Texas Register October 22, 2021 Volume: 46 Number: 43

Texas Register Table of Contents

1 Health and Human Services Commission
2 Texas Department of Licensing and Regulation
- - 2.0.1 Proposed Rules Re:
3 Department of State Health Services
- - 3.0.1 Proposed Rules Re:
    - 3.0.1.1 New 25 TAC §§229.1 – 229.4, describing disclosure requirements for prescription drug prices.
  - 3.0.2 In Addition Re:
    - 3.0.2.1 Licensing Actions for Radioactive Materials
4 Texas Board of Physical Therapy Examiners
- - 4.0.1 Adopted Rules Re:
    - 4.0.1.1 Amending 22 TAC §322.1 to allow certain physical therapists to treat patients for fifteen (15) consecutive business days before requiring a referral from a qualified healthcare practitioner.
    - 4.0.1.2 Amending 22 TAC §329.7 to update the proof of residency requirements for military spouses.

Health and Human Services Commission

Emergency Rules Re:

New 26 TAC §500.21, updating End Stage Renal Disease (ESRD) facility regulatory guidelines regarding staffing ratios, in-home visits, telemedicine, incident reporting, and education and training requirements for staff.

CHAPTER 500. COVID-19 EMERGENCY HEALTH CARE FACILITY LICENSING
SUBCHAPTER B. END STAGE RENAL DISEASE FACILITIES
26 TAC §500.21

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) adopts on an emergency basis in Title 26 Texas Administrative Code, Chapter 500, COVID-19 Emergency Health Care Facility Licensing, new §500.21, concerning an emergency rule in response to COVID-19 in order to update and continue the regulatory requirements for end stage renal disease (ESRD) facilities to reduce barriers to treatment during the COVID-19 pandemic.

HHSC is adopting an emergency rule to reduce barriers to treatment for dialysis patients by updating ESRD facility regulatory guidelines regarding staffing ratios, in-home visits, telemedicine, incident reporting, and education and training requirements for staff.

BACKGROUND AND JUSTIFICATION

As authorized by Texas Government Code §2001.034, HHSC may adopt an emergency rule without prior notice or hearing upon finding that an imminent peril to the public health, safety, or welfare requires adoption on fewer than 30 days’ notice. Emergency rules adopted under Texas Government Code §2001.034 may be effective for not longer than 120 days and may be renewed for not longer than 60 days.

The purpose of the emergency rulemaking is to support the Governor’s March 13, 2020 proclamation certifying that the COVID-19 virus poses an imminent threat of disaster in the state and declaring a state of disaster for all counties in Texas. In this proclamation, the Governor authorized the use of all available resources of state government and of political subdivisions that are reasonably necessary to cope with this disaster and directed that government entities and businesses would continue providing essential services. HHSC accordingly finds that an imminent peril to the public health, safety, and welfare of the state requires immediate adoption of this rule for ESRD Facility Requirements During the COVID-19 Pandemic.

New 26 TAC §§500.41 – 500.44, adjusting operational requirements for Chemical Dependency Treatment Facilities to address staff shortages, reduce the risk of transmission of COVID-19, and reduce barriers to treatment for patients.

CHAPTER 500. COVID-19 EMERGENCY HEALTH CARE FACILITY LICENSING
SUBCHAPTER D. CHEMICAL DEPENDENCY TREATMENT FACILITIES
26 TAC §§500.41 – 500.44

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) adopts on an emergency basis in Title 26 Texas Administrative Code, Chapter 500 COVID-19 Emergency Health Care Facility Licensing, new §500.41, concerning an emergency rule on telemedicine and telehealth in order to reduce the risk of transmission of COVID-19; new §500.42, concerning an emergency rule on maximum caseloads in order to permit an intensive residential program in a chemical dependency treatment facility (CDTF) to temporarily increase counselor caseloads to 20 clients per counselor; new §500.43, concerning an emergency rule on service delivery via two-way, real-time internet or telephone communications in order to reduce the risk of transmission of COVID-19; and new §500.44, concerning an emergency rule on treatment planning and service provision documentation deadlines in order to provide CDTFs additional time to document service delivery, as counselor caseloads may have increased in intensive residential treatment programs in response to the COVID-19 pandemic.

