive procedural rulings.  Why?  Because if there is a parliamentarian on the committee, he or she can dominate the discussion just because he or she knows Robert’s Rules inside and out.  Also, it’s impractical to expect everyone on the committee to know all of the rules, and we don’t want to put them at a disadvantage during meetings.  So, don’t get bogged down in Robert’s Rules – think fundamental fairness.

The last one deals with how to record what happened at a meeting.  You should have someone take notes to prepare the minutes of the meeting.  The minutes record the decisions of the committee.  We’ll save what should be in minutes, and what should be left out of minutes, in a future Question of the Week, which hopefully, won’t be in two weeks.

If you have a quick question about this, e-mail Nick Calabrese at ncalabrese@hortyspringer.com.

June 13, 2024

QUESTION:
We have several clinical departments that have either weak chairs or chairs who are there entirely by “default” and really seem to have very little interest in the position.  Our support staff then have to spend a significant amount of their time chasing down these chairs for the documentation and other input they are required to provide into our processes – which takes these folks away from their own functions.  Department chairs are relied upon to perform a really important role.  How can we get stronger leaders interested?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
In many hospitals, it has been traditional to rotate the department chair position so that everyone gets (or is forced to take?) their turn.  However, not every physician, quite frankly, has an aptitude for, or interest in, medical staff leadership.  One answer might be to develop stronger qualifications for serving in medical staff leadership roles, including officers and department chairs, and to provide compensation for these roles.  Another question to ask is if there are too many departments.  Consider consolidating departments.  By having fewer positions to fill, you then have a larger pool of qualified people who want to serve.

That said, one of the biggest changes that we have seen in medical staff leadership in the recent past (and one which we now recommend strongly!) is to eliminate the use of “ad hoc” nominating committees for identifying medical staff leaders – whether they be officers, department chairs, or committee chairs – and the movement toward a standing committee dedicated to leadership development and succession planning that meets throughout the year.  Having a standing committee in place allows the leadership to take a more comprehensive look at the medical staff, identifying new members who might make good leaders in the future – giving them time for training, education, and development.

June 6, 2024

QUESTION:
Our chair runs the most horrible meeting ever.  The problem with that is that I’m the chair!  Do you have any tips that could help me?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Do we ever.  The chair is the presiding officer and being the chair is hard work, so here are some tips for the chairs, or anyone, to have an efficient meeting:

Tip #1. Start on time.  If a meeting isn’t started on time, chances are it won’t end on time.  Starting on time shows that the chair has expectations for his or her meeting.  If the chair is taking the meeting seriously, the participants will more than likely take it seriously, and not treat it as a weekly, monthly, etc., casual get‑together.

Also, if a meeting always starts on time, the participants will more than likely be there on time.  No one likes to walk into a meeting late.  But, if the meeting never starts on time, the participants may start thinking “Well, it’s 15 minutes past the start time, so the meeting probably didn’t start, but if it did, I’m not going to be that late.”  Or, being late becomes a joke “I can believe you started already – it’s only 15 minutes past the start time!  What happened, did everyone synchronize their watches?”

Being late to a meeting disrupts the meeting.  The participant who is late may not pick up on the discussion, or if the chair summarizes what has already been discussed for the late-comer, the chair may “lose” those who were there on time.

So, start on time, no matter who is in the room, don’t summarize for late-comers – that can be done after the meeting, and no excuses for being late.  It sounds rigid, but when the word gets around that you start on time, that’s one building block in running an efficient and effective meeting.

Tip #2. Encourage participation.  The chair should get every attendee involved.  Some attendees may not speak because he or she may be shy, or feel intimidated, but the chair should draw those attendees in to get multiple points of view.

Tip #3. Limit the conversation.  This doesn’t mean that the chair should not hear from everyone who wants to contribute their point of view.  The purpose of a meeting is to get different points of view, then make a decision.  What “limit the conversation” means is that if a couple of people in the room are making the same point, over and over again, that’s unproductive, so the chair should step in and say “Ok, any other points of view that we haven’t discussed yet?”  Also, if a discussion “drifts,” the chair should step in and restate the purpose of the discussion.  This can be hard to do, because chairs don’t want to be seen as dictators, but it is a skill that needs to be developed.  Otherwise, the participants start thinking the meeting is a waste of time, and the downward spiral begins.

