Author: Courtney Patterson

January 13, 2022

Posted on by Courtney Patterson

QUESTION:
We’ve had a question raised about a Medical Staff member who performed a test on a family member without going through the formal patient registration process.  What can we do to educate our medical staff about the risks involved with these kinds of practices?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
We have found it to be helpful to set forth guidelines that remind Medical staff members of the concerns that can arise when a physician treats him or herself, a family member, or others with whom the physician has a close relationship.  A good starting spot is the Standard E-8.19 in the American Medical Association’s Code of Ethics, which speaks to how such actions can compromise professional objectivity and unduly influence medical judgment.  In addition, your state medical board may have guidance on this issue.

Relying on these resources, Medical Staff leaders can then adopt policy language that reinforces the standards of acceptable medical practice in these situations.

January 6, 2022

Posted on by Courtney Patterson

QUESTION:
Our peer review committee is wondering if the name of the physician under review should be redacted so that committee members are not aware of the physician’s identity.  Would this promote a fair review process?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY PHIL ZARONE:

While at first blush it might seem like a good idea, we do not recommend that the “blinding” of reviews be part of the peer review/professional practice evaluation (“PPE”) process.  Here’s why:

  • This practice could actually create unnecessary legal risk because it makes it more difficult to manage conflicts of interest. If a disqualifying conflict of interest exists between a committee member and the physician under review, the blinding of information might prevent this from being identified early on.  As such, there could be an allegation later that the committee member actually knew the identity of the subject physician but was deliberately not recused.
  • Obtaining input from the physician under review is an essential component of a fair and effective process. While this input is generally written, there are times a meeting is beneficial as well.  While you could probably shield the identity of physicians when they submit written comments, of course it would be impossible to do so for meetings.  Thus, physicians would be treated differently depending on whether a meeting was held or not.
  • If blinding of information is a component of the peer review process but members of the committee determine the identity of the physician in some cases (e.g., because they heard of a certain case or because there is only one physician in a certain subspecialty), it could lead to allegations by an unhappy physician that the committee violated its policy/practice because the committee knew the identity of that individual. It could be alleged this is “proof” that the committee members were biased in their review.
  • It would take a tremendous amount of careful work to attempt to blind reviews consistently and we think it is impractical on a day-to-day basis. It would stress the PPE specialists (i.e., those who support the review process) more than is necessary, distract them from assisting the process in other and better ways, and all for no great gain.
  • Despite everyone’s best efforts, it is exceedingly difficult to do this completely and ensure anonymity. In many cases, committee members will still know the identity of the physician subject to review.
  • There may be times when the committee members want to access a portion of the EHR during deliberations, which would clearly reveal the identity of the physician.

•   Once the case at issue is assessed, it is then critical for the committee members to know the physician’s history, personality, circumstances, etc.  This information will help the committee identify the most appropriate performance improvement tool (e.g., collegial counseling, educational letter, etc.) and who should be involved.

December 16, 2021

Posted on by Courtney Patterson

QUESTION:
Our Medical Executive Committee initiated a formal investigation a few weeks ago – the first one we have done in years.  The investigating committee has met several times and is ready to make its recommendations. The bylaws reference a “report,” but the committee members would rather just come to the MEC meeting and give the findings in person. Is a written report really necessary?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY LEEANNE MITCHELL:
Yes, yes, and YES.  A written report is required not only because your medical staff bylaws require one (which frankly, in a heightened legal process like a formal investigation would be reason enough to ensure a written report is created), but, more importantly, should a matter that led to an investigation result in an adverse recommendation (i.e., revocation of appointment and/or privileges, a restriction of privileges, etc.), the investigating committee report will likely be the most important document that helps to explain the reasoning of the MEC when it made that adverse recommendation.  Most medical staff bylaws permit the MEC to delegate the investigation process to another standing committee or to an ad hoc committee, and they do not require the MEC perform the investigation itself.  The MEC then relies heavily on the fact-finding, conclusions, and recommendations made by the investigating committee.  It is vitally important that such information be reduced to writing in order to create a strong record.