HHSC is adopting emergency rules to temporarily adjust CDTF operational requirements to: (1) permit a licensed CDTF to provide telehealth and telemedicine treatment services to clients in order to reduce the risk of transmission of COVID-19; (2) permit an intensive residential program in a CDTF to increase counselor caseloads from 10 to 20 clients per counselor due to CDTF staff shortages; (3) permit a licensed CDTF to provide treatment services through two- way, real-time internet or telephone communications to clients in order to reduce the risk of transmission of COVID-19; and (4) extend treatment planning and service provision documentation deadlines to provide CDTFs additional time to document service delivery, as counselor caseloads may have increased in intensive residential treatment programs. These emergency rules will address staff shortages, reduce the risk of transmission of COVID-19, and reduce barriers to treatment for patients seeking treatment for substance use disorders and chemical dependency.

BACKGROUND AND JUSTIFICATION

New 26 TAC §500.51, permitting supervision of licensed chemical dependency counselor (LCDC) interns through the use of two-way, real-time internet or telephone communications.

CHAPTER 500. COVID-19 EMERGENCY HEALTH CARE FACILITY LICENSING
SUBCHAPTER E. LICENSED CHEMICAL DEPENDENCY COUNSELORS
26 TAC §500.51

OVERVIEW

HHSC is adopting an emergency rule to temporarily permit: (1) counselor interns with more than 1,000 hours of supervised work experience to provide services in person or through two-way, real-time internet or telephone communications; (2) supervisors of LCDC interns with less than 2,000 hours of supervised work experience to provide supervision in person or through two-way, real-time internet or telephone communications; and (3) a certified clinical supervisor, or the clinical training institution coordinator or intern’s supervising qualified credentialed counselor at a clinical training institution, to provide supervision to a counselor intern using two-way, real-time internet or telephone communications to observe and document the intern performing assigned activities and to provide and document one hour of face-to-face individual or group supervision. This emergency rule will address staff shortages, reduce the risk of transmission of COVID-19 and reduce barriers to treatment for patients seeking treatment for substance use disorders and chemical dependency.

BACKGROUND AND JUSTIFICATION

The purpose of the emergency rulemaking is to support the Governor’s March 13, 2020 proclamation certifying that the COVID-19 virus poses an imminent threat of disaster in the state and declaring a state of disaster for all counties in Texas. In this proclamation, the Governor authorized the use of all available resources of state government and of political subdivisions that are reasonably necessary to cope with this disaster and directed that government entities and businesses would continue providing essential services. HHSC accordingly finds that an imminent peril to the public health, safety, and welfare of the state requires immediate adoption of this emergency rule for Supervision of LCDC Interns During the COVID-19 Pandemic.

Renewing 26 TAC §551.46 to describe requirements for containing COVID-19 at intermediate care facilities for individuals with an intellectual disability or related condition.

CHAPTER 551. INTERMEDIATE CARE FACILITIES FOR INDIVIDUALS WITH AN INTELLECTUAL DISABILITY OR RELATED CONDITIONS
SUBCHAPTER C. STANDARDS FOR LICENSURE
26 TAC §551.46

OVERVIEW

The Health and Human Services Commission is renewing the effectiveness of emergency new §551.46 for a 60-day period. The text of the emergency rule was originally published in the June 25, 2021, issue of the Texas Register (46 Tex Reg 3781).

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) renews on an emergency basis in Title 26, Part 1, Texas Administrative Code, Chapter 551, Subchapter C, new §551.46, concerning an emergency rule to mitigate and contain COVID-19 in an intermediate care facility for individuals with an intellectual disability (ICF/IID) or related condition.

The purpose of the new rule is to describe requirements for ICF/IID Provider Response to COVID-19.

BACKGROUND AND JUSTIFICATION

As authorized by Texas Government Code §2001.034, the Commission may adopt an emergency rule without prior notice or hearing upon finding that an imminent peril to the public health, safety, or welfare requires adoption on fewer than 30 days’ notice. Emergency rules adopted under Texas Government Code §2001.034 may be effective for not longer than 120 days and may be renewed for not longer than 60 days.

The purpose of this emergency rulemaking is to support the Governor’s March 13, 2020 proclamation certifying that the COVID-19 virus poses an imminent threat of disaster in the state and declaring a state of disaster for all counties in Texas. In this proclamation, the Governor authorized the use of all available resources of state government and of political subdivisions that are reasonably necessary to cope with this disaster and directed that government entities and businesses would continue providing essential services. HHSC accordingly finds that an imminent peril to the public health, safety, and welfare of the state requires immediate adoption of this emergency rule for ICF/IID Provider Response to COVID-19 – Mitigation.

Adopted Rules Re:

Amending 1 TAC §355.727 to extend the period in which add-on payments for Home and Community-based Services Waiver (HCS) Supervised Living and Residential Support Services (SL/RSS) are effective.

CHAPTER 355. REIMBURSEMENT RATES
SUBCHAPTER F. REIMBURSEMENT METHODOLOGY FOR PROGRAMS SERVING PERSONS WITH MENTAL ILLNESS OR INTELLECTUAL OR DEVELOPMENTAL DISABILITY
1 TAC §355.727

OVERVIEW

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §355.727, concerning Add-on Payment Methodology for Home and Community-Based Services Supervised Living and Residential Support Services. Section 355.727 is adopted without changes to the proposed text as published in the August 13, 2021, issue of the Texas Register (46 Tex Reg 4927). This rule will not be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the adopted amendment extends the period in which add-on payments for Home and Community-based Services Waiver (HCS) Supervised Living and Residential Support Services (SL/RSS) are effective.

The amendment is necessary to comply with 2022-23 General Appropriations Act, Senate Bill (S.B.) 1, 87th Legislature, Regular Session, 2021 (Article II, HHSC, Rider 30), which requires HHSC to maintain rate increases authorized by the 2020-21 General Appropriations Act, House Bill 1, 86th Legislature, Regular Session, 2019 (Article II, HHSC, Rider 44).

The amendment to §355.727(b) revises the last date in which HHSC will pay an add-on to the direct care portion of the SL/RSS rates from August 31, 2021, to August 31, 2023. The amendment to §355.727(c)(1) revises the period in which providers may be required to submit cost reports in addition to other reporting requirements. This amendment corresponds with the date revision in the change to subsection (b). The amendment to §355.727(c)(1) also revises the name of HHSC Rate Analysis to reflect the new name of the department: the HHSC Provider Finance Department.

Amending 1 TAC §355.8061 to clarify rules relating to outpatient hospital reimbursements.

CHAPTER 355. REIMBURSEMENT RATES
SUBCHAPTER J. PURCHASED HEALTH SERVICES
DIVISION 4. MEDICAID HOSPITAL SERVICES
1 TAC §355.8061

OVERVIEW

The Texas Health and Human Services Commission (HHSC) adopts an amendment to §355.8061, concerning Outpatient Hospital Reimbursement. The amendment to §355.8061 is adopted with changes to the proposed text as published in the August 13, 2021, issue of the Texas Register (46 Tex Reg 4931). This rule will be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the amendment is to comply with Senate Bill (S.B.) 1, Article II, HHSC, Rider 8(f), 87th Legislature, Regular Session 2021, and to make other amendments to enhance clarity, consistency, and specificity. HHSC is required by S.B. 1 to allocate certain funds appropriated to provide an increase to outpatient reimbursement rates for rural hospitals. HHSC will implement an increase to outpatient services reimbursement by removing the cap that was established September 1, 2013, and applying a percentage increase to the cost to charge ratios for rural hospitals.

The amendment will also eliminate the cost settlement of payments to maintain the level of payment directed by the rider. Rider 8 states that reimbursement for outpatient emergency department services which do not qualify as emergency visits may not exceed 65 percent of the cost. Therefore, HHSC will decrease the allowable percentage to 55 percent for these services to accommodate the increase in cost to charge ratios and retain the payments below 65 percent of the cost.

