The American Society of Clinical Oncology (ASCO) is urging the Department of Health and Human Services (DHHS) to require that Medicare and other insurers consider articles in peer-reviewed journals when determining coverage of medications for off-label uses. In a statement published in a recent issue of the Journal of Clinical Oncology, ASCO notes that cancer patients experience problems with access to off-label therapies that represent the standard of care because insurers refuse to cover them. “Medicare contractors are routinely ignoring significant reports of clinical benefit from off-label uses of cancer drugs reported in peer-reviewed journals,” the ASCO statement asserted. Such coverage denials occur with Medicare, Medicaid, managed care, and other private health insurers, ASCO said.
The law requires Medicare and Medicaid to cover off-label uses supported by approved drug compendia. Most states also require such reimbursement. ASCO cited a few problems with the current system, and offered solutions.
- State law does not apply to health insurance self-funded by employers as such plans are protected by the Employee Retirement Income Security Act (ERISA). ASCO urged federal legislation to remove this exemption and make all private plans subject to the same requirement as Medicare.
- “Concerns have been expressed” about the speed with which approved drug compendia update based upon new evidence. ASCO urged DHHS to augment the list of qualified compendia if the currently approved one do not update quickly enough. The Center for Medicare & Medicaid Services (CMS) has received requests to increase the number of approved compendia, and the Medicare Coverage Advisory Committee (MCAC) recommended characteristics of any new compendia added in April.
- ASCO also suggested that DHHS identify peer-reviewed journals for carriers to use in determining coverage, as allowed by statute. It asked that DHHS work with the cancer community to develop the list of approved journals. ASCO urged that DHHS use its authority to require contractors to consider peer-reviewed literature as well as compendia, and to consider high-quality Phase II trials as sufficient evidence to justify reimbursement.

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