BILL ANALYSIS Ó SB 360 Page 1 Date of Hearing: July 5, 2011 Counsel: Sandy Uribe ASSEMBLY COMMITTEE ON PUBLIC SAFETY Tom Ammiano, Chair SB 360 (DeSaulnier) - As Amended: May 10, 2011 As Proposed to be Amended in Committee SUMMARY : Makes changes to the Controlled Substance Utilization Review and Evaluation System (CURES) and the Prescription Drug Monitoring Program (PDMP). Specifically, this bill : 1)Expands the requirements imposed on security-printer applicants to print prescription forms for controlled substance prescriptions to include the names and addresses of any individual owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms; a signed statement regarding any prior criminal convictions for these parties, and fingerprints for the same. 2)Clarifies that the fee assessed by the Department of Justice (DOJ) to process the application of a security printer shall be sufficient to cover inspections of security printers in addition to the other costs specified by statutes. 3)Requires that controlled substance forms shall be provided in person only to established customers. 4)Requires a security printer to obtain the customer's photo identification and log the information. 5)Limits the mailing of controlled substance only to an address verified by the Drug Enforcement Agency (DEA) or Medical Board of California. 6)Requires a security printer to report the theft or loss of controlled substance prescription forms to DOJ within 24 hours of its occurrence. 7)Requires DOJ to impose sanctions on security printers who SB 360 Page 2 violate applicable statutes and regulations, including failure to comply with guidelines, failure to take reasonably precautions to prevent dishonest or illegal actions with regard to the access and control of security prescription forms, and the theft or fraudulent use of a prescriber's identity to obtain forms. 8)Specifies that the sanctions for a violation of applicable statutes and regulations are a fine of up to $1,000 for a first violation, a fine of up to $2,500 for a second or subsequent violation; disciplinary proceedings for suspension or revocation of security printer status for third or subsequent violations. 9)Modifies the PDMP to include the following features: a) Allows any practitioner licensed to prescribe controlled substances of Schedules II-IV or any pharmacist to apply to participate in the PDMP, as specified; and, b) Gives the program participant Internet access to view the electronic history of controlled substances dispensed to an individual under his or her case based on data contained in CURES. 10)Provides that a PDMP application may be denied, or a subscriber suspended from the program for material falsification of an application, failure to maintain effective controls for access to the patient activity report, a suspended or revoked DEA registration, an arrest for a drug offense, or accessing information for any reason other than patient care. 11)Requires an authorized subscriber to notify DOJ within 10 days of any changes to the subscriber account. 12)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. 13)Authorizes DOJ to audit the PDMP system and its users. 14)Authorizes DOJ to establish regulations for a system to issue SB 360 Page 3 citations for unauthorized use of the CURES data by subscribers with PDMP access, and provides for orders or abatement, fines of up to $2,500 per violation, and a hearing process if a subscriber is in violation of the CURES-PDMP statutes or corresponding regulations. 15)Requires citations issued by DOJ to be in writing, to particularly describe the violation including a specific citation to the statute or regulation violated, and to notify the subscriber of the opportunities to request a hearing and/or an informal conference, and the deadlines for requesting them. 16)Provides that the failure of a subscriber to pay a fine within 30 days, or to comply with an abatement order within the time subscribed, may result in disciplinary action unless the citation is being appeal. 17)Provides that any administrative fines collected shall be deposited in the CURES Program Special Fund. 18)Specifies that the sanctions authorized pursuant to this bill shall be separate and in addition to any other administrative, civil or criminal remedies, but that a criminal action may not be initiated for a specific offense if a citation has been issued for that matter, and that if a criminal action has been filed, a citation cannot be issued for the same offense. Notwithstanding this provision, nothing shall prevent DOJ from prosecuting a suspension or revocation of a subscriber. 19)Requires an affected PMDP prescriber to immediately report the theft or loss of controlled substance prescription forms to DOJ, and specifies the reporting shall be done no later than three days after the discovery of the theft of loss. EXISTING LAW : 1)Requires health care providers to obtain prescription forms for controlled substance prescriptions from security printers approved by the DOJ. İHealth and Safety Code (HSC) Section 11161.5(a).] 2)Requires an entity applying be to security printer to include specified information in its application and to provide fingerprints for the purposes. İHSC Section 11161.5(b).] SB 360 Page 4 3)Requires DOJ to maintain the 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. İHSC Section 11165(a).] 4)Requires a dispensing pharmacy or clinic to provide specified prescription data for each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance to DOJ on a weekly basis. İHSC Section 11165(d).] 5)Allows a licensed health care practitioner who is eligible to prescribe Schedule II, Schedule III, or Schedule IV controlled substances, or a pharmacist to make a written request to DOJ for the history of controlled substances dispensed to an individual under his or her care. İHSC Section 11165.1(a)(1).] 