Pursuant to S.B. 170, 86th Legislature, Regular Session, 2019 and S.B. 1621, 86th Legislature, Regular Session, 2019, HHSC’s managed care contracts require managed care organizations to reimburse rural hospitals using a minimum fee schedule for services delivered through the Medicaid managed care program. The proposed amendment adds subsection (e), requiring a Medicaid minimum fee schedule for all rural hospitals, to conform the rule to the current law as well.

In addition, the amendment explains the cost to charge ratio (CCR) rate-setting process by including a section specific to rural hospitals.

In Addition Re:

Maximum Fees Allowed for Providing Health Care Information Effective September 1, 2021

The Health and Human Services Commission licenses and regulates the operation of general and special hospitals in accordance with Chapter 241 of the Health and Safety Code. In 1995, the Texas Legislature amended this law to address the release and confidentiality of health care information. In 2009, the Texas Legislature amended the statute again to change the definition of health care information and to add a category of fees for records provided on digital or other electronic media and delivered electronically.

In accordance with Health and Safety Code, §241.154(e), the fee that was effective as of September 1, 2020, for providing a patient’s health care information is increasing by 5.8% to reflect the most recent changes to the consumer price index that measures the average changes in prices of goods and services purchased by urban wage earners and clerical workers as published by the Bureau of Labor Statistics of the United States Department of Labor.

This information is provided only as a courtesy to licensed hospitals. Hospitals are responsible for verifying that fees for health care information are charged in accordance with Health and Safety Code Chapters 241, 311, and 324.

Details regarding the fees can be found in this week’s issue of the Texas Register at 46 Tex Reg 7248.

Texas Department of Licensing and Regulation

Proposed Rules Re:

Amending 16 TAC §130.40 and §130.42 to update requirements related to the application and renewal of a Doctor of Podiatric Medicine License.

CHAPTER 130. PODIATRIC MEDICINE PROGRAM
SUBCHAPTER D. DOCTOR OF PODIATRIC MEDICINE
16 TAC §130.40, §130.42

OVERVIEW

The Texas Department of Licensing and Regulation (Department) proposes amendments to existing rules at 16 Texas Administrative Code (TAC), Chapter 130, Subchapter D, §130.40 and §130.42, Subchapter F, §130.60, and the repeal of an existing rule at Subchapter F, §130.61, regarding the Podiatry Program. These proposed changes are referred to as the “proposed rules.”

BACKGROUND AND JUSTIFICATION

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

The proposed rules implement Texas Occupations Code §202.261 by establishing a limited faculty license type, harmonize the waiver provisions for licensure between the full and provisional license rules, establish the fee and license term for a limited faculty license, and repeal an expired transition rule for license fees. The proposed rules are necessary to implement the limited faculty license for the opening of Texas’s first podiatry school, the University of Texas Rio Grande Valley School of Podiatry. Additionally, the proposed rules are necessary to harmonize the provisions allowing the Department’s executive director to waive the requirements for the Graduate Podiatric Medical Education (GPME) and National Board Part III (formerly known as PM Lexis). These waiver provisions are currently found in the provisional license rule (§130.43) and are being copied to the normal doctor of podiatric medicine license rule (§130.40). These waiver provisions were inadvertently left out when the podiatry program was transferred from the Texas State Board of Podiatric Medicine to the Department. They continue to be relevant as other states did not implement the requirements for the GPME or National Board Part III until after Texas, hampering the application for podiatrists licensed in other jurisdictions. Finally, the proposed rules repeal the transition rule for two-year license terms (§130.61), which expired on August 31, 2020.

The proposed rules were presented to and discussed by the Podiatric Medical Examiners Advisory Board at its meeting on October 4, 2021. 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.

