BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 809|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
UNFINISHED BUSINESS
Bill No: SB 809
Author: DeSaulnier (D) and Steinberg (D), et al.
Amended: 9/3/13
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 7-2, 4/15/13
AYES: Price, Block, Corbett, Galgiani, Hernandez, Hill, Padilla
NOES: Emmerson, Wyland
NO VOTE RECORDED: Yee
SENATE GOVERNANCE & FINANCE COMMITTEE : 5-2, 5/8/13
AYES: Wolk, Beall, DeSaulnier, Hernandez, Liu
NOES: Knight, Emmerson
SENATE APPROPRIATIONS COMMITTEE : 5-1, 5/23/13
AYES: De León, Hill, Lara, Padilla, Steinberg
NOES: Gaines
NO VOTE RECORDED: Walters
SENATE FLOOR : 23-14, 5/28/13 (FAIL)
AYES: Beall, Block, Corbett, De León, DeSaulnier, Evans,
Hancock, Hernandez, Hill, Hueso, Jackson, Lara, Leno, Lieu,
Liu, Monning, Padilla, Pavley, Price, Steinberg, Torres, Wolk,
Wright
NOES: Anderson, Berryhill, Calderon, Cannella, Correa, Fuller,
Gaines, Galgiani, Huff, Knight, Nielsen, Roth, Wyland, Yee
NO VOTE RECORDED: Emmerson, Walters, Vacancy
SENATE FLOOR : 39-0, 5/30/13
AYES: Anderson, Beall, Berryhill, Block, Calderon, Cannella,
Corbett, Correa, De León, DeSaulnier, Emmerson, Evans, Fuller,
Gaines, Galgiani, Hancock, Hernandez, Hill, Hueso, Huff,
CONTINUED
SB 809
Page
2
Jackson, Knight, Lara, Leno, Lieu, Liu, Monning, Nielsen,
Padilla, Pavley, Price, Roth, Steinberg, Torres, Walters,
Wolk, Wright, Wyland, Yee
NO VOTE RECORDED: Vacancy
ASSEMBLY FLOOR : 77-1, 9/9/13 - See last page for vote
SUBJECT : Controlled substances: reporting
SOURCE : Attorney General Kamala Harris
DIGEST : This bill establishes a funding mechanism to update
and maintain the Controlled Substance Utilization Review and
Evaluation System (CURES) and Prescription Drug Monitoring
Program (PDMP), requires all prescribing health care
practitioners to apply to access CURES information, and
establishes processes and procedures for regulating prescribing
licensees through CURES and securing private information.
Assembly Amendments remove the urgency clause; require CURES to
operate under existing provisions of law to safeguard the
privacy and confidentiality of patients and specifies the manner
in which data obtained from CURES is provide to specified
entities; and make clarifying and technical amendments.
ANALYSIS : Existing law, under the Health and Safety Code,
establishes the California Uniform Controlled Substances Act
which regulates controlled substances.
Existing law, under the Business and Professions Code:
1. Establishes various Acts which provide for the licensing,
certification, and regulation of health practitioners by
boards within the Department of Consumer Affairs (DCA).
2. Provides that a certified nurse-midwife or nurse
practitioner may furnish or order drugs or devices, including
controlled substances, in accordance with standardized
procedures or protocols as specified.
3. Establishes the Pharmacy Law which provides for the
licensure and regulation of pharmacies, pharmacists and
CONTINUED
SB 809
Page
3
wholesalers of dangerous drugs or devices by the Board of
Pharmacy within the DCA.
4. Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a
person from furnishing any dangerous drug or device except
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor.
5. Requires the MBC to periodically develop and disseminate
information and educational materials regarding various
subjects, including pain management techniques, to each
licensed physician and surgeon and to each general acute care
hospital in California.
This bill:
1. Assesses an annual $6 fee on the following licensees to pay
the reasonable costs associated with operating and
maintaining CURES for the purpose of regulating those
licensees:
A. Physicians, dentists, podiatrists, veterinarians,
naturopathic doctors, pharmacists, registered nurse,
certified nurse-midwives, nurse practitioners, physician
assistants, and optometrists, as specified;
B. Wholesalers and nonresident wholesalers of dangerous
drugs, as specified;
C. Nongovernmental clinics, nonprofit clinics, and free
clinics, as specified; and,
D. Nongovernmental pharmacies, as specified.
2. Requires, beginning April 1, 2014, the assessed fee to be
billed and collected by the regulating agency of each
licensee at the time of the licensee's license renewal, and
states that if the reasonable regulatory cost of operating
and maintaining CURES is less than $6 per licensee, the DCA
may, by regulation, reduce the fee to the reasonable
regulatory cost.
3. Requires the fees collected to be deposited in the CURES
CONTINUED
SB 809
Page
4
Fund, which is created within the State Treasury.
4. Requires moneys in the CURES Fund to be, upon appropriation
by the Legislature, available to DCA to reimburse the
Department of Justice (DOJ) for costs to operate and maintain
CURES for the purposes of regulating the specified licensees.
