|
|
A BILL TO BE ENTITLED
|
|
AN ACT
|
|
|
relating to controlled substance prescriptions and reimbursement |
|
for treatment for certain substance use disorders; authorizing a |
|
fee. |
|
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
|
SECTION 1. Section 552.118, Government Code, is amended to |
|
read as follows: |
|
Sec. 552.118. EXCEPTION: CONFIDENTIALITY OF OFFICIAL |
|
PRESCRIPTION PROGRAM INFORMATION. Information is excepted from the |
|
requirements of Section 552.021 if it is: |
|
(1) information on or derived from an official |
|
prescription form filed with the Texas State Board of Pharmacy |
|
under Section 481.0755, Health and Safety Code, or an electronic |
|
prescription record filed with the Texas State Board of Pharmacy |
|
under Section 481.075, Health and Safety Code; or |
|
(2) other information collected under Section 481.075 |
|
or 481.0755 of that code. |
|
SECTION 2. Sections 481.002(10) and (47), Health and Safety |
|
Code, are amended to read as follows: |
|
(10) "Designated agent" means an individual |
|
designated under Section 481.074(b-2) [481.073] to communicate a |
|
practitioner's instructions to a pharmacist in an emergency. |
|
(47) "Official prescription form" means a |
|
prescription form that is used for a Schedule II controlled |
|
substance under Section 481.0755 and contains the prescription |
|
information required by Section 481.0755(e) [481.075]. |
|
SECTION 3. 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, 481.0756, 481.076, 481.0761, 481.0762, 481.0763, |
|
481.07635, 481.07636, 481.0764, 481.0765, and 481.0766. The board |
|
may adopt rules to administer Sections [481.073,] 481.074, 481.075, |
|
481.0755, 481.0756, 481.076, 481.0761, 481.0762, 481.0763, |
|
481.07635, 481.07636, 481.0764, 481.0765, and 481.0766. |
|
SECTION 4. Section 481.074, Health and Safety Code, is |
|
amended by amending Subsections (b), (c), (e), (f), (g), (h), (k), |
|
and (q) and adding Subsections (b-1) and (b-2) to read as follows: |
|
(b) Except in an emergency as defined by board rule under |
|
Subsection (b-1) [of the board] or as otherwise provided by |
|
[Subsection (o) or] Section 481.075(j) or (m) or 481.0755, a person |
|
may not dispense or administer a controlled substance [listed in
|
|
Schedule II without a written prescription of a practitioner on an
|
|
official prescription form or] without an electronic prescription |
|
that meets the requirements of and is completed by the practitioner |
|
in accordance with Section 481.075. |
|
(b-1) In an emergency as defined by board rule, a person may |
|
dispense or administer a controlled substance [listed in Schedule
|
|
II] on the oral or telephonically communicated prescription of a |
|
practitioner. The person who administers or dispenses the |
|
substance shall: |
|
(1) if the person is a prescribing practitioner or a |
|
pharmacist, promptly comply with Subsection (c); or |
|
(2) if the person is not a prescribing practitioner or |
|
a pharmacist, promptly write the oral or telephonically |
|
communicated prescription and include in the written record of the |
|
prescription the name, address, and Federal Drug Enforcement |
|
Administration number issued for prescribing a controlled |
|
substance in this state of the prescribing practitioner, all |
|
information required to be provided by a practitioner under Section |
|
481.075(e)(1), and all information required to be provided by a |
|
dispensing pharmacist under Section 481.075(e)(2). |
|
(b-2) In an emergency described by Subsection (b-1), an |
|
agent designated in writing by a practitioner defined by Section |
|
481.002(39)(A) may communicate a prescription by telephone. A |
|
practitioner who designates a different agent shall designate that |
|
agent in writing and maintain the designation in the same manner in |
|
which the practitioner initially designated an agent under this |
|
subsection. On the request of a pharmacist, a practitioner shall |
|
furnish a copy of the written designation. This subsection does not |
|
relieve a practitioner or the practitioner's designated agent from |
|
the requirement of Subchapter A, Chapter 562, Occupations Code. A |
|
practitioner is personally responsible for the actions of the |
|
designated agent in communicating a prescription to a pharmacist. |
|
(c) Not later than the seventh day after the date a |
|
prescribing practitioner authorizes an emergency oral or |
|
telephonically communicated prescription, the prescribing |
|
practitioner shall cause an [a written or] electronic prescription, |
|
completed in the manner required by Section 481.075, to be |
|
delivered to the dispensing pharmacist at the pharmacy where the |
|
prescription was dispensed. [A written prescription may be
|
|
delivered in person or by mail. The envelope of a prescription
|
|
delivered by mail must be postmarked not later than the seventh day
|
|
after the date the prescription was authorized. On receipt of a
