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Commentary: NCCN Guidelines™ and Impact on Coverage Policy

By William T. McGivney, PhD, CEO

NCCN has had, from its inception, the guiding objective of “positively influencing and improving decisions that influence and impact the access to, availability of, utilization of, and delivery of appropriate cancer care on behalf of patients”. For NCCN, this has not been some idle axiom. NCCN has sought to actively develop and communicate the guidelines information in formats most useful to end-user groups. It is critical that provider scientific/clinical organizations do so in order to assert what are indeed the most appropriate and effective interventions for patients with cancer.

Coverage Policy:
The most striking application of the NCCN scientific, evaluative, and evidence-based information is the story of the NCCN Drugs & Biologics Compendium (NCCN Compendium™). In late 2004, NCCN decided to transpose and translate the recommendations about the use of drugs and biologics in the NCCN Guidelines into a compendium format. Compendia are listings of appropriate uses of drugs and biologics. Indeed, in the late 1980s and early 1990s, laws were passed in 32 states that mandated the use of three compendia (AMA Drug Evaluations, USP-DI, AHFS Formulary) by private payors in coverage decisions about the use of drugs. These laws were precipitated by an insurance practice of denying uses of drugs that were not explicitly approved by the FDA as demarcated on the U.S. Food and Drug Administration (FDA) labels for such drugs. In oncology, this was a major issue as, at the time, upwards of 50 percent of the use of drugs was beyond the scope of the FDA label. Indeed, for patients with serious and life-threatening diagnoses of cancer, denial of a drug with evidence supporting its use was a major concern and serious threat to that patient’s viability. If a compendium indicated a use was appropriate or was listed, the private payor had to cover that use of that drug. In 1993, the Congressional Omnibus Budget Reconciliation Act included a provision that mandated that the Medicare program do the same. In 1994, this legislative provision was incorporated into regulation and followed by guidance to intermediaries and carriers that required the compendia to be the basis for coverage determinations.

In January of 2008, UnitedHealthcare (UHC), the largest private payor in the United States, announced that UHC would be the first private payor to base coverage determinations about the use of drugs and biologics in cancer care on the NCCN Compendium™. This announcement has been followed by communications from most other large private payors that they would also use the NCCN Compendium as the basis for coverage policy and determinations. On June 5, 2008, the Centers for Medicare & Medicaid Services (CMS) announced that the NCCN Compendium would become a mandated resource to be used by Medicare contractors for the establishment of coverage policy. The importance of these announcements is that in a matter of 10 years, NCCN has been able to flip the “decision-making system” so that an organization of major cancer centers and their physician thought leaders, after review of scientific evidence, put forth recommendations about what constitutes appropriate care for patients and these recommendations are being followed and adhered to by public and private payors.

In summary, NCCN has successfully adapted the content of the NCCN Guidelines into formats, like the NCCN Compendium, that inform and facilitate decision-making about appropriate interventions in oncology. These different decision formats or tools serve to assure that innovative technologies are available for use appropriately in patients based upon positive coverage determinations by public and private payors.   

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