The report should include a summary of the review process (e.g., a list of documents that were reviewed, any individuals who were interviewed, etc.), specific findings and conclusions regarding each concern that was under review, and the investigating committee’s ultimate recommendations.  Capturing that level of detail in a verbal discussion in a (typically) one hour or less meeting, where individuals are asking questions and side discussions often occur, is very difficult.  You really want to have more than a set of minutes to rely upon in explaining the findings that were made.

December 9, 2021

Posted on by Courtney Patterson

QUESTION:
Early on during the pandemic, stress got the best of a well-thought-of member of our Medical Staff, resulting in the Leadership Council issuing this physician a letter of reprimand, a copy of which went into his file.  The issue never became a problem again and recently he asked if we could remove the letter from his file, as he is worried this could come back to haunt him if he decides to seek opportunities elsewhere.  Is it okay honor his request?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY IAN DONALDSON:
While we can understand this individual’s frustrations about having negative information in his file, there are a number of reasons why we recommend thinking twice before removing anything from a practitioner’s confidential file.

First, removing documentation from the file may create insurance coverage issues.  Some hospitals that we work with have been told by their professional liability carriers that removing information from a practitioner’s file would violate the hospital’s condition of coverage because it would hinder the carrier’s ability to defend any claims involving that practitioner.  Another reason we’ve found is that in those rare instances where an MEC does have to take an adverse action against a physician, it is often based on a history or pattern of conduct.  It is extremely difficult to justify such an action if the documentation of these past events is no longer available.  Similarly, removal of such documentation hampers the institutional memory of the hospital, making it more difficult for future Medical Staff leaders to fully understand past issues and the steps that were taken to mend them.

It is a good idea to have access to confidential files policy in place, so your leadership team can anticipate these types of requests and how they will be handled when they come up.  In the meantime, it may be helpful to explain why you can’t honor this particular physician’s request (based on the reasons above), but then invite him to provide a written update or response to the original concern that will be made a part of his file as well.

December 2, 2021

Posted on by Courtney Patterson

QUESTION:
Who should be on our Credentials Committee and what should be the terms of service for the members?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY CHARLES CHULACK:
A Credentials Committee is best composed of experienced leaders, such as past chiefs of staff or other physicians who have had medical staff leadership experience.  Many medical staffs have representation from a variety of specialties to ensure that the Credentials Committee has the expertise necessary to address difficult credentialing and privileging issues.  With the increasing number of advanced practice providers (e.g., nurse practitioners and physician assistants) providing services in hospitals, more and more Medical Staffs are appointing an advanced practice provider to the Credentials Committee as a voting member and for that individual’s input and expertise on the topic of credentialing and privileging these providers.

Service on the Credentials Committee should be the primary medical staff obligation of the members and terms should be at least three years so that committee members have an opportunity to gain some experience and expertise in credentialing.  The terms should also be staggered so that there is always a repository of expertise on the committee.  The Credentials Committee’s primary responsibility is to review and make recommendations on applications for medical staff appointment and clinical privileges.  It can also oversee the development of threshold eligibility criteria for clinical privileges.

For answers to all your credentialing questions, join Lauren Massucci and Charlie Chulack for the Horty, Springer & Mattern seminar “Credentialing for Excellence” on March 10 through 12, 2022 in Savannah, Georgia, or April 7 through 9, 2022 in New Orleans.

November 18, 2021

Posted on by Courtney Patterson

QUESTION:
Our hospital has more than 100 employees.  Do we have to comply with both the OSHA vaccine mandate and the one issued by CMS?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
OSHA has issued two different Emergency Temporary Standards (“ETS”) that are the source of some confusion.  The first was issued on June 21, 2021.  It required that covered health care employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in their workplaces related to the following:  patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting.  The June OSHA ETS encouraged but did not require vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.

In early November, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers (not just health care employers) with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption.  This ETS that was enjoined by the 5th Circuit Court of Appeals this past Friday, and the 5th Circuit  ordered that OSHA take no steps to implement or enforce the ETS until further court order.  CMS said it worked closely with OSHA to ensure that the November regulations of both agencies were complementary.

The FAQs issued with the CMS rule on November 5 contained the following guidance:

Q. Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the upcoming (or new) OSHA Emergency Temporary Standard?

