Texas Register July 16, 2021 Volume: 46 Number: 29

Governor

Proclamation 41-3847 Re:

Proclamation 41-3847, renewing the disaster proclamation for all counties in Texas in response to COVID-19.

OVERVIEW

In accordance with the authority vested by Section 418.014 of the Texas Government Code, Governor hereby renews the disaster proclamation for all counties in Texas:

• Pursuant to Section 418.017, I authorize the use of all available resources of state government and of political subdivisions that are reasonably necessary to cope with this disaster.
• Pursuant to Section 418.016, any regulatory statute prescribing the procedures for conduct of state business or any order or rule of a state agency that would in any way prevent, hinder, or delay necessary action in coping with this disaster shall be suspended upon written approval of the Office of the Governor. However, to the extent that the enforcement of any state statute or administrative rule regarding contracting or procurement would impede any state agency’s emergency response that is necessary to cope with this declared disaster, I hereby suspend such statutes and rules for the duration of this declared disaster for that limited purpose.

BACKGROUND AND JUSTIFICATION

Governor’s rationale for issuing Proclamation 41-3847 is included in this week’s edition of the Texas Register (46 Tex Reg 4237).

Texas Medical Board

Emergency Rules Re:

Amending 22 TAC §174.5 to allow certain physicians to utilize telemedicine to continue issuing previous prescriptions for scheduled medications to established chronic pain patients.

CHAPTER 174. TELEMEDICINE
SUBCHAPTER A. TELEMEDICINE
22 TAC §174.5

OVERVIEW

The Texas Medical Board (Board) adopts, on an emergency basis, amendments to 22 TAC §174.5, effective July 1, 2021 at 12:01 a.m.

The emergency amendment would allow physicians to utilize telemedicine to continue issuing previous prescription(s) for scheduled medications to established chronic pain patients, if the physician has, within the past 90 days, seen a patient in-person or via a telemedicine visit using two-way audio and video communication.

BACKGROUND AND JUSTIFICATION

On March 13, 2020, the Governor of Texas certified COVID-19 as posing an imminent threat of disaster to the public health and safety and declared a state of disaster in all counties of Texas. On March 19, 2020, the Texas Governor issued a waiver suspending the strict enforcement of §174.5(e)(2)(A) which generally prohibits the utilization of telemedicine to prescribe scheduled drugs for the treatment of chronic pain. The waiver was issued in order to protect public health and curb the spread of COVID-19 by providing patients access to schedule drugs needed to ensure on-going treatment of chronic pain and avoid potential adverse consequences associated with the abrupt cessation of pain medication. On March 1, 2021, the Board adopted, on an emergency basis, amendments to 22 TAC §174.5. Such rule is set to expire at 11:59 p.m. on June 30, 2021.

Therefore, the emergency amendment to §174.5(e) is immediately necessary to help the state’s physicians, physician assistants and other health care professionals continue to mitigate the risk of exposure to COVID-19 and provide necessary medical services to related to issuance of prescriptions including controlled substances for patients. Pursuant to the Governor’s declaration of disaster issued on March 13, 2020, related to COVID-19, physicians can continue the treatment of chronic pain with scheduled drugs for established patients after having an in-person or two-way audio and video communications telemedicine medical services within the last 90 days.

Texas Board of Nursing

Emergency Rules Re:

Amending 22 TAC §217.24 to update requirements for the treatment of chronic pain with scheduled drugs through the use of telemedicine medical services.

CHAPTER 217. LICENSURE, PEER ASSISTANCE AND PRACTICE
22 TAC §217.24

OVERVIEW

The Texas Board of Nursing (Board) adopts emergency amendments to §217.24(e), relating to Telemedicine Medical Service Prescriptions, pursuant to a finding of imminent peril to the public health, safety, and welfare, which requires adoption in fewer than thirty (30) days’ notice, as authorized by Tex. Gov’t. Code §2001.034.

