BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 360| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ UNFINISHED BUSINESS Bill No: SB 360 Author: DeSaulnier (D) Amended: 7/7/11 Vote: 21 SENATE PUBLIC SAFETY COMMITTEE : 7-0, 5/3/11 AYES: Hancock, Anderson, Calderon, Harman, Liu, Price, Steinberg SENATE APPROPRIATIONS COMMITTEE : 9-0, 5/26/11 AYES: Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley, Price, Runner, Steinberg SENATE FLOOR : 39-0, 6/2/11 (Consent) AYES: Alquist, Anderson, Berryhill, Blakeslee, Calderon, Cannella, Corbett, Correa, De León, DeSaulnier, Dutton, Emmerson, Evans, Fuller, Gaines, Hancock, Harman, Hernandez, Huff, Kehoe, La Malfa, Leno, Lieu, Liu, Lowenthal, Negrete McLeod, Padilla, Pavley, Price, Rubio, Simitian, Steinberg, Strickland, Vargas, Walters, Wolk, Wright, Wyland, Yee NO VOTE RECORDED: Runner ASSEMBLY FLOOR : 78-0, 9/7/11 - See last page for vote SUBJECT : Controlled substances SOURCE : Attorney General DIGEST : This bill makes certain changes to the law CONTINUED SB 360 Page 2 regarding security printers for prescription forms for controlled substance prescriptions, as specified. This bill establishes the Controlled Substance Utilization Review and Evaluation System revise Prescription Drug Monitoring Program to allow controlled substance subscribers and pharmacists to have Internet access to the controlled substance prescription history of persons under their care, as specified. Assembly Amendments add language relative to reporting the theft or loss of prescription forms. ANALYSIS : Existing law includes the Controlled Substance Utilization Review and Evaluation System (CURES) system of electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provide for the electronic transmission of Schedule II, III and IV prescription data to the Department of Justice (DOJ) at the time prescriptions are dispensed. (Health & Safety Code Section 11165.) Existing law states that the purpose of CURES is to assist law enforcement and regulatory agencies in controlling diversion and abuse of Schedule II, III and IV controlled substances and for statistical analysis, education and research. (Health & Safety Code Section 11165, subdivision (a).) Existing law provides that pharmacists, in filling a controlled substance prescription, shall provide to DOJ the patient's name, date of birth, the name, form, strength and quantity of the drug, and the pharmacy name, pharmacy number and the prescribing physician information. (Health & Safety Code Section 11165, subdivision (d).) Existing law provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, may make a written request to the DOJ for the history of controlled substances dispensed to an individual based on the data in CURES. (Health & Safety Code Section 11165.1, subdivision (a).) Existing law provides that the DOJ may initiate the referral of the history controlled substances dispensed to SB 360 Page 3 an individual, based on the CURES data, to licensed health care practitioners and pharmacists, as specified. (Health & Safety Code Section 11165.1, subdivision (b).) Existing law provides that the history of controlled substances dispensed to a patient based on CURES data that is received by a practitioner or pharmacist shall be considered medical information, as specified. (Health & Safety Code Section 11165.1, subdivision (c).) Existing law provides that CURES data "shall only be provided to appropriate state, local and federal persons or public agencies for disciplinary, civil or criminal purposes." CURES data shall also only be provided, as determined by DOJ, to other agencies or entities for educating practitioners and others, in lieu of disciplinary, civil or criminal actions. (Health & Safety Code Section 11165 subdivision (b).) Existing law allows non-identifying CURES data to be provided to public and private entities for education, research, peer review and statistical analysis. (Health & Safety Code Section 11165, subdivision (c).) Existing law provides that prescriptions for controlled substances must be made on special security forms to prevent copying or forgery of prescriptions. (Health & Safety Code Section 11162.1.) Existing law requires health practitioners who prescribe or administer a controlled substance classified in Schedule II to make a record containing the name and address of the patient, date, and the character, name, strength, and quantity of the controlled substance prescribed, as well as the pathology and purpose for which the controlled substance was administered or prescribed. (Health & Safety Code Section 11190, subdivision (a)-(b).) Existing law requires prescribers who are authorized to dispense Schedule II, III or IV controlled substance in their office or place of practice to record and maintain