6)Permits DOJ to give the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners and pharmacists providing care or services to the individual in order to prevent the inappropriate, improper, or illegal use of controlled substances. İHSC Section 11165.1(b).] 7)Provides that the history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from DOJ pursuant to this section shall be considered medical information subject to specified confidentiality provisions. İHSC Section 11165.1(c).] 8)Requires every practitioner, other than a pharmacist, who prescribes or administers a controlled substance classified in Schedule II, III or IV to record specified information relating to the transaction. (HSC Section 11190.) FISCAL EFFECT : Unknown COMMENTS : 1)Author's Statement : According to the author, "Due to the rise in prescription drug abuse, controlled drugs prescription history information is available and maintained by the SB 360 Page 5 Department of Justice (DOJ) CURES program. In 2009, the DOJ launched an automated Prescription Drug Monitoring Program (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. However, current efforts at maintaining privacy and control of CURES data are inadequate to protect confidential patient information and to deter its misuse. "SB 360 will help to prevent the misuse of confidential information collected through the CURES and ensure the integrity of the program and process for practitioners and pharmacists to appropriately use patient's controlled substances history information. "The DOJ manages the California Security Prescription Printer Program. While the DOJ has established guidelines for the security of prescription forms, current law lacks sufficient safeguards against theft and fraudulent use of prescription pads and the DOJ has seen an increase in criminal enterprises involved in prescription form theft and fraud. SB 360 provides additional requirements and sanctions for Security Printers to deter fraudulent use of prescription pads and the illegal distribution of controlled substances." 2)Background : The CURES was established in 1997 by AB 3042 (Takasugi), Chapter 738, Statutes of 1996, in response to recommendations of the Controlled Substance Prescription Advisory Council. (SCR 74, 1992.) The program initially was intended to electronically monitor the prescribing and dispensing of Schedule II controlled substances, such as oxycodone. The CURES provides for real-time electronic transmission of specified prescription data to DOJ. Essentially the data is analyzed for indications that controlled substances are being improperly prescribed, or that drug abusers are obtaining prescriptions from many doctors (doctor shopping). Currently, Physicians and pharmacists, have access to CURES data through patient activity reports. 3)Argument in Support : According to the Attorney General's Office , the sponsor of this bill: "Under existing law, CURES provides for electronic monitoring of the prescribing and SB 360 Page 6 dispensing of Schedule II, III and IV controlled substances. In 2009, DOJ launched the automated Prescription Drug Monitoring Program (PDMP). The program allows licenses heath care practitioners to patient controlled substance prescription information in real-time, 24 hours a day at the point of care. 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. "The PDMP is a valuable investigative, preventative, and educational tool for law enforcement, regulatory boards, and health care providers. However, current efforts at maintaining privacy and control of CURES sate are inadequate to protect confidential patient information, and to deter misuse of confidential CURES data. SB 360 authorizes DOJ to initiate administrative enforcement actions to prevent and deter misuse of confidential patient information collected through the CURES program. "Under existing law, DOJ also manages the California Security Prescription Printer Program, including approval of "Security Prescription Printer" applications. Fraudulent prescriptions are lucrative. One blank prescription pad of 500 prescriptions can generate millions of dollars from the illegal sale of controlled substances such as Oxycontin, Xanax, or Vicodin. DOJ has seen an increase in criminal enterprises, from gangs to organized crime, involved in prescription drug fraud. Current law lacks adequate safeguards against the theft and illegal distribution of prescription pads from Security Prescription Printers. SB 360 provides additional requirements and sanctions for Security Printers and their employees who have direct contact with, or access to, controlled substance prescription drug forms to deter fraudulent prescriptions and illegal distribution of controlled substances." 4)Prior Legislation : a) AB 2968 (Mullin), Chapter 286, Statutes of 2006, added more information to the requirements for a physician to prescribe a controlled substance, and required electronic monitoring of Schedule IV drugs. b) SB 734 (Torlakson), Chapter 487, Statutes of 2005, made SB 360 Page 7 various technical and clarifying changes to the CURES. c) SB 151 (Burton), Chapter 406, Statutes of 2004, made the CURES reporting system permanent d) AB 3042 (Takasugi), Chapter 738, Statutes of 1996, established CURES as a three-year pilot program. REGISTERED SUPPORT / OPPOSITION : Support Department of Justice (Sponsor) California Narcotic Officers' Association California Peace Officers' Association California Police Chiefs Association California State Sheriffs' Association California Statewide Law Enforcement Association Consumer Attorneys of California Peace Officers Research Association of California Opposition None Analysis Prepared by : Sandy Uribe / PUB. S. / (916) 319-3744