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AB-1753 Controlled substances: CURES database.(2017-2018)

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Date Published: 04/19/2018 04:00 AM
AB1753:v98#DOCUMENT

Amended  IN  Assembly  April 18, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 1753


Introduced by Assembly Member Low

January 03, 2018


An act to amend Sections 11161.5, 11162.1, and 11165 of the Health and Safety Code, relating to controlled substances.


LEGISLATIVE COUNSEL'S DIGEST


AB 1753, as amended, Low. Controlled substances: CURES database.
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. Existing law requires prescription forms for controlled substance prescriptions to be obtained from security printers approved by the Department of Justice, as specified. Existing law requires a dispensing pharmacy, clinic, or other dispenser to report specified information to the Department of Justice.
This bill would, beginning January 1, 2020, require would authorize the Department of Justice to reduce or limit the number of approved printers to 3, as specified. The bill would require prescription forms for controlled substance prescriptions to have a uniquely serialized number, in a manner prescribed by the Department of Justice, and would require a printer to submit specified information to the Department of Justice for all prescription forms delivered. The bill would require the information submitted by a dispensing pharmacy, clinic, or other dispenser to the Department of Justice to include the serial number for the corresponding prescription pad, form, if applicable.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


SECTION 1.

 The Legislature finds and declares the following:
(a) The prevailing use of paper prescription pads to prescribe controlled substances leads to significant instances of theft and fraud each year, contributing to the prescription drug abuse crisis and fueling criminal enterprises engaged in drug diversion.
(b) Prescribing controlled substances by means of electronic transmission prescription, or e-prescribing, has long been considered the most effective way to combat prescription pad theft and fraud.
(c) Many states have begun to require that all controlled substances must be prescribed electronically as a means of addressing the public health and public safety crises associated with prescription drug abuse and diversion.
(d) Until mandatory e-prescribing is established in California, it is critical that tighter restrictions be placed on the manufacturing and tracking of prescription pads used within the state.

SEC. 2.

 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 email 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.

(o)Beginning January 1, 2020, the Department of Justice shall limit the number of approved printers to three. The Department of Justice shall establish policies governing the selection of the three approved vendors based on ability to meet demand and prevent fraud and theft of prescription pads and the process of revoking approval for currently authorized printers in excess of three.

(o) In order to facilitate the standardization of all prescription forms and the serialization of prescription forms with unique identifiers, the Department of Justice may cease issuing new approvals of security printers to the extent necessary to achieve these purposes. The department may, pursuant to regulation, reduce the number of currently approved security printers to no fewer than three vendors. The department shall ensure that any reduction or limitation of approved security printers does not impact the ability of vendors to meet demand for prescription forms.

SEC. 3.

 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.
(15) (A)A uniquely serialized number, in a manner prescribed by the Department of Justice.

(B)Within the next working day following delivery, a security printer shall submit via Web-based application, as specified by the Department of Justice, all of the following information for all prescription forms delivered:

(i)Serial numbers of all prescription forms delivered.

(ii)All prescriber names and Drug Enforcement Administration Controlled Substance Registration Certificate numbers displayed on the prescription forms.

(iii)The delivery shipment recipient names.

(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.

(d) Within the next working day following delivery, a security printer shall submit via Web-based application, as specified by the Department of Justice, all of the following information for all prescription forms delivered:
(1) Serial numbers of all prescription forms delivered.
(2) All prescriber names and Drug Enforcement Administration Controlled Substance Registration Certificate numbers displayed on the prescription forms.
(3) The delivery shipment recipient names.
(4) The date of delivery.

SEC. 4.

 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, and Schedule 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 access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.
(b) The 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 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, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. 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) 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 is provided and keep 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, 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, clinic, or other dispenser shall report the following information to the Department of Justice as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed, in a format specified by the 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, 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 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) International Statistical Classification of 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) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(11) The serial number for the corresponding prescription pad, form, if applicable.
(e) The 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. All prescriber and dispenser 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 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 of Justice may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.