Expiration dates for PHE flexibilities
When the COVID-19 Public Health Emergency (PHE) ended on May 11, 2023, many of the flexibilities for telehealth, remote patient monitoring, and other virtual healthcare services[1] ended or a date was identified for such flexibilities to end. Significant PHE flexibilities for virtual healthcare and related expiration dates are summarized below.
Telehealth flexibilities extended through 2024
The following telehealth flexibilities will continue through December 31, 2024, with restrictions scheduled to return on January 1, 2025, unless changes are enacted in the meantime:
Restriction[2] |
Flexibility through 2024 |
With some exceptions (e.g., substance use disorder (SUD) and mental health services) the patient must generally be at a healthcare facility or office in a rural area |
Patient can be at any location in the U.S., including the home |
Telehealth services must be performed using interactive audio/video technology |
Audio-only modalities are allowed for some services |
Professionals eligible to bill for telehealth services as distant site providers are limited to physicians, nurse practitioners, physician assistants, certified nurse assistants, certified registered nurse anesthetists, clinical psychologists, licensed clinical social workers, registered dieticians and nutrition professionals |
Any professionals allowed to bill Medicare are eligible to bill for telehealth. This extends telehealth eligibility to physical therapists (PTs), occupational therapists, speech language pathologists and audiologists |
Federally qualified health centers (FQHCs) and rural health centers (RHCs) are not eligible distant sites |
Allow FQHCs and RHCs to bill for telehealth as distant site providers |
In-person visit (within 6 months before the initial telehealth service and then annually) required for mental telehealth in the home (other than for SUDs and co-occurring mental health disorders) |
In-person visit not required |
In-person hospice eligibility recertification |
May be via telehealth |
Face-to-face home health assessment |
May be via telehealth |
Hospital in-patient services |
Acute Hospital Care at Home (AHCH) program allows hospitals to provide some services in patient home |
Deductibles under HSA high deductible health plans (HDHPs) need to be satisfied before telehealth coverage |
Allow HDHPs to provide telehealth coverage before deductibles satisfied |
Telehealth flexibilities through 2023
The following Medicare PHE flexibilities are scheduled to end at the close of the day on December 31, 2023 unless extended by the Centers for Medicare & Medicaid Services (CMS):
Restriction |
PHE flexibility |
Medicare eligible telehealth services |
Added temporary telehealth service codes |
Immediate availability for services requiring direct supervision by a physician or NPP |
Allow virtual presence through real-time a/v technology |
Lower payment for telehealth than in-person services at the office |
Payment parity |
Required reporting of home service location if physician provides services from home |
Allow practitioner services from home without reporting home address |
Recently expired PHE virtual healthcare flexibilities
Various flexibilities for virtual healthcare ended with the PHE on May 11, 2023, including the following:
Reinstated restriction |
Expired PHE Flexibility |
Established patient relationship required prior to remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), remote evaluations, virtual check-ins, e-visits |
Allowed for new (in addition to established) patients[3] |
Face-to-face initiating visit required |
Initiating visit via telehealth was allowed |
Prior patient consent required |
Consent at time of service was allowed |
At least 16 days of monitoring required in a 30 day billing period for RPM or RTM supply of medical device and transmission |
Minimum was reduced to 2 days for patients with actual or suspected COVID-19 |
Telehealth frequency restrictions for subsequent inpatient or SNF visit or a critical consult |
Frequency limits were temporarily removed |
Face-to-face visit required for end-stage renal disease (ESRD) home dialysis, National Coverage Determination (NCD) or Local Coverage Determination (LCD) |
Telehealth visits were allowed |
Potential fraud and abuse (e.g., anti-kickback and civil monetary penalty) exposure for routine waiver or reduction of patient cost-sharing |
Office of Inspector General (OIG) Telehealth Policy Statement said OIG would not impose administrative sanctions for waiver or reduction of patient cost-sharing for telehealth services |
Stark Law physician self-referral restrictions and potential exposure |
Blanket waivers of some Stark Law restrictions, such as fair market value for some arrangements, and in-office ancillary services location requirements (allowed services outside office, such as in patient’s home) |
Federal Anti-Kickback Statute |
OIG enforcement discretion for some of the Stark Law blanket waivers |
Soon to expire PHE virtual healthcare flexibilities
The Office for Civil Rights (OCR) exercised enforcement discretion during the PHE to allow good faith use of non-public-facing telehealth platforms. OCR’s 90-day transition period to come into compliance with HIPAA standards will expire at the end of the day on August 9, 2023.
Controlled substance telehealth prescribing
The Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act) requires an in-person medical evaluation prior to dispensing controlled substances via internet telehealth prescription, subject to some exceptions. During the PHE the Drug Enforcement Administration (DEA) allowed prescriptions via telehealth using an audio-visual, real time interactive platform.
The DEA published proposed rules on March 1, 2023, that would permit prescribing via telemedicine under certain circumstances[4] and establish additional recordkeeping requirements. On May 10, 2023, the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) published a temporary rule extending the PHE controlled substance prescribing flexibilities through November 11, 2023, while DEA and SAMHSA consider revisions to the proposed rules, which generated over 38,000 comments. The temporary rule also extends the flexibilities through November 11, 2024, for prescriber-patient telemedicine prescribing relationships established on or before November 11, 2023.
Virtual healthcare providers and their leaders, advisers, vendors and business associates should watch for future statutory, regulatory, and payor updates, review their business models and related policies, procedures and training in order to plan ahead for adjustments, keeping in mind that significant lead time may be needed in order to effectively implement the necessary changes.
For more information on virtual healthcare or related matters, please contact the author or a member of McDonald Hopkins' national Healthcare Practice Group.
[1] This article uses “virtual healthcare” broadly to include telehealth, remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), chronic care management (CCM), and transitional care management (TCM), as well as other communication technology-based services (CTBS) such as remote evaluations, virtual check-ins and e-visits.
[2] Restrictions and flexibilities are for Medicare billing except for the HDHP references.
[3] CMS has clarified that patients who received RPM, RTM or other communication technology-based services during PHE and consented are considered established patients even without an initiating visit.
[4] Prescribing would be allowed under the proposed rule if the prescriber performed a prior in-person medical evaluation, if the patient is referred by a practitioner who conducted a prior in-person medical evaluation, if the patient is in the physical presence of a DEA-registered practitioner during the audio-video telemedicine encounter, or if the prescription is for a 30-day initial Schedule III to V prescription.