|
|
written prescription, the dispensing pharmacy shall file the
|
|
transcription of the telephonically communicated prescription and
|
|
the pharmacy copy and shall send information to the board as
|
|
required by Section 481.075.] On receipt of the [an] electronic |
|
prescription, the pharmacist shall annotate the electronic |
|
prescription record with the original authorization and date of the |
|
emergency oral or telephonically communicated prescription. |
|
(e) The partial filling of a prescription for a controlled |
|
substance listed in Schedule II is permissible in accordance with |
|
applicable federal law[, if the pharmacist is unable to supply the
|
|
full quantity called for in a written or electronic prescription or
|
|
emergency oral prescription and the pharmacist makes a notation of
|
|
the quantity supplied on the face of the written prescription, on
|
|
the written record of the emergency oral prescription, or in the
|
|
electronic prescription record. The remaining portion of the
|
|
prescription may be filled within 72 hours of the first partial
|
|
filling; however, if the remaining portion is not or cannot be
|
|
filled within the 72-hour period, the pharmacist shall so notify
|
|
the prescribing individual practitioner. No further quantity may
|
|
be supplied beyond 72 hours without a new prescription]. |
|
(f) A prescription for a Schedule II controlled substance |
|
for a patient in a long-term care facility (LTCF) or for a hospice |
|
patient with a medical diagnosis documenting a terminal illness may |
|
be filled in partial quantities to include individual dosage units. |
|
If there is any question about whether a hospice patient may be |
|
classified as having a terminal illness, the pharmacist must |
|
contact the practitioner before partially filling the |
|
prescription. Both the pharmacist and the practitioner have a |
|
corresponding responsibility to assure that the controlled |
|
substance is for a terminally ill hospice patient. The pharmacist |
|
must record the prescription [on an official prescription form or] |
|
in the electronic prescription record and must indicate [on the
|
|
official prescription form or] in the electronic prescription |
|
record whether the patient is a "terminally ill hospice patient" or |
|
an "LTCF patient." A prescription that is partially filled and does |
|
not contain the notation "terminally ill hospice patient" or "LTCF |
|
patient" is considered to have been filled in violation of this |
|
chapter. For each partial filling, the dispensing pharmacist shall |
|
record [on the back of the official prescription form or] in the |
|
electronic prescription record the date of the partial filling, the |
|
quantity dispensed, the remaining quantity authorized to be |
|
dispensed, and the identification of the dispensing pharmacist. |
|
Before any subsequent partial filling, the pharmacist must |
|
determine that the additional partial filling is necessary. The |
|
total quantity of Schedule II controlled substances dispensed in |
|
all partial fillings may not exceed the total quantity prescribed. |
|
Schedule II prescriptions for patients in a long-term care facility |
|
or hospice patients with a medical diagnosis documenting a terminal |
|
illness are valid for a period not to exceed 60 days following the |
|
issue date unless sooner terminated by discontinuance of the |
|
medication. |
|
(g) A person may not dispense a controlled substance in |
|
Schedule III or IV that is a prescription drug under the Federal |
|
Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) without |
|
a [written, electronic, oral, or telephonically communicated] |
|
prescription of a practitioner defined by Section 481.002(39)(A) or |
|
(D), except that the practitioner may dispense the substance |
|
directly to an ultimate user. A prescription for a controlled |
|
substance listed in Schedule III or IV may not be filled or refilled |
|
later than six months after the date on which the prescription is |
|
issued and may not be refilled more than five times, unless the |
|
prescription is renewed by the practitioner. A prescription under |
|
this subsection must comply with other applicable state and federal |
|
laws. |
|
(h) A pharmacist may dispense a controlled substance listed |
|
in Schedule III, IV, or V under a [written, electronic, oral, or
|
|
telephonically communicated] prescription issued by a practitioner |
|
defined by Section 481.002(39)(C) [and] only if the pharmacist |
|
determines that the prescription was issued for a valid medical |
|
purpose and in the course of professional practice. A prescription |
|
described by [issued under] this subsection may not be filled or |
|
refilled later than six months after the date the prescription is |
|
issued and may not be refilled more than five times, unless the |
|
prescription is renewed by the practitioner. |
|
(k) A prescription for a controlled substance must show: |
