BILL ANALYSIS
AB 2268
Page 1
Date of Hearing: April 13, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 2268 (Chesbro) - As Introduced: February 18, 2010
SUBJECT : Alcohol and drug abuse.
SUMMARY : Authorizes physician and surgeons in California who
are qualified to treat opioid addiction, pursuant to the federal
Data Addiction Treatment Act (DATA) of 2000, to prescribe
buprenorphine in an office-based setting.
EXISTING LAW :
1)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.
2)Requires DADP to license and inspect narcotic treatment
programs (NTPs), which use replacement narcotic therapy (RNT)
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.
3)Authorizes the following controlled substances for use in RNT
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 RNT.
4)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.
5)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
AB 2268
Page 2
through direct administration and dispensing services.
6)Requires physicians in OBOT programs to dispense or administer
pharmacologic treatment for opiate addiction that has been
approved by the FDA.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . 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.
2)NTPs . According to DADP, NTPs are licensed to provide RNT,
the most widely known and well-researched treatment for
individuals who are addicted to such opioids as morphine,
oxycodone, and codeine. RNT 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. To receive these medications in
a licensed NTP, a patient is required to participate in a
comprehensive treatment program, which includes a medical
evaluation and counseling. Patients must also comply with
body specimen testing to ensure the safety of patients in
treatment. DADP indicates that there are two phases of RNT:
detoxification, in which a patient receives medication in
titrate doses for a period of up to 21 days to ease adverse
physical and psychological effects caused by withdrawal from
the use of opiates; and, maintenance, in which a patient is
provided replacement narcotic medication in sustained, stable,
medically determined doses to reduce or eliminate chronic
opiate addiction.
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
AB 2268
Page 3
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.
3)OBOT PROGAMS . 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 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.
4)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.
5)DATA . Pursuant to 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
AB 2268
Page 4
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. The federal Substance
Abuse and Mental Health Services Administration Web site
indicates that there are 1,121 physicians and 182 treatment
programs in California authorized to treat opioid addiction
with buprenorphine. This bill clarifies that authorized
prescribers of buprenorphine in California include physicians
who have obtained prescribing waivers pursuant to DATA 2000,
in addition to physicians who are associated with NTPs and
OBOT programs.
6)SUPPORT . As sponsor of this bill, 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, not knowing that state law
does not conform to DATA. 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 would substantially increase access to treatment for
underserved populations in rural areas that do not have NTPs
or clients who use public transit and must travel hours to the
nearest NTP. Supporters, including the California Medical
Association, Drug Policy Alliance and the California
Association of Alcoholism and Drug Counselors, add that this
bill will increase access for patients in need of
detoxification and maintenance treatments and enable
physicians to treat their patients with the full complement of
services at their disposal.
7)RELATED LEGISLATION . AB 417 (Beall), among other things, adds
buprenorphine to the list of controlled substances authorized
for use in RNT by licensed NTPs. AB 417 is a two-year bill
pending in the Senate Appropriations Committee.
8)PRIOR LEGISLATION .
a) 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 DATA
to practice office-based opioid treatment but who is not
affiliated or associated with an NTP. AB 1055 died on the
AB 2268
Page 5
Assembly Appropriations Committee Suspense File.
b) SB 1807 (Vasconcellos), Chapter 815, Statutes of 2000,
directs DADP to establish OBOT programs and requires
physicians in OBOT programs to dispense or administer
pharmacologic treatment for opiate addiction that has been
approved by the FDA.
c) SB 1838 (Chesbro), Chapter 862, Statutes of 2004, among
other provisions, authorizes the following controlled
substances for use in RNT by licensed NTPs: 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 RNT.
9)AUTHOR'S AMENDMENTS . The author intends to offer technical
amendments to clarify that, notwithstanding any other
provision of state law, physicians in California may treat
opioid addiction pursuant to DATA.
REGISTERED SUPPORT / OPPOSITION :
Support
Department of Alcohol and Drug Programs (sponsor)
California Association of Alcoholism and Drug Abuse Counselors
California Medical Association
City and County of San Francisco
Drug Policy Alliance
Opposition
None on file.
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097