A.  If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.  If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation 11 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.  This rule takes priority above other federal vaccination requirements.  CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.  The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations.  Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.

Hospitals that participate in Medicare subject to the CMS’s Omnibus Staff Vaccination Rule which amended the Conditions of participation, so per this FAQ guidance hospitals are NOT subject to the November ETS which requires weekly testing for those who remain unvaccinated without an eligible exemption.  Therefore, testing is not an alternative for staff who have not been exempted from the CMS vax requirement to comply with the rule.

On the other hand, while testing is not a substitute for vaccinations under the CMS rule, hospitals are allowed to require testing of unvaccinated/exempt workforce members as a mitigation measure.  The CMS FAQs say:  “In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients” but this does not require testing.

CMS explained in the preamble to the regulation:  “we considered requiring daily or weekly testing of unvaccinated individuals.  We have reviewed scientific evidence on testing and found that vaccination is a more effective infection control measure.  As such, we chose not to require such testing for now but welcome comment.  Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.”  86 Fed. Reg. 61614.

However, the September 2020 CMS emergency rule that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19 is still in effect.  The new FAQs say:  “CMS expects continued compliance with this requirement.”

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

Also, listen to HortySpringer’s latest podcast on the CMS vaccine mandate here.

November 11, 2021

Posted on by Courtney Patterson

QUESTION:
Last month, our hospital announced a policy requiring individuals who are physically present on the premises to be fully vaccinated with the COVID-19 vaccine.  We understand that this policy applies to advanced practice professionals and members of the Medical Staff, but we are not sure how to enforce it.  Any suggestions would be appreciated.

ANSWER:
The Medical Staff Bylaws and Credentials Policy (“Medical Staff Governance Documents”) probably require members “to abide by the medical staff documents and the policies of the Hospital.”  That’s a start, but you may want more.  Here are some ideas.

We recommend that the Medical Staff Governance Documents include a threshold criterion that requires individuals to “document compliance with immunization and health screening requirements (e.g., TB testing, mandatory vaccines, and infectious agent exposures).”  We also recommend that your documents expressly state: “Failure of an individual to continuously satisfy any of the threshold eligibility criteria will result in the administrative relinquishment of appointment and clinical privileges, unless a waiver is granted.”

If you don’t have that language now, the Medical Executive Committee may be able to add it to your Medical Staff Governance Documents, but you’ll have to check the notice requirements and the amendment process.

Another alternative is to rely on language in your Medical Staff Governance Documents that requires individuals to provide information when it is requested by a medical staff leader.  Specifically, we recommend the following language:  “Failure of an individual to provide information pertaining to an individual’s qualifications for appointment or clinical privileges in response to a written request from any medical staff leader or any other authorized committee will result in the administrative relinquishment of appointment and clinical privileges until the information is provided to the satisfaction of the requesting party.”  Since the hospital policy requires proof of vaccination, we are comfortable using this language to help enforce the hospital policy.

Remember, a relinquishment is administrative in nature and is not considered an adverse professional review action.  Therefore, the individual is not entitled to a hearing and the hospital is not required to report the individual to the National Practitioner Data Bank or the State Board.

November 4, 2021

Posted on by Courtney Patterson

QUESTION:
We know that we can provide a computer system that includes cybersecurity technology and related services to our employed physicians.  However, we have received several inquiries from independent members of our medical staff asking whether the Hospital can assist them to obtain cybersecurity technology and related services.  What can we do?

ANSWER:
By way of background, the Stark EMR Donation exception has, for many years, permitted a hospital to donate software, information technology and/or training services (but not hardware) to the physicians on the hospital’s medical staff so long as the arrangement is: (i) pursuant to a written agreement that specifies the items and services being provided; (ii) the software is interoperable; (iii) the donor does not affect the interoperability of the software; (iv) the physician pays 15% of the donor’s cost; (v) the receipt of the item or service is not a condition of doing business with the hospital; and (vi) neither the eligibility of a physician nor the amount of the donation is determined in a manner that takes into account the volume or value of referrals.

