BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 2268
A
AUTHOR: Chesbro
B
AMENDED: April 20, 2010
HEARING DATE: June 9, 2010
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CONSULTANT:
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Dunstan/
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SUBJECT
Alcohol and drug abuse
SUMMARY
Authorizes physicians and surgeons in California who are
registered with the U.S. Attorney General, pursuant to
specified federal law, to provide addiction treatments that
are allowed under federal law.
CHANGES TO EXISTING LAW
Existing law:
Establishes the Department of Alcohol and Drug Program
(DADP) to license treatment facilities that provide a broad
range of services in a supportive environment to adults who
are addicted to alcohol or drugs.
Requires DADP to license and inspect narcotic treatment
programs (NTPs), which use replacement narcotic therapy in
the treatment of addicted persons whose addiction was
acquired or supported by the use of a narcotic drug or
drugs not in compliance with a physician and surgeon's
legal prescription.
Authorizes the following controlled substances for use in
Continued---
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replacement narcotic therapy by licensed NTPs: methadone,
levo-alphacetylmethadol (LAAM), buprenorphine products or
combination products approved by the federal Food and Drug
Administration (FDA) for maintenance or detoxification of
opioid dependence and any other federally approved
controlled substances used for the purpose of replacement
narcotic therapy.
Requires DADP to establish a program for the operation and
regulation of office-based opiate treatment (OBOT) programs
that are required to hold a primary NTP license or be
affiliated and associated with a primary licensed NTP.
Defines an OBOT program as a program in which interested
and knowledgeable physicians provide addiction treatment
services, and in which community pharmacies supply
necessary medication both to these physicians for
distribution to patients and through direct administration
and dispensing services.
Allows physicians in the office-based narcotic treatment
program to dispense or administer pharmacologic treatment
for narcotic addiction that has been approved by the
federal Food and Drug Administration such as LAAM or
methadone.
This bill:
Authorizes physicians and surgeons in California who are
registered with the U.S. Attorney General, pursuant to
specified federal law, to provide addiction treatments that
are allowed under federal law.
FISCAL IMPACT
This bill is keyed nonfiscal.
BACKGROUND AND DISCUSSION
According to the author, AB 2268 will align California law
with the federal Drug Addiction and Treatment Act (DATA) of
2000, which authorizes federally certified physicians to
conduct office-based opioid treatment using certain
medications authorized by the FDA. The author notes that
the effect of this change will be to allow physicians to
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prescribe buprenorphine, a medication for the treatment of
opioid addiction, from their office. The author notes that
existing California law does not conform to the federal
DATA 2000, creating a legal risk to over 1,200 physicians
in California who are certified by the Center for Substance
Abuse Treatment (CSAT) under the Substance Abuse and Mental
Health Administration (SAMHSA) to conduct OBOT.
According to the sponsor, DADP, this bill is intended to
ensure California's physicians maintain their key role in
the treatment of addiction. DADP notes that this bill
clarifies that existing law allowing NTPs and OBOT programs
to prescribe buprenorphine does not restrict the ability of
other physicians who are qualified to treat opioid
addiction, pursuant to federal law, and who are not
associated with these programs, to provide this treatment
option to their patients.
Background
According to DADP, NTPs are licensed to provide replacement
narcotic therapy, the most widely known and well-researched
treatment for individuals who are addicted to such opioids
as morphine, oxycodone, and codeine. Replacement therapy
is a comprehensive treatment with synthetic opiates
approved by the FDA for opiate-addicted patients.
Authorized narcotic replacement medications are methadone
and LAAM, which are available to patients receiving
treatment in a licensed NTP
According to DADP, the majority of California's NTPs are
privately operated. The remaining NTPs are operated by
local government agencies. Treatment aspects of each
program are under the supervision of a medical director who
is a licensed physician and surgeon. Overall program
operation is the responsibility of a designated program
director. DADP is responsible for ensuring that patients
who enroll in NTPs receive therapeutic care and that the
health and safety of each patient is upheld.
OBOT programs provide medical addiction treatment services
in areas of California that currently lack these services
by allowing existing NTPs to contract with physicians to
provide addiction treatment in office-based settings under
the license and supervision of physicians in the primary
licensed NTP. Physicians in the OBOT program and their
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patients are required to adhere to all current state and
federal regulations regarding urine testing, counseling,
restrictions on take-home medications, and medical use of
methadone and LAAM in the treatment of opiate addiction.
Physicians in OBOT programs are authorized under current
law to prescribe all FDA approved medication for the
treatment of opiate addiction, including buprenorphine.
Buprenorphine is used to treat addiction to opioids by
preventing withdrawal symptoms so that a person can stop
taking the opioid drug to which he or she is addicted. In
October 2002, the FDA approved two buprenorphine products,
Subutex and Suboxone, for use in opioid addiction
treatment. Subutex and Suboxone were the first narcotic
drugs available for the treatment of opiate dependence that
can be prescribed in an office setting under the federal
DATA of 2000. Prior to DATA, opiate dependence treatments
like methadone could be dispensed in a limited number of
clinics that specialize in addiction treatment. Under
DATA, medications for the treatment of opiate dependence
are subject to less restrictive controls. Buprenorphine
can be prescribed in an office-based setting by specially
qualified physicians, and patients can obtain a 30-day
supply from a pharmacy.
Pursuant to the federal DATA, qualified physicians are
required to obtain a waiver from the federal Center for
Substance Abuse Treatment to prescribe buprenorphine.
Physicians seeking a waiver must have a current state
medical license and valid Drug Enforcement Agency number;
be certified in specialty or subspecialty addiction from
the American Board of Medical Specialties, American Society
of Addiction Medicine, or American Osteopathic Association;
and, complete appropriate training. Once a physician
obtains the waiver, he or she may treat up to 30 patients
for narcotic addiction with buprenorphine. Physicians may
increase their patient limit to 100 if they have had their
waiver for a year or more and request the higher limit in
writing.
Related bills
AB 417 (Beall) requires buprenorphine services to be
included within the scope of Drug Medi-Cal services,
subject to certain requirements. AB 417 is in Senate
Appropriations Committee.
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Prior legislation
AB 1055 (Chesbro) of 2009, similar to this bill, would have
clarified that current law regarding NTP-affiliated
office-based addiction services is not intended to restrict
the scope of practice of a physician who complies with the
federal DATA 2000 to practice office-based opioid treatment
but who is not affiliated or associated with an NTP. AB
1055 was held on the Assembly Appropriations Committee
Suspense File.
SB 1838 (Chesbro), Chapter 862, Statutes of 2004, among
other provisions, authorizes for use in replacement
narcotic therapy by licensed NTPs the following controlled
substances: methadone, LAAM, buprenorphine products or
combination products approved by the FDA for maintenance or
detoxification of opioid dependence, and any other
federally approved controlled substances used for the
purpose of narcotic replacement treatment.
Arguments in support
DADP writes that this bill will eliminate the legal risk to
over 1,200 qualified physicians in California who are
already prescribing buprenorphine in their offices, and may
not know that state law does not conform to the federal
DATA of 2002. DADP states that this bill will clarify that
qualified physicians in California are authorized to treat
opioid dependence in their private practices as they would
any other illness, subject to the requirements of DATA, and
will substantially increase access to treatment for
underserved populations in rural areas that do not have
NTPs and have residents must use public transit and travel
hours to the nearest NTP.
PRIOR ACTIONS
Assembly Health Committee 8-0
Assembly Floor 71-0
POSITIONS
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Support: Department of Alcohol and Drug Programs (ADP)
(sponsor)
Oppose: None received
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