Proposed Amendments to Administrative Rules

Chapter 130. Podiatric Medicine

Proposal Filed: December 18, 2019 – Published in the Texas Register: January 3, 2020

Deadline for Public Comment: February 4, 2020

Underlined text is new language.

[ Strikethrough text ] is deleted language.

The Texas Department of Licensing and Regulation (Department) proposes amendments to existing rules at 16 Texas Administrative Code (TAC), Chapter 130, Subchapter D, §§130.42, 130.44, and 130.45; Subchapter E, §§130.53, 130.56, and 130.58; Subchapter F, §130.60; and Subchapter G, §130.72; and proposed new rule Subchapter E, §130.59, regarding the Podiatry Program. These proposed changes are referred to as “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 require practitioners to complete a human trafficking training course as required by House Bill (HB) 2059 and the newly-created Chapter 116 of the Occupations Code.

The proposed rules establish limits on prescribing opioids for acute pain, address electronic prescribing, and require continuing education on prescribing and monitoring controlled substances. These rules implement HB 2174, HB 3284, and HB 3285, which revised the Texas Controlled Substances Act in Chapter 481 of the Health and Safety Code.

The proposed rules also clarify the scope of delegation permitted and allow for a podiatrist to delegate to a qualified and properly trained podiatric medical assistant as outlined in HB 2847. Implementing a transfer from the Texas Medical Board to the Department’s regulatory authority in HB 2847, the proposed rules provide for the regulation of podiatric medical radiological technicians and establish a fee for this license.

The proposed rules update the administrative penalties and sanctions for podiatrists, implementing HB 1899 and Occupations Code, Chapter 108, as well as penalties for improperly accessing the Texas Prescription Monitoring Program provided for in HB 3284 and the Texas Controlled Substances Act.

Finally, the proposed rules provide for the orderly transition of assessing continuing medical education hours as the Department transitions to biennial podiatric license terms. Biennial license terms were adopted in a previous rulemaking and made effective September 1, 2019 (44 TexReg 4725).

The proposed rules were presented to and discussed by the Podiatric Medical Examiners Advisory Board at its meeting on November 18, 2019. The Advisory Board made the following changes to the proposed rules: removed duplicate comma in §130.53(c). The Advisory Board voted and recommended that the proposed rules with changes be published in the Texas Register for public comment.

SECTION-BY-SECTION SUMMARY

The proposed rules amend §130.42 to require the completion of human trafficking prevention training for each renewal on or after September 1, 2020. This training is required by Texas Occupations Code §116.003.

The proposed rules amend §130.44 to require two hours of continuing medical education (CME) related to prescribing and monitoring controlled substances prior to the first anniversary of podiatric medical licensure. The amendment requires one hour of CME covering best practices, alternative treatment options, and multimodal approaches to pain management for podiatrists whose practice involves the prescription and dispensation of opioids. Additionally, the amendment revises the CME due date requirements and provides a guide to transition for CME requirements as the Department moves podiatric license renewal to biennial periods.

The proposed rules amend §130.45, by deleting subsection (f), which was duplicative of a similar subsection in §130.44.

The proposed rules amend §130.53, by establishing regulatory authority over podiatric medical radiological technicians as created by HB 2847. The amendment also specifies a requirement of 60 x-rays for student training and requires completion of human trafficking prevention training for each renewal on or after September 1, 2020. The amendment deletes a reference to an act of moral turpitude as grounds for the Department to refuse renewal of a podiatric medical radiology technician license.

The proposed rules amend §130.56 to clarify the scope of delegated authority from a podiatrist to a podiatric medical assistant.

The proposed rules amend §130.58 to permit a podiatrist to designate an agent to communicate prescriptions to a pharmacist. Additionally, the amendment specifies that unauthorized access of the Texas Prescription Monitoring Program (PMP) is grounds for disciplinary action by the Department.

The proposed rules create new §130.59 that outlines the limits on the prescription of opioids to treat acute pain. The new section also requires the electronic prescription of all controlled substance prescriptions after September 1, 2021, and provides a list of exceptions for this requirement.

