BILL ANALYSIS
AB 417
Page 1
Date of Hearing: April 28, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 417 (Beall) - As Amended: April 14, 2009
SUBJECT: Medi-Cal Drug Treatment Program: buprenorphine.
SUMMARY : Requires buprenorphine services to be included within
the scope of Drug Medi-Cal services, but only if buprenorphine
is prescribed by a physician who complies with federal
requirements; requires a separate narcotic replacement therapy
dosing fee for buprenorphine to be established; and prohibits
this bill from being implemented if the Department of Health
Care Services (DHCS) determines the provisions of this bill
require an unbundling of Drug Medi-Cal reimbursement rates.
Specifically, this bill :
1)Requires buprenorphine services to be included within the
scope of Drug Medi-Cal Services, but only if buprenorphine is
prescribed by a physician who complies with federal
requirements regarding qualifications, certification, and
limitations on the number of patients for whom the physician
may prescribe buprenorphine.
2)Requires the Department of Drug and Alcohol Programs (DADP) to
establish a separate narcotic replacement therapy dosing fee
for buprenorphine.
3)Requires DADP, for purposes of establishing the dosing fees,
to include comprehensive services that include physician and
medication services.
4)Adds buprenorphine to the list of controlled substances
authorized for use in replacement narcotic therapy by licensed
narcotic treatment programs.
5)Defines "buprenorphine" as buprenorphine or buprenorphine
combination products approved by the federal Food and Drug
Administration (FDA) for maintenance or detoxification of
opioid dependence.
6)Prohibits the above provisions from being implemented if the
director of DHCS determines these provisions would require an
unbundling of Drug Medi-Cal reimbursement rates, and states
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legislative intent that this bill not result in the unbundling
of reimbursement rates for Drug Medi-Cal Services.
EXISTING LAW:
1)Establishes the Medi-Cal Program, administered by DHCS and
under which qualified low-income persons receive health care
benefits. The schedule of benefits available under Medi-Cal
includes the purchase of prescribed drugs, subject to the
Medi-Cal List of Contract Drugs and utilization controls.
2)Establishes the Medi-Cal Drug Treatment Program (Drug
Medi-Cal), under which each county enters into contracts with
DADP for the provision of various drug treatment services to
Medi-Cal recipients, or DADP directly arranges for the
provision of these services if a county elects not to do so.
3)Requires DADP to establish a narcotic replacement therapy
dosing fee for methadone and levo-alphacetylmethadol (LAAM),
requires narcotic treatment programs to be reimbursed for the
ingredient costs of methadone or LAAM dispensed to Medi-Cal
beneficiaries, and requires reimbursement for narcotic
replacement therapy dosing and ancillary services provided by
narcotic treatment programs to be based on a per capita
uniform statewide daily reimbursement rate for each individual
patient, as established by DADP, in consultation with DHCS.
Requires the uniform statewide daily reimbursement rate for
narcotic replacement therapy dosing and ancillary services to
be based upon, where available and appropriate, specified
factors.
4)Provides the following services under Drug Medi-Cal
administered by DADP and to the extent consistent with state
and federal law:
a) Narcotic treatment program services (admission, physical
evaluation and diagnosis, drug screening, pregnancy tests,
narcotic replacement therapy dosing, intake assessment,
treatment planning, and counseling services);
b) Day care rehabilitative services;
c) Perinatal residential services for pregnant women and
women in the postpartum period;
d) Naltrexone services; and,
e) Outpatient drug-free services.
