Author: Courtney Patterson

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.

October 14, 2021

Posted on by Courtney Patterson

QUESTION:
What should be done if an applicant for reappointment is under investigation but his current term of appointment is set to expire before the investigation is completed?

ANSWER:
As most know, the Joint Commission has made it clear that privileges are granted for a period not to exceed two years and that continuations or extensions are not appropriate.  While this rule likely came about to avoid routine extensions due to administrative failures to process reappointments in a timely manner, it makes situations like the one above difficult to manage.

Keeping in mind this two-year limitation, we’ve found the best way to address applicants for reappointment who are currently under investigation is through a short-term conditional reappointment pending the outcome of the process.  This keeps the hospital on the right side of the Joint Commission, while providing time for the investigation to work its way out.

Having language in your Medical Staff Bylaws documents to support this approach is a key to good credentialing.

October 7, 2021

Posted on by Courtney Patterson

QUESTION:
In June, a federal court dismissed claims brought by employees of Houston Methodist Hospital who alleged the hospital’s vaccination requirement was illegal.  In this past week, another federal judge dismissed a similar lawsuit brought by employees of St. Elizabeth Medical Center.  How many hospitals/health systems have a mandatory vaccination requirement?

ANSWER:
As of September, approximately 2,600 hospitals and health systems put in place a mandatory vaccination requirement.  There were also over a dozen states, and even several cities, that imposed the requirement on health care workers.  There were some requirements that had exemptions for medical or religious reasons, and the penalties for not being vaccinated ranged from suspension to termination to weekly testing, among other things.  So, the requirement is on the upswing, and we’re staying alert for any updates.

September 30

Posted on by Courtney Patterson

QUESTION:
As we are preparing for a medical staff hearing, a member of our Medical Executive Committee asked why our Medical Staff Bylaws state that the Chief Executive Officer appoints the hearing panel and not the Chief of Staff since it’s the Chief of Staff who knows most of the members of the medical staff.  We are trying to figure out whether this was a typo or not.  Should the Chief of Staff appoint the panel?

ANSWER:
No – that’s not a typo!  While we do still sometimes see bylaws which assign the Chief of Staff the responsibility to appoint the hearing panel (and worse yet, occasionally it’s the whole Medical Executive Committee that does so), it’s long been our recommendation that the CEO or the CMO fulfill that responsibility – in consultation with the Chief of Staff.

This is because, generally speaking, the Chief of Staff, both in his/her role as a Medical Staff officer as well as a member of the MEC (the body that will most often be making the adverse recommendation that triggers a hearing) tends to be someone who is very intimately involved in the underlying matter that led to the hearing.  The Chief of Staff will frequently be the individual who engaged in collegial intervention and other progressive steps with the affected physician, who was involved in the development of any conditions or restrictions and, ultimately, is involved in the adverse recommendation made by the MEC as the chair of that committee.  When an involved Chief of Staff is then responsible for appointing the hearing panel and presiding officer, we have seen the argument made that the selections were biased in favor of the MEC and are not neutral – which can lead to objections and legal challenges (both before and after the hearing) to the appointment of the panel.

While we know that these claims are largely groundless, it is very important to manage the appearance of fairness at all steps of the hearing process.  The goal is to isolate the volunteer physician leaders – like the Chief of Staff – from these types of claims and allegations as much as possible, which is why the CEO or CMO should appoint the panel after consulting with the Chief of Staff.

September 23, 2021

Posted on by Courtney Patterson

QUESTION:
We are involved in an overhaul of our medical staff governance documents.  We put together a task force of system leaders to guide us through the process, including an advanced practice professional (APP).  Historically, our documents only referenced APPs in a single article.

The task force is being challenged to be more inclusive and integrate APPs throughout the documents, including as members of the medical staff, and as members of key committees like the Credentials Committee, Medical Executive Committee and the Peer Review Committee.  What are you seeing around the country?

ANSWER:
We are seeing change – you might even say a transformation – with respect to how APPs are addressed in medical staff governance documents.  As you suggest, historically, APPs were mentioned in a separate article of the bylaws or perhaps there was a separate policy to address how to credential and privilege them.

As licensing statutes have changed and, as the role of APPs in providing care in hospitals has continued to expand, questions about their involvement in the Medical Staff are now routinely being discussed and debated.  As is often the case, there is no single right answer. Each organization has flexibility and discretion to decide whether, when and how to incorporate APPs into their bylaws, with some exceptions.

Let’s start with the exception which is the requirement that APPs (including advance practice nurses and physician assistants), who provide a medical level of care, must be credentialed and privileged through the medical staff process.  Additionally, since APPs are granted privileges, their performance must be evaluated through the peer review process.

These requirements lend support for integrating APPs into your medical staff governance documents so you don’t need companion documents to address requirements pertaining to them.  However, whether they are members of the Medical Staff and what role they play on the Medical Staff is another question.

In our experience, many Medical Staffs are including an APP category in the Bylaws for “convenient reference” but clearly state:  “The APP Staff is not a category of the Medical Staff.”  More recently, we have seen Medical Staffs add an APP category (akin to the Courtesy or Consulting Staff) to the Bylaws.  This would afford APPs membership status but their rights and prerogatives would be very limited (e.g., no right to vote at the Medical Staff or department level, no ability to serve in a leadership position).

A few Medical Staffs are going a step further and identifying APPs as members of each category of the Medical Staff as long as they meet the patient contact or other criteria.  In these situations, to ensure compliance with the Conditions of Participation and accreditation standards, the Bylaw typically note that APPs are not eligible to serve as an officer or department chairperson.  The rules are different at critical access hospitals.

As you suggest, other key issues are whether to include APPs on committees like the Credentials Committee, Medical Executive Committee, and the Peer Review Committee.  While we won’t say there is a national consensus, we are definitely seeing a movement in this direction including a designated spot on these committees for an APP (usually appointed by the Chief of Staff or Medical Executive Committee).  Some Medical Staffs still want to clarify that the APPs are present to address APP issues but must leave when there is a credentialing or peer review issue pertaining to a physician, but most are not this restrictive.  And my personal bias is if you make an APP a member of a committee and expect them to show up and participate, they should have a right to vote.

And these are the easy issues.  The much tougher issues involving APPs are around required training, clinical privileges, and changes in practice.  We’ll leave these for another day.