Texas State Agencies Weigh in on Governor’s Order on Non-Urgent Surgeries, But do They Provide Clarity?

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As previously reported, Texas Governor Greg Abbott issued Executive Order GA-15 extending the ban on surgeries and procedures with modifications regarding diagnostic procedures, timely (rather than immediate) need for surgical intervention, and a new exception for surgeries and procedures in licensed facilities. Following the Seyfarth Legal Update on April 21, both the Texas Medical Board (Board) and Texas Health and Human Services Commission (HHSC) issued guidance on implementation of the order which went into effect on April 22. These guidance items do not directly answer all questions arising from GA-15, but do provide additional context. Working with the guidance can help providers establish a framework for their practices moving forward in anticipation for what could be continued restrictions at least in the near term.

HHSC Guidance - Frequently Asked Questions (FAQs) April 22, 2020

HHSC is the state agency responsible for licensing numerous types of health care facilities, including hospitals and ambulatory surgery centers (ASCs), and is expressly designated in GA-15 to receive written certifications under the new exception for facilities that will reserve 25% of their hospital capacity and will not request personal protective equipment (PPE) from a public source (the “Facility Certification Exception”). On April 22, HHSC issued FAQs regarding GA-15.

In the FAQs, the HHSC clarifies that its role in implementing the Facility Certification Exception “is to receive . . . certifications from licensed health care facilities.” The FAQs cross-reference HHSC’s April 17, 2020 Guidance Letter, GL 20-1007, regarding the certification process. GL 20-1007 directs facilities on how to submit the certification and advises that certifying facilities will receive an acknowledgement via e-mail.¹Notably, HHSC admonishes that facilities cannot “limit or qualify the required certification language in any way.”

In practice, HHSC’s position may conflict with recent Board guidance, described below, which requires physicians to verify with HHSC that the facility submitted the certification. If HHSC does not see its responsibility as communicating with physicians regarding the certifications, it may not have the capacity or time to accommodate physicians in this regard which could delay medical care.

HHSC does not state expressly that this exception – referred to by HHSC as the “second exemption” – is limited to hospitals, but suggests that could be the case in answer to one of the FAQs:

Q. What if my licensed health care facility cannot make the required certifications for the second exemption?

A. If your licensed health care facility cannot make the certifications required for the second exemption, your facility cannot use that exemption. Please refer to GA-15 for your options under the general prohibition and the first exemption.

The “first exemption” relates to procedures (not surgeries) which do not deplete hospital capacity or PPE.

As indicated in Seyfarth’s prior report, ASCs are not required under their license to have hospital capacity, and a facility cannot certify it will reserve something it does not have. This FAQ could be interpreted that ASCs, and other facilities without licensed hospital beds, cannot use the Facility Exemption Exception.

HHSC goes on, however, to take a broad view of what “hospital capacity” means.

Q. What kind of beds should my facility include in the calculation of “25% of its hospital capacity” for the required certification?

A. Executive Order GA-15 finds that “a shortage of hospital capacity or personal protective equipment would hinder efforts to cope with the COVID-19 disaster.” In guarding against such a shortage, GA-15 does not qualify or limit the term “hospital capacity,” or distinguish between types of hospital beds.

HHSC does not use the term “licensed” hospital or “licensed” bed. Waivers at the Federal and State levels have authorized ASCs, and more recently freestanding emergency rooms, to provide hospital capacity under certain circumstances in response to the COVID-19 public health emergency. Facilities that take advantage of these waivers now, or in the future, may be in a position to make the certification for the Facility Certification Exception. HHSC’s procedure for submitting certifications does not allow for limitations or qualifications in this regard, however. Facilities with questions should proceed with caution with the advice of counsel.

HHSC takes a similarly broad view of the type of PPE that is subject to the Facility Certification Exception and clarifies that one certification can serve for multiple facilities if it is signed by an individual with authority to bind each of the facilities.

Board Guidance and Emergency Rules

The Board issued revised FAQs on April 21 to address GA-15. Generally, the Board characterizes GA-15 as “loosening” the restrictions on non-urgent procedures and reminds physicians to be “mindful of their obligations for the safety of patients, fellow healthcare providers, providing quality care, and ensuring best possible outcomes for their patients.” In this regard, the Board again stresses the importance of the physician’s discretion in determining whether to do the procedure or surgery.

With respect to the new exception, the revised FAQs state that the physician has an independent duty to verify with HHSC that the facility has submitted the necessary written certification and to document the verification in the medical record. The Board does not provide guidance on how the physician is supposed to fulfill this duty. As stated above, physicians may have difficulty verifying with HHSC. The Board also does not elaborate further on issues of depletion of PPE or the depletion or reservation of hospital capacity.

