86R28348 JSC-D
 
  By: Sheffield, Price, Burns, Howard, Stucky H.B. No. 3284
 
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to prescribing and dispensing controlled substances and
  monitoring the prescribing and dispensing of controlled substances
  under the Texas Controlled Substances Act; providing for
  administrative penalties.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter C, Chapter 481, Health and Safety
  Code, is amended by adding Section 481.0755 to read as follows:
         Sec. 481.0755.  WRITTEN, ORAL, AND TELEPHONICALLY
  COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections
  481.073, 481.074, and 481.075, a person prescribing or dispensing a
  controlled substance must use the electronic prescription record
  and may not use a written, oral, or telephonically communicated
  prescription.
         (b)  A prescriber may issue a written, oral, or
  telephonically communicated prescription for a controlled
  substance as authorized under this subchapter only if the
  prescription is issued:
               (1)  by a veterinarian;
               (2)  in circumstances in which electronic prescribing
  is not available due to temporary technological or electronic
  failure, as prescribed by board rule;
               (3)  by a practitioner to be dispensed by a pharmacy
  located outside this state, as prescribed by board rule;
               (4)  when the prescriber and dispenser are the same
  entity;
               (5)  in circumstances in which necessary elements are
  not supported by the most recent electronic prescription drug
  software;
               (6)  for a drug for which the United States Food and
  Drug Administration requires additional information in the
  prescription that is not possible with electronic prescribing;
               (7)  for a non-patient-specific prescription pursuant
  to a standing order, approved protocol for drug therapy,
  collaborative drug management, or comprehensive medication
  management, in response to a public health emergency or in other
  circumstances in which the practitioner may issue a
  non-patient-specific prescription;
               (8)  for a drug under a research protocol;
               (9)  by a prescriber who is employed by or is practicing
  a health care profession at a health-related institution, as
  defined by Section 62.161, Education Code, as added by Chapter 448
  (H.B. 7), Acts of the 84th Legislature, 2015;
               (10)  by a practitioner who has received a waiver under
  Subsection (c) from the requirement to use electronic prescribing;
  or
               (11)  under circumstances in which the practitioner has
  the present ability to submit an electronic prescription but
  reasonably determines that it would be impractical for the patient
  to obtain the drugs prescribed under the electronic prescription in
  a timely manner and that a delay would adversely impact the
  patient's medical condition.
         (c)  The board shall adopt rules establishing a process by
  which a practitioner may request and receive a waiver under
  Subsection (b)(10), not to exceed one year, from the requirement to
  use electronic prescribing. The board shall adopt rules
  establishing the eligibility for a waiver, including:
               (1)  economic hardship;
               (2)  technological limitations not reasonably within
  the control of the practitioner; or
               (3)  other exceptional circumstances demonstrated by
  the practitioner.
         (d)  A written, oral, or telephonically communicated
  prescription must comply with the applicable requirements
  prescribed by Sections 481.074 and 481.075.
         (e)  A dispensing pharmacist who receives a controlled
  substance prescription in a manner other than electronically is not
  required to verify that the prescription is exempt from the
  requirement that it be submitted electronically.
         (f)  The board shall enforce this section.
         SECTION 2.  Sections 481.076(a), (f), (g), and (h), 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)  the board, the Texas Medical Board, the Texas
  Department of Licensing and Regulation, with respect to the
  regulation of podiatrists [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 or other [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,
  if the board is provided a warrant, subpoena, or other court order
  compelling the disclosure;
               (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;
               (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); or
               (8)  a health care facility certified by the federal
  Centers for Medicare and Medicaid Services.
         (f)  If the board accesses [director permits access to]
  information under Subsection (a)(2) relating to a person licensed
  or regulated by an agency listed in Subsection (a)(1), the board
  [director] shall notify and cooperate with that agency regarding
  the disposition of the matter before taking action against the
  person, unless the board [director] determines that notification is
  reasonably likely to interfere with an administrative or criminal
  investigation or prosecution.
         (g)  If the board provides [director permits] access to
  information under Subsection (a)(3) relating to a person licensed
  or regulated by an agency listed in Subsection (a)(1), the board
  [director] shall notify that agency of the disclosure of the
  information not later than the 10th working day after the date the
  information is disclosed.
