By: Hinojosa, et al. S.B. No. 316
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to powers and duties of certain prescribers and dispensers
  of controlled substances and the regulatory agencies that issue a
  license, certification, or registration to the prescriber or
  dispenser; following the recommendations of the Sunset Advisory
  Commission.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Section 481.003(a), Health and Safety Code, is
  amended to read as follows:
         (a)  The director may adopt rules to administer and enforce
  this chapter, other than Sections 481.073, 481.074, 481.075,
  481.076, [and] 481.0761, 481.0762, 481.0763, 481.0764, and
  481.0765.  The board may adopt rules to administer Sections
  481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
  481.0763, 481.0764, and 481.0765.
         SECTION 2.  Section 481.074(q), Health and Safety Code, is
  amended to read as follows:
         (q)  Each dispensing pharmacist shall send all required
  information, including any information required to complete the
  Schedule III through V prescription forms, to the board by
  electronic transfer or another form approved by the board not later
  than the next business [seventh] day after the date the
  prescription is completely filled.
         SECTION 3.  Section 481.075(i), Health and Safety Code, is
  amended to read as follows:
         (i)  Each dispensing pharmacist shall:
               (1)  fill in on the official prescription form or note
  in the electronic prescription record each item of information
  given orally to the dispensing pharmacy under Subsection (h) and
  the date the prescription is filled, and:
                     (A)  for a written prescription, fill in the
  dispensing pharmacist's signature; or
                     (B)  for an electronic prescription,
  appropriately record the identity of the dispensing pharmacist in
  the electronic prescription record;
               (2)  retain with the records of the pharmacy for at
  least two years:
                     (A)  the official prescription form or the
  electronic prescription record, as applicable; and
                     (B)  the name or other patient identification
  required by Section 481.074(m) or (n); and
               (3)  send all required information, including any
  information required to complete an official prescription form or
  electronic prescription record, to the board by electronic transfer
  or another form approved by the board not later than the next
  business [seventh] day after the date the prescription is
  completely filled.
         SECTION 4.  Sections 481.076(a) and (d), Health and Safety
  Code, are amended to read as follows:
         (a)  The board may not permit any person to have access to
  information submitted to the board under Section 481.074(q) or
  481.075 except:
               (1)  [an investigator for] the board, the Texas Medical
  Board, the Texas State Board of Podiatric Medical Examiners, the
  State Board of Dental Examiners, the State Board of Veterinary
  Medical Examiners, the Texas Board of Nursing, or the Texas
  Optometry Board for the purpose of:
                     (A)  investigating a specific license holder; or
                     (B)  monitoring for potentially harmful
  prescribing or dispensing patterns or practices under Section
  481.0762;
               (2)  an authorized officer or member of the department
  or authorized employee of the board engaged in the administration,
  investigation, or enforcement of this chapter or another law
  governing illicit drugs in this state or another state;
               (3)  the department on behalf of a law enforcement or
  prosecutorial official engaged in the administration,
  investigation, or enforcement of this chapter or another law
  governing illicit drugs in this state or another state;
               (4)  a medical examiner conducting an investigation;
               (5)  provided that accessing the information is
  authorized under the Health Insurance Portability and
  Accountability Act of 1996 (Pub. L. No. 104-191) and regulations
  adopted under that Act:
                     (A)  a pharmacist or a pharmacy technician, as
  defined by Section 551.003, Occupations Code, acting at the
  direction of a pharmacist; or
                     (B)  a practitioner who:
                           (i)  is a physician, dentist, veterinarian,
  podiatrist, optometrist, or advanced practice nurse or is a
  physician assistant described by Section 481.002(39)(D) or an
  employee or other agent of a practitioner acting at the direction of
  a practitioner; and
                           (ii)  is inquiring about a recent Schedule
  II, III, IV, or V prescription history of a particular patient of
  the practitioner[, provided that the person accessing the
  information is authorized to do so under the Health Insurance
  Portability and Accountability Act of 1996 (Pub. L. No.   104-191)
  and rules adopted under that Act];
               (6)  a pharmacist or practitioner who is inquiring
  about the person's own dispensing or prescribing activity; or
               (7)  one or more states or an association of states with
  which the board has an interoperability agreement, as provided by
  Subsection (j).
