Bill Summary – FastDemocracy

-- S 0648 SUBSTITUTE A
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     LC002460/SUB A
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                       STATE               OF        RHODE                ISLAND
                                          IN GENERAL ASSEMBLY
                                        JANUARY SESSION, A.D. 2021
                                              ____________
                                                 AN ACT
       RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT
                Introduced By: Senators Valverde, DiMario, and Miller
                Date Introduced: March 18, 2021
                Referred To: Senate Health & Human Services
     It is enacted by the General Assembly as follows:
         SECTION 1. Section 21-28-3.32 of the General Laws in Chapter 21-28 entitled "Uniform
 Controlled Substances Act" is hereby amended to read as follows:
         21-28-3.32. Electronic prescription database. [Effective until January 1, 2023.].
         (a) The information contained in any prescription-drug-monitoring database maintained by
 the department of health pursuant to § 21-28-3.18 of this chapter shall be disclosed only:
         (1) To a practitioner who certifies that the requested information is for the purpose of
 evaluating the need for, or providing medical treatment to, a current patient to whom the
 practitioner is prescribing or considering prescribing a controlled substance;
         (2) To a pharmacist who certifies that the requested information is for a current client to
 whom the pharmacist is dispensing, or considering dispensing, a controlled substance;
         (3) To an authorized designee of the practitioner and/or pharmacist to consult the
 prescription-drug-monitoring database on the practitioner's and/or pharmacist's behalf, or to a
 medical director of the practitioner's practice for quality improvement activities within the practice,
 provided that:
         (i) The designee so authorized is employed by the same professional practice or pharmacy;
         (ii) The practitioner or pharmacist takes reasonable steps to ensure that such designee is
 sufficiently competent in the use of the database;
         (iii) The practitioner or pharmacist remains responsible for ensuring that access to the
 database by the designee is limited to authorized purposes as provided for in subsections (a)(1) and
 (a)(2);
           (iv) The practitioner or pharmacist remains responsible for ensuring access to the database
 by the designee occurs in a manner that protects the confidentiality of information obtained from
 the database and remains responsible for any breach of confidentiality;
           (v) The practitioner or pharmacist terminates the designee's access to the database at the
 termination of the designee's employment; and
           (vi) The ultimate decision as to whether or not to prescribe or dispense a controlled
 substance remains with the practitioner or pharmacist and is reasonably informed by the relevant,
 controlled-substance history information obtained from the database;
           (4) Pursuant to a valid search warrant based on probable cause to believe a violation of
 federal or state criminal law has occurred and that specified information contained in the database
 would assist in the investigation of the crime;
           (5) By a department employee to a certified law enforcement prescription drug diversion
 investigator of a qualified law enforcement agency for use in an investigation.
           (i) A certified law enforcement prescription drug diversion investigator shall provide to the
 department the following information in order to receive information from the database:
           (A) The identification credentials assigned by the department; and
           (B) The case number of the investigation.
           (ii) A qualified law enforcement agency shall submit to the department quarterly reports of
 the data received by all certified law enforcement prescription drug diversion investigators in the
 qualified law enforcement agency, including, without limitation:
           (A) Written verification that the inquiries were part of a lawful prescription drug diversion
 investigation as provided to the department through the case number of the investigation; and
           (B) A brief description of each case closed during that quarter for which the qualified law
 enforcement agency used information from the database; and
           (C) The disposition of the investigation.
           (iii) The department shall:
           (A) Create a verification form for use under subsection (5)(ii)(A) of this section; and
           (B) Make the verification form available annually to the qualified law enforcement agency.
           (iv) The verification form under subsection (5)(ii)(A) of this section shall be submitted to
 the department within thirty (30) days of receipt of the form by the qualified law enforcement
 agency.
           (v) Failure to submit a verification form under subsection (5)(iv) of this section shall result
 in the immediate suspension of disclosure of information from the database by the department to
                                        LC002460/SUB A - Page 2 of 11
 the qualified law enforcement agency and its certified law enforcement prescription drug diversion
 investigators until a determination is made by the department to allow continued disclosure.