The adoption of emergency amendments to §217.24(e) is immediately necessary to allow APRNs to provide necessary treatment to established patients with chronic pain while mitigating the risk of exposure to COVID-19. Under the emergency amendments, the treatment of chronic pain with scheduled drugs through the use of telemedicine medical services by any means other than via audio and video two-way communication is prohibited, unless certain conditions are met. First, a patient must be an established chronic pain patient of the APRN. Second, the patient must be receiving a prescription that is identical to a prescription issued at the previous visit. Third, the patient must have been seen by the prescribing APRN or physician or health professional as defined in Tex. Occ. Code §111.001(1) in the last 90 days, either in-person or via telemedicine using audio and video two-way communication. These requirements are consistent with the rules adopted by the Texas Medical Board at 22 Tex. Admin. Code §174.5 (relating to Issuance of Prescriptions) on an emergency basis, effective July 1, 2021, and the provisions of federal law that currently permit the use of telemedicine medical services for the prescription of controlled substances during the COVID-19 pandemic.

Further, an APRN must exercise appropriate professional judgment in determining whether to utilize telemedicine medical services for the treatment of chronic pain with controlled substances. In order to ensure that telemedicine medical services are appropriate for the APRN to use, the adopted rule requires an APRN to give due consideration to factors that include, at a minimum, the date of the patient’s last in-person visit, patient co-morbidities, and occupational related COVID-19 risks. These are not the sole, exclusive, or exhaustive factors an APRN should consider under this rule. Further, the emergency amendments only apply to those APRNs whose delegating physicians permit them to issue re-fills for patients, and the refills are limited to controlled substances contained in Schedules III through V only. If a patient is treated for chronic pain with scheduled drugs through the use of telemedicine medical services as permitted by this rule, the medical records must document the exception and the reason that a telemedicine visit was conducted instead of an in-person visit.

BACKGROUND AND JUSTIFICATION

On March 13, 2020, the Governor of the State of Texas certified COVID-19 as posing an imminent threat of disaster to the public health and safety and declared a state of disaster in all counties of Texas. On March 23, 2020, the Office of the Governor granted a waiver of 22 Tex. Admin. Code §217.24(e), which prohibits an advanced practice registered nurse (APRN) from treating chronic pain with scheduled drugs through the use of telemedicine medical services, unless otherwise permitted under federal and state law. The waiver, however, expired on June 6, 2020.

The Board held a public meeting on June 8, 2020, to consider the adoption of an emergency rule to permit APRNs to treat chronic pain with scheduled drugs through the use of telemedicine medical services under certain conditions during the COVID-19 pandemic. At the conclusion of the meeting, the Board voted to adopt the emergency amendments to 22 Tex. Admin. Code §217.24(e). The emergency amendments took effect June 8, 2020; were published in the Texas Register on June 19, 2020; and expired on July 7, 2020.

Texas Health and Human Services Commission

Proposed Rules Re:

Amending 1 TAC §351.823 to change the e-Health Advisory Committee (eHAC) reporting requirement from annually to biennially.

CHAPTER 351. COORDINATED PLANNING AND DELIVERY OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B. ADVISORY COMMITTEES
DIVISION 1. COMMITTEES
1 TAC §351.823

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to Texas Administrative Code Title 1, Part 15, Chapter 351, Subchapter B, Division 1, §351.823, concerning e-Health Advisory Committee.

BACKGROUND AND PURPOSE

Texas Administrative Code Title 1, Part 15, §351.823(d), currently requires the e-Health Advisory Committee (eHAC) to prepare and submit an annual written report to the executive commissioner and Texas Legislature. eHAC reports are produced by members who are non-HHS employees.

In a July 2020 eHAC meeting, members voted to amend the rule to change the reporting requirement from annually to biennially. This amendment would afford members more time between reports, thus enabling members to more thoroughly research and address any recommendations made by the committee to HHSC.

Under Texas Government Code §2110.006, state agencies must annually evaluate the work of advisory committees as well as their usefulness and associated costs. To ensure HHSC continues to meet this obligation related to eHAC, HHSC staff proposed eHAC members prepare an informational briefing memorandum in non-report years to report costs, accomplishments, and areas of focus for the eHAC. Such documentation would permit the agency to comply with its obligations under Texas Government Code §2110.006.

Additional amendments to §351.823 reorganize and format the rule so that the eHAC rule is consistent with other HHSC advisory committee rules established under Texas Government Code §531.012.

A section-by-section summary can be found in 46 Tex Reg 4243.

---

Amending 1 TAC §354.1941 and §354.1942 to strengthen current conflict-of-interest policies applicable to the Drug Utilization Review Board.

CHAPTER 354. MEDICAID HEALTH SERVICES
SUBCHAPTER F. PHARMACY SERVICES
DIVISION 8. DRUG UTILIZATION REVIEW BOARD
1 TAC §354.1941, §354.1942

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §354.1941, concerning Drug Utilization Review Board, and §354.1942, concerning Conflict of Interest Policy.

