Author: jwilbert

October 17, 2024

Posted on by jwilbert

QUESTION:
Our leadership team is getting a lot of conflicting information as to what we can and cannot do regarding political campaigns.  Where can we go to find the rules?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICK CALABRESE:
A 501(c)(3) organization cannot participate in or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.  The word “any” is emphasized because no de minimis amount of political intervention is permitted and the penalties can be harsh – penalties range from a warning, to an injunction, to a tax on prohibited political expenditures, to revocation of tax‑exempt status.

Since the penalties can be so serious, the IRS has provided a number of guides to help hospitals recognize and to avoid these penalties:

Rev. Rul. 2007‑41 provides 21 examples of Political Campaign Dos and Don’ts

April 12, 2024, Congressional Research Service Guide

August 19, 2024, IRS FAQ about the ban on Political Intervention

2024 IRS Mini Course on the ban on Political Intervention

We also recommend this short podcast by HortySpringer partners Dan Mulholland and Henry Casale in which they review the rules and also discuss the guidance from the IRS in terms of what a hospital can and cannot do this election season.

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

August 1, 2024

Posted on by jwilbert

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

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 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.

December 21, 2023

Posted on by jwilbert

QUESTION:
I have always found the OIG’s past “Compliance Guidance” to be vague and not particularly helpful.  Is there anything more recent that will provide an analytical framework to comply with the Anti-kickback statute?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
The Anti-kickback statute is an intent-based statute.  So, the OIG can be forgiven to a certain extent for their “it depends” guidance on compliance with this law.  However, given the fact the Anti‑kickback statute is a criminal statute and that federal health care program claims resulting from a violation of this law will also constitute a violation of the False Claims Act, even the OIG has realized that more definitive guidance is required.

The OIG seems to have heard your plea for help, and has provided the following analytical framework for compliance with the Anti-kickback statute on Pages 12-14 of the November 6, 2023, OIG General Compliance Program Guidance (“GCPG”).

When attempting to identify problematic arrangements under the federal Anti-kickback statute, some relevant inquiries to explore and consider can include the following.  This list of questions is illustrative, not exhaustive, and the answers to these questions alone are not determinative as to whether an arrangement violates the federal Anti-kickback statute.

Key Questions:

(1)        Nature of the relationship between the parties –

        • What degree of influence do the parties have, directly or indirectly, on the generation of federal health care program business for each other?

(2)        Manner in which participants were selected –

        • Were parties selected to participate in an arrangement in whole or in part because of their past or anticipated referrals?

(3)        Manner in which the remuneration is determined –

        • Does the remuneration take into account, either directly or indirectly, the volume or value of business generated?
        • Is the remuneration conditioned in whole or in part on referrals or other business generated between the parties? Is the arrangement itself conditioned, either directly or indirectly, on the volume or value of federal health care program business?  Is there any service provided other than referrals?

(4)        Value of the remuneration.

        • Is the remuneration fair market value in an arm’s-length transaction for legitimate, reasonable, and necessary services that are actually rendered?
        • Is the entity paying an inflated rate to a potential referral source? Is the entity receiving free or below-market-rate items or services from a provider, supplier, or other entity involved in health care business?
        • Is compensation tied, either directly or indirectly, to federal health care program reimbursement?
        • Is the determination of fair market value based upon a reasonable methodology that is uniformly applied and properly documented?

(5)        Nature of items or services provided.

        • Are the items and services actually needed and rendered, commercially reasonable, and necessary to achieve a legitimate business purpose?

(6)        Federal program impact.

        • Does the remuneration have the potential to affect costs to any of the federal health care programs or their beneficiaries?
        • Could the remuneration lead to overutilization or inappropriate utilization?

(7)        Clinical decision making.

        • Does the arrangement or practice have the potential to interfere with, or skew, clinical decision making?
        • Does the arrangement or practice raise patient safety or quality of care concerns?
        • Could the payment structure lead to cherry-picking healthy patients or lemon-dropping patients with chronic or other potentially costly conditions to save on costs?

(8)        Steering.

        • Does the arrangement or practice raise concerns related to steering patients or health care entities to a particular item or service, or steering to a particular health care entity to provide, supply, or furnish items or services?

(9)        Potential conflicts of interest.

