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SCLD Update |
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| Other Topics in this Issue: Breast Cancer
Detection |
State-of-the-Art
Treatment Two states—Kentucky and Maine—enacted laws prohibiting specified insurers, including HMOs, from excluding coverage for any off-label use of a drug prescribed for the treatment of cancer on the grounds that the drug has not been approved by the Federal Food and Drug Administration (FDA) for that indication. In both states, coverage must include medically necessary services associated with the administration of the drug; however, neither state's law requires coverage for drugs not otherwise approved for any indication by the FDA. In Kentucky, H.B. 618 requires that the drug be: (1) prescribed for an individual diagnosed with cancer, and (2) recognized as safe and effective for the indication in the Official Compendium or specified medical literature; however, coverage is not required for experimental drugs that are not approved for any indication. Also, coverage is not required by HMOs when the drug is: (1) dispensed by a provider without a contract with the HMO, or (2) not included in the HMO's drug formulary. Maine's law (LD. 2068) requires that the off-label use of the drug must be recognized as safe and effective in at least one of the specified compendia or two articles from major peer-reviewed medical literature. Specified insurers and HMOs are permitted to apply deductibles, maximum benefit limits, and other coinsurance provisions to the same extent that such provisions are applicable to coverage of all prescription drugs. Clinical Trials A Georgia law (S.B. 603) requires specified individual and group insurers, including HMOs and any state health plan, that provide medical coverage for dependent children, to provide coverage for routine patient care costs incurred in connection with approved clinical trial programs for the treatment of children's cancer. Coverage must be provided for dependent children who: (1) have been diagnosed with cancer prior to their nineteenth birthday; (2) are enrolled in an approved clinical trial program for the treatment of children's cancer; and (3) are not eligible for benefits, payments, or reimbursement from other payors. "Approved clinical trial program for treatment of children's cancer" means: (1) a Phase II and III prescription drug clinical trial program in the state, as approved by the FDA or the National Cancer Institute (NCI), for the treatment of cancer that generally manifests itself in children under the age of 19; and (2) a program that tests, seeks to discover, or introduces new therapies or regimens for the treatment of cancer in children. Maryland enacted two laws (H.B. 45 and S.B. 137) that require specified individual and group insurers, including HMOs, to provide coverage for the cost of a medically necessary health care service that clinical trial participants have incurred as a result of prevention, early detection, and treatment studies on cancer. The laws are effective January 1, 1999. Policies, contracts, or health benefit plans in effect prior to the effective date must comply by January 1, 2000. Coverage is required if: (1) the treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer; (2) the treatment is being provided in a clinical trial approved by, among others, the NCI Clinical Cooperative Group or the NCI Community Clinical Oncology Program; (3) the facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise; (4) there is no clearly superior, noninvestigational treatment alternative; and (5) the available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative. The Insurance Commissioner is required to create a Workgroup on Insurance Coverage for Patient Care Cost in Clinical Trials to assess the costs and benefits of the subject insurance coverage. |
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