         (h)  If the board [director] withholds notification to an
  agency under Subsection (f), the board [director] shall notify the
  agency of the disclosure of the information and the reason for
  withholding notification when the board [director] determines that
  notification is no longer likely to interfere with an
  administrative or criminal investigation or prosecution.
         SECTION 3.  Section 481.0766, Health and Safety Code, is
  amended by adding Subsection (c) to read as follows:
         (c)  The board shall make the information reported under
  Subsection (a) available to the State Board of Veterinary Medical
  Examiners for the purpose of routine inspections and
  investigations.
         SECTION 4.  Subchapter C, Chapter 481, Health and Safety
  Code, is amended by adding Sections 481.0767 and 481.0768 to read as
  follows:
         Sec. 481.0767.  ADVISORY COMMITTEE. (a)  The board shall
  establish an advisory committee to make recommendations regarding
  information submitted to the board and access to that information
  under Sections 481.074, 481.075, 481.076, and 481.0761, including
  recommendations for:
               (1)  operational improvements to the electronic system
  that stores the information, including implementing best practices
  and improvements that address system weaknesses and workflow
  challenges;
               (2)  resolutions to identified data concerns;
               (3)  methods to improve data accuracy, integrity, and
  security and to reduce technical difficulties; and
               (4)  the addition of any new data set or service to the
  information submitted to the board or the access to that
  information.
         (b)  The board shall appoint the following members to the
  advisory committee:
               (1)  a physician licensed in this state who practices
  in pain management;
               (2)  a physician licensed in this state who practices
  in family medicine;
               (3)  a physician licensed in this state who performs
  surgery;
               (4)  a physician licensed in this state who practices
  in emergency medicine at a hospital;
               (5)  a physician licensed in this state who practices
  in psychiatry;
               (6)  an oral and maxillofacial surgeon;
               (7)  a physician assistant or advanced practice
  registered nurse to whom a physician has delegated the authority to
  prescribe or order a drug;
               (8)  a pharmacist working at a chain pharmacy;
               (9)  a pharmacist working at an independent pharmacy;
               (10)  an academic pharmacist; and
               (11)  two representatives of the health information
  technology industry, at least one of whom is a representative of a
  company whose primary line of business is electronic medical
  records.
         (c)  Members of the advisory committee serve three-year
  terms. Each member shall serve until the member's replacement has
  been appointed.
         (d)  The advisory committee shall annually elect a presiding
  officer from its members.
         (e)  The advisory committee shall meet at least two times a
  year and at the call of the presiding officer or the board.
         (f)  A member of the advisory committee serves without
  compensation but may be reimbursed by the board for actual expenses
  incurred in performing the duties of the advisory committee.
         Sec. 481.0768.  ADMINISTRATIVE PENALTY:  DISCLOSURE OR USE
  OF INFORMATION.  (a)  A person authorized to receive information
  under Section 481.076(a) may not disclose or use the information in
  a manner not authorized by this subchapter or other law.
         (b)  A regulatory agency that issues a license,
  certification, or registration to a prescriber or dispenser shall
  periodically update the administrative penalties, or any
  applicable disciplinary guidelines concerning the penalties,
  assessed by that agency for conduct that violates Subsection (a).
         (c)  The agency shall set the penalties in an amount
  sufficient to deter the conduct.
         SECTION 5.  Section 801.307, Occupations Code, is amended by
  adding Subsection (a-1) to read as follows:
         (a-1)  The board by rule shall require a veterinarian to
  complete two hours of continuing education related to opioid abuse
  and controlled substance diversion, inventory, and security every
  two years to renew a license to practice veterinary medicine.
         SECTION 6.  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,
  481.0755, 481.076, 481.0761, 481.0762, 481.0763, 481.0764,
  481.0765, [and] 481.0766, 481.0767, and 481.0768.  The board may
  adopt rules to administer Sections 481.073, 481.074, 481.075,
  481.0755, 481.076, 481.0761, 481.0762, 481.0763, 481.0764,
  481.0765, [and] 481.0766, 481.0767, and 481.0768.