BACKGROUND AND PURPOSE

To increase transparency about financial and other relationships members of the Texas Drug Utilization Review Board (DUR Board) may have with drug manufacturers with business before the DUR Board, HHSC determined to strengthen the conflict-of-interest provisions to which the members of the DUR Board are subject. In Texas, the DUR Board makes recommendations about the drugs that should be included on the Medicaid Preferred Drug List (PDL) and whether drugs will be subject to PDL prior authorizations and suggestions regarding clinical prior authorizations.

The proposed amendments strengthen current conflict-of-interest policies applicable to the DUR Board. These strengthened policies increase transparency by requiring DUR Board members to disclose financial relationships with drug manufacturers or labelers with products before the DUR Board, minimize the opportunity for pharmaceutical manufacturers or labelers to influence a member of the DUR Board when making recommendations about the PDL, and increase public confidence in DUR Board decisions.

Other proposed amendments ensure DUR Board membership aligns with the Social Security Act §1927(g)(3) and Texas Government Code §531.0736; define terms; and align language with state and federal definitions.

SECTION-BY-SECTION SUMMARY

• The proposed amendment to §354.1941 clarifies that board membership composition complies with Social Security Act §1927(g)(3) and Texas Government Code §531.0736. This amendment also clarifies DUR Board members are appointed by HHSC’s Executive Commissioner.
• The proposed amendment to §354.1942 defines the following terms: conflict of interest, DUR Board, entity, family member or relative, and financial relationship. Subsection (b) states that a DUR Board member may have a conflict of interest with DUR Board duties, if the member or a family member or relative of the member has (1) a financial relationship with an entity that may have business before the DUR Board; (2) an ownership or financial interest in a third party, such as a pharmaceutical manufacturer or labeler, with a product on the Texas Drug Code Index; or (3) any other interest that may be seen to impair the DUR Board member’s judgment on a matter before the DUR Board. To avoid a conflict of interest, the proposed amendment requires the DUR Board member to disclose any relationships described in subsection (b) and comply with any action HHSC or the DUR Board may require. Subsection (c) details disclosure requirements for DUR Board members and applicants. In addition to current disclosure requirements, the proposed amendments require a member or applicant to describe financial relationships and financial interests that either the member or applicant, or a family member or relative of the member or applicant, that may create a conflict of interest within timelines established by HHSC. Under subsection (d), if HHSC determines that a potential conflict of interest impairs the board member’s exercise of independent judgment, HHSC may recommend to the DUR Board that the member recuse him or herself on certain issues or may recommend other actions to avoid or mitigate a potential conflict of interest.

---

New 1 TAC §355.8070, to update financial requirements for hospitals providing care to Medicaid clients and the uninsured through the creation of the Hospital Augmented Reimbursement Program.

CHAPTER 355. REIMBURSEMENT RATES
SUBCHAPTER J. PURCHASED HEALTH SERVICES
DIVISION 4. MEDICAID HOSPITAL SERVICES
1 TAC §355.8070

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes new §355.8070, concerning the Hospital Augmented Reimbursement Program, for program periods on or after October 1, 2021.

BACKGROUND AND PURPOSE

HHSC plans to create this program to continue the financial transition for providers who have historically participated in the Delivery System Reform Incentive Payment program. We continue to work on solutions to preserve the financial resources many of our hospitals depend on to provide access to quality care to Medicaid clients and the uninsured. The Hospital Augmented Reimbursement Program would be created, subject to approval by the Centers for Medicare and Medicaid Services (CMS), through the Medicaid state plan. State plan programs and services do not impact 1115 Waiver budget neutrality. HHSC intends to submit state plan amendments to CMS to request authorization to make payments as described under new §355.8070 to non-state government-owned and -operated hospitals and to private hospitals. State plan amendments to include various hospital ownership types may be submitted on individual timelines. State plan amendment submission timelines will be determined outside of the rulemaking process in accordance with the state plan amendment administrative processes. The program will provide additional funding to hospitals to help offset the cost hospitals incur while providing Medicaid services.

The payment calculation will be based on a participating hospital’s Medicare payment gap and/or Average Commercial Reimbursement (ACR) gap. The hospital’s maximum payment before any reductions will be the combined Medicare payment gap and ACR gap for hospitals that submitted ACR data and the Medicare gap for those that did not submit ACR data. Payments will be capped at the total aggregate Medicare Upper Payment Limit (UPL) gap for all hospital services. The most current Medicare UPL demonstration available at the time of calculation will be used.