        • Would acceptance of the remuneration diminish, or appear to diminish, the objectivity of professional judgment?
        • If the remuneration relates to the dissemination of information, is the information complete, accurate, and not misleading?

(10)      Manner in which the arrangement is documented.

        • Is the arrangement properly and fully documented in writing?
        • Are the parties documenting the items and services they provide? Are the entities monitoring items and services provided?
        • Are arrangements actually conducted according to the terms of the written agreements (when written to comply with the law)?

Is this perfect guidance – No.  But it is a significant improvement over any compliance guidance that the OIG has provided in the past.  In fact, we find the OIG’s New General Compliance Guidance to provide an excellent framework for compliance with the Anti-kickback statute, and a number of other federal laws that affect health care providers.

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

For an in-depth discussion of the OIG’s November 6, 2023, OIG General Compliance Program Guidance, please check out the Horty Springer Health Law Expressions Podcast  “New OIG General Compliance Program Guidance by Dan Mulholland and Henry Casale.”

 

June 1, 2023

Posted on by jwilbert

QUESTION:
Our hospital recently employed a small group of urologists.  The hospital wanted more control over the group’s on-site hours and scheduling.  While three of the urologists are great culture fits, there was concern about one group member whose behavior with staff has raised eyebrows in the past, but no action was ever taken.  There was an incident last week in the cafeteria where this troublesome urologist allegedly yelled and confronted 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 and should we work with the hospital as the urologist’s employer?

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 is not dependent on the administrator filing a complaint.

The Professionalism Policy should require that appropriate fact-finding take place and that the urologist has 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.  Review of the urologist’s behavior should not be in isolation, and if the previous issues alluded to in your question have been recorded, medical staff leadership should be using those to provide context to the fact-finding.  The question for your medical staff leadership would be whether there’s a behavioral trend that needs to be addressed via collegial intervention, a performance improvement plan, or other means.

As for working with the urologist’s employer, the hospital, we highly recommend doing so.  While the medical staff’s final action and the employer’s final action regarding the confrontation are independent of each other, the fact-finding process of each can be beneficial to the other.  Within proper channels, the sharing of information can allow both the employer and your medical staff to make a more informed disposition of the urologist’s confrontational behavior.

If you have a quick question about this, e-mail John Wieczorek at jwieczorek@hortyspringer.com.

 

March 9, 2023

Posted on by jwilbert

QUESTION:
A few weeks ago, an anesthesiologist resigned from our medical staff to take an opportunity out of state.  Recently, one of the anesthesiologist’s cases was flagged by a peer review specialist who sent me an email asking whether we should continue with our standard peer review process.  Do you have any guidance?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY JOHN WIECZOREK:
This situation is more common than you’d think, but always tricky.  Because the anesthesiologist is no longer a member of your medical staff, we would advise that peer review of that anesthesiologist’s medical services provided at your hospital should be discontinued.  The purpose of peer reviewing a specific physician is to ensure and improve quality; this purpose can no longer be effectuated if the anesthesiologist has left the medical staff.  Among other things, many of the tools that could be used to improve care would no longer be available (such as asking the questions about the case, having the anesthesiologist complete additional training, or monitoring a few of the anesthesiologist’s cases at the hospital).

Also, depending on state law, a malpractice attorney may argue that the peer review privilege no longer applies to reviews conducted after the anesthesiologist has left the medical staff.  Finally, if the anesthesiologist turns around and sues the hospital for whatever reason, continuing peer review of the anesthesiologist after their departure may give an eager plaintiff’s attorney something to hang onto (e.g., allegations that the purpose of the review is to harm the physician).

This does not mean the case should completely fall out of review; system-issues that were identified outside of the care being provided by the anesthesiologist are still relevant and should be addressed.  We would just advise that any issues related to the anesthesiologist’s practice at the hospital be put aside.

