BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 973
AUTHOR: Hernandez
AMENDED: March 28, 2014
HEARING DATE: April 24, 2014
CONSULTANT: Diaz
SUBJECT : Narcotic treatment programs.
SUMMARY : Revises existing law related to patient treatment in
narcotic treatment programs.
Existing law:
1.Requires the Department of Health Care Services (DHCS) to
license narcotic treatment programs (NTPs) to use narcotic
replacement therapy in the treatment of addicts 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.
2.Requires DHCS to establish a program for the operation and
regulation of office-based NTPs. Requires office-based NTPs to
either hold a primary NTP license or be affiliated and
associated with a primary licensed NTP. Requires patients of
an office-based NTP to be registered as patients in the
primary licensed NTP. Allows office-based NTPs to provide
treatment for a maximum of 20 patients.
3.Requires DHCS to establish and enforce the criteria for the
eligibility of NTP patients, program operation guidelines, and
any regulations that are necessary to protect the safety and
well-being of the patient, the local community, and the
public.
4.Allows NTPs to admit a patient to narcotic maintenance or
narcotic detoxification treatment only seven days after
completion of a prior withdrawal treatment episode.
5.Requires NTPs to provide take-home doses that are diluted in a
solution that has a volume of not less than one ounce. States
the Legislature's intent that self-administered dosage only be
provided when the patient is clearly adhering to the
requirements of the NTP program, and where daily attendance at
a clinic would be incompatible with gainful employment,
Continued---
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education, and responsible homemaking. Requires DHCS to
prohibit NTPs from admitting new patients or from providing
take-home doses if the NTP fails to comply with requirements
to secure narcotic medications and prevent diversion, or
repeatedly violates state or federal regulations governing
take-home doses.
6.Requires NTPs to have samples from each patient's urinalysis
or other body fluid test collected and analyzed for evidence
of certain substances, as specified.
7.Requires NTPs to assign consecutive numbers to patients as
they are admitted.
This bill:
1.Allows for other accurate, reliable, and medically necessary
body fluid analyses to be used for purposes of testing for
substances in a NTP patient's system.
2.Permits a program to admit a patient to narcotic maintenance
or detoxification treatment at the discretion of a NTP's
medical director, rather than after seven days after
completion of a prior treatment episode.
3.Prohibits NTPs from providing take-home doses that require
dilution.
4.Adds benzodiazepines and deletes barbiturates from the list of
substances for which NTPs are required to test.
5.Requires NTPs to assign a unique identifier to, and maintain
an individual record for, each patient of the program rather
than assigning consecutive numbers to each patient.
6.Adds to legislative intent in existing law that
self-administered take-home doses be provided when daily
attendance at a NTP clinic would be incompatible with
retirement or medical disability, or if the program is closed
on Sundays or holidays and providing a take-home dose is not
contrary to federal laws and regulations governing narcotic
treatment programs.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
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COMMENTS :
1.Author's statement. According to the author, state statute
and regulations have not been updated to keep up with the
changing substance use disorder (SUD) population. Current law
requires a seven-day waiting period between detoxification or
maintenance treatment attempts. Making patients wait seven
days to re-enter treatment at any point during addiction
recovery not only presents a lost opportunity for keeping a
person in treatment but also causes unnecessary suffering for
those who are already vulnerable because of complex health and
social factors, such as co-occurring disorders, homelessness,
and stigma. In order to cope with withdrawal symptoms while
waiting to re-enter treatment, patients often return to
substance abuse. SUD is a recognized chronic disease that has
proven to cause a strain on emergency rooms, public resources,
the criminal justice system, and the general public. Because
SUD is a chronic disease, treatment failures and relapses are
common, particularly in the early stages of addiction
recovery. This bill removes barriers to accessing treatment
and prevents unnecessary discomfort for patients in addiction
recovery by allowing NTPs to admit patients at the discretion
of the NTP's medical director. This bill also revises current
law to update other aspects of patient treatment.
2.Background. According to the National Institute on Drug
Abuse's (NIDA) Principles of Drug Addiction Treatment, Third
Edition (revised December 2012), because addiction is a
disease, most people cannot simply stop using drugs for a few
days and be cured. Patients typically require long-term or
repeated episodes of care to achieve the ultimate goal of
sustained abstinence and recovery of their lives. NIDA also
states that potential patients can be lost if treatment is not
immediately available or readily accessible, and as with other
chronic diseases, the earlier treatment is offered in the
disease process, the greater the likelihood of positive
outcomes. Because individuals often leave treatment
prematurely, programs should include strategies to engage and
keep patients in treatment. NIDA cites research that tracks
individuals in treatment over extended periods that shows that
most people who get into and remain in treatment stop using
drugs, decrease their criminal activity, and improve their
occupational, social, and psychological functioning. One
example is a 2009 study in Baltimore, Maryland, which found
that opioid-addicted prisoners who started methadone
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treatment, along with counseling, in prison and continued it
after release had better outcomes than those who only received
counseling while in prison or those who only started methadone
treatment after their release.
NIDA states that in 2011, 21.6 million people aged 12 or older
needed treatment for an illicit drug or alcohol use problem
but only 2.3 million received treatment at a specialty
substance abuse facility. NIDA states that substance abuse
costs the nation over $600 billion annually, and treatment is
much less expensive than its alternatives, such as
incarcerating addicted people. NIDA estimates that one full
year of methadone maintenance treatment is approximately
$4,700 per patient, whereas one full year of imprisonment
costs approximately $24,000 per year. However, according to
the Vera Institute of Justice Web site, in 2012, the annual
average cost per inmate in California was $47,421, and
according to the California Legislative Analyst's Office Web
site, the cost per inmate in 2008-09 was $47,102.
