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Telehealth: New Executive Order and CY2021 Proposed Regulatory Changes

On August 3, 2020, President Trump issued an Executive Order seeking to improve care provided to individuals in rural communities by increasing access to care through telehealth.1 On the same day, the Centers for Medicare & Medicaid Services (CMS) published the CY2021 Medicare Physician Fee Schedule Proposed Rule (“CY 2021 PFS Proposed Rule”)2, which includes numerous enhancements to CMS’ coverage and payment for telehealth services.  

Executive Order on Improving Rural Health and Telehealth Access

The Executive Order outlines the following actions that will be taken to increase accessibility to telehealth services for rural patients:

  • HHS will implement a new model to test innovative payment mechanisms to rural health providers. The model will aim to ensure that rural health providers have flexibility from Medicare rules, predictable reimbursement, and encourage value-based care. Of note, on August 11, CMS announced a new Community Health Access and Rural Transformation (CHART) Model related to this directive.3

  • The Secretary and the Secretary of Agriculture will develop and implement a strategy to improve the physical and communications healthcare infrastructure available to rural Americans. 

  • The Secretary will provide a report to the President that includes rural health specific policy initiatives aimed at: increasing access to healthcare by eliminating regulatory burdens; preventing disease and mortality; reducing maternal mortality and morbidity; and improving mental health. 

The Secretary will propose a regulation to extend the flexibilities put in place in response to the public health emergency (“PHE”), which include additional telehealth services, as well as service, reporting, staffing, and supervision flexibilities for providers in rural areas. 

The aforementioned actions must be taken within 30 or 60 days of the issuance of the Executive Order. 

FY2021 Medicare Physician Fee Schedule Proposed Rule

Stakeholder comments on the CY 2021 PFS Proposed Rule are due on October 5, 2020.  Of note, CMS is waiving the 60-day delay in the effective date of the final rule, and replacing it with a 30-day delay in the effective date of the final rule, meaning that the final rule may be published closer to the effective date than in prior years.  This article summarizes the following provisions of the proposed rule:

  • Telehealth Services

  • Extended Payment for Telehealth Services through Distinct Time Period

  • Communication Technology Based (“CTB”) Services

  • Remote Physiologic Monitoring (“RPM”)

  • Direct Supervision by Interactive Telecommunications Technology

Telehealth Services

CMS considers whether to add new services to the Medicare Telehealth Services List on an annual basis.  As a result of PHE, CMS issued numerous waivers and flexibilities that added services to the Medicare Telehealth Services List on an interim basis.  

For CY 2021, CMS is proposing to add the following services to the Medicare telehealth list on a Category 1 basis:

  • Group Psychotherapy (CPT code 90853)

  • Domiciliary, Rest Home, or Custodial Care services, Established patients (CPT codes 99334-99335)

  • Home Visits, Established Patient (CPT codes 99347- 99348)

  • Cognitive Assessment and Care Planning Services (CPT code 99483)

  • Visit Complexity Inherent to Certain Office/Outpatient E/Ms (HCPCS code GPC1X)

  • Prolonged Services (CPT code 99XXX)

  • Psychological and Neuropsychological Testing (CPT code 96121)

CMS is also proposing to add the following services to the Medicare telehealth list on a Category 3 basis:

  • Emergency Department Visits (99281-99283)

  • Domiciliary, Rest Home, or Custodial Care services, Established patients (99336, 99337)

  • Home Visits, Established Patient (99349, 99350)

  • Nursing facilities management (99315, 99316)

  • Psychological and Neuropsychological Testing (96130-96133)

Extended Payment for Telehealth Services through Distinct Time Period

In the CY 2003 PFS final rule, CMS established a process to allow the public to submit requests to add or delete services from the Medicare telehealth services list. Under this process, CMS assigns any submitted request to one of two categories: Category 1—services similar to services already on the Medicare telehealth list, and Category 2—services not similar to those to services already on the Medicare telehealth list. In the CY 2021 PFS Proposed Rule, CMS is proposing to create a temporary, third category which would add several services to the Medicare telehealth list through the calendar year in which the PHE ends.

