By Rossanna Howard and Allison Shelton, Brown & Fortunato, P.C.
In 2018, the Centers for Medicare & Medicaid Services introduced new CPT Codes for remote physiologic monitoring (RPM). The purpose of the RPM codes, generally, is to allow providers to bill for time spent monitoring and managing patients using medical devices that are capable of storing and transmitting physiologic data. Such data may include the patient’s blood pressure, weight, pulse oximetry, and respiratory rate flow. RPM codes fall under the category of evaluation and management codes, which can only be ordered and billed by physicians or other advance practice professionals (APPs), such as nurse practitioners. The interaction with the patient and the collection of the data may be performed by clinical staff under the general supervision of the physician or APP.
The benefits of RPM have been felt acutely in the past year with the COVID-19 pandemic. Interest in remotely provided healthcare and monitoring services increased during the pandemic, which has given rise to both temporary and permanent changes to law and guidance. These changes have prompted companies to seek ways to partner and contract with physicians, APPs and other healthcare providers to facilitate services like RPM. In this article, we provide a short summary of the RPM codes as well as some considerations for providers that are approached by companies wanting to contract with them to provide RPM services.
CPT Codes 99453 and 99454 relate to the provision of the medical device used to collect and transmit the patient’s physiologic data. The medical device must meet the definition of a medical device set by the U.S. Food and Drug Administration (FDA). Delivery and set-up of the device, and education of the patient on the use of the device, may be performed by either clinical staff or non-clinical auxiliary personnel acting under the general supervision of the billing physician or APP. Auxiliary personnel can include any employee of the provider or an employee that is leased to the provider.
CPT Codes 99457 and 99458 are used to report the time spent communicating with the patient and conducting care management services for the patient. These codes also require the use of a medical device that meets the definition set by the FDA. Services provided under these codes must be furnished by clinical staff acting under the general supervision of the billing physician or APP.
With the development of these codes, various companies have sought partnerships with providers to offer comprehensive RPM programs for the providers’ patients. Under such programs, the companies may seek to furnish various services such as: delivery and set-up of the medical device on the patient; patient education; management, monitoring, and collection of the patient’s physiologic data; providing the clinical staff to review the data and reach out to patients; and billing for the services on behalf of the provider. The exact terms and functions of the programs promoted by the companies vary. Services can be provided directly by one company or by a company under contract with one or more other entities. Under some programs promoted by these companies, providers may only be contacted to address patients whose data falls outside of the normal parameters. The common theme in all programs, however, is that the provider bills for services under the provider’s payor contracts, which may include Medicare. As such, these programs can place an incautious provider at significant legal risk.
RPM programs have the potential to implicate federal laws such as the False Claims Act, federal anti-kickback statute (AKS) and Stark Law, as well as the state analogs. For example, the AKS could be implicated if the RPM company agrees to market the RPM services furnished by the provider, and the provider pays the company for each patient that the company generates for the program. Likewise, the AKS and the Stark Law could be implicated if the physician refers patients to the company or its affiliates for designated health services, like durable medical equipment, in exchange for the company providing free RPM equipment or other valuable items and services to the physician.
When examining whether to contract with a company for the provision of RPM services, providers should consider, among other things, the types of entities involved in the arrangement; whether there is a referral relationship between the parties; the compensation terms; the exact services and division of responsibilities between the parties; what types of patients will be monitored under the arrangement; and payor-specific billing requirements. Providers should also reach out to their health care regulatory counsel to walk through the proposed arrangement and any potential legal risks before signing on the dotted line. RPM services have the potential to benefit patients with chronic and/or complex medical conditions that require active monitoring. But, providers should also insist on a thorough review by competent health care regulatory counsel to navigate landmines and mitigate the risks that these types of arrangements can pose.