CMS finalizes Medicare remote patient monitoring policy changes and guidance

The Centers for Medicare & Medicaid Services (CMS) on December 1 revised and offered guidance on Medicare payment requirements for remote patient monitoring (RPM) and other services within its Medicare Physician Fee Schedule (PFS) final rule for calendar year (CY) 2021.  The RPM guidance and revisions are largely (but not entirely) in line with the PFS 2021 proposed rule’s changes and commentary, which were summarized in an earlier August blog post.

Within the last several years, CMS has recognized seven CPT codes for RPM (referred to in the code descriptors as “remote physiologic monitoring”) relating to the collection and analysis of patient physiologic data by providers who develop and manage a treatment plan for patients’ chronic or acute conditions. During the COVID-19 public health emergency (PHE), CMS temporarily revised Medicare payment policies to loosen RPM reimbursement requirements and to allow expanded use of RPM. The PHE status, which affects these RPM flexibilities, is scheduled to expire on January 21, 2021, subject to early termination or further renewal by the U.S. Department of Health and Human Services.

CMS notes that five of the seven CPT codes for RPM have generated “frequent questions from stakeholders” and CMS had previously stated that it would provide future guidance about these codes. As a result, CMS now attempts to clarify its reading of the CPT code descriptors and instructions relating to Medicare billing for the following services:

1. 99453 (initial set-up and patient education)
2. 99454 (monthly supply and transmission)
3. 99091 (collection and interpretation of physiologic data by a practitioner)
4. 99457 (RPM treatment management, first 20 minutes)
5. 99458 (RPM treatment management, additional 20 minutes)

CMS provides significant guidance on the application of the RPM codes in the following explanations:

• Eligible providers - CPT codes 99453, 99454, 99091, 99457, and 99458 are evaluation and management (E/M) codes, so these RPM services can only be ordered and billed by physicians or non-physician practitioners (NPPs) who are eligible to bill Medicare for E/M services.  Moreover, RPM services are not diagnostic tests, and therefore cannot be furnished or billed by an independent diagnostic testing facility.
• Who can perform RPM services? RPM services under codes 99453, 99454, 99457 and 99458 can be furnished by clinical staff under the general supervision of the billing physician or NPP. CMS is finalizing its proposal to allow auxiliary personnel to furnish 99453 and 99454 services under the general supervision of the billing physician or practitioner even if the auxiliary personnel do not qualify as clinical staff.
• Eligible patients - Patients with either acute or chronic conditions can be eligible recipients of RPM and CMS indicates that these services may be medically necessary. CMS had previously indicated that RPM was limited to patients with chronic conditions, before clarifying earlier this year that RPM can also be provided to patients with acute conditions during the PHE.
• Interactive communication time requirement - For purposes of satisfying the “interactive communication” element under CPT codes 99457 (initial 20 minutes) and 99458 (additional 20 minutes), CMS defines “interactive communication” to mean a real-time conversation with synchronous, two-way interactions that can be enhanced with video or other kinds of data transmission.
  • Note: In the PFS proposed rule, CMS interpreted codes 99457 and 99458 to require at least 20 minutes of interactive communication with the patient. CMS has now clarified (in its Fact Sheet for the PFS final rule) that CPT codes 99457 and 99458 can include time furnishing care management services as well as for the required interactive communication. 
• Device requirements - In order to receive the monthly payment under CPT code 99454, the device must:
  • Satisfy the Food and Drug Administration’s definition of a medical device as defined by § 201(h) of the Federal Food, Drug and Cosmetic Act, although FDA clearance is not necessarily required.
  • Digitally (automatically) upload patient physiologic data rather than self-reported.
  • Be reasonable and necessary for the diagnosis or treatment of the patient’s illness or injury, or to improve the functioning of a malformed body member (This is a reminder of the importance to document medical necessity for all RPM services.).
  • Be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient’s health status to develop and manage a plan of treatment.
• CPT codes 99091 and 99457 can be billed together in some cases - CMS recognizes that CPT codes 99091 and 99457 describe different services and so can sometimes be reported for the same patient if reasonable and necessary and, in addition, the same time is not used to satisfy both codes. CMS noted that in some cases involving the collection of complex data it may be necessary to devote additional time to data analysis and interpretation, and that therefore the billing of both codes may be justified.

CMS will permanently allow:

• Patient consent to be obtained when RPM services are furnished (rather than requiring prior consent).
•  Auxiliary personnel to furnish RPM services under CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.

CMS will reimpose the following policies at the expiration of the PHE:

• The standard requirement that an established physician-patient relationship must exist prior to the performance of RPM services (but RPM services may continue to be furnished to new patients for the duration of the PHE).
• At least 16 days (rather than 2 days during the PHE) of data each 30 days will be required to be collected and transmitted to meet the requirements to bill CPT codes 99453 and 99454.

The PFS final rule is scheduled to be published in the Federal Register on December 28.

For more information on these RPM changes for CY 2021, please contact the attorneys below.