Telehealth, RPM Updates and Why Compliance is Key

On December 1, 2020, the Centers for Medicare & Medicaid Services (CMS) released the final 2021 Physician Fee Schedule (PFS). Read CLA’s 2021 PFS Regulatory Advisor for a full run-down, but today we provide an overview of the telehealth and virtual health policy changes. We also highlight how they add onto an already fluid telehealth and virtual health environment due to the COVID-19 pandemic, and remind readers about the importance of their compliance activities in light of it all.

Audits and Compliance

Understanding telehealth and other virtual/digital health care services has always been relatively complicated due to varying state licensure requirements, privacy requirements and coding and billing requirements. However, many of these prior policies have either been modified or waived temporarily during the Public Health Emergency (PHE), making compliance efforts even more important.

For example, the federal government granted many temporary waivers over the past year to help stop the spread of COVID while maintaining access to care. These flexibilities included Medicare adding dozens of additional codes to its reimbursable “telehealth” list, waiving telehealth’s rural originating site requirement, allowing for telehealth in a person’s home, and reimbursing for audio-only codes to name a few.

While these flexibilities were welcomed during the pandemic, they have not gone unnoticed by the Department of Health & Human Services (HHS) Office of Inspector General (OIG). And it is within telehealth’s already complicated regulatory paradigm that we take note of the OIG’s February 2021 letter, which stated:

“Consequential decisions often were made quickly to respond to the emergency and provide relief in the way of funding, supplies, and reductions in regulatory and procedural burden. This quick response and scope of relief make oversight, enforcement, transparency, program integrity, and accountability all the more important…It is important that new policies and technologies with potential to improve care and enhance convenience achieve these goals and are not compromised by fraud, abuse, or misuse. OIG is conducting significant oversight work assessing telehealth services during the public health emergency.”  [bold added]

The OIG’s active audits and evaluations already include seven telehealth-related items, including a two-phased audit of physicians and other Part B providers and auditing telehealth in home care. For the former, OIG states:

“it will conduct a series of audits of Medicare Part B telehealth services in two phases. Phase one audits will focus on making an early assessment of whether services such as evaluation and management, opioid use order, end-stage renal disease, and psychotherapy (Work Plan number W-00-21-35801) meet Medicare requirements. Phase two audits will include additional audits of Medicare Part B telehealth services related to distant and originating site locations, virtual check-in services, electronic visits, remote patient monitoring, use of telehealth technology, and annual wellness visits to determine whether Medicare requirements are met.

This is why it is important to keep your compliance hat on when reviewing ongoing use of telehealth/virtual health and how the 2021 PFS revisions (and any future changes) fit in.

PFS 2021 – Telehealth

In the final PFS 2021 rule, CMS addresses multiple flexibilities stemming from the PHE, including making a few changes permanent, extending others and indicating it will revert back to previous requirements on additional areas.

CMS finalizes the permanent addition of nine codes to the Medicare telehealth list under Category 1. Those includes codes from group psychotherapy (90853) to home visits with established patients (99347-99348) and prolonged office/outpatient Evaluation & Management (E/M) services (G2212) among others.

CMS also includes the temporary addition of codes under what they are calling “Category 3.” Codes in this category will remain on the telehealth list through the end of the year in which the PHE ends or December 31, 2021. CMS had originally proposed 13 codes under Category 3 but finalized the inclusion of 63 codes for the list.

See the full list of codes in CLA’s 2021 PFS Regulatory Advisor.

CMS Subsequently Removes 4 Codes

In a March 17, 2021 notice, CMS removed four codes under Category 3 that it inadvertently included:

• 96121: Neurobehavioral status exam
• 99221-99223: Initial hospital care 

PFS 2021 – Communication Technology Based Services (CTBS)

CTBS codes are not considered “telehealth” under Medicare regulations and, therefore, do not have to meet the same originating or distant site requirements, for example. CMS has been building up its slate of non-telehealth codes over the past few years.  

For HCPCS G2061 through G2063, CMS permanently extends the ability for clinical social workers and clinical psychologists, Physical Therapists, Occupational Therapists and Speech Language Pathologists who bill Medicare directly for their services to bill for these services. These flexibilities were provided during the PHE and now are permanent.

CMS provides two additional G codes for certain nonphysician practitioners (NPP) who cannot independently bill for Evaluation & Management (E/M) services: G2250 and G2251. These are valued identical to G2010 and G2012, respectively. CMS finalizes an extended audio-only assessment service, G2252. Billing for the code will mirror G2012. However, CMS indicates the audio-only code is only temporary through 2021.

PFS 2021 – Remote Physiologic Monitoring (RPM)

Since RPM is relatively new for Medicare, CMS provides various clarifications and updates at the request of stakeholders. CMS highlights that regardless of the number of medical devices, the services for all the devices can only be billed once per patient per 30-day period and only when at least 16 days of data has been collected. CMS clarifies that 99453, 99454, 99091, 99457, and 99458 can be ordered and billed only by physicians or NPPs who are eligible to bill Medicare for E/M services.

CMS notes that data should digitally (that is, automatically) upload and that the data should not be patient self-recorded and/or self-reported. While medical devices need to meet the FDA’s definition of such a device, CMS indicates it does not need to be FDA approved. Several flexibilities provided during the PHE will be made permanent. This includes that RPM services may be used with patients who have acute conditions. CMS also makes permanent that consent may be obtained at the time that RPM services are furnished, and, allowing auxiliary personnel (which includes other individuals who are not clinical staff but are employees, or leased or contracted employees) to furnish services described by 99453 and 99454 under the general supervision of the billing physician or practitioner.

Responding to industry request, CMS provides some information on how it interprets code descriptors and instructions associated with 99453, 99454, 99091, 99457, and 99458. CMS states that the RPM process begins with 99453 and 99454. CPT code 99453 is valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices. CPT code 99454 is valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring.

After analyzing and interpreting a patient’s remotely collected physiologic data, CMS states next in the RPM process is the development of a treatment plan that is informed by the analysis and interpretation of the patient’s data under 99457 and 99458. At this point, the physician or NPP develops a treatment plan with the patient and/or caregiver (that is, develops a patient-centered plan of care) and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care. CMS indicates stakeholders requested additional clarification on various aspects of these codes, primarily, who can furnish the codes as well as details on “interactive communication” with a patient.

CMS responds that it addressed who can furnish 99457 and 99458 in the Calendar Year 2020 PFS final rule when they designated both codes as care management services. CMS explained that, like other care management services, those may be furnished by clinical staff under the general supervision of the physician or NPP. CMS also clarified that ‘‘interactive communication’’ for purposes of 99457 and 99458 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. However, in a January 11, 2021 technical corrections release, CMS clarifies that the 20-minutes of intra-service work associated with 99457 and 99458 includes a practitioner’s time engaged in interactive communication as well as time engaged in non-face-to-face care management services during a calendar month.

CMS clarifies that for 99453 and 99454, they are to be reported only once during a 30-day period even if multiple medical devices are provided to a patient. Additionally, CMS reiterates that services associated with all the medical devices can be billed by only one practitioner, only once per patient, per 30-day period, and only when at least 16 days of data have been collected; and that the services must be reasonable and necessary. CMS also reminds providers to use and bill a more specific code if available.

How We Can Help

During the pandemic, regulators eased a variety of requirements for providing health care remotely. We know some of these flexibilities will be made permanent, as demonstrated in the recent 2021 PFS final rule, while many others will end when the PHE ends. Therefore, it will be important to continue to monitor the telehealth/virtual health landscape for these ongoing adjustments and review your approach to remote care with a compliance mindset.

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