Adheris Inc. Files For Preliminary Injunction To Stop U.S. Government From Infringing On Constitutionally Protected Speech
Lawsuit Seeks Relief from Unconstitutional Rule That Threatens Valuable Reminder Programs Accessed by Millions of Patients with Chronic Diseases
WASHINGTON, Sept. 6, 2013 /PRNewswire/ -- 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 23rd. 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."
About inVentiv Health
inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv offers convergent services that deliver extraordinary outcomes to clients whose goal is improving human life. In 40 countries around the world, inVentiv's 12,000 employees help clients rapidly transform promising ideas into commercial reality. inVentiv clients include more than 550 pharmaceutical, biotech and life sciences companies, as well as companies that now see health as part of their mission. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inventivhealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays and cancellations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of the consummation of any future acquisitions; the impact of any change in our current credit ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact of pricing pressures on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our client base, including the impact of the final HIPAA Privacy Rule on the willingness of pharmaceutical manufacturers to sponsor patient adherence programs; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; any potential impairment of goodwill or intangible assets; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the actual impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.
1 Peterson AM, Takiya L, Finley R. Meta-analysis of trials of interventions to improve medication adherence. Am J Health Syst Pharm. 2003;60:657-65.
2 DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002;40:794-811.
3 Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353: 487-97.
CONTACT: Sydney Rubin, Chief Communications Officer, inVentiv Health, Inc., +1 781 425 4646, Sydney.firstname.lastname@example.org
SOURCE inVentiv Health, Inc.
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