         (vi) The director shall, beginning January 1, 2018, and annually thereafter, review
 disclosure of information pursuant to subsection (a)(5) of this section. Thereafter, the disclosure of
 information pursuant to subsection (a)(5) of this section shall automatically renew for successive
 one-year terms unless the director provides written notice to:
         (A) The qualified law enforcement agencies; and
         (B) The speaker of the house and the president of the senate, at least sixty (60) days in
 advance of the then-existing term's end, that the department wishes to discontinue providing
 information from the database pursuant to this subsection. The director may reinstitute disclosure
 by providing written notice to the same parties;
         (6) To a patient who requests his or her own prescription information, or the parent or legal
 guardian of a minor child who requests the minor child's prescription information;
         (7) To a health professional regulatory board that documents, in writing, that the requested
 information is necessary for an investigation related to licensure, renewal, or disciplinary action
 involving the applicant, licensee, or registrant to whom the requested information pertains;
         (8) To any vendor or contractor with whom the department has contracted, pursuant to state
 purchasing law and regulations in the contracting of vendors, to establish or maintain the electronic
 system of the prescription-drug-monitoring database;
         (9) To public or private entities for statistical, research, or educational purposes, after
 removing the patient and prescriber information that could be used to identify individual patients.
 This shall not include entities receiving a waiver from the institutional review board; or
         (10) To any vendor, agent, contractor, or designee who operates an electronic health record
 or clinical-management system for the purpose of sharing data with practitioners, pharmacists, or
 licensed healthcare facilities or designees.
         (b) Information stored in the prescription-drug-monitoring database shall include only the
 following:
         (1) Patient's first and last name and/or patient identification number; provided, however,
 the patient's social security number shall not be recorded in whole or in part, patient sex, patient
 date of birth, and patient address;
         (2) Prescribing practitioner's name and Drug Enforcement Administration prescriber-
 information number;
         (3) Prescribing practitioner's office or hospital contact information;
         (4) Prescription name, prescription number, prescription species code, national drug code
                                       LC002460/SUB A - Page 3 of 11
 number, prescription dosage, prescription quantity, days' supply, new-refill code, number of refills
 authorized, date the prescription was written, date the prescription was filled, payment type;
 provided, however, no credit card number shall be recorded in whole or in part; and
         (5) The Drug Enforcement Administration pharmacy number of the pharmacy filling the
 prescription.
         (c) The department shall disclose any information relating to a patient maintained in the
 prescription-drug-monitoring database to that patient, at no cost to the patient, within thirty (30)
 business days after the department receives a written request from the patient for the information.
 This information shall include the records maintained by the department pursuant to subsection (e).
 Notwithstanding the above, the department may, at the request of the law-enforcement agency,
 withhold, for up to sixty (60) days following the conclusion of a law-enforcement investigation that
 has been confirmed by the department, the disclosure to the patient that information has been
 obtained pursuant to subsections (a)(4) and (a)(5) of this section.
         (d) A patient may request, from the dispensing pharmacy, correction of any inaccurate
 information contained within the prescription-drug-monitoring database in accordance with the
 procedure specified by § 5-37.3-5(c).
         (e) The department shall, for the period of time that prescription information is maintained,
 maintain records of the information disclosed through the prescription-drug-monitoring database,
 including, but not limited to:
         (1) The identity of each person who requests or receives information from the prescription-
 drug-monitoring database and the organization, if any, the person represents;
         (2) The information released to each person or organization and the basis for its release
 under subsection (a); and
         (3) The dates the information was requested and provided.
         (f) Prescription information contained within the prescription-drug-monitoring database
 shall be removed no later than five (5) years from the date the information is entered into the
 database. Records in existence prior to the enactment of this section shall be removed no later than
 ten (10) years from the date the information is entered into the database.
         (g) The department shall promptly notify any affected individual of an improper disclosure
 of information from the prescription-drug-monitoring database or a breach in the security of the
 prescription-drug-monitoring database that poses a significant risk of disclosure of patient
 information to an unauthorized individual.
         (h) At the time of signing a prescription that is required by the department to be entered
 into the prescription-drug-monitoring database, the prescribing practitioner shall inform the patient
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 in writing of the existence of the prescription-drug-monitoring database; the patient's right to access
 his or her own prescription information; and the name and contact information of the agency
 operating the program.
          (i) No person shall access information in the prescription-monitoring-database except to
 the extent and for the purposes authorized by subsection (a).
          (j) In any civil action allowing a violation of this chapter, the court may award damages,
 including punitive damages, and reasonable attorneys' fees and costs to a prevailing plaintiff, and
 injunctive and any other appropriate relief.
          (k) Any pharmacist who, in his or her professional judgment, refuses to fill a prescription
 based on information contained within the prescription-drug-monitoring database shall inform the
 prescribing physician within twenty-four (24) hours.
