The COVID-19 Declaration of a Public Health Emergency (“the PHE”) issued by the Department of Health and Human Services (“HHS”) on January 31, 2020 officially comes to an end on May 11, 2023.

While the pandemic was undeniably one of the most tragic events of our lifetime, the virtual care flexibilities announced by HHS and the Centers for Medicare & Medicaid Services (“CMS”) to ensure access to medical care as in-person medical visits came to a halt catalyzed healthcare innovation and moved us forward from a policy perspective by leaps and bounds. 

The end of the PHE means the expiration of some — but not all! — of these flexibilities, presenting both challenges and opportunities for telehealth and other digital health companies here in the U.S. as these flexibilities expire or approach expiration. This article provides an overview of the most significant changes that will impact telehealth, virtual care management, and remote care companies.

Below is a summary of pre-PHE policy, COVID PHE flexibilities, and Post-PHE changes to those flexibilities relating to Telehealth, Tele-Behavioral Health, Remote Patient Monitoring, and Virtual Care Management services.

Changes to Telehealth Post-PHE

Originating Site and Geographic Restrictions

Pre-PHE: Telehealth services were only available to Medicare beneficiaries located in rural or under-served areas of the country, and beneficiaries were required to travel to an “originating site” such as their physician’s office or a Rural Health Clinic in order to receive telehealth services.

COVID PHE Waiver: Medicare beneficiaries may receive telehealth services authorized in the 2023 Medicare Physician Fee Schedule from any originating site, including their home, and need not be located in a designated rural/underserved area of the country.

Post-PHE:  Congress extended this waiver through December 31, 2024 by legislative action under the Consolidated Appropriations Act of 2023. Advocates anticipate that further legislation will be passed to make telehealth permanently available to Medicare beneficiaries without the burdensome pre-PHE restrictions.

Eligible Providers of Telehealth Services

Pre-PHE:  A limited list of providers eligible to bill Medicare could be reimbursed for providing certain telehealth services to beneficiaries.

COVID PHE Waiver: All providers eligible to bill Medicare, including Physical Therapists (“PTs”), Occupational Therapists (“OTs”), Speech Language Pathologists (“SLPs”), and Audiologists may be reimbursed for providing certain telehealth services to beneficiaries.

Post-PHE:  Congress extended this waiver through December 31, 2024 by legislative action under the Consolidated Appropriations Act of 2023. Advocates are pushing hard for PTs, OTs, SLPs, and Audiologists to be permanently added to the list of providers eligible to bill Medicare for telehealth services.

Expanded list of Telehealth Services

Pre-PHE:  Only a limited list of services were eligible for reimbursement when provided via telehealth.

COVID PHE Waiver:  CMS, through its Medicare Physician Fee Schedules issued from 2020 to 2023, dramatically expanded the list of services eligible to be provided via telehealth. 

Post-PHE:  The current list of services eligible for reimbursement when provided via telehealth will remain effective through December 31, 2023. However, note that this list may be expanded through the 2024 Medicare Physician Fee Schedule process as CMS continues to evaluate which services are appropriate for reimbursement when delivered via telehealth.

Tele-prescribing of Controlled Substances

Pre-PHE: Except in very limited circumstances involving the presence of another practitioner, prescribing controlled substances in the context of a telehealth visit was prohibited without a prior in-person visit with the prescribing practitioner. 

COVID PHE Waiver: Tele-prescribing of controlled substances by a practitioner is permitted in the context of a telehealth visit with that practitioner even when the patient is at home or in another physical location, and without the requirement of an in-person visit. Drugs for the maintenance and management of Opioid Use Disorder may be prescribed after an audio-only telehealth visit.

Post-PHE:  Following a wave of negative feedback on the Drug Enforcement Agency’s (“DEA”) proposed rule around tele-prescribing, DEA has issued a temporary rule allowing all COVID waivers relating tele-prescribing to remain in place through November 11, 2023. For practitioner-patient relationships established prior to November 11, 2023, the waivers will extend through November 11, 2024. Expect a new rule to be released that better incorporates stakeholder feedback.

Part B Co-Pays for Telehealth Services

Pre-PHE:  By statute, Medicare providers are obligated to collect the 20% beneficiary copay for Part B services. Providers failing to do so could be penalized by the Office of Inspector General for beneficiary inducement illegal under the Civil Monetary Penalties Law (“CMPL”).

