Author: Courtney Patterson

June 15, 2023

Posted on by Courtney Patterson

QUESTION:
What are the laws/regulations around listing providers on a hospital directory? We’re revamping our provider directory, and have heard there are certain requirements for listing a provider in a directory.  Can we limit the providers listed to just those who are employed by us?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The OIG has long had a safe harbor for “referral services.”  The regulation, at 42 CFR §1001.952(f), reads as follows:

Referral services.  As used in section 1128B of the Act, “remuneration” does not include any payment or exchange of anything of value between an individual or entity (“participant”) and another entity serving as a referral service (“referral service”), as long as all of the following four standards are met –

(1)        The referral service does not exclude as a participant in the referral service any individual or entity who meets the qualifications for participation.

(2)        Any payment the participant makes to the referral service is assessed equally against and collected equally from all participants and is based only on the cost of operating the referral service, and not on the volume or value of any referrals to or business otherwise generated by either party for the other party for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs.

(3)        The referral service imposes no requirements on the manner in which the participant provides services to a referred person, except that the referral service may require that the participant charge the person referred at the same rate as it charges other persons not referred by the referral service, or that these services be furnished free of charge or at reduced charge.

(4)        The referral service makes the following five disclosures to each person seeking a referral, with each such disclosure maintained by the referral service in a written record certifying such disclosure and signed by either such person seeking a referral or by the individual making the disclosure on behalf of the referral service –

(i)         The manner in which it selects the group of participants in the referral service to which it could make a referral;

(ii)        Whether the participant has paid a fee to the referral service;

(iii)       The manner in which it selects a particular participant from this group for that person;

(iv)       The nature of the relationship between the referral service and the group of participants to whom it could make the referral; and

(v)        The nature of any restrictions that would exclude such an individual or entity from continuing as a participant.

Based on this, it would be OK to only list your employed providers in the directory. Just make sure that the list clearly discloses that only employed physicians are listed.

If you have a quick question about this, e-mail Dan Mulholland at DMulholland@hortyspringer.com.

June 8, 2023

Posted on by Courtney Patterson

QUESTION:
An independent member of our Medical Staff has a long history of unprofessional conduct.  Our Leadership Council addressed various complaints using progressive steps under the Professionalism Policy, such as educational letters and collegial meetings.  We even tried sending the physician to an on-site educational course on behavior with no success.  Before we refer him to the Medical Executive Committee for its review under the Bylaws, are there any other options we could try?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:
Yes.  A “personal code of conduct” might be successful where other efforts have failed.  A personal code of conduct outlines specific expectations for behavior and, more importantly, specific consequences for failing to meet those expectations.

With respect to expectations, a personal code of conduct may simply require compliance with the standards for behavior set forth in the Professionalism Policy.  (To assist with enforcement of the personal code of conduct, it’s very helpful if the Professionalism Policy includes specific examples of inappropriate behavior.)  Additional expectations might include periodic mentoring meetings with Medical Staff leaders, 360 reviews, or additional training.

The personal code of conduct could then describe the process that will be followed to review the facts if an additional concern is raised about the physician’s behavior.  This fact-finding process may include steps in addition to those set forth in the Professionalism Policy.

The personal code of conduct could then outline the consequences if the Leadership Council determines that there has been a “formal violation.”  The Leadership Council has the flexibility to define these consequences in any reasonable manner.  For example, the first confirmed violation could result in a final letter of warning, the second could result in the physician not exercising his or her clinical privileges for five or 10 days, and the third could result in a referral to the Medical Executive Committee for a formal investigation under the Medical Staff Bylaws.  The personal code of conduct could be indefinite or have a fixed term, and the number of formal violations could be re-set to zero if the physician goes “x” months/years without a violation.

It’s important to include other language in the personal code of conduct, such as a statement that truly egregious behavior can be referred immediately to the Medical Executive Committee.

In our experience, two formal violations are not common and three formal violations are very rare.  As long as the Leadership Council is willing to enforce personal codes of conduct, they can be an effective tool for physician leaders who are attempting to deal with long-term inappropriate behavior.

If you have a quick question about this, e-mail Phil Zarone at PZarone@hortyspringer.com.