SECTION-BY-SECTION SUMMARY

Proposed new §355.8070:

• Subsection (a) describes the purpose and goals of the program.
• Subsection (b) defines key terms used in the section.
• Subsection (c) describes participation requirements.
• Subsection (d) describes payments for non-state government-owned and operated hospitals, including eligibility requirements, the non-federal share of program payments, and describes the payment calculation and methodology.
• Subsection (e) describes payments for private hospitals including the requirements for participation, eligibility requirements, the non-federal share of program payments, and describes the payment calculation and methodology.
• Subsection (f) describes payments for state-owned hospitals including the requirements for participation, eligibility requirements, the non-federal share of program payments, and describes the payment calculation and methodology.
• Subsection (g) describes payments for state government-owned Institutions for Mental Diseases including the requirements for participation, eligibility requirements, the non-federal share of program payments, and describes the payment calculation and methodology.
• Subsection (h) describes the payments for state private Institutions for Mental Diseases, including the requirements for participation, eligibility requirements, and the non-federal share of program payments, and describes the payment calculation and methodology.
• Subsection (i) describes requirements in the case of changes in operation.
• Subsection (j) discusses the reconciliation of the amount of the non-federal funds actually expended.
• Subsection (k) describes the frequency of the payments.

---

In Addition Re:

Public Notice – Amendment to the Home and Community-based Services (HCS) Waiver effective August 31, 2021.

OVERVIEW

The Texas Health and Human Services Commission (HHSC) is submitting to the Centers for Medicare & Medicaid Services (CMS) a request to amend the waiver application for the Home and Community-based Services (HCS) waiver program authorized under §1915(c) of the Social Security Act. CMS has approved the HCS waiver application through August 31, 2023. The proposed effective date for this amendment is August 31, 2021.

BACKGROUND AND JUSTIFICATION

This amendment request proposes to make the following changes:

• Appendix B: Waiver years 3, 4, and 5 will reflect an increase in the Point-in-Time (PIT) and unduplicated participants (Factor C). Waiver year 3 PIT will increase from 28,207 to 28,607. Waiver years 4 and 5 PIT will increase from 28,216 to 28,566. Waiver years 3, 4, and 5 Factor C will increase from 27,457 to 27,933.

• Appendix I: The period in which add-on payments for Supervised Living and Residential Support Services are effective will be extended to August 31, 2023. This proposal is necessary to comply with the 2022-23 General Appropriations Act, Senate Bill 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).

• Appendix J: Revising PIT and Factor C will have an impact on the calculations for the overall projected cost of waiver services (Factor D) and the overall projected cost of other Medicaid services furnished to waiver participants (D Prime (D’)) for the same waiver years. The HCS waiver program provides services and supports to individuals with intellectual disabilities who live in their own homes, in the home of a family member, or another community setting such as a three-person or four-person residence operated by an HCS program provider. Services and supports are intended to enhance quality of life, functional independence, and health and well-being in continued community-based living and to supplement, rather than replace, existing informal or formal supports and resources. Services in the HCS waiver program include day habilitation, respite, supported employment, adaptive aids, audiology, occupational therapy, physical therapy, prescribed drugs, speech and language pathology, financial management services, support consultation, behavioral support, cognitive rehabilitation therapy, dental treatment, dietary services, employment assistance, minor home modifications, nursing, residential assistance, social work, supporting home living, and transition assistance services.

---

Public Notice – Amendment to the Medically Dependent Program (MDCP) Waiver effective August 31, 2021.

OVERVIEW

The Texas Health and Human Services Commission (HHSC) is submitting to the Centers for Medicare & Medicaid Services (CMS) a request to amend the waiver application for the Medically Dependent Children Program (MDCP) waiver, authorized under §1915(c) of the Social Security Act. CMS has approved the MDCP waiver application through August 31, 2022. The proposed effective date for this amendment is August 31, 2021.

BACKGROUND AND JUSTIFICATION

This amendment request proposes to make the following changes:

• Appendix B: Waiver years 4 and 5 will reflect an increase in the Point-in-Time (PIT) and unduplicated participants (Factor C). Waiver year 4 PIT will increase from 5,602 to 6,589. Waiver year 5 PIT will increase from 5,603 to 6,281. Waiver year 4 Factor C will increase from 6,289 to 7,123. Waiver year 5 Factor C will increase from 6,305 to 6,796.

