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.

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.

QUESTION:
There is a closed Facebook group for Medical Staff professionals in which members seek advice on practitioner credentialing, privileging, and peer review matters.  Although these posts don’t identify the practitioners involved, they may include specific details about problematic credentialing files or behavior incidents.  Also, the name of the professional, hospital email address, or place of employment may appear in the posts.  Does this raise any legal concerns?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

We don’t mean to discourage professional interactions among Medical Staff professionals, but there are legal risks to discussing credentialing and peer review issues about individual practitioners on social media.

First, there is never any guarantee that anything posted on social media will remain private, even if a group is “closed.”  A member of the group could have a reason for disclosing information outside the group, and a screenshot can easily be sent around the world.

Second, efforts to “de-identify” information don’t always work.  It’s surprising – and unsettling – how seemingly small bits of information can be put together so that a supposedly de-identified post becomes identifiable.  By comparison, many HIPAA violations have resulted when hospital employees thought they were removing all information that could be used to identify a patient only to learn later that they were wrong.  One of my favorite stories is of a physician blogger who posted an account of exemplary care provided to a supposedly de-identified ED patient.  The physician was proud of the team and wanted to share the good news.  He didn’t use names and even changed certain facts of the case to further protect the patient’s identity.  Shortly after he posted, someone commented on the post by stating (accurately) that he was a relative of the patient.

There are a variety of legal risks if a post about a credentialing or peer review matter gets back to the practitioner who is the subject of the post.  First, the practitioner could claim that the post was defamatory because it disclosed unfavorable information in a public setting.  Also, the practitioner could argue that the post constituted a breach of the confidentiality obligations set forth in the Medical Staff Bylaws, “tortiously interfered” with his employment prospects, or constituted a “breach of contract” under state law.

Social media posts could be problematic even if they are disclosed to individuals other than the practitioner in question.  For example, plaintiffs’ attorneys could use such posts as a reason to look for problems at a hospital.  Also, attorneys representing plaintiffs in malpractice or negligent credentialing cases could argue that the disclosure of peer review information on social media resulted in a waiver of the peer review privilege under state law of any information related to that matter.

Again, we don’t mean to discourage professional interactions among Medical Staff professionals.  There are certainly many topics that could be discussed that don’t raise the potential problems discussed above.  However, recognize that there are risks to disclosing practitioner-specific information on social media.

QUESTION:
We are in the middle of an investigation involving a spine surgeon.  As part of that investigation, we obtained two external reviews.  One is highly critical of our surgeon’s patient/procedure selection, clinical skill, and medical record documentation.  The other reached a few findings regarding medical record documentation, but did not reach any other findings of “wrongdoing” on the part of our surgeon.  Our committee is weighing these reviews and trying to figure out how to proceed.  In the meantime, we were wondering whether we need to give a copy of the external review reports to the spine surgeon.  To avoid opening a can of worms, do you think we could wait until the Committee decides which report it agrees with and then share only that report with the physician (since it is the one the Committee will be relying on)?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY RACHEL REMALEY:
It is our recommendation that the peer review process serves everyone (including physician leaders and the subjects of review) best when the process is transparent and informed.  So, it would be our recommendation that you share both of the external reviews with the physician, as part of the investigating committee’s process of communicating with, and obtaining information/input from, the physician during the course of the investigation.

If you are concerned about interference or retaliation by the spine surgeon (for example, the spine surgeon calling the external reviewer privately to discuss the report), you may wish to take the step of having the surgeon sign a confidentiality and non-retaliation agreement in advance.  Be sure to include language stating that the practitioner is not permitted to contact the external reviewer.

You might also be concerned about the fact that multiple external reviews have given your committee inconsistent reports.  While the committee likely needs to give the reports additional scrutiny to figure out why the reports are different, how much weight it is appropriate to give to each report, etc., please know that it is not unheard of for a Medical Staff committee to obtain reports that make varied findings and conclusions.  Sometimes, it’s because the training or experience of the reviewer differs.  Sometimes, it’s because the reviewers have practiced in different locations where different practices are more or less common.  There are a lot of explanations.  Your committee has the expertise to sort it out (and, if they need additional assistance, can always turn to the CMO or legal counsel for help).

Know, however, that the solution to this sort of uncertainty is not to withhold one or both reports from the physician.  Rather, lean in to transparency.  Share the entire report.  Seek the practitioner’s input.  If the practitioner obtains another external review and submits that report, work it into the fold in the same way (consider how much weight should be given to that report based on a variety of factors, including the reviewer’s education, training, and experience, the thoughtfulness of the report, etc.).  It’s never the wrong answer to keep the surgeon informed about the Committee’s concerns and it is always a best practice to welcome more information from the physician.  This way, when the investigation is over, if tough decisions (like an adverse professional review recommendation) have to be made, it will be clear that no stone was left unturned and the physician had every opportunity to respond to the information being relied on by the Committee in coming to that decision.

QUESTION:
Did the Department of Justice – Antitrust Division (“DOJ”) recently withdraw its support for several safe harbors from enforcement actions?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY NICHOLAS CALABRESE:
Yes. On February 3, 2023, the DOJ Antitrust Division withdrew from what it called “three outdated antitrust policy statements related to enforcement in healthcare markets.”  The three policy statements are “Department of Justice and FTC Antitrust Enforcement Policy Statement in the Health Care Area” issued in 1993; “Statements of Antitrust Enforcement Policy in Health Care” from 1996; and “Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” issued in 2011.

The policy statements addressed issues such as antitrust safety zones for:  hospital mergers; hospital joint ventures that encompass expensive medical equipment; and joint purchasing arrangements between health care providers, among other things.

Although new guidance may be coming at some point, for now, the Antitrust Division stated “[r]ecent enforcement actions and competition advocacy in healthcare provide guidance to the public, and a case-by-case enforcement approach will allow the Division to better evaluate mergers and conduct in healthcare markets that may harm competition.”