On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was issued in tandem with a presidential executive order, which directed the Secretary of the US Department of Health and Human Services (HHS) to propose regulations expanding telehealth services covered by Medicare. CMS stated that the proposed rule “is one of several proposed rules that reflect a broader Administration-wide strategy to create a healthcare system that results in better accessibility, quality, affordability, empowerment, and innovation.”

IN DEPTH

In response to the coronavirus (COVID-19) public health emergency (PHE), CMS has issued several temporary waivers and flexibilities that expand telehealth reimbursement under Medicare, Medicaid and the Children’s Health Insurance Program for the duration of the COVID-19 PHE. CMS issued these waivers under authorities granted pursuant to HHS’s public health declaration, as well as legislation passed in response to the pandemic. Many of these waivers have substantially altered the Medicare telehealth reimbursement landscape and, as we detailed in our prior On the Subject, many can be made permanent via regulatory action. The proposed rule represents the first official word that CMS will take such action to make certain of its waivers permanent. These policy changes have the potential to greatly increase the availability of telehealth to Medicare beneficiaries around the country.

CMS will accept comments, either electronically or by mail, on the proposed rule until 5 pm EDT on October 5, 2020.

Changes to Medicare Telehealth Services

CMS proposed to add several services, listed below, to its list of services that may be delivered via telehealth. Many of these were previously added on an interim final rule basis for the duration of the PHE. The proposed rule would keep them on the Medicare telehealth services list even after the PHE ends.

CMS also proposed a new method for adding or deleting services from the Medicare telehealth services list. Currently, CMS evaluates new services for inclusion based on two categories: Category 1 is for services that are similar to professional consultations, office visits and office psychiatry visits that are already on the Medicare telehealth services list, while Category 2 is for services that are not similar to those already on the list, but that would still be appropriate to include. Because of the COVID-19 PHE, CMS has proposed to add a Category 3, which would include services that would be temporarily on the Medicare telehealth services list. CMS proposed this third category because, while CMS currently has the authority to waive or modify Medicare telehealth payment requirements during the PHE, that authority will expire once the PHE ends. And once the PHE expires, Medicare payment policy will return to the most recently established Medicare telehealth services list, which would not include many of the services temporarily added to the list for the duration of the PHE.

At the outset, Category 3 would include all telehealth services added to the list during the PHE, which would ensure that healthcare providers would not suddenly be prevented from offering the services via telehealth, and would also enable CMS to evaluate whether the services should be added on a more permanent basis. Services added through the Category 3 pathway would remain on the Medicare telehealth services list through the end of the calendar year in which the PHE ends.

Services Proposed to Permanently Remain on the Medicare Telehealth Services List

Furnishing Telehealth Visits in Inpatient and Nursing Facility Settings

CMS requires that residents of skilled nursing facilities receive an initial visit from a physician and subsequent periodic personal visits from either a physician or a nonphysician practitioner (NPP). Historically, physicians and NPPs were prohibited from performing those visits via telehealth, but CMS issued a waiver that permitted such visits to be performed via telehealth for the duration of the PHE. CMS now seeks comment on whether it should extend this flexibility beyond the PHE.

CMS also noted that it has received requests to remove frequency limitations on the number of subsequent inpatient visits that can be conducted via telehealth. CMS announced that it would not propose to modify this policy, on the grounds that in-person care is preferable “to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis.”

That said, CMS proposed to revise the limit on providing subsequent nursing facility visits via telehealth from once every 30 days to once every three days. CMS said that it was persuaded by stakeholder comments that this limitation hinders access to care and that clinicians should have the authority to determine how often their patients should receive visits via a Medicare telehealth service.

Communication-Technology-Based Services

In the March 31, 2020, interim final rule for the Medicare and Medicaid programs, CMS announced that certain NPPs, consistent with their respective benefit category, could bill HCPCS codes G2061 through G2063 for the duration of the PHE. These HCPCS codes, which include services such as online assessment and management for an established patient for up to seven days, could be billed by licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists and speech-language pathologists. CMS has now proposed to adopt these policies permanently. Notably, this is not an exhaustive list, and CMS seeks comments on other benefit categories into which these services fall.