Interestingly, the Board made a change from its March 29 FAQs that is not related to the changes in GA-15 and which may further complicate matters. As reported previously, the Board provides a 4-step decision process for physicians in determining whether to do a procedure. In the March 29 FAQs, part of that process was determining whether the surgery or procedure was immediately medically necessary to correct a serious medical condition or to preserve the life of a patient; or whether the patient, without immediate performance of the surgery or procedure, would be at risk for serious adverse medical consequences or death.

If the medical act is a surgery or procedure, then you must ask the following questions:

• Is this immediately medically necessary to correct a serious medical condition or to preserve the life of a patient?
• Would this patient, without immediate performance of the surgery or procedure, be at risk for serious adverse medical consequences or death?

If you answer yes to either of the above questions, you can proceed with the medical act. You should document the medical necessity and serious risk in the patient’s medical record.

In the April 21 FAQs, the Board seems to require that both these factors must be present before a physician can proceed with a surgery or procedure (absent an exception for the depletion of PPE and hospital capacity).

If the medical act is a surgery or procedure, then you must ask the following questions:

• Is this medically necessary to diagnose or correct a serious medical condition of or to preserve the life of a patient who without timely performance of the surgery or procedure would be at risk for serious adverse medical consequences or death?
• Would this patient, without performance of the surgery or procedure, be at risk for serious adverse medical consequences or death?

If you answer yes to this question, you can proceed with the medical act. You should document the medical necessity and serious risk in the patient’s medical record.

As an initial matter, the April 21 FAQ is consistent with GA-15’s addition of diagnosis and adjustment for timely rather than immediate. Unlike the March 29 FAQ, the new FAQ combines both medical necessity/preservation of life and timely performance into the first factor, then redundantly adds timely performance as the second factor. The redundancy may be a clerical error, but requiring both medical necessity and timely performance is a meaningful departure from prior guidance and seems inconsistent with the Board characterization of GA-15 as loosening restrictions. Providers with questions or concerns should consult counsel on the impact of this change.

The Board provides several resources that a physician may review to help guide his or her decision, including Centers for Disease Control and Prevention (CDC) guidelines; Centers for Medicare & Medicaid Services (CMS) guidelines; and a Joint Statement from the American College of Surgeons (ACS), American Society of Anesthesiologists (ASA), Association of Perioperative Registered Nurses (APRN), and American Hospital Association (AHA): Roadmap for Resuming Elective Surgery after COVID-19 Pandemic. Any surgeries or procedures performed in reliance on GA-15 should take these guidelines into account.

The Board emphasizes that it wants to work with physicians and patients in navigating current environment and that patient safety and quality of care should be of primary concern. The Board also exhorts, and in some cases, requires, physicians to maintain documentation regarding any surgery or procedure that is performed and decision to move forward.

The Board also revised its earlier emergency rules based on GA-09. As previously reported, the Board responded to GA-09 by amending Rule 187.57 (22 Tex. Admin. Code § 187.57) to authorize temporary suspension or restriction of a physician’s license for performing a procedure in violation of the GA-09. The Board also amended Rule 178.4 (22 Tex. Admin. Code § 178.4) requiring facilities and other licensees with a reporting obligation to file a complaint with the Board immediately upon discovery of any scheduled procedure in violation of the GA-09.

In response to GA-15, the Board withdrew emergency rule 178.4 requiring reporting violations of the Governor’s order to the Board. Violations of GA-15 can be the subject of a standard Board complaint, however. In addition, while violations of the Governor’s order are still grounds for temporary suspension or restriction under 22 Tex. Admin. Code § 187.57, the Board revised 22 Tex. Admin. § 190.8, which defines “unprofessional conduct” for purposes of a suspension or restriction, to change the GA-09 references to GA-15 such that a violation of GA-15 is deemed unprofessional conduct by the Board.

Impact

HHSC and the Board did not provide bright line rules on how physicians and facilities can move forward under the Governor’s new order. Much of the application of the FAQs will depend on the particular factual circumstances of the provider and patient. It will be important for providers and their advisors to understand the parameters of what is legal in the context of the providers’ practice focus and patient population. The FAQs, particularly from the Board, emphasize the discretion of the provider in determining the best interest for the patient.

In this regard, loosening the restrictions on surgeries and procedures will allow patients who have been suffering with myriad health conditions to access medical care that was unavailable under GA-09. In identifying which patients can benefit from this increased access, physicians and facilities must also ensure the safety of their patients, their staffs, and themselves from further spread of COVID-19.

Documentation will be key in demonstrating compliance both with GA-15 and with patient safety requirements. Providers moving forward under the new order should consider additional documentation in the clinical record consistent with Board recommendations and additional patient disclosure and consent forms that highlight the risks associated COVID-19.

Physicians and providers should consider how GA-15 loosens restrictions on their practice and work with the guidance to develop a clinical and legal framework for moving forward so that they can be prepared for future orders that may continue to impose limitations in this area for what could be the foreseeable future.

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¹HHSC amended its instructions for submission of the certification on April 23, 2020. See GL 20-1007-A.