Medicare Changing Reference Book for Approving
Anti-Cancer Chemotherapy Drugs
National Comprehensive Cancer Network Drugs &
Biologics Compendium is new source
June
5, 2008 – Senior citizen Medicare patients and their cancer care
providers will no longer use the American Medical Association Drug
Evaluations (AMA-DE) book to determine which drugs are covered under
Medicare Part B to treat patients undergoing chemotherapy. The Centers
for Medicare & Medicaid Services says it is no longer being updated and
the agency is switching to a new source to ensure the most
up-to-date information.
CMS will now recognize the National Comprehensive
Cancer Network (NCCN) Drugs & Biologics Compendium as an additional
source of information.
Medicare law directs CMS to consider certain listed
compendia when deciding whether or not the use of a drug is medically
accepted for the treatment of cancer. The law also allows the agency to
revise the list.
Both of these revisions will be reflected in CMS’
Medicare Benefit Policy Manual.
"We use these compendia to ensure that that
Medicare beneficiaries can be assured that the Medicare contractors and
their physicians have the most up-to-date drug information and the best
available treatment options,” said CMS Acting Administrator Kerry Weems.
“This is important because today's ever-expanding
industry of drug treatments is dynamic, requiring the constant
monitoring and assessment of new interventions.”
A compendium is a comprehensive listing of
FDA-approved drugs and biologics. In some cases, compendia specialize
in a particular subset of drugs, such as those used for anti-cancer
treatment.
Compendia include a summary of how each drug works
in the body, as well as information for health care practitioners about
proper dosing and whether the drug is recommended or endorsed for use in
treating a specific disease.
The Medicare local contractors, who process and pay
Medicare claims and approve coverage for drugs under Medicare Part B,
use compendia as one of several tools to determine whether an
anti-cancer drug should be covered under Medicare Part B.
Before approving coverage for a drug, contractors
look at whether the drug is FDA approved for use in treating the
beneficiary’s type of cancer in the beneficiary’s specific clinical
circumstances. In some instances, however, the medical community may
have scientific evidence that supports using a drug to treat a disease
even if the drug’s FDA approved label does not include those clinical
conditions.
In these instances, certain drug compendia may
recommend uses beyond those included in the FDA approved labels.
Over the years, some compendia have merged with
other publications or have discontinued updating their entries. In
particular, one of the compendia listed in the law, the AMA-DE
Compendium, has not been published since 1995.
To ensure that contractors continue to have access
to up-to-date drug compendia to make coverage decisions for anti-cancer
drugs, CMS created a process to change its compendia reference list.
This process included the recommendations from CMS’
Medicare Evidence Development & Coverage Advisory Committee, which
advised CMS on the factors the Agency should consider when updating the
list of compendia. The process also includes a 30-day public comment
period.
Today’s decision to recognize the NCCN Drugs &
Biologics Compendium and discontinue use of the AMA-DE Compendium is
CMS’ first step in updating its compendia reference listing.