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For Immediate Release: October 5, 2010
Association of Community Cancer Centers Launches Part B—Drug Information Guide
An indispensable online and print resource for the oncology team
ROCKVILLE, Md.—The Association of Community Cancer Centers (ACCC) has launched its Part B - Drug Information Guide to help oncologists and pharmacists, as well as oncology support and administrative staff, navigate the increasingly complex area of drug information and coverage. ACCC's Part B - Drug Information Guide is a compilation of oncology drugs from the nationally recognized drug compendia, as well as the conditions that the compendia list for these drugs.
"ACCC's Part B - Drug Information Guide is designed as an easy-to-use listing—both in print and online," said ACCC President Al B. Benson III, MD, FACP. "It is the first step in determining whether there is evidence on the appropriateness of use of an oncology drug for a specific oncology-related condition."
The following information is included within the Part B - Drug Information Guide:
- Generic and brand name of oncology-related drugs: Any drug with a J-code in the oncology range of J8500-J9600. These are the drugs that are covered under Part B of the Medicare Program.
- Newly approved drugs that may not yet have had a code assigned to them (i.e., drugs approved by FDA for an oncology indication after July 1, 2008)
- Drugs that have been approved by the FDA for oncology use that have a designated J-code outside J8500 to J9600 (Drugs labeled for supportive care or only as adjuncts to therapeutic regimens are not included.)
- Condition, with the associated ICD-9 diagnosis code
- Manufacturer and contact information for the manufacturer
- Medicare Administrative Contractor (MACs) and contractor requirements for claims.
ACCC's Part B - Drug Information Guide is available online at www.accc-cancer.org/druginfo. Listings will be updated online on the first day of each month. The publication is printed annually.
"ACCC's Part B - Drug Information Guide requires users to actively participate in the coverage process," said Dr. Benson, "and is not a stand-alone document. It is the first step in determining whether there is evidence on the appropriateness of use of an oncology drug for a specific oncology-related indication."
Where such evidence exists users must obtain more information by 1) reading through the relevant sections of each compendium themselves or 2) contacting the manufacturer(s) and asking for evidence of appropriateness. This evidence may then be submitted to carriers to support coverage.
A listing of an indication for a drug or biologic in the Part B - Drug Information Guide means that at least one of the four nationally recognized drug compendia lists that indication in its reviews of that drug or biologic. The four CMS-recognized compendia as of September 2010 include: The American Hospital Formulary Service Drug Information® (AHFS-DI®); Thomson Reuters DrugDex®; the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™; and Gold Standard/Elsevier’s Clinical Pharmacology. A compendium is a comprehensive listing of FDA-approved drugs and biologics. Compendia may include a summary of how each drug works in the body, as well as information for healthcare practitioners about proper dosing and whether the drug is recommended or accepted for use in treating a specific disease.
In the majority of cases, a listing within the Part B - Drug Information Guide means that the listing compendium concludes that the use of a drug for the indication is supported by evidence and is appropriate. However, this is not always the case. In some instances the listing compendium is ambivalent or may even explicitly reject use of the listed drug for a specific indication.
Off-label drug use refers to indications outside of the U.S. Food and Drug Administration (FDA) label. The policy that Medicare consider coverage of an off-label use of a cancer drug if it is in the CMS-recognized drug compendia, or is supported by peer-reviewed articles in certain journals outlined by Medicare, became law with the passage of the Rockefeller-Levin Bill. Named after its sponsors, Senator Jay Rockefeller (D-WV) and Representative Sander Levin (D-MI), the bill passed as part of the Omnibus Reconciliation Act of 1993 (OBRA 93).
ACCC's Part B - Drug Information Guide has been designed to replace ACCC's Compendia-based Drug Bulletin.