Today's Law As Amended


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SB-809 Controlled substances: reporting.(2013-2014)



As Amends the Law Today


SECTION 1.
 The Legislature finds and declares all of the following:
(a) The Controlled Substance Utilization Review and Evaluation System (CURES) is a valuable preventive, investigative, and educational tool for health care providers, regulatory agencies, educational researchers, and law enforcement. Recent budget cuts to the Attorney General’s Division of Law Enforcement have resulted in insufficient funding to support CURES and its Prescription Drug Monitoring Program (PDMP). The CURES PDMP is necessary to ensure health care professionals have the necessary data to make informed treatment decisions and to allow law enforcement to investigate diversion of prescription drugs. Without a dedicated funding source, the CURES PDMP is not sustainable.
(b) Each year CURES responds to more than 800,000 requests from practitioners and pharmacists regarding all of the following:
(1) Helping identify and deter drug abuse and diversion of prescription drugs through accurate and rapid tracking of Schedule II, Schedule III, and Schedule IV controlled substances.
(2) Helping practitioners make prescribing decisions.
(3) Helping reduce misuse, abuse, and trafficking of those drugs.
(c) Schedule II, Schedule III, and Schedule IV controlled substances have had deleterious effects on private and public interests, including the misuse, abuse, and trafficking in dangerous prescription medications resulting in injury and death. It is the intent of the Legislature to work with stakeholders to fully fund the operation of CURES which seeks to mitigate those deleterious effects and serve as a tool for ensuring safe patient care, and which has proven to be a cost-effective tool to help reduce the misuse, abuse, and trafficking of those drugs.
(d) The following goals are critical to increase the effectiveness and functionality of CURES:
(1) Upgrading the CURES PDMP so that it is capable of accepting real-time updates and is accessible in real-time, 24 hours a day, seven days a week.
(2) Upgrading the CURES PDMP in California so that it is capable of operating in conjunction with all national prescription drug monitoring programs.
(3) Providing subscribers to prescription drug monitoring programs access to information relating to controlled substances dispensed in California, including those dispensed through the United States Department of Veterans Affairs, the Indian Health Service, the Department of Defense, and any other entity with authority to dispense controlled substances in California.
(4) Upgrading the CURES PDMP so that it is capable of accepting the reporting of electronic prescription data, thereby enabling more reliable, complete, and timely prescription monitoring.

SEC. 2.

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

208.
 (a) Beginning April 1, 2014, a CURES fee of six dollars ($6) shall be assessed annually on each of the licensees specified in subdivision (b) to pay the reasonable costs associated with operating and maintaining CURES for the purpose of regulating those licensees. The fee assessed pursuant to this subdivision shall be billed and collected by the regulating agency of each licensee at the time of the licensee’s license renewal. If the reasonable regulatory cost of operating and maintaining CURES is less than six dollars ($6) per licensee, the Department of Consumer Affairs may, by regulation, reduce the fee established by this section to the reasonable regulatory cost.
(b) (1) Licensees authorized pursuant to Section 11150 of the Health and Safety Code to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances or pharmacists licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2.
(2) Wholesalers and nonresident wholesalers of dangerous drugs licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2.
(3) Nongovernmental clinics licensed pursuant to Article 13 (commencing with Section 4180) and Article 14 (commencing with Section 4190) of Chapter 9 of Division 2.
(4) Nongovernmental pharmacies licensed pursuant to Article 7 (commencing with Section 4110) of Chapter 9 of Division 2.
(c) The funds collected pursuant to subdivision (a) shall be deposited in the CURES Fund, which is hereby created within the State Treasury. Moneys in the CURES Fund shall, upon appropriation by the Legislature, be available to the Department of Consumer Affairs to reimburse the Department of Justice for costs to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).
(d) The Department of Consumer Affairs shall contract with the Department of Justice on behalf of the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Board of the Medical Board of California, the Osteopathic Medical Board of California, the Naturopathic Medicine Committee of the Osteopathic Medical Board, the State Board of Optometry, and the California Board of Podiatric Medicine to operate and maintain CURES for the purposes of regulating the licensees specified in subdivision (b).