May 25, 2023

Posted on by Courtney Patterson

QUESTION:
We had an incident at one of our physician offices a couple of miles from the hospital’s main campus. Someone mentioned there may be some EMTALA concerns. Since the issue didn’t occur in the hospital’s emergency room, there is no cause for concern regarding EMTALA, correct?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
EMTALA may or may not be a concern here – depending on how the physician office operates. EMTALA requires that if an individual comes to a hospital’s emergency department “and a request is made on the individual’s behalf for examination or treatment for a medical condition, the hospital must provide for an appropriate medical screening examination within the capability of the hospital’s emergency department.”

However, just because the incident did not occur in the hospital’s emergency room does not automatically mean that EMTALA was not triggered. EMTALA responsibilities also extend to individuals who present anywhere on a hospital’s campus – not just in the emergency department – and request to be examined or treated for an emergency medical condition or if a prudent person would believe that the individual is suffering from an emergency medical condition. The hospital’s campus includes spaces like the parking lot, sidewalk, driveway, and hospital departments, including any building owned by and within 250 yards of the hospital.

Even if the physician office is several miles away, EMTALA might still apply. EMTALA can also apply to off-site departments or facilities that are deemed to be “dedicated emergency departments” of a hospital.  This would require two things.  First, the office in question would have to be operated as an “outpatient department of the hospital” (i.e., a provider-based entity under 42 C.F.R. §413.65) AND either holds itself out to the public as a place that provides care for emergency medical conditions on an urgent basis without requiring a previously scheduled appointment; OR provided at least one-third of all of its visits for the treatment of emergency medical conditions on an urgent basis without requiring a previously scheduled appointment.

So while EMTALA is likely not an issue of concern for events that took place in this physician office several miles away, remember that events that occur outside of a hospital’s emergency department may also trigger EMTALA obligations.

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

May 18, 2023

Posted on by Courtney Patterson

QUESTION:
What is a Medicare NCD and why would an NCD be relevant to the delineation of hospital clinical privileges for certain procedures?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HENRY CASALE:
A National Coverage Determination (“NCD”) is a general outline of coverage which is applicable regardless of which Medicare Administrative Contractor (“MAC”) is administering Medicare claims for a particular region.  According to CMS, NCDs are made through an evidence-based process and in some cases are supplemented by outside assistance in order to establish nationwide Medicare payment conditions for the treatment or procedure subject to the NCD.

Medicare does not have the authority to dictate the practice of medicine.  However, the Medicare program does have the authority to define what it will pay for, and under what conditions.  That is where the NCDs (as well as LCDs which are Local Coverage Determinations and are specific to a particular MAC) become relevant to clinical privilege delineations.

For example, the NCD for Percutaneous Left Atrial Appendage Closure (“LAAC”) describes the conditions under which Medicare will pay for LAAC technical and professional services.  Among the requirements of the current NCD, the LAAC must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who satisfies the following criteria:

(1)        Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and

(2)        Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and

(3)        Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a 2-year period.

What happens if you do not use the NCD in your delineation of clinical privileges for an LAAC?  That is not unlawful.  But neither the Hospital’s nor the physician’s claim will be reimbursed by Medicare if the physician who performs the LAAC does not at least satisfy the requirements in the NCD (or any other procedure where an NCD or LCD specifies certain training and/or experience).

If a claim has been submitted for such a procedure by a physician who did not satisfy the NCD or LCD’s criteria, then both the technical and the professional fees paid by the Medicare program for that procedure must be refunded.  Submitting a claim to Medicare in reckless disregard or in deliberate ignorance of Medicare’s conditions of payment constitutes a False Claim.  Keeping the reimbursement for a claim that should not have been submitted to Medicare because it did not satisfy the requirements of an NCD or LCD constitutes a “reverse false claim.”   The penalty for a violation of the False Claims Act is three times the amount of the claim plus a possible per claim penalty of between $13,508-$27,018.

Therefore, a prudent hospital will be aware of Medicare’s conditions of payment, where they exist, and will make their delineation of clinical privileges for an LAAC, or any other procedure where physician qualifications are defined in an NCD or LCD, so that at a minimum, the clinical privileges needed to perform that procedure in the hospital meet or exceed the requirements in any relevant NCD or LCD.