COVID PHE Waiver:  The Office of Inspector General announced that it would not enforce Part B copay requirements for telehealth and other virtual care services during the PHE, thereby permitting Medicare providers to choose to waive Part B copay requirements for their patients without risk of CMPL penalties. 

Post-PHE: As of May 11, 2023, the Office of the Inspector General will once again enforce the statutory requirement for Medicare providers to collect a 20% Part B copay from patients for telehealth visits.

Use of Non-HIPAA Compliant Telehealth Technology Platforms

Pre-PHE:  Telehealth technology must comply with HIPAA requirements.

COVID PHE Waiver: The Office of Civil Rights (“OCR”) announced it would exercise its enforcement discretion and would not penalize telehealth companies or providers for using communication/technology platforms that do not meet HIPAA requirements. 

Post-PHE:  OCR will resume enforcement of HIPAA requirements for telehealth communication/technology platforms on May 11, 2023.

FQHCs and RHCs as Telehealth Providers

Pre-PHE:  Federally Qualified Health Centers and Rural Health Clinics were “originating sites” for Medicare beneficiaries in rural areas seeking telehealth services. These beneficiaries were required to travel to an “originating site” such as an FQHC or RHC to receive telehealth services from a “distant site” provider, often a specialist located in a city.

COVID PHE Waiver: Medicare beneficiaries may receive telehealth services from FQHCs or RHCs in their homes or other locations; FQHCs and RHCs are deemed “eligible providers.”

Post-PHE:  This waiver has been made permanent. 

Telehealth as an “Excepted Benefit”

Pre-PHE:  Employers were unable to offer standalone telehealth services as a benefit to employees not participating in their full medical plan.

COVID PHE Waiver:  Telehealth and remote care services were permitted to be treated as standalone “excepted benefits” offered by employers to their employees.

Post-PHE:  This waiver ends with conclusion of the PHE on May 11, 2023. Telehealth advocates are urging Congress to pass legislation codifying telehealth and remote care services as excepted benefits.

Changes to Tele-Behavioral Health Post-PHE

No Originating Site restrictions for Tele-Behavioral Health Services

Pre-PHE:  Medicare beneficiaries could only receive Tele-Behavioral Health services if they were located in a rural or underserved area, and they were required to travel to an FQHC or RHC as the originating site for these services.

COVID PHE Law: In 2020, Congress passed a Consolidated Appropriations Act that included new legislation around Tele-Behavioral Health services for Medicare beneficiaries. This legislation allows all beneficiaries – not just beneficiaries located in a rural or underserved area – to receive Tele-Behavioral Health services from their home if they had an in-person exam with the tele-behavioral health practitioner within the prior six months and annually thereafter. This requirement does not apply to Substance Use Disorder patients, and the in-person visit requirements are postponed until December 31, 2024. 

Post-PHE:  This law remains in effect permanently unless/until it is amended. Many advocates would like to see the requirements for periodic in-person visits removed entirely. The in -person visit requirements are postponed until December 31, 2024.

Eligible Tele-Behavioral Health Services

Pre-PHE: A limited list of behavioral health services were included on the list of eligible telehealth services, but originating site and geographic restrictions applied.

COVID PHE Waiver:  An expanded list of behavioral health services were added to the list of eligible telehealth services. Originating site and geographic restrictions did not apply to any telehealth services, including tele-behavioral health services. Medicare beneficiaries could receive these services in their homes or any other locations. 

Post-PHE:  The behavioral health services included in the 2023 list of services eligible to be provided via telehealth can be provided and billed through December 31, 2024. 

Audio-Only Behavioral Health Services Permitted

Pre-PHE: Audio-only services were not considered “telehealth services” and were not reimbursable.

COVID PHE Waiver: Certain audio-only behavioral health services were included on the 2023 list of reimbursable telehealth services. 

Post-PHE:  CMS has indicated that these audio-only behavioral health services will remain on the telehealth list. Additional services may be added in future Medicare Physician Fee Schedules.

Changes to Remote Physiologic Monitoring (“RPM”) and Virtual Care Management Services Post-PHE

16-Day Requirement for RPM

Pre-PHE:  As of the 2021 Medicare Physician Fee Schedule, a patient must electronically transmit 16 days of physiologic data during each 30-day period in order for the billing practitioner to receive reimbursement for the supply of a device or devices used for Remote Physiologic Monitoring services during that period. 

