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July 28, 2021

COVID-19’s Spotlight on Remote Patient Monitoring – How Virtual Medicine has Quickly Changed How Patients Think about Medicine

By Caroline Poma

The onset of the COVID-19 pandemic dramatically and quickly shifted the landscape of how consumers access healthcare services. By June 2020, various healthcare providers reported an increase of 50 to 175 times the number of telehealth visits than prior to COVID-19.1 Furthermore, while just 11 percent of consumers used telehealth in 2019, as of June 2020, 46 percent of consumers were using telehealth in place of or to replace canceled healthcare visits.2 While the day-to-day effects of the pandemic will eventually dissipate, the pandemic likely accelerated the healthcare industry’s move to the evolving age of telehealth services earlier than many anticipated. The question post-pandemic is whether healthcare providers will continue to expand access to telehealth resources and whether consumers will continue to expect telehealth visits as an alternative care option.

The Centers for Medicare & Medicaid Services (CMS) helped continue the trend toward increased use of telehealth services in its newly issued reimbursement policies. Specifically, CMS finalized reimbursement policies related to remote patient monitoring, or remote physiologic monitoring (RPM). The 2021 Physician Fee Schedule Final Rule was released in the Federal Register in December 2020 (2021 Physician Fee Schedule),3 with additional clarification released in the Federal Register in January 2021.4 In addition to the many other challenges the pandemic caused for the healthcare industry, healthcare providers have been left scrambling to understand how to shift their practices and reimbursement methods to incorporate telehealth technologies. Which codes to use, by what providers, how frequently, and when, make the new rules for RPM particularly challenging. 

What is Remote Physiologic Monitoring?

RPM “involves the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition.”5 Healthcare providers have the ability to “monitor weight, blood pressure, blood glucose, pulse, temperature, oximetry, respiratory flow rates” and other health indicators by using RPM technology.6 It is important to note that CMS will not reimburse for general health monitoring of patients. Rather, there must be a chronic or acute condition, and the purpose of the RPM services must ultimately be the diagnosis, management, and treatment of the patient. The inclusion of “acute health illness or conditions” in the definition of RPM is noteworthy, as CMS expanded the use of RPM services to those with acute health illnesses or conditions in the 2021 Physician Fee Schedule.7 With this expansion, a provider could, for example, monitor the oxygen saturation levels of a patient with acute respiratory virus without requiring the patient to stay at a healthcare facility or travel back and forth to the provider for scheduled appointments.8 This expansion of RPM services reimbursable by CMS allows for greater access to care for more patients. Especially during a pandemic when face-to-face appointments are not feasible and could put both the provider and patient at risk of contracting COVID-19, RPM services allow healthcare providers to provide continuity of care for patients, including developing a broader understanding of a patient’s health over a period of time.

Development of the RPM CPT Codes

Reimbursement for RPM services is still a new concept, as CMS began reimbursing for RPM services on January 1, 2018.9 At this time, reimbursement was only provided through the use of one previously established Current Procedural Terminology (CPT) Code – 99091. One year later, beginning on January 1, 2019, CMS expanded reimbursement for RPM services to three new CPT codes – 99453, 99454, and 99457.10 Beginning with the 2020 Medicare Physician Fee Schedule, CMS again expanded reimbursement to include an add-on CPT code – 99458.11

On April 6, 2020, CMS published interim final rules for RPM related to the COVID-19 public health emergency (PHE).12 These rules were published due to the increased concern for exposure risks to healthcare professionals and patients.13 At this time, the Centers for Disease Control and Prevention (CDC) urged healthcare professionals to use remote technology rather than in-person visits.14 In response to the CDC’s guidance, CMS approved various waivers on an interim basis during the PHE, including the following significant interim waivers related specifically to RPM: (1) permitting RPM services to be furnished to new patients in addition to the established policy of furnishing services to only previously established patients, (2) permitting consent to receive RPM services to be obtained once annually, including at the time services are furnished, and (3) permitting RPM CPT codes to be used for monitoring of patients with acute as well as chronic conditions.15