The January 19, 2021 Rules have amended the EMR Donation Rule to:  (i) permit the donation of cybersecurity software and services (but not hardware); (ii) delete the restriction that the arrangement does not violate the Medicare Anti-Kickback Statute; (iii) require the 15% share by the physician to be paid before the donation; (iv) delete the requirement that the donor does not have actual knowledge whether the physician receiving the EMR possesses equivalent items or services; and (v) eliminate the December 31, 2021 sunset on donations pursuant to this section.

Therefore, while this exception may be used, its limitations outweigh its usefulness, especially when compared to the new cybersecurity technology and related services exception that was added by the January 19, 2021 Rules.  The new exception will provide much more flexibility for a hospital that is interested in donating cybersecurity technology and related services to a referring physician.

This new cybersecurity technology and related services exception, 42 C.F.R. § 411.357(bb), protects nonmonetary remuneration (consisting of hardware, software, or other types of information technology and services) that are necessary and used predominantly to implement, maintain, or reestablish cybersecurity, if all of the following conditions are met:  (i) neither the eligibility of a physician for the technology or services, nor the amount or nature of the technology or services, is determined in any manner that directly takes into account the volume or value of referrals or other business generated between the parties; (ii) neither the physician nor the physician’s practice (including employees and staff members) makes the receipt of technology or services, or the amount or nature of the technology or services, a condition of doing business with the donor; and (iii) the arrangement is documented in writing.

Please note that a hospital is not required to provide cybersecurity items and services to every physician on the hospital’s medical staff.  Rather, a hospital is given discretion to select the recipients of its donated cybersecurity items or services, so long as the hospital complies with the above-stated requirements.

Unlike the EMR Donation Rule described above, this new exception permits the donation of cybersecurity hardware such as encrypted servers, encrypted drives and network appliances but only if the hardware is necessary and used predominantly to implement, maintain or reestablish cybersecurity.  If the donated technology includes functions other than cybersecurity, the core functionality of the technology and services must be implementing, maintaining or reestablishing cybersecurity and cybersecurity must predominate.

Also, unlike the EMR Donation Rule, the physician is not required to pay the 15% cost sharing required by the EMR Rule.  However, the cybersecurity item or service must be nonmonetary.  Therefore, a hospital could not reimburse a physician for the cost of previously obtained cybersecurity technology or services.  Nor would this exception permit a hospital to make a ransomware payment on behalf of a non-employed physician in response to a cyberattack.

October 28, 2021

Posted on by Courtney Patterson

QUESTION:
I noticed that part two of the surprise billing rules were published.  Do these new rules require any action prior to their January 1, 2022 effective date?

ANSWER:
The surprise billing saga continues! Are you ready for January 1?

By way of background, on July 13, 2021, the Departments of Health and Human Services, Labor, and Treasury published an interim final rule implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Provisions Act of 2021.  Effective January 1, 2022, the interim final rule affords patients protection against balance billing and cost sharing for certain out-of-network services, prohibits out-of-network providers and health care facilities from balance billing patients under specific circumstances absent notice and consent, and requires providers to disclose federal and state patient protections against balance billing.  You can tune in to our audio conference or read about it here to learn more about what part one of the Surprise Billing rules require of you.

On September 30, 2021, the Departments issued a second interim rule with additional provisions aimed at protecting consumers from surprise medical bills under the No Surprises Act.  Among other things, this rule removes the consumer from payment disputes by requiring providers and health plans to follow outlined payment dispute processes to resolve any remaining costs for out‑of-network services not billed to the patient.

In addition, beginning January 1, 2022, providers will be required to provide uninsured and self‑pay consumers “good faith” estimates of expected charges for items or services within one business day after scheduling or within three business days after the consumer requests the estimate.  A “good faith” estimate should include an itemized list of and expected charges for the scheduled item or service and any other related item or service likely to be provided.

In anticipation of these rules taking effect, you should begin to review the dispute resolution language in your payor contracts, if such language exists, to ensure that it is aligned with the processes outlined in the second interim rule.  You should also begin drafting a good faith estimate form or adopt CMS’ template, which can be found here.