|
(1) the quantity of the substance prescribed: |
|
(A) [numerically, followed by the number written
|
|
as a word, if the prescription is written;
|
|
[(B)] numerically, if the prescription is |
|
electronic; or |
|
(B) [(C)] if the prescription is communicated |
|
orally or telephonically, as transcribed by the receiving |
|
pharmacist; |
|
(2) the date of issue; |
|
(2-a) if the prescription is issued for a Schedule II |
|
controlled substance to be filled at a later date under Subsection |
|
(d-1), the earliest date on which a pharmacy may fill the |
|
prescription; |
|
(3) the name, address, and date of birth or age of the |
|
patient or, if the controlled substance is prescribed for an |
|
animal, the species of the animal and the name and address of its |
|
owner; |
|
(4) the name and strength of the controlled substance |
|
prescribed; |
|
(5) the directions for use of the controlled |
|
substance; |
|
(6) the intended use of the substance prescribed |
|
unless the practitioner determines the furnishing of this |
|
information is not in the best interest of the patient; and |
|
(7) the name, address, Federal Drug Enforcement |
|
Administration number, and telephone number of the practitioner at |
|
the practitioner's usual place of business[, which must be legibly
|
|
printed or stamped on a written prescription; and
|
|
[(8)
if the prescription is handwritten, the signature
|
|
of the prescribing practitioner]. |
|
(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 day after the date the prescription is |
|
completely filled. |
|
SECTION 5. The heading to Section 481.075, Health and |
|
Safety Code, is amended to read as follows: |
|
Sec. 481.075. SCHEDULE II PRESCRIPTIONS [OFFICIAL
|
|
PRESCRIPTION PROGRAM]. |
|
SECTION 6. Sections 481.075(a), (e), (g), (h), (i), and |
|
(j), Health and Safety Code, are amended to read as follows: |
|
(a) A practitioner who prescribes a controlled substance |
|
listed in Schedule II shall, except as provided by Section |
|
481.074(b-1) or 481.0755 or a rule adopted under Section 481.0761, |
|
record the prescription [on an official prescription form or] in an |
|
electronic prescription that includes the information required by |
|
this section. |
|
(e) Each [official prescription form or electronic] |
|
prescription used to prescribe a Schedule II controlled substance |
|
must contain: |
|
(1) information provided by the prescribing |
|
practitioner, including: |
|
(A) the date the prescription is issued; |
|
(B) the controlled substance prescribed; |
|
(C) the quantity of controlled substance |
|
prescribed, shown[:
|
|
[(i)] numerically[, followed by the number
|
|
written as a word, if the prescription is written; or
|
|
[(ii)
numerically, if the prescription is
|
|
electronic]; |
|
(D) the intended use of the controlled substance, |
|
or the diagnosis for which the controlled substance [it] is |
|
prescribed, and the instructions for use of the substance; |
|
(E) the practitioner's name, address, and |
|
Federal Drug Enforcement Administration number issued for |
|
prescribing a controlled substance in this state; |
|
(F) the name, address, and date of birth or age of |
|
the person for whom the controlled substance is prescribed; and |
|
(G) if the prescription is issued to be filled at |
|
a later date under Section 481.074(d-1), the earliest date on which |
|
a pharmacy may fill the prescription; |
|
(2) information provided by the dispensing |
|
pharmacist, including the date the prescription is filled; and |
|
(3) [for a written prescription, the signatures of the
|
|
prescribing practitioner and the dispensing pharmacist or for an
|
|
electronic prescription,] the prescribing practitioner's |
|
electronic signature or other secure method of validation |
|
authorized by federal law. |
|
(g) Except for an emergency oral or telephonically |
|
communicated prescription described by [prescribed under] Section |
|
481.074(b-1) [481.074(b)], the prescribing practitioner shall: |
|
(1) record [legibly fill in,] or direct a designated |
|
agent to record [legibly fill in, on the official prescription form
|
|
or] in the electronic prescription[,] each item of information |
|
required to be provided by the prescribing practitioner under |
|
Subsection (e)(1), unless the practitioner determines that: |
|
(A) under rule adopted by the board for this |
|
purpose, it is unnecessary for the practitioner or the |
|
practitioner's agent to provide the patient identification number; |
|
or |
|
(B) it is not in the best interest of the patient |
|
for the practitioner or practitioner's agent to provide information |
|
regarding the intended use of the controlled substance or the |
|
diagnosis for which it is prescribed; and |
|
(2) [sign the official prescription form and give the
|
|
form to the person authorized to receive the prescription or, in the
|
|
case of an electronic prescription,] electronically sign or |
|