SEC. 3.

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

209.
 The Department of Justice, in conjunction with the Department of Consumer Affairs and the boards and committees identified in subdivision (d) of Section 208, shall do all of the following:
(a) Identify and implement a streamlined application and approval process to provide access to the CURES Prescription Drug Monitoring Program (PDMP) database for licensed health care practitioners eligible to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule IV controlled substances and for pharmacists. Every reasonable effort shall 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 or 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.

SEC. 4.

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

2196.8.
 The board shall periodically develop and disseminate information and educational material regarding assessing a patient’s risk of abusing or diverting controlled substances and information relating to the Controlled Substance Utilization Review and Evaluation System (CURES), described in Section 11165 of the Health and Safety Code, to each licensed physician and surgeon and to each general acute care hospital in this state. The board shall consult with the State Department of Public Health, the boards and committees specified in subdivision (d) of Section 208, and the Department of Justice in developing the materials to be distributed pursuant to this section.

SEC. 5.

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

11164.1.
 (a) (1) Notwithstanding any other provision of  law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.
(2) A prescription All prescriptions  for a  Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance and Schedule IV controlled substances  dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.
(b) A pharmacy  Pharmacies  may dispense a prescription  prescriptions  for a  Schedule III, Schedule IV, or and  Schedule V controlled substance substances  from an  out-of-state prescriber prescribers  pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.  
(c) This section shall become operative on January 1, 2021.

SEC. 6.

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

11165.
 (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV,  and Schedule V IV  controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and internet Internet  access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV,  and Schedule V IV  controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
(b) The department  Department of Justice  may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.
(2) (A)  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 public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department,  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,  Department of Justice,  for educational, peer review, statistical, or research purposes, if  provided that  patient information, including any  information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied.  Further, data disclosed to an any  individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department  any third party. The Department of Justice  shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.  
(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.
(3) The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:
(A) The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.
(B) The purposes for which a health care practitioner may access information in CURES.
(C) The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.
(D) The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.
(4) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patient’s medical record in compliance with subdivision (d) of Section 11165.1.
(d) For each prescription for a Schedule II, Schedule III, Schedule IV,  or Schedule V IV  controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14,  and 1308.15, 1308.14,  respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor  Department of Justice  as soon as reasonably possible, but not more than one working day  seven days  after the date a controlled substance is released to the patient or patient’s representative,  dispensed,  in a format specified by the department: Department of Justice: 
(1) Full name, address, and, if available, 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 gender,  and date of birth of the ultimate user.
(2) The prescriber’s category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a any  prescriber using the federal controlled substance registration number of a government-exempt facility.
(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled substance dispensed.
(5) Quantity of the controlled substance dispensed.
(6) The  International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy,  Diseases, 9th revision (ICD-9) or 10th revision (ICD-10) 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) Prescribing date of  Date of origin of  the prescription.
(10) Date of dispensing of the prescription.
(11) The serial number for the corresponding prescription form, if applicable.
(e) The department  Department of Justice  may 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. A All  prescriber or and  dispenser invitee invitees  shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
(f) The department  Department of Justice  shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
(g) The department  Department of Justice  may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
(h) (1) The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.
(2) Data obtained from CURES may be provided to authorized users of another state’s prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.
(3) An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.
(4) For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another state’s prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that state’s prescription drug monitoring program.
(5) The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).
(i) Notwithstanding subdivision (d), a veterinarian shall report the information required by that subdivision to the department as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed.
(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.

SEC. 7.

