Bill Text: CA SB360 | 2011-2012 | Regular Session | Enrolled
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Controlled Substance Utilization Review and Evaluation
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2011-10-02 - Chaptered by Secretary of State. Chapter 418, Statutes of 2011. [SB360 Detail]
Download: California-2011-SB360-Enrolled.html
Bill Title: Controlled Substance Utilization Review and Evaluation
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Passed) 2011-10-02 - Chaptered by Secretary of State. Chapter 418, Statutes of 2011. [SB360 Detail]
Download: California-2011-SB360-Enrolled.html
BILL NUMBER: SB 360 ENROLLED BILL TEXT PASSED THE SENATE SEPTEMBER 9, 2011 PASSED THE ASSEMBLY SEPTEMBER 7, 2011 AMENDED IN ASSEMBLY JULY 7, 2011 AMENDED IN SENATE MAY 10, 2011 AMENDED IN SENATE APRIL 14, 2011 AMENDED IN SENATE MARCH 22, 2011 INTRODUCED BY Senator DeSaulnier FEBRUARY 15, 2011 An act to amend Sections 11161.5, 11162.1, 11165, and 11165.1 of, and to add Sections 11165.2 and 11165.3 to, the Health and Safety Code, relating to controlled substances. LEGISLATIVE COUNSEL'S DIGEST SB 360, DeSaulnier. Controlled Substance Utilization Review and Evaluation System. Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice, contingent upon the availability of adequate funds from various funds related to health care, as specified, 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 defines a security printer as a person approved to produce controlled substance prescription forms. Existing law requires that prescription forms for controlled substance prescriptions be obtained from security printers approved by the Department of Justice. These provisions authorize the department to approve a security printer who provides specified information to the department, including the location, names, and titles of the applicant's agent for service of process, all principal corporate officers, if any, and all managing general partners, if any. Existing law also requires those persons to provide a signed statement indicating whether they have ever been convicted of, or pled no contest to, a violation of any law or ordinance. Existing law authorizes the department to revoke its approval of a security printer for a violation of these provisions or action that would permit a denial. This bill would expand those requirements imposed on an applicant for approval as a security printer to additionally require the applicant to provide the location, names, and titles of any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms and require those persons to submit the signed statement described above. The bill would also make conforming and related changes. In addition, the bill would require that controlled substance prescription forms provided in person be restricted to established customers. The bill would require security printers to obtain photo identification from the customer and maintain a log of the information, and to report any theft or loss of controlled substance prescription forms to the department via fax or e-mail within 24 hours of the incident. The bill would also require that controlled substance prescription forms be shipped only to the prescriber's address on file and verified with the federal Drug Enforcement Administration or the Medical Board of California. The bill would specify penalties for certain violations, including, among others, failure to comply with security printer guidelines, failure to take reasonable precautions to prevent any dishonest act or illegal activity related to the access and control of security prescription forms, and theft or fraudulent use of a prescriber's identity in order to obtain security prescription forms. By creating new crimes, this bill would impose a state-mandated local program. Existing law governs the prescription forms for controlled substances. Among other things, the forms are required to include the preprinted name, category of licensure, license number, and federal controlled substance registration number of the prescribing practitioner. This bill would also require the forms to include the address of the prescribing practitioner. The bill would make an additional change relating to forms ordered for use by prescribers when treating patients in licensed health care facilities or certain clinics that are exempt from other requirements governing these forms. The bill would provide that prescription forms that are not in compliance with these provisions shall not be accepted after July 1, 2012. The bill would establish a specified process by which a licensed health care practitioner or a pharmacist may obtain approval to access information stored on the Internet regarding the controlled substance history of a patient, as specified. The bill would require that the theft or loss of prescription forms be reported immediately to the department, as specified. The bill would also require the department to conduct audits of the CURES prescription drug monitoring system and authorize the department to establish a system for issuing citations, and for assessing and imposing administrative fines, not to exceed $2,500 for each violation, that would be deposited in the CURES Program Special Fund, for violations of the program, as specified. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 11161.5 of the Health and Safety Code is amended to read: 11161.5. (a) Prescription forms for controlled substance prescriptions shall be obtained from security printers approved by the Department of Justice. (b) The department may approve security printer applications after the applicant has provided the following information: (1) Name, address, and telephone number of the applicant. (2) Policies and procedures of the applicant for verifying the identity of the prescriber ordering controlled substance prescription forms. (3) Policies and procedures of the applicant for verifying delivery of controlled substance prescription forms to prescribers. (4) (A) The location, names, and titles of the applicant's agent for service of process in this state; all principal corporate officers, if any; all managing general partners, if any; and any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms. (B) A report containing this information shall be made on an annual basis and within 30 days after any change of office, principal corporate officers, managing general partner, or of any person described in subparagraph (A). (5) (A) A signed statement indicating whether the applicant, any principal corporate officer, any managing general partner, or any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms, has ever been convicted of, or pled no contest to, a violation of any law of a foreign country, the United States, or any state, or of any local ordinance. (B) The department shall provide the applicant and any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor of the applicant who has direct access to, or management or control of, controlled substance prescription forms, with the means and direction to provide fingerprints and related information, in a manner specified by the department, for the purpose of completing state, federal, or foreign criminal background checks. (C) Any applicant described in subdivision (b) shall submit his or her fingerprint images and related information to the department, for the purpose of the department obtaining information as to the existence and nature of a record of state, federal, or foreign level convictions and state, federal, or foreign level arrests for which the department establishes that the applicant was released on bail or on his or her own recognizance pending trial, as described in subdivision (l) of Section 11105 of the Penal Code. Requests for federal level criminal offender record information received by the department pursuant to this section shall be forwarded to the Federal Bureau of Investigation by the department. (D) The department shall assess against each security printer applicant a fee determined by the department to be sufficient to cover all processing, maintenance, and investigative costs generated from or associated with completing state, federal, or foreign background checks and inspections of security printers pursuant to this section with respect to that applicant; the fee shall be paid by the applicant at the time he or she submits the security printer application, fingerprints, and related information to the department. (E) The department shall retain fingerprint impressions and related information for subsequent arrest notification pursuant to Section 11105.2 of the Penal Code for all applicants. (c) The department may, within 60 calendar days of receipt of the application from the applicant, deny the security printer application. (d) The department may deny a security printer application on any of the following grounds: (1) The applicant, any individual owner, partner, corporate officer, manager, agent, representative, employee, or subcontractor for the applicant, who has direct access, management, or control of controlled substance prescription forms, has been convicted of a crime. A conviction within the meaning of this paragraph means a plea or verdict of guilty or a conviction following a plea of nolo contendere. Any action which a board is permitted to take following the establishment of a conviction may be taken when the time for appeal has elapsed, the judgment of conviction has been affirmed on appeal, or when an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under the provisions of Section 1203.4 of the Penal Code. (2) The applicant committed any act involving dishonesty, fraud, or deceit with the intent to substantially benefit himself, herself, or another, or substantially injure another. (3) The applicant committed any act that would constitute a violation of this division. (4) The applicant knowingly made a false statement of fact required to be revealed in the application to produce controlled substance prescription forms. (5) The department determines that the applicant failed to demonstrate adequate security procedures relating to the production and distribution of controlled substance prescription forms. (6) The department determines that the applicant has submitted an incomplete application. (7) As a condition for its approval as a security printer, an applicant shall authorize the Department of Justice to make any examination of the books and records of the applicant, or to visit and inspect the applicant during business hours, to the extent deemed necessary by the board or department to properly enforce this section. (e) An approved applicant shall submit an exemplar of a controlled substance prescription form, with all security features, to the Department of Justice within 30 days of initial production. (f) The department shall maintain a list of approved security printers and the department shall make this information available to prescribers and other appropriate government agencies, including the Board of Pharmacy. (g) Before printing any controlled substance prescription forms, a security printer shall verify with the appropriate licensing board that the prescriber possesses a license and current prescribing privileges which permits the prescribing of controlled substances with the federal Drug Enforcement Administration (DEA). (h) Controlled substance prescription forms shall be provided directly to the prescriber either in person, by certified mail, or by a means that requires a signature signifying receipt of the package and provision of that signature to the security printer. Controlled substance prescription forms provided in person shall be restricted to established customers. Security printers shall obtain a photo identification from the customer and maintain a log of this information. Controlled substance prescription forms shall be shipped only to the prescriber's address on file and verified with the federal Drug Enforcement Administration or the Medical Board of California. (i) Security printers shall retain ordering and delivery records in a readily retrievable manner for individual prescribers for three years. (j) Security printers shall produce ordering and delivery records upon request by an authorized officer of the law as defined in Section 4017 of the Business and Professions Code. (k) Security printers shall report any theft or loss of controlled substance prescription forms to the Department of Justice via fax or e-mail within 24 hours of the theft or loss. (l) (1) The department shall impose restrictions, sanctions, or penalties, subject to subdivisions (m) and (n), against security printers who are not in compliance with this division pursuant to regulations implemented pursuant to this division and shall revoke its approval of a security printer for a violation of this division or action that would permit a denial