         (d)  Information submitted to the board under this section
  may be used only for:
               (1)  the administration, investigation, or enforcement
  of this chapter or another law governing illicit drugs in this state
  or another state;
               (2)  investigatory, [or] evidentiary, or monitoring
  purposes in connection with the functions of an agency listed in
  Subsection (a)(1);
               (3)  the prescribing and dispensing of controlled
  substances by a person listed in Subsection (a)(5); or
               (4) [(3)]  dissemination by the board to the public in
  the form of a statistical tabulation or report if all information
  reasonably likely to reveal the identity of each patient,
  practitioner, or other person who is a subject of the information
  has been removed.
         SECTION 5.  Section 481.0761, Health and Safety Code, is
  amended by adding Subsections (h), (i), (j), and (k) to read as
  follows:
         (h)  The board, in consultation with the department and the
  regulatory agencies listed in Section 481.076(a)(1), shall
  identify potentially harmful prescribing or dispensing patterns or
  practices that may suggest drug diversion or drug abuse. The board
  shall develop indicators for levels of prescriber or patient
  activity that suggest that a potentially harmful prescribing or
  dispensing pattern or practice may be occurring or that drug
  diversion or drug abuse may be occurring.
         (i)  The board may, based on the indicators developed under
  Subsection (h), send a prescriber or dispenser an electronic
  notification if the information submitted under Sections
  481.074(q) and 481.075 indicates that a potentially harmful
  prescribing or dispensing pattern or practice may be occurring or
  that drug diversion or drug abuse may be occurring.
         (j)  The board by rule may develop guidelines identifying
  patterns that may indicate that a particular patient to whom a
  controlled substance is prescribed or dispensed is engaging in drug
  abuse or drug diversion. These guidelines may be based on the
  frequency of prescriptions issued to and filled by the patient, the
  types of controlled substances prescribed, and the number of
  prescribers who prescribe controlled substances to the patient.
  The board may, based on the guidelines developed under this
  subsection, send a prescriber or dispenser an electronic
  notification if there is reason to believe that a particular
  patient is engaging in drug abuse or drug diversion.
         (k)  The board by rule may develop guidelines identifying
  additional behavior that would suggest that drug diversion or drug
  abuse is occurring. A person described by Section 481.076(a)(5)(A)
  who observes that behavior by a person to whom a controlled
  substance is to be dispensed shall access the information under
  Section 481.076(a)(5) regarding the patient for whom the
  prescription for the controlled substance was issued.
         SECTION 6.  Subchapter C, Chapter 481, Health and Safety
  Code, is amended by adding Sections 481.0762, 481.0763, 481.0764,
  and 481.0765 to read as follows:
         Sec. 481.0762.  MONITORING BY REGULATORY AGENCY. (a)  Each
  regulatory agency that issues a license, certification, or
  registration to a prescriber shall promulgate specific guidelines
  for prescribers regulated by that agency for the responsible
  prescribing of opioids, benzodiazepines, barbiturates, or
  carisoprodol.
         (b)  A regulatory agency that issues a license,
  certification, or registration to a prescriber shall periodically
  access the information submitted to the board under Sections
  481.074(q) and 481.075 to determine whether a prescriber is
  engaging in potentially harmful prescribing patterns or practices.
         (c)  If the board sends a prescriber an electronic
  notification authorized under Section 481.0761(i), the board shall
  simultaneously send an electronic notification to the appropriate
  regulatory agency.
         (d)  In determining whether a potentially harmful
  prescribing pattern or practice is occurring, the appropriate
  regulatory agency, at a minimum, shall consider:
               (1)  the number of times a prescriber prescribes
  opioids, benzodiazepines, barbiturates, or carisoprodol; and
               (2)  for prescriptions described by Subdivision (1),
  patterns of prescribing combinations of those drugs and other
  dangerous combinations of drugs identified by the board.
         (e)  If, during a periodic check under this section, the
  regulatory agency finds evidence that a prescriber may be engaging
  in potentially harmful prescribing patterns or practices, the
  regulatory agency may notify that prescriber.
         (f)  A regulatory agency may open a complaint against a
  prescriber if the agency finds evidence during a periodic check
  under this section that the prescriber is engaging in conduct that
  violates this subchapter or any other statute or rule.
         Sec. 481.0763.  REGISTRATION BY REGULATORY AGENCY. A
  regulatory agency that issues a license, certification, or
  registration to a prescriber or dispenser shall provide the board
  with any necessary information for each prescriber or dispenser,
  including contact information for the notifications described by
  Sections 481.0761(i) and (j), to register the prescriber or
  dispenser with the system by which the prescriber or dispenser
  receives information as authorized under Section 481.076(a)(5).