CMS notes that some services added to the Medicare telehealth list as a result of the PHE will remain, for the duration of the emergency period, as Category 2 codes. Such services have been identified as not appropriate for Category 3 status, which will continue through the end of the year in which the PHE ends, due to increased concerns for patient safety and quality of care, and whether, outside of the PHE, the services can be furnished fully and effectively by a remotely located clinician via two-way, audio/video telecommunications technology. 

CMS seeks comment on whether the following services should be added to the Medicare telehealth services list on a temporary Category 3 basis:

  • Initial and final/discharge interactions (CPT codes 99234-99236 and 99238-99239)

  • Higher level emergency department visits (CPT codes 99284-99285)

  • Hospital, Intensive Care Unit, Emergency care, Observation stays (CPT codes 99217-99220; 99221-99226; 99484-99485, 99468-99472, 99475- 99476, and 99477- 99480)

In light of the extensive number of services added to the Medicare telehealth list during the public health emergency, CMS is soliciting comments from the public on the specific codes the agency is not proposing to add temporarily on a Category 3 basis or not proposing to add to the Medicare telehealth list permanently.

Communication Technology Based (“CTB”) Services

In 2019 CMS finalized separate payment for a number of services that could be furnished via telecommunications technology but that are not considered Medicare telehealth services, appropriately labeled Communication Technology Based (“CTB”) services. 

CTB services include certain remote patient monitoring, virtual check-ins, and remote asynchronous services. These differ from Medicare telehealth in that they are not ordinarily furnished in person but are routinely furnished using a telecommunications system. 

CMS clarifies in the CY 2021 PFS Proposed Rule that CTB services are not considered telehealth and, therefore are not subject to the same restriction. CMS seeks comment on whether additional services similarly fall outside the scope of telehealth services and as such, do not need to be on the Medicare telehealth services list in order to be paid when furnished using telecommunications technology. 

In regard to CTB services, CMS notes that they received several questions regarding the benefit categories for HCPCS codes G20614 and G20635. As a result of the PHE, CMS established on an interim basis that these services could be billed by non-physician practitioners, which CMS clarifies, that while not an exhaustive list, includes licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists who bill Medicare directly for their services when the service furnished falls within the scope of the practitioner’s benefit categories. CMS is proposing to adopt this policy on a permanent basis and seeks comment on other benefit categories into which these services fall. 

CMS is proposing to allow billing of other CTB services by certain non-physician practitioners through the addition of two HCPCS G codes, G20X06 and G20X27. Further, to facilitate care provided by therapists, CMS is also proposing to designate HCPCS codes G20X0, G20X2, G2061, G2062, and G2063 as “sometimes therapy” services.

Remote Physiologic Monitoring (RPM)

In recent years CMS finalized 7 CPT codes for RPM, a majority of which have been the focus of frequent questions. CMS offers significant clarification in the CY 2021 PFS Proposed Rule regarding reimbursement for RPM services. 

CMS clarifies that a medical device used to provide RPM services must meet the definition of medical device as defined by the FDA. However, the medical device does not need to be FDA cleared or prescribed by a physician. The device should have the capability of digitally uploading patient physiologic data, which CMS clarifies as data that is not patient self-recorded and/or self-reported.  The device should be reasonable and necessary for the diagnosis and treatment of the patient and must be used to collect and transmit reliable and valid physiologic data that allows a provider to develop and manage a treatment plan. 

RPM services can be ordered and billed by physicians and non-physician practitioners who are eligible to bill Medicare evaluation and management (“E/M”) services, and may be furnished to patients with acute and chronic conditions. Importantly, CMS clarifies that at the end of the PHE, RPM services will only be allowed to be furnished to established patients. However, CMS is proposing on a permanent basis to allow consent to be obtained at the time of the RPM service.

The Proposed Rule offers clarification regarding the use of several RPM codes:

  • CPT 99453 and 99454: In order to appropriately bill CPT codes 994538and 994549, the initial set-up and 30-day monitoring codes, providers must account for the following:

    • Patient monitoring must occur over at least 16 days of a 30-day period. 

    • The codes may not be reported for a patient more than once during a 30-day period. 

    • If multiple medical devices are used, the services associated with all the medical devices can be billed only once per patient per 30 day period and only when at least 16 days of data have been collected. 

    • CPT 99453 can be billed only once per episode of care where an episode of care is defined as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals.

