Healthcare Regulators Begin to Ease Restrictions on Elective, Nonurgent Procedures

May 07, 2020

The Centers for Medicare & Medicaid Services released guidance on April 19 updating its previous recommendation to delay all elective surgeries and procedures during the coronavirus (COVID-19) pandemic. In response, state and local officials are issuing updated orders easing or removing restrictions previously placed on elective, nonurgent surgeries and procedures.

Updated CMS Guidance

An update to its March 18 recommendation, the new CMS guidance, Opening Up America Again: Centers for Medicare & Medicaid Services (CMS) Recommendations – Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I, provides a flexible approach for state and local health officials, healthcare facilities, and healthcare providers determining whether they should allow or perform elective surgeries and procedures. The guidance recognizes that all states are experiencing COVID-19 differently by acknowledging that some states continue to experience a high number of COVID-19 cases, others are experiencing a decline in cases, and others continue to maintain a low incidence rate.

In a press release, CMS Administrator Seema Verma stated that the new guidance's recommendations are not meant to be implemented by every community at this time, and that governors and local leaders ultimately need to make decisions on whether the recommendations are appropriate for their communities. The administrator indicated that the recommendations specifically target communities that are in Phase 1 of the White House's Guidelines for Opening Up America Again, with a low or decreasing number of COVID-19 cases.

The guidance states that careful planning is required to resume in-person care of patients requiring non-COVID-19 care and that all aspects of care must be considered. Maximum use of telehealth is encouraged. Non-COVID-19 care should be offered to patients as clinically appropriate and within a state, locality, or facility that has the resources to properly provide such care and the ability to quickly respond to a surge in COVID-19 cases, if necessary.

CMS recommends that general considerations should include the following:

  • In coordination with state and local public health officials, evaluate the incidence and trends for COVID-19 in the area where restarting in-person care is being considered.
  • Evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical and procedural care and high-complexity chronic disease management; however, select preventive services may also be highly necessary.
  • Consider establishing non-COVID-19 care zones that would screen all patients for symptoms of COVID-19, including temperature checks. Staff would be routinely screened, including physicians, nurses, housekeeping, and delivery, as well as all people entering the area.
  • Sufficient resources should be available to the facility across phases of care (i.e., availability of clinicians, nurses, anesthesia, pharmacy, imaging, pathology support, and post-acute care), including personal protective equipment (PPE), a healthy workforce, facilities, supplies, testing capacity, and post-acute care, without jeopardizing surge capacity.

The guidance sets forth specific considerations regarding PPE, workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

For communities experiencing a high number of cases and thus have not yet entered Phase 1, CMS Administrator Verma encouraged those communities to “continue following the recommendations made by CMS last month,” including guidance issued on April 7.

New State Orders Subsequent to CMS Guidance

Subsequent to the release of the updated CMS guidance, many states issued new orders concerning the provision of elective, nonurgent procedures. In addition to considering the updated CMS guidance, healthcare facilities and providers should remain current with state and local executive orders and other binding law. State and local laws will dictate what options are available to healthcare facilities and providers and may or may not defer to CMS guidance.

For example, in Texas, Governor Greg Abbott issued a series of executive orders, including Executive Order GA-15 on April 17, which loosened restrictions on elective, nonurgent procedures put in place by Executive Order GA-09 on March 22. Like GA-09, GA-15 required all licensed healthcare professionals and facilities to postpone all surgeries and procedures that are not medically necessary to diagnose or correct a serious medical condition or to preserve the life of a patient.

However, GA-15 provided two exceptions, allowing (1) any procedure that when performed consistently with standards of clinical practice would not deplete the hospital capacity or the PPE needed to cope with COVID-19, and (2) any surgery or procedure performed in a licensed healthcare facility that has certified in writing to the Texas Health and Human Services Commission (HHSC) both that it will reserve at least 25% of its hospital capacity for treatment of COVID-19 patients across the range of clinical severity, and that it will not request any PPE from any federal, state, or local public source for the duration of the COVID-19 pandemic.

Then, on April 27, Texas Governor Abbott issued Executive Order GA-19, superseding GA-15 and removing restrictions placed on elective, nonurgent procedures. GA-19 obligates licensed healthcare professionals to limit their practice by any emergency rules promulgated by their respective licensing agencies dictating minimum standards for safe practice during the COVID- 19 pandemic. GA-19 also requires licensed hospitals to reserve 15% of hospital capacity for the treatment of COVID-19 patients, accounting for the range of clinical severity, as determined by the Texas HHSC.

On April 30, the Texas Medical Board promulgated a new emergency rule that (1) repeals previous limitations on the provision of elective, nonurgent surgeries, and (2) requires healthcare providers to follow certain social distancing protocols and minimal safety standards. Guidance released by the Texas Medical Board on May 1 indicates that a violation of the new emergency rule could be considered unprofessional conduct that may result in the suspension or termination of a provider's license.

On the other hand, some states continue to prohibit elective surgeries and procedures. For example, Massachusetts continues to ban elective surgeries and procedures, and the official guidance has remained unchanged since the ban first went into effect. The Massachusetts Department of Public Health issued an order and guidance on March 15 directing all hospitals and ambulatory surgical centers to postpone or cancel any nonessential, elective invasive procedures until the state of emergency is terminated by the governor or until the department rescinds the order.

As of May 2, the order issued by the Massachusetts Department of Public Health and the state of emergency remain in effect. On April 28, Massachusetts Governor Charles D. Baker extended the state's stay-at-home order through May 18, suggesting the state of emergency and the ban on elective procedures and surgeries may remain in effect for some time.

All in all, whether a healthcare facility or provider should proceed with a procedure should be analyzed from multiple perspectives, including from a CMS guidance perspective, a state licensure perspective (which relates to a provider remaining in good standing with his or her licensure board), and a public relations perspective. Further, all activity should be compliant with applicable state and local executive orders and other binding law.

As healthcare providers bring employees back to work, they should also be aware of the range of employment issues that will arise as they begin reopening parts of their workplace.

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