The Centers for Medicare & Medicaid Services (CMS) has finalized its rule on in-person exam requirements for Medicare coverage of telehealth-based mental health services when the patient is located at home. The Frequently Asked Questions below are based on CMS’ policies in the 2022 Physician Fee Schedule Final Rule.
1. When does the rule take effect?
The rule goes into effect the day after the Public Health Emergency ends.
2. What does the new rule require?
Under the rule, Medicare will cover a telehealth service delivered while the patient is located at home if the following conditions are met:
- The practitioner conducts an in-person exam of the patient within the 6 months before the initial telehealth service;
- The telehealth service is furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder (other than for treatment of a diagnosed substance use disorder (SUD) or co-occurring mental health disorder); and
- The practitioner conducts at least one in-person service every 12 months of each follow-up telehealth service.
If these conditions are met (as well as other claim requirements generally), the telehealth service may be covered by Medicare even though the patient’s home is not a qualified originating site under the statutory coverage laws (and therefore not otherwise eligible for reimbursement). The distinction between the telehealth and non-telehealth services must be documented in the patient’s medical record.
3. Are there any situations where the in-person exam requirement does not apply?
Yes. Here are three examples provided by CMS in the Final Rule:
- If the patient is located at a qualifying originating site in an eligible geographic area (e.g., a practitioner office in a rural Health Professional Shortage Area) and the arrangement meets the statutory requirements for telehealth service coverage under Medicare, an in-person exam is not a prerequisite for reimbursement.
- The in-person exam does not apply to telehealth treatment of a diagnosed SUD or co-occurring mental health disorders (the SUPPORT Act already made the patient’s home an eligible originating site for such services).
- If the patient and practitioner agree the benefits of an in-person, non-telehealth service within 12 months of the mental health telehealth service are outweighed by risks and burdens associated with an in-person service, and the basis for that decision is documented in the patient’s medical record, the in-person visit requirement will not apply for that particular 12-month period.
4. What scenarios might support waiving the follow-up in-person exam requirement?
With regard to waiving the in-person exam for follow-up care, there are some situations in which the risks and burdens associated with an in-person service may outweigh the benefit. CMS stated these situations could include, for example, instances when an in-person service is likely to cause disruption in service delivery or has the potential to worsen the patient’s condition(s). The risks and burdens associated with an in-person service could also outweigh the benefit if a patient is in partial or full remission and only requires a maintenance level of care. Other examples include the practitioner’s professional judgement that the patient is clinically stable and/or that an in-person visit has the risk of worsening the patient’s condition, creating undue hardship on self or family, or if it is determined that the patient is at risk for disengagement with care that has been effective in managing the illness.
If using this exception, practitioners must document that the patient has the ability to obtain any needed point of care testing, including vital sign monitoring and laboratory studies. Practitioners must note the exception for each applicable 12-month interval.
There is no exception to the requirement for an in-person, non-telehealth service within 6 months prior to initiation of mental health services via telehealth.
5. What constitutes the patient’s home for purposes of the rule?
CMS’ definition of home, both in general and for this purpose, is more than just the patient’s primary residence, and can include temporary lodging, such as hotels and homeless shelters. For circumstances where the patient, for privacy or other personal reasons, chooses to travel a short distance from the exact home location during a telehealth service, the service is still considered to be furnished “in the home of an individual” for purposes of this rule.
6. What constitutes a telehealth service furnished for the diagnosis, evaluation, or treatment of a mental health disorder?
The determining factor is the International Classification of Diseases (ICD-10) diagnosis codes. CMS stated it will distinguish between mental health services furnished for a diagnosed SUD or co-occurring mental health disorder (which do not require the in-person exam) and those furnished to beneficiaries without a SUD diagnosis (which do require the in-person exam) on the basis of ICD-10 diagnosis codes included on claims when the services are billed.
7. Who must conduct the in-person exam vs the telehealth services?
The Final Rule suggests the practitioner would conduct both the first in-person exam and the initial telehealth service. For the follow-up in-person exam every 12 months, a clinician colleague in the same subspecialty in the same group as the practitioner can furnish the in-person, non-telehealth service to the patient if the original practitioner is unavailable. This flexibility is consistent with longstanding CMS policy, which defines an established patient as an individual who receives professional services from the physician/NPP or another physician of the same specialty and subspecialty who belongs to the same group within the previous three years, for purposes of billing for Evaluation and Management (E/M) services.