• Appendix J: Revising PIT and Factor C will have an impact on the calculations for the overall projected cost of waiver services (Factor D) and the overall projected cost of other Medicaid services furnished to waiver participants (D Prime (D’)) for the same waiver years. The MDCP waiver provides home and community-based services to medically fragile individuals from birth through age 20 who, without the waiver, would require institutionalization in a nursing facility. Services in the MDCP waiver include respite, adaptive aids, minor home modifications, employment assistance, supported employment, financial management services, transition assistance services, and flexible family support services. Texas uses the MDCP waiver to provide services to Texans in the least restrictive environment possible. These environments include the individual’s or a family member’s home, or a Child Protective Services foster care home which can meet the individual’s complex medical needs.

---

Department of State Health Services

Proposed Rules Re:

Amending 25 TAC §295.202 and §295.212 to update the Texas environmental lead reduction standards.

CHAPTER 295. OCCUPATIONAL HEALTH
SUBCHAPTER I. TEXAS ENVIRONMENTAL LEAD REDUCTION
25 TAC §295.202, §295.212

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §295.202, concerning Definitions, and §295.212, concerning Standards for Conducting Lead-Based Paint Activities.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with Texas Occupations Code, §1955.051, which requires that Texas environmental lead reduction rules be consistent with federal standards. The Environmental Lead Program (program) is updating the Texas environmental lead reduction rules for consistency with the United States Environmental Protection Agency (EPA) regulation under 40 Code of Federal Regulations (CFR), §745.227(h)(3), effective January 6, 2020, and 40 CFR §§745.223 and 745.227(e)(8)(viii), effective December 21, 2020, and as required in 40 CFR §745.325(e)(1).

The EPA lowered the dust-lead hazard standards and dust-lead clearance standards for lead in dust on floors and window sills from 40 micrograms (µg) of lead in dust per square foot (ft2) on floors and 250 µg of lead in dust per ft2 on interior window sills, to 10 µg/ft2 and 100 µg/ft2, respectively. The EPA provided that states authorized to administer lead abatement programs have two years to update the state rules to be at least as protective as the new EPA rule. As a result, the deadline for implementation of the federal dust-lead hazard standard is January 6, 2022, and the dust-lead clearance standard is March 8, 2023.

These new lower levels are consistent with the levels that the United States Department of Housing and Urban Development (HUD) requires of property owners that do lead hazard control and lead abatement to receive HUD funding assistance. HUD requires certain property owners to conduct lead hazard control or lead abatement and meet the 10 µg/ft2 and 100 µg/ft2 dust-lead hazard and clearance levels.

SECTION-BY-SECTION SUMMARY

• The proposed amendment to §295.202 corrects outdated references, including the EPA dust-lead standards, and edits the rule language for consistency with EPA and health and human services formatting of rules.
• The proposed amendment to §295.212 updates the EPA dust-lead hazard and clearance standards, corrects an internal reference, and edits the rule language for consistency with health and human services formatting of rules.

---

Adopted Rules Re:

Amending 25 TAC §289.226 to clarify and update requirements regarding registration of radiation machine use and services.

CHAPTER 289. RADIATION CONTROL
SUBCHAPTER E. REGISTRATION REGULATIONS
25 TAC §289.226

OVERVIEW

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts an amendment to §289.226, concerning Registration of Radiation Machine Use and Services. Section 289.226 is adopted with changes to the proposed text as published in the April 2, 2021, issue of the Texas Register (46 Tex Reg 2187). The rule will be republished.

BACKGROUND AND JUSTIFICATION

The amendment corrects rule citation references and defines registrant responsibilities. Other changes to §289.226 include clarifying rule requirements as suggested by staff and stakeholders and updating terminology. The amendment prohibits the use of a machine for both human and veterinary medicine under certain circumstances, clarifies qualifications for radiation safety officers (RSOs), requires RSOs to review operating and safety procedures at least annually, and clarifies the service company responsibility to perform equipment performance evaluations on radiation machines within 30 days of installation or repair that affects radiation output. In addition, the amendment adds safety requirements to Operating and Safety Procedures and strengthens the requirements for quality control of digital imaging. Minor editorial changes were made to create less ambiguity within the amendment.