On May 15, 2020, the same date on which Louisiana Governor John Bel Edwards lifted the statewide stay at home order as further discussed in this blog entry, the Louisiana Department of Health issued an emergency order continuing (and not further expanding) the effectiveness of its April 20, 2020 updated notice/order permitting 3 specific categories of medical and surgical procedures to be performed, and providing further guidance concerning certain other healthcare services that may be provided, during the declared statewide COVID-19 public health emergency. As previously reported, on April 24, 2020, the Department issued a clarification message intended to “simplify and clarify” the April 20 updated notice/order that remains in effect. This clarification confirms that any physician “operating in good faith will not be in violation of the [April 20 updated notice/order]”. Accordingly, although the statewide stay at home order has now been lifted, certain restrictions continue in connection with medical and surgical procedures and various other healthcare services “until further notice” as further described herein.
Permissible Medical and Surgical Procedures
The April 20 updated notice/order, which remains in effect, expands the categories of medical and surgical procedures that may be performed during the declared statewide COVID-19 public health emergency to include procedures necessary to treat “time-sensitive medical conditions.” As previously reported, the Department’s earlier March 21 updated notice ordered all medical and surgical procedures to be postponed except for those procedures that fall into one of two categories:
- Medical and surgical procedures necessary to treat an “emergency medical condition” as defined at 42 C.F.R. § 489.24 (e., “(1) [a] medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that absence of immediate medical attention could reasonably be expected to result in (i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; (ii) [s]erious impairment to bodily functions; or (iii) [s]erious dysfunction of any bodily organ or part; or (2) [w]ith respect to a pregnant woman who is having contractions—(i) [t]hat there is inadequate time to effect a safe transfer to another hospital before delivery; or (ii) [t]hat transfer may pose a threat to the health or safety of the woman or unborn child); and
- Medical and surgical procedures necessary to avoid further harms from an underlying condition or disease.
The April 20 updated notice/order continues to permit these two categories of medical and surgical procedures to be performed during the declared statewide COVID-19 public health emergency and, effective April 27, 2020, also permits a third category of medical and surgical procedure to be performed during this emergency, specifically:
- Medical and surgical procedures necessary to treat “time-sensitive medical conditions”.
Time-Sensitive Procedures and Conditions Defined: The April 24 clarification message defines those medical and surgical procedures necessary to treat “time-sensitive medical conditions” as “those medical [and] surgical…procedures in which a delay, in the opinion of the medical…professional, might adversely affect the patient or underlying disease process [of the patient] if delayed” and “can include preventive procedures with appropriate precautions.” Appropriate precautions include screening patients for COVID-19 prior to and at the time of the procedure, observance of social distancing protocols, and compliance with the Centers for Disease Control and Prevention (CDC) guidance on availability of personal protective equipment (PPE). The April 24 clarification message further defines time-sensitive medical conditions as “those that [require a procedure] because they have been postponed due to the [Department’s] previous order [on postponement of elective medical and surgical procedures] and because of that delay, may cause pain, distress, or further negative outcomes for the patient”.
Conditions/Requirements for Performing Time-Sensitive Procedures: The April 20 updated notice/order also provides that medical or surgical procedures necessary to treat time-sensitive medical conditions may only be performed during the declared statewide COVID-19 public health emergency if each of the following six enumerated conditions/requirements are fully satisfied (as further clarified in the April 24 clarification message):
- Each patient must undergo an appropriate pre-operative clinical evaluation to minimize the risk that the patient has COVID-19 and, if available, such clinical evaluation must include appropriate COVID-19 testing;
Clarification: COVID-19 testing does not have to be performed on all patients who are undergoing a procedure but only those “exhibiting symptoms, which include a fever, cough, shortness of breath, etc.” If required, appropriate COVID-19 testing is testing “performed, or referred, through normal available testing channels using an FDA approved or EUA COVID-19 test”, patients can be referred for such testing to their primary care physician, local hospital or testing site (and should be asked to call ahead), and such testing may be conducted “by any accredited medical facility/laboratory/test.”
- Each patient must be required to comply with strict social distancing measures from the time of the pre-operative clinical evaluation through the day of the surgery;
Clarification: The CDC capacity limits of no more than 10 people in a gathering and social distancing protocols should be followed whenever possible. It is recommended that a healthcare provider not have patients packed in its waiting room but rather call patients back individually at the time of their scheduled visit and otherwise have them wait outside (in vehicles) whenever possible.
