Author: jwilbert

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.

January 20, 2022

Posted on by jwilbert

QUESTION:

Our hospital has granted clinical privileges to practitioners who work primarily in outpatient facilities which are a part of the same health system as the hospital.  How do we conduct FPPE to confirm competence and OPPE for these practitioners when they have limited to no volume in the hospital, but the hospital wants them to retain their privileges in case it needs them to provide patient care services?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLIE CHULACK:

During the COVID-19 pandemic, this is an important question because hospitals are scrambling for methods to cover the clinical needs of an influx of patients when there are community spikes in infections and hospitalizations.  Thus, they may want to have practitioners “at the ready” even though their primary practice location is not in a hospital.

Nonetheless, you do have some options when it comes to these “low volume practitioners.”  To use The Joint Commission terminology, for “focused professional practice evaluation” (or “FPPE”) to confirm competence and “ongoing professional practice evaluation” (or “OPPE”), the hospital can have the low volume practitioner provide one or more of the following types of information:  (1) information from their primary practice location, such as ongoing professional practice evaluation reports, a quality profile, and/or patient satisfaction surveys, (2) detailed reference requests from their primary practice location, (3) detailed peer evaluations from individuals who have directly observed or who are in a regular referral relationship with the practitioner, or (4) medical records of patients treated at the primary practice location so that the hospital may conduct an evaluation of the care provided.

If the low volume practitioner works almost exclusively in outpatient settings, the above information, if part of a general request, may not address their clinical skills in a hospital setting.  But, you can structure the requests so that the information received relates to the clinical privileges that the practitioner has in the hospital.  For example, while not completely analogous, if the primary practice location is an Urgent Care Center for a practitioner seeking or granted clinical privileges in emergency medicine, the information requested could target the performance of histories and physicals, the ordering and interpretation of diagnostic studies, the administration of medications, and the requesting of consultations/making of appropriate referrals.

For those hospitals that are accredited by The Joint Commission, keep in mind the FAQ issued on March 4, 2021, which provides as follows:  “When practitioner activity at the ‘local’ level is low or limited, supplemental data may be used from another CMS-certified organization where the practitioner holds the same privileges.  The use of supplemental data may NOT be used in lieu of a process to capture local data.”  Thus, The Joint Commission requires that at least some of the data used to confirm competence come from the hospital conducting the evaluation.  The Joint Commission gives hospitals significant flexibility in the type of information collected by the hospital for professional practice evaluation, so you can be creative.

We should mention that for health systems that have outpatient locations operating as departments of the hospital (i.e., as provider-based outpatient departments), then any FPPE or OPPE that was completed in that outpatient setting would be viewed as having occurred “in the hospital.”  In this case, The Joint Commission requirements would be satisfied based on what was done in the outpatient setting.

Another tool to deal with low volume practitioners is to grant an exception that permits them to remain subject to FPPE to confirm competence for the duration of the Practitioner’s appointment term for some or all clinical privileges.  This option may be used because of community need, coverage requirements, the rare nature of a given procedure or treatment, or other relevant factors.  We believe this is a reasonable interpretation of the relevant standards based on the needs of hospitals during the COVID-19 pandemic.

May 13, 2021

Posted on by jwilbert

QUESTION:   We have a practitioner on the Medical Staff with a long, well-documented history of behavior problems.  We have tried to work with him collegially – and not just once.  Our file is, no kidding, 300+ pages and includes conversations, memos, reprimands, “agreements,” mentorship arrangements, coaching, and more.  Nothing works!  Truth be told, everyone is fed up, but this practitioner has a dual diagnosis of PTSD and alcoholism (in recovery now).  Is there anything we can do without it constituting disability discrimination?

ANSWER:       A hospital and/or its Medical Staff leaders are well within their authority to take action on inappropriate/ unprofessional conduct even when the individual displaying that conduct is suffering from a legally-protected disability (and even when the disability may be contributing to the individual’s undesirable behaviors).

Before taking adverse professional review action (e.g. suspension, revocation) against the practitioner, consider:

  • Would we take the same action against any other (non-disabled) practitioner who displayed these behaviors?
  • Are the objectionable behaviors clearly articulated in our policies and procedures, so that the practitioner was on notice that this type of behavior is not acceptable at our workplace?
  • Might a reasonable accommodation help this provider to control his/her health condition, so that he/she can come into compliance with our policies (by modifying his/her behaviors)? Has the practitioner asked for an accommodation?
  • Have we exhausted all collegial efforts that could reasonably be used to try to help the practitioner to modify his/her conduct and voluntarily come into compliance?

The Americans with Disabilities Act and other anti-discrimination laws (which in some jurisdictions apply to independent contractors, such as Medical Staff members) provide important protections to the disabled, to help ensure that disabled individuals who are able to work are not prevented from doing so because of unsupported presumptions about their conditions or plain bigotry.  However, those laws do not require employers and workplaces to continue to tolerate conduct that violates internal policies simply because the individual is disabled.

Many Medical Staff leaders worry about being sued for discrimination if they pursue peer review activity with respect to a colleague who has a known disability.  While there is always the risk of a lawsuit (litigiousness seems to be a growing hobby!), know that if the conduct of the practitioner has been documented, clearly violates policy, and has been addressed in accordance with your professionalism or peer review process, the risk of liability from moving forward is low.  And the improvement to the workplace is sure to be exponential.

