Adheris files suit against HHS for attempting to restrain speech that serves public health interest

Sep 7 2013

Adheris, Inc., an inVentiv Health company, filed suit today against the U.S. Department of Health and Human Services, asking a federal court to enjoin the government from implementing a new regulation that imposes unconstitutional restrictions on the speech of a company whose business is encouraging patients to properly take their medicine.

The motion for preliminary injunction, Adheris, Inc. v Kathleen Sebelius et al, was filed in the U.S. District Court for the District of Columbia seeking relief from sweeping new regulations that will otherwise take effect September 23^rd. The rule threatens to end refill reminder programs that serve millions of Americans with chronic diseases, including many elderly patients. The suit charges the federal government with attempting to restrain speech protected by the First Amendment.   

Adheris, working with pharmacies and pharmaceutical companies, sends letters that, in addition to reminding people to take their medications, include educational information about disease conditions and side effects, information on how to take the drug properly and the consequences of stopping treatment prematurely.

For years, HHS recognized the well-documented value of such treatment communications and the government encouraged their use. Then, HHS' Office of Civil Rights (OCR) changed the rules on refill reminder programs as part of regulations implementing the 2009 Health Information Technology for Economic and Clinical Health Act, or HITECH. While OCR crafted language that jeopardizes refill programs, other agencies within HHS, such as the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, promote and encourage such refill programs.

"This rule undermines a valuable extension of a physician's treatment that promotes patient health, helps save lives and reduces healthcare costs – all of which are in the public interest and consistent with the objectives of the Affordable Care Act," said Eric Sherbet, General Counsel for inVentiv Health, the parent company of Adheris. "It is a misguided regulation and one that impinges on our right to speech that serves a significant public health interest."

Through its partnership with more than three dozen large pharmacy chains, Adheris sends communications sponsored by pharmaceutical companies to millions of patients. The sponsor is clearly indicated in the refill reminder letters, which also provide patients with an easy way to opt-out of receiving reminder letters.

Adheris strictly abides by all federal and state laws regarding the protection of patient privacy and has invested millions of dollars to develop technologies and processes to protect patient privacy. Since 1993, Adheris has sent hundreds of millions of communications to patients and handled billions of prescription records without ever having a known security breach.

Adheris refill reminders focus on chronic diseases like heart disease, diabetes, osteoporosis, depression, and asthma where studies have shown that adherence to treatment makes a huge difference. According to the Centers for Disease Control, about 133 million Americans - nearly 1 in 2 adults - live with at least one chronic illness.

Nearly two-thirds of Americans who take medications do not take them properly. Sixty-four percent of Americans who take medications report that they are not always taking their medications as prescribed, according to a national poll from last spring by Greenberg Quinlan Rosner Research and Public Opinion Strategies.

Those who face the challenge of managing multiple medications are most likely to not adhere; 70 percent of individuals who take 3 or more medications do not take them properly, compared to 56 percent among those with 1 or 2 prescription medications, the poll noted.

In the United States, non-adherence to prescribed therapy is estimated to cause about 125,000 deaths per year, at least 10% of hospitalizations¹ and a substantial increase in morbidity and mortality.² Non-adherence has been estimated to cost the U.S. healthcare system between $100 billion and $289 billion each year.³

The Motion for a Preliminary Injunction points out that Adheris' speech in the form of communications to patients is constitutionally protected by the First Amendment's role in furthering the "free flow of information." In the recent Supreme Court ruling on Sorrell v IMS Health, Inc., the Court affirmed that "speech in aid of pharmaceutical marketing… is a form of expression protected by the Free Speech Clause of the First Amendment" and that the free flow of information "in the fields of medicine and public health… can save lives."

The United States has a long history of placing special protections around free speech.  Attempts to restrict speech are subject to "heightened scrutiny" and must be shown to advance a substantial government interest. In this case, the new rule fails to pass such scrutiny and does not advance any government interest. On the contrary, the government's interest is in improving public health while keeping down costs - and refill reminders further these interests.

The new regulation imposes restrictions on Adheris because its reminder communications are funded by pharmaceutical manufacturers. The same reminder funded by the government, non-profit organization or others is allowed without similar restrictions under the new rules.

"We are asking the court to stop HHS in its attempt to restrict communications to patients in a manner that is high-handed and inconsistent," Sherbet said. "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."