5. Requires DCA to contract with DOJ on behalf of the Medical
Board of California (MBC), the Dental Board of California,
the Board of Pharmacy, the Veterinary Medical Board, the
Board of Registered Nursing, the Physician Assistant Board of
the MBC, the Osteopathic Medical Board, the Naturopathic
Medicine Committee of the Osteopathic Medical Board, the
Board of Optometry, and the Board of Podiatric Medicine to
operate and maintain CURES for the purposes of regulating
licensees.
6. Requires DOJ, in conjunction with DCA and the appropriate
boards and committees, to do all of the following:
A. Identify and implement a streamlined application and
approval process to provide access to the CURES PDMP
database for pharmacists and licensed health care
practitioners eligible to prescribe, order, administer,
furnish, or dispense Schedule II, Schedule III, or
Schedule IV controlled substances, and requires every
reasonable effort be made to implement a streamlined
application and approval process that a licensed health
care practitioner or pharmacist can complete at the time
that he or she is applying for licensure or renewing
his/her license.
B. Identify necessary procedures to enable licensed
health care practitioners and pharmacists with access to
the CURES PDMP to delegate their authority to order
reports from the CURES PDMP.
C. Develop a procedure to enable health care
practitioners who do not have a federal Drug Enforcement
Administration (DEA) number to opt out of applying for
access to the CURES PDMP.
7. Requires MBC to periodically develop and disseminate
information and educational material regarding assessing a
CONTINUED
SB 809
Page
5
patient's risk of abusing or diverting controlled substances
and information relating to CURES to each licensed physician
and surgeon and to each general acute care hospital in this
state; and further requires MBC to consult with the
Department of Public Health, appropriate boards and
committees, and DOJ in developing the materials to be
distributed.
8. Requires a California pharmacy to report dispensing a
Schedule IV controlled substance issued by a prescriber in
another state for delivery to a patient in another state to
CURES.
9. Authorizes pharmacies to dispense Schedule III, IV, and V
controlled substances prescriptions from out-of-state
prescribers as specified.
10.Requires DOJ to maintain CURES to assist health care
practitioners in their efforts to ensure appropriate
prescribing, ordering, administering, furnishing, and
dispensing of controlled substances.
11.Deletes provisions stating that the reporting of Schedules
III and IV controlled substances shall be contingent upon the
availability of adequate funds from DOJ.
12.Requires DOJ to annually report to the Legislature and make
available to the public the amount and source of funds it
receives for support of CURES.
13.Permits DOJ to seek and use grant funds to pay the costs
incurred by the operation and maintenance of CURES.
14.Requires CURES to comply with all applicable federal and
state privacy and security laws and regulations.
15.Requires DOJ to establish policies, procedures, and
regulations regarding the use, access, evaluation,
disclosure, management, implementation, operation, storage,
and security of the information within CURES.
16.Requires a pharmacy, clinic, or other dispenser to report
specified information, including a prescribers national
provider identifier number, to DOJ as soon as reasonably
CONTINUED
SB 809
Page
6
possible, but not more than seven days after the date a
controlled substance is dispensed.
17.Permits DOJ to invite stakeholders to assist, advise, and
make recommendations on the establishment of rules and
regulations necessary to ensure the proper administration and
enforcement of the CURES database. All prescriber and
dispenser invitees must be licensees, as specified, in active
practice in California, and a regular user of CURES.
18.Requires DOJ, prior to upgrading CURES, to consult with
prescribers licensed by one of the relevant boards or
committees, the boards or committees themselves, and any
other stakeholders for the purpose of identifying desirable
capabilities and upgrades to the CURES PDMP.
19.Permits DOJ to establish a process to educate authorized
subscribers of the CURES PDMP on how to access and use the
CURES PDMP.
20.Requires a health care practitioner authorized to prescribe,
order, administer, furnish, or dispense Schedule II-IV
controlled substances or a pharmacist to, before January 1,
2016, or upon receipt of a federal DEA registration,
whichever occurs later, submit an application to DOJ to
access information online regarding the controlled substance
history of a patient, as specified.
21.Requires DOJ, upon approval of an application to access
patient information, release to the practitioner or
pharmacist the electronic history of controlled substances
dispensed to an individual under his/her care based on data
contained in the CURES PDMP.
22.States that a health care practitioner authorized to
prescribe Schedules II-IV controlled substances, shall be
deemed to have completed the requirements to access
individual patient information if he/she has applied to
access CURES PDMP at the time he/she applied for licensure or
renewal.
23.Requires a pharmacist to submit an application, as
specified, to obtain approval to access CURES PDMP.
CONTINUED
SB 809
Page
7
24.Permits DOJ to seek voluntarily contributed private funds
from insurers, health care service plans, and qualified
manufacturers for the purpose of supporting CURES. Insurers,
health care service plans, qualified manufacturers, and other
donors may contribute by submitting their payment to the
State Controller for deposit into the CURES Fund.
Contributions to the CURES Fund shall be nondeductible for
state tax purposes.
25.Defines the following terms:
A. "Controlled substance" means a drug, substance, or
immediate precursor in Schedule II, III, or IV.
B. "Health care service plan" means an entity licensed
pursuant to the Knox-Keene Health Care Service Plan Act of
1975.