The proposed rules amend §130.60 to provide the fees applicable for Active Duty Military Members ($0), and Podiatric Medical Radiological Technicians ($25).

The proposed rules amend §130.72 to establish grounds for disciplinary actions and sanctions based upon improper access and dissemination of information obtained from the PMP. Additionally, the amendment incorporates denial of licensure, and suspension or revocation of licenses, for offenses identified in Chapter 108, Subchapter B, of the Occupations Code.

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 rules are in effect, there are no estimated additional costs or reductions in costs to state or local government as a result of enforcing or administering the proposed rules.

The proposed rules will require human trafficking training developed or approved by the Texas Health and Human Service Commission, which will include a free training course option. The proposed rules implement legislation addressing the opioid crisis by adding continuing medical education requirements, e-prescribing, and prescribing limits for opioids. There are no anticipated additional costs to the State associated with the implementation or regulation for these changes.

The proposed rules bring regulation of Podiatric Medical Radiological Technicians fully under the Department’s jurisdiction and allow for the Department to establish a fee for Podiatric Medical Radiological Technician registrations. Existing staff will only have a slightly higher workload renewing the registrations and therefore there will be no additional costs to the State.

Mr. Couvillon, has determined that for each year of the first five years the proposed rules are in effect, there is no estimated loss in revenue to the State because the proposed rules do not reduce or remove any fees that would reduce revenue. However, for each of the first five years the proposed rules are in effect there will be an estimated increase in state revenue. The Podiatric Medical Radiological Technician registration fee will result in roughly $11,000 of revenue annually for the currently 438 Podiatric Medical Radiological Technicians that will be charged $25.00 each for registration. This fee is less than the $35.00 fee assessed by the previous agency (Texas State Board of Podiatric Medical Examiners) but currently there is no registration fee assessed by the Department.

Mr. Couvillon has determined that for each year of the first five years the proposed rules are in effect, enforcing or administering the proposed rules does not have foreseeable implications relating to costs or revenues of local governments because local governments are not responsible for the regulation of podiatry.

LOCAL EMPLOYMENT IMPACT STATEMENT

Mr. Couvillon has determined that the proposed rules will not affect the local economy, so the agency is not required to prepare a local employment impact statement under Government Code §2001.022.

PUBLIC BENEFITS

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 require certain health care practitioners who provide “direct patient care” to complete a human trafficking training course developed or approved by the Texas Health and Human Services Commission as a condition of license renewal, which will help raise human trafficking awareness to help prevent it. The proposed rules also establish limits on prescribing opioids for acute pain, require that prescriptions for controlled substances be submitted electronically rather than in writing, with certain exceptions, and requires continuing education practitioners related to approved procedures of prescribing and monitoring controlled substances to help end the opioid crisis. The proposed rules allow a podiatrist to delegate to a qualified and properly trained podiatric medical assistant and provides for the regulation of podiatric medical radiological technicians, to better maximize the services provided to patients.

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 will be additional costs to persons who are required to comply with the proposed rules. There will be an annual fee of $25.00 to the Department for Podiatric Medical Radiological Technicians. The addition of the new fee, which previously was not imposed by the Department due to lack of statutory authority, will result in additional costs for the first five years the proposed rules are in effect.

FISCAL IMPACT ON SMALL BUSINESSES, MICRO-BUSINESSES, AND RURAL COMMUNITIES

There will be no adverse effect on small businesses, micro-businesses, or rural communities as a result of the proposed rules. Since the agency has determined that the proposed rules 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, is not required.

ONE-FOR-ONE REQUIREMENT FOR RULES WITH A FISCAL IMPACT

The proposed rules do have a fiscal note that imposes a cost on regulated persons, including another state agency, a special district, or a local government; however, the proposed rules fall under the exceptions for rules that are necessary to protect the health, safety, and welfare of the residents of this state and are necessary to implement legislation, under §2001.0045(c)(6), (9). 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 require an increase or decrease in fees paid to the agency.