pursuant to subdivision (d) of this section. (2) When the department revokes its approval, it shall notify the appropriate licensing boards and remove the security printer from the list of approved security printers. (m) The following violations by security printers shall be punishable pursuant to subdivision (n): (1) Failure to comply with the Security Printer Guidelines established by the Security Printer Program as a condition of approval. (2) Failure to take reasonable precautions to prevent any dishonest act or illegal activity related to the access and control of security prescription forms. (3) Theft or fraudulent use of a prescriber's identity in order to obtain security prescription forms. (n) A security printer approved pursuant to subdivision (b) shall be subject to the following penalties for actions leading to the denial of a security printer application specified in subdivision (d) or for a violation specified in subdivision (m): (1) For a first violation, a fine not to exceed one thousand dollars ($1,000). (2) For a second or subsequent violation, a fine not to exceed two thousand five hundred dollars ($2,500) for each violation. (3) For a third or subsequent violation, a filing of an administrative disciplinary action seeking to suspend or revoke security printer approval. SEC. 2. Section 11162.1 of the Health and Safety Code is amended to read: 11162.1. (a) The prescription forms for controlled substances shall be printed with the following features: (1) A latent, repetitive "void" pattern shall be printed across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word "void" shall appear in a pattern across the entire front of the prescription. (2) A watermark shall be printed on the backside of the prescription blank; the watermark shall consist of the words "California Security Prescription." (3) A chemical void protection that prevents alteration by chemical washing. (4) A feature printed in thermochromic ink. (5) An area of opaque writing so that the writing disappears if the prescription is lightened. (6) A description of the security features included on each prescription form. (7) (A) Six quantity check off boxes shall be printed on the form so that the prescriber may indicate the quantity by checking the applicable box where the following quantities shall appear: 1-24 25-49 50-74 75-100 101-150 151 and over. (B) In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form. (8) Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the "Prescription is void if the number of drugs prescribed is not noted." (9) The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner. (10) Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered. (11) The date of origin of the prescription. (12) A check box indicating the prescriber's order not to substitute. (13) An identifying number assigned to the approved security printer by the Department of Justice. (14) (A) A check box by the name of each prescriber when a prescription form lists multiple prescribers. (B) Each prescriber who signs the prescription form shall identify himself or herself as the prescriber by checking the box by his or her name. (b) Each batch of controlled substance prescription forms shall have the lot number printed on the form and each form within that batch shall be numbered sequentially beginning with the numeral one. (c) (1) A prescriber designated by a licensed health care facility, a clinic specified in Section 1200, or a clinic specified in subdivision (a) of Section 1206 that has 25 or more physicians or surgeons may order controlled substance prescription forms for use by prescribers when treating patients in that facility without the information required in paragraph (9) of subdivision (a) or paragraph (3) of this subdivision. (2) Forms ordered pursuant to this subdivision shall have the name, category of licensure, license number, and federal controlled substance registration number of the designated prescriber and the name, address, category of licensure, and license number of the licensed health care facility the clinic specified in Section 1200, or the clinic specified in Section 1206 that has 25 or more physicians or surgeons preprinted on the form. Licensed health care facilities or clinics exempt under Section 1206 are not required to preprint the category of licensure and license number of their facility or clinic. (3) Forms ordered pursuant to this section shall not be valid prescriptions without the name, category of licensure, license number, and federal controlled substance registration number of the prescriber on the form. (4) (A) Except as provided in subparagraph (B), the designated prescriber shall maintain a record of the prescribers to whom the controlled substance prescription forms are issued, that shall include the name, category of licensure, license number, federal controlled substance registration number, and quantity of controlled substance prescription forms issued to each prescriber. The record shall be maintained in the health facility for three years. (B) Forms ordered pursuant to this subdivision that are printed by a computerized prescription generation system shall not be subject to subparagraph (A) or paragraph (7) of subdivision (a). Forms printed pursuant to this subdivision that are printed by a computerized prescription generation system may contain the prescriber's name, category of professional licensure, license number, federal controlled substance registration number, and the date of the prescription. (d) This section shall become operative on January 1, 2012. Prescription forms not in compliance with this division shall not be valid or accepted after July 1, 2012. SEC. 3. Section 11165 of the Health and Safety Code is amended to read: 11165. (a) To assist law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, and Schedule IV controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds from the Contingent Fund of the Medical Board of California, the Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board of Registered Nursing Fund, and the Osteopathic Medical Board of California Contingent Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and Internet access to information regarding, 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. (b) The reporting of Schedule III and Schedule IV controlled substance prescriptions to CURES shall be contingent upon the availability of adequate funds from the Department