CMS proposed to allow billing of other communication-technology-based services by certain NPPs through the creation of two additional telehealth codes:

• The first code, G20X0, relates to remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous seven days nor leading to a service or procedure within the next 24 hours or soonest available appointment.

• The second code, G20X2, allows for brief communication-technology-based service (e.g., virtual check-in) by a qualified healthcare professional who cannot report evaluation and management (E/M) services, provided to an established patient, not originating from a related service provided within the previous seven days nor leading to a service or procedure within the next 24 hours or soonest available appointment, totaling five to ten minutes of medical discussion.

CMS recognized that it previously valued similar services differently based on who can and cannot bill independently for office/outpatient E/M services, with higher values placed on practitioners who can independently bill E/M services. CMS noted that similar check-ins provided by nurses and other clinical staff could be important aspects of coordinated patient care, and thus CMS proposed to value codes G20X0 and G20X2 identically to other physician telehealth check-in codes G2010 and G2012. To further facilitate the billing of communication-technology-based services by therapists, CMS proposed to designate HCPCS codes G20X0, G20X2, and G2061 through G2063 as “sometimes therapy” services.

Practitioners must continue to obtain patient consent so that patients are mindful of their co-pay obligations when receiving these services. CMS does not believe that the timing or manner in which patient consent is acquired should interfere with the delivery of brief communication-technology-based services. Further, a patient’s consent to receive these services can be documented by auxiliary staff under general supervision, as well as by the billing practitioner.

Direct Supervision

CMS recognizes that, in some instances, technology allows appropriate supervision without the physical presence of a physician (or other supervising practitioner) when a service or procedure is performed. CMS adopted an interim final policy revising the definition of direct supervision to include virtual presence using interactive audio and video technology for the duration of the PHE to reduce exposure risk to the supervising practitioner, and CMS has now proposed to extend this policy until the end of the calendar year in which the PHE ends, or December 31, 2021, whichever is later. CMS opted to do so because it recognizes that the unique circumstances faced by individual communities may continue after the PHE ends, and extending this policy provides time to solicit public input on situations where the flexibility to use real-time audio and video technology to offer direct virtual supervision could still be necessary and appropriate.

In the proposed rule, CMS clarified that direct supervision does not require real-time presence or observation, but instead requires the supervising physician (or other practitioners) to be immediately available to engage via audio/video technology (excluding audio-only). Despite CMS’s flexibility in revising the direct supervision definition, CMS remains concerned that direct supervision through virtual presence may be insufficient to support the PFS payment permanently, due to patient safety issues. Therefore, CMS seeks information from commenters on whether there should be any additional “guardrails” or limitations to ensure patient safety and clinical appropriateness. CMS also seeks information on what risks this policy might introduce to patients as they receive care from practitioners that would supervise care virtually in this way and potential concerns around induced utilization and fraud, waste and abuse, and how those concerns might be addressed.

Payment for Audio-Only Services

The proposed rule also solicits comments on the continuation of payment for audio-only services. In particular, CMS is soliciting comments on whether it should develop coding and payment for a service similar to the virtual check-in but for a more extended unit of time and with an accordingly higher value. It is also seeking input from commentators on the appropriate duration interval for such services and the resources in both work and practice expense that would be associated with furnishing them. Additionally, CMS is looking for comments on whether separate payment for such telephone-only services should be a provisional policy to remain in effect until a year or some other period after the end of the PHE or if it should be a PFS payment policy permanently.

Many providers and patients have benefited from the increased flexibility of audio-only services during the PHE, and the delivery of these services will be interrupted if the PHE ends before CMS has decided whether and how to continue payment for audio-only services. This presents a significant challenge for providers, who will have to consider how to continue providing care to these patients in the absence of payment audio-only services.