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

If you want to learn more about the False Claims Act, Anti-Kickback Statute, the Stark law, amendments to the regulations of those laws, and much more, consider joining Dan Mulholland and Henry Casale in Phoenix November 16-18, 2023, for our next seminar.  

In the interim, be sure to check out “The Kickback Chronicles” on the Health Law Expressions Podcast featuring Hala Mouzaffar and Henry Casale, so you can learn from the misfortune of others.

May 11, 2023

Posted on by Courtney Patterson

QUESTION:
In the Your Government at Work section of this week’s Health Law Express, it looks like the DEA and SAMHSA are intent on allowing controlled medications to be prescribed through telehealth.  Will other telehealth allowances implemented by the federal government during the Public Health Emergency continue after it ends?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
The short answer is “yes,” with the federal government extending some telehealth flexibilities temporarily and others permanently.  The Consolidated Appropriations Act of 2023 (“CAA”), for example, temporarily extended, through December31, 2024, the expansion of the types of practitioners that could bill Medicare for telehealth services.  This allows physical therapists, occupational therapists, and speech language pathologists to provide, and bill for, telehealth services provided to Medicare patients.  The CSA also temporarily allows: (1) patients to continue to access telehealth services in any geographic area (and not just rural areas), (2) patients to receive telehealth services in their homes rather than requiring travel to a health care facility, and (3) some telehealth visits to be delivered using audio-only technology (but see below for permanent changes for behavioral telehealth patients).

Many of the permanent changes to the rules have to do with behavioral telehealth services.  For example, going forward behavioral health patients can be provided with telehealth services in their homes and do not have to travel to a hospital or other health care facility.  In addition, Federal Qualified Health Centers and Rural Health Centers will qualify as distant sites (the site from where the practitioner providing the telehealth service is located) for behavior telehealth services.  Finally, behavioral health patients will continue to be able to access audio-only behavioral health services.

These extensions reflect a greater acceptance of the utility of telehealth services in the provision of health care to patients.  Don’t be surprised if in the coming years there is an additional loosening of the telehealth rules resulting in an increased use of telehealth for patients.  If you have a quick question about this, e-mail Charlie Chulack at CChulack@hortyspringer.com.

May 4, 2023

Posted on by Courtney Patterson

QUESTION:
We have recently had several applicants who are returning to practice after a significant gap in time.  What kind of policy or practices do you recommend for practitioners who are reentering practice after an extended time off?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
Practitioners may take an extended leave from practice for a variety of reasons, including family obligations, personal health, alternative careers, or retirement. Several resources for physicians returning to practice are available through the AMA and the Federation of State Medical Boards, among others.

From a Medical Staff perspective, one of the eligibility criteria we typically include in our Credentials Policy is that practitioners are not even eligible for privileges unless they can demonstrate clinical activity in their specialty in an acute care hospital setting in the past two years.  Any exception could be considered through the waiver process and might include conditions on their appointment to ensure a safe return to practice.

We have also worked with hospitals to develop a Practitioner Re-Entry Policy that gives the Medical Staff leaders the authority to develop a Re-Entry Plan for any such applicant.  Depending on the circumstances surrounding the practitioner’s absence, such a Re-Entry Plan could include, among other things, a competency evaluation, a refresher course, and/or retraining in order to ensure that the individual’s general and specialty skills are up to date.

The bottom line is that the Medical Staff must confirm the individual’s current clinical competence before putting its stamp of approval on them.

April 27, 2023

Posted on by Courtney Patterson

QUESTION:
Our state statutes and regulations governing the scope of practice for CRNAs does not require them to be supervised.  But, we are not on CMS’s opt-out list.  Why?  What does that mean?  Does that make any sense?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
The Centers for Medicare & Medicaid Services (“CMS”), through the Conditions of Participation for Hospitals, requires anesthesia services provided by a CRNA to be supervised by an anesthesiologist or the operation practitioner, with the supervisor being immediately available – unless the services are provided in an “opt-out state.”  Opt-out states are those where the state governor has specifically and in writing requested to opt out of the CRNA supervision requirements.