5. The proposed rules do create a new regulation.

6. The proposed rules do expand, limit, or repeal an existing regulation.

7. The proposed rules do not increase or decrease the number of individuals subject to the rule's applicability.

8. The proposed rules do not positively or adversely affect this state's economy.

The proposed rules establish an annual $25.00 fee for Podiatric Medical Radiological Technicians which is necessary for the administration of the program. Additionally, the proposed rules implement statutory provisions to address opioid abuse. The proposed rules also expand possible administrative penalties and sanctions to include misuse of the Prescription Monitoring Program database as required by Texas Occupations Code, Chapter 108.

The proposed rules expand the requirements for renewal of a podiatrist license to include the requirement to complete a human trafficking prevention training and also expand the standards for prescribing controlled substances and dangerous drugs to allow a podiatrist to designate an agent to communicate a prescription to a pharmacist.

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.

PUBLIC COMMENTS

Comments on the proposed rules may be submitted to Vanessa Vasquez, Legal Assistant, Texas Department of Licensing and Regulation, P.O. Box 12157, Austin, Texas 78711, or facsimile (512) 475-3032, or electronically: erule.comments@tdlr.texas.gov . The deadline for comments is 30 days after publication in the Texas Register.

STATUTORY AUTHORITY

The proposed rules are proposed under Texas Occupations Code, Chapters 51 and 202, which authorize the Texas Commission of Licensing and Regulation, the Department’s governing body, 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 Occupations Code, Chapter 108, which establishes the Department’s authority to deny, suspend or revoke podiatrists for certain criminal convictions; Texas Occupations Code, Chapter 116, which requires the completion of human trafficking prevention training for health professions licensees; and Texas Health and Safety Code, Chapter 481, which mandates certain continuing education for controlled substance prescribers, places limits on the prescription of opioids for acute pain, requires the submission of electronic prescriptions for controlled substances, and forbids unauthorized access to the PMP.

The statutory provisions affected by the proposed rules are those set forth in Texas Occupations Code, Chapters 51, 108, 116, and 202; and Texas Health and Safety Code, Chapter 481.

No other statutes, articles, or codes are affected by the proposed rules.

Subchapter D. Doctor of Podiatric Medicine.

§130.42. Doctor of Podiatric Medicine License--Term; Renewal.

(a) A Doctor of Podiatric Medicine license is valid for two years.

(b) To renew a Doctor of Podiatric Medicine license the licensee must:

(1) submit a department-approved renewal application;

(2) complete all required continuing medical education hours as required by §130.44; and

(3) pay the required fee.

(c) For each license renewal on or after September 1, 2020, a Doctor of Podiatric Medicine must complete the human trafficking prevention training required under Occupations Code, Chapter 116, and provide proof of completion as prescribed by the department.

§130.44. Continuing Medical Education--General Requirements.

(a) Each person licensed to practice podiatric medicine in the State of Texas is required to have 50 hours of continuing medical education (CME) every two years for the renewal of the license to practice podiatric medicine. One hour of training is equal to one hour of CME.

(b) Two hours of the required 50 hours of department approved CME shall be a course, class, seminar, or workshop in: Ethics in the Delivery of Health Care Services and/or Rules and Regulations pertaining to Podiatric Medicine in Texas. Topics on Human Trafficking Prevention, Healthcare Fraud, Professional Boundaries, Practice Risk Management or Podiatric Medicine related Ethics or Jurisprudence courses, Abuse and Misuse of Controlled Substances, Opioid Prescription Practices, and/or Pharmacology, including those sponsored by an entity approved by CPME, APMA, APMA affiliated organizations, AMA, AMA affiliated organizations, or governmental entities, or the entities described in subsections (e) [ (c) ] and (f) [ (d) ] are acceptable.

(c) Each person initially licensed to practice podiatric medicine in the State of Texas is required to complete two hours of continuing medical education related to approved procedures of prescribing and monitoring controlled substances prior to the first anniversary of date the license was originally issued.

(d) For each person licensed to practice podiatric medicine in the State of Texas whose practice includes prescription or dispensation of opioids shall annually attend at least one hour of continuing medical education covering best practices, alternative treatment options, and multi-modal approaches to pain management that may include physical therapy, psychotherapy, and other treatments.