5)Requires, upon federal approval of a Medicaid state plan
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amendment authorizing federal financial participation in the
following services, and subject to an appropriation of funds,
Drug Medi-Cal services to also include the following services,
administered by DADP, and to the extent consistent with state
and federal law:
a) Day care habilitative services, which are outpatient
counseling and rehabilitation services provided to persons
with alcohol or other drug abuse diagnoses;
b) Case management services, including supportive services
to assist persons with alcohol or other drug abuse
diagnoses in gaining access to medical, social,
educational, and other needed services; and,
c) Aftercare services.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE . According to the author, this bill requires DADP to
allow for the use of buprenorphine treatment in narcotic
treatment programs. Under current law, narcotic treatment
programs are only eligible to claim reimbursement for two
medication-assisted treatments: methadone and LAAM. LAAM is
no longer manufactured, leaving methadone as the only
treatment option. Buprenorphine was approved for use in the
treatment of opioid addiction in 2002 through federal law, and
the author states private sector health care and insurance
also cover buprenorphine. To date, DADP has not authorized
reimbursement for buprenorphine therapy in the Drug Medi-Cal
program. The unavailability of buprenorphine as a therapy
option has created a two-tiered system of care that the author
argues prevents providers from utilizing the most advanced
medication available. The author states substance abuse
exacts a devastating toll in California, ruining lives,
destroying families, and devouring tax dollars. According to
the author, more than 70% of the cost associated with prison,
parole, local criminal adjudication, and child welfare are
related to untreated alcohol and other drug abuse problems.
The author continues that in 2005 alone, California spent $44
billion rectifying the fallout from drug and other alcohol
abuse. Research shows that substance abuse treatment is
effective, but is most effective when tailored to meet the
needs of the individual, and this bill adds an additional
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option for treating substance abuse.
2)BUPRENORPHINE . Prescription pain relievers like morphine,
oxycodone, and codeine are opioids. 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 Drug Addiction
Treatment Act (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. Under federal regulations,
physicians who prescribe buprenorphine must have a Drug
Enforcement Agency number, must successfully complete
appropriate training, and must have a buprenorphine waiver
from the Center for Substance Abuse Treatment (CSAT).
According to the Substance Abuse and Mental Health Services
Administration Web site, there are 1,121 physicians and 182
treatment programs in California authorized to treat opioid
addiction with buprenorphine.
Subutex and Suboxone are available through "regular" Medi-Cal
(not Drug Medi-Cal) with a treatment authorization request,
but there is not a reimbursement rate amount established
through Drug Medi-Cal administered by DADP. In 2008, there
were 3,764 prescriptions dispensed in Medi-Cal for the two
medications, with a total amount paid of $890,505.
3)BACKGROUND ON DRUG MEDI-CAL . Drug Medi-Cal provides five
different statutorily defined modes of treatment services: a)
Narcotic treatment; b) Naltrexone; c) Outpatient drug free; d)
Day care habilitative; and, e) Perinatal residential services.
These services are provided in an outpatient setting. Drug
Medi-Cal services are reimbursed on a fee-for-service basis at
maximum rates set by the state, and are not provided through
Medi-Cal managed care plans. These community treatment
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services are "carved out" from the regular Medi-Cal Program,
which means that they are delivered by a specialized system of
providers certified by the state rather than through
participating physicians or health plans. Drug Medi-Cal
served 58,829 persons in 2007-08 with an alcohol or drug abuse
problem. The Governor's 2009-10 budget proposed to fund Drug
Medi-Cal through a new special fund called the Drug and
Alcohol Prevention and Treatment Fund, which was to be
supported by an increase in the excise tax on alcohol (the
"nickel-a-drink" tax). That proposal was not adopted by the
Legislature. The 2009-10 budget for Drug Medi-Cal has a total
estimated budget of $220 million ($114.3 million General
Fund).
4)LEGISLATIVE ANALYST'S OFFICE . In its analysis of the
Governor's proposed 2004-05 budget, the Legislative Analyst's
Office (LAO) recommended as part of its proposal to contain
the fast-growing state cost for methadone services, the
Legislature consider integrating buprenorphine into Drug
Medi-Cal. The LAO indicated it was advised that for many
clients (although by no means all); buprenorphine treatment
offers some advantages over methadone. It can be distributed
in tablet form through the offices of qualified physicians
instead of just through narcotic treatment clinics,
potentially making these services more widely accessible to
clients without the stigma perceived from visitation to a
drug-treatment clinic. Formulation of the drug in a
combination with another medication called naloxone lowers the
risk that the drug itself can be abused, as has sometimes been
the case for methadone. The LAO states published medical
evaluations show that it is less toxic and poses fewer medical
risks to clients, and that treatment can often be phased out
in a shorter period of time than methadone. The LAO indicates
that while the cost per dose for buprenorphine is higher than
for methadone, the overall cost per treatment episode can be
lower for buprenorphine due primarily to the shorter duration
of treatment.
