- Federal officials have given the green light to a digital health company’s plan to loan free smartphones to patients enrolled in an mHealth project tracking medication adherence.
The Office of the Inspector General issued the ruling last month in favor of the unidentified virtual care company, an affiliate of a global pharmaceutical corporation. The company plans to give the phones to patients enrolled in a digital therapeutic program in which they track medication adherence through an ingestible sensor and corresponding mHealth platform.
The approval is reportedly the sixth recently issued by the OIG in favor of telehealth and mHealth projects, many of which aim to use digital health platforms to increase collaboration between providers and consumers and improve health and wellness outcomes.
In this case, the program aims to reach a wide variety of participants, including Medicare beneficiaries, who have been prescribed a specific medication. That drug is combined with a digital therapeutic, a small sensor that tracks when the drug is ingested and transmits that data to a smartphone app. That data, along with other information entered by the patient, is then transmitted to the patient’s care team to measure medication adherence and the effectiveness of the treatment.
The project features several strict guidelines. The smartphones – refurbished iPhones and Android devices with limited functionality outside the program’s parameters – will only be given to patients who have been prescribed the drug, meet insurance and low-income requirements, don’t already have a phone that could be sued in the program and are US citizens. In addition, the company would get those phones back or disable them after the program runs its course.
According to an analysis of the ruling by Nathaniel Lacktman, chair of the Telemedicine and Digital Health Industry team at Foley & Lardner, and Emil Wein, a healthcare lawyer with the firm, the OIG ruled that the program does not violate anti-kickback laws for five reasons:
- The mHealth app “is essential to the patient accessing the full scope of benefits of the digital health therapy, and loaning a smartphone to make that possible would improve patients’ ability to benefit from the drug.”
- The program won’t likely interfere with clinical treatment because the phones are only being offered to patients who meet specific guidelines. In addition, a doctor would likely prescribe the drug based on its ability to transmit data through a remote patient monitoring platform, not because the patient could get a free smartphone for 8-12 weeks.
- The free smartphone won’t likely be used for anything other than the program, and it won’t lead to extra costs to federal health care programs.
- The program isn’t being directly advertised to patients – “an important safeguard against improper beneficiary influence or inducements.”
- “The limited smartphone functionality and 12-week duration were favorable elements, and OIG notably stated if the phone offered additional functionality (e.g., internet access), they might have reached a different conclusion on the proposed arrangement.”
Lacktman and Wein noted that the OIG’s ruling is specific to the case, but it points to support by the federal government for programs that improve access to care and health outcomes.
“OIG included its traditional disclaimer that the advisory opinion can only be relied upon by the specific company that requested it, and the opinion would be null if any material facts were not disclosed,” they wrote. “Companies offering similar digital health therapeutics or remote patient monitoring programs should closely review the opinion because it offers insight into the government’s view on how technology can promote access to care. Companies evaluating or developing similar programs offering free or discounted technology should carefully consider the safeguards enumerated in OIG’s analysis prior to launch.”