SECTION-BY-SECTION SUMMARY

The proposed rules amend §130.40, Doctor of Podiatric Medicine License – General Requirements and Application. The proposed rules amend the title of the rule to “Doctor of Podiatric Medicine License – General Requirements and Application; Limited Faculty License.” The proposed rules make clarifying changes in subsection (a), add a new subsection (b) outlining the issuance of limited faculty licenses as provided by Texas Occupations Code §202.261, add new subsections (c), (d) and (e) containing the waiver provisions for the GPME and National Board Part III requirements from the existing provisional license rule (§130.43), and reletter the other subsections accordingly.

The proposed rules amend §130.42, Doctor of Podiatric Medicine License–Term; Renewal, by adding a new subsection (d). The new subsection outlines the term of the limited faculty license, which is the same as a normal doctor of podiatric medicine license term except that the Department may terminate the license immediately upon receiving notice that the faculty appointment of the podiatrist holding the limited faculty license has been terminated.

Amending 6 TAC §130.60 to outline the initial license fee and renewal fee for the new limited faculty license.

CHAPTER 130. PODIATRIC MEDICINE PROGRAM
SUBCHAPTER F. FEES
16 TAC §130.60

OVERVIEW

The proposed rules amend §130.60, Fees, by adding new paragraphs (7) and (8) in subsection (b). These new paragraphs outline the initial license fee ($125) and renewal fee ($60) for the new limited faculty license. The other paragraphs are renumbered accordingly.

BACKGROUND AND JUSTIFICATION

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

Repealing 16 TAC §130.61 because the rule is no longer necessary as the transition to two-year licenses for the Podiatry Program has been completed.

CHAPTER 130. PODIATRIC MEDICINE PROGRAM
SUBCHAPTER F. FEES
16 TAC §130.61

OVERVIEW

The proposed rules repeal §130.61, Transition Rule for Two-year License Terms, a rule which expired on August 31, 2020. The rule is no longer necessary as the transition to two-year licenses has been completed.

BACKGROUND AND JUSTIFICATION

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

Department of State Health Services

Proposed Rules Re:

New 25 TAC §§229.1 – 229.4, describing disclosure requirements for prescription drug prices.

CHAPTER 229. FOOD AND DRUG
SUBCHAPTER A. PRESCRIPTION DRUG PRICE DISCLOSURE
25 TAC §§229.1 – 229.4

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §§229.1 – 229.4, concerning Prescription Drug Price Disclosure.

BACKGROUND AND JUSTIFICATION

In 2019, House Bill (H.B.) 2536 created Texas Health and Safety Code Chapter 441 and required drug manufacturers to report the wholesale acquisition cost of all United States Food and Drug Administration-approved drugs sold in or into Texas. Manufacturers were also required to report on price increases exceeding a certain threshold compared to prices at certain time frames, and manufacturers were required to provide reasons for the price increase on the HHSC website. No rules were developed.

The proposed new sections are necessary to comply with H.B. 1033, 87th Legislature, Regular Session, 2021, that amended Texas Health and Safety Code, Chapter 441. H.B. 1033 requires prescription drug manufacturers to report certain cost data and price increases for prescription drugs. The promulgation of rules allows DSHS to administer fines for failure to disclose price increases. The proposed new rules specify the fee of $250 that is required when drug manufacturers submit each report.

SECTION-BY-SECTION SUMMARY

New §229.1, Purpose, provides the purpose of the subchapter that establishes the procedures for Prescription Drug Price Disclosure.
New §229.2, Definitions, adds the following definitions for “Department,” “Calendar Year,” “Exclusivity,” “Patent,” and “Patent Exclusivity.”
New §229.3, Fee, provides specifics on the amount of fee and time frame for submission. A reporting fee of $250 is submitted with each report.
New §229.4, Administrative Penalties, details the assessment of penalties for failure to follow reporting requirements. Subsection (a) provides that the department shall assess penalties in accordance with Texas Health and Safety Code Chapter 441, this proposed new subchapter, Texas Government Code Chapter 2001, and the department’s hearing procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures). Subsection (b) provides the criteria for the assessment of administrative penalties that includes the Pharmaceutical Drug Manufacturer’s previous violations, the seriousness of the violation, the Pharmaceutical Drug Manufacturer’s demonstrated good faith, and any other matters as justice may require. Subsection (c) provides that each day a violation continues may be considered a separate violation.