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

11165.1.
 (a) (1) (A) (i) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV,  or Schedule V IV  controlled substances pursuant to Section 11150 shall, before January 1, 2016, or  upon receipt of a federal Drug Enforcement Administration (DEA) registration, whichever occurs later,  submit an application developed by the department  Department of Justice  to obtain approval to electronically  access information online  regarding the controlled substance history of a patient that is maintained by the department. Upon  stored on the Internet and maintained within the Department of Justice, and, upon  approval, the department shall release to the practitioner or their delegate  that practitioner  the electronic history of controlled substances dispensed to an individual under the practitioner’s  his or her  care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).
(ii) A pharmacist shall, upon licensure,  before January 1, 2016, or upon licensure, whichever occurs later,  submit an application developed by the department  Department of Justice  to obtain approval to electronically  access information online  regarding the controlled substance history of a patient that is maintained by the department. Upon  stored on the Internet and maintained within the Department of Justice, and, upon  approval, the department shall release to the pharmacist or their delegate  that pharmacist  the electronic history of controlled substances dispensed to an individual under the pharmacist’s  his or her  care based on data contained in the CURES PDMP.
(iii) A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.
(iv) The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.
(B) The department may deny an application or suspend a subscriber, for reasons that 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 to access information contained in the CURES database. for a subscriber. 
(ii) Failing Failure  to maintain effective controls for access to the patient activity report.
(iii) Having their  Suspended or revoked  federal DEA registration suspended or revoked. registration. 
(iv) Violating a  Any subscriber who is arrested for a violation of  law governing controlled substances or another  any other  law for which the possession or use of a controlled substance is an element of the crime.
(v) Accessing  Any subscriber accessing  information for a reason  any  other than to diagnose or treat a patient, or to document compliance with the law. reason than caring for his or her patients. 
(C) An Any  authorized subscriber shall notify the department  Department of Justice  within 30 days of a change any changes  to the subscriber account.
(D) An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the department’s online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.
(E) An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:
(i) The entity will not use or disclose data received from the CURES database for a purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.
(ii) The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:
(I) The date of the query.
(II) The time of the query.
(III) The first and last name of the patient queried.
(IV) The date of birth of the patient queried.
(V) The identification of the CURES user for whom the system is making the query.
(iii) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.
(iv) The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.
(F) No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.
(G) The department shall not access patient-identifiable information in an entity’s health information technology system.
(H) An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.
(I) The department may prohibit integration or terminate a health information technology system’s ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).
(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV,  or Schedule V IV  controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.
(b) A 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. Department of Justice. 
(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV,  or Schedule V IV  controlled substances, the department  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  Department of Justice  pursuant to this section is  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 practitioner prescriber  or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14,  and 1308.15 1308.14  of Title 21 of the Code of Federal Regulations.
(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.
(g) For purposes of this section, the following terms have the following meanings:
(1) “Automated basis” means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.
(2) “Department” means the Department of Justice.
(3) “Entity” means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.
(4) “Health information technology system” means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.
(h) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.

SEC. 8.

 Section 11165.5 is added to the Health and Safety Code, to read:

11165.5.
 (a) The Department of Justice may seek voluntarily contributed private funds from insurers, health care service plans, qualified manufacturers, and other donors for the purpose of supporting CURES. Insurers, health care service plans, qualified manufacturers, and other donors may contribute by submitting their payment to the Controller for deposit into the CURES Fund established pursuant to subdivision (c) of Section 208 of the Business and Professions Code. The department shall make information about the amount and the source of all private funds it receives for support of CURES available to the public. Contributions to the CURES Fund pursuant to this subdivision shall be nondeductible for state tax purposes.
(b) For purposes of this section, the following definitions apply:
(1) “Controlled substance” means a drug, substance, or immediate precursor listed in any schedule in Section 11055, 11056, or 11057 of the Health and Safety Code.
(2) “Health care service plan” means an entity licensed pursuant to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340) of Division 2 of the Health and Safety Code).
(3) “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.
(4) “Qualified manufacturer” means a manufacturer of a controlled substance, but does not mean a wholesaler or nonresident wholesaler of dangerous drugs, regulated pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the Business and Professions Code, a veterinary food-animal drug retailer, regulated pursuant to Article 15 (commencing with Section 4196) of Chapter 9 of Division 2 of the Business and Professions Code, or an individual regulated by the Medical Board of California, the Dental Board of California, the California State Board of Pharmacy, the Veterinary Medical Board, the Board of Registered Nursing, the Physician Assistant Committee of the Medical Board of California, the Osteopathic Medical Board of California, the State Board of Optometry, or the California Board of Podiatric Medicine.