September 15, 2022

QUESTION:
What is the “counterparts” provision of a contract?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICK CALABRESE:
A counterparts provision basically recognizes that, sometimes, all of the parties can’t be in the same room together, at the same time, and sign the agreement.  So, separate copies of the agreement are signed.  This usually occurs in large transactions with many multiple parties, but can occur even in smaller transactions.  In any event, none of the copies will have all of the signatures on them.  So, if the CEO signs his or her copy, and the other party signs its copy, the contract is valid.  If, say, the CEO wants to make sure the other party actually signed the agreement, the CEO could ask that party to send a copy of the signature page, or even the entire agreement, to the hospital.

A typical counterparts provision will state:  “This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute a single Agreement.”

But, note that the absence of a counterpart provision may not in and of itself invalidate an agreement that the parties execute by separate counterparts.  However, it helps to prevent a party from claiming that an agreement is not binding because there is no single copy of it that is signed by all the parties.

September 8, 2022

QUESTION:
Can the medical staff of a critical access hospital be part of a unified medical staff within a multi-hospital system?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
As of the date of this e-mail (September 8, 2022), the answer is no, but a change could be in the works soon.  In 2014, the Centers for Medicare & Medicaid Services (“CMS”) revised the Medicare Conditions of Participation to allow a “unified and integrated” medical staff in hospitals that are part of a health system.  Previously, CMS had required that each hospital have its own separate medical staff.  In the past, even if medical staffs in a system had overlapping membership, CMS required that the medical staffs be “separate.”  However, the CMS Interpretive Guidelines provide as follows:

[A] hospital system that includes certain types of hospitals, i.e., Hospitals-within-Hospitals or Hospital Satellites, that are being paid under a Medicare payment system other than the Hospital Inpatient Prospective Payment System (IPPS) might jeopardize the Medicare payment status of those excluded hospitals if it owns both the tenant and host hospitals and uses a unified medical staff for both.  (Emphasis added.)

42 CFR §482.22(b)(4).  This effectively prevented CAHs from being part of a unified medical staff within a system.  CMS reiterated this rule in 2017 when it approved an application from The Joint Commission to have deemed status for surveys of CAHs. 82 Fed. Reg. 49,817, 49,818 (Oct. 27, 2017).

However, on July 6, 2022, CMS proposed that this prohibition be lifted and that medical staffs of CAHs be permitted to be part of a unified medical staff within a multi-hospital system subject to essentially the same rules (e.g., opt-in and opt-out rights, consideration of local circumstances, etc.) that apply to unified medical staffs within PPS hospitals. 87 Fed. Reg. 40350, 40376.  Comments closed on August 29, 2022, so the proposal may be final at any time now.  Stay tuned for further developments in the Health Law Express.

September 1, 2022

QUESTION:
We have new Medical Staff leaders taking office the first of the year and would like to get them trained up when they start. Do you have any virtual options available?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
Do we ever!!! Several partners here at HSM have been working on a new virtual Medical Staff Leader Orientation & Toolkit program that will be available on January 26, 2023. This six-hour course will cover leadership, credentialing, and peer review topics, providing your new leaders with the tools they will need to get off on the right foot!

You can obtain more information and register for this program here.

August 25, 2022

QUESTION:
I just got back from what was probably the worst-run medical staff committee meeting ever. The problem is that I’m the chair and was running the meeting!  I thought it would be easy, but it was a lot harder than it looked. Any pointers?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Running a meeting is hard work – here are some tips that may help:

Tip #1.  Start on time.  This is one of the most important tips.  If a meeting isn’t started on time, chances are it won’t end on time, and that has consequences which we’ll discuss below.  If a meeting always starts on time, the attendees will more than likely be there on time, since no one likes to walk into a meeting late, and being late disrupts the meeting.

Tip #2.  Limit the conversation.  What “limit the conversation” means is that if a couple of attendees 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, 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 #3.  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 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 when there are so many conflicting points of view that the issue won’t be able to be resolved at the meeting.  The chair knows that no matter how much more discussion there is, the issue won’t be resolved.  So, 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 #4.  End on time.  This is the most important tip.  If a meeting is to end at 8:30 a.m., end the meeting.  Although some attendees don’t mind going over, others will start thinking about work that needs to be done, or another meeting to go to, or an appointment to make – focus is lost.  A meeting that runs on and on and on isn’t efficient and becomes much less effective as time goes on.  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.