Of course, it’s always a good idea to consult with legal counsel when considering an adverse professional review action, as they can help you to evaluate your documentation and compliance with internal policies – to ensure not only your defense against future claims, but also to ensure that any missteps that may have occurred during the peer review process are identified and corrected now, before any action is taken.

April 1, 2021

Posted on by jwilbert

QUESTION:       I’m supposed to take minutes of meetings I attend, but I don’t know what to include, what not to include, etc., and everyone I ask has a different view.  Help!

ANSWER:           We’re not sure either so we can’t help you at all.  APRIL FOOLS!  We’ve reviewed minutes that could have fit on a 5 by 7 inch index card, and others that are as thick as a phone book (if those even exist anymore).  Here are the “Do’s” for taking minutes:

    1. DO – write down the name of the committee that’s meeting.
    2. DO – write down the date of the meeting.
    3. DO- list who’s in attendance, and who’s absent.
    4. DO – list if there are any guests or visitors at the meeting.
    5. DO – note the time the meeting was called to order, who called it to order, and the time it was adjourned.
    6. DO – note whether it’s a regular or special meeting of the committee.
    7. DO – note that if it’s a special meeting, that notice was given to the committee members, and the way notice was given (mail, e-mail, personal delivery, etc.).
    8. DO – note whether a quorum was present (this eliminates the argument that the action of the committee wasn’t valid because of the lack of a quorum).
    9. DO – note whether the previous minutes were read and approved.
    10. DO – note the result of the votes, for example, 7 – 1 to suspend the physician’s privileges. This is the most important “Do” since the vote is the      committee’s action.  If the result of the vote is written down in black and white at the time it’s taken, there is little room to argue in the future that it was inaccurate.

…and here are the “Don’ts:”

    1. Don’t record the details of any discussion. This is the most important “Don’t”.  Sometimes, in the heat of the moment, someone may say something that they don’t mean.  Or that can be misinterpreted.  Or that was meant as a joke, but looks sinister in black and white.  If it’s recorded in the minutes, it’s there forever, and may turn up again.  There isn’t really a need to record the details of a discussion.  What’s important is the vote, the committee’s action. But, with every rule, there’s an exception.  The exception here is “Do put details of a discussion in if it helps” and it helps when a committee makes an adverse recommendation against a physician.  In that case, the minutes could be your best friend.  The details would allow the committee to record the objective reasons for taking action – physician was disruptive on this date, this date and this date and did this and this and this.  The reasons can be explained, but, comments shouldn’t be attributed to any one individual.
    2. Don’t record how each member voted, unless a committee member wants his/her vote recorded. There’s also an exception to this rule.  When a committee’s going to make an adverse recommendation and a competing physician is on the committee, the minutes should reflect that the conflict of interest principles were followed (Dr. Jones fully answered the committee’s questions, left the room prior to the vote, the vote was taken, and Dr. Jones returned to the room).
    3. Don’t record who made a motion and who seconded them.
    4. Don’t record who said what to someone else.
    5. Don’t record personal remarks unrelated to the committee’s business. For example, when discussion is regarding revocation of privileges, don’t record “Dr. Jones said that Dr. Smith pranked him on April Fools’ Day by telling him that the Health Law Express was ending.”  The only thing that’s relevant is Dr. Smith’s competence.  So record “The committee recommended that Dr. Smith’s surgical privileges be revoked because of competence concerns.”

For more about the “Do’s” and “Don’ts” as well as: confidentiality, the peer review privilege, and how to lose it; what goes in (and what, if ever, can come out of) a practitioner’s confidential file, and; sharing files with a practitioner or within a health care system, tune in to the Grand Rounds Audioconference “Medical Staff Documentation – How to Keep It Confidential” on May 4, 2021.

March 25, 2021

Posted on by jwilbert

QUESTION:       Can our professional practice evaluation/peer review committee use e-mail to communicate with physicians about the review of clinical or behavioral concerns?

ANSWER:           Yes.  Physician leaders have told us that they prefer communicating via e-mail (both internally and with the physician under review) because it’s quick and less formal than regular mail.  The lack of formality can help to reduce anxiety on the part of the recipient and convey the message that the PPE/peer review process is meant to be educational, not punitive.  In contrast, using certified mail sends the message that the Hospital is anticipating a confrontation and that lawyers will soon be involved.

Using e-mail to discuss PPE/peer review matters would not, on its own, waive the peer review privilege under state law.  However, there are several best practices that should be adopted:

    • All e-mails should include a standard convention, such as “Confidential PPE/Peer Review Communication” in the subject line.
    • E-mail should not be sent to non-Hospital accounts unless the e-mail merely directs recipients to check their Hospital e-mail.
    • If the e-mail contains any Protected Health Information (as that term is defined by the HIPAA Privacy Rule), the e-mail must comply with the Hospital’s HIPAA policies. Often, this will require that the e-mail be encrypted.
    • If an e-mail includes a deadline for a response (for example, a request for input or to attend a meeting), the Hospital may want to send a text message or call the physician to say that the e-mail is being sent. The goal is to ensure the physician is aware of the e-mail so the deadline is not missed.  However, the Hospital’s policy should also make clear that failure to send a text message or make a phone call is not an excuse for the physician to miss a deadline.

Of course, there are times when it’s more appropriate to use a formal letter.  If a physician has not responded to prior collegial efforts, a letter may help to convey the seriousness of the matter.  Also, the applicable Medical Staff policy should always be checked to ensure it does not require correspondence to be sent via certified mail or some other form of “Special Notice.”  This is typically the case where a matter has progressed to a formal Investigation or a Medical Staff hearing is under way.