Proposed Administrative Rules
Chapter 130. Podiatric Medicine Program
Proposal Filed: December 14, 2020– Published in the Texas Register: December 25, 2020
Deadline for Public Comment: January 25, 2021
Underlined text is new language.
Strikethrough text ] is deleted language.
The Texas Department of Licensing and Regulation (Department) proposes amendments to an existing rule at 16 Texas Administrative Code (TAC), Chapter 130, Subchapter E, §130.59; and proposed repeal of an existing rule at Subchapter G, §130.74, regarding the Podiatry program. These proposed changes are referred to as the “proposed rules.”
EXPLANATION OF AND JUSTIFICATION FOR THE RULES
The rules under 16 TAC Chapter 130, implement Texas Occupations Code, Chapter 202, Podiatrists.
The proposed 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 proposed 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 The statutory requirement for adopting a penalty matrix rule in Texas Occupations Code §202.6011 was repealed by HB 2847, 86th Legislature, Regular Session (2019).
The proposed rules were presented to and discussed by the Podiatric Medical Examiners Advisory Board at its meeting on December 7, 2020. The Advisory Board did not make any changes to the proposed rules. The Advisory Board voted to recommend that the proposed rules be published in the Texas Register for public comment.
The proposed rules amend 16 TAC §130.59, Opioid Prescription Limits and Required Electronic Prescribing. The proposed 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 proposed 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 Texas Commission of Licensing and Regulation (Commission), the Department’s governing body, 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.
FISCAL IMPACT ON STATE AND LOCAL GOVERNMENT
Tony Couvillon, Policy Research and Budget Analyst, has determined that for each year of the first five years the proposed rule is in effect, enforcing or administering the proposed rules do not have foreseeable implications relating to costs or revenues of state or local governments. The proposed rules will not impact the Department's costs or fees paid to the Department. Additionally, local governments are not responsible for enforcing or administering the proposed rules.
LOCAL EMPLOYMENT IMPACT STATEMENT
Mr. Couvillon has determined that the proposed rules will not affect the local economy, so the Department is not required to prepare a local employment impact statement under Texas Government Code §2001.022.
Mr. Couvillon also has determined that for each year of the first five-year period the proposed rules are in effect, the public benefit will be that the proposed rules provide for more effective and efficient regulation of podiatrists regarding prescribing of controlled substances which enhances the public health, safety, and welfare. Some members of the public and their families will benefit from the electronic prescribing requirements waivers. Podiatrists who are granted a waiver will not be required to send an electronic prescription for controlled substances directly to a pharmacy, and instead will be able to provide a paper prescription. Podiatrists that have documented circumstances justifying a waiver will still be able to serve clients who require controlled substance prescriptions to assist in their podiatric treatment.
Repealing the redundant penalty matrix from rule will reduce confusion for the public and licensees by providing one document that contains the most up-to-date information, and allowing the Commission to update the matrix as needed through revisions to the Department’s enforcement plan rather than the rule amendment process required by the Administrative Procedure Act. The podiatry penalty matrix was incorporated into the Department’s enforcement plan when it was created for the rules and it will continue to serve its purpose there after the matrix is repealed from the rules.
PROBABLE ECONOMIC COSTS TO PERSONS REQUIRED TO COMPLY WITH PROPOSAL
Mr. Couvillon has determined that for each year of the first five-year period the proposed rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.
FISCAL IMPACT ON SMALL BUSINESSES, MICRO-BUSINESSES, AND RURAL COMMUNITIES
There will be no adverse economic effect on small businesses, micro-businesses, or rural communities as a result of the proposed rules. Since the agency has determined that the proposed rule will have no adverse economic effect on small businesses, micro-businesses, or rural communities, preparation of an Economic Impact Statement and a Regulatory Flexibility Analysis, as detailed under Texas Government Code §2006.002, are not required.
ONE-FOR-ONE REQUIREMENT FOR RULES WITH A FISCAL IMPACT
The proposed rules do not have a fiscal note that imposes a cost on regulated persons, including another state agency, a special district, or a local government. Therefore, the agency is not required to take any further action under Government Code §2001.0045.
GOVERNMENT GROWTH IMPACT STATEMENT
Pursuant to Government Code §2001.0221, the agency provides the following Government Growth Impact Statement for the proposed rules. For each year of the first five years the proposed rules will be in effect, the agency has determined the following:
1. The proposed rules do not create or eliminate a government program.
2. Implementation of the proposed rules does not require the creation of new employee positions or the elimination of existing employee positions.
3. Implementation of the proposed rules does not require an increase or decrease in future legislative appropriations to the agency.
4. The proposed rules do not require an increase or decrease in fees paid to the agency.
5. The proposed rules do not create a new regulation.
6. The proposed rules do expand, limit, or repeal an existing regulation.
The proposed rules expand an existing regulation in 16 TAC §130.59 by outlining the parameters under which the Department may grant a waiver from the electronic prescribing requirements for controlled substance prescriptions.
The proposed rules also repeal 16 TAC §130.74. This section is no longer statutorily required with the repeal of Texas Occupations Code §202.6011, and repealing the rule reduces regulatory redundancy and harmonizes the program with other Department programs which do not maintain a penalty matrix in rule.
7. The proposed rules do not increase or decrease the number of individuals subject to the rules’ applicability.
8. The proposed rules do not positively or adversely affect this state's economy.
TAKINGS IMPACT ASSESSMENT
The Department has determined that no private real property interests are affected by the proposed rules and the proposed rules do not restrict, limit, or impose a burden on an owner’s rights to his or her private real property that would otherwise exist in the absence of government action. As a result, the proposed rules do not constitute a taking or require a takings impact assessment under Government Code §2007.043.
Comments on the proposed rules may be submitted electronically on the Department’s website at https://ga.tdlr.texas.gov:1443/form/gcerules ; by facsimile to (512) 475-3032; or by mail to Vanessa Vasquez, Legal Assistant, Texas Department of Licensing and Regulation, P.O. Box 12157, Austin, Texas 78711. The deadline for comments is 30 days after publication in the Texas Register.
The proposed rules are proposed 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 proposed 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 proposed 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 proposed rules.
SUBCHAPTER E. PRACTITIONER RESPONSIBILITIES AND CODE OF ETHICS
§130.59. Opioid Prescription Limits and Required Electronic Prescribing
(a) – (b) (No change.)
(c) After January 1, 2021 all controlled substances must be prescribed electronically except:
(1) – (7) (No change.);
(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) (No change.)
(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.
The proposed repeal is proposed 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 repeal is also proposed 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 proposed repeal 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 proposed rules.
SUBCHAPTER G. ENFORCEMENT.
§130.74. Penalty Matrix ]
REVIEW BY AGENCY COUNSEL
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency’s legal authority to adopt.
Filed with the Office of the Secretary of State, on December 14, 2020.
Texas Department of Licensing and Regulation