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.

August 18, 2022

QUESTION:
Our On-Call Policy requires physicians to have 30 admissions or operating cases at the hospital per year to participate in the on-call schedule. The Policy also gives discretion to the department chairs, who develop the call schedules, to limit the ability of a particular physician to participate in the schedule for a number of reasons, some of which have nothing to do with the quality of care being provided. Do these provisions in our Policy pose any legal concerns?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
Yes. First, conditioning participation in the call schedule on admissions at, or procedures done in, the hospital could be interpreted as conditioning participation on referrals to the hospital. Such a requirement could present compliance issues with the federal Anti-Kickback Statute. In Supplemental Compliance Program Guidance for Hospitals, the Department of Health and Human Services Office of Inspector General (“OIG”) cautioned that “conditioning privileges on a particular number of referrals or requiring the performance of a particular number of procedures, beyond volumes necessary to ensure clinical proficiency, potentially raise substantial risks under the [Anti-Kickback] statute.” Some state courts have found that participation on the call-coverage roster constitutes a “privilege.”

This issue is something that is on the Department of Justice’s radar as well.  For example, in 2010, a hospital agreed to pay the United States $108 million to settle claims that it violated the Anti‑Kickback Statute and the False Claims Act by limiting the opportunity to work at an outpatient cardiology testing unit to cardiologists who referred business to the hospital, giving the cardiologists a percentage of time in the testing unit which corresponded with the gross revenue attributed to the cardiologists’ referrals.  Conditioning participation on the call roster on admissions or performing cases at the hospital presents similar risks.

If compensation is involved in the call coverage arrangements, there is further concern under the Anti‑Kickback Statute. The OIG has warned that under the Anti-Kickback Statute there is “considerable risk” in conditioning compensation for on-call coverage on “doing business at a hospital.”

Finally, giving the department chairs the discretion to limit the ability of a physician to take call poses anticompetitive concerns. While there may be legitimate reasons to limit the ability of a physician to take call, such as issues with a physician’s quality of care, such decisions should not be made solely by potential competitors in the department.

August 11, 2022

QUESTION:
Our state Department of Health informed us that we are required to have cameras installed in our chemotherapy unit so that patients receiving treatment can be observed via a monitor at the nurses’ station. Since we will be recording patient care activity, do we need to post signs stating that cameras are in use?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
CMS’s Interpretive Guidelines to the Medicare COPs regarding physical privacy indicate that “audio/video monitoring (does not include recording) of patients in medical surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring,” and the monitors or speakers are not visible or audible to visitors or the public.  However, “video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.”

If the hospital is only monitoring the patients via video and not creating a recording, the patients and their representatives only need to be “aware of the monitoring.” In that case, signs would satisfy the requirement and be an appropriate way to inform them that monitoring is occurring.  On the other hand, if a true “recording” will be made, then a more formal consent would be required by CMS.

It is also important to check state law in these circumstances, as most states have their own laws that govern audio and video recordings that could be applicable.

August 4, 2022

QUESTION:
We are developing a hospital-wide animal visitation policy. What are some things we need to consider including so that we are compliant with the Americans with Disabilities Act?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
This is a great policy to have. We all love animals, but it’s important to make sure that you take the necessary steps to identify the proper use of service animals and acceptable visitation rules for therapy animals. Today, let’s focus on service animals. Under the ADA, covered entities, like most hospitals, are required to provide reasonable accommodations for people with disabilities. The service animal rule falls under this requirement. In other words, places that have a “no animals allowed” policy provide an exception that allows service animals in their facility.

What is a service animal? Well, it is a dog of any breed that has been trained to work or perform a task for an individual with a disability. For example, a person with a panic disorder may have a dog that is trained to sense an upcoming panic attack and to help lessen its impact.

When building an animal visitation policy, you want to include a section that considers service animals and sets out general rules for your staff to follow. For instance, when it is unclear as to whether a dog in your facility is a service animal, your staff may not inquire into the nature of the person’s disability, may not ask for documentation, and may not require that the dog perform its trained task. Rather, your staff may only ask (1) if the dog is a service animal that is required because of a disability and (2) what work or tasks has the dog been trained to perform.

