Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment

Class-Action Lawsuit Filed Against Cigna for Allegedly Denying Depression Treatment

Case Raises Questions of Bias Regarding Independent Review Organizations

By Marketwired .

September 9, 2015 08:00 AM EDT

 

LOS ANGELES, CA -- (Marketwired) -- 09/09/15 -- A class-action lawsuit has been filed against Cigna by Psych-Appeal, Inc., in conjunction with Zuckerman Spaeder LLP, on behalf of mental health patients suffering from depression. The federal lawsuit alleges Cigna has categorically refused to cover Transcranial Magnetic Stimulation (TMS), a safe and effective treatment approved by the U.S. Food and Drug Administration.

"Although Medicare and numerous commercial insurers routinely cover TMS, Cigna has unjustifiably categorized this treatment as 'experimental and investigational,'" said Brian Hufford, partner at Zuckerman Spaeder LLP. "By denying coverage for TMS and restricting patients from receiving potentially lifesaving treatment, Cigna is improperly elevating its own interests above the welfare of its members."

The suit involves a 61-year-old woman who has tried multiple treatments for severe depression. In 2008, the FDA cleared TMS for patients who have failed to respond to psychotropic medications. TMS, unlike electroshock therapy, is performed on an outpatient basis without sedation and does not typically result in side effects such as memory loss.

The complaint also alleges that MCMC, LLC, an independent review organization directly contracted with Cigna to evaluate external appeals of the company's TMS denials, rubber-stamps the insurer by relying on outdated clinical research.

"In California alone, at least 75 external appeals to other independent review organizations have recognized TMS as a valid evidence-based treatment for depression since 2011," said Meiram Bendat, mental health attorney and founder of Psych-Appeal, Inc. "We expect this case to highlight the conflicts of interest that independent review organizations have when they are allowed to contract directly with insurers to evaluate claim denials."

On Sept. 3, 2015, Psych-Appeal, Inc. and Zuckerman Spaeder LLP filed a similar class action complaint against Aetna and MCMC.

Interested parties may contact Meiram Bendat at mbendat@psych-appeal.com or Brian Hufford at dbhufford@zuckerman.com.

About Psych-Appeal, Inc.
Los Angeles-based Psych-Appeal, Inc. is a law firm exclusively dedicated to mental health insurance claims, advocating on behalf of patients, clinicians and treatment facilities to overcome insurer denials of treatment. For more information, visit www.psych-appeal.com.

Contact:
Chantal Allan
310-598-3690 x.201
Email Contact

http://news.sys-con.com/node/3447654

FDA Approves First Device to Treat Migraine Pain

FDA Approves First Device to Treat Migraine Pain

Susan Jeffrey

December 13, 2013

The US Food and Drug Administration (FDA) today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS; eNeura Therapeutics), the first device approved to relieve pain caused by migraine headache with aura.

"Millions of people suffer from migraines, and this new device represents a new treatment option for some patients," Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a statement.

The device is used by prescription after onset of pain associated with migraine with aura. Using both hands, the patient holds the device to the back of the head and, pressing a button, releases a pulse of magnetic energy that stimulates the occipital cortex, stopping or reducing the pain associated with this type of migraine.

"The FDA reviewed the data for the Cerena TMS through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device," the FDA statement notes.

They reviewed data from a randomized control clinical trial including 201 patients with mostly moderate to severe migraine headaches with auras preceding at least 30% of episodes. Of these patients, 113 recorded treating a migraine at least once when pain was present, and the analysis of these 113 patients was used to support the marketing authorization, the release said.

Results showed that nearly 38% of patients using the TMS device were pain-free 2 hours after using the device vs 17% of control patients. After 24 hours, nearly 34% of treated patients were pain-free vs 10% of the control group.

However, treatment was not associated with relief of other associated symptoms of migraine, including sensitivity to light or sound and nausea, the FDA adds. The device is for use in patients 18 years of age or older, and the study did not evaluate performance of the device in other types of headaches.

Adverse events reported with treatment were rare in both device and control groups, the FDA release said, but included single reports of sinusitis, aphasia, and vertigo. "Dizziness may be associated with the use of the device," the agency adds.

The device should not be used in patients who have metals in the head, neck, or upper body; who have an implanted medical device such as a deep brain stimulator or pacemaker; or those who have suspected or diagnosed epilepsy or a personal or family history of seizures, the FDA statement said.

"The recommended daily usage of the device is not to exceed 1 treatment in 24 hours," it concludes.

http://www.medscape.com/viewarticle/817831