(e) [ (c) ] A licensee shall receive credit for each hour of podiatric medical meetings and training sponsored by APMA, APMA affiliated organizations, TPMA, state, county or regional podiatric medical association podiatric medical meetings, university sponsored podiatric medical meetings, hospital podiatric medical meetings or hospital podiatric medical grand rounds, medical meetings sponsored by the Foot & Ankle Society or the orthopedic community relating to foot care, and others at the discretion of the Board. A practitioner may receive credit for giving a lecture, equal to the credit that a podiatrist attending the lecture obtains.

(f) [ (d) ] A licensee shall receive credit for each hour of training for non-podiatric medical sponsored meetings that are relative to podiatric medicine and department approved. The department may assign credit for hospital grand rounds, hospital CME programs, corporate sponsored meetings, and meetings sponsored by the American Medical Association, the orthopedic community, the American Diabetes Association, the Nursing Association, the Physical Therapy Association, and others if approved.

(g) [ (e) ] It shall be the responsibility of the licensee to ensure that all CME hours being claimed meet the standards for CME as set by the commission. Practice management, home study and self-study programs will be accepted for CME credit hours only if the provider is approved by the Council on Podiatric Medical Education. The licensee may obtain up to, but not exceed twenty (20) hours of the aforementioned hours per biennium.

(h) [ (f) ] Cardiopulmonary Resuscitation (CPR) certification is eligible for up to three (3) hours of CME credit and Advanced Cardiac Life Support (ACLS) certification for up to six (6) hours of CME credit. Practitioners may only receive credit for one, not both. No on-line CPR certification will be accepted for CME credit.

(i) [ (g) ] If a practitioner has an article published in a peer review journal, the practitioner may receive one (1) hour of CME credit for the article, with credit for the article being provided only once, regardless of the number of times or the number of journals in which the article is published.

(j) [ (h) ] With the exception of the allowed hours carried forward, the required 50 [ These ] hours of continuing medical education must be obtained in a [ the ] 24-month period immediately preceding the date in [ year for ] which the license is to be renewed [ was issued ]. The 24-month [ two-year ] period will begin on the first full day of the month after the practitioner’s date of renewal [ November 1 ] and end [ on October 31 ] two years later. [ The year in which the 50-hour credit requirement must be completed after the original license is issued is every odd-numbered year if the original license was issued in an odd-numbered year and is every even-numbered year if the original license was issued in an even-numbered year. ] A licensee who completes more than the required 50 hours during the preceding CME period may carry forward a maximum of ten (10) hours for the next renewal CME period.

(k) [ (i) ] The department shall employ an audit system for continuing education reporting. The license holder shall be responsible for maintaining a record of his or her continuing education experiences. The certificates or other documentation verifying earning of continuing education hours are not to be forwarded to the department at the time of renewal unless the license holder has been selected for audit.

(l) [ (j) ] The audit process shall be as follows:

(1) The department shall select for audit a random sample of license holders to ensure compliance with CME hours.

(2) If selected for an audit, the license holder shall submit copies of certificates, transcripts or other documentation satisfactory to the department, verifying the license holder's attendance, participation and completion of the continuing education.

(3) Failure to timely furnish this information within thirty (30) calendar days or providing false information during the audit process or the renewal process are grounds for disciplinary action against the license holder.

(4) If selected for continuing education audit during the renewal period, the license holder may renew and pay renewal fees.

(m) [ (k) ] Licensees that are deficient in CME hours must complete all deficient CME hours and current biennium CME requirement in order to maintain licensure.

(n) [ (l) ] Continuing education obtained as a part of a disciplinary action is not acceptable credit towards the total of fifty (50) hours required every two years.

(o) The 85th Texas Legislature enacted changes to Chapter 202, Occupations Code, providing the commission with authority to establish a one or two-year license term for Doctors of Podiatric Medicine licensees. See H.B.3078, 85th Legislature, Regular Session (2017). The purpose of this transition rule is to provide guidance on how continuing medical education will be assessed when transitioning from a one to two-year license term. This rule applies only to licenses renewing on or after September 1, 2019. Beginning September 1, 2019, the department shall stagger the continuing medical education biennium of licenses as follows. Practitioners renewing in an odd-numbered year are to obtain 50 hours of CME for a 24-month period between 2019 and 2021; and for every 2-years thereafter in between renewal dates. Practitioners renewing in an even-numbered year are to obtain 50 hours of CME for a 24-month period between 2020 and 2022; and for every 2-years thereafter in between renewal dates. This rule expires on August 31, 2022.