of Justice. The department may seek and use grant funds to pay the costs incurred from the reporting of controlled substance prescriptions to CURES. Funds shall not be appropriated from the Contingent Fund of the Medical Board of California, the Pharmacy Board Contingent Fund, the State Dentistry Fund, the Board of Registered Nursing Fund, the Naturopathic Doctor's Fund, or the Osteopathic Medical Board of California Contingent Fund to pay the costs of reporting Schedule III and Schedule IV controlled substance prescriptions to CURES. (c) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal persons or public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the Department of Justice, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the Department of Justice, for educational, peer review, statistical, or research purposes, provided that patient information, including any information that may identify the patient, is not compromised. Further, data disclosed to any individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to any third party. (d) For each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy or clinic shall provide the following information to the Department of Justice on a weekly basis and in a format specified by the Department of Justice: (1) Full name, address, and the telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender, and date of birth of the ultimate user. (2) The prescriber's category of licensure and license number; federal controlled substance registration number; and the state medical license number of any prescriber using the federal controlled substance registration number of a government-exempt facility. (3) Pharmacy prescription number, license number, and federal controlled substance registration number. (4) NDC (National Drug Code) number of the controlled substance dispensed. (5) Quantity of the controlled substance dispensed. (6) ICD-9 (diagnosis code), if available. (7) Number of refills ordered. (8) Whether the drug was dispensed as a refill of a prescription or as a first-time request. (9) Date of origin of the prescription. (10) Date of dispensing of the prescription. (e) This section shall become operative on January 1, 2005. SEC. 4. Section 11165.1 of the Health and Safety Code is amended to read: 11165.1. (a) (1) A licensed health care practitioner eligible to prescribe Schedule II, Schedule III, or Schedule IV controlled substances or a pharmacist may provide a notarized application developed by the Department of Justice to obtain approval to access information stored on the Internet regarding the controlled substance history of a patient maintained within the Department of Justice, and the department may release to that practitioner or pharmacist, the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP). (A) An application may be denied, or a subscriber may be suspended, for reasons which include, but are not limited to, the following: (i) Materially falsifying an application for a subscriber. (ii) Failure to maintain effective controls for access to the patient activity report. (iii) Suspended or revoked federal Drug Enforcement Administration (DEA) registration. (iv) Any subscriber who is arrested for a violation of law governing controlled substances or any other law for which the possession or use of a controlled substance is an element of the crime. (v) Any subscriber accessing information for any other reason than caring for his or her patients. (B) Any authorized subscriber shall notify the Department of Justice within 10 days of any changes to the subscriber account. (2) To allow sufficient time for licensed health care practitioners eligible to prescribe Schedule II, Schedule III, or Schedule IV controlled substances and a pharmacist to apply and receive access to PDMP, a written request may be made, until July 1, 2012, and the Department of Justice may release to that practitioner or pharmacist the history of controlled substances dispensed to an individual under his or her care based on data contained in CURES. (b) Any request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the Department of Justice. (c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, or Schedule IV controlled substances, the Department of Justice may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual. (d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the Department of Justice pursuant to this section shall be considered medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code. (e) Information concerning a patient's controlled substance history provided to a prescriber or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, and 1308.14 of Title 21 of the Code of Federal Regulations. SEC. 5. Section 11165.2 is added to the Health and Safety Code, to read: 11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users. (b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter. (c) The system shall contain the following provisions: (1) Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated. (2) Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation. (3) In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations. (4) An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code. (5) In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation. (6) Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated: (A) A citation may be issued without the assessment of an administrative fine. (B) Assessment of administrative fines may be limited to only particular violations of law or department regulations. (d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure. (e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program. (f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed. (g) Nothing in this section shall be deemed to prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist. SEC. 6. Section 11165.3 is added to the Health and Safety Code, to read: 11165.3. The theft or loss of prescription forms shall be reported immediately by the security printer or affected prescriber to the CURES Prescription Drug Monitoring Program, but no later than three days after the discovery of the theft or loss. This notification may be done in writing utilizing the Bureau of Narcotic Enforcement 1175 Reporting Theft/Loss Form or may be reported by the authorized subscriber through the CURES Prescription Drug Monitoring Program. SEC. 7. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.