Amended in Assembly September 3, 2013

Amended in Assembly August 5, 2013

Amended in Assembly June 26, 2013

Amended in Senate May 28, 2013

Amended in Senate May 24, 2013

Amended in Senate May 14, 2013

Amended in Senate May 1, 2013

Senate BillNo. 809


Introduced by Senators DeSaulnier and Steinberg

(Coauthors: Senators Hancock, Lieu, Pavley, and Price)

(Coauthor: Assembly Member Blumenfield)

February 22, 2013


An act to add Sections 208, 209, and 2196.8 to the Business and Professions Code, and to amend Sections 11164.1, 11165, and 11165.1 of, and to add Sectionbegin delete 11165.4end deletebegin insert 11165.5end insert to, the Health and Safety Code, relating to controlled substances.

LEGISLATIVE COUNSEL’S DIGEST

SB 809, as amended, DeSaulnier. Controlled substances: reporting.

(1) Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances.

Existing law requires dispensing pharmacies and clinics to report, on a weekly basis, specified information for each prescription of Schedule II, Schedule III, or Schedule IV controlled substances, to the department, as specified.

This bill would establish the CURES Fund within the State Treasury to receive funds to be allocated, upon appropriation by the Legislature, to the Department of Justice for the purposes of funding CURES, and would make related findings and declarations.

This billbegin delete wouldend deletebegin insert would, beginning April 1, 2014,end insert require an annual fee of $6 to be assessed on specified licensees, including licensees authorized to prescribe, order, administer, furnish, or dispense controlled substances, and require the regulating agency of each of those licensees to bill and collect that fee at the time of license renewal. The bill would authorize the Department of Consumer Affairs to reduce, by regulation, that fee to the reasonable cost of operating and maintaining CURES for the purpose of regulating those licensees, if the reasonable regulatory cost is less than $6 per licensee. The bill would require the proceeds of the fee to be deposited into the CURES Fund for the support of CURES, as specified. The bill would also permit specified insurers, health care service plans, qualified manufacturers, and other donors to voluntarily contribute to the CURES Fund, as described.

(2) Existing law requires the Medical Board of California 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 would additionally require the board to periodically develop and disseminate to each licensed physician and surgeon and to each general acute care hospital in California information and educational materials relating to the assessment of a patient’s risk of abusing or diverting controlled substances and information relating to CURES.

(3) Existing law permits a licensed health care practitioner, as specified, or a pharmacist to apply to the Department of Justice to obtain approval to access information stored on the Internet regarding the controlled substance history of a patient under his or her care. Existing law also authorizes the Department of Justice to provide the history of controlled substances dispensed to an individual to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.

This bill would require, by January 1, 2016, or upon receipt of a federal Drug Enforcement Administration registration, whichever occurs later, health care practitioners authorized to prescribe, order, administer, furnish, or dispense controlled substances, as specified, and pharmacists to apply to the Department of Justice to obtain approval to access information stored on the Internet regarding the controlled substance history of a patient under their care. The bill would require the Department of Justice, in conjunction with the Department of Consumer Affairs and certain licensing boards, to, among other things, develop a streamlined application and approval process to provide access to the CURES database for licensed health care practitioners and pharmacists. The bill would make other related and conforming changes.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

P3    1

SECTION 1.  

The Legislature finds and declares all of the
2following:

3(a) The Controlled Substance Utilization Review and Evaluation
4System (CURES) is a valuable preventive, investigative, and
5educational tool for health care providers, regulatory agencies,
6educational researchers, and law enforcement. Recent budget cuts
7to the Attorney General’s Division of Law Enforcement have
8resulted in insufficient funding to support CURES and its
9Prescription Drug Monitoring Program (PDMP). The CURES
10PDMP is necessary to ensure health care professionals have the
11necessary data to make informed treatment decisions and to allow
12law enforcement to investigate diversion of prescription drugs.
13Without a dedicated funding source, the CURES PDMP is not
14sustainable.

15(b) Each year CURES responds to more than 800,000 requests
16from practitioners and pharmacists regarding all of the following:

17(1) Helping identify and deter drug abuse and diversion of
18prescription drugs through accurate and rapid tracking of Schedule
19II, Schedule III, and Schedule IV controlled substances.

20(2) Helping practitioners make prescribing decisions.

21(3) Helping reduce misuse, abuse, and trafficking of those drugs.