Other Proposed Changes Included in the Proposed Rule

In addition to the above proposed changes, the proposed rule:

1. Would remove regulatory references that exclude “telephones, facsimile machines, and electronic mail systems” from the definition of “interactive telecommunications system.” CMS expressed concern that the reference to “telephones” may be confusing in cases where a smartphone may be used to deliver telehealth services, and pointed out that the definition of “interactive telecommunications system” otherwise sufficiently describes the applicable requirements.

2. Solicits comments on coding and payment for virtual services. In the past, CMS has received requests to add certain services, such as chronic care management or remote physiologic monitoring, to the enumerated list of telehealth services based on section 1834(m) of the Social Security Act. However, because these services are substantially different than the enumerated list of telehealth services, in that they are not akin to a service that would ordinarily be furnished in-person, CMS has not considered them to be Medicare telehealth services that are subject to the telehealth reimbursement restrictions (e.g., the originating site and geographic location requirements).

   • CMS seeks comment on whether there are additional services that fall outside the scope of telehealth services under section 1834(m) of the Act for which it would be helpful for CMS to clarify that the services are inherently non-face-to-face and therefore do not need to be on the Medicare telehealth services list in order to be reimbursed when furnished using telecommunications technology rather than in-person.

   • CMS also seeks comment on whether there are physician services that use evolving technologies to improve patient care that may not be fully recognized by current PFS coding and payment. These include, for example, additional or more specific coding for care management services.

3. Proposed various clarifications to CMS’s existing PFS policies for telehealth services, including the following:

   • Distant site practitioners are permitted to bill for telehealth services that are provided “incident to” their services. While no regulations currently prohibit this practice, direct supervision requirements have historically called for the onsite (physical) presence of the billing practitioner. However, given that the proposed rule would permit virtual presence to satisfy direct supervision requirements, CMS will permit services that are provided “incident to” to be billed if direct supervision requirements are met at both the originating and distant site via the virtual presence of the billing practitioner.

   • If a practitioner uses audio/video technology to deliver a service to a beneficiary located in the same institutional or office setting, the visit would not be considered a telehealth visit that would be subject to the typical telehealth requirements in the Social Security Act. Rather, the practitioner should bill for the visit as if it were furnished in person.

4. Would modify requirements regarding the presence of teaching physicians during Medicare telehealth services.

   • Usually, Medicare pays for services provided by residents only if the physician is physically present for the service or procedure. In the March 31, 2020, interim final rule, CMS temporarily allowed teaching physicians to provide direct supervision of medical residents when providing Medicare telehealth services through audio/video real-time communications technology.

   • CMS is concerned that permitting the virtual presence of the teaching physician may not allow the teaching physician to render sufficient personal and identifiable physicians’ services to the patient to exercise full, personal control over the service to warrant separate payment on the PFS. CMS solicits comments on whether this policy should continue once the PHE ends.

   • CMS seeks comments to help it understand how the option to allow teaching physician presence using audio/video real-time communications technology could support patient safety for all patients and particularly at-risk patients, ensure burden reduction without creating risks to patient care or increasing fraud, avoid duplicative payment between the PFS and the inpatient prospective payment system for graduate medical education programs, and support emergency preparedness.

5. Would finalize certain policy changes related to remote patient monitoring (RPM) and make certain clarifications regarding codes associated with RPM services. Key proposals include:

   • RPM codes may only be billed by physicians and NPPs who are otherwise eligible to bill Medicare for E/M services.

   • RPM services may be used to collect and analyze physiological data from patients with acute conditions and patients with chronic conditions.

   • RPM codes that relate to the development of a treatment plan based on the collection and analysis of the patient’s physiological data may be furnished by clinical staff under the general supervision of a physician or NPP.

   • CMS proposed to permanently permit consent to be obtained at the time that RPM services are furnished, which is currently permitted for the duration of the PHE.

   • After the PHE ends, CMS would only permit RPM services to be furnished to established patients.

   • CMS seeks comment on whether the current RPM codes “accurately and adequately describe the full range of clinical scenarios” where RPM services may benefit patients.