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Why Might Insurers Deny Patients Harvoni Coverage

Insurance denials can be frustrating for patients and physicians alike.  For patients suffering from Hepatitis C, a coverage denial for Harvoni can be the difference between a complete cure and additional years of suffering.

Following FDA approval of Gilead Science’s breakthrough Hepatitis C treatment, Harvoni, in October 2014, insurances companies and state Medicaid received many claims from patients eager to take the drug. But, the drug is expensive, costing roughly $63,000 to nearly $100,000 per person.  So, approving Harvoni for all those who suffer from Hepatitis C would likely cost insurers millions.

Denials Come in Several Forms

Some insurers enacted stringent “pre-authorization” guidelines setting thresholds of medical necessity to determine who would be approved for the drug.  Some of the common restrictions include:

– That patients demonstrate proof of cirrhosis of the liver, or in some cases, advanced cirrhosis versus merely having cirrhosis.

– That patients demonstrate that receiving treatment is “medically necessary,” with simple confirmation of Hepatitis C infection or liver damage not serving as cause enough to warrant coverage.

– That patients pass a urine test to rule out current use of drugs or alcohol; failure to pass results in coverage denial.

– That only prescriptions written by a limited pool of doctors, such as liver specialists, will be accepted and covered, delaying access for those patients who are unable to afford or get an appointment with the few, in-demand practitioners in each state who meet the criteria.

Depending on the circumstances, these coverage denials may be unlawful and may subject private insurers to lawsuits.  These lawsuits may include claims of breach of contract, intentional infliction of emotion distress, insurance bad faith, breach of fiduciary duty, or other common law torts.