validate the electronic prescription as authorized by federal law |
|
and transmit the prescription to the dispensing pharmacy. |
|
(h) In the case of an emergency oral or telephonically |
|
communicated prescription described by [prescribed under] Section |
|
481.074(b-1) [481.074(b)], the prescribing practitioner shall give |
|
the dispensing pharmacy the information needed to complete the |
|
[official prescription form or] electronic prescription record. |
|
(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 day after the date the prescription is completely filled. |
|
(j) A medication order written for a patient who is admitted |
|
to a hospital at the time the medication order is written and filled |
|
is not required to be recorded [on an official prescription form or] |
|
in an electronic prescription record that meets the requirements of |
|
this section. |
|
SECTION 7. Subchapter C, Chapter 481, Health and Safety |
|
Code, is amended by adding Sections 481.0755 and 481.0756 to read as |
|
follows: |
|
Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY |
|
COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections 481.074 |
|
and 481.075, a prescription for a controlled substance is not |
|
required to be issued electronically and may be issued in writing 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 in the same |
|
location or under the same license; |
|
(5) in circumstances in which necessary elements are |
|
not supported by the most recently implemented national data |
|
standard that facilitates electronic prescribing; |
|
(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 practitioner who has received a waiver under |
|
Section 481.0756 from the requirement to use electronic |
|
prescribing; |
|
(10) 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; or |
|
(11) before January 1, 2021. |
|
(b) 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. The pharmacist |
|
may dispense a controlled substance pursuant to an otherwise valid |
|
written, oral, or telephonically communicated prescription |
|
consistent with the requirements of this subchapter. |
|
(c) Except in an emergency, a practitioner must use a |
|
written prescription to submit a prescription described by |
|
Subsection (a). In an emergency, the practitioner may submit an |
|
oral or telephonically communicated prescription as authorized |
|
under Section 481.074(b-1). |
|
(d) A written prescription for a controlled substance other |
|
than a Schedule II controlled substance must include the |
|
information required under Section 481.074(k) and the signature of |
|
the prescribing practitioner. |
|
(e) A written prescription for a Schedule II controlled |
|
substance must be on an official prescription form and include the |
|
information required for an electronic prescription under Section |
|
481.075(e), the signature of the practitioner, and the signature of |
|
the dispensing pharmacist after the prescription is filled. |
|
(f) The board by rule shall authorize a practitioner to |
|
determine whether it is necessary to obtain a particular patient |
|
identification number and to provide that number on the official |
|
prescription form. |
|
(g) On request of a practitioner, the board shall issue |
|
official prescription forms to the practitioner for a fee covering |
|
the actual cost of printing, processing, and mailing the forms. |
|
Before mailing or otherwise delivering prescription forms to a |
|
practitioner, the board shall print on each form the number of the |
|
form and any other information the board determines is necessary. |
|
(h) Each official prescription form must be sequentially |
|
numbered. |
|
(i) A person may not obtain an official prescription form |
|
unless the person is a practitioner as defined by Section |
|
481.002(39)(A) or an institutional practitioner. |
|
(j) Not more than one Schedule II prescription may be |
|
recorded on an official prescription form. |
|
(k) Not later than the 30th day after the date a |
|
practitioner's Federal Drug Enforcement Administration number or |
|
license to practice has been denied, suspended, canceled, |
|
surrendered, or revoked, the practitioner shall return to the board |
|
all official prescription forms in the practitioner's possession |
|
that have not been used for prescriptions. |
|
(l) Each prescribing practitioner: |
|
(1) may use an official prescription form only to |
|
submit a prescription described by Subsection (a); |
|
(2) shall date or sign an official prescription form |
|
only on the date the prescription is issued; and |
|
(3) shall take reasonable precautionary measures to |
|
ensure that an official prescription form issued to the |
|
practitioner is not used by another person to violate this |
|
subchapter or a rule adopted under this subchapter. |
|
(m) In the case of an emergency oral or telephonically |
|
communicated prescription described by Section 481.074(b-1), the |
|
prescribing practitioner shall give the dispensing pharmacy the |
