Legal Summary

After The Public Health Emergency

William h. maRuCa, esquiRe

On January 31, 2020, while most of us were only vaguely aware of a new virus being reported overseas (and only seven cases had been confirmed within the U.S.) Secretary Alex Azar of the Department of Health and Human Services formally declared a nationwide Public Health Emergency (PHE) to confront the 2019 Novel Coronavirus. This PHE has been extended nine times by Secretary Azar and his successor, Xavier Becarra, most recently through January 11, 2023. After nearly three years of battling the COVID-19 pandemic, the PHE may be allowed to expire sometime next year. The Department has promised to provide a 60-day notice of termination or expiration of the PHE, but health care providers should begin to prepare for special COVID-related rules and exceptions to revert to pre-2020 status when that happens.

In anticipation, the Centers for Medicare and Medicaid Services (CMS) published guidance on August 18, 2022, on its website entitled “Creating a Roadmap for the End of the COVID-19 Public Health Emergency”. As CMS notes, a number of emergency authority waivers, regulations, enforcement discretion and guidance have been issued since January 31, 2022, to ensure access to care and give health care providers the flexibilities needed to respond to COVID-19. However, some of these changes were designed to be temporary and to expire when the PHE ends. Other new rules, such as telemedicine flexibility, have been implemented in a manner that will extend beyond the PHE, at least for some additional period of time. Other temporary measures have already been rescinded, such as waivers of training standards for long term care staff, which CMS believes may have led to increases in such facilities’ residents’ weight-loss, depression, and incidence of pressure ulcers. Similarly, waivers of physician visit requirements in skilled nursing facilities and waivers relating to delegation of tasks by physicians in SNFs were terminated on May 7, 2022.

CMS has published a list of COVID-related waivers here: https:// www.cms.gov/coronavirus-waivers. Unless otherwise specified, these waivers will end with the PHE. They include:

Flexibility for Medicare Telehealth

Services—This waiver expands the types of health care professionals who can furnish distant site telehealth services to include all those who are eligible to bill Medicare for their professional services. This allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services, including physical therapists, occupational therapists, speech language pathologists, and others, to receive payment for Medicare telehealth services. This waiver will end 151 days after the conclusion of the PHE. However, a separate waiver, making it easier for telemedicine services to be furnished to a hospital’s patients through an agreement with an off-site hospital, will end at the conclusion of the PHE.

Audio-Only Telehealth for Certain

Services—This waiver allows the use of audio-only equipment to furnish evaluation and management services and behavioral health counseling and educational services. This waiver will also end 151 days after the conclusion of the PHE.

EMTALA Screening—This waiver allowed hospitals, psychiatric hospitals, and critical access hospitals to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, as long as it is consistent with a state’s emergency preparedness or pandemic plan.

Verbal Orders—Requirements for authentication of certain verbal orders in hospitals were relaxed to address “surge” situations.

Medical Staff and Credentialing— This waiver allowed physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval. A similar waiver applied to Ambulatory Surgery Facilities.

Physical Environment in Hospitals— This waiver allowed hospitals to utilize facility and non-facility space that is not normally used for patient care to be utilized for patient care or quarantine, provided the location is approved by the state and is consistent with the state’s emergency preparedness or pandemic plan to handle surges and quarantine needs.

Hospital Physician Services—This provision waived the requirement that Medicare patients be under the care of a physician if consistent with a state’s emergency preparedness or pandemic plan, to allow for expanded use of extenders during physician shortages.

Anesthesia Services—CMS waived the requirement that a certified registered nurse anesthetist (CRNA) must be under the supervision of a physician as long as the arrangements for anesthesia are consistent with state law and a state’s emergency preparedness or pandemic plan.

Responsibilities of Physicians in

Critical Access Hospitals (CAHs)— CMS waived the requirement that a M.D. or D.O. must be present at all times in a CAH to provide medical direction, consultation, and supervision for the services provided.

Physician Supervision of NPs in

Certain Clinics—CMS waived the requirement that physicians must provide medical direction to nurse practitioners in Rural Health Clinics and Federally Qualified Health Centers, so long as they are in contact via telehealth or other remote communications. The pre-PHE rules will be restored at the end of the calendar year that the PHE ends, but CMS is exploring options to make this flexibility permanent.

Practitioner Locations and

Licensure—CMS waived the rule that required out-of-state practitioners be licensed in the state where they are providing services in certain situations so long as they are licensed in another state. Many states implemented similar waivers to allow physicians to travel across state lines to assist with acute physician shortages early in the pandemic. When the PHE ends, current regulations will continue to defer to state law (including state waivers), so practitioners should check applicable state rules.

Expedited Enrollment—CMS expedited any pending or new applications from practitioners, providers and suppliers beginning March 1, 2020. When the PHE ends, CMS will resume normal application processing times. Locum Tenens Billing—CMS waived the 60-day limit under which a substitute physician’s services could be billed to Medicare under the absent physician’s provider number. This waiver will expire 61 days after the end of the PHE.

Stark Self-Referral Law—Certain “blanket” waivers were implemented which loosened the requirements for written agreements under the Stark law, permitted amendment of arrangements that qualified for exceptions, expanded the exception for indirect compensation arrangements, and modified the requirements for loans and income guarantees with physicians. These waivers will expire with the end of the PHE.

Be Prepared

If you are utilizing any of the waivers that are set to expire either upon the end of the PHE or within certain defined periods, now is the time to prepare for going back to the way things were done during the “before times.” Expect significant pressure on regulators to preserve some of these flexibilities, particularly those regarding telemedicine. The announcement of the impending end of the PHE will likely be a major news item, and will give you at least 60 days to get ready. Take advantage of this lead time to implement the necessary changes and consult your health care attorney for further guidance.

William H. Maruca is a health care partner with the Pittsburgh office of the national law firm of Fox Rothschild LLP. He can be reached at wmaruca@ foxrothschild.com or 412.394.5575