         SECTION 7.  Section 481.128(a), Health and Safety Code, is
  amended to read as follows:
         (a)  A registrant or dispenser commits an offense if the
  registrant or dispenser knowingly:
               (1)  distributes, delivers, administers, or dispenses
  a controlled substance in violation of Subchapter C [Sections
  481.070-481.075];
               (2)  manufactures a controlled substance not
  authorized by the person's Federal Drug Enforcement Administration
  registration or distributes or dispenses a controlled substance not
  authorized by the person's registration to another registrant or
  other person;
               (3)  refuses or fails to make, keep, or furnish a
  record, report, notification, order form, statement, invoice, or
  information required by this chapter;
               (4)  prints, manufactures, possesses, or produces an
  official prescription form without the approval of the board;
               (5)  delivers or possesses a counterfeit official
  prescription form;
               (6)  refuses an entry into a premise for an inspection
  authorized by this chapter;
               (7)  refuses or fails to return an official
  prescription form as required by Section 481.075(k);
               (8)  refuses or fails to make, keep, or furnish a
  record, report, notification, order form, statement, invoice, or
  information required by a rule adopted by the director or the board;
  or
               (9)  refuses or fails to maintain security required by
  this chapter or a rule adopted under this chapter.
         SECTION 8.  Section 481.129(a), Health and Safety Code, is
  amended to read as follows:
         (a)  A person commits an offense if the person knowingly:
               (1)  distributes as a registrant or dispenser a
  controlled substance listed in Schedule I or II, unless the person
  distributes the controlled substance as authorized under the
  federal Controlled Substances Act (21 U.S.C. Section 801 et seq.);
               (2)  uses in the course of manufacturing, prescribing,
  or distributing a controlled substance a Federal Drug Enforcement
  Administration registration number that is fictitious, revoked,
  suspended, or issued to another person;
               (3)  issues a prescription bearing a forged or
  fictitious signature;
               (4)  uses a prescription issued to another person to
  prescribe a Schedule II controlled substance;
               (5)  possesses, obtains, or attempts to possess or
  obtain a controlled substance or an increased quantity of a
  controlled substance:
                     (A)  by misrepresentation, fraud, forgery,
  deception, or subterfuge;
                     (B)  through use of a fraudulent prescription
  form; [or]
                     (C)  through use of a fraudulent oral or
  telephonically communicated prescription; or
                     (D)  through the use of a fraudulent electronic
  prescription; or
               (6)  furnishes false or fraudulent material
  information in or omits material information from an application,
  report, record, or other document required to be kept or filed under
  this chapter.
         SECTION 9.  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, 481.0755, 481.076, 481.0761, 481.0762,
  481.0763, 481.0764, 481.0765, [and] 481.0766, 481.0767, and
  481.0768, Health and Safety Code.
         SECTION 10.  Section 565.003, Occupations Code, is amended
  to read as follows:
         Sec. 565.003.  ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING
  APPLICANT FOR OR HOLDER OF NONRESIDENT PHARMACY LICENSE. Unless
  compliance would violate the pharmacy or drug statutes or rules in
  the state in which the pharmacy is located, the board may discipline
  an applicant for or the holder of a nonresident pharmacy license if
  the board finds that the applicant or license holder has failed to
  comply with:
               (1)  Subchapter C, Chapter 481 [Section 481.074 or
  481.075], Health and Safety Code;
               (2)  Texas substitution requirements regarding:
                     (A)  the practitioner's directions concerning
  generic substitution;
                     (B)  the patient's right to refuse generic
  substitution; or
                     (C)  notification to the patient of the patient's
  right to refuse substitution;
               (3)  any board rule relating to providing drug
  information to the patient or the patient's agent in written form or
  by telephone; or
               (4)  any board rule adopted under Section 554.051(a)
  and determined by the board to be applicable under Section
  554.051(b).
         SECTION 11.  Sections 481.076(a-3), (a-4), and (a-5), Health
  and Safety Code, are repealed.
         SECTION 12.  To the extent of any conflict, this Act prevails
  over another Act of the 86th Legislature, Regular Session, 2019,
  relating to nonsubstantive additions to and corrections in enacted
  codes.
         SECTION 13.  Section 481.0755, Health and Safety Code, as
  added by this Act, applies only to a prescription issued on or after
  the effective date of this Act.
         SECTION 14.  Section 481.0768(a), Health and Safety Code, as
  added by this Act, applies only to conduct that occurs on or after
  the effective date of this Act.
         SECTION 15.  Section 801.307(a-1), Occupations Code, as
  added by this Act, applies only to the renewal of a license to
  practice veterinary medicine on or after September 1, 2020. The
  renewal of a license before that date is governed by the law in
  effect immediately before the effective date of this Act, and the
  former law is continued in effect for that purpose.
         SECTION 16.  This Act takes effect September 1, 2019.