Question Of The Week

July 25, 2024

Posted on by jwilbert

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

Posted on by Courtney Patterson

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

Posted on by jwilbert

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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.

May 23, 2024

Posted on by Courtney Patterson

QUESTION:
Recently, as part of our routine peer review process, a physician was asked to provide a written response to a behavioral concern that had been reported by one of our nurses.  The physician now wants to know who filed the report.  Should we disclose the identity of the nurse?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZZAFAR:
No.  At this stage in the peer review process, we strongly recommend protecting the identity of any individual willing to come forward and raise a concern.

In most cases, who raised the concern is irrelevant.  For clinical concerns, the matter will be evaluated based on what is in the medical record, so whoever reported the matter is unrelated to the concern.  For behavioral concerns, assuming that witnesses are interviewed, and they corroborate the original reported concern, the individual’s identity is also irrelevant.

However, even if you do not disclose the identity of the nurse, that does not mean that the physician under review cannot guess who filed the report.  Accordingly, it is useful to gently remind physicians to avoid any action that could be perceived as retaliatory, even if retaliation isn’t the intent.

Depending on how far into the peer review process this matter gets, it is possible that you will eventually disclose the reporter’s identity.  For instance, if you get to the point that a Medical Staff hearing is going to be held to consider restricting the physician’s clinical privileges, the physician should be provided access to the same documents considered by the hearing committee.

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

May 16, 2024

Posted on by Courtney Patterson

QUESTION:
We’re a hospital located in Pennsylvania and want to enter into a services agreement with a company in South Carolina.  The company has a good reputation, but has filed lawsuits against a few hospitals for breach of contract.  One of our concerns is that if the relationship doesn’t go well, it would be extremely expensive and disruptive to defend a lawsuit in South Carolina. What can we do?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
You should make sure the agreement contains a “Choice of Law and Venue” provision that favors the hospital.  This provision states where a lawsuit is to be filed (venue), and which state’s law applies.  If the hospital drafts the agreement, it should give itself the home field advantage by stating that Pennsylvania law applies and any lawsuit is to be filed in courts having jurisdiction over the county in which the hospital is located.  If the company drafts the agreement, it will most likely give itself the advantage.  However, even if the company drafts the agreement, you can still try to negotiate with it so that the hospital has the advantage.  How the negotiations turn out is, of course, about leverage.

Home field advantage is huge too – the party that has it knows the state’s law, knows the judges, and knows the courtroom.  Also, the party with the advantage does not have to find local counsel to work with its in-house lawyers, or incur costs for itself and/or its lawyers by traveling to and from the location of the lawsuit (which can be an enormous cost and inconvenience in the case of extended litigation).

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