22(c) Schedule II, Schedule III, and Schedule IV controlled
23substances have had deleterious effects on private and public
P4    1interests, including the misuse, abuse, and trafficking in dangerous
2prescription medications resulting in injury and death. It is the
3intent of the Legislature to work with stakeholders to fully fund
4the operation of CURES which seeks to mitigate those deleterious
5 effects and serve as a tool for ensuring safe patient care, and which
6has proven to be a cost-effective tool to help reduce the misuse,
7abuse, and trafficking of those drugs.

8(d) The following goals are critical to increase the effectiveness
9and functionality of CURES:

10(1) Upgrading the CURES PDMP so that it is capable of
11accepting real-time updates and is accessible in real-time, 24 hours
12a day, seven days a week.

13(2) Upgrading the CURES PDMP in California so that it is
14capable of operating in conjunction with all national prescription
15drug monitoring programs.

16(3) Providing subscribers to prescription drug monitoring
17programs access to information relating to controlled substances
18dispensed in California, including those dispensed through the
19United States Department of Veterans Affairs, the Indian Health
20Service, the Department of Defense, and any other entity with
21authority to dispense controlled substances in California.

22(4) Upgrading the CURES PDMP so that it is capable of
23accepting the reporting of electronic prescription data, thereby
24enabling more reliable, complete, and timely prescription
25monitoring.

26

SEC. 2.  

Section 208 is added to the Business and Professions
27Code
, to read:

28

208.  

(a) begin deleteA end deletebegin insertBeginning April 1, 2014, a end insertCURES fee of six dollars
29($6) shall be assessed annually on each of the licensees specified
30in subdivision (b) to pay the reasonable costs associated with
31operating and maintaining CURES for the purpose of regulating
32those licensees. The fee assessed pursuant to this subdivision shall
33be billed and collected by the regulating agency of each licensee
34at the time of the licensee’s license renewal. If the reasonable
35regulatory cost of operating and maintaining CURES is less than
36six dollars ($6) per licensee, the Department of Consumer Affairs
37may, by regulation, reduce the fee established by this section to
38the reasonable regulatory cost.

39(b) (1) Licensees authorized pursuant to Section 11150 of the
40Health and Safety Code to prescribe, order, administer, furnish,
P5    1or dispense Schedule II, Schedule III, or Schedule IV controlled
2substances or pharmacists licensed pursuant to Chapter 9
3(commencing with Section 4000) of Division 2.

4(2) Wholesalers and nonresident wholesalers of dangerous drugs
5licensed pursuant to Article 11 (commencing with Section 4160)
6of Chapter 9 of Division 2.

7(3) Nongovernmental clinics licensed pursuant to Article 13
8(commencing with Section 4180) and Article 14 (commencing
9with Section 4190) of Chapter 9 of Division 2.

10(4) Nongovernmental pharmacies licensed pursuant to Article
117 (commencing with Section 4110) of Chapter 9 of Division 2.

12(c) The funds collected pursuant to subdivision (a) shall be
13deposited in the CURES Fund, which is hereby created within the
14State Treasury. Moneys in the CURES Fund shall, upon
15appropriation by the Legislature, be available to the Department
16of Consumer Affairs to reimburse the Department of Justice for
17costs to operate and maintain CURES for the purposes of regulating
18the licensees specified in subdivision (b).

19(d) The Department of Consumer Affairs shall contract with
20the Department of Justice on behalf of the Medical Board of
21California, the Dental Board of California, the California State
22Board of Pharmacy, the Veterinary Medical Board, the Board of
23Registered Nursing, the Physician Assistant Board of the Medical
24Board of California, the Osteopathic Medical Board of California,
25the Naturopathic Medicine Committee of the Osteopathic Medical
26Board, the State Board of Optometry, and the California Board of
27Podiatric Medicine to operate and maintain CURES for the
28purposes of regulating the licensees specified in subdivision (b).

29

SEC. 3.  

Section 209 is added to the Business and Professions
30Code
, to read:

31

209.  

The Department of Justice, in conjunction with the
32Department of Consumer Affairs and the boards and committees
33identified in subdivision (d) of Section 208, shall do all of the
34following:

35(a) Identify and implement a streamlined application and
36approval process to provide access to the CURES Prescription
37Drug Monitoring Program (PDMP) database for licensed health
38care practitioners eligible tobegin delete prescribeend deletebegin insert prescribe, order, administer,
39furnish, or dispenseend insert
Schedule II, Schedule III, or Schedule IV
40controlled substances and for pharmacists. Every reasonable effort
P6    1shall be made to implement a streamlined application and approval
2process that a licensed health care practitioner or pharmacist can
3complete at the time that he or she is applying for licensure or
4renewing his or her license.

5(b) Identify necessary procedures to enable licensed health care
6practitioners and pharmacists with access to the CURES PDMP
7to delegate their authority to order reports from the CURES PDMP.

8(c) Develop a procedure to enable health care practitioners who
9do not have a federal Drug Enforcement Administration (DEA)
10number to opt out of applying for access to the CURES PDMP.

11

SEC. 4.  

Section 2196.8 is added to the Business and Professions
12Code
, to read:

13

2196.8.  

The board shall periodically develop and disseminate
14information and educational material regarding assessing a patient’s
15risk of abusing or diverting controlled substances and information
16relating to the Controlled Substance Utilization Review and
17Evaluation System (CURES), described in Section 11165 of the
18Health and Safety Code, to each licensed physician and surgeon
19and to each general acute care hospital in this state. The board
20shall consult with the State Department of Public Health, the boards
21and committees specified in subdivision (d) of Section 208, and
22the Department of Justice in developing the materials to be
23distributed pursuant to this section.

24

SEC. 5.  

Section 11164.1 of the Health and Safety Code is
25amended to read:

26

11164.1.  

(a) begin insert(1)end insertbegin insertend insert Notwithstanding any other provision of law,
27a prescription for a controlled substance issued by a prescriber in
28another state for delivery to a patient in another state may be
29dispensed by a California pharmacy, if the prescription conforms
30with the requirements for controlled substance prescriptions in the
31state in which the controlled substance was prescribed.

begin delete

32(b)

end delete

33begin insert(end insertbegin insert2)end insert All prescriptions for Schedule II, Schedule III, and Schedule
34IV controlled substances dispensed pursuant to this subdivision
35shall be reported by the dispensing pharmacy to the Department
36of Justice in the manner prescribed by subdivision (d) of Section
3711165.

begin insert

38(b) Pharmacies may dispense prescriptions for Schedule III,
39Schedule IV, and Schedule V controlled substances from
40out-of-state prescribers pursuant to Section 4005 of the Business
P7    1and Professions Code and Section 1717 of Title 16 of the California
2Code of Regulations.

end insert
3

SEC. 6.  

Section 11165 of the Health and Safety Code is
4amended to read:

5

11165.  

(a) To assist health care practitioners in their efforts
6to ensure appropriate prescribing, ordering, administering,
7furnishing, and dispensing of controlled substances, law
8enforcement and regulatory agencies in their efforts to control the
9diversion and resultant abuse of Schedule II, Schedule III, and
10Schedule IV controlled substances, and for statistical analysis,
11education, and research, the Department of Justice shall, contingent
12upon the availability of adequate funds in the CURES Fund,
13maintain the Controlled Substance Utilization Review and
14Evaluation System (CURES) for the electronic monitoring of, and
15Internet access to information regarding, the prescribing and
16dispensing of Schedule II, Schedule III, and Schedule IV controlled
17substances by all practitioners authorized to prescribe, order,
18administer, furnish, or dispense these controlled substances.

19(b) The Department of Justice may seek and use grant funds to
20pay the costs incurred by the operation and maintenance of
21CURES. The department shall annually report to the Legislature
22and make available to the public the amount and source of funds
23it receives for support of CURES.

24(c) (1) The operation of CURES shall comply with all
25applicable federal and state privacy and security laws and
26regulations.

27(2) CURES shall operate under existing provisions of law to
28safeguard the privacy and confidentiality of patients. Data obtained
29from CURES shall only be provided to appropriate state, local,
30and federal public agencies for disciplinary, civil, or criminal
31purposes and to other agencies or entities, as determined by the
32Department of Justice, for the purpose of educating practitioners
33and others in lieu of disciplinary, civil, or criminal actions. Data
34may be provided to public or private entities, as approved by the
35Department of Justice, for educational, peer review, statistical, or
36research purposes, provided that patient information, including
37any information that may identify the patient, is not compromised.
38Further, data disclosed to any individual or agency as described
39in this subdivision shall not be disclosed, sold, or transferred to
40any third party. The Department of Justice shall establish policies,
P8    1procedures, and regulations regarding the use, access, evaluation,
2management, implementation, operation, storage, disclosure, and
3security of the information within CURES, consistent with this
4subdivision.

5(d) For each prescription for a Schedule II, Schedule III, or
6Schedule IV controlled substance, as defined in the controlled
7substances schedules in federal law and regulations, specifically
8Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21
9of the Code of Federal Regulations, the dispensing pharmacy,
10clinic, or other dispenser shall report the following information to
11the Department of Justice as soon as reasonably possible, but not
12more than seven days after the date a controlled substance is
13dispensed, in a format specified by the Department of Justice:

14(1) Full name, address,begin delete andend deletebegin insert and, if available,end insert telephone number
15of the ultimate user or research subject, or contact information as
16determined by the Secretary of the United States Department of
17Health and Human Services, and the gender, and date of birth of
18the ultimate user.

19(2) The prescriber’s category of licensure,begin insert license number,end insert
20 national provider identifier (NPI) number,begin insert if applicable,end insert the federal
21controlled substance registration number, and the state medical
22license number of any prescriber using the federal controlled
23substance registration number of a government-exempt facility.

24(3) Pharmacy prescription number, license number, NPI number,
25and federal controlled substance registration number.

26(4) National Drug Code (NDC) number of the controlled
27substance dispensed.

28(5) Quantity of the controlled substance dispensed.

29(6) International Statistical Classification of Diseases, 9th
30revision (ICD-9) or 10th revision (ICD-10) Code, if available.

31(7) Number of refills ordered.

32(8) Whether the drug was dispensed as a refill of a prescription
33or as a first-time request.

34(9) Date of origin of the prescription.

35(10) Date of dispensing of the prescription.

36(e) The Department of Justice may invite stakeholders to assist,
37advise, and make recommendations on the establishment of rules
38and regulations necessary to ensure the proper administration and
39enforcement of the CURES database. All prescriber and dispenser
40invitees shall be licensed by one of the boards or committees
P9    1identified in subdivision (d) of Section 208 of the Business and
2Professions Code, in active practice in California, and a regular
3user of CURES.

4(f) The Department of Justice shall, prior to upgrading CURES,
5consult with prescribers licensed by one of the boards or
6committees identified in subdivision (d) of Section 208 of the
7Business and Professions Code, one or more of the boards or
8committees identified in subdivision (d) of Section 208 of the
9Business and Professions Code, and any other stakeholder
10identified by the department, for the purpose of identifying
11desirable capabilities and upgrades to the CURES Prescription
12Drug Monitoring Program (PDMP).

13(g) The Department of Justice may establish a process to educate
14authorized subscribers of the CURES PDMP on how to access and
15use the CURES PDMP.

16

SEC. 7.  

Section 11165.1 of the Health and Safety Code is
17amended to read:

18

11165.1.  

(a) (1) begin insert(A)end insertbegin insertend insertbegin insert(i)end insertbegin insertend insertA health care practitioner authorized
19to prescribe, order, administer, furnish, or dispense Schedule II,
20Schedule III, or Schedule IV controlled substances pursuant to
21Section 11150begin delete or a pharmacistend delete shall, before January 1, 2016, or
22upon receipt of a federal Drug Enforcement Administration (DEA)
23registration, whichever occurs later, submit an application
24developed by the Department of Justice to obtain approval to access
25information online regarding the controlled substance history of
26a patient that is stored on the Internet and maintained within the
27Department of Justice, and, upon approval, the department shall
28release to that practitionerbegin delete or pharmacistend delete the electronic history of
29controlled substances dispensed to an individual under his or her
30care based on data contained in the CURES Prescription Drug
31Monitoring Program (PDMP).

begin insert

32(ii) A pharmacist shall, before January 1, 2016, or upon
33 licensure, whichever occurs later, submit an application developed
34by the Department of Justice to obtain approval to access
35information online regarding the controlled substance history of
36a patient that is stored on the Internet and maintained within the
37Department of Justice, and, upon approval, the department shall
38release to that pharmacist the electronic history of controlled
39substances dispensed to an individual under his or her care based
40on data contained in the CURES PDMP.

end insert
begin delete

P10   1(A)

end delete

2begin insert(B)end insert An application may be denied, or a subscriber may be
3suspended, for reasons which include, but are not limited to, the
4following:

5(i) Materially falsifying an application for a subscriber.

