Patient service program are loosely monitored for regulatory compliance, says Helio Health

Particularly for specialty pharmaceuticals that require lots of follow-on services, the pharma industry is investing in a growing number of patient support programs, both financial (copay programs, etc.) and advisory or educational (for both HCPs and patients). But there are risks if the programs are not closely monitored, says Helio Health. The number of qui tam (whistleblower) lawsuits and regulatory actions is growing. Potential violations occur with the False Claims Act, HIPAA privacy rules, and anti-kickback regulations.

In its latest survey, conducted across 28 drug manufacturers, Helio finds a number of critical areas:

• 88% of companies polled had a patient assistance program that funded copay foundations or charities, but only 65% had defined review process, and internal systems, to monitor how funding is disbursed.
• 65% of respondents have a “data privacy management program” (as Helio defines it) in place; the rest do not or are uncertain.

Patient support is an evolving area of pharma functionality. Most companies have an internal patient services team; this team can handle the variety of services ranging from prior authorization support to followup patient care administration. Many companies supplement (or hand off entirely) patient support with outside providers, including hub services vendors or specialty pharmacies. The Helio survey shows that 20-30% of respondents use specialty pharmacies for prior authorization, benefit verification and copay assistance, while 50-70% of respondents use hub providers (and some manage these functions internally.)

“The trend is for activities involving financial support, such as copay programs, to be managed by the outsourced provider, while patient education might be handled internally,” says Minna Bak, senior manager at Helio. “The overriding question is, what is a bona fide service as defined by HHS regulations? There are safe harbor arrangements where a service can be offered by an independent third party, but the appropriateness of this is determined almost on a case-by-case basis.”

Helio Health provides a range of consulting and monitoring services to ensure regulatory compliance with state and federal rules; contact them directly (www.heliohealthgroup.com) for details on the survey.