Tune in to our next surprise billing audio conference on January 4, 2022 for more information on the implementation of the Surprise Billing rules.

October 21, 2021

Posted on by Courtney Patterson

QUESTION:
We are trying to implement care guidelines for hip and knee replacements across the system.  The leadership has agreed on the guidelines generally and is now discussing implementation and enforcement.  They want to monitor the established metrics through the OPPE process and, if a practitioner is outside the metrics, have them automatically referred for FPPE (the matter would be referred to the Medical Staff peer review committee for further review and a determination of what collegial measures, if any, could be taken to get the practitioner into compliance).  If the practitioner remains outside the metrics cutoff after 90 days, the leadership has recommended that the practitioner’s joint replacement privileges be deemed automatically relinquished for failure to comply.  This method of enforcement does seem a whole lot easier than conducting an investigation and going through all of the procedures that are necessary to revoke privileges.  What do you think?

ANSWER:
While it is true that implementing an automatic relinquishment is easier than conducting an investigation, making an adverse professional review recommendation, and/or conducting a hearing and appeal process, not every situation is well suited to automatic relinquishment.

The situations where automatic relinquishment is most appropriate are those that are objectively assessed, require little to no evaluation of the practitioner’s competence or conduct, and tend to be focused on administrative requirements.  For example, failure to comply with documentation requirements, failure to attend a meeting when requested by the Medical Staff leadership, or loss of licensure are all matters that routinely lead to automatic relinquishment within hospitals/medical staffs all across the country.

There are some situations where failure to follow a protocol or guideline could appropriately lead to implementation of automatic relinquishment.  For example, consider the scenario where a hospital and medical staff establish a clinical protocol requiring a practitioner to either comply with the protocol or, alternatively, document contemporaneously in the file the reason why he or she is not following the protocol.  Automatic relinquishment of privileges for failure to comply with the administrative requirement of documenting the reasons for non-compliance would be acceptable, since the evaluation of the matter would be objective (e.g. did the practitioner comply?  If not, was there documentation of why in the chart?).  Further, the relinquishment would be related to an administrative matter (failure to comply with a documentation requirement applicable when not complying with a protocol).

However, if the practitioner were being reviewed because, although he or she was documenting the reasons for not following the protocol, the Medical Staff leadership felt those reasons were not good – that would be a different matter.  That would involve evaluation of the practitioner’s clinical judgment (e.g., the explanations for why the protocol was not followed), which would require subjective evaluation, clinical expertise, and a judgment about the practitioner’s clinical competence and/or conduct. Because of that, the consideration of whether the practitioner was justified in not following the protocol would better lend itself to review under the Medical Staff professional practice evaluation process (which is specifically designed to evaluate performance issues utilizing the expertise of the Medical Staff leaders and, afterwards, implement collegial solutions to help practitioners improve).

The situation you describe sounds like it may be more akin to the latter situation described above, in which case automatic relinquishment would not be the best solution.  It’s true that words like “guidelines” and “metrics” give the initial impression that a matter is being objectively evaluated – and that can lead many to believe that automatic relinquishment is a viable option for all situations involving failure to comply.  Our suggestion is to focus more on the actual metrics that are under consideration.  Is non-compliance with those metrics measured objectively, without the need to consider the explanation of the practitioner (e.g. H&P was on the chart prior to surgery, surgical note was on the chart prior to surgeon leaving the OR)?  If the metrics are “administrative” in nature, like these, then automatic relinquishment may be the right enforcement method.

But, if non-compliance with metrics is measured objectively at first –and then requires subjective evaluation to verify whether non-compliance was justified (e.g. patient was an appropriate candidate for the procedure, diagnostic tests were appropriate, appropriate medications were given), then review through the peer review process may be a better option than resorting to automatic relinquishment.  In your scenario, since the original plan is to refer matters of non-compliance into the FPPE process, it sounds like your guidelines may require subjective evaluation and be less “administrative” and, in turn, less suited to automatic relinquishment.

Of course, as always, the best option is to consult with your in-house or Medical Staff counsel, as the best answer depends on the specific protocols/guidelines you are looking to implement and enforce, as well as the language of your Medical Staff Bylaws and related governance documents.