C. "Insurer" means an admitted insurer writing health
insurance, as defined in Section 106 of the Insurance
Code, and an admitted insurer writing workers'
compensation insurance, as defined in Section 109 of the
Insurance Code.
D. "Qualified manufacturer" means a manufacturer of a
controlled substance, but does not mean a wholesaler or
nonresident wholesaler of dangerous drugs, as specified, a
veterinary food-animal drug retailer, as specified, or an
individual regulated by the MBC, the Dental Board of
California, the Board of Pharmacy, the Veterinary Medical
Board, the Board of Registered Nursing, the Physician
Assistant Committee of the MBC, the Osteopathic Medical
Board, the Board of Optometry, or the Board of Podiatric
Medicine.
26.Makes clarifying and technical amendments.
27.Makes legislative findings and declarations.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Assembly Appropriations Committee, ongoing
special fund costs in the $1.5 million range, fully covered by
CONTINUED
SB 809
Page
8
the proposed fee structure, to staff and maintain the upgraded
PDMP. The related costs to upgrade the PDMP database - almost
$3 million - received funding in the 2013-14 Budget Bill.
SUPPORT : (Verified 9/9/13)
Attorney General Kamala Harris (source)
ALPHA Fund
American Cancer Society Cancer Action Network
American Medical Association
Association of California Healthcare Districts
Association of California Insurance Companies
Association of California Life and Health Insurance Companies
Association of Northern California Oncologists
Behind the Orange Curtain, the Documentary
California Academy of Physician Assistants
California Association for Nurse Practitioners
California Association of Joint Powers Authority
California Association of Oral and Maxillofacial Surgeons
California Chapter of the American College of Emergency
Physicians
California Coalition on Workers' Compensation
California Hospital Association
California Joint Powers Insurance Authority
California Labor Federation
California Medical Association
California Narcotic Officers Association
California Pharmacists Association
California Police Chiefs Association
California Professional Association of Specialty Contractors
California Retailers Association
California Self-Insurers Association
California Society of Health-System Pharmacists
California Special Districts Association
California State Association of Counties
California State Board of Pharmacy
California State Sheriffs' Association
Center for Public Interest Law
City and County of San Francisco
CompPharma
County Alcohol and Drug Program Administrators Association of
California
County of San Diego
CSAC Excess Insurance Authority
CONTINUED
SB 809
Page
9
Department of Insurance
Deputy Sheriffs' Association of San Diego County
Employers Group
Gallagher Bassett Services, Inc.
Golden Oak Cooperative Corporation
Grimmway Farms
Health Officers Association of California
Healthcare Distribution Management Association
Independent Insurance Agents and Brokers of California
Los Angeles County District Attorney's Office
Medical Oncology Association of Southern California, Inc.
Metro Risk Management
Michael Sullivan and Associates
National Association of Chain Drug Stores
National Coalition Against Prescription Drug Abuse
Nordstrom
Safeway
Schools Insurance Authority
Schools Insurance Group
Sedgwick Claims Management Services
Shaw, Jacobsmeyer, Crain, and Claffey
South Orange County Coalition
Troy and Alana Pack Foundation
University of California
Western Occupational and Environmental Medical Association
Western Propane Gas Association
ARGUMENTS IN SUPPORT : According to the author's office, the
automated PDMP within the CURES program is a valuable
investigative, preventative, and educational tool for law
enforcement, regulatory boards, and health care providers, but
recent budget cuts to the Attorney General's Division of Law
Enforcement have resulted in insufficient funding to support the
CURES PDMP. The author's office states that the PDMP is
necessary to ensure health care professionals have the necessary
data to make informed treatment decisions and to allow law
enforcement to investigate prescription drug diversion. Without
a dedicated funding source, the CURES PDMP is not sustainable
and will be suspended July 1, 2013. To keep the program going
and increase its effectiveness, this bill establishes funds to
upgrade the system to be fully modernized and provides dedicated
ongoing funding to ensure the program is sustainable.
The bill's sponsor, California Attorney General Kamala Harris
CONTINUED
SB 809
Page
10
(AG), notes that without the funding this bill provides, the AG
will be forced to disband the CURES program later this year,
making California one of only two states in the nation without a
PDMP and that closing the CURES program would "exacerbate a
prescription drug diversion problem that is already the fastest
growing drug problem in the United States."
ASSEMBLY FLOOR : 77-1, 9/9/13
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,
Dahle, Daly, Dickinson, Eggman, Fong, Fox, Frazier, Beth
Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon, Gorell, Gray,
Grove, Hagman, Hall, Harkey, Roger Hernández, Holden, Jones,
Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,
Mansoor, Medina, Melendez, Mitchell, Morrell, Mullin,
Muratsuchi, Nazarian, Nestande, Olsen, Pan, Patterson, Perea,
V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas,
Skinner, Stone, Ting, Wagner, Waldron, Weber, Wieckowski, Wilk,
Williams, Yamada, John A. Pérez
NOES: Donnelly
NO VOTE RECORDED: Vacancy, Vacancy
MW:k 9/9/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED