CMS Clarifies Coverage and Payment for Remote Therapeutic Monitoring Services - McDermott Will & Emery

CMS Clarifies Coverage and Payment for Remote Therapeutic Monitoring Services

Overview


On November 1, 2022, the US Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2023 final rule for services reimbursed under the Medicare Physician Fee Schedule (MPFS) (the Final Rule). The Final Rule establishes changes to Medicare Part B professional payment policies and rates for the upcoming year. The Final Rule provides much-anticipated clarity regarding Medicare coverage and payment for remote therapeutic monitoring (RTM) services and continues to develop CMS’s payment policies following the 2022 introduction of the RTM codes.

CMS finalized certain changes to the existing CPT codes for RTM services but declined to finalize the proposed replacement of these CPT codes with four new, specific Healthcare Common Procedure Coding System (HCPCS) G-codes (G-codes) for RTM services. Most importantly, CMS has addressed the supervision standards for clinical staff, prerequisites for billing RTM codes, and the potential creation of a general device code for RTM. Finally, CMS has finalized its payment policy for the new RTM code for cognitive behavioral therapy.

In Depth


Remote Monitoring Background

In recent years, CMS has expanded its payment for remote monitoring services, which generally use digital technologies (primarily medical devices, together with software) to collect medical and other forms of health data from patients in one location to electronically transmit the information to the patient’s healthcare provider in a different location for assessment and care management. Beginning in 2019, with the introduction of CPT codes for remote physiological monitoring (RPM), CMS has gradually established payment rates and provided guidance on requirements and appropriate utilization for remote monitoring services.

RTM refers to the use of medical devices to monitor a patient’s health or response to treatment using non-physiological data. RTM can be used to monitor medication adherence, response to therapy, musculoskeletal activity, and respiratory activity. This means that RTM can be used, for example, to monitor treatment specific to pain, functional status, and adherence and response to therapy. Effective in 2022, the American Medical Association (AMA) created five new codes for RTM services as a separate category of remote patient monitoring services. The five codes for RTM services were new CPT codes 98975, 98976, 98977, 98980 and 98981. These include three practice expense-only (PE-only) codes (98975, 98976 and 98977) and two codes for treatment management (98980 and 98981).

CMS established payment policies for RTM last year and currently allows payment using the RTM codes for services that support an episode of therapy where the clinical issue ties to musculoskeletal, respiratory, or medication adherence and response. As Medicare is a major payor for healthcare items and services in the United States, the availability of reimbursement for RTM services has led to an explosion of interest from digital health companies, established providers and start-up companies in furnishing RTM services.

Unlike remote physiological monitoring (RPM) codes, RTM allows for self-reported data from the patient and are categorized as general medicine, rather than as evaluation and management (E/M), services. RPM services, as E/M services, have been categorized by CMS as “designated care management” services, which permits billing professionals such as physicians and nurse practitioners (NPs) to bill for services furnished by clinical auxiliary personnel (generally, lower-level licensed or unlicensed personnel), provided the services were furnished under the billing professional’s general supervision and the requirements for billing “incident to” the billing professional’s services are met. “General” supervision means the procedure is furnished under the billing provider’s overall direction and control, but the billing provider’s presence is not required during the procedure. In contrast, “direct” supervision requires that the billing provider be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure.

Physical therapists (PTs), occupational therapists (OTs), speech-language pathologists (SLPs) and clinical social workers (CSWs), among other similar licensed clinician types, are not generally eligible to furnish E/M services under Medicare payment requirements. These licensed clinicians could furnish RPM services under the general supervision of a physician or higher-level licensed clinician (for example, a nurse practitioner or physician assistant), but were not eligible to directly furnish and bill for RPM services. Accordingly, the availability of Medicare reimbursement for RTM services expanded the healthcare professionals who could directly provide and bill for RTM services. However, under the existing Medicare coverage and payment requirements, RTM services furnished by clinical auxiliary personnel required direct supervision by the billing professional. This, in turn, limited the ability of a PT, OT or other healthcare professional to bill for services that were provided in part by lower-level clinical auxiliary personnel.

In the MPFS Proposed Rule issued on July 7, 2022 (the Proposed Rule), CMS proposed modifying the payment policies for RTM services by establishing four new G-codes that were intended to address these supervising and billing limitations inherent in the current RTM CPT codes. Specifically, while PTs, OTs, SLPs and CSWs were eligible to bill for RTM services, the Medicare benefits that are eligible to be furnished by these healthcare professionals do not include the ability to bill for services furnished “incident to” these individuals’ personally performed professional services. CMS noted that a primary reason for developing the RTM codes was to increase beneficiary access to remote monitoring services by allowing the services to be furnished by a broad array of qualified nonphysician healthcare professionals, but the design of the RTM codes could reduce the availability of RTM services.

Two of the four proposed G-codes, as contemplated by the Proposed Rule, would have allowed certain non-physician qualified healthcare professionals to furnish RTM services. Meanwhile, the other two G-codes would have allowed for general supervision of auxiliary personnel by physicians and non-physician practitioners. In the Final Rule, however, CMS declined to finalize the new G-codes. CMS did, however, finalize guidance that the existing CPT codes for RTM services may be provided under general supervision, as opposed to direct supervision. In the Final Rule, CMS noted that it will continue to weigh the possible tradeoffs that would be necessary to further reduce coding and billing complexity for RTM and increase care delivery flexibility and retain appropriate beneficiary access to RTM services.

