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Helio Health survey sees nagging compliance problems
In line with a general call for more “patient centricity,” pharma companies have been stepping up their patient support services, often managed through outsourced hub providers. This is generally a good thing, both for patients and for brand owners themselves; but there are significant risks around meeting strict regulatory concerns and ensuring patient privacy. So, it’s somewhat surprising that this year’s survey from Helio Health, a compliance consulting firm, finds that upwards of 25% of brand owners are “uncertain” whether their programs are HIPAA-compliant; and an equal percentage do no auditing of patient support services—even those that involve financial support of patients.
“This year’s survey shows that pharma companies are expanding the patient support services they offer which is in-line with the trend of moving to specialty rare / ultra-rare therapeutic areas,” says Manny Tzavlakis, managing partner of Helio Health. “At the same time—and despite a track record of sanctions against companies in regard to these patient services through recent corporate integrity agreements (CIAs)—compliance controls are still lacking or not being implemented across programs.”
Now in its third year, Helio Health’s survey obtained responses from 36 companies, spread across small, medium and large firms. From 2018 to 2019, the number of companies with dedicated patient-services teams grew slightly, from 25 to 28.5%. The volume of services being provided has grown for the most part, or become more specialized: over 90% provide call center support (vs. under 70% last year); 55% provide for nurse educators (vs. 38% in 2018). Field-based reimbursement support, where specialists spend time in doctor’s offices, has zoomed to 65% (vs. 25% in 2018).
Companies are more serious about internal legal and compliance oversight, with 60% having dedicated resources this year (vs. 39% in 2018); correspondingly, the number of companies that perform only legal review dropped from around 29% to around 12%. But there remain nagging gaps or worries: 40% of respondents do not record patient interactions with patient-service team members; about 20% are uncertain whether a data-privacy program is in place; and about 7% are aware that sales reps have access to patient data (a topic for which companies have been penalized in the recent past). This is despite that fact that “sales rep-patient interactions” is a “biggest concern” of 44% of respondents.
More results of the survey are available from Helio.