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Attorney General's News Release

April 7, 2009

Attorney General Chris Koster Supports Restricting Off-Label Treatment

Jefferson City, Mo. - Attorney General Chris Koster joined with 16 other state Attorneys General in supporting a proposed federal rule to prevent insurance companies from requiring patients to use drugs "off-label."

Off-label treatment occurs when a health plan mandates that patients first try drugs that are not approved by the FDA for the specified diagnosis, before the plan will cover the doctor-prescribed medications. Health care plans do not fall under the strict laws that regulate marketing of drugs for off-label uses.

The Centers for Medicare and Medicaid Services (CMS) has proposed a rule to stop insurance companies from requiring a patient to first try a drug off-label before it will provide Medicare Part D coverage. The letter from Attorney General Koster and other state Attorneys General to CMS stated that the practice of mandating off-label treatments was "dangerous and should not be permitted."

"Increasingly, I hear from patients who have been denied their medications by third party payors more concerned with profits than patient safety," said Koster. "Patients deserve the care their doctors order, instead of having the insurance company mandate use of a non-FDA approved drug for treatment."

Koster also expressed concern about commercial insurance practices in Missouri that required forced off-label therapy before granting access to doctor-prescribed medications.

"One proposal pending in the Missouri legislature merits the attention of the General Assembly," Koster said. "House Bill 458, sponsored by Representative Bryan Stevenson and put forward by Republican and Democratic leaders, is a serious bi-partisan effort to address transparency in medical care." HB 458 regulates pharmacy benefit managers and requires notice to patients and doctors if any insurer switches prescriptions or treatment.

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