This evolution of reimbursement for RPM services and the PHE interim rules leads to the 2021 Physician Fee Schedule where each of the five CPT codes and the interim rules are discussed. The sections of the 2021 Physician Fee Schedule Final Rule related to RPM provide guidance on how CMS interprets these CPT code descriptors and include instructions relating to the use of these five CPT codes in practice.16

The CMS guidance categorizes these RPM CPT codes as various steps in the RPM process. The three steps in the RPM process are: (1) the use of practice expense (PE) only codes, (2) analysis and interpretation of the physiologic data, and (3) the development of the treatment plan.17  One element that each of these codes has in common is that all five codes are considered “Evaluation and Management” (E/M) codes, which means that these codes can only be ordered and billed by physicians or non-physician practitioners (NPPs)18 who are eligible to bill Medicare for E/M services.19

PE Only Codes – 99453 and 99454

The RPM process begins with two PE only codes used for data collection that are “valued to include clinical staff time, supplies, and equipment, including the medical device for the typical case of remote monitoring.”20 The following CPT codes are considered the “PE only codes” in the RPM process that may be billed:

  • 99453 - (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment).21 This code is “valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices.”22 CPT Code 99453 can be billed only once per episode of care where an episode of care begins “when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals.”23
  • 99454 - (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days).24 This code is “valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring.”25 The medical devices that are supplied to the patient and used to collect physiologic data for the practitioner are considered equipment and therefore are direct PE inputs.26

CMS references the CPT 2021 Professional Codebook (CPT Codebook) to clarify information for the PE only CPT codes. For these codes to be billed, monitoring must occur over at least 16 days of a 30-day period and the codes cannot be reported more than once during a 30-day period for a single patient.27  CMS further clarified in its corrections to the 2021 Physician Fee Schedule that only one practitioner can bill the PE codes during a 30-day period and only when at least 16 days of data have been collected on at least one medical device as defined by the Food and Drug Administration (FDA) in section 201(h)28 of the Federal, Food, Drug and Cosmetic Act (FD&C Act).29 Similarly, if multiple medical devices are provided to a patient, the services associated with all of the medical devices can be billed by the practitioner only once per patient per 30-day period, given that at least 16 days of data have been collected.30 CMS clarified that when a more specific code is available to describe a service, the more specific code should be billed rather than CPT codes 99453 and 99454.31 For example, there may exist a specific code for billing, such as a CPT code 95250 for continuous glucose pressure monitoring, that also allows RPM.32  

Although a medical device used to collect a patient’s physiologic data under these PE only codes must be a medical device as defined by the FD&C Act, the CPT Codebook does not indicate that a medical device has to be FDA “cleared”33 nor does the CPT Codebook indicate that a medical device has to be prescribed by a physician.34 However, CMS notes that clearance may be appropriate and some medical devices may be prescribed by a physician.35 Additionally, the medical device supplied for CPT code 99454 must digitally, or automatically, upload patient data to the healthcare provider, meaning that the data cannot be self-recorded or self-reported by the patient.36 Finally, the medical device must be “reasonable and necessary for the diagnosis or treatment of a patient’s illness or injury or to improve the functioning of a malformed body member,” and the medical device “must be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient's health status in order to develop and manage a plan of treatment.”37 Examples of potential medical devices that could be used include blood pressure monitors, continuous glucose monitors, anticoagulation testing devices, heart rate monitors, pulse oximeters, and smart scales, among others.38

Finally, a noteworthy change to the PE only CPT codes in the 2021 Physician Fee Schedule is that in addition to clinical staff, auxiliary personnel are now permitted to furnish services related to CPT codes 99453 and 99454 “incident to”39 the billing practitioner’s services and under the general supervision of the billing practitioner.40 Auxiliary personnel include “individuals who are not clinical staff but are employees or leased or contracted employees.”41

Analysis and Interpretation - 99091

The next step in the RPM process is the analysis and interpretation by the practitioner of the physiologic data that is collected.42 The following CPT code is used to analyze and interpret physiologic data and includes only professional work:

  • 99091 - (Collection and interpretation of physiologic data (e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, each 30 days).43 CMS explains that, “The valuation for CPT code 99091 includes a total time of 40 minutes of physician or NPP work, broken down as follows: 5 minutes of preservice work (for example, chart review); 30 minutes of intra-service work (for example, data analysis and interpretation, report based upon the physiologic data, as well as a possible phone call to the patient); and 5 minutes of post-service work (that is, chart documentation).”44

CMS notes that there is confusion around the requirement that the service is furnished by a “physician or other qualified healthcare professional, qualified by education, training, licensure/regulation.”45 While CMS again turns to CPT standards to better understand the definition of a “physician or other qualified health care professional,”46 CMS summarizes that a qualified healthcare professional “is an individual whose scope of practice and Medicare benefit category includes the service, and who is authorized to independently bill Medicare for the service.”47

Development of Treatment Plan - 99457 and 99458

The final step in the RPM process is the development by a physician or NPP, with the patient and/or caregiver, of a treatment plan or a patient-centered plan of care.48 The physician or NPP then manages the treatment plan until the targeted goals of the plan are achieved, signifying the end of the “episode of care.”49 The following CPT codes describe the treatment and management services associated with RPM:

  • 99457 - (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; first 20 minutes).50
  • 99458 - (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; each additional 20 minutes (list separately in addition to code for primary procedure)).51 This is an add-on code to 99457 and therefore cannot be billed independently.52

These care management services described by CPT codes 99457 and 99458 can be furnished by clinical staff under the general supervision of the physician or NPP.53 Furthermore, because these services are not considered to be diagnostic tests, they cannot be furnished and billed by an independent diagnostic testing facility on the order of a qualified practitioner.54

The services described by these CPT codes are typically furnished remotely using communications technologies that allow “interactive communication.”55 CMS understands “interactive communication” to mean “real-time interaction, between a patient and the physician, NPP, or clinical staff who provide the services.”56 CMS clarified that “interactive communication” in this context “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.”57 CMS instructs, based on the CPT Codebook, that for CPT code 99457 to be reported and reimbursed, the “interactive communication” should total at least 20 minutes of time with the patient over the course of a calendar month.58 Each additional 20 minutes of interactive communication between the patient and the physician/NPP/clinical staff would be reported using CPT code 99458 as an add-on.59 CMS further clarifies in its corrected 2021 Physician Fee Schedule that the 20 minutes of intra-service work associated with CPT codes 99457 and 99458 can also include the practitioner’s time engaged in non-face-to-face care management services during a calendar month.60 This clarification by CMS benefits practitioners, as it expands the scope of reimbursable services for the practitioner.  

CMS Provides Additional Clarification

CMS provides expanded feedback in its responses on whether CPT codes 99091 and 99457 can be billed together. Much of the confusion stems from the fact that the CPT Codebook states, “Do not report 99091 in conjunction with 99457” and “Do not report 99091 for time in a calendar month when used to meet the criteria for . . . 99457. . . . ”61 CMS explains that if the use of both codes is reasonable and necessary, the two codes provide different types of services and “could be billed for the same patient in the same month as long as the same time was not used to meet the criteria for both CPT codes.”62 Therefore, the use of both codes simultaneously in the same month would require separate time being reported for each code. CMS states that because of the required 40 minutes of practitioner work in the valuation of CPT code 99091,63 “in some instances when complex data are collected, more time devoted exclusively to data analysis and interpretation by a physician or NPP may be necessary such that the criteria could be met to bill for both CPT codes 99091 and 99457 within a 30-day period.”64

Second, various commenters to the regulations share the belief that CMS should permit fewer than the required 16 days of monitoring per month that are required to bill CPT codes 99453 and 99454. Commenters suggested that six to eight days may be more appropriate.65 CMS agrees that 16 days may not always be reasonable and necessary.66 However, while CMS acknowledges general support for a shorter time frame, it received insufficient data on specific clinical situations which require a shorter monitoring period.67 Therefore, CMS is only permitting fewer than 16 days in specific situations in a 30-day period until the end of the PHE for COVID-19.68 Practitioners should continue to track this requirement because based on the response from CMS, CMS indicates that it may agree to reconsider the 16 days requirement if specific clinical situations require it.

What’s Next?

