Patient Assistance Programs (PAPs) have proliferated in recent years, despite the fact that many commonly-prescribed medications have lost patent protection and the Affordable Care Act (ACA) has attempted to eliminate pre-existing condition discrimination by insurance companies. Still, drug costs remain unaffordable to many patients, particularly those with high-cost, chronic conditions, even when patients have insurance coverage. An article published recently in the New England Journal of Medicine suggests that the ACA has increased insurance coverage for an estimated 10 million previously uninsured individuals in 2014, some insurers are structuring drug formularies in a manner that discriminates against (and discourages enrollment of) patients suffering from particular high-cost conditions.
Regardless of the cause, the need for and utilization of PAPs raises interesting questions related to privacy and security of protected health information (PHI). I had the opportunity to co-present a workshop session on HIPAA at CBI’s 16th Annual Patient Assistance and Access Programs Conference in Baltimore, MD this week with Paula Stannard, Esq. of Alston & Bird. The conference was well-attended, and Paula and I were asked a number of questions during and after our workshop that showed interest in HIPAA compliance by PAP entities, as well as confusion regarding it.
Paula and I crafted a scenario in which a PAP’s data system is hacked, and the hacker gains access to individually identifiable health information stored on the system. Both Patient A and Patient B have insurance, but suffer from a condition requiring a medication not on their carriers’ formularies. Patient A put his own information into the PAP system after learning about the PAP from TV ad. Patient B let his physician put her information into the PAP system, after the physician explained that the hospital at which the physician works has an arrangement with the PAP whereby the PAP will help with getting insurance coverage.
We asked the audience whether the hacker’s access to Patient A’s and Patient B’s information in the PAP was a HIPAA breach. A follow up to this blog will discuss the factors relevant to deciding when HIPAA applies to PAPs (and individually identifiable information they maintain) and when it doesn’t.