information for each such prescription that includes the patient's name, address, gender, and date of birth, prescriber's license and license number, federal controlled SB 360 Page 4 substance registration number, state medical license number, National Drug Code number of the controlled substance dispensed, quantity dispensed, diagnosis code, if available, and original date of dispensing. This information shall be provided to DOJ on a monthly basis. (Health & Safety Code Section 11190 subd. (c).) This bill provides that any security prescription form printer shall provide DOJ with the following information: the names and addresses of an owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms. This bill provides that a security printer shall inform DOJ if any owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms has been convicted of, or pleaded no contest, any crime. This bill directs DOJ to inform any owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms how to provide fingerprints and other required information to DOJ for criminal background checks. This bill requires that controlled substance forms shall be provided in person only to established customers. The printer shall obtain the customer's photo identification and log the information. Controlled substance forms shall only be mailed to an address verified by the Drug Enforcement Agency (DEA) or Medical Board of California. This bill requires security printers to report theft of loss of controlled substance prescription forms to DOJ by fax or e-mail within 24 hours. This bill requires DOJ to impose sanctions on security printers who violate applicable statutes and regulations, as specified. This bill provides that the following security printer SB 360 Page 5 violations are subject to a fine of up to $1,000 for a first violation, a fine of up to $2,500 for each subsequent violation; a printer who violates these rules for a third time is subject to disciplinary proceeding for suspension or revocation of security printer status: Failure to comply with guidelines. Failure to take reasonable precautions to prevent dishonest or illegal actions concerning control of controlled substance forms. Theft or fraudulent use of a prescriber's identity to obtain forms. This bill establishes the Prescription Drug Monitoring Program (PDMP), with the following features: Any practitioner licensed to prescribe Schedules II through IV controlled substances or pharmacist may apply to participate in the PMDP, as specified. Under the PMDP the participating practitioner or pharmacist (subscriber) may access, using the Internet, the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in CURES. A practitioner or pharmacist PDMP subscriber may access through the PDMP the number, amount, and type of controlled substances being dispensed to an individual under his or her care, in order to control the diversion and resultant abuse of, and to ensure the safe and lawful dispensing of, Schedule II, Schedule III, and Schedule IV controlled substances. DOJ may release to the subscribing practitioner or pharmacist the electronic history of controlled substances dispensed to a person under the care of the practitioner or pharmacist based on data in the CURES Prescription Drum Monitoring Program (PDMP). This bill provides that an application may be denied, or a subscriber suspended, for any of the following: SB 360 Page 6 Materially falsifying an application. Failing to maintain effective controls for access to the patient activity report. Suspended or revoked DEA registration. Arrest of a subscriber for a controlled substance offense. Accessing information for any reason except patient care. This bill provides that an authorized subscriber shall notify DOJ within 10 days of any changes to the subscriber account. This bill allows, until July 12, 2012, a health care practitioner or pharmacist to make a written request for controlled substance history information about a person under the care of the practitioner or pharmacist, in order to provide sufficient time for subscribers to apply for access to PDMP. This bill provides that DOJ may audit the PDMP system and its users. This bill provides that DOJ may establish, by regulation, a system for issuing a citation to a PDMP subscriber. This bill provides that the citation may contain an order or abatement or to pay a fine if the subscriber is in violation of the CURES-PDMP statutes or corresponding regulations: Citations shall be written and particularly describe the violation, including a specific citation of the statute or regulation violated. When appropriate, the citation shall include a reasonable time for abatement of the violation. An administrative fine shall not exceed $2,500 for each violation and shall be based on the gravity of the