§130.45. Continuing Medical Education--Exceptions and Allowances; Approval of Hours.

(a) Delinquency for continuing education may be allowed in cases of hardship as determined on an individual basis by the executive director. In cases of such hardships, hours of delinquency must be current at the end of a three-year period.

(b) Any practitioner not actively practicing podiatric medicine shall be exempt from these requirements; however, upon resuming practice of podiatric medicine, that person shall fulfill the requirements of the preceding year from the effective date prior to the resumption of practice.

(c) Any program approved by the Council on Podiatric Medical Education of the American Podiatric Medical Association is acceptable to the department.

(d) Hours obtained in Colleges or Universities while working on a degreed or non-degreed program or an approved residency program by the Council on Podiatric Medical Education and providing these courses shall be of a medical nature, shall be considered as having fulfilled the requirements of continuing education hours for the fiscal year.

(e) Hours of continuing education submitted to the department for approval, must be certified by the Continuing Education Director of the institution or organization from which the hours were obtained, that he/she was in actual attendance for the specified period.

[ (f) Holders of current Cardio-Pulmonary Resuscitation certificates are eligible for three (3) hours credit of continuing education or, current Advance Life Support Course certificates are eligible for six (6) hours credit of continuing education. ]

STATUTORY AUTHORITY

The proposed rules are proposed under Texas Occupations Code, Chapters 51 and 202, which authorize the Texas Commission of Licensing and Regulation, the Department’s governing body, 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 Occupations Code, Chapter 108, which establishes the Department’s authority to deny, suspend or revoke podiatrists for certain criminal convictions; Texas Occupations Code, Chapter 116, which requires the completion of human trafficking prevention training for health professions licensees; and Texas Health and Safety Code, Chapter 481, which mandates certain continuing education for controlled substance prescribers, places limits on the prescription of opioids for acute pain, requires the submission of electronic prescriptions for controlled substances, and forbids unauthorized access to the PMP.

The statutory provisions affected by the proposed rules are those set forth in Texas Occupations Code, Chapters 51, 108, 116, 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.

§130.53. Podiatric Medical Radiological Technicians .

(a) This section does not apply to persons certified by the Texas Medical Board under the Medical Radiologic Technologist Certification Act who are Non-Certified Technicians (NCTs), Certified Medical Radiologic Technologists (MRTs) or Limited Medical Radiologic Technologists (LMRTs).

(b) It is the practitioner’s responsibility to ensure that all individuals wishing to perform podiatric radiological procedures are properly trained and apply for registration with the department as a podiatric medical radiological technician.

(c) Podiatric equipment training[ Training ] course providers, and standards for curricula and instructors must be approved by the department [ Texas Medical Board ].

(d) Podiatric medical radiological technician applicants must:

(1) be 18 years of age or older;

(2) successfully complete the following 20 hours of clinical and didactic training requirements and provide proof of completion to the department:

(A) 5 class hours and 5 out of class hours of radiation safety and protection for the patient, self, and others;

(B) 1 class and 2 out of class hours of radiographic equipment used in podiatric medicine, including safety standards, operation, and maintenance;

(C) 1 class and 4 out of class hours in podiatric radiologic procedures, imaging production and evaluation; and

(D) 1 class and 1 out of class hour in methods of patient care and management essential to radiologic procedures, excluding CPR, BCLS, ACLS and similar subjects; and

(3) submit a department-approved application.

(e) Out of classroom training hours must be verified by a supervising podiatrist and require the student to maintain a log demonstrating the successful production of 60 x-rays in the clinical setting overseen and signed by the supervising podiatrist .

(f) A podiatric medical radiological technician must hold a registration and may perform only podiatric radiological procedures.

(g) A podiatric medical radiological technician registrant shall perform radiological procedures only under the supervision of a practitioner physically present on the premises.