|
information needed to complete the official prescription form if |
|
the pharmacy is not required to use the electronic prescription |
|
record. |
|
(n) Each dispensing pharmacist receiving an oral or |
|
telephonically communicated prescription under Subsection (m) |
|
shall: |
|
(1) fill in on the official prescription form each |
|
item of information given orally to the dispensing pharmacy under |
|
Subsection (m) and the date the prescription is filled and fill in |
|
the dispensing pharmacist's signature; |
|
(2) retain with the records of the pharmacy for at |
|
least two years: |
|
(A) the official prescription form; 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, to |
|
the board by electronic transfer or another form approved by the |
|
board not later than the next business day after the date the |
|
prescription is completely filled. |
|
Sec. 481.0756. WAIVERS FROM ELECTRONIC PRESCRIBING. (a) |
|
The appropriate regulatory agency that issued the license, |
|
certification, or registration to a prescriber is authorized to |
|
grant a prescriber a waiver from the electronic prescribing |
|
requirement under the provisions of this section. |
|
(b) The board shall convene an interagency workgroup that |
|
includes representatives of each regulatory agency that issues a |
|
license, certification, or registration to a prescriber. |
|
(c) The work group described by Subsection (b) shall |
|
establish recommendations and standards for circumstances in which |
|
a waiver from the electronic prescribing requirement is appropriate |
|
and a process under which a prescriber may request and receive a |
|
waiver. |
|
(d) 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 prescriber; or |
|
(3) other exceptional circumstances demonstrated by |
|
the prescriber. |
|
(e) Each regulatory agency that issues a license, |
|
certification, or registration to a prescriber shall adopt rules |
|
for the granting of waivers consistent with the board rules adopted |
|
under Subsection (d). |
|
(f) A waiver may be issued to a prescriber for a period of |
|
one year. A prescriber may reapply for a subsequent waiver not |
|
earlier than the 30th day before the date the waiver expires if the |
|
circumstances that necessitated the waiver continue. |
|
SECTION 8. Sections 481.0761(c) and (d), Health and Safety |
|
Code, are amended to read as follows: |
|
(c) The board by rule may: |
|
(1) [permit more than one prescription to be
|
|
administered or dispensed and recorded on one prescription form for
|
|
a Schedule III through V controlled substance;
|
|
[(1-a)] establish a procedure for the issuance of |
|
multiple prescriptions of a Schedule II controlled substance under |
|
Section 481.074(d-1); |
|
(2) remove from or return to the official prescription |
|
program any aspect of a practitioner's or pharmacist's hospital |
|
practice, including administering or dispensing; |
|
(3) waive or delay any requirement relating to the |
|
time or manner of reporting; |
|
(4) establish compatibility protocols for electronic |
|
data transfer hardware, software, or format, including any |
|
necessary modifications for participation in a database described |
|
by Section 481.076(j); |
|
(5) establish a procedure to control the release of |
|
information under Sections 481.074, 481.075, and 481.076; and |
|
(6) establish a minimum level of prescription activity |
|
below which a reporting activity may be modified or deleted. |
|
(d) The board by rule shall authorize a practitioner to |
|
determine whether it is necessary to obtain a particular patient |
|
identification number and to provide that number [on the official
|
|
prescription form or] in the electronic prescription record. |
|
SECTION 9. Subchapter C, Chapter 481, Health and Safety |
|
Code, is amended by adding Sections 481.07635 and 481.07636 to read |
|
as follows: |
|
Sec. 481.07635. CONTINUING EDUCATION. (a) A person |
|
authorized to receive information under Section 481.076(a)(5) |
|
shall, not later than the first anniversary after the person is |
|
issued a license, certification, or registration to prescribe or |
|
dispense controlled substances under this chapter, complete two |
|
hours of professional education related to approved procedures of |
|
prescribing and monitoring controlled substances. |
|
(b) A person authorized to receive information may annually |
|
take the professional education course under this section to fulfil |
|
hours toward the ethics education requirement of the person's |
|
license, certification, or registration. |
|
(c) The regulatory agency that issued the license, |
|
certification, or registration to a person authorized to receive |
|
information under Section 481.076(a)(5) shall approve professional |
|
education to satisfy the requirements of this section. |
|
Sec. 481.07636. OPIOID PRESCRIPTION LIMITS. (a) In this |
|
section, "acute pain" means the normal, predicted, physiological |
