Remote Therapeutic
Monitoring

CPT codes 98976 and 98977, billed for the ongoing supply of RTM devices, provide reimbursement for devices that monitor the respiratory (98976) or musculoskeletal (98977) system. For both RTM and RPM services, the CPT Manual states that devices used must be “medical devices” as that term is defined by the U.S. Food and Drug Administration (FDA) in the Food, Drug & Cosmetics Act (“FD&C Act”). This means that the device must go through the appropriate FDA regulatory pathway which may require clearance, approval, or exemption. Importantly, the FDA’s definition of a “medical device” includes certain software functions. More information regarding medical devices under the FD&C Act can be found on the FDA website.

Yes. Augment Therapy’s software platform is considered a medical device under applicable FDA regulations.

Yes. As with all Medicare services, patients are responsible for all applicable co-payments and cost-sharing amounts. Medicare Part B beneficiaries are typically responsible for a 20% co-pay each time a code is billed. During the COVID-19 Public Health Emergency (“PHE”) , providers may opt to waive the collection of patient copays.

Providers should follow current billing practices and ensure that all the requirements for each code are met, such as documenting medical necessity for ordering RTM services and patient consent in the medical record.

Providers who are eligible to bill Medicare directly for their services and whose scope of practice includes RTM services are eligible to bill for RTM services. This may include:

Physicians

Anesthesiology Assistants

Certified Nurse Midwives

Certified Registered Nurse Anesthetists

Clinical Nurse Specialists, Clinical Social Workers

Nurse Practitioners

Occupational Therapists in Private Practice

Physical Therapists in Private

Practice

Physician Assistants

Psychologists

Qualified Audiologists

Speech Language Pathologists in Private Practice

Registered Dietitians or Nutrition Professionals

No. The American Medical Association’s CPT Manual (the “CPT Manual”) states that RTM and RPM should not be billed for the same patient in the same month.

Yes. Although the 2023 Rule is silent on the matter, the CPT Manual states that device CPT codes 98975, 98976, 98977 should not be reported if monitoring is less than 16 days. Please note that CMS and auditors generally defer to language in the CPT manual when the MPFS is silent. There is no prohibition, however, on billing the treatment management services codes (CPT codes 98980 and 98981) if less than 16 days of transmissions have occurred, as along as the 20 minutes of time has been accrued and all other billing requirements are met.

While CMS has not explicitly designated the RTM codes as “care management services,” in the 2023 Medicare Physician Fee Schedule, CMS stated that “[a]ny RTM service may be furnished under our general supervision requirements.” This is a change in policy from when the RTM codes were first established in 2022, and it allows the use of outsourced clinical staff who are not present in the same location as the billing practitioner for treatment management services as appropriate under that practitioner’s billing guidelines. Although “clinical staff” is not included in the RTM code descriptors, CMS clarified that when the billing practitioner’s benefit allows services to be furnished incident-to their professional services, RTM services can be provided by clinical staff under general supervision.

If the RTM services are performed as “not therapy services”, meaning the services are being performed by a physician/NPP outside of a therapy plan of care, a clinical staff member is defined in the CPT Manual as “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 who does not individually report that service.” This means that the type of personnel that qualify as “clinical staff” for purposes of RTM varies by state law and providers should look to applicable scope of practice laws in the patient’s state to determine who can and cannot provide monitoring services.

CMS does not specifically define “physiologic” data for RPM or “non-physiologic” data for RTM, though it does reference “therapy response” and/or “therapy adherence” data, including medication response/adherence. In the 2022 Rule, CMS gives examples of health conditions where non-physiologic data can be collected, including musculoskeletal system status, respiratory system status, therapy (for example, medication) adherence, and therapy (for example, medication) response. Providers should use their professional judgment in determining what constitutes “non-physiologic” or “therapeutic” for purposes of RTM.

Yes. RTM data can be patient-reported or automatically transmitted through a SaaS platform that is classified by the FDA as Software as a Medical Device (“SaMD”) like the Augment Therapy platform.

In order to bill CPT codes 98976 and 98977, the CPT manual requires providers to supply to patients the medical device that captures the recordings and/or programmed alert(s) transmission to monitor the respiratory or musculoskeletal system. If the patient is using their own medical device (“Bring Your Own Device” or “BYOD”) or obtains the medical device from another provider, the billing provider cannot bill CPT code(s) 98976 or 98977. However, if the billing provider pays a device supplier or RTM vendor for devices distributed to patients on the practice’s behalf, this would still be considered “supply” of the device and is therefore reimbursable under the device supply codes.