BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 830|
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THIRD READING
Bill No: AB 830
Author: Cook (R)
Amended: 8/25/09 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 10-0, 7/15/09
AYES: Alquist, Strickland, Aanestad, Cedillo, Cox,
DeSaulnier, Leno, Negrete McLeod, Pavley, Wolk
NO VOTE RECORDED: Maldonado
SENATE APPROPRIATIONS COMMITTEE : 8-0, 8/24/09
AYES: Kehoe, Cox, Corbett, Denham, Price, Runner, Walters,
Wolk
NO VOTE RECORDED: Hancock, Leno, Oropeza, Wyland, Yee
ASSEMBLY FLOOR : 77-0, 5/21/09 - See last page for vote
SUBJECT : Drugs and devices
SOURCE : Association of Northern California Oncologist
Medical Oncology Association of Southern
California
DIGEST : This bill deletes current statutory references
to specific drug compendia and replaces them with drug
compendia approved by the federal Centers for Medicare and
Medicaid Services for mandated "off-label" coverage of
medication by health care service plans, health insurers,
and Medi-Cal.
CONTINUED
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ANALYSIS : Existing state law references various drug
compendia for purposes of the coverage of off-label drug
use b health care service plans, health insurers, and
Medi-Cal. Off-label drug use refers to the use of drugs to
treat conditions that are not specifically approved by the
federal Food and Drug Administration (FDA) for that
purpose. If an off-label drug is listed in a compendium
recognized by the Centers for Medicare and Medicaid
Services (CMS), Medi-Cal, Medicare, and health plans and
insurers are required to pay for it as a treatment, as
specified. Drugs are prescribed "off-label" to treat
life-threatening or chronic conditions such as cancer, HIV,
and AIDS.
This bill deletes references to the American medical
Association Drug Evaluations, which is no longer in
publication, and the United States Pharmacopoeia Dispensing
Information, which was purchased by Thomson Micromedex
DrugDex.
This bill inserts references to the following compendia, as
approved by CMS:
1.The American Hospital Formulary Service Drug Information,
where not already referenced.
2.The Elselvier Gold Standard's Clinical Pharmacology.
3 The National Comprehensive Cancer Network Drug and
Biologics Compendium.
4.The Thomson Micromedex DrugDex.
Background on Compendia
According to the federal CMS, a compendium is a listing of
FDA-approved drugs and biologics. A compendium includes a
summary of the pharmacologic characteristics of each drug
or biological, and may include information on dosage as
well as recommended or endorsed uses in specific diseases.
This bill deletes in state law statutory references to the
AMA Drug Evaluation and U.S. Pharmacopoeia. The federal
government indicates the AMA Drug Evaluation is no longer
in publication, and U.S. Pharmacopoeia has been purchased
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by Thomson Micromedex.
A recent change in federal law allows the Secretary of the
federal Department of Health and Human Services to revise
the statutory list of compendia as appropriate for
identifying medical accepted indications for drugs used in
an anti-cancer chemotherapeutic regimen to Medicare.
Federal regulations establish a process for listing
compendia for determining medically accepted uses of drugs
to anti-cancer treatment, including a formal written
request for changes to the list of compendia, publishing
the list of the requests and soliciting public comment,
considering the compendium's attainment of the Medicare
coverage advisory committee's (MedCAC) recommended
desirable characteristics of compendia, and considering the
compendium's grading of evidence. MedCAC identified the
following desirable characteristics in compendia:
1.Extensive breadth of listings.
2.Quick processing from application for inclusion to
listing.
3.Detailed description of the evidence reviewed for every
individual listing.
4.Use of pre-specified published criteria for weighing
evidence.
5.Use of prescribed published process for making
recommendations.
6.Publicly transparent process for evaluating therapies.
7.Explicit "Not recommended" listing when validated
evidence is appropriate.
8.Explicit listing and recommendations regarding
therapies, including sequential use or combinations in
relation to other therapies.