In the Proposed Rule, CMS also requested feedback related to requests to develop a generic device code for RTM services. CMS requested information on RTM devices that could be used to deliver “reasonable and necessary” services to Medicare beneficiaries, including types of data collected using RTM devices, how data is used to assist in treating specific health conditions, and what those health conditions are, together with how long the typical episode of care may be, depending on condition type.

In the Proposed Rule, CMS reviewed a new CPT code that is intended to be used for remote therapeutic monitoring for devices used to monitor cognitive behavioral therapy. However, during the AMA’s review of the code, specialty societies noted that the technologies for the service were still developing and there were no invoices for devices specific to cognitive behavioral therapy monitoring services that could be provided to price the code. In the Final Rule, CMS finalized its proposal to accept the AMA’s recommendation to have pricing set for the new CPT code 98978 (a PE-only device code) established by the Medicare Administrative Contractors (MACs). CMS also explained that it will work with MACs to examine devices and device costs incurred from claims for payment for the new cognitive behavioral monitoring code, CPT code 98978.

ANALYSIS

In line with CMS’s continuing trend of gradually expanding payment for remote monitoring services, CMS expanded the ability for RTM services to be furnished under the general supervision of the billing provider. However, there are marked differences between the Proposed Rule and the Final Rule.

Due to concerns about the complexity of the proposed G-codes, CMS declined to finalize this proposal in the Final Rule. While commenters generally expressed support for the expansion of the non-physician healthcare professionals who could furnish and bill for RTM services, CMS explained that the totality of the comments warranted continued discussion before CMS finalizes changes to the current coding and payment policies. Some commenters expressed concern that CMS’s goals of increasing access to RTM services while reducing the associated burdens may not manifest due to the creation of four specific G-codes to replace the existing two CPT codes. Specifically, commenters noted that creating G-codes could instead generate confusion and increase the burden on RTM providers. Commenters suggested that, as an alternative to creating the proposed G-codes, CMS should modify the supervision requirements for services furnished incident to a practitioner’s professional service to require a general, rather than direct, level of supervision for the existing codes.

CMS also noted continued public concern and confusion regarding the supervision and billing requirements for RTM services and expressed concern that finalizing the G-codes as proposed would create a possible chilling effect on the availability of RTM services. For example, CMS noted commenters’ apprehension that limitations, burdensome requirements, or possible payment denials or recovery actions may disincentivize providers from offering RTM services, thereby reducing beneficiary access. Given these concerns, the scope of the Final Rule was more limited than the Proposed Rule in that, rather than create additional G-codes, CMS merely refined the supervision and documentation requirements for RTM services under the existing codes (CPTs 98975, 98976, 98977, 98980 and 98981).

In sum, in the Final Rule, CMS clarified and finalized its policies regarding billing requirements for the current RTM codes, effective January 1, 2023. All RTM services may be furnished under CMS’s general supervision requirements. General supervision does not require that the physician and clinical staff be in the same building at the same time as the RTM services are furnished. Rather, the billing provider may bill for services furnished by auxiliary clinical staff under general supervision, provided that the other requirements for “incident to” services are met.

Finally, CMS discussed in the Final Rule requests from stakeholders to create a new generic RTM device code. The current RTM device codes (CPT codes 98976 and 98977) do not apply broadly to all conditions and systems encompassed by RTM. Rather, these codes are specific to devices that monitor respiratory, musculoskeletal, therapy adherence and therapy response, and do not extend to, for example, devices that monitor neurological, vascular, endocrine and digestive systems. CMS expressed concern about the ability to implement a generic device code for RTM, given the wide variability of devices that may be used and how the devices support delivery of RTM services. Finally, CMS noted that use of a generic device code could undermine the development of a wider set of specific codes for various devices that may be used to furnish RTM services.

CMS explained in the Final Rule that it appreciated the insight from stakeholders about the key questions posed by CMS in the Proposed Rule:

(1) RTM devices that are used to deliver services that are “reasonable and necessary” for a Medicare beneficiary
(2) The types of data collected using RTM devices
(3) How the data that are collected solve specific health conditions and what health conditions are particularly improved by RTM services
(4) Costs associated with RTM devices that are available to collect RTM data
(5) How long the typical episode of care by condition type might last
(6) The potential number of beneficiaries for whom an RTM device might be used by the health condition type.

While CMS did not take any action based on this feedback, it noted that it would consider stakeholder comments as it contemplates policies in future rulemaking cycles.

Practical Implications

There has been an explosion of interest in remote monitoring (both RTM and RPM) services over the past several years. Medicare has seen an explosion in the utilization of RPM services and it would not be surprising if there is a concomitant increase in the utilization of RTM services. With the Final Rule, CMS is aiming to reduce the coding and billing complexity for RTM services while increasing care delivery flexibility and promoting beneficiary access to RTM services. However, it remains to be seen whether CMS will accomplish these goals due to the limited nature and continued confusion regarding proper billing and supervision of RTM (and RPM) services. CMS is also actively considering the need for further guidance, education, program instructions or further rulemaking regarding remote monitoring services.

Given the relatively quick development and implementation of CMS policies for RPM and RTM services and the increasing utilization of these codes by a wide variety of clinical specialties, affected stakeholders should monitor developments in CMS coverage and payment policies closely. CMS continues to request feedback from affected stakeholders on a wide variety of issues (as noted above), presenting the opportunity for continued engagement with CMS on these issues.