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ASCO recently revised its policy on insurance coverage for off-label uses of oncology products. The issue of access to medically appropriate off-label use of cancer drugs and biologics has been a focus of ASCO advocacy for decades, and ASCO's efforts have demonstrably improved patient access to off-label drug uses.
Because of sponsorship by ASCO and other cancer advocates, federal payment programs like Medicare and Medicaid offer specific legislative support for reimbursement of medically appropriate off-label uses. Medicare Part B and Part D as well as Medicaid reimburse off-label uses that are listed in selected drug compendia, and Medicare Part B also provides reimbursement for off-label uses that are supported by peer-reviewed medical literature.
Since the passage of off-label provisions governing Medicare Part B, as part of the Omnibus Budget Reconciliation Act of 1993 (OBRA 93), 39 state legislatures have followed with similar legislation. State statutes generally require coverage on the basis of compendia listings, although some also require coverage based on articles in peer-reviewed journals. These state laws have limited impact because they do not apply to self-insured health plans, which instead are regulated according to the federal Employee Retirement Income Security Act, or ERISA.
While legislation and policy positions have served oncology interests well with respect to off-label coverage, introduction of new drugs (sometimes at breathtakingly high prices) and other developments in reimbursement policy continue to raise questions about payment for these uses. Because of this, ASCO leadership decided to revisit and update its policy on coverage of off-label uses of oncology products. The updated policy was published in the Journal of Clinical Oncology, July 1, 2006.1
ASCO anticipates that its members and others in the cancer community will utilize the updated policy statement as an advocacy tool when responding to questions from third-party payers about the appropriateness of off-label coverage. Advocacy efforts may be critical in persuading private insurers to follow the example of Medicare and Medicaid and in ensuring Medicare payment for off-label uses that are supported by peer-reviewed medical literature. Although private insurers often follow the payment policies of public payers, they may resist providing reimbursement for off-label uses. This resistance may be overcome through advocacy by oncologists and patient advocates. Because Medicare contractors have discretion in decisions on coverage of uses supported by the medical literature, the efforts of ASCO members, patients and families, and their allies may be crucial to convincing Medicare contractors to exercise their discretion in favor of coverage.
Providers or patients having difficulty in securing coverage for legitimate off-label uses of oncology products should consider approaching local medical societies or patient advocate groups as allies in pressing the adoption of the principles reflected in the updated policy.
Local oncologists and state societies have had mixed success in advocating for appropriate off-label coverage with Medicare carriers, state Medicaid agencies, and private payers. Here we relay the stories of two oncologists involved with the issue, both of whom emphasize the need to build relationships with institutional decision makers.
John A. Keech Jr, DO, says that in California, the oncology community has developed a solid working relationship with the state's Medicare carrier (National Heritage Insurance Company [NHIC]). In addition, similar relationships govern discussions of off-label issues with the commercial carriers in California, but communication with the California Medicaid program is not as positive.positive.
“For 3 or 4 years, we held regular meetings between our physician representatives, the society executive directors, and the NHIC medical director,” says Keech, “He saw that we reliably practiced high-level, evidence-based care. He became increasingly comfortable with [the state's two oncology professional societies'] recommendations for off-label use.”
As a result, NHIC ceased to require “repayment edits” or pretreatment decisions about the appropriateness of off-label prescriptions. NHIC reserved the right to review records post-treatment and to request repayment with interest if the use was not proven valid, but Keech reports that such a request never occurred. “The value of face-to-face meetings cannot be overemphasized,” says Keech.
With the California Medicaid agency, off-label use has been highly problematic, and the agency lags badly in reimbursing oncologists for FDA-approved drugs used to treat Medicaid patients. As a result, the state societies are pursuing a legislative solution to ensure that the California Medicaid program provides appropriate payments for newly approved drugs and coverage of off-label drugs.
According to Keech, commercial carriers in California generally rely on the compendia or on two peer-reviewed articles to uphold off-label usage. When practitioners have requested exceptions, there have been one-on-one conversations between that physician and the oncologist for the carrier, with mixed results.
Thomas A. Marsland, MD, who practices in Orange Park, Florida, also describes the productive process created by years of meetings between representatives of both the state society and the Medicare carrier on the issue of off-label use.use.
Although the Medicare statute requires coverage of drugs listed in the compendia, the carrier had adopted a process that required development of a written policy on each drug, including a comment period. This process led to long delays in coverage. Marsland reports that the state society convinced the carrier to put in place a process for automatic coverage of any drug listed in a compendium. This process for automatic coverage based on compendium listings circumvented those delays.
The Florida oncology community has formed an off-label committee of community and academic oncologists that has phone meetings approximately four times a year to address off-label issues not covered by the compendia. These are mostly for rare cancers. “We present the literature we find that supports a drug's usage to the carrier. In most circumstances, the carrier has been responsive. Rarely have they said the data aren't strong enough.”
Marsland would like to see some mechanism put in place whereby compelling abstracts presented at major cancer meetings could serve to justify off-label usage. He stated, “As an oncology community, we need to push for these abstracts being accepted without the definitive article having been published as well.”
In its revised policy, ASCO has called on the Secretary of Health and Human Services to ensure that all qualified compendia are recognized by the Medicare program and to increase the number of peer-reviewed journals on the list of those that carriers may rely upon in making coverage decisions. ASCO has subsequently recommended the addition of the National Comprehensive Cancer Network compendium to the list of qualified compendia and requested that eight additional peer-reviewed journals be recognized.