Brief⁽¹⁾

S.B. 108, as amended by House Committee, enacts new laws related to coverage of certain "off label" drugs. The term "off label" is prescribing prescription drugs for treatments other than those stated in the labeling approved by the federal Food and Drug Administration.

The bill would prohibit insurance companies and health maintenance organizations that provide coverage for prescription drugs from excluding coverage of a prescription drug for cancer treatment on the grounds the prescription drug has not been approved by the Food and Drug Administration for that covered indication. The drug being prescribed for off-label use must be recognized for treatment of the covered indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature. If requested by the insurer, the prescribing provider must submit documentation supporting the off-label use.

The bill does not change existing law limiting coverage of drugs that have not been approved by the Food and Drug Administration; does not require coverage for any prescription drug when the Food and Drug Administration has determined its use is contraindicated; and does not require coverage for experimental drugs not otherwise approved for any indication. A House Committee amendment adds nothing in the new laws is to be construed to limit, restrict, or prohibit the prescribing and coverage of off-label drugs for any condition other than cancer.

Background

S.B. 108 was requested by the Health Care Reform Legislative Oversight Committee that reviewed the subject of off-label use of drugs in the 1998 interim. The bill was supported by the American Cancer Society, the Kansas Pharmacists Association, the Association of Kansas Hospices, the Kansas Public Health Association, and the Kansas Medical Society.

Representatives of the Kansas Association of Health Plans, the Kansas Chamber of Commerce and Industry, and the Kansas Employer Coalition on Health opposed the bill.

The House Committee amendments delete the definition of prescription drug added to the bill in the Senate.

1. *Supplemental notes are prepared by the Legislative Research Department and do not express legislative intent. The supplemental note and fiscal note for this bill may be accessed on the Internet at http://www.ink.org/public/legislative/bill_search.html.