February 9, 2023

Posted on by jwilbert

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

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

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

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

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

January 12, 2023

Posted on by jwilbert

QUESTION:
We have a contract with a Patient Safety Organization (“PSO”) and are concerned by the Garcia case summarized in this week’s Health Law Express.  Is there anything that we can do to enhance the eligibility of information we are generating for protection under the Patient Safety and Quality Improvement Act (“PSQIA”)?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK:
Information becomes Patient Safety Work Product (“PSWP”) when it is collected as a part of a provider’s Patient Safety Evaluation System (“PSES”).  Therefore, it makes sense for health care providers that have an agreement with a PSO (or who are considering one) to draft a robust PSES Policy that specifically identifies information that is being collected as a part of its PSES.  The policy should also state that the information is being collected “solely” for reporting to a PSO and constitutes PSWP.  However, before identifying information to include in the PSES, a health care provider should review any applicable laws and regulations that define information collection and reporting obligations.  For example, Pennsylvania requires healthcare entities to report patient safety events to the state.  Under HHS Guidance (and most of the case law on the subject), such information would not be considered PSWP because it is not developed “solely” for reporting to a PSO – it is also being developed for reporting to the state.  The court in Garcia goes one step further, holding that a contractual obligation to generate patient safety information renders that information ineligible for protection as PSWP under the PSQIA. As noted above, this is an incredibly narrow interpretation of the privilege under the PSQIA and sees no support in the PSQIA regulations (although it is consistent with another recent case from a federal court in Oregon – Dence v. Wellpath).  The court appears to indicate that the contract’s reference to accreditation standards provides another reason the mortality review was generated, further removing it from the PSQIA protection.  However, the PSQIA regulations contain a PSWP disclosure exception for “voluntary disclosure[s] to an accrediting body.”  This suggests that information could qualify as PSWP and still be shared with an accreditation entity, such as The Joint Commission, to demonstrate that a health care provider is meeting accreditation standards.  Thus, the court’s reliance on obligations created by accreditation standards as a justification for certain information not being eligible to become PSWP is puzzling.  Nevertheless, development of a PSES is a tricky task, and a health care provider should review its information generation and reporting obligations to assist in defining its PSES and what qualifies as PSWP.

December 22, 2022

Posted on by jwilbert

QUESTION:

Our hospital has noticed that on-call coverage by other local hospitals has gotten thinner since the pandemic.  If other hospitals adopt lighter on-call schedules, it means more patients are transferred to our hospital and our on-call physicians have more of a burden.  Is it acceptable for these other hospitals to have limited (or zero) on-call requirements for their specialists?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

The Emergency Medical Treatment and Labor Act (“EMTALA”) requires every Medicare-participating hospital with an Emergency Department to have an on‑call schedule.  Specifically, each hospital is required to have “a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition.”  42 C.F.R. §489.20(r)(2).

The Centers for Medicare & Medicaid Services (“CMS”) expects a hospital to provide adequate on-call coverage consistent with the services provided at the hospital and the resources the hospital has available.  If a hospital has physicians on the Medical Staff who routinely provide services in their specialty to patients in the community, the hospital is expected to also provide a reasonable amount of on-call coverage in that specialty.

Prior to 2003, CMS informally operated under the “three‑physician rule.”  This rule stated that if there were three or more specialists on a hospital’s Medical Staff, CMS expected that hospital to provide on-call coverage 24 hours a day, 365 days a year.  In other words, under the three-physician rule, physicians were each expected to provide about 10 days of on-call coverage per month.

In 2003, CMS specifically disavowed the three‑physician rule.  In lieu of the three‑physician rule, CMS said it will use an “all relevant factors” test by which CMS will:

  • consider all relevant factors, including the number of physicians on staff, other demands on these physicians, the frequency with which the hospital’s patients typically require services of on‑call physicians, and the provisions the hospital has made for situations in which a physician in the specialty is not available or the on‑call physician is unable to respond.

CMS has refused to give any firm guidance on the number of days of coverage a hospital must have per physician under the “all relevant factors” test.  Thus, a hospital will only know if its on-call schedule is compliant if, after a complaint and CMS investigation, the hospital is found to be in compliance with EMTALA.

If you have reason to believe that another hospital’s on-call coverage is inadequate or nonexistent, you may want to first gather data to attempt to confirm this is the case.  If the data seem to confirm a problem exists, you might want to arrange a meeting with the other hospital to discuss the issues.  EMTALA allows for hospitals to work together to develop “community call plans” – this might allow all the involved hospitals to make better use of their resources.

There’s certainly no easy solution to on-call problems.  Hopefully, gathering data and communicating will result in better outcomes than any of the alternatives.