          (l) All practitioners shall, as a condition of the initial registration or renewal of the
 practitioner's authority to prescribe controlled substances, register with the prescription-drug-
 monitoring database maintained by the department of health.
          (m) The prescription-monitoring program shall be reviewed prior to starting any opioid. A
 prescribing practitioner, or designee as authorized by subsection (a)(3) of this section, shall review
 the prescription-monitoring program prior to refilling or initiating opioid therapy with an
 intrathecal pump. For patients the prescribing practitioner is maintaining on continuous opioid
 therapy for pain for three (3) months or longer, the prescribing practitioner shall review information
 from the prescription-monitoring program at least every three (3) months. Documentation of that
 review shall be noted in the patient's medical record.
          (n) The department shall improve the usefulness and value of the prescription-drug-
 monitoring database program by increasing its analytical functionality, timeliness, and scope, such
 as by:
          (1) Utilizing data from additional data sources as permissible under state and federal
 statutes;
          (2) Analyzing information submitted to the prescription-drug-monitoring database to
 ensure that prescription data collected from dispensing pharmacists is readily accessible for a given
 patient; to identify unusual or aberrant patterns of prescribing, dispensing, or receiving controlled
 substances; and to generate an automatic alert when such patterns arise to automate standard
 reports; and to provide ad hoc reports on a real-time basis on this data as well as other data feeds.
 These reports shall comply with the patient confidentiality requirements of federal and state law;
          (3) Developing regulations to ensure that prescription-drug-monitoring analyses are
 updated and disseminated regularly to appropriate officials and that summary reports are provided
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 to the general assembly on or before February 1st of each year. Given the intent to decrease the
 number of Rhode Island citizens affected by opioid use, the department shall provide an interim
 report on the status of the directives included herein and any progress made as of October 1, 2016.
 In the development of said regulations, the department may include any of the following analytical
 functions, within the boundaries of patient confidentiality rights under state and federal law:
         (i) Consolidate raw prescription data collected from dispensing pharmacists into a single
 view of all prescriptions filled for a given patient;
         (ii) Identify unusual or aberrant patterns of prescribing controlled substances, by relevant
 prescriber attributes, and generate an automatic alert when such patterns arise;
         (iii) Identify unusual or aberrant patterns of receiving prescriptions for controlled
 substances, by relevant patient attributes, and generate an automatic alert when such patterns arise;
         (iv) Identify unusual or aberrant patterns of dispensing controlled substances, by relevant
 dispenser attributes, and generate an automatic alert when such patterns arise;
         (v) Identify and visually display linkages among prescribers, patients, and dispensers that
 can be used to detect any collusive behaviors; and
         (vi) The department shall apply for federal funding in support of the goals and objectives
 contained in this subsection.
         21-28-3.32. Electronic prescription database. [Effective January 1, 2023.].
         (a) The information contained in any prescription-drug-monitoring database maintained by
 the department of health pursuant to § 21-28-3.18 of this chapter shall be disclosed only:
         (1) To a practitioner who certifies that the requested information is for the purpose of
 evaluating the need for, or providing medical treatment to, a current patient to whom the
 practitioner is prescribing or considering prescribing a controlled substance;
         (2) To a pharmacist who certifies that the requested information is for a current client to
 whom the pharmacist is dispensing, or considering dispensing, a controlled substance;
         (3) To an authorized designee of the practitioner and/or pharmacist to consult the
 prescription-drug-monitoring database on the practitioner's and/or pharmacist's behalf, or to a
 medical director of the practitioner's practice for quality improvement activities within the practice,
 provided that:
         (i) The designee so authorized is employed by the same professional practice or pharmacy;
         (ii) The practitioner or pharmacist takes reasonable steps to ensure that such designee is
 sufficiently competent in the use of the database;
         (iii) The practitioner or pharmacist remains responsible for ensuring that access to the
 database by the designee is limited to authorized purposes as provided for in subsections (a)(1) and
                                       LC002460/SUB A - Page 6 of 11
 (a)(2);
           (iv) The practitioner or pharmacist remains responsible for ensuring access to the database
 by the designee occurs in a manner that protects the confidentiality of information obtained from
 the database and remains responsible for any breach of confidentiality;
           (v) The practitioner or pharmacist terminates the designee's access to the database at the
 termination of the designee's employment; and
           (vi) The ultimate decision as to whether or not to prescribe or dispense a controlled
 substance remains with the practitioner or pharmacist and is reasonably informed by the relevant,
 controlled-substance-history information obtained from the database.