(h) A podiatric medical radiological technician registrant shall not perform any dangerous or hazardous procedures as identified by the Texas Medical Board.

(i) All registrants must comply with the safety rules of the Texas Department of State Health Services, Radiation Control Program relating to the control of radiation.

(j) Registration is valid for one year and must be renewed annually by submitting a department-approved application. For each registration renewal on or after September 1, 2020, a radiological technician must complete the human trafficking prevention training required under Occupations Code, Chapter 116, and provide proof of completion as prescribed by the department.

(k) Registrants shall inform the department of any address change or change of supervising podiatric physician within two (2) weeks.

(l) The department may refuse to issue or renew a registration to an applicant or a podiatric medical radiological technician who:

(1) violates the Podiatric Medical Practice Act, the Rules, an order of the executive director or commission previously entered in a disciplinary proceeding, or an order to comply with a subpoena issued by the department;

(2) violates the Medical Radiologic Technologist Certification Act, or the Rules promulgated by the Texas Medical Board;

(3) violates the Rules of the Texas Department of State Health Services for Control of Radiation;

(4) obtains, attempts to obtain, or uses a registration by bribery or fraud;

(5) engages in unprofessional conduct, including but not limited to, conviction of a crime or [ , ] commission of any act that is in violation of the laws of the State of Texas if the act is connected with provision of health care[ , and commission of an act or moral turpitude ];

(6) develops or has an incapacity that prevents the practice of podiatric medical radiological technician with reasonable skill, competence, and safety to the public as a result of:

(A) an illness;

(B) drug or alcohol dependency; or habitual use of drug or intoxicating liquors; or

(C) another physical or mental condition;

(7) fails to practice in an acceptable manner consistent with public health and welfare;

(8) has disciplinary action taken against a radiological certification, permit, or registration in another state, or by another regulatory agency;

(9) engages in acts requiring registration under these rules without a current registration from the department;

(10) has had a registration revoked, suspended, or has received disciplinary action.

(m) The commission, executive director, or department, as appropriate, may suspend, revoke, or refuse to issue or renew the registration upon finding that a podiatric medical radiological technician has committed any offense listed in this section.

§130.56. General Authority to Delegate.

(a) A practitioner may delegate to a qualified and properly trained podiatric medical assistant [ person ] acting under the podiatrist's appropriate supervision any podiatric medical act that a reasonable and prudent podiatrist would find within the scope of sound medical judgment to delegate if:

(1) in the opinion of the delegating podiatrist, the act:

(A) can be properly and safely performed by the podiatric medical assistant [ person ] to whom the podiatric medical act is delegated; and

(B) is performed in its customary manner and not in violation of any other statute; and

[ (C) is not in violation of any other statute; and ]

(2) the podiatric medical assistant [ person ] to whom the podiatric medical act is delegated [ delegation is made ] does not represent to the public that the podiatric medical assistant [ person ] is authorized to practice podiatric medicine.

(b) The delegating podiatrist is [ remains ] responsible for the podiatric medical acts of the podiatric medical assistant [ person ] performing the delegated medical acts.

(c) The department may determine whether:

(1) an act constitutes the practice of podiatric medicine; and[ . ]

(2) a podiatric medical act may be properly or safely delegated by podiatrists.

§130.58. Standards for Prescribing Controlled Substances and Dangerous Drugs.

(a) Podiatrists shall comply with all federal and state laws and regulations relating to the ordering and prescribing of controlled substances in Texas, including but not limited to requirements set forth by the United States Drug Enforcement Administration, United States Food & Drug Administration, Texas Health & Human Services Commission, Texas Department of Public Safety, Texas State Board of Pharmacy, and the department.

(b) A podiatrist may not prescribe a controlled substance except for a valid podiatric medical purpose and in the course of podiatric practice.

(c) A podiatrist may not confer upon and may not delegate prescriptive authority (the act of prescribing or ordering a drug or device) to any other person.

