The US healthcare system rapidly adopted telehealth and remote monitoring services during the response to the covid-19 pandemic, possibly transforming the future of health care delivery.  This progress, however, may be undermined by ambiguous policies, which may challenge the implementation of digital medical services. The recently released draft 2021 Physician Fee Schedule by the Centers for Medicare & Medicaid Services (CMS) included substantial proposals to telehealth and remote physiologic monitoring services. [2,3] We examine the coverage and payment advances proposed in the 2021 Physician Fee Schedule, and discuss the potential challenges facing digital medical services in the U.S.
Telehealth and RPM in the 2021 Medicare Physician Fee Schedule
The proposed 2021 fee schedule seeks to make reimbursement permanent for certain telehealth services. These changes are duly categorized: Category 1 services (non-telehealth services added to the Medicare telehealth services list when the non-telehealth services are similar to existing telehealth services), Category 2 services (those that require evidence demonstrating the service improves the diagnosis or treatment of an illness), and, new this year, Category 3 services (pandemic-related temporary additions to build evidence). Emergency department telehealth visits are a notable example of Category 3 services.  While these constitute important advances to further expand telehealth’s scope, other aspects of the proposal pertaining to digital medical services have ambiguities that may undermine such progress.
CPT® codes and CMS Interpretation
These ambiguities may lead to uncertainty because of the potential for discrepancies between the descriptor of CPT® codes and how payers may interpret them. The American Medical Association® developed the CPT® code set; it standardizes physician and professional service descriptions. Payors may not reimburse for these services if ambiguity in a CPT® codes leaves uncertainty about what fits under the code. For remote physiologic monitoring (RPM) in the 2021 PFS, there are seven RPM codes that CMS has approved since 2018, and the 2021 proposed changes are supposed to clarify their adoption. 
With the widespread use of digital medical devices, including software as a medical device (SaMD) like those incorporated into Apple’s watch, monitoring physiologic data is increasingly common. However, the proposed rules have some ambiguity surrounding the RPM codes which may compromise its clinical implementation. For example, CPT® code 99091 (collection and interpretation of physiologic data) does not solely mandate real-time communication between the patient and the provider, only instructing “at least one communication (e.g. phone call or e-mail exchange) with the patient.” On the other hand, CPT® code 99457 (remote physiologic monitoring treatment management services) includes “interactive communication” in its descriptor.  Without specifying the real-time modality used for the communication, it is unclear whether, for example, a treatment plan communicated over e-mail would fulfill the code’s requirements. CMS proposes to entirely base the 20-minute professional work of code 99457 on “synchronous, real-time audio communication with the patient.” Therefore, if a physician reviews blood pressure values transmitted from a patient’s home and makes medication changes in response to the measurements, but communicates this plan to the patient over e-mail, CMS could choose not to reimburse such a service under CPT® code 99457.
Another proposal in the rule addresses the supply of digital medical equipment by different physicians for the same patient. Technical component CPT® codes 99453 and 99454 (remote monitoring of physiologic parameter) do not clarify how many unaffiliated specialists may set-up and provide equipment to monitor the same patient remotely. For example, a cardiologist titrates a patient’s beta-blocker dose while monitoring for bradycardia using remotely-measured heart rate data. However, if another physician was monitoring the same patient’s weight and remotely tracked the patient’s weight using a medical-grade weight scale to adjust the weight loss regimen, could that service be reimbursed as well? The current CPT® language only specifies that this code can be used once per month and does not have conditions on whether reporting is allowed between different providers. Yet, the current CMS proposal would limit the reporting of 99453 and 99454 to once per month, per patient, suggesting that only one medical specialist would be allowed to provide these services. This situation may create a problem when a specialist is not aware of another specialist reporting the same patient’s RPM code for monitoring and managing a different condition.
Another issue relates to the cumbersome frequency and duration of data collection requirements for remote physiologic monitoring codes that may interfere with implementation. For example, 99454 requires a minimum of 16 days of measurements in 30 days to qualify for reimbursement. Measuring blood pressure every other day may be too burdensome especially for patients with multiple chronic conditions. Importantly, if the patient could not measure blood pressure on the 16th day, CMS would not reimburse tailoring care based on 15-days worth of blood pressure measures. Based on as few as 3-day measurements, home monitoring may yield a representative blood pressure value to guide care.  It is important to codify a practical frequency of measurements to facilitate reasonable use of this code.
Finally, in ensuring that payors reimburse digital medical services, clinicians and administrators need to recognize that CMS mandates that physiologic medical device data be measured and transmitted automatically to clinicians.  In other words, if a patient measures blood pressure at home, transposes values into a spreadsheet, and self-reports that data to a clinician, such a transaction of physiologic data is not considered sufficient for RPM payment.
The rapid adoption of digital medical technology requires increasing clarification of coverage and payment rules and policies. Nuances, traditionally unfamiliar to many payers, physicians, and administrators, may be problematic. Rules surrounding the reimbursement of digital medical services require careful analysis to ensure the appropriate use of such codes and digital health services to be incentivized as intended.
Makoto Mori, Division of Cardiac Surgery, Yale School of Medicine, New Haven, Connecticut and Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
Robert Jarrin, Department of Emergency Medicine, George Washington University and Department of Biochemistry and Molecular & Cellular Biology, Georgetown University Medical center
Harlan M. Krumholz, Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut and Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine and the Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut.
- The Impact of the COVID-19 Pandemic on Outpatient Visits: Changing Patterns of Care in the Newest COVID-19 Hot Spots. Accessed October 1, 2020. https://www.commonwealthfund.org/publications/2020/aug/impact-covid-19-pandemic-outpatient-visits-changing-patterns-care-newest
- Proposed Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021 | CMS. Accessed September 23, 2020. https://www.cms.gov/newsroom/fact-sheets/proposed-policy-payment-and-quality-provisions-changes-medicare-physician-fee-schedule-calendar-year-4
- CMS-1734-P | CMS. Accessed September 23, 2020. https://www.cms.gov/medicaremedicare-fee-service-paymentphysicianfeeschedpfs-federal-regulation-notices/cms-1734-p
- American Medical Association. Self-measured blood pressure CPT coding. Published 2020. Accessed September 23, 2020. https://www.ama-assn.org/system/files/2020-06/smbp-cpt-coding.pdf
- Bello NA, Schwartz JE, Kronish IM, Oparil S, Anstey DE, Wei Y, Cheung YKK, Muntner P, Shimbo D. Number of Measurements Needed to Obtain a Reliable Estimate of Home Blood Pressure: Results From the Improving the Detection of Hypertension Study. J Am Heart Assoc. 2018;7(20):e008658. https://www.ahajournals.org/doi/10.1161/JAHA.118.008658