Remote patient monitoring (“RPM”) continues to see increased growth and evolution. With that industry growth, the government has begun to examine whether certain RPM models may have fraud and abuse concerns when others will not. To that end, on June 26, 2025, the Department of Justice (“DOJ”) announced that Health Wealth Safe, Inc. (“Health Wealth Safe”) and owner, Dr. Subodh Agrawal, paid $1.29 million to settle allegations of submitting false claims to Medicare under the False Claims Act (“FCA”). Health Wealth Safe allegedly failed to refund the government for 2.5 years of claims for improperly provided RPM services in violation of the FCA’s “reverse false claims” provision. Additionally, the United States alleged that Health Wealth Safe paid physician practice groups illegal kickbacks in exchange for patient referrals, and billed Medicare for RPM services that DOJ alleged were not reimbursable.
RPM involves the use of digital devices to remotely monitor a patient’s health outside of a traditional clinical setting. The device transmits patient health data to their provider without requiring an in-office visit. For example, blood pressure, weight, and glucose levels are common data points collected remotely. Medicare covers RPM for the collection of physiologic data using a variety of medical devices for chronic and acute conditions. In order to properly use RPM for Medicare fee-for-service enrollees, there are three required components, including, the focus of the government’s allegations: (1) the enrollee must have a chronic or acute condition; (2) an internet connected device approved by the Food and Drug Administration (“FDA”) must be used; and (3) a minimum amount of data must be collected and transmitted during a 30-day period.
In United States ex rel. Chavous v. Health Wealth Safe, Inc., the United States alleged that Dr. Agrawal submitted claims to Medicare for RPM services that were not reimbursable as they did not meet the foregoing requirements instituted by the Centers for Medicare & Medicaid Services (“CMS”). Dr. Agrawal operated Health Wealth Safe, a company providing RPM and Chronic Care Management (“CCM”) services through an app. Health Wealth Safe allegedly did not provide the required devices to its patients for a 2-year period. Instead, patients uploaded their own data to the app. The United States alleged that Health Wealth Safe called and collected data from patients who did not have the app. The FDA does not consider mobile apps in which patients record and log data themselves to be medical devices and therefore not eligible under CMS’ rules for reimbursement.
Health Wealth Safe allegedly then failed to properly bill for services even after providing the devices. The United States alleged that Health Wealth Safe intercepted patients’ messages to their physicians and relied on untrained and unqualified employees to determine whether escalation was necessary. This was allegedly conducted without patients’ knowledge and without the assurance of proper physician supervision. The United States alleged that Health Wealth Safe did not properly ensure patients’ RPM usage met the 16 days of data out of 30 days rule for the particular codes at issue. Rather, they checked for app engagement 1 day per month. It was also alleged that neither the physicians nor Health Wealth Safe documented how the data collected would be used to develop and manage a treatment plan for the patients’ illnesses.
Moreover, the United States alleged that Health Wealth Safe and Dr. Agrawal offered kickbacks to physician practices for enrolling patients to receive their RPM and CCM services. The physician practices allegedly provided Health Wealth Safe and its affiliate billing company, Medical Office Force, LLC, with access to their EMR systems. Health Wealth Safe allegedly reviewed patient records to determine who was eligible, then cold called patients for referrals.
RPM is experiencing rapid expansion as an increasingly critical piece of healthcare technology. Its growth is due in part to the rising prevalence of chronic disease, an increase in the aging population, a greater demand for home-based care, and a shift towards value-based care focused on prevention. Other factors, such as technological advances like AI and wearable devices, along with patient demands for convenience also play a role in the expansion of RPM. With expansion, anticipate additional investigator scrutiny moving forward. Settlements such as the one described in this post can help provide signals on where DOJ’s focus may identify models with fraud and abuse concerns.
McGuireWoods LLP will continue to monitor for updates related to RPM and anticipates publishing more in the near term. For more information, please consult one of the authors.
McGuireWoods’ False Claims Act Investigations & Litigation team draws on the deep experience of our nationally recognized Government Investigations & White Collar Litigation and Healthcare practices to respond to emerging healthcare enforcement priorities, such as the RPM company described in this post. Further, McGuireWoods’ Healthcare Compliance, Regulatory & Policy assists healthcare providers, investors and innovators comply with such regulatory requirements before they affect their business. Please contact the authors or any member of McGuireWoods’ False Claims Act Investigations & Litigation and Healthcare Compliance, Regulatory & Policy teams to discuss further.
Special thanks to summer associate Cleo M. Medina for her significant contribution to this legal alert. She is not licensed to practice law.