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Harvoni Treatment Denied Lawsuit Accuses Insurer of ERISA Violations

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San Francisco, CAYet another Gilead Hep C Denied Insurance Claim Lawsuit was quietly rolled out in July, accusing a noted health insurer of violating the Employee Retirement Income Security Act (ERISA) and other violations of a contractual nature, related to the alleged withholding of Harvoni treatment for hepatitis C.

According to court documents, Anthem Blue Cross (Anthem) is accused of denying plaintiff Marina Sheynberg the treatment she needs because, in Anthem’s view, Sheynberg simply is not sufficiently ill enough to warrant the expensive treatment. Specifically, the lawsuit asserts that Anthem is using its stance to avoid paying out the substantial dollars required to mount a treatment regimen with the highly effective, but prohibitively expensive drug.

Prior to the advent and approval of Harvoni, treatment options for hepatitis C were limited and marginally effective, with sometimes grievous side effects. Harvoni, a once-daily pill that was approved by the US Food and Drug Administration (FDA) last year, is effective in 95 to 99 percent of the cases.

However, insurers have been balking at the price tag, which is high: a 12-week treatment regimen runs at about $99,000. Various Harvoni lawsuits have been launched against Harvoni manufacturer Gilead Sciences Inc. in an attempt to ascertain why the drug is so prohibitively expensive. In the meantime, plaintiffs are left to file Harvoni Denied Insurance Claim Lawsuits against their insurance providers for filibustering on the approval of medically necessary treatment.

Sheynberg’s lawsuit alleges that Anthem, in denying medically necessary treatment, has added “artificial restrictions” to her plan that had not been disclosed previously, or so the plaintiff alleges.

“Hepatitis C is only the second disease or condition for which a cure has been discovered in a single life-span from the discovery of the disease or condition,” the complaint states. “Hepatitis C was discovered in 1990 and the cure arrived in 2014. Hepatitis C could become completely eradicated in the coming few years as a result of Harvoni, assuming patients, such as Ms. Sheynberg, have access to this incredible cure.”

In denying her treatment, Anthem has allegedly told Sheynberg that her liver must reach a certain level of scarring before treatment becomes necessary and would be approved. According to the Harvoni lawsuit, Anthem has also failed to identify just who makes those decisions - information that is necessary for the plaintiff to review the qualifications of those unnamed individuals.

“In violation of ERISA statutes and regulations, Anthem has systematically ignored the treatment recommendations of insureds’ providers and used internal clinical guidelines which are inconsistent with the plain language of insureds’ plans,” the suit claims.

Harvoni was approved by the FDA in October 2014. Since then there has been a growing outcry over the prohibitive cost of the drug, at the same time as doctors are marveling at the effectiveness of the Hep C treatment and are recommending Harvoni to those patients for whom Harvoni would be beneficial. In the face of high cost, a trend has been emerging amongst health insurers to employ stonewalling tactics to prevent or delay treatment.

Harvoni lawsuits have followed in kind. The case is Sheynberg v. Anthem Blue Cross Life and Health Insurance Co., Case No. 3:15-cv-03417, in the US District Court for the Northern District of California.


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