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:
• 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
• 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 2022 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.
CMS did not designate the RTM code set as “Care Management Services”. This means that when RTM services are provided incident-to the billing practitioner, clinical staff must be supervised under direct supervision, meaning the billing practitioner must be in the same physical office location as the clinical staff. During the PHE, direct supervision may be provided through virtual direct supervision, meaning the billing practitioner must be immediately available by virtual means while clinical staff are providing monitoring services.
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 direct supervision. The following practitioners’ benefits allow for billing incident to their professional services: Physicians, Physician Assistants, Nurse Practitioners, Clinical Nurse Specialists, Certified Nurse Midwifes, and Clinical Psychologists. During the PHE, direct supervision may be provided through virtual direct supervision, meaning the billing practitioner must be immediately available by virtual means while clinical staff are providing monitoring services.
The type of personnel that qualify as “clinical staff” for purposes of RTM varies by state law. If the RTM services are performed as “not therapy services”, meaning the services are being performed by a physician or a nonphysician practitioner (“NPP”) outside of a therapy plan of care, the CPT Manual defines clinical staff 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”. Under the CPT definition, 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-physiological” data for RTM. In the 2022 Rule, CMS gives examples of health conditions all where non-physiologic data can be collected, including musculoskeletal system status, respiratory system status, therapy adherence (e.g., prescribed exercise program adherence), and therapy response (e.g., response to prescribed exercise). 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.