BILL ANALYSIS
AB 830
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Date of Hearing: May 13, 2009
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Kevin De Leon, Chair
AB 830 (Cook) - As Amended: April 23, 2009
Policy Committee: Health Vote:19-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill deletes current law references to specific drug guides
and replaces them with a compendium to be approved by the
federal Centers for Medicare and Medicaid (CMS).
FISCAL EFFECT
No direct fiscal impact for providers and payers to continue to
provide treatment and reimbursement for off-label uses of
medications, especially medications used in oncology.
COMMENTS
1)Rationale . This bill is co-sponsored by the Association of
Northern California Oncologists (ANCO) and the Medical
Oncology Association of Southern California (MOASC) to conform
California code references to changes made by CMS with regard
to medically accepted indications for off-label use of various
medications. Off-label use refers to clinically indicated uses
that are not specifically approved by Federal Drug
Administration (FDA). The author and sponsors indicate the
current specificity in state law requires periodic statutory
updating. This bill reduces the need for future updates.
2)Background . Various compendia, such as the American Medical
Association Drug Evaluations or the United States
Pharmacopoeia-Drug Information, play a role in medical care
when alternative uses for drugs help patients and providers
access the newest, most effective drugs when evidence becomes
available to support specific off-label indications. Oncology
in particular, practiced by the sponsors of this bill, relies
heavily on off-label uses for drugs.
AB 830
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For example, Avastin is a drug that was initially approved by
the FDA for the treatment of colon cancer. Subsequently, the
FDA approved this medication for the off-label treatment of
breast and lung cancer. If an off-label drug is listed in one
of the reference guides recognized by CMS, various payers,
including Medi-Cal, Medicare, and health plans and insurers
are required to pay for it as a treatment. Additional examples
of off-label use include Carmustine, which was initially
approved for brain tumor treatment and subsequently approved
for skin lymphomas and Aletramine, initially approved for
ovarian cancer treatment and subsequently used to treat lung
cancer.
Analysis Prepared by : Mary Ader / APPR. / (916) 319-2081