|
response to a stimulus such as trauma, disease, and operative |
|
procedures. Acute pain is time limited. The term does not include: |
|
(1) chronic pain; |
|
(2) pain being treated as part of cancer care; |
|
(3) pain being treated as part of hospice or other |
|
end-of-life care; or |
|
(4) pain being treated as part of palliative care. |
|
(b) For the treatment of acute pain, a practitioner may not: |
|
(1) issue a prescription for an opioid in an amount |
|
that exceeds a 10-day supply; or |
|
(2) provide for a refill of an opioid. |
|
(c) Subsection (b) does not apply to a prescription for an |
|
opioid approved by the United States Food and Drug Administration |
|
for the treatment of substance addiction that is issued by a |
|
practitioner for the treatment of substance addiction. |
|
(d) A dispenser is not subject to criminal, civil, or |
|
administrative penalties for dispensing or refusing to dispense a |
|
controlled substance under a prescription that exceeds the limits |
|
provided by Subsection (b). |
|
SECTION 10. 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 481.0755(k) [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 11. 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 12. Section 32.024, Human Resources Code, is |
|
amended by adding Subsection (z-2) to read as follows: |
|
(z-2) The limits on prescription drugs and medications |
|
under the medical assistance program provided by Subsections (z) |
|
and (z-1) do not apply to a prescription for an opioid for the |
|
treatment of acute pain under Section 481.07636, Health and Safety |
|
Code. |
|
SECTION 13. Subchapter B, Chapter 32, Human Resources Code, |
|
is amended by adding Section 32.03115 to read as follows: |
|
Sec. 32.03115. REIMBURSEMENT FOR MEDICATION-ASSISTED |
|
TREATMENT FOR OPIOID OR SUBSTANCE USE DISORDER. (a) In this |
|
section, "medication-assisted opioid or substance use disorder |
|
treatment" means the use of methadone, buprenorphine, oral |
|
buprenorphine/naloxone, or naltrexone to treat opioid or substance |
|
use disorder. |
|
(b) Notwithstanding Sections 531.072 and 531.073, |
|
Government Code, or any other law and subject to Subsections (c) and |
|
(d), the commission shall provide medical assistance reimbursement |
|
for medication-assisted opioid or substance use disorder treatment |
|
without requiring a recipient of medical assistance or health care |
|
provider to obtain prior authorization or precertification for the |
|
treatment, except as needed to minimize the opportunity for fraud, |
|
waste, or abuse. |
|
(c) The duty to provide medical assistance reimbursement |
|
for medication-assisted opioid or substance use disorder treatment |
|
under Subsection (b) does not apply with respect to: |
|
(1) a prescription for methadone; |
|
(2) a recipient for whom medication-assisted opioid or |
|
substance use disorder treatment is determined to be medically |
|
contraindicated by the recipient's physician; or |
|
(3) a recipient who is subject to an age-related |
|
restriction applicable to medication-assisted opioid or substance |
|
use disorder treatment. |
|
(d) The commission may provide medical assistance |
|
reimbursement for medication-assisted opioid or substance use |
|
disorder treatment only if the treatment is prescribed to a |
|
recipient of medical assistance by a licensed health care provider |
|
who is authorized to prescribe methadone, buprenorphine, oral |
|
buprenorphine/naloxone, or naltrexone. |
|
(e) This section expires August 31, 2023. |
|
SECTION 14. 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, 481.0756, 481.076, |
|
481.0761, 481.0762, 481.0763, 481.07635, 481.07636, 481.0764, |
|
481.0765, and 481.0766, Health and Safety Code. |
|
SECTION 15. 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) Section 481.074, [or] 481.075, 481.0755, |
|
481.0756, 481.076, 481.0761, 481.0762, 481.0763, 481.07635, |
|
481.07636, 481.0764, 481.0765, or 481.0766, 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 16. Sections 481.073, 481.074(o) and (p), and |
|
481.075(b), (c), (d), (f), (k), and (l), Health and Safety Code, are |
|
repealed. |
|
SECTION 17. A person who holds a license, certification, or |
|
registration to prescribe or dispense a controlled substance issued |
|
before September 1, 2020, is required to take the continuing |
|
education course provided by Section 481.07635, Health and Safety |
|
Code, as added by this Act, not later than September 1, 2021. |
|
SECTION 18. If before implementing any provision of this |
|
Act a state agency determines that a waiver or authorization from a |
|
federal agency is necessary for implementation of that provision, |
|
the agency affected by the provision shall request the waiver or |
|
authorization and may delay implementing that provision until the |
|
waiver or authorization is granted. |
|
SECTION 19. This Act takes effect September 1, 2019. |
|
|
|
* * * * * |