The LAO states the Legislature has the option of formally
integrating the medication through statutory and regulatory
changes into both the regular Medi-Cal Program and Drug
Medi-Cal, and modifying state licensing and certification
procedures for treatment programs. As part of this change in
approach, the LAO indicates the Legislature may wish to
consider:
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a) Including counseling as a part of buprenorphine
treatment, due to evidence suggesting that counseling
reduces relapse rates of persons treated with the
medication;
b) A "step therapy" approach by which buprenorphine would
ordinarily become the first method of treatment attempted
for narcotic addicts before other methods, such as
methadone, was attempted.
c) Phasing in a licensing requirement specifying that
narcotic treatment clinics establish a network of qualified
physicians sufficient to meet the needs of their caseload
of clients receiving buprenorphine treatment. The LAO
indicates a delay of several years before full
implementation of such a rule would almost certainly be
necessary to ensure that a sufficient number of physicians
with the necessary qualifications were available to clinics
to manage the buprenorphine caseload.
The LAO indicates the cost of a daily dose of buprenorphine is
relatively high compared to methadone. The LAO states the
Medi-Cal Program is already able to obtain rebates under
federal and state law to lower the cost of the medication to
the state, and the cost of the drug could drop significantly
when it could become available in "generic" form.
5)SUPPORT . Health care providers and drug treatment advocates
argue buprenorphine is a safe and affective alternative to
methadone for treating opioid dependence when used under the
supervision of a physician. The County Alcohol and Drug
Program Administrators Association of California (CADPAAC)
writes in support that DADP has never authorized a
reimbursement code for buprenorphine therapy in Drug-Medi-Cal,
even though private sector health plans authorize coverage of
this medication as an appropriate, successful, and effective
treatment. CADPAAC argues the unavailability of the therapy
in Drug Medi-Cal leads to a two-tiered system of care, and
limits providers from using the most effective therapies for
treating opioid addiction. The Drug Policy Alliance writes in
support that buprenorphine is a proven opioid treatment,
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office-based treatment makes treatment more accessible, and
access to opioid treatment is important and cost-effective and
has shown to be cost-neutral compared to methadone
maintenance.
6)SUPPORT IF AMENDED . The California Opioid Maintenance
Providers (COMP), which represents narcotic treatment clinics
that serve the opioid-addicted population, writes requesting
the definition of buprenorphine services be expanded to
include buprenorphine when it is administered by a narcotic
treatment program where the medication is ordered by a
physician who complies with federal requirements regarding
qualifications and certification. COMP argues this language
is necessary to ensure that narcotic treatment programs can
provide buprenorphine and not just reimburse physicians in
private practice. Additionally, COMP seeks an amendment to
replace references to "methadone and LAAM" with "medication"
in the provision of existing law requiring DADP to reimburse
narcotic treatment program for drug ingredient costs, and that
authorizes these costs to be determined based on an average
daily dose. COMP argues this change is necessary to ensure
that in developing the buprenorphine rate, DADP uses the cost
of buprenorphine and not the cost of the much less expensive
methadone to establish the rate.
This bill currently contains language requested by COMP
prohibiting its implementation if the Director of DHCS
determines that the provisions of this bill require an
unbundling of Drug Medi-Cal reimbursement rates. If DHCS were
to require an unbundling of Drug Medi-Cal reimbursement rates,
the provisions of this bill would not take effect.
7)PREVIOUS LEGISLATION . SB 1838 (Chesbro), Chapter 862,
Statutes of 2004, among other provisions, authorizes the
following controlled substances for use in replacement
narcotic therapy by licensed narcotic treatment programs:
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.
REGISTERED SUPPORT / OPPOSITION :
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Support
American Federation of State, County and Municipal Employees,
AFL-CIO
California Medical Association
California Psychiatric Association
County Alcohol and Drug Program Administrators Association of
California
Drug Policy Alliance
Opposition
None on file.
Analysis Prepared by : Scott Bain / HEALTH / (916) 319-2097