Tip #4. Take an issue off-line.  There are times when a meeting is getting bogged down because no one has the information needed to make a decision.  For example, is the bylaws revision being discussed a Joint Commission Standard?  A Medicare Condition of Participation?  A best practice?  If no one knows for sure, further discussion will not help the committee make a decision, so that issue should be taken off the agenda until the next meeting, to research the issue.

Another reason to take an issue off the agenda is because there are so many conflicting points of view that won’t be able to be resolved at the meeting.  The chair should be able to recognize that no matter how much more discussion there is, the issue won’t be resolved.  So, at that point, the chair should stop the discussion, and maybe appoint a small group to investigate or research the issue, then bring the results back to the committee.

Tip #5. End on time.  If a meeting is to end at 8:30 a.m., end the meeting.  Although some attendees don’t mind going over, the majority will start thinking about work that needs to be done, or another meeting to go to, or an appointment to make.  A meeting that runs on and on and on isn’t efficient and becomes much less effective as time goes on.  The chair should remember that he or she is dealing with attendees who have volunteered their time to participate on this committee and be at this meeting, so respect their time.

Also, not ending on time affects meeting attendance.  If an attendee knows that the meeting always goes over, he or she is less likely to attend the meeting.

It’s just a fact that sometimes agendas are just too full, or there may have been too much discussion on one issue, etc. – that happens.  But, instead of plowing on through with more and more disinterested attendees as each minute ticks by, just end the meeting, and hold those agenda items over for the next meeting.  The exception is if the issue is of critical importance, but that will be few and far between.

Final Tip: Introduce visitors.  The chair should introduce visitors, or participants who are attending their first meeting and may not know everyone in the room.  This will make them feel welcome, and keep everyone focused on the meeting instead of asking, or thinking “Who is that, and why are they here?”

If you have a quick question about this, e-mail Nick Calabrese at ncalabrese@hortyspringer.com.

May 30, 2024

QUESTION:
Are provider-based services performed in a mobile unit in an off-campus location covered by the site neutrality rules passed in 2016?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
No.  Just like “grandfathered” services and off‑campus dedicated emergency departments, hospital services provided in an off-campus location through a mobile facility or portable unit are excepted from that rule and are reimbursed at the full hospital outpatient rate.

Section 603 of the Bipartisan Budget Act of 2015 generally eliminated reimbursement under the Medicare outpatient prospective payment system for items and services furnished in off-campus hospital outpatient provider‑based departments established on or after November 2, 2015. Instead, hospitals would be reimbursed at the lower Medicare physician fee schedule rate.  CMS promulgated rules implementing this law in 2016, and since then the site neutrality rules have been expanded from time to time.

The key exceptions to this rule are services performed in on-campus facilities (within 200 yards of the main hospital building), dedicated emergency departments, off-campus facilities that were in operation or “mid-build” on the date the law was enacted, or a “remote location of the hospital” (a facility furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider hospital). But services performed through a mobile facility and/or portable unit are excepted as well and paid at the full OPPS rate. See CMS Transmittal 2394 (November 15, 2019).

Mobile facilities and portable units are services that require medical equipment which is provided in a vehicle or the equipment for the service is transported to multiple locations within a geographic area. The most common types of mobile facilities/portable units are mobile diagnostic testing facilities, portable X‑ray units, portable mammography units and mobile clinics. But the equipment must travel around.  A hospital can’t just park a mobile facility or leave a portable unit permanently in a off-site provider-based location and then get paid at the full OPPS rate.

Also, physical therapists and other practitioners (e.g., physicians, nurse practitioners, physician assistants) who perform services at multiple locations (e.g., house calls, assisted living facilities) are not considered to be mobile facilities/portable units.  They’re people.

On the other hand, physician services performed on mobile units are reimbursed by Medicare Part B as if they were performed in a freestanding office rather that in a hospital as they normally would be in a provider-based facility.  That is, they are reimbursed at the full physician fee schedule rate. See Medicare Claims Processing Manual 20.4.2 – Use Place of Service Code 15.

If you are still awake after that spiel and have a quick question about this topic, e‑mail Dan Mulholland at dmulholland@hortyspringer.com.