ResMed under investigation

SAN DIEGO - ResMed in July received a federal administrative subpoena from the Office of Inspector General requesting documents and other information related to its patient resupply software.

“We are cooperating with the OIG to respond to its requests,” the company stated in a 10-K filed Aug. 5 with the Security and Exchange Commission.

The OIG's investigation could affect ResMed in a number of ways, which the company outlines in the form.

Right off the bat, ResMed warns that “responding to investigations can be time and resource consuming and can divert management's attention from the business.”

Also, as a result of the investigation, “healthcare providers and entities may have to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement,” ResMed says.

Lastly, if the company is found to be in violation of anti-kickback and fraud regulations, it may be “subject to penalties, including civil and criminal penalties, damages, fines disgorgement, exclusion from governmental health care programs and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our financial results,” ResMed says.

ResMed notes in the form that it operates under regulations like the Anti-Kickback Statute, HIPAA, the Physician Sunshine Act and others.

One of ResMed's main competitors, Philips Respironics, recently settled a lawsuit for $34.8 million that alleged the company provided medSage automated resupply services for free to providers that bought its products, violating the Anti-Kickback Statute.