(d) A podiatrist may designate an agent to communicate a prescription to a pharmacist. A podiatrist who designates an agent shall provide a pharmacist on request with a copy of the podiatrist’s written authorization for a designated agent to communicate a prescription and shall maintain at the podiatrist’s usual place of business a list of the designated agents. The podiatrist remains personally responsible for the actions of the designated agent who communicates a prescription to a pharmacist.

(e) [ (d) ] Responsible prescribing of controlled substances requires that a podiatrist consider certain elements prior to issuing a prescription, including, but not limited to:

(1) reviewing the patient's Schedule II, III, IV, and V prescription drug history report by accessing the Texas State Board of Pharmacy's - Texas Prescription Monitoring Program (PMP) database;

(2) the patient’s date of birth matches with proper identification;

(3) an initial comprehensive history and physical examination is performed;

(4) the Schedule II prescription copy is in the chart or record found for each prescription written; and

(5) alternative therapy (e.g. ultrasound, TENS) discussed and prescribed for the patient.

(f) [ (e) ] Prior to prescribing opioids, benzodiazepines, barbiturates, or carisoprodol, a podiatrist shall review the patient's Schedule II, III, IV, and V prescription drug history report by accessing the Texas State Board of Pharmacy's - Texas Prescription Monitoring Program (PMP) database. Failure to do so is grounds for disciplinary action by the department.

(g) [ (f) ] Prior to prescribing any controlled substance, a podiatrist may review the patient’s Schedule II, III, IV, and V prescription drug history report by accessing the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database.

(h) [ (g) ] An employee of the podiatrist acting at the direction of the podiatrist may perform the function described in subsection (e) and (f) [ of this section ] so long as that employee acts in compliance with HIPAA and only accesses information related to a particular patient of the podiatrist.

(i) [ (h) ] A podiatrist or an employee of a podiatrist acting at the direction of the podiatrist may access the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database to inquire about the podiatrist’s own Schedule II, III, IV, and V prescription drug activity.

(j) A podiatrist or an employee of a podiatrist acting at the direction of the podiatrist may not access the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database for reasons not directly related to a patient under their care. Unauthorized access is grounds for disciplinary action by the department.

(k) [ (i) ] If a podiatrist uses an electronic medical records management system (health information exchange) that integrates a patient's Schedule II, III, IV, and V prescription drug history data from the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database, a review of the electronic medical records management system (health information exchange) with the integrated data shall be deemed compliant with the review of the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database as required under §481.0764(a) of the Texas Health and Safety Code and these rules.

(l) [ (j) ] The duty to access a patient's Schedule II, III, IV, and V prescription drug history report through the Texas State Board of Pharmacy's – Texas Prescription Monitoring Program (PMP) database as described in subsection (e) [ of this section ] does not apply in the following circumstances: (1) it is clearly noted in the patient’s medical record that the patient has a diagnosis of cancer or is in hospice care; or (2) the podiatrist or an employee of the podiatrist makes a good faith attempt to access the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database but is unable to access the information because of circumstances outside the control of the podiatrist or an employee of the podiatrist and the good faith attempt and circumstances are clearly documented in the patient’s medical record for prescribing a controlled substance.

(m) [ (k) ] Information obtained from the Texas State Board of Pharmacy’s – Texas Prescription Monitoring Program (PMP) database may be included in any form in the searched patient’s medical record and is subject to any applicable state or federal confidentiality, privacy or security laws.

(n) [ (l) ] In accordance with Texas Health and Safety Code Chapter 483, Subchapter E., a podiatrist may prescribe an opioid antagonist to a person at risk of experiencing an opioid-related drug overdose or to a family member, friend, or other person in a position to assist the person who is at risk of experiencing an opioid-related drug overdose. A podiatrist who prescribes an opioid antagonist shall document the basis for the prescription in the medical record of the person who is at risk of experiencing an opioid-related drug overdose.

§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) The 10-day limit 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) 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; 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.

STATUTORY AUTHORITY

The proposed rules are proposed under Texas Occupations Code, Chapters 51 and 202, which authorize the Texas Commission of Licensing and Regulation, the Department’s governing body, 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 Occupations Code, Chapter 108, which establishes the Department’s authority to deny, suspend or revoke podiatrists for certain criminal convictions; Texas Occupations Code, Chapter 116, which requires the completion of human trafficking prevention training for health professions licensees; and Texas Health and Safety Code, Chapter 481, which mandates certain continuing education for controlled substance prescribers, places limits on the prescription of opioids for acute pain, requires the submission of electronic prescriptions for controlled substances, and forbids unauthorized access to the PMP.