If the patient requires basic assistance from staff, then staff may be required to accompany the patient while they attend to their service animal (i.e., taking their dog for a walk, but requiring a wheelchair). Under the ADA, the patient, or service animal handler, bears full responsibility for the dog and must be in control of it at all times. This includes making arrangements to pass the dog off to family members, or even boarding the dog, in the event that the patient is unable to provide the necessary care.

Make sure to review the ADA regulations governing service animals in detail, and feel free to reach out to Mary Paterni with any additional questions.

July 28, 2022

QUESTION:
I see in this week’s New Cases that the Connecticut No Surprises Act does not have a private cause of action in the event an insurance company fails to reimburse a provider who provides care to an Out-Of-Network (“OON”) emergency department patient in the manner required by that state’s No Surprises Act.  Is this the same under the federal No Surprises Act that went into effect on January 1, 2022?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
No. The federal No Surprises Act (“NSA”) anticipates that disputes will arise and has two separate arbitration processes that may be used in the event of a dispute. One arbitration process is for  patients who receive medical bills for a non-covered service that exceeds the good faith estimate required by the NSA by at least $400.  The other arbitration process is specifically intended to apply in the event of a dispute between an OON provider and an insurer, such as the one that was described in the Connecticut case.

To summarize, the NSA restricts a hospital (or where permitted by state law, an independent emergency department) and/or the emergency department physicians from charging OON patients who receive emergency services at the OON emergency department more than the OON patients would be charged if the OON patients were treated at an in-network emergency department.

If the NSA applies, then neither the hospital, the emergency department physicians, nor the insurer can charge the OON emergency patient more than the in-network amount.  The NSA then requires the insurer to reimburse the hospital and the emergency department physicians for the care they have provided to the OON emergency department patient.  However, the NSA does not dictate the amount that the insurer must pay the OON hospital and the emergency department physicians unless the amount is required by a state All-Payer Model Agreement or specified by state law.

In the absence of an applicable All-Payer Model Agreement or specified state law, the insurer must make an initial payment or a denial of payment to the OON provider within 30 calendar days. The hope is that the insurer and the OON providers will be able to agree on the amount of reimbursement due the OON hospital and the emergency department physicians.  However, if the parties cannot agree, then, unlike the Connecticut law, the NSA has a dispute resolution process that must be followed by all involved in any fee dispute.

If either party believes that the payment amount is not appropriate (it is either too high or too low), it has 30 business days from the date of initial payment or denial of payment to notify the other party that it would like to negotiate.  Once notified, the parties may enter into a 30-business day open negotiation period to determine an alternate payment amount.  If following this 30-business day period, the OON providers are still not happy with the amount being offered by the insurer, then the OON providers may take advantage of the NSA’s arbitration process in order to determine the amount of payment.

Unfortunately, on February 23, 2022, the United States District Court for the Eastern District of Texas, in the case of Texas Medical Ass’n, et al. v. United States Department of Health and Human Services, et al., Case No. 6:21-cv-425 (E.D. Tex.), invalidated the NSA regulations governing this arbitration process.  However, in April 2022, CMS and the Departments of Labor and the Treasury issued Independent Dispute Resolution (IDR) Guidance for Certified IDR Entities.  Those guidelines can be found at: https://www.cms.gov/sites/default/files/2022-04/Revised-IDR-Process-Guidance-Certified-IDREs.pdf

Section 6 of these guidelines addresses payment disputes.  The guidelines have retained “baseball” (i.e., High/Low) type arbitration.  In this type of arbitration, the arbitrator must choose one of the party’s offers.  The arbitrator has no authority to “split the baby in half” or otherwise deviate from either of those offers.

The guidelines then require the arbitrator to consider the “Qualified Payment Amount” (“QPA”).  Unlike the original regulations that were the subject of the Federal Court’s injunction, these guidelines also permit the arbitrator to also take into account additional credible information relating to the offers submitted by the parties that relates to the circumstances.

Generally, the QPA is defined as the median of the contracted rates recognized by the plan for the same or similar item or service that is provided by a provider in the same or similar specialty and provided in the same geographic region in which the item or service under dispute was furnished, increased by inflation. The plan must calculate the QPA using a methodology established in the July 2021 NSA interim final rules.  The guidelines then state that information is considered credible if, upon critical analysis, the information is worthy of belief and is trustworthy.