3.NTPs. NTPs are outpatient clinics licensed by DHCS and are
permitted to use methadone, levoalphacetylmethadol (LAAM),
buprenorphine, or any other federally approved controlled
substance used for the purpose of narcotic replacement
therapy. According to the DHCS Web site, treatment aspects of
each NTP are under the supervision of a medical director, who
is a licensed physician. Patients receive treatment as long as
medically necessary to reduce or eliminate the craving to use
or abuse legal and illegal drugs, with the ultimate goal of
becoming productive members of society. All patients receive a
medical evaluation and screening for diseases that are common
in the substance abusing population. Patients are evaluated
and provided counseling for such things as medical, alcohol,
criminal, and psychological problems. Patients are also
required to undergo regular testing to ensure that drugs are
not being abused during treatment. According to DHCS, there
are 156 NTP licenses issued at 142 locations, and there is one
primary licensed NTP with five office-based NTP locations.
4.Federal regulation. According to the Substance Abuse and
Mental Health Services Administration's (SAMHSA) Center for
Substance Abuse Treatment's Treatment Improvement Protocol
Series, No. 43 (TIP 43), the federal Food and Drug
Administration (FDA) issued regulations in 1972 governing
eligibility, evaluation procedures, dosages, take-home
medications, frequency of patient visits, medical and
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psychiatric services, counseling, support services, and
related details for methadone treatment programs. Several
modifications were made to these regulations during the 1980s.
In 2001, oversight for opioid treatment programs (OTPs, the
federal name for NTPs) was shifted from the FDA to SAMHSA, and
the existing regulations were repealed. SAMHSA adopted new
regulations that same year, which made significant revisions
to acknowledge that addiction is a medical disorder and not
amenable to one-size-fits-all treatment. According to TIP 43,
regulations under the FDA were criticized by physicians for
placing burdens on their practice of medicine. Addiction
treatment specialists also complained that proscriptive
regulations failed to leave room for treatment innovation. The
new federal regulations in Title 42 preserve individual
states' authority to regulate OTPs, according to TIP 43.
Oversight of treatment medications remains a three-party
system involving the states, SAMHSA, and the federal
Department of Justice's Drug Enforcement Agency.
According to a Federal Register related to these regulations
(July 22, 1999, No. 140, Volume 64), initial federal
regulations required a seven-day waiting period between each
detoxification treatment admission because when regulations
were initially issued in 1972 there was a concern that
overlapping detoxification admissions could lead to a de facto
maintenance treatment without comprehensive treatment
requirements. According to the Federal Register, the Secretary
of the Health and Human Services Agency concluded that seven
days is more time than is needed for this purpose and may
unnecessarily expose addicts to increased risks from HIV and
other infectious diseases. The seven-day waiting period was
not included in the final regulations (42 CFR Part 8).
5.Prior legislation. AB 2268 (Chesbro), Chapter 93, Statutes of
2010, authorized physician 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.
AB 631 (Leno), Chapter 544, Statutes of 2006, required the
Department of Alcohol and Drug Programs (ADP), until January
1, 2010, to establish a program for the operation and
regulation of mobile NTPs and required a mobile NTP to hold a
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primary NTP license or be affiliated and associated with a
primary licensed NTP.
AB 1349 (Goldberg), Chapter 1349, Statutes of 2005, made
changes to NTP law, including revising the Legislature's
intent in licensing NTPs to be to provide a means whereby a
patient may be rehabilitated and will no longer need to
support a dependency on opiates, and the ultimate goal of NTPs
would be to aid a patient in altering his or her lifestyle and
eventually to eliminate the improper use of legal drugs and
the use of illegal drugs.
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 therapy.
SB 1807 (Vasconcellos), Chapter 815, Statutes of 2000, made a
legislative finding and declaration that licensed physicians,
experienced in the treatment of addiction, should be allowed
and encouraged to treat addiction by all appropriate means;
required ADP to establish a program for the operation and
regulation of office-based opiate treatment programs that
would either be affiliated and associated with a primary
licensed NTP or hold a primary NTP license; and authorized any
person who is participating in a deferred entry of judgment
program or a preguilty plea program to also participate in a
licensed methadone or LAAM program if certain conditions are
met.
AB 930 (Calderon), Chapter 717, Statutes of 1999, made various
changes to statutes related to NTPs, including licensing
actions, program inspection and evaluation, patient admission,
take-home dosages, and administrative hearings.
6.Support. California Opioid Maintenance Providers (COMP) writes
in support of this bill, citing the federal Center for Disease
Control and Prevention's reporting that overdose deaths have
tripled since the 1990s. COMP argues that there is significant
need for opioid addiction treatment and that there currently
are some very medically outdated laws that deny patients
treatment.
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The County Alcohol and Drug Program Administrators Association
of California states that this bill will enable programs to
provide best treatment practices and help individuals they
serve to access the best treatment available for substance use
disorders.
The Drug Policy Alliance states that this bill removes
problematic and potentially very harmful requirements that can
lead to adverse health impacts, including overdose.
Pacific Clinics writes in support that this bill will remove
barriers in state laws that prevent some individuals from
accessing appropriate care and that it will ensure better
access and continuity of care.
7.Technical amendments. The author requested that the committee
approve the following technical amendments on page 2:
1) Line 14, after "reporting," insert:
requirements for
2) Line 14, delete "accurate,"
3) Line 15, delete "reliable," and insert:
reliable
4) Line 15, after "analysis" insert:
that is at least as or more accurate than current testing
methods
5) Line 15, delete "requirements"
SUPPORT AND OPPOSITION :
Support: California Opioid Maintenance Providers
California Society of Addiction Medicine
County Alcohol and Drug Program Administrators
Association of California
Drug Policy Alliance
Pacific Clinics
Oppose: None received.
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