Background

As remote patient monitoring (RPM) continues to grow as a vital component of modern healthcare, so too does scrutiny from federal agencies like the Department of Justice (DOJ) and the Department of Health and Human Services’ Office of Inspector General (OIG). While government enforcement actions have long focused on improper billing, lack of medical necessity, and illegal kickback arrangements, regulators are increasingly circling the RPM space as a potential “hotbed” for fraud. The following recent settlements provide critical insights into the government's priorities, offering a clear warning to telehealth providers about the importance of robust compliance programs.

Recent Enforcement Actions

Health Wealth Safe

In a significant case, Health Wealth Safe, Inc., and its owner, Dr. Subodh Agrawal (“HWS”), agreed to pay $1.29 million to resolve allegations that they knowingly submitted false claims to Medicare. The settlement, initiated by a qui tam lawsuit under the False Claims Act, detailed a number of serious compliance failures.

The government’s allegations were wide-ranging, claiming that HWS:

· Billed Medicare for RPM services using non-FDA-approved devices that did not automatically transmit data. Instead, HWS directed patients to manually enter health data via a mobile app. In some instances, HWS contacted patients to obtain health data over the phone when patients stopped using the provided app.

· Failed to collect sufficient data required for billing. The DOJ alleged that HWS failed to collect data for the required minimum of 16 days per month, instead checking for engagement only once per month.

· Intercepted patients’ messages to their providers, employing untrained staff to review messages to determine whether escalation to the treating physician was necessary.

While these allegations alone would be sufficient for FCA liability, the DOJ further alleged that HWS offered kickbacks to physician practices for enrolling patients to receive RPM and chronic care management (“CCM”) services. In exchange, providers provided HWS with access to their EMR systems, allowing HWS to review patients’ records for eligibility and cold-call patients for referrals.

Capital Health System

In another case, Capital Health System, Inc., a healthcare provider in New Jersey, agreed to pay $528,937.50 for allegedly violating the Civil Monetary Penalties Law. The OIG alleged that Capital Health submitted claims to federal healthcare programs for remote physiologic monitoring (“RPM”) services that did not satisfy coverage and payment requirements.

Unlike the Health Wealth Safe case, this settlement was the result of a self-disclosure by Capital Health. The OIG's press release stated that the organization submitted claims for RPM services that were non-reimbursable. While the specific details of the non-compliance were not disclosed, this case serves as an important reminder that even minor, self-identified compliance issues can lead to significant settlements. It also demonstrates the government’s willingness to resolve cases that are voluntarily disclosed, a key consideration for providers who discover potential fraud.

Other Notable Settlements

While the Capital Health and Health Wealth Safe settlements are among the most recent, they exemplify a broader trend. In late 2023, BioTelemetry Inc. and its subsidiary, LifeWatch Services Inc., paid more than $14.7 million to resolve allegations that it billed for higher, more expensive levels of remote cardiac monitoring services than were ordered or medically necessary. Earlier this year, LiveCare Inc. settled for up to $4.9 million to resolve allegations that it unlawfully paid a marketing service for referrals of Medicare beneficiaries. As RPM continues to cement its place in the industry as a critical form of care delivery, these settlements are a stark reminder that enforcement and regulatory scrutiny are showing no signs of slowing down.

Health Law Alliance: Your Trusted Partners in RPM Compliance

The recent wave of enforcement actions serves as a clear warning to telehealth providers: the government is actively monitoring RPM services. For providers looking to expand their telehealth offerings, Health Law Alliance’s healthcare fraud and compliance experts give you the tools you need to provide RPM services with confidence.

At Health Law Alliance, our attorneys are experts in helping providers structure compliant RPM programs and referral arrangements. We can assist your practice with:

· Proactive Compliance: We provide comprehensive legal guidance to help you develop and implement a robust compliance plan that minimizes your risk of being audited or reported to federal regulators.

· Internal Audits: Our team can conduct thorough internal audits to identify and address potential billing errors or compliance gaps before they become a problem.

· Regulatory Guidance: We stay up to date on the latest Medicare and private payor rules and enforcement trends to ensure your practice remains compliant with the ever-changing regulatory landscape.

Facing a federal investigation or RPM audit? Led by former prosecutors, our healthcare fraud group has decades of experience defending providers from kickback and False Claims Act allegations, using tailored defense strategies designed to protect your practice, finances, and professional reputation.

Ready to see how Health Law Alliance can help your practice? Contact us today for a free consultation—we’re just a phone call away.