HHS throws a roadblock into refill reminders; Adheris files suit for injunctive relief

Everyone agrees that better adherence to drug therapies results in better outcomes and lower overall healthcare costs; more and more programs are being set up to accomplish this. But a detail in the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, now about to be enforced by HHS, throws a monkey wrench into one avenue of patient communications. With the deadline looming, Adheris (an inVentiv Health company, based in Burlington, MA)—which derives over 90% of its revenues from providing industry-sponsored refill reminders through 38 drugstore chains—has filed suit in federal court for injunctive relief, asserting that these reminders are protected commercial speech under the First Amendment.

According to Sydney Rubin, chief communications officer, inVentiv attempted to obtain guidance on the rule from HHS through a variety of channels over the past spring and summer. Although the company received promises of assistance, it received no clarification. By the end of August, the company felt it had no choice but to pursue a remedy through the courts. “The lack of guidance already has had a chilling effect on pharmacies and companies who support refill reminder programs,” he says.

HHS has exempted reminder notices from requirements for “marketing” communications if the financial remuneration received in exchange for creating them is reasonably related to a covered entity’s costs, and defines a reasonable amount as the sum “that cover(s) only the costs of labor, supplies, and postage to make the communications.” Patient privacy is also an issue; Adheris’ position is that it has invested in substantial technology to obtain, process, and store the data securely that they use to send reminders. The costs of this IT infrastructure greatly exceed the costs of drafting, printing, and mailing reminders.

Also, the HITECH Act requires patients’ authorization for treatment communications such as refill reminders. Adheris’ customers have read HHS rules to mean that the company’s reminder services, which use protected health information, cannot be conducted without patients’ authorizations, which the company claims is not economically feasible to obtain.

Adheris notes that randomized controlled studies on the effectiveness of its programs have found that patients receiving them are 2-7% more likely to take their medications. The Congressional Budget Office has estimated that a 1% increase in prescription refills in the US could decrease Medicare’s spending on medical services by one fifth of one percent, which translates into more than a billion dollars in savings for each 1% increase in refills.

In a press statement, Eric Sherbet, general counsel for inVentiv Health, notes that other parts of HHS are encouraging the use of adherence programs, adding that “This rule addresses a non-existent problem with an unconstitutional regulation that is contrary to the best interest of patients and society. We are hopeful that the court will agree.”