What Physician Organizations Need to Know: Key Considerations for the End of the PHE

May 11, 2023

As the COVID-19 Public Health Emergency comes to an end on May 11, various regulatory flexibilities simultaneously expire, including certain waivers issued by the Centers for Medicare & Medicaid Services, among other regulatory agencies. Physician organizations should take stock of these impending regulatory changes as the more relaxed regulations of the COVID-19 era revert to the pre-pandemic rules.

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. Certain regulatory flexibilities permitted by the Centers for Medicare & Medicaid Services (CMS) and other government agencies will terminate concurrently with the PHE on that date, while other waivers of regulatory requirements will continue through the end of 2023 or later.

The regulatory flexibilities implemented during the PHE allowed physician organizations and other healthcare providers to focus on providing care on the front lines of the COVID-19 pandemic instead of on burdensome regulatory requirements. These relaxed rules were a welcome relief for physician organizations attempting to react swiftly to the unprecedented challenges of the PHE. With the end of the PHE, business for physician organizations will return to the (new) normal.

Physician organizations should plan accordingly for the expiration of these various regulatory flexibilities. Below are key changes that will impact physician organizations as the PHE and corresponding regulatory waivers terminate. This list is non-exhaustive and physician organizations are advised to review CMS and other agency guidance, as applicable.


Medicare Enrollment and Opt-Out Flexibilities

Throughout the PHE, CMS has expedited any pending or new Medicare enrollment applications from physicians and other healthcare providers and suppliers. Upon the expiration of the PHE, the agency will revert to its normal processing times for enrollment applications. CMS has also allowed providers to cancel their opt-out status early in order to enroll in Medicare and provide care to additional patients during the pandemic.

Medicare Administrative Contractors (MACs) were permitted to accept opt-out cancellation requests through email, fax, or phone during the PHE, and providers were not required to provide separate written notice of cancellation of their opt-out status. This waiver will terminate concurrently with the PHE and providers that have opted out will not be able to cancel such status earlier than provided in 42 CFR § 405.445.

Physician Licensure and Practice Location Flexibility

For the duration of the PHE, CMS waived Medicare’s requirement that a physician be licensed in the state in which the physician was practicing if certain requirements were met. Specifically, the physician must have (1) been enrolled in Medicare; (2) had a valid license to practice in the state reflected in the physician’s Medicare enrollment; (3) furnished services (either in person or through telehealth) in a state in which the PHE was occurring in order to contribute to pandemic relief efforts in the physician’s professional capacity; and (4) not been affirmatively excluded from practice in the state or any other state under the Section 1135 waiver emergency area.

In other words, this waiver allowed licensed physicians to bill Medicare for services provided in one or more states beyond their state of enrollment. This waiver did not, however, waive state or local government licensure or licensure waiver requirements. In any case, CMS acknowledged that its regulations allowed for deferral to state law with respect to provider licensure and practice location rules even before the PHE. Accordingly, with the PHE expiring, CMS will continue to defer to state law in this regard.

Relatedly, CMS permitted physicians and other practitioners to provide telehealth services from their homes without reporting their home addresses in their Medicare enrollments. Accordingly, providers could continue to bill from their enrolled location despite actually providing services from home. Effective upon the termination of the PHE, physicians and other providers must report their home address on their Medicare enrollment if that location is where they will continue to provide services from.


Stark Law Blanket Waivers and Related AKS Enforcement Discretion

On March 30, 2020, CMS issued blanket waivers to certain Stark Law requirements (Stark Blanket Waivers), effectively allowing referrals and billing for designated health services that otherwise would have been prohibited by this strict liability statute.

Shortly thereafter, on April 3, 2020, the US Department of Health and Human Services published a policy statement explaining that the agency would exercise its enforcement discretion to not impose sanctions under the Federal Anti-Kickback Statute (AKS) for certain remuneration protected by the Stark Blanket Waivers.

Accordingly, absent any determination of fraud or abuse, physician organizations and other healthcare providers were exempted from satisfying certain Stark Law requirements without fear of sanctions and could also be assured of similar treatment under the AKS with respect to remuneration under certain of the Stark Blanket Waivers. Both the Stark Blanket Waivers and related AKS enforcement discretion are set to expire concurrently with the PHE on May 11, 2023. 

For additional guidance on how physician organizations that have relied on the Stark Blanket Waivers and related AKS enforcement discretion can best prepare for the end of these regulatory flexibilities, refer to our standalone LawFlash on these topics.


Telehealth Regulatory Flexibilities

In response to the pandemic, various waivers were put in place to facilitate the provision of telehealth to Medicare and Medicaid beneficiaries. These waivers relaxed various rules on the use of telehealth technology in order for physician organizations and other providers to continue to provide care, while also minimizing the spread of COVID-19. Many of these flexibilities, which have undoubtedly contributed to the accelerated adoption of telehealth nationwide, will remain in place after the end of the PHE.

For more details on how the end of the PHE will impact physician organizations’ ability to provide care via telehealth, refer to our separate blog post on these topics.

Remote Prescription for Controlled Substances

During the PHE, the Drug Enforcement Administration (DEA) permitted physicians and other DEA-registered providers to prescribe controlled substances for patients via telehealth without requiring an in-person evaluation, subject to certain conditions. On May 9, 2023, the DEA extended this relaxed rule for an additional six months.

Accordingly, physician organizations may continue to prescribe controlled substances via telehealth through November 11, 2023. Additionally, for any physician-patient relationships that are established by November 11, 2023, physicians will be able to prescribe controlled substances via telehealth through November 11, 2024.


E/M Visit CPT Code Change

CMS permitted use of the level one E/M visit (CPT code 99211) during the PHE. While this CPT code is typically used for services furnished to an established patient, CMS allowed its use when clinical staff assessed a patient and collected a specimen for a COVID-19 test for either a new or established patient. As the PHE ends, the standard requirements for using this CPT code will again apply.

Physician Orders for COVID-19 Tests

During the PHE, Medicare covered the first COVID-19 test for a beneficiary without requiring a physician or other provider order, while subsequent tests required an order. Upon termination of the PHE, Medicare requires all COVID-19 and related diagnostic testing performed by a laboratory to be ordered by a physician or other provider.


It is prudent for physician organizations to assess how the termination of the pandemic-era regulatory flexibilities will impact their day-to-day practice and make a plan for the changes effective on May 12, 2023.


If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following:

B. Scott McBride (Houston / Dallas)