Author: Courtney Patterson

August 18, 2022

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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

Posted on by Courtney Patterson

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.

July 7, 2022

Posted on by Courtney Patterson

QUESTION:
We have several clinical departments that either have weak chairs or chairs who are there entirely by default because “it was their turn!”  These individuals 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 in the department gets his or her turn. However, not every physician has an aptitude for, or interest in, medical staff leadership. And to be perfectly honest, many do not even know what the role will require of them before they assume the position.  One answer may be to develop stronger qualifications for serving in medical staff leadership roles, including officers and department chairs, and to provide compensation for department chairs.  Another question to ask is if there are too many departments. Consider including guidelines in the governance documents that provide factors for the Medical Executive Committee to consider when deciding whether to eliminate (or establish) clinical departments that clearly explain the functions that the individuals within such a department have to fulfill. On that basis, you might consider consolidating departments or doing what many hospitals have done, which is moving to a service line model. By having fewer positions to fill, you then have a larger pool of qualified people who want to serve!

June 30, 2022

Posted on by Courtney Patterson

QUESTION:
A doctor on our medical staff recently wrote an inappropriate comment to a coder after she requested that he provide clarification to some medical record documentation.  The comment included profanity, and did not answer the coder’s question, but it was not otherwise aggressive or insulting.

As Chief of Staff, my inclination is to simply send the practitioner a “knock it off” email and then leave it alone.  It was inappropriate, sure, but why make a mountain out of a molehill?

Is this consistent with good peer review?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:

Medical Staff leaders have a lot of flexibility to determine those interventions that are most appropriate for a given situation.  With that said, there are some principles that tend to promote “good” peer review and which we would suggest you consider as you decide to proceed:

  • First, there is value in keeping a good record of everything that is reviewed through the peer review process (whether informal or formal peer review efforts). So, if you have not already done so, we recommend that you refer this matter to the Hospital personnel who support the peer review process (often the Medical Staff Services director or a dedicated quality/professional practice evaluation professional) and ask that they keep a record of this reported concern in their databases.  Further, a copy of any written report of this matter should be kept in the practitioner’s confidential file.
  • Second, it is a good idea to pull the practitioner’s peer review history before you decide how to review and manage this incident. If this practitioner has a history of other professionalism issues, you might choose to pursue the matter differently.  So, while you’re talking to the Medical Staff Office/PPE professionals about logging in the new reported concern, it is a good idea to also ask that the practitioner’s peer review history be pulled so that you can review any relevant information.
  • Third, before you finalize your decision on how to proceed, please make sure you consult the Medical Staff Bylaws and relevant policies (in this type of case, that will probably be the Medical Staff Credentials Policy, Medical Staff Professionalism Policy, and Rules and Regulations) to identify the specific rule(s) that have been violated and, additionally, identify whether your policies call for the matter to be referred to a specific individual or body for a fact inquiry and further management. While many Medical Staff Bylaws and policies give the Chief of Staff the authority/discretion to manage low-lying peer review matters collegially and informally, some dictate that all reported concerns of professionalism will immediately be referred to a particular individual or body (e.g., the Leadership Council or CMO).
  • Fourth, if you find that your policies give you the discretion to manage the matter collegially and informally, understand that there is value in a peer review process that is methodical. The general, at-large Medical Staff will feel more confident in the peer review system if they observe consistency and feel that the process gives the same treatment to every practitioner.  This does not mean that your Bylaws and policies should not give Medical Staff leaders discretion to tailor the response to match the conduct at issue.  But, be sure that flexibility is not taken to the extreme.  It would undermine trust in the process if one practitioner were given a formal, written reprimand for the type of note you are dealing with, while another was simply told in passing to “knock it off.”  So, as you move forward, consider – Is the approach that you have in mind consistent with how similar issues have been handled in the past?
  • Fifth, many modern peer review policies (including Medical Staff Professionalism Policies) give leaders the discretion to manage low level issues through informal “mentoring” efforts (or other similar efforts, sometimes termed “collegial conversations,” “cup of coffee conversations,” etc.). Acknowledging that these types of conversations happen – and are part of our peer review process – helps to ensure that they are protected and avoids claims that these efforts are being conducted in bad faith, outside the process.  Informal efforts need not be verbal, if you think that a written communication (e.g., email or a brief letter) would be better.  Letters of guidance, letters of education, and other similar writings (e.g., letters of awareness) are often used to serve a similar purpose – to inform a practitioner about an opportunity for improvement without, as you put it, “making a mountain out of a molehill.”  The tone is often direct and to the point, setting forth the need to comply with the relevant standard going forward, but without getting too confrontational.  For informal communications such as this, there is usually no response from the practitioner required or expected.