In Addition Re:

Licensing Actions for Radioactive Materials

OVERVIEW

During the second half of August 2021, the Department of State Health Services (Department) has taken actions regarding Licenses for the possession and use of radioactive materials as listed in the tables (in alphabetical order by location). The subheading “Location” indicates the city in which the radioactive material may be possessed and/or used. The location listing “Throughout TX [Texas]” indicates that the radioactive material may be used on a temporary basis at locations throughout the state.

BACKGROUND AND JUSTIFICATION

In issuing new licenses and amending and renewing existing licenses, the Department’s Business Filing and Verification Section has determined that the applicant has complied with the licensing requirements in Title 25 Texas Administrative Code (TAC), Chapter 289, for the noted action. In granting termination of licenses, the Department has determined that the licensee has complied with the applicable decommissioning requirements of 25 TAC, Chapter 289. In granting exemptions to the licensing requirements of Chapter 289, the Department has determined that the exemption is not prohibited by law and will not result in a significant risk to public health and safety and the environment.

HEARING DETAILS

A person affected by the actions published in this notice may request a hearing within 30 days of the publication date. A “person affected” is defined as a person who demonstrates that the person has suffered or will suffer actual injury or economic damage and, if the person is not a local government, is (a) a resident of a county, or a county adjacent to the county, in which radioactive material is or will be located, or (b) doing business or has a legal interest in land in the county or adjacent county. 25 TAC §289.205(b)(15); Health and Safety Code §401.003(15). Requests must be made in writing and should contain the words “hearing request,” the name and address of the person affected by the agency action, the name and license number of the entity that is the subject of the hearing request, a brief statement of how the person is affected by the action what the requestor seeks as the outcome of the hearing, and the name and address of the attorney if the requestor is represented by an attorney. Send hearing requests by mail to: Hearing Request, Radiation Material Licensing, MC 2835, PO Box 149347, Austin, Texas 78714-9347, or by fax to: 512-834-6690, or by e-mail to: RAMlicensing@dshs.texas.gov.

Specific details can be found in this week’s issue of the Texas Register at 46 Tex Reg 7248-61.

Texas Board of Physical Therapy Examiners

Adopted Rules Re:

Amending 22 TAC §322.1 to allow certain physical therapists to treat patients for fifteen (15) consecutive business days before requiring a referral from a qualified healthcare practitioner.

CHAPTER 322. PRACTICE
22 TAC §322.1

The Texas Board of Physical Therapy Examiners adopts amendments to 22 Texas Administrative Code (TAC) §322.1(a), concerning Initiation of physical therapy services, pursuant to HB 1363 amendments to Sec. 453.301, Occupations Code during the 87th Legislative Session. The amendment is adopted in order to include physical therapists who have a doctoral degree in physical therapy and are certified by an entity approved by the PT Board in the group that can treat patients for fifteen (15) consecutive business days before requiring a referral from a qualified healthcare practitioner. The amendments are adopted without changes to the proposed text as published in the August 27, 2021, issue of the Texas Register (46 Tex Reg 5338). The rule will not be republished.

Amending 22 TAC §329.7 to update the proof of residency requirements for military spouses.

CHAPTER 329. LICENSING PROCEDURE
22 TAC §329.7

The Texas Board of Physical Therapy Examiners adopts amendments to 22 Texas Administrative Code (TAC) §329.7, Exemptions from Licensure, pursuant to HB 139 amendment of Sec. 55.0041. RECOGNITION OF OUT-OF-STATE LICENSE OF MILITARY SPOUSE to Chapter 55, Occupations Code during the 87th Legislative Session. The amendment is adopted in order to include providing a copy of the permanent change of station order for the military service member to whom the spouse is married to the proof of residency requirement. The amendments are adopted without changes to the proposed text as published in the August 27, 2021, issue of the Texas Register (46 Tex Reg 5339). The rule will not be republished.