violation, the good faith of the subscriber and any previous violations. SB 360 Page 7 The citation shall inform the subscriber that he/she may, within 30 days of receiving a citation, request a hearing. A subscriber may, within 10 days of receiving a citation, request in writing an informal conference with DOJ. DOJ may, pursuant to the conference, affirm, modify or dismiss the citation. If the citation is affirmed, the subscriber may request a formal hearing. If the citation is modified, the original citation shall be deemed withdrawn and a new citation issued. The subscriber may request a formal hearing on the subsequent citation. Failure to pay a fine within 30 days, or to comply with an order of abatement within the time prescribed to do so, may result in disciplinary action by DOJ, unless the citation is being appealed. If the citation is not contested and the fine is not paid, the subscriber's account will be terminated. A citation may be issued without a fine. Fines may be limited to particular violations. If a fine is paid, payment shall represent satisfactory resolution of the matter for public disclosure. Administrative fines shall be deposited in the CURES Program Special Fund and "shall provide support for costs association with hearings, maintenance, and updates to the ÝPDMP]." These sanctions shall be in separate form and in addition to any other administrative, civil or criminal remedies. A criminal action may not be initiated for a specific offense if a citation has been issued for that matter. A citation may not be issued for a specific offense, if SB 360 Page 8 a criminal action has been filed for that violation. However, nothing in the citation provisions shall prevent DOJ from prosecuting a suspension or revocation of a subscriber. Provides that the theft or loss of prescription forms must be reported immediately by the security printer or affected prescriber to the CURES Prescription Drug Monitoring Program. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes According to the Senate Appropriations Committee: Fiscal Impact (in thousands) Major Provisions 2011-12 2012-13 2013-14 Funds Regulation development Unknown; significant costs in the General and establishment of hundreds of thousands; future offset Special* system for regulation of in whole or in part by fine/fee revenue PDMP access Expanded security Unknown, enforcement costs fully Special* printer requirementsoffset by fee/fine revenue and fines PDMP maintenance Potential minor cost pressure to Special** contracts existing contracts *CURES Program Special Fund **Contingent Fund of Medical Board, Pharmacy Board Contingent Fund, State Dentistry Fund, Board of Registered Nursing Fund, Osteopathic Medical Board Contingent Fund SUPPORT : (Verified 9/7/11) SB 360 Page 9 Attorney General (source) California Narcotic Officers Association California Peace Officers Research Association California Police Chiefs Association California State Sheriffs' Association California Statewide Law Enforcement Association Consumer Attorneys of California Los Angeles County District Attorney's Office ARGUMENTS IN SUPPORT : According to the author's office, due to the rise in prescription drug abuse, controlled drugs prescription history information is available and maintained by the DOJ CURES program. In 2009, the DOJ launched an automated PDMP. The program allows licensed health care practitioners eligible to prescribe controlled substances access to patient controlled substance prescription information. Prescribers and pharmacists can now make informed decisions about patient care and detect patients who may be abusing controlled substances by obtaining multiple prescriptions from various practitioners. Current efforts at maintaining privacy and control of CURES data are inadequate to protect confidential patient information and to deter its misuse. The DOJ also manages the California Security Prescription Printer Program. While DOJ has established guidelines for the security of prescription forms, current law lacks sufficient safeguards against theft and fraudulent use of prescription pads. The DOJ has seen an increase in criminal enterprises involved in prescription theft and fraud. ASSEMBLY FLOOR : 78-0, 9/7/11 AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, Brownley, Buchanan, Butler, Charles Calderon, Campos, Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Roger Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell, Monning, Morrell, Nestande, Nielsen, Norby, SB 360 Page 10 Olsen, Pan, Perea, V. Manuel Pérez, Portantino, Silva, Skinner, Smyth, Solorio, Swanson, Torres, Valadao, Wagner, Wieckowski, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Furutani, Gorell RJG:do 9/8/11 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****