CMS’s interim rules have been geared toward reducing exposure risks to COVID-19 for both providers and patients while also increasing access to healthcare services.69 The changes eliminate barriers to allow patients to access resources quickly during the pandemic. However, at the conclusion of the PHE, some barriers will be put back in place, making it more difficult to access RPM services. For example, for the remainder of the PHE, CMS expanded RPM services to new patients as well as previously established patients.70 However, at the conclusion of the PHE, RPM services will only be available to established patients.71 CMS explains that an established patient would likely have already received E/M services in which the provider would have been able to collect patient history, conduct a face-to-face physical exam, and in turn obtain the information needed to understand the patient’s medical status and needs prior to furnishing care in a remote manner.72 In addition, it is important to remember that state licensure requirements and the standard of care may also require healthcare providers to first establish a relationship with the patient prior to ordering RPM services. Similarly, other RPM policies were only approved on an interim basis until the conclusion of the PHE including: (1) “allowing consent to be obtained by individuals providing RPM services under contract with the billing physician or practitioner;” and (2) “allowing RPM codes to be billed for a minimum of two days of data collection over a 30-day period, rather than the required 16 days of data collection over a 30-day period as provided in the CPT code descriptors.”73

It is noteworthy that CMS extended or proposed other rules to be established permanently due to the progress of care seen during the PHE. First, CMS now permanently allows consent to be obtained at the time services are furnished for CPT codes 99453 and 99454. Second, auxiliary personnel are permitted to furnish services of CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.74 Finally, after the PHE, healthcare practitioners will continue to be permitted to furnish RPM services to patients with acute conditions.75

While the interim rules helped to shift the landscape at a time when it was not practicable for patients to have in-person appointments, the healthcare industry needs expanded access to telehealth to continue to evolve so the benefits of RPM and other telehealth technologies post-pandemic can be used to support and enhance a patient’s care management. Ease of access to healthcare through telehealth is a powerful tool that can help improve health outcomes and lessen the burden on the healthcare system due to poorly controlled chronic health conditions. A study by McKinsey & Company estimates that up to $250 billion of the healthcare spending in 2020 could eventually be shifted to virtual or near-virtual care.76 While COVID-19 has accelerated the use of telehealth, it is likely that telehealth and RPM services will continue to be an important component of the health delivery system and CMS will receive continued pressure to maximize reimbursement for RPM services. 