Even though these communications are informal, a copy should be placed in the practitioner’s confidential file.  We recommend letting the practitioner know – and inviting him or her to respond if he or she wishes to do so (in which case you should keep the response in the file, too).

  • Finally, most modern “good” peer review processes have built in oversight. So, whenever a case is managed by a leader or leadership body (e.g., a committee), the results should be reported to a central source (either through recording the disposition in an electronic system or reporting the outcome to an individual, such as the PPE professional) so that data can be tracked and studied regarding all cases that are identified for peer review, who is handling them, how they are being handled, etc.  This not only helps to promote consistency in the process, but also helps to avoid reported concerns falling through the cracks and not being addressed.

June 23, 2022

Posted on by Courtney Patterson

QUESTION:
We’re updating our process for peer review of clinical concerns. We want it to be more effective and less feared by Medical Staff members. Any tips?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
Yes!  Here are a few:

  1. Create a Multi-Specialty Committee. Create a multi-specialty committee that works with practitioners on a voluntary basis to address clinical concerns.  If the multi-specialty committee believes there’s an opportunity for improvement with the care provided by a practitioner, the committee presents an improvement plan to the practitioner and asks the individual to voluntarily participate.  If the practitioner disagrees with the need for the improvement plan, the matter would be referred to the Medical Executive Committee for its independent review under the Medical Staff Bylaws/Credentials Policy.  This approach allows the multi-specialty committee to remain a supportive committee with no disciplinary authority, while the MEC is a second layer of review when needed.
  1. Obtain Specialty Expertise. Identify small committees or individuals (depending on state law) for each specialty that provide the specialty expertise that informs the decisions of the multi-specialty committee.  In larger hospitals with more volume, these committees/individuals can be authorized to take certain performance improvement actions (such as sending educational letters or engaging in collegial counseling discussions) while more significant concerns are sent to the multi-specialty committee for its review.
  1. Get Input from the Practitioner. A process will be perceived as more fair and credible if the practitioner under review has been provided notice of any concerns and an opportunity to provide input about those issues.  No performance improvement action should occur until the practitioner’s input has been obtained.
  1. Adopt Mechanisms to Identify “Lessons Learned” and “System/Process Issues.” Peer review should help everyone get better.  Case review forms and committee minutes should specifically ask if a review identified a lesson that would be of value to others in the specialty, or a system/process issue that needs to be fixed.  There should be mechanisms to ensure that such lessons learned or system/process issues are shared with the appropriate individuals or committees for follow-up action, and the multi-specialty committee should keep these items on its agenda until it receives word that they have been addressed.
  1. Stop Scoring. Rather than asking reviewers to assign a numerical value or category to a case, the reviewer should simply assess whether there was a concern with the care provided.  If so, how could that concern be addressed?  Scoring causes practitioners to be defensive and diverts energy away from what really matters in the review process (i.e., how to help a practitioner improve).
  1. Words Matter! The term “peer review” is viewed negatively by most practitioners.  Using new terminology will help to emphasize that a new process has been created that is educational and not focused on restrictions of privileges.  Consider creating a “Committee for Professional Enhancement” or “Performance Improvement Committee” rather than a more traditional “Peer Review Committee.”  Similarly, refer to the process as the “professional practice evaluation” process rather than “peer review” process.

For more information about creating an effective peer review process for clinical concerns, please join us this season at The Peer Review Clinic in Las Vegas, Orlando, or Nashville!

June 16, 2022

Posted on by Courtney Patterson

QUESTION:
We would like to learn more information about a new statement of policy issued recently by our State Medical Board.  Do State Medical Boards have to respond to Freedom of Information Act (“FOIA”) requests?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
It depends.  The federal FOIA provides public access to all federal agency records not covered by an exception or exclusion.  According to 5 U.S.C.A. § 552, FOIA requests apply only to federal agencies, not to records held by Congress, the courts, or by state or local government agencies.  Since State Medical Boards are functions of state governments, they fall outside the limits of FOIA requests.

However, all states have implemented their own FOIA-like statutes that parallel the federal FOIA and allow access to information related to state agencies.  Before you can definitively determine whether a State Medical Board would have to respond to a state FOIA-like request, you need to consider any possible exceptions the state may have carved out for health professional related agencies.

For example, Oregon has developed its own FOIA request system, but if an individual wants to access the public records of a health professional regulatory or health licensing board that have been deemed confidential or exempt from public disclosure, they must demonstrate to the Attorney General, “by clear and convincing evidence that the public interest in disclosure outweighs,” the public