8. Why did CMS create this in-person exam requirement?
CMS did not create it. Congress compelled CMS to implement this regulation, following statutory changes in the Consolidated Appropriations Act of 2021 (read our analysis here). In December 2020, Congress imposed new conditions on telemental health coverage under Medicare, creating an in-person exam requirement alongside coverage of telemental health services at the patient home. These new conditions, codified as amendments to 42 U.S.C. § 1395m(m)(7), caused confusion in the industry, particularly because it was the first instance of a federal statute mandating an in-person exam as a prerequisite for Medicare coverage of a telehealth-based service. In contrast, the overwhelming majority of federal and state flexibilities during the Public Health Emergency were telemedicine-friendly and promoted the use of digital health technology to deliver medical care.
9. Does this affect SUD telehealth services under the SUPPORT Act?
No. The in-person visit requirements under this CMS rule do not apply to telehealth treatment of a diagnosed SUD or co-occurring mental health disorders, as the SUPPORT Act already requires Medicare payment for such services. Learn more about the SUPPORT Act here.
10. What telemedicine modality is required for telemental health services while the patient is located at home?
In connection with the recent regulation changes, CMS stated an interactive telecommunications system can include “interactive, real-time, two-way audio-only technology” for telehealth services furnished for the diagnosis, evaluation, or treatment of a mental health disorder, under the following conditions:
- The patient is located in their home at the time of service as described at 42 C.F.R § 410.78 (b)(3)(xiv);
- The distant site physician or practitioner has the technical capability at the time of the service to use an interactive telecommunications system that includes video; and
- The patient is not capable of, or does not consent to, the use of video technology for the service.
To that end, CMS created a service-level modifier for use in these situations where mental health telehealth services are furnished to a patient in their home using audio-only communications technology. CMS further stated SUD services are considered mental health services for purposes of this amended definition of “interactive telecommunications system” to include audio-only services under 42 C.F.R § 410.78(a)(3). These changes are intended to improve access to care for mental health conditions and contribute to overall health equity.
11. What was changed in the official regulation?
Here are the changes to the regulation.
42 C.F.R. § 410.78(b)—Telehealth Services
(a) * * *
(3) Interactive telecommunications system means, except as otherwise provided in this paragraph, multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. For services furnished for purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient in their home, interactive telecommunications may include two-way, real-time audio-only communication technology if the distant site physician or practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology. A modifier designated by CMS must be appended to the claim for services described in this paragraph to verify that these conditions have been met.
* * * * *
(b) * * *
(3) * * *
(xiv) The home of a beneficiary for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder for services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 except as otherwise provided in this paragraph. Payment will not be made for a telehealth service furnished under this paragraph unless the following conditions are met:
(A) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service;
(B) The physician or practitioner has furnished an item or service in-person, without the use of telehealth, at least once within 12 months of each subsequent telehealth service described in this paragraph, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens associated with an in-person service outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reason(s) for this decision in the patient’s medical record.
(C) The requirements of paragraphs (b)(3)(xiv)(A) and (B) may be met by another physician or practitioner of the same specialty and subspecialty in the same group as the physician or practitioner who furnishes the telehealth service, if the physician or practitioner who furnishes the telehealth service described under this paragraph is not available.
(4) * * *
(iv) * * *
(D) Services furnished on or after the first day after the end of the PHE as defined in our regulation at § 400.200 for the purposes of diagnosis, evaluation, and/or treatment of a mental health disorder. Payment will not be made for a telehealth service furnished under this paragraph unless the physician or practitioner has furnished an item or service in person, without the use of telehealth, for which Medicare payment was made (or would have been made if the patient were entitled to, or enrolled for, Medicare benefits at the time the item or service is furnished) within 6 months prior to the initial telehealth service and within 6 months of any subsequent telehealth service.
CMS will monitor claims data regarding use of telehealth mental health services to identify areas for further investigation and to inform future rulemaking, including situations where there is evidence beneficiaries are potentially experiencing adverse health outcomes or increased difficulty accessing in-person care, or if inappropriate use or billing of telehealth mental health services is suspected.
Want to Learn More?
- American Telemedicine Association EDGE Conference
- Is This the Worst Medicare Telehealth Law of 2020?
- Telehealth and Substance Use Disorder Treatment: Regulatory Barriers to Entry Can Mean Opportunity for Innovative Companies
For more information on telemedicine, telehealth, virtual care, remote patient monitoring, digital health, and other health innovations, including the team, publications, and representative experience, visit Foley’s Telemedicine & Digital Health Industry Team Page.