9.Explicit "Equivocal" listing when validated evidence is
equivocal.
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10.Process for public identification and notification of
potential conflicts of interest of the compendia's
parent and sibling organizations, reviewers and
committee members, with and established procedure to
manage recognized conflicts.
The federal government recognizes different compendia for
Medicaid (Medi-Cal in California) and Medicare, and
different compendia within Medicare for anti-cancer
medication. For Medicare Part D (prescription drug
coverage), CMS indicates it recognizes two compendia for
non-cancer drugs: AHFSDI and Thomson Micromedex DrugDex.
For cancer drugs in Medicare Part B (physician services)
and Part D, CMS recognizes the four compendia referenced in
this bill: AHFSDI, Elsevier Gold Standard's Clinical
Pharmacology, NCCN Drug and Biologics Compendium, and
Thomson Micromedex DrugDex. CMS declined a request to add
Thomson Micromedex DrugPoints to the list of compendia,
stating it failed to satisfactorily address several of the
desirable characteristics recommended by the MedCAC and
referenced in federal regulation, including that it did not
explicitly note when the use of a drug or biologic is not
recommended, nor did it explicitly note an "Equivocal"
listing when validated evidence is equivocal.
The compendia not specifically listed in federal law were
recognized by Medicare for anti-cancer drug coverage
following CMS review. Effective January 1, 2010, no
compendia can be included on the list for anti-cancer
medication unless the compendia has a publicly transparent
process for evaluating therapies and for identifying
potential conflicts of interest.
Federal Medicaid law requires a drug use review program.
The program is required to assess data on drug use against
pre-determined standards, consistent with peer-reviewed
medical literature and three statutorily listed compendia:
AHFSDI, U.S. Pharmacopoeia (or its successor publications)
and the DrugDex Information System. CMS indicates federal
law does not give it the authority to add or delete
compendia.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
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Local: No
SUPPORT : (Verified 8/25/09)
Association of Northern California Oncologist (co-source)
Medical Oncology Association of Southern California
(co-source)
California Medical Association
ARGUMENTS IN SUPPORT : The Medical Oncology Association
of Southern California (MOASC) and the Association of
Northern California Oncologists (ANCO) jointly sponsor this
bill, arguing this bill updates California codes in regards
to off-label compendia approved by CMS. MOASC writes that
off label drugs approved for treating certain cancers are
listed in CMS-approved compendia, and that the State of
California recognizes the approved compendia by adding them
to the codes. MOASC states that the problem is that each
individual compendium is listed by name in the California
codes, and when CMS approves a new compendium, legislation
needs to be introduced in California to put the new name of
the compendium in the codes. MOASC writes that medical
oncologists risk non-reimbursement from payers for the
off-label drug during the timer period when state law does
not contain current compendia because the codes have yet to
be updated. MOASC writes this bill makes the codes more
efficient by keeping them current with CMS action.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Anderson, Arambula, Beall, Bill
Berryhill, Tom Berryhill, Blakeslee, Block, Blumenfield,
Brownley, Buchanan, Caballero, Charles Calderon, Carter,
Chesbro, Conway, Cook, Coto, Davis, De La Torre, De Leon,
DeVore, Duvall, Emmerson, Eng, Evans, Feuer, Fletcher,
Fong, Fuller, Furutani, Gaines, Galgiani, Garrick,
Gilmore, Hagman, Hall, Harkey, Hayashi, Hernandez, Hill,
Huber, Huffman, Jeffries, Jones, Knight, Krekorian, Lieu,
Logue, Bonnie Lowenthal, Ma, Mendoza, Miller, Monning,
Nestande, Niello, Nielsen, John A. Perez, V. Manuel
Perez, Portantino, Price, Ruskin, Salas, Silva, Skinner,
Smyth, Solorio, Audra Strickland, Swanson, Torlakson,
Torres, Torrico, Tran, Villines, Yamada, Bass
NO VOTE RECORDED: Fuentes, Nava, Saldana
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RJG:cm 8/25/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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