  • CPT 99091: Following the 30 day collection period, 9909110 allows reimbursement for the professional work of analyzing and interpreting the physiologic data collected. 

    • Valuation of the code 99091 includes 40 minutes of physician or non-physician practitioner work, which includes 5 minutes of pre-service work, 30 minutes of intraservice work and 5 minutes of post-service work. 

    • The CPT descriptor phrase “physician or other qualified health care professional” is defined as “an individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within his/her scope of practice and independently reports that professional service. These qualified individuals are distinct from “clinical staff,” which is a person who works under the supervision of a physician or other qualified healthcare professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service. For Medicare purposes, a physician or qualified healthcare professional is an individual who is authorized to independently bill Medicare for the service.

  • CPT 99457 and 99458: Following analysis and interpretation of the physiologic data, CPT codes 9945711 and 9945812 offer reimbursement for the development and management of a treatment plan informed by the patient’s data. 

    • CPT codes 99457 and 99458 can be furnished by clinical staff under the general supervision of a physician or non-physician practitioner. 

    • “Interactive communication,” is real-time interaction between a patient and the physician or non-physician practitioner or clinical staff who provides the service. CMS clarifies that for purposes of 99457 and 99458, interactive communication involves at a minimum, a real-time synchronous, two-way audio interaction that is capable of being enhanced with video or other kinds of data transmission. 

    • CMS notes that while “time” is typically considered to be the face-to-face time with the patient or their medical decision maker. For RPM services, which are not typically furnished in person, CMS interprets time in the code descriptor as the time spent in direct, real-time interactive communication with the patient. 

CMS is seeking comment on whether current RPM coding accurately and adequately describes the full range of clinical scenarios where RPM services may be of benefit to patients. 

Direct Supervision by Interactive Telecommunications Technology

The PFS requires some level of supervision for many services for which payment is made. “Direct supervision” as defined in §§ 410.26 and 410.32(b)(3)(ii) requires the physician or non-physician practitioner (“NPP”) be present in the office suite and immediately available to furnish assistance and direction throughout performing a particular service or procedure. Direct supervision does not, however, require the physician or NPP to be present in the actual room when the service or procedure is performed. 

To limit unnecessary exposure to COVID-19, CMS has adopted an interim policy which would revise the definition of “direct supervision.” Under the new definition, virtual presence of the supervising physician or NPP using interactive audio and video real-time communications technology (85 FR 19245) would satisfy the direct supervision requirement. Audio-only telephone calls would not satisfy that same requirement. 

CMS is proposing to extend this interim policy until 1) the calendar year in which the public health emergency ends or 2) December 31, 2021, whichever comes later. Beyond limiting exposure to COVID-19, CMS hopes that an extended period of flexibility here will allow the agency to obtain public input from clinicians and others on which services and circumstances this policy would be appropriate on a permanent basis.

© Polsinelli PC, Polsinelli LLP in CaliforniaNational Law Review, Volume X, Number 237

About this Author

Cybil G. Roehrenbeck, Polsinelli PC, Precision Medicine Lawyer, Genomics Attorney

Focusing on emerging health care sectors, Cybil Roehrenbeck is dedicated to helping clients achieve their objectives by employing a comprehensive, interdisciplinary approach to their legal and business challenges. She counsels clients on federal legislative and regulatory opportunities in the following areas:

  • Health information technology  

  • mHealth and telehealth

  • Precision medicine and genomics

  • Innovative health care delivery...

Joelle M. Wilson Health Care Polsinelli Chicago, IL

Joelle Wilson is dedicated to creating results-driven solutions and opportunities within the complex regulatory and policy health care environment. Her practice focuses on the implementation and management of compliance matters and advising clients on legal, operational and regulatory health care issues.

Joelle leverages her deep understanding of health care to represent hospitals, physician groups and other health care professionals and organizations in a variety of matters. She has experience advising clients on compliance risk mitigation, corrective action and response to...

David E. Bird Associate Kansas City Health Care Services Health Care Industry

David Bird is dedicated to providing effective, efficient and innovate legal solutions to health care clients. As an Associate in the Health Care Alignment and Organization practice, David applies his understanding of health care issues towards representing hospitals, physician groups, and other health care professionals and organizations in a variety of health care matters.