Justification for Adoption of Administrative Rules

JUSTIFICATION FOR ADMINISTRATIVE RULE ADOPTION

Podiatric Medicine Program
16 TAC Chapter 130, amends Subchapter E, §130.59; and repeals Subchapter G, §130.74.

The Texas Commission of Licensing and Regulation (Commission) adopts amendments to existing rules at 16 Texas Administrative Code (TAC), Chapter 130, Subchapter E, §130.59, and repeal of an existing rule at Subchapter G, §130.74, regarding the Podiatry Program without changes to the proposed text as published in the December 25, 2021, issue of the Texas Register (45 TexReg 9381).

EXPLANATION OF AND JUSTIFICATION FOR THE RULES

The rules under 16 TAC Chapter 130, implement Texas Occupations Code, Chapter 202, Podiatrists.

The adopted rules provide for a waiver of the requirements in Texas Health and Safety Code §481.074 and §481.075 for controlled substance prescriptions to be issued electronically (electronic prescribing requirements) and repeal the rule adopting a penalty matrix. House Bill (HB) 2174, 86th Legislature, Regular Session (2019), and Texas Health and Safety Code §481.0756 authorize the Department to grant licensed podiatrists a waiver from electronic prescribing requirements. The adopted rules also repeal the rule adopting a penalty matrix for the Podiatry program. The statutory requirement for adopting a penalty matrix rule in Texas Occupations Code §202.6011 was repealed by HB 2847, 86th Legislature, Regular Session (2019).

SECTION-BY-SECTION SUMMARY

The adopted rules amend 16 TAC §130.59, Opioid Prescription Limits and Required Electronic Prescribing. The adopted rules establish a procedure and specify criteria for the Department to apply when granting a waiver from the electronic prescribing requirements for controlled substances. New subsection (d) establishes the Department’s authority to require a form, the one-year time period for a waiver, and the renewal application timeline. New subsection (e) establishes the criteria that a waiver request must satisfy for the Department to grant a waiver. New subsection (f) establishes the Department’s authority to revoke or refuse to grant a waiver.

The adopted rules repeal 16 TAC §130.74, Penalty Matrix. The repeal of this rule reduces redundancy and increases efficiency by harmonizing the program with other Department programs which do not maintain a penalty matrix in rule. Texas Occupations Code §51.302(c) requires the Commission to establish a written enforcement plan that provides specific ranges of penalties for specific violations and the criteria by which the Department determines the amount of the penalty. The Department’s enforcement plan contains a schedule of penalties for each program known as a “penalty matrix.” The podiatry penalty matrix was incorporated into the Department’s enforcement plan when it was created and it will continue to serve its purpose there after 16 TAC §130.74 is repealed. A public notice of revisions to the enforcement plan is published in the Texas Register as required by Texas Occupations Code §51.302(c) each time a program’s penalty matrix is revised.

PUBLIC COMMENTS

The Department drafted and distributed the proposed rules to persons internal and external to the agency. The proposed rules were published in the December 25, 2020, issue of the Texas Register (45 TexReg 9381). The deadline for public comments was January 25, 2021. The Department received comments from two interested parties on the proposed rules during the 30-day public comment period. The public comments are summarized below.

Comment: One commenter is a Doctor of Podiatric Medicine who is in support of the waiver for electronic prescribing requirements, because the cost for electronic prescribing would be a burden on his small practice.

Department Response: The Department appreciates the comment in support of the proposed rules. No changes have been made to the proposed rules as a result of this comment.

Comment: One commenter is a Doctor of Podiatric Medicine who requested the paperwork for a waiver so that he could complete his request to continue prescribing by paper instead of electronically.

Department Response: This comment is not related to the substance of the proposed rules, but the Department has provided this comment to the appropriate staff so that they may assist this commenter with his inquiry. The Department has made no changes to the proposed rules as a result of this comment.

COMMISSION ACTION

At its meeting on March 3, 2021, the Commission adopted the proposed rules as recommended by the Department.

STATUTORY AUTHORITY

The rules are adopted under Texas Occupations Code, Chapters 51 and 202, which authorize the Commission to adopt rules as necessary to implement these chapters and any other law establishing a program regulated by the Department. The rules are also adopted under Texas Health and Safety Code Chapter 481, which mandates that practitioners observe electronic prescription requirements for controlled substances, and requires agencies which regulate practitioners to implement a process for granting waivers from electronic prescription requirements.

The statutory provisions affected by the adopted rules are those set forth in Texas Occupations Code, Chapters 51 and 202, and Texas Health and Safety Code Chapter 481. No other statutes, articles, or codes are affected by the adopted rules.

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SUBCHAPTER E. PRACTITIONER RESPONSIBILITIES AND CODE OF ETHICS

  • 130.59. Opioid Prescription Limits and Required Electronic Prescribing

(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 and 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 podiatrist 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) After January 1, 2021 all controlled substances must be prescribed electronically except:

(1) in an emergency or in circumstances in which electronic prescribing is not available due to temporary technological or electronic failure, in a manner provided for by the Texas State Board of Pharmacy rules;

(2) by a practitioner to be dispensed by a pharmacy located outside this state, in a manner provided for by the Texas State Board of Pharmacy rules;

(3) when the prescriber and dispenser are in the same location or under the same license;

(4) in circumstances in which necessary elements are not supported by the most recently implemented national data standard that facilitates electronic prescribing;

(5) 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;

(6) 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;

(7) for a drug under a research protocol;

(8) by a practitioner who has received a waiver under Section 481.0756 of the Texas Health and Safety Code from the requirement to use electronic prescribing, as provided by subsections (d)-(e); or

(9) 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.

(d) To obtain a waiver of the requirement to use electronic prescribing, a practitioner must submit a waiver request on a form approved by the department. The waiver request form must document sufficient evidence of the circumstances justifying the waiver as outlined in subsection (e). A waiver granted by the department under this section shall expire one year after the date of approval. A practitioner 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.

(e) A practitioner’s waiver of electronic prescribing request form must contain sufficient evidence of one or more of the following that, in the judgment of the executive director, justify the issuance of a waiver:

(1) economic hardship, including:

(A) any special situational factors affecting either the cost of compliance or ability to comply;

(B) the likely impact of compliance on profitability or viability; and

(C) the availability of measures that would mitigate the economic impact of compliance;

(2) technological limitations not reasonably within the control of the practitioner;

(3) issuance of fifty or fewer prescriptions for controlled substances in the year immediately prior to the application for a waiver, as documented by the Texas Prescription Monitoring Program; or

(4) other exceptional circumstances demonstrated by the practitioner.

(f) The department may revoke or refuse to issue a waiver under this section if the practitioner violates any provision of Texas Occupations Code, Chapters 51 or 202, this chapter, or any rule or order of the executive director or commission.

STATUTORY AUTHORITY

The repeal is adopted under Texas Occupations Code, Chapters 51 and 202, which authorize the Commission to adopt rules as necessary to implement these chapters and any other law establishing a program regulated by the Department.

The statutory provisions affected by the adopted repeal are those set forth in Texas Occupations Code, Chapters 51 and 202. No other statutes, articles, or codes are affected by the adopted repeal.

SUBCHAPTER G. ENFORCEMENT.

  • 130.74. Penalty Matrix

REVIEW BY AGENCY COUNSEL

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency’s legal authority. 

Filed with the Office of the Secretary of State, on March 12, 2021.


Brad Bowman
General Counsel
Texas Department of Licensing and Regulation