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AB-40 CURES database: health information technology system.(2017-2018)

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Date Published: 04/19/2017 09:00 PM
AB40:v98#DOCUMENT

Amended  IN  Assembly  April 19, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 40


Introduced by Assembly Member Santiago

December 05, 2016


An act to amend Sections 11165.1 and 11165.2 Section 11165.1 of the Health and Safety Code, relating to controlled substances, and declaring the urgency thereof, to take effect immediately.


LEGISLATIVE COUNSEL'S DIGEST


AB 40, as amended, Santiago. CURES database: health information technology system.
Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a Schedule II, Schedule III, or Schedule IV controlled substance.
This bill would require the Department of Justice to make the electronic history of controlled substances dispensed to an individual under a health care practitioner’s care, based on data contained in the CURES database, available to the practitioner through either an online Internet Web portal or an authorized health information technology system, as defined. The bill would authorize a health information technology system to establish an integration with and submit queries to the CURES database if the system can certify, among other requirements, that the data received from the CURES database will not be used for any purpose other than delivering the data to an authorized health care practitioner or performing data processing activities necessary to enable delivery, and that the system meets applicable patient privacy and information security requirements of state and federal law. The bill would also authorize the Department of Justice to require an entity operating a health information technology system to enter into a memorandum of understanding or other agreement setting forth terms and conditions with which the entity must comply.

Existing law authorizes the Department of Justice to conduct audits of the CURES database and its users.

This bill would authorize the Department of Justice to conduct audits of any authorized health information technology system integrated with the CURES database.

This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2/3   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


SECTION 1.

 Section 11165.1 of the Health and Safety Code, as amended by Section 2 of Chapter 708 of the Statutes of 2016, 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, or Schedule IV controlled substances pursuant to Section 11150 shall, before July 1, 2016, or upon receipt of a federal Drug Enforcement Administration (DEA) registration, whichever occurs later, submit an application developed by the department to obtain approval to access information regarding the controlled substance history of a patient through an online Internet Web portal that is maintained by the department, or through an authorized health information technology system, and, upon approval, the department shall release to that practitioner, through an online Internet Web portal or an authorized health information technology system, 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).
(ii) A pharmacist shall, before July 1, 2016, or upon licensure, whichever occurs later, submit an application developed by the department to obtain approval to access information online regarding the controlled substance history of a patient that is stored on the Internet and maintained within the department, and, upon approval, the department shall release to that pharmacist the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in the CURES PDMP.
(B) 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 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.
(C) Any authorized subscriber shall notify the department within 30 days of any changes to the subscriber account.
(D) A health information technology system may establish an integration with and submit queries to the CURES database on either a user-initiated basis or an automated basis if the system can certify all of the following:
(i) The health information technology system can establish it has been authorized to query the CURES database on behalf of an authorized health care practitioner on either a user-initiated basis, an automated basis, or both, for purposes of delivering patient data from the CURES database to assist an authorized health care practitioner with evaluating the need for medical or pharmaceutical treatment or providing medical or pharmaceutical treatment to a patient for whom a health care practitioner is providing or has provided care.
(ii) The health information technology system will not use or disclose data received from the CURES database for any purpose other than delivering the data to an authorized health care practitioner or performing data processing activities that may be necessary to enable this delivery.
(iii) The health information technology system authenticates the identity of any authorized health care practitioner initiating queries to the CURES database on either a user-initiated basis or an automated basis and maintains an audit trail documenting this authentication. 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.
(iv) The health information technology system meets applicable patient privacy and information security requirements of state and federal law.
(E) The department may, in its discretion, determine whether to establish a direct system integration between one or more health information technology systems and the CURES database, or whether to develop a gateway system to which multiple health information technology systems can establish an integration for purposes of accessing the CURES database.
(F) The department may require an entity that operates a health information technology system to enter into a memorandum of understanding or other agreement that sets forth terms and conditions with which the entity shall comply, including, but not limited to, all of the following:
(i) Paying a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.
(ii) Enforcement mechanisms for failure to comply with oversight or audit activities by the department, up to and including termination of access to the CURES database.
(iii) Any other term or condition that the department may determine in its reasonable discretion is necessary to carry out the intent of this section.
(2) A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, or Schedule 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) 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.
(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, or Schedule IV controlled substances, the department 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. An authorized health care practitioner may use a health information technology system, either on a user-initiated basis or an automated basis, to initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to other licensed health care practitioners, pharmacists, or both.
(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 pursuant to this section is 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.
(f) A health care practitioner, pharmacist, and any 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 any false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for any 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 established or approved by a health care practitioner to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner by an audit trail in the health information technology system.
(2) “Department” means the Department of Justice.
(3) “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.
(4) “User-initiated basis” means an authorized health care practitioner has taken an action to initiate the query to the CURES database, such as clicking a button, issuing a voice command, or taking some other action that can be attributed to a specific health care practitioner by an audit trail in the health information technology system.

SEC. 2.Section 11165.2 of the Health and Safety Code is amended to read:
11165.2.

(a)The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users, including any authorized health information technology system, as defined in subdivision (g) of Section 11165.1, integrated with the CURES database.

(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. 3.SEC. 2.

 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to ensure that information in the CURES database is available to prescribing physicians so they may prevent the dangerous abuse of prescription drugs and to safeguard the health and safety of the people of this state, it is necessary that this act take effect immediately.