- The facility and healthcare provider must have an adequate and appropriate supply of PPE to treat the patient, as well as any other patient, including COVID-19 positive patients, in the facility; at no time shall a facility’s PPE supply to treat COVID-19 positive patient fall below a 5-day supply on hand at the facility; and the facility must not be dependent on the state or another governmental body to supply the 5-day requirement;
Clarification: PPE needs and the necessary stockpile thereof should be determined by the medical professional performing the procedure and should correspond to the CDC guidance for the particular procedure being performed. A daily “burn rate” of PPE can be determined by, among other factors, the number of staff in the facility, the number of patients seen, and the number of procedures to be performed.
- There must be an adequate supply chain to the facility and healthcare provider for medical equipment, supplies, and medications;
- The facility and healthcare provider must have adequate medical staff, including surgical, surgical support, recovery, and nursing staff, to meet the needs of all patients;
- The facility and healthcare provider must conduct constant monitoring of hospital, regional, and state resources, as well as Emergency Support Function #8 (ESF-8) reports, indicating the coronavirus burden of disease and impact.
Postpone or Conduct Procedures Via Telehealth, If Possible: Consistent with earlier guidance from the Department, the April 20 updated notice/order continues to provide that “any medical or surgical procedure in which a delay will not adversely affect the particular patient or the underlying disease process should continue to be postponed” and “[w]hen available and medically appropriate, preventive checks or procedures should continue to be conducted via telehealth.”
Authorization of Time-Sensitive Procedures May Be Subsequently Rescinded: The April 20 updated notice/order further provides that the Louisiana State Health Officer may, at any time upon providing notice, rescind the authorization for healthcare providers to perform medical and surgical procedures for the treatment of time-sensitive medical conditions. In determining whether to rescind such authorization, the Louisiana State Health Officer may consider the number of new admit COVID-19 cases in Louisiana and the statewide (or regionwide) availability (or non-availability) of ventilators, ICU beds and med surg beds.
Permissible Healthcare Services Other Than Medical and Surgical Procedures
Also effective April 27, 2020, in connection with healthcare services other than medical and surgical procedures, the April 20 updated notice/order, which remains in effect, mandates that “any in-person healthcare services be postponed when patient outcomes would not be compromised.” In fulfilling this mandate, the updated notice provides that healthcare providers (a) “shall use their best medical judgment within the scope of their license to make this determination,” (b) “shall consider the entire clinical picture when determining if a service can be safely postponed, including the consequences to the patient of postponement and the consequences to the healthcare system,” and (c) “[if] acting in good faith shall not be found to be in violation of this directive.” Consistent with this mandate, the April 20 updated notice/order further directs all healthcare providers to “offer – when medically appropriate and when the same standard of care can be met – a telehealth mode of delivery, rather than an in-person visit.” In complying with this directive, the updated notice provides that healthcare providers (a) “shall make a determination about the appropriateness of telehealth on a case-by-case basis,” (b) “may encounter legitimate and valid barriers to telehealth delivery and may not be able to shift all services to telehealth,” and (c) “[if] acting in good faith shall not be found to be in violation of this directive.”
Monitoring and Reporting Requirements
Also effective April 27, 2020, as subsequently clarified by the April 24 clarification message, which remain in effect, a healthcare provider must, within 10 to 14 days after performing any invasive medical or surgical procedure on a patient in accordance with the April 20 updated notice/order, contact the patient to determine whether the patient has any signs or symptoms consistent with COVID-19 or has tested positive for COVID-19 since the procedure was performed or service provided. This contact must be documented in the patient’s medical record and, if the patient reports (a) signs or symptoms consistent with COVID-19 or (b) that he or she has tested positive for COVID-19, the healthcare provider must immediately inform the Louisiana Office of Public Health via electronic notification. Further, to the extent that the patient falls in the former category (i.e., reports signs or symptoms consistent with COVID-19), the healthcare provider must make recommendations to the patient in connection therewith, including that the patient obtain appropriate testing. It is recommended that the patient’s medical record also document what the patient reports, any recommendations provided, and any report made to the Louisiana Office of Public Health as a result of this required follow up contact.
Additional Guidance from CMS
The April 20 updated notice/order also recommends that any healthcare provider who performs any medical or surgical procedure on, or provides other healthcare services to, a patient in accordance with the April 20 updated notice/order, comply with the recommendations issued by the Centers for Medicare and Medicaid Services (CMS) on April 19, 2020, regarding “Re-opening Facilities to Provide Nonemergent Non-COVID-19 Healthcare: Phase I” (as well as any subsequent applicable recommendations or guidance issued by CMS).
Finally, the April 20 updated notice/order, which remains in effect, confirms that its mandates apply to all licensed health care facilities in Louisiana and all healthcare professionals licensed, certified, authorized, or permitted by any board, authority or commission under the Department.