COVID PHE Waiver: In an Interim Rule, CMS reduced the required number of data transmissions for reimbursement from 16 days each 30-day period to 2 days each 30-day period, but ONLY for the diagnosis of suspected COVID or treatment of COVID. 

Post-PHE:  This waiver expires at the end of the PHE on May 11, 2023. Stakeholders are strongly urging CMS to revisit the 16-day requirement as arbitrary to demonstrating improved outcomes.

RPM for Established Patients Only

Pre-PHE: CMS required that RPM services could only be ordered and provided for established patients of a billing practitioner, meaning an initiating visit was required for patients not seen within the last year. 

COVID PHE Waiver: CMS waived the requirement of an established patient relationship and a separately billable initiating visit for patients not seen within the last year, instead allowing RPM services to be ordered and provided to both new and established patients without a separate initiating visit. 

Post PHE:  This waiver expires at the end of the PHE on May 11, 2023.  Telehealth and in-person practices who have been ordering RPM services during a first encounter with a patient will need to conduct an initiating visit prior to ordering RPM. 

Part B Co-Pays for Virtual Care Management Services

Pre-PHE:  By statute, Medicare providers are obligated to collect the 20% beneficiary copay for Part B services, including for Remote Physiologic Monitoring services and other Virtual Care Management services like Chronic Care Management, Principal Care Management, and Behavioral Health Integration services. Providers failing to do so could be penalized by the Office of Inspector General for beneficiary inducement illegal under the Civil Monetary Penalties Law (“CMPL”). 

COVID PHE Waiver:  The Office of Inspector General announced that it would not enforce Part B copay requirements for telehealth and virtual care management services like RPM and CCM during the PHE, thereby permitting Medicare providers to choose to waive Part B copay requirements for their patients without risk of CMPL penalties.

Post-PHE:  As of May 11, 2023, the Office of the Inspector General will once again enforce the statutory requirement for Medicare providers to collect a 20% Part B copay from patients. Members of Congress have introduced legislation aimed at eliminating the 20% Part B co-pay for services like Chronic Care Management services. Stakeholders are encouraging similar legislation for RPM. 

What’s next?

With expiration dates on various flexibilities looming, May 11th starts the clock on Congress, CMS, and other regulatory agencies to make permanent policy improvements that continue to support patient access to technology-driven healthcare. Industry stakeholders should keep the expiration dates for flexibilities top of mind as they create and implement new programs and, in the meantime, collect clinical data supporting efficacy of telehealth and advocate for more permanent changes through Congress and other appropriate regulatory bodies. Below are some key takeaways to consider now to help you prepare for the post-PHE legal and regulatory environment.

Key Takeaways for Telehealth

• Physical Therapists, Occupational Therapists, Audiologists, and Speech Language Pathologists should advocate for their ability to successfully provide services via telehealth.  

• Many telehealth flexibilities require Congress to make permanent changes through legislation – and we should loudly encourage them to do so. 

• Watch for the DEA to issue a new proposed rule on tele-prescribing and make your voice heard!  

Key Takeaways for Tele-Behavioral Health

• Permanent removal of the originating site and geographic restrictions for tele-behavioral health services is a big win to be celebrated!

• Behavioral Health providers should ask Congress to permanently remove the in-person visit requirements for tele-behavioral health services to patient. 

Key Takeaways for Remote Patient Monitoring and Virtual Care Management vendors and providers

• As of May 11, 2023, practitioners must first establish a bona fide practitioner-patient relationship before ordering RPM, and patients must transmit at least 16 days of data in a 30-day period. Stakeholders should collect data accumulated during the pandemic to demonstrate efficacy of RPM programs for new patients as well as established patients. 

• Providers of RPM and other virtual care management services believe that waiving copays for these services encouraged patients to utilize them, resulting in a reduction to the overall cost of care. Stakeholder should collect and share this data with Congress and encourage legislation to remove the Part B copay requirements for RPM and virtual care management services. 

Stay Up to Date in a Post-PHE Regulatory Landscape

While the end of the PHE brings with it the termination of several flexibilities, it also offers a chance for telehealth and digital health companies to adapt and thrive in a post-PHE landscape.

By staying informed about these changes and seizing new opportunities, your organization can continue to innovate and contribute to the ongoing transformation of healthcare.

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