6(ii) Failure to maintain effective controls for access to the patient
7activity report.

8(iii) Suspended or revoked federal DEA registration.

9(iv) Any subscriber who is arrested for a violation of law
10governing controlled substances or any other law for which the
11possession or use of a controlled substance is an element of the
12crime.

13(v) Any subscriber accessing information for any other reason
14than caring for his or her patients.

begin delete

15(B)

end delete

16begin insert(C)end insert Any authorized subscriber shall notify the Department of
17Justice within 30 days of any changes to the subscriber account.

18(2) A health care practitioner authorized tobegin delete prescribeend deletebegin insert prescribe,
19order, administer, furnish, or dispenseend insert
Schedule II, Schedule III,
20or Schedule IV controlled substances pursuant to Section 11150
21or a pharmacist shall be deemed to have complied with paragraph
22(1) if the licensed health care practitioner or pharmacist has been
23approved to access the CURES database through the process
24developed pursuant to subdivision (a) of Section 209 of the
25Business and Professions Code.

26(b) Any request for, or release of, a controlled substance history
27pursuant to this section shall be made in accordance with guidelines
28developed by the Department of Justice.

29(c) In order to prevent the inappropriate, improper, or illegal
30use of Schedule II, Schedule III, or Schedule IV controlled
31substances, the Department of Justice may initiate the referral of
32the history of controlled substances dispensed to an individual
33based on data contained in CURES to licensed health care
34practitioners, pharmacists, or both, providing care or services to
35the individual.

36(d) The history of controlled substances dispensed to an
37individual based on data contained in CURES that is received by
38a practitioner or pharmacist from the Department of Justice
39pursuant to this section shall be considered medical information
40subject to the provisions of the Confidentiality of Medical
P11   1Information Act contained in Part 2.6 (commencing with Section
256) of Division 1 of the Civil Code.

3(e) Information concerning a patient’s controlled substance
4history provided to a prescriber or pharmacist pursuant to this
5section shall include prescriptions for controlled substances listed
6in Sections 1308.12, 1308.13, and 1308.14 of Title 21 of the Code
7of Federal Regulations.

8

SEC. 8.  

Sectionbegin delete 11165.4end deletebegin insert 11165.5end insert is added to the Health and
9Safety Code
, to read:

10

begin delete11165.4.end delete
11begin insert11165.5.end insert  

(a) The Department of Justice may seek voluntarily
12contributed private funds from insurers, health care service plans,
13qualified manufacturers, and other donors for the purpose of
14supporting CURES. Insurers, health care service plans, qualified
15manufacturers, and other donors may contribute by submitting
16their payment to the Controller for deposit into the CURES Fund
17established pursuant to subdivision (c) of Section 208 of the
18Business and Professions Code. The department shall make
19information about the amount and the source of all private funds
20it receives for support of CURES available to the public.
21Contributions to the CURES Fund pursuant to this subdivision
22shall be nondeductible for state tax purposes.

23(b) For purposes of this section, the following definitions apply:

24(1) “Controlled substance” means a drug, substance, or
25immediate precursor listed in any schedule in Section 11055,
2611056, or 11057 of the Health and Safety Code.

27(2) “Health care service plan” means an entity licensed pursuant
28to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter
292.2 (commencing with Section 1340) of Division 2 of the Health
30and Safety Code).

31(3) “Insurer” means an admitted insurer writing health insurance,
32as defined in Section 106 of the Insurance Code, and an admitted
33insurer writing workers’ compensation insurance, as defined in
34Section 109 of the Insurance Code.

35(4) “Qualified manufacturer” means a manufacturer of a
36controlled substance, but does not mean a wholesaler or nonresident
37wholesaler of dangerous drugs, regulated pursuant to Article 11
38(commencing with Section 4160) of Chapter 9 of Division 2 of
39the Business and Professions Code, a veterinary food-animal drug
40retailer, regulated pursuant to Article 15 (commencing with Section
P12   14196) of Chapter 9 of Division 2 of the Business and Professions
2Code, or an individual regulated by the Medical Board of
3California, the Dental Board of California, the California State
4Board of Pharmacy, the Veterinary Medical Board, the Board of
5Registered Nursing, the Physician Assistant Committee of the
6Medical Board of California, the Osteopathic Medical Board of
7California, the State Board of Optometry, or the California Board
8of Podiatric Medicine.



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