According to the American Association of Nurse Anesthesiology (AANA) website, “[to] date, 22 states and Guam have opted out of the federal physician supervision requirement, including Iowa, Nebraska, Idaho, Minnesota, New Hampshire, New Mexico, Kansas, North Dakota, Washington, Alaska, Oregon, Montana, South Dakota, Wisconsin, California, Colorado, Kentucky, Arizona, Oklahoma, Utah, Michigan, and Arkansas.”

If your state is not an opt-out state, then the standard rule applies; that is, CRNA services provided in the hospital must be provided with an anesthesiologist or the “operating practitioner” immediately available (in the same operating suite, not just on the premises of the hospital).

Of course, if you are a sensible person (and we presume you are!), you are probably wondering why on Earth CMS would require a governor to request an opt-out, rather than simply deferring to state law on the matter of scope of practice and supervision of CRNAs.  How does the opt-out process make any sense?

The reasoning can be found in the original rule that created the opt-out exception.  If you read the preamble to the final rule (https://www.govinfo.gov/content/pkg/FR-2001-11-13/html/01-28439.htm), you will see that, originally, CMS proposed to modify the Conditions of Participation to simply defer to state law regarding supervision of CRNAs (on the basis that states generally handle scope of practice regulation and CMS could not find persuasive evidence that it was necessary to have a federal rule requiring greater supervision of CRNAs than allowed under state law).

However, after receiving comments, CMS delayed implementation of the rule and made changes prior to finalization.  In the final rule, CMS retained the rule requiring supervision of CRNAs, but allowed governors to opt out after consulting with the state boards of nursing and medicine.  According to CMS, this change was made to account for the fact that states, when drafting their scope of practice laws, might have been relying on the fact that CMS had a stringent supervision requirement and, therefore, if CMS removed that requirement suddenly, some states might be surprised to find that CRNAs were free to practice independently (emphasis added below):

The final rule was published on January 18, 2001 (66 FR 4674) and was to have been effective March 19, 2001.  In accordance with the proposed rule, the January 2001 final rule changed the physician supervision requirement for CRNAs furnishing anesthesia services in hospitals, ASCs, and CAHs.  Under that rule, State laws would control which professionals would be permitted to administer anesthesia and the level of supervision required for CRNAs.  It did not prohibit, limit, or restrict in any way the practice of medicine by a physician or anesthesiologist.  Hospitals, ASCs, and CAHs retained the ability to exercise stricter standards than those required by State law.

On March 19, 2001, the effective date was delayed 60 days in accordance with the memorandum to the President from the Chief of Staff, dated January 20, 2001, and published in the Federal Register (see 66 FR 15352).  On May 18, the rule was further delayed for 180 days, until November 14, 2001, in order to explore alternatives for implementation (see 66 FR 27598).  In reviewing the January 2001 final rule, we identified two important questions that were not raised and thus not addressed previously.

One question concerned the States’ reliance on Medicare physician supervision requirements in establishing State scope-of-practice laws and monitoring practices.  In some cases, State laws and regulations may have been written with the assumption that Medicare would continue its longstanding policy requiring physician supervision of the anesthesia care provided by CRNAs.  Eliminating Medicare requirements now could change supervision practices in some States without allowing States to consider their individual situations.  In the absence of Federal regulations, we were concerned that States might have promulgated different laws or different monitoring practices.

* * * Both were legitimate implementation questions; thus, in addition to delaying the effective date of the January final rule, we published a new proposed rule on July 5, 2001 (66 FR 35395), which proposed an alternative method for implementing the independent practice proposal in lieu of proposing an immediate removal of the requirement.  Our alternative proposal was to – (1)        Establish an exemption from the physician supervision requirement by recognizing a Governor’s written request to us attesting that, after consultation with the State’s Boards of Medicine and Nursing on issues related to access to and the quality of anesthesia services, and consistent with State law, he or she is aware of the State’s right to an exemption from the requirement and has determined that it is in the best interests of the State’s citizens to exercise this exemption….

As you can see, even though a state may not require CRNA supervision through its own statutes and regulations, until the governor of that state requests to “opt out” of the supervision requirement of the Medicare Conditions of Participation, supervision is still required in hospitals.

April 20, 2023

Posted on by Courtney Patterson

QUESTION:
Our peer review committee recently developed a plan for a physician that involved proctoring of a number of the physician’s cases.  It came up in our meeting as to whether patients had to be informed that their physician is being proctored.  Is this required?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Proctoring is part of the confidential peer review/professional practice evaluation process.  But, as a practical matter, patients may need to be made aware of the fact that another physician may be involved in their care.  Proctoring – whether in surgical or non-surgical situations – often includes not only review of the patient’s medical record but also an examination of the patient, which means that some explanation regarding that individual’s presence must be provided.  While not always the case, if proctors are instructed to intervene in a surgical procedure if necessary, the patient should be in­formed that the proctor may participate in the procedure and that information should be included in the patient’s written consent to the procedure.

While it is the proctored physician’s responsibility to inform his or her patients about the proctoring, the patient does not have to be informed of the reason for the proctoring.  A simple statement will suffice, such as:  “The hospital and our team are committed to providing appropriate care.  Dr. Proctor will also be [working with me/may examine you/review your medical record/scrub in and be ready to assist in your procedure if necessary].”

Finally, documentation completed by the proctor should not be included in the patient’s medical record.  We recommend that proctors be provided with “proctoring forms” that elicit information in as objective a format as possible about the issues that are being assessed, and that these forms be maintained as part of the hospital’s peer review/professional practice evaluation process – not as clinical records maintained in the medical record.

April 13, 2023

Posted on by Courtney Patterson

QUESTION:
I recently started taking minutes at Medical Executive Committee meetings, and the Chair told me that it’s very important to record who made a motion, and who seconded it.  It makes me nervous because I’m new and don’t know the names of everyone, and sometimes two or three members second a motion.  Help!

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
There’s no reason to record who made a motion and who seconded it – that’s too much detail.  The reason to keep minutes is to record the actions taken at a meeting.  A lot of hospitals we work with don’t want to put anything in the minutes, and other hospitals want to put everything in the minutes – both make it hard to figure out what happened at the meeting.  Minutes aren’t supposed to fit on a 5 by 7-inch index card, but they aren’t supposed to be a transcript of a meeting either.  The most important thing that minutes should do is to record the actions taken at a meeting.  So, for motions, what is important is that a motion was made, and that it was seconded – who made it and who seconded it are just too much detail.

April 6, 2023

Posted on by Courtney Patterson

QUESTION:
Our hospital is considering adopting a standard, universal consent form for patients, or their representatives, to review and sign upon admission to our intensive care unit. This form will include a list of several commonly performed invasive procedures on the unit.  What are the benefits and potential problems with universal consent?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY MARY PATERNI:
This is an interesting question.  Universal, or “bundled,” consent can be an efficient means to obtain permission to perform common procedures in the intensive care unit ahead of their indicated need.  By obtaining informed consent for common procedures upon admission, the hospital’s intensive care unit may see an increase in documented informed consent, as well as a swifter response time to emergent events that require one or several procedures listed on the signed form.

In addition, obtaining universal consent at the outset can afford patients and their family members greater opportunity to dialogue with the physician regarding each of the procedures listed on the consent form and can better align these anticipated procedures with the patient’s goals of care.  Overall, this practice may serve as an efficient alternative to obtaining per-procedure consent in haste or performing a procedure without the patient’s express consent.

However, there is a difference between merely asking the patient to sign-off on a laundry list of procedures and engaging in an informed discussion with the patient regarding each procedure and its risks, benefits, and alternatives.  If it is the hospital’s practice to do the former, then there may be cause for concern that the patient, or their representative, is not providing actual informed consent.  In addition, expecting universal consent immediately upon admission for procedures that may occur could prove overwhelming, upsetting, or stressful to the patient or their representative.  Therefore, when considering whether to adopt universal consent forms, it is important to ensure that patient understanding, patient goals, and good bedside manner are not compromised as a result of the appeal of efficient documentation and expeditious care.