BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 417
A
AUTHOR: Beall
B
AMENDED: May 19, 2009
HEARING DATE: July 8, 2009
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CONSULTANT:
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Bain/
7
SUBJECT
Medi-Cal Drug Treatment Program: buprenorphine
SUMMARY
Requires buprenorphine services to be included within the
scope of Drug Medi-Cal services, subject to certain
requirements (buprenorphine is used to treat opioid
addiction). Additionally, this bill requires a separate
narcotic replacement therapy dosing fee for buprenorphine
to be established. This bill would not be implemented if
the Department of Health Care Services (DHCS) determines
the provisions of this bill require an unbundling of Drug
Medi-Cal reimbursement rates.
CHANGES TO EXISTING LAW
Existing law:
Existing law establishes the Medi-Cal Program, which is
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.
Existing law establishes the Medi-Cal Drug Treatment
Program (Drug Medi-Cal), under which each county enters
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into contracts with the Department of Alcohol and Drug
Programs (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.
Existing law requires DADP to establish a narcotic
replacement therapy dosing fee for methadone and
levo-alphacetylmethadol (LAAM), requires narcotic treatment
programs (NTPs) 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 NTPs to be based
on a per capita uniform statewide daily reimbursement rate
for each individual patient, as established by DADP, in
consultation with DHCS. Existing law 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.
Existing requires DADP to establish a program for the
operation and regulation of an office-based NTP. An
office-based NTP established must meet either of the
following conditions:
Hold a primary NTP license; or
Be affiliated and associated with a primary licensed NTP.
An office-based NTP meeting this requirement is not
required to have a license separate from the primary
licensed NTP with which it is affiliated and associated.
Existing law provides the following services under Drug
Medi-Cal administered by DADP and to the extent consistent
with state and federal law:
NTP services (admission, physical evaluation and
diagnosis, drug screening, pregnancy tests, narcotic
replacement therapy dosing, intake assessment, treatment
planning, and counseling services);
Day care rehabilitative services;
Perinatal residential services for pregnant women and
women in the postpartum period;
Naltrexone services; and,
Outpatient drug-free services.
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This bill:
This bill requires buprenorphine services to be included
within the scope of Drug Medi-Cal Services, but only if
buprenorphine is:
Administered by a licensed NTP and ordered or prescribed
by a physician who complies with federal requirements and
works under the license of the NTP; or,
Prescribed by a physician who complies with federal
requirements, but does not work under the license of an
NTP.
This bill requires the Department of Drug and Alcohol
Programs (DADP) to establish a separate narcotic
replacement therapy dosing fee for buprenorphine. DADP
must, for purposes of establishing the dosing fee for
buprenorphine, LAAM, and methadone, include comprehensive
services that include physician and medication services.
This bill adds buprenorphine to the list of controlled
substances authorized for use in replacement narcotic
therapy by licensed NTPs.
This bill defines "buprenorphine" as buprenorphine or
buprenorphine combination products approved by the federal
Food and Drug Administration (FDA) for maintenance or
detoxification of opioid dependence.
This bill prohibits its provisions from being implemented
if the director of DHCS determines these provisions would
require an unbundling of Drug Medi-Cal reimbursement rates,
and states legislative intent that this bill not result in
the unbundling of Drug Medi-Cal Services
reimbursement rates.
FISCAL IMPACT
According to the Assembly Appropriations Committee:
If 10 percent of current methadone patients convert to
buprenorphine and their time on the drug averages three
months (as evidence suggests) rather than the much longer
treatment using methadone, the savings to the Drug
Medi-Cal Program would be in excess of $20 million ($10
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million General Fund).
Workload associated with adding buprenorphine to the
current bundled rate should be minor, likely less than
$100,000.
BACKGROUND AND DISCUSSION
According to the author, this bill requires DADP to allow
for the use of buprenorphine treatment in NTPs. Under
current law, NTPs 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, but 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 percent 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 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
option for treating substance abuse.
Background on 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
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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 Website, there
are 1,159 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. The manufacturer of the drugs indicates the
federal patent protection for these two medications ends in
October 2009.
2004 Legislative Analyst's Office Report on Drug Medi-Cal.
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, that 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 visiting a drug-treatment clinic.
Formulation of the drug in a combination with another
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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 that 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 that the
Legislature may wish to consider:
Including counseling as a part of buprenorphine
treatment, due to evidence suggesting that counseling
reduces relapse rates of persons treated with the
medication;
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; and,
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 that to methadone. The LAO
states that the Medi-Cal Program is already able to obtain
rebates under federal and state law to lower the cost of
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the medication to the state, and the cost of the drug could
drop significantly when it could become available in
"generic" form.
Arguments in 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 some 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.
Related bills
AB 1055 (Chesbro) would allow physicians who meet the
criteria in federal DATA to engage in office-based
treatment of opioid dependence, provided the physician is
not affiliated or associated with a licensed NTP. AB 1055
would also expand the definition of an "alcoholism or drug
abuse recovery or treatment facility" to include a premise,
place, or building that provides 24-hour services that do
not require a health facility license to adults who are
recovering from problems related to alcohol, drug, or
alcohol and drug misuse or abuse and who need alcohol,
drug, or alcohol and drug recovery treatment or
detoxification services, and which may include, at the sole
discretion of the facility, detoxification services
assisted by licensed physicians. AB 1055 was held on the
Assembly Appropriations suspense file.
Prior legislation
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
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purpose of narcotic replacement treatment.
COMMENTS
1.Prescribing buprenorphine outside NTP. This bill
includes buprenorphine within Drug Medi-Cal services
under two circumstances: (a) when buprenorphine services
are administered by a licensed NTP and they are ordered
or prescribed by a physician who complies with federal
requirements and works under the license of the NTP; and
(b) the buprenorphine services are prescribed by a
physician who complies with federal requirements, but
does not work under the license of an NTP (e.g., when the
drug is prescribed outside of an NTP).
DADP, which administers Drug Medi-Cal, indicates the second
provision providing coverage of buprenorphine for a
physician who does not work under the license of an NTP
would require it to oversee the prescribing and
dispensing practices of individual physicians who it does
not currently have billing relationship or regulatory
oversight.
PRIOR ACTIONS
Assembly Floor: 78-0
Assembly Appropriations:12-0
Assembly Health: 18-0
POSITIONS
Support: California Association of Alcohol and Drug
Program Executives, Inc.
California Medical Association
California Opioid Maintenance Providers
County Alcohol and Drug Program Administrators
Association of California
Support (prior version):
American Federation of State, County and
Municipal Employees, AFL-CIO
California Psychiatric Association
Drug Policy Alliance
Oppose: None received
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