Miracle Hepatitis C Drug Cure Being Denied: Not Sick Enough

Have you been denied medically necessary prescription drug treatment for Hepatitis C? If you have, Kantor & Kantor, LLP has a solution to help navigate you toward insurance carrier approval of Harvoni treatment for Hepatitis C.

In October 2014, the FDA approved Harvoni (ledipasvir-sofosbuvir), a prescription drug that dramatically changes the lives of those infected with Hepatitis C. Harvoni is a once daily tablet that contains two drugs, ledipasvir and sofosbuvir, and has been shown to successfully treat patients with chronic Hepatitis C.

Harvoni tablet treatment lasts for eight, twelve or twenty-four weeks depending on the viral load of the individual who has been diagnosed with Hepatitis C. Harvoni’s efficacy has been well-documented and established. Various clinical trials, consisting of more than 1,500 participants, have shown treatment success rates of well over 90% for patients with varying stages of Hepatitis C. It is now the standard of practice in the medical community to prescribe Harvoni regimens for individuals with varying levels of Hepatitis C.

Individuals with Hepatitis C are diagnosed with varying stages of liver fibrosis. Advanced liver fibrosis results in cirrhosis, liver failure, and portal hypertension and often requires liver transplantation. For individuals with Hepatitis C, the stakes are extremely high when it comes to making claims for a potentially curing drug, like Harvoni. Each day that passes by without proper treatment could cause potentially permanent harm to an individual’s health and condition.

Depending on the method used by treating professionals to diagnose their patients, individuals with Hepatitis C are classified with, for example, a METAVIR score (a scoring system used to quantify the health of one’s liver) of F0-F4. Based on this scoring system, various insurance carriers are denying medical professional-prescribed Harvoni treatment and artificially regulating access to the proven and effective treatment.

Here are some examples of frequent insurance company restrictions on access to Harvoni treatment:
Anthem Blue Cross/Express Scripts (internal guidelines revised October 15, 2014):
• Anthem's Harvoni Pre-Authorization Guidelines
• Anthem covers ledipasvir/sofosbuvir for adults with genotype 1 chronic hepatitis C infections and compensated liver disease with a liver fibrosis staging score of 3 or 4, but not 0-2.

UnitedHealthcare Insurance Company (guidelines effective October 15, 2014):
• UHIC'S Harvoni Guidelines
• UHIC limits the use of ledipasvir/sofosbuvir to patients with genotype 1 chronic hepatitis C infections who have advanced liver disease with a staging score of 3 or 4, not 0 -2.

HealthNet (guidelines effective October 28, 2014):
• HealthNet Harvoni Guidelines
• Health Net’s interim guidelines for ledipasvir/sofosbuvir provide coverage for patients with genotype 1 chronic hepatitis C infections who have not failed previous treatment that included sofosbuvir and who have fibrosis demonstrated by liver biopsy or noninvasive test corresponding to METAVIR score of 2-4, not 0-1.

Why Are Insurers Denying Harvoni Treatment?

Insurance companies have no other basis to deny claims for Harvoni treatment than purely financial and profit-seeking interests. Harvoni treatment regimens cost roughly $94,000-$100,000 (depending on the estimate) for a 12-week program. However, insurance companies are not allowed to advance a financial basis for denial because no such factor should be considered in determining what services are covered as defined in the terms of your health insurance plan. Insurance companies are arbitrarily regulating access to this expensive but curative treatment under the guise of “practicing” medicine through their internal clinical guidelines. In the cross-hairs of the carriers’ profit motive are individuals who have earlier stages of Hepatitis C.

Can Insurance Carriers Use Their Arbitrary Clinical Guidelines To Artificially Limit Access to Harvoni Treatment?

No, the laws and regulations which govern legal actions brought under the Employee Retirement Income Security Act (“ERISA”) DO NOT allow carriers to adopt any internal clinical guidelines they choose and then rely upon those guidelines with impunity. Rather, insurance carriers may rely only upon those guidelines that reasonably interpret the insurance plan which governs your health insurance coverage.

At Kantor & Kantor, LLP, we believe it is a SOCIETAL IMPERATIVE that all individuals with Hepatitis C are adequately treated with the treatments they are prescribed by their treating professionals. If your claim for Harvoni treatment has been denied, our firm may be able to help and get you on track to get the treatment you need.

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