“Worthy of belief and is trustworthy” information that may be considered by the arbitrator includes the level of training, experience, and quality and outcomes measurements of the provider or facility that furnished the item or service in dispute; the experience or level of training of a provider that was necessary to provide the item or service to the patient; whether their experience or training made an impact on the care that was provided; the market share held by the provider or facility or that of the plan in the geographic region in which the item or service was provided; how the market share affects the appropriate out‑of‑network rate; and the acuity and complexity of the care provided.

Therefore, regardless of the terms of any state law, the federal NSA provides OON providers with the right to arbitrate payment disputes and to provide information that is trustworthy and pertains to the care at issue.

TO LEARN MORE ABOUT THE NSA, THE OIG FRAUD ENFORCEMENT ACTIONS DISCUSSED IN THIS WEEK’S GOVERNMENT AT WORK, THE FEDERAL FRAUD AND ABUSE LAWS, AND MUCH MORE, JOIN HENRY CASALE, DAN MULHOLLAND AND MARY PATERNI FOR OUR “HOSPITAL-PHYSICIAN CONTRACTS AND COMPLIANCE CLINIC” THAT WILL BE HELD IN LAS VEGAS, NEVADA FROM NOVEMBER 17‑19

July 21, 2022

QUESTION:
Our hospital recently employed a small group of orthopedic surgeons. There have been rumblings that hospital administration was unhappy with the performance of the private orthopods and there is clear tension between administration and the private group. There was an incident last week in the cafeteria where one of the private orthopods allegedly yelled and got in the face of one of our hospital administrators. The administrator wants to deescalate the situation and hasn’t filed a complaint, but how should we as a medical staff handle the matter?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY JOHN WIECZOREK:
This is an excellent question and the administrator’s response is completely understandable, but the best practice in this situation is to follow your Medical Staff Professionalism Policy.  If medical staff leaders become aware that a practitioner’s behavior in the hospital may be inconsistent with the expectations for medical staff members, the leadership can and should review that behavior under the Professionalism Policy.  The review by the medical staff leadership does not depend on the administrator filing a complaint.

The Professionalism Policy should require that appropriate fact-finding take place and that the private orthopod have an opportunity to provide input.  This fact-finding and input will allow the medical staff leaders to understand the context in which the dispute occurred.

As I said, the administrator’s hesitance in filing a complaint is natural.  From that individual’s perspective, filing a complaint will not only increase the tension that seems to be occurring between hospital administration and the private orthopods, but it will also open a door for the private orthopods to claim they are being targeted by administration.  However, the risk of not acting is that potentially inappropriate behavior is not addressed.  This is bad for the culture at the hospital and the credibility of the medical staff leadership.  Also, allegations that administration is targeting the private orthopods can be addressed by good fact-finding and documentation (e.g., by talking with others who witnessed the event).  Allegations of bias, while scary, would be easily dispelled in this situation.

Additionally, the downsides of not filing a complaint are potentially much greater.  For example, what if the surgeon’s behavior continues to cause disruption in the hospital and the medical staff needs to impose some form of discipline?  Without addressing this particular incident, your medical staff will be missing a key part of the record to use if and when the time comes to deal with the surgeon’s behavioral issues.

July 14, 2022

QUESTION:
We’re revising our Medical Staff Bylaws, which require that we run criminal background checks at initial appointment on all Medical Staff applicants.  There’s no disagreement there, but there is disagreement as to whether we should also run criminal background checks at reappointment.  Any thoughts?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Although this differs from hospital to hospital, in our experience, the majority of hospitals are not running new criminal background checks at reappointment.  Why?  Most hospitals have strong language in the Medical Staff Bylaws that require Medical Staff members to keep the hospital updated on any new criminal activity. So, the rationale is that once an individual is on the Medical Staff, the hospital will know about any additional criminal activity because Medical Staff members have an obligation to inform the hospital of such activity.  While this is not necessarily foolproof – a hospital can only truly verify that criminal activity hasn’t occurred by running subsequent background checks – in terms of an industry standard, we feel comfortable saying that many hospitals are only running full checks at initial appointment, not reappointment.  So, a hospital could reasonably decide not to run these background checks on an ongoing basis.  There is one caveat here – you should check to see if there are any state law requirements regarding criminal background checks and how often to run them.