BILL ANALYSIS
AB 830
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CONCURRENCE IN SENATE AMENDMENTS
AB 830 (Cook)
As Amended August 25, 2009
Majority vote
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|ASSEMBLY: |77-0 |(May 21, 2009) |SENATE: |36-0 |(August 31, |
| | | | | |2009) |
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Original Committee Reference: HEALTH
SUMMARY : Revises various provisions in existing law requiring
health plan coverage of "off label" medication used to treat
life-threatening or chronic and seriously debilitating
conditions, and Medi-Cal coverage of drugs to treat
AIDS-associated opportunistic infections and cancer to delete
references to specific drug guides, or compendia, and include,
instead, specified drug compendia approved by the federal
Centers for Medicare and Medicaid Services (CMS).
The Senate amendments :
1)Narrow the scope of the bill to apply to statutory references
in existing law governing mandated "off-label" coverage of
medication by health care service plans, health insurers, and
Medi-Cal.
2)Clarify the provisions of this bill that include peer reviewed
medical literature in the definition of compendia.
3)Specify that only federally-authorized compendia approved for
Medicaid programs may be used by Medi-Cal in order to mitigate
any potential unmatched General Fund expenditures for
off-label drug use.
4)Make other technical and clarifying changes.
EXISTING LAW :
1)Provides for the regulation of health plans by the Department
of Managed Health Care (DMHC) and health insurers by the
California Department of Insurance (CDI).
AB 830
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2)Prohibits health plans and health insurance policies that
cover prescription drug benefits from limiting or excluding
coverage for a drug that is prescribed for an off-label use,
provided that specified conditions are met, including that the
drug has been recognized for treatment of that condition by
either the American Medical Association-Drug Evaluations
(AMA-DE), the American Hospital Formulary Service-Drug
Information (AHFS-DI), and the U.S. Pharmacopoeia, or any
other similar drug compendium, as determined annually by the
Department of Health Care Services (DHCS).
3)Establishes the independent medical review (IMR) process
within DMHC and CDI to review appeals of enrollees or
insureds, respectively, involving a disputed health care
service that has been denied or modified by a health plan or
health insurer based on medical necessity of a treatment, an
experimental or investigational therapy for certain medical
conditions, or a claims denial for emergency or urgent medical
services.
4)Requires the IMR process to meet specified criteria including
a determination based on relevant medical and scientific
evidence from specified sources including AMA-DE, AHFS-DI, and
U.S. Pharmacopoeia, or any other similar drug compendium, as
determined annually by DHCS.
5)Requires coverage, as a Medi-Cal covered benefit, for any drug
or biologic used to treat opportunistic infections associated
with AIDS that has been found to be a medically accepted
indication that has either been approved by the federal Food
and Drug Administration (FDA) or recognized for use by the
AMA-DE or the U.S. Pharmacopoeia.
6)Requires coverage, as a Medi-Cal covered benefit, for any drug
or biologic used in an anti-cancer chemotherapeutic regimen
for a medically accepted indication which has been approved by
the FDA, or recognized for that use in the AMA-DE or the U.S.
Pharmacopoeia.
7)Establishes the Medi-Cal program, administered by DHCS, which
provides health benefits to low-income children, their
parents, or caretaker relatives, pregnant women, elderly,
blind or disabled persons, and other individuals who meet
specified eligibility criteria.
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AS PASSED BY THE ASSEMBLY , this bill was substantially similar
to the version approved by the Senate.
FISCAL EFFECT : According to the Senate Appropriations
Committee, minor and absorbable costs.
COMMENTS : The Senate version differs from the Assembly-approved
version in that the Senate amendments limit the additional
compendia being added to state law by this bill to those
recognized by CMS for use in an anti-cancer therapeutic regimen,
ensure that the compendia included in the Medi-Cal related
provisions of this bill are consistent with those referenced in
federal Medicaid law, and make additional changes to clarify the
intent of this bill.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097
FN: 0002492