HHS Inspector General: Smartphone App Won’t Violate Kickback Laws

The Health and Human Services inspector general has green-lighted a sponsor’s request to offer smart phones to poor patients so they can take an antipsychotic drug with an electric sensor.

The sponsor’s name was redacted from the IG’s document but a spokesman for Otsuka America Pharmaceuticals confirmed to IDDM that it stemmed from his company’s request to hand out smart phones to patients taking Otsuka’s Abilify MyCite, a drug-and-device combination antipsychotic.

Otsuka told the IG it wanted to use a smart phone app to help ensure that patients took Abilify on time and correctly. The drug has an electronic signal that records when it has been taken, which would eventually be recorded on a smartphone app.

But some unidentified numbers of patients who need the drug can’t afford a smartphone and Otsuka was concerned that loaning out phones with the app would violate rules against inducements and anti-kickback laws.

In a letter released last week, the IG said that, even if the smartphone could “potentially” violate the anti-kickbacks law, HHS won’t pursue any charges as long as Otsuka agrees to strip the phone down so that it’s mostly focused on registering doses.