         Sec. 481.0764.  DUTIES OF PRESCRIBERS, PHARMACISTS, AND
  RELATED HEALTH CARE PRACTITIONERS. (a)  A person authorized to
  receive information under Section 481.076(a)(5), other than a
  veterinarian, shall access that information with respect to the
  patient before prescribing or dispensing opioids, benzodiazepines,
  barbiturates, or carisoprodol.
         (b)  A person authorized to receive information under
  Section 481.076(a)(5) may access that information with respect to
  the patient before prescribing or dispensing any controlled
  substance.
         (c)  A veterinarian authorized to access information under
  Subsection (b) regarding a controlled substance may access the
  information for prescriptions dispensed only for the animals of an
  owner and may not consider the personal prescription history of the
  owner.
         (d)  A violation of Subsection (a) is grounds for
  disciplinary action by the regulatory agency that issued a license,
  certification, or registration to the person who committed the
  violation.
         (e)  This section does not grant a person the authority to
  issue prescriptions for or dispense controlled substances.
         Sec. 481.0765.  EXCEPTIONS. (a)  A prescriber is not
  subject to the requirements of Section 481.0764(a) if:
               (1)  the patient has been diagnosed with cancer or the
  patient is receiving hospice care; and
               (2)  the prescriber clearly notes in the prescription
  record that the patient was diagnosed with cancer or is receiving
  hospice care, as applicable.
         (b)  A dispenser is not subject to the requirements of
  Section 481.0764(a) if it is clearly noted in the prescription
  record that the patient has been diagnosed with cancer or is
  receiving hospice care.
         (c)  A prescriber or dispenser is not subject to the
  requirements of Section 481.0764(a) and a dispenser is not subject
  to a rule adopted under Section 481.0761(k) if the prescriber or
  dispenser makes a good faith attempt to comply but is unable to
  access the information under Section 481.076(a)(5) because of
  circumstances outside the control of the prescriber or dispenser.
         SECTION 7.  Section 554.051(a-1), Occupations Code, is
  amended to read as follows:
         (a-1)  The board may adopt rules to administer Sections
  481.073, 481.074, 481.075, 481.076, [and] 481.0761, 481.0762,
  481.0763, 481.0764, and 481.0765, Health and Safety Code.
         SECTION 8.  (a)  The Senate Committee on Health and Human
  Services shall conduct an interim study on the monitoring of the
  prescribing and dispensing of controlled substances in this state.
         (b)  The interim study must:
               (1)  include the number of prescribers and dispensers
  registered to receive information electronically under Section
  481.076, Health and Safety Code, as amended by this Act;
               (2)  evaluate the accessing of information under
  Section 481.076, Health and Safety Code, as amended by this Act, by
  regulatory agencies to monitor persons issued a license,
  certification, or registration by those agencies;
               (3)  address any complaints, technical difficulties,
  or other issues with electronically accessing and receiving
  information under Section 481.076, Health and Safety Code, as
  amended by this Act;
               (4)  examine controlled substance prescribing and
  dispensing trends that may be affected by the passage and
  implementation of this Act;
               (5)  evaluate the integration of any new data elements
  required to be reported under this Act;
               (6)  evaluate the existence and scope of diversion of
  controlled substances by animal owners to whom the substances are
  dispensed by veterinarians; and
               (7)  explore the best methods for preventing the
  diversion of controlled substances by animal owners.
         (c)  The committee shall solicit feedback from regulatory
  agencies, prescribers, dispensers, and patients affected by the
  passage of this Act.
         (d)  The committee shall submit a report to the legislature
  on the results of the interim study, including any legislative
  recommendations for improvements to information access and
  controlled substance prescription monitoring, not later than
  January 1, 2019.
         SECTION 9.  A person is not required to comply with Section
  481.0761(k), Health and Safety Code, as added by this Act, before
  September 1, 2018.
         SECTION 10.  Section 481.0764(a), Health and Safety Code, as
  added by this Act, applies only to:
               (1)  a prescriber who issues a prescription for a
  Schedule II controlled substance on or after September 1, 2018;
               (2)  a prescriber who issues a prescription for a
  controlled substance on any schedule on or after September 1, 2019;
               (3)  a person authorized by law to dispense a
  controlled substance who dispenses a Schedule II controlled
  substance on or after September 1, 2018; or
               (4)  a person authorized by law to dispense a
  controlled substance who dispenses a controlled substance on any
  schedule on or after September 1, 2019.
         SECTION 11.  This Act takes effect September 1, 2017.