The statutory provisions affected by the proposed rules are those set forth in Texas Occupations Code, Chapters 51, 108, 116, and 202; and Texas Health and Safety Code, Chapter 481.

No other statutes, articles, or codes are affected by the proposed rules.

Subchapter F. Fees .

§130.60. Fees.

(a) Fees paid to the department are non-refundable.

(b) Fees are as follows:

(1) Temporary Residency License (Initial and Renewal)--$125

(2) Extended Temporary License extension--$50

(3) Provisional License--$125

(4) Doctor of Podiatric Medicine Initial License--$750

(5) Doctor of Podiatric Medicine Renewal License--$700

(6) Voluntary Charity Care Status License (Initial and Renewal)--$0

(7) Active Duty Military Members--$0

(8) [ (7) ] Hyperbaric Oxygen Certificate--$25

(9) [ (8) ] Nitrous Oxide Registration--$25

(10) [ (9) ] Podiatric Medical Radiological Technicians--$25[ $0 ]

(11) [ (10) ] Duplicate License/replacement license--$25

(12) [ (11) ] The fee for a criminal history evaluation letter is the fee prescribed under §60.42 [ of this title ] (relating to Criminal History Evaluation Letters).

(13) [ (12) ] A dishonored/returned check or payment fee is the fee prescribed under §60.82 [ of this title ] (relating to Dishonored Payment Device).

(14) [ (13) ] Late renewal fees for licenses issued under this chapter are provided under §60.83 [ of this title ] (relating to Late Renewal Fees).

STATUTORY AUTHORITY

The proposed rules are proposed under Texas Occupations Code, Chapters 51 and 202, which authorize the Texas Commission of Licensing and Regulation, the Department’s governing body, 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 Occupations Code, Chapter 108, which establishes the Department’s authority to deny, suspend or revoke podiatrists for certain criminal convictions; Texas Occupations Code, Chapter 116, which requires the completion of human trafficking prevention training for health professions licensees; and Texas Health and Safety Code, Chapter 481, which mandates certain continuing education for controlled substance prescribers, places limits on the prescription of opioids for acute pain, requires the submission of electronic prescriptions for controlled substances, and forbids unauthorized access to the PMP.

The statutory provisions affected by the proposed rules are those set forth in Texas Occupations Code, Chapters 51, 108, 116, 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.

§130.72. Administrative Penalties and Sanctions.

(a) If a person or entity violates any provision of Texas Occupations Code, Chapters 51 or 202, this chapter, or any rule or order of the executive director or commission, proceedings may be instituted to impose administrative penalties, administrative sanctions, or both in accordance with the provisions of Texas Occupations Code, Chapters 51 and 202, any associated rules, and consistent with the department’s enforcement plan.

(b) A person authorized to receive information by accessing the Texas State Board of Pharmacy's - Texas Prescription Monitoring Program (PMP) database may not disclose or use the information in a manner not authorized by law.

(c) A person authorized to receive information by accessing the Texas State Board of Pharmacy's - Texas Prescription Monitoring Program (PMP) database commits an offense if the person discloses or uses the information in a manner not authorized by law.

(d) A person authorized to receive information by accessing the Texas State Board of Pharmacy's - Texas Prescription Monitoring Program (PMP) database commits an offense if the person makes a material misrepresentation or fails to disclose a material fact in the request for information.

(e) The department shall deny an application for license, and shall revoke the license of a person licensed under Chapter 202, Texas Occupations Code, as required by Chapter 108, Subchapter B, Texas Occupations Code.

(f) A person whose application for licensure has been denied, or whose license has been revoked, pursuant to Texas Occupations Code, Chapter 108, Subchapter B may reapply or seek reinstatement as provided by that subchapter.

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 18, 2019.

Brad Bowman

General Counsel

Texas Department of Licensing and Regulation