Medicare Telehealth and the End of the Public Health Emergency
Throughout the COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services (CMS) used a combination of emergency authority waivers, regulations, enforcement discretion, guidance, and reliance on new legislation to provide broad flexibilities under the Medicare and Medicaid programs. With the expiration of the PHE on May 11, 2023, health care providers should be aware of major changes that are in store regarding reimbursement flexibilities related to Medicare telehealth and other types of remote and virtual care.
An area of significant impact is Medicare telehealth services under Section 1834(m) of the Social Security Act, which ordinarily imposes strict requirements for the delivery of such services. During the PHE, CMS exercised various waiver and statutory authorities to remove certain geographic and originating site restrictions, as well as restrictions on who may furnish telehealth services. The agency also allowed for certain telehealth services to be furnished via audio-only communication technology. Altogether, this paved the way for a new landscape of relaxed telehealth flexibilities over the last three years.
Additionally, the COVID-19 PHE was the impetus for new and/or temporary policies by CMS to provide alternatives to face-to-face and in-person encounters between vulnerable Medicare beneficiaries and health care professionals (and each other), such as through remote patient monitoring (RPM), virtual supervision, and the relaxing of face-to-face service requirements. Initially born out of necessity, health providers and beneficiaries have become accustomed to these policies and this new way of furnishing care.
With the end of the PHE, Congress must act if some of these flexibilities are to become permanent fixtures of the Medicare program. At the same time, CMS must grapple with what it can do under its existing authorities, such as the Section 1834(m) Medicare telehealth provision, particularly in light of lessons learned during the PHE. Indeed, the PHE has forced the agency to reevaluate what services are appropriate for telehealth, particularly in the area of behavioral health services which lends itself to virtual telehealth encounters as compared to other services. Additionally, while CMS adopted certain policies on a temporary basis during the PHE, CMS has signaled that it may be open to making such policies permanent. For example, despite its current plans to return to the pre-PHE direct supervision rules, CMS has previously solicited comments about whether to make the temporary exception (direct supervision through virtual presence) permanent or to apply such policies to a subset of services, and sought additional data or evidence that might justify such a change. Accordingly, this is a key time and opportunity for stakeholders and other interested parties to weigh in on these issues, such as in the upcoming Physician Fee Schedule rulemaking cycle for calendar year 2024, to inform future policy development and, where applicable, potentially persuade the agency to restore or retain certain PHE-related exceptions or flexibilities. As several fraud and abuse waivers expire, adherence to the adjusted policies is critical.
To aid health care providers as they adapt to the changing reimbursement landscape, the chart below provides a description of key flexibilities afforded during the PHE and identifies the dates that these policies lapse. For additional summaries of these past PHE flexibilities, please see prior editions of Arnold & Porter’s Virtual and Digital Health Digest.
CMS also has published materials to aid health care providers and ensure a smooth transition with the end of PHE, including a transition fact sheet, FAQs about the PHE waivers, and a memorandum discussing guidance for the expiration of the PHE.
End of the PHE: Medicare Telehealth and Other Virtual and Remote Care Changes
Description of PHE Flexibilities
Key Expiration Dates
|Remote Patient Monitoring (RPM) Extension||
During the PHE, CMS permitted physicians to use RPM on both new and established patients so long as consent was obtained. 85 Fed. Reg. 19264. Previously, RPM could only be used with established patients.
|Expired on May 11, 2023|
|Face-to-Face and In-Person Requirements||During the PHE, CMS adopted an interim policy for national coverage determinations (NCDs) and local coverage determinations (LCDs) that set aside requirements for face-to-face and in-person encounters for evaluations, assessments, certifications, or other implied face-to-face services that would otherwise apply. 85 Fed. Reg. 19266. This policy did not extend, however, to statutory face-to-face encounter requirements for DMEPOS Power Mobility Devices.||Expired on May 11, 2023|
|Relaxing “Direct Supervision” Requirements||
During the PHE, CMS temporarily altered the definition of “direct supervision” as it pertains to diagnostic tests, physicians’ services, and some hospital outpatient services to allow supervising health care providers to be available “through audio/video real-time communication technology,” rather than physical presence. 85 Fed. Reg. 19245; 86 Fed. Reg. 65062; 87 Fed. Reg. 69467.
After December 31, 2023, the pre-PHE rules at 42 CFR § 410.32(b)(3)(ii) apply and direct supervision again means “that the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure.”
|Expires on December 31, 2023|
|Telehealth Payment Parity||As we highlighted in our December Digest, during the PHE, CMS modified its billing policy and allowed payment to physicians and practitioners for Medicare telehealth services at the same reimbursement rate as services furnished in-person. 87 Fed. Reg. 69466.||Expires on December 31, 2023|
|Extended Telehealth Flexibilities||
(1) Allowing telehealth services to be furnished in any geographic location and any originating site (including the patient’s home)
(2) Expanding the list of practitioners eligible to furnish telehealth services
(3) Extending coverage of telehealth services furnished by Federally Qualified Health Centers and Rural Health Clinics
(4) Delaying the in-person visit requirements under Medicare for mental health services furnished through telehealth and telecommunications technology
(5) Allowing the furnishing of audio-only telehealth services
(6) Allowing the use of telehealth to conduct face-to-face encounters prior to recertification of eligibility to hospice care
|Expires on December 31, 2024|
|Relaxing of Prescribing of Controlled Substances||
The Drug Enforcement Agency (DEA) made two major changes related to prescribing controlled substances during the PHE.
(1) Under the Ryan Haight Act, practitioners are required to conduct an in-person evaluation of a patient before they can prescribe controlled substances over the internet. During the PHE, however, providers were permitted to prescribe a controlled substance to a patient via a two-way, audio-video telemedicine appointment.
(2) During the PHE, qualifying practitioners were also permitted to prescribe buprenorphine to new and existing patients with opioid use disorder based only on a telephone evaluation.
On May 10, 2024, DEA, in concert with HHS, published a temporary rule extending all telemedicine flexibilities regarding the prescribing of controlled substances that were in place during the PHE until November 11, 2023. 88 Fed. Reg. 30037.
The temporary rule also specifies that, “if a patient and practitioner establish a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.”
This temporary rule comes in light of two controversial proposed rules DEA issued in February, 2023 (available here and here). As we discussed in the March Digest, many stakeholders were frustrated with the proposed narrowing of telemedicine flexibilities in these proposed rules after expanding access to controlled substances via telemedicine during the PHE. DEA received 38,369 comments and is in the process of “considering revisions” to the two proposed rules.
© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.