Footnotes

  1. Bestsennyy, O.,  Gilbert, G.,  Harris, A.,  &  Rost, J., Telehealth: A quarter-trillion-dollar post-COVID-19 reality?, McKinsey & Company (May 29, 2020)
  2.  Id.
  3.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. 84472 (Dec. 28, 2020).
  4.  Correction to CY 2021 Payment Policies Under the Physician Fee Schedule, 86 Fed. Reg. 5020 (Jan. 19, 2021).
  5.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84542.
  6.  Remote Physiologic Monitoring (RPM) Fact Sheet Overview and Updates as of May 2020, Comagine Health (last visited Apr. 26, 2021).
  7.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84543.
  8.  Comagine Health, supra n. 6.
  9.  Providing and Billing Medicare for Remote Patient Monitoring, PYA, P.C. (2019)
  10.  Id.
  11.  CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule, 84 Fed. Reg. 62568, 62697 (Nov. 15, 2019).
  12.  Medicare and Medicaid Programs; Policy and Regulatory Revisions in response to the COVID-19 Public Health Emergency, 85 Fed. Reg. 19230 (Apr. 6, 2020).
  13.  Id. at 19264.
  14.  Id.
  15.  Id.
  16.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. 84472, 84542-84543 (Dec. 28, 2020).
  17.  Id. at 84543-84544.
  18.  Examples of NPPs include nurse practitioners, clinical nurse specialists and certified nurse midwifes. See generally Medicare Claims Processing Manual Chapter 12 – Physicians/Nonphysician Practitioners, Centers for Medicare and Medicaid Services (Mar. 12, 2021).
  19.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84545.
  20.  Id. at 84543.
  21.  Id.
  22.  Id.
  23.  Id. (quoting CPT® 2021 Professional Codebook, pp. 52-53)
  24.  Id.
  25.  Id.
  26.  Id.
  27.  Id.
  28.  A “device” as defined in the FD&C Act is an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of the man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” The definition also excludes certain software functions. 21 U.S.C. § 321(h). In summary, a device is one that affects the structure or function of the body but does not work by chemical or metabolic action.
  29.  Correction to CY 2021 Payment Policies Under the Physician Fee Schedule, 86 Fed. Reg. 5020, 5021 (Jan. 19, 2021).
  30.  Id.
  31.  Id.
  32.  Id.
  33.  Per Section 510(k) of the FD&C Act, a device manufacturer must notify the FDA of its intent to market a medical device at least 90 days in advance. During this process, the FDA determines whether the device is safe and effective or substantially equivalent to another device that has already been reviewed by the FDA and is legally marketed (a “predicate” device). The manufacturer submitting the 510(k) notice must compare the device to a predicate device and provide support for the claim.  If the FDA determines that the device is substantially similar to a predicate and determines that the device can be marketed in the United States, then the FDA issues an order in the form of a letter to the manufacturer which clears the device for marketing. Premarket Notifications 510(k), Food and Drug Administration (March 13, 2020).
  34.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. 84472, 84543 (Dec. 28, 2020).
  35.  Id.
  36.  Id.
  37.  Id.
  38.  The Ultimate Guide to Remote Patient Monitoring Devices, Welkin (Oct. 16, 2020)
  39.  Please note that practitioners must follow the CMS regulations for auxiliary personnel and conditions for payment “incident to” services as set forth in 42 C.F.R. § 410.26(a). CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84543-84544.
  40.  Id. at 84544-84546.
  41.  Id. at 84544.
  42.  Id. at 84543.
  43.  Id. Per 42 C.F.R. § 410.26(a), auxiliary personnel means “any individual who is acting under the supervision of a physician (or other practitioner), regardless of whether the individual is an employee, leased employee, or independent contractor of the physician (or other practitioner) or of the same entity that employs or contracts with the physician (or other practitioner), has not been excluded from the Medicare, Medicaid and all other federally funded health care programs by the Office of Inspector General or had his or her Medicare enrollment revoked, and meets any applicable requirements to provide incident to services, including licensure, imposed by the State in which the services are being furnished.”
  44.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84543.
  45.  Id.
  46.  CMS refers to and quotes the definition provided by CPT. This definition as quoted in the Federal Register provides that a “physician or other qualified health care professional” is “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 professionals are distinct from “clinical staff . . . [which refers to] a person who works under the supervision of a physician or other qualified health care 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.” Id. (quoting CPT).
  47.  Id.
  48.  Id. at 84544.
  49.  Id.
  50.  Id.
  51.  Id.
  52.  Id.
  53.  Id.
  54.  Id.
  55.  Id.
  56.  Id. CMS further provides that the remote, non-face-to-face exchange reimbursed by CPT codes 99457 and 99458 is similar to HCPCS code G2012. Id.
  57.  Id.
  58.  Id.
  59.  Id.
  60.  Correction to CY 2021 Payment Policies Under the Physician Fee Schedule, 86 Fed. Reg. 5020, 5021 (Jan. 19, 2021).
  61.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84545.
  62.  Id.
  63.  See supra n. 44 discussing Code 99091.
  64.  CY 2021 Payment Policies Under the Physician Fee Schedule, 85 Fed. Reg. at 84545
  65.  Id. at 84546.
  66.  Id.
  67.  Id.
  68.  Id.
  69.  Id. at 84544.
  70.  Id. at 84544-84545.
  71.  Id.
  72.  Id. at 84544.
  73.  Id.
  74.  Id. at 84544-84546.
  75.  Id at 84546.
  76.  Bestsennyy et al., supra n. 1.
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Caroline Poma, Esq.

Hancock, Daniel & Johnson, P.C., Richmond, VA

Caroline Poma is an Associate with Hancock, Daniel & Johnson, P.C. in Richmond, Virginia. She advises clients in corporate transactions and compliance matters including asset sales, joint ventures and other affiliation models, corporate governance, regulatory compliance, and various physician and business contracts. She may be reached at [email protected]