Maria T Currier is a Partner in Holland & Knight's Miami office
On Jan. 29, 2019, the Office of Inspector General (OIG), in Advisory Opinion 19-2, issued its first opinion on the new "promotes access to care" exception to the beneficiary inducement Civil Monetary Penalties (CMP) law and its first guidance on Digital Medicine (DM) technology as part of a patient assistance program.
This favorable opinion demonstrates that, with proper safeguards in place, the OIG shows its willingness to support low-income patients with technologies that can enhance patient care. The requester is a pharmaceutical manufacturer that makes a DM product recently approved by the FDA, which is a combined drug/ingestion sensor that can monitor patient utilization of the drug used to treat mental illness. Patients with this particular mental illness have drug adherence problems causing them to have poor outcomes and higher use of additional healthcare services. The DM technology, which requires an app, allows the patients' physicians and caregivers to access the drug utilization information through a web-based portal. To use the technology, the patient must have a smartphone capable of running the app. For low-income patients without access to a smartphone, the pharmaceutical manufacturer proposes to loan them a phone.
The OIG based its favorable opinion on the following factors: (1) the...