TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 133. HOSPITAL LICENSING

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

25 TAC §133.54

The Texas Health and Human Services Commission (HHSC) adopts new §133.54, concerning Hospital at Home Program Application and Operational Requirements.

New §133.54 is adopted with changes to the proposed text as published in the October 20, 2023, issue of the Texas Register (48 TexReg 6171). This rule will be republished.

BACKGROUND AND JUSTIFICATION

The new section is necessary to implement House Bill (H.B.) 1890, 88th Legislature, Regular Session, 2023. H.B. 1890 amended Texas Health and Safety Code (HSC) Chapter 241 by adding new Subchapter M to allow a licensed hospital to operate a hospital at home program with approval from the Centers for Medicare and Medicaid Services (CMS) and HHSC.

HSC §241.403(a), as added by H.B. 1890, requires HHSC to adopt rules establishing minimum standards for operation of a hospital at home program by a hospital.

In March 2020, CMS created the Acute Hospital Care at Home program, originally called the Hospitals Without Walls program, to increase hospital capacity during the COVID-19 pandemic.

In response to state and federal state of disaster declarations relating to COVID-19, HHSC adopted an emergency rule in Texas Administrative Code, Title 26, Chapter 500 §500.4, relating to Participating in the Centers for Medicare and Medicaid Services Acute Hospital Care at Home Program During the COVID-19 Pandemic. This emergency rule expired July 28, 2023.

COMMENTS

The 31-day comment period ended November 20, 2023.

During this period, HHSC received comments regarding the proposed rule from two commenters: the Teaching Hospitals of Texas (THOT) and the Texas Hospital Association (THA). A summary of comments relating to the rule and HHSC's responses follows.

Comment: THOT appreciated HHSC's work to implement the new rule as required by H.B. 1890 to ensure the Acute Hospital Care at Home Program continues and expressed their overall support for the new section.

Response: HHSC acknowledges this comment.

Comment: THA said they appreciate HHSC's clear and concise rulemaking.

Response: HHSC acknowledges this comment.

Comment: THOT and THA recommended amending §133.54(e) to clarify whether the renewal application fee is based on the number of beds designated for the hospital at home program at the time of the application or a prediction of the number of beds the hospital may designate to the program in the future. THOT noted it would be difficult to predict how many beds the hospital may use in the hospital at home program and administratively burdensome to submit a new payment each time a hospital adds a new bed after HHSC approves the initial application. THA additionally asked HHSC clarify how the 10 beds are calculated and the process for adding a group of 10 beds between renewal years. THA noted flexibility is important for a hospital at home program to succeed and hospitals would appreciate clear and simple policies for adding and removing beds.

Response: HHSC revises §133.54(e) to clarify the renewal application fee is based on the number of beds a hospital designates for the hospital at home program in the hospital's renewal application. HHSC also adds new §133.54(f), and renumbers subsequent subsections accordingly, to clarify when a hospital increases the number of beds designated for its hospital at home program between license renewal periods, the hospital shall notify HHSC and pay a nonrefundable fee of $390 per block of 10 beds the hospital adds to their program.

Comment: THA recommended amending §133.54(f)(3)(A), renumbered to §133.54(g)(3)(A), to clarify the requirements for hospital policies and procedures to ensure patient health and safety. THA noted it was unclear whether the hospital's policies and procedures to ensure a patient's health and safety must address latent issues, such as mold, working smoke detectors within the patient's home, or neighborhood crime.

Response: HHSC declines to revise §133.54(f)(3)(A), renumbered to §133.54(g)(3)(A), because a hospital may determine the scope of its policies and procedures to ensure patient safety, provided the policies and procedures meet the minimum requirements under §133.54(g).

Comment: THOT and THA expressed concern about §133.54(f)(4)(A), renumbered to §133.54(g)(4)(A), precluding patients residing in assisted living facilities, group homes, hotels, or other non-traditional residential settings from qualifying for the hospitals at home program. THOT noted CMS allows patients residing in assisted living facilities to participate in the Acute Hospital Care at Home program and recommended amending §133.54(f)(4)(A) to either remove the word "residential" or allow additional home settings to improve flexibility and access. THA also noted that meeting federal qualifications should suffice for state regulatory purposes.

Response: HHSC revises §133.54(f)(4)(A), renumbered to §133.54(g)(4)(A), to remove the word "residential" from the requirement for a patient's home to be located at a physical address. HHSC notes a hospital is responsible for determining which home settings may participate in the hospital's program.

Comment: THOT and THA recommended amending §133.54(f)(4)(B) - (D), renumbered to §133.54(g)(4)(B) - (D), to require hospital policies to include how the hospital will address disruptions in electricity, water, and wastewater services at a participating patient's home in an emergency rather than disallowing disruptions and requiring hospitals assume responsibility for such services. THOT suggested HHSC use the following language: "maintain electricity service, water and wastewater with emergency policies and procedures in place in the event of a service loss that affects patient care. This may include transferring patients to a hospital setting if necessary."

Response: HHSC revises §133.54(f)(4)(B) - (D), renumbered to §133.54(g)(4)(B) - (D), to reorganize the subparagraphs under §133.54(g)(4)(B) and include a requirement for the hospital to identify how the hospital addresses any disruptions in electricity, water, and wastewater services in an emergency.

Comment: THOT and THA recommended amending §133.54(f)(4)(E), renumbered to §133.54(g)(4)(A)(ii), to remove the words "at designated times" to allow for hospital staff entry in emergency situations. THA noted times are generally consistent and designated in advance, but this wording could limit access in emergency situations outside of defined timelines. THOT noted hospital staff typically notify patients when they will arrive, but a hospital may interpret the phrase "designated times" as hospital staff being limited in ways that could be inconsistent with best practices for patient care and emergency situations.

Response: HHSC revises §133.54(f)(4)(E), renumbered to §133.54(g)(4)(A)(ii), to replace the phrase "at designated times" with "as needed."

Comment: THA asked if the requirements in §133.54(f)(4) and (5), renumbered to §133.54(g)(4), are exhaustive and requested HHSC include any additional requirements beyond those listed in §133.54(f)(4) and (5) or note if the requirements listed are minimum requirements.

Response: HHSC revises §133.54(f), renumbered to §133.54(g), to reorganize paragraphs (4) and (5) into subparagraphs under §133.54(g)(4) and renumbers the subsequent paragraphs in §133.54(g) accordingly. HHSC also clarifies that a hospital's policies and procedures must, at a minimum, require the patient and the patient's home to meet the requirements under that paragraph.

Comment: THOT and THA expressed concern with the requirement in §133.54(f)(6), renumbered to §133.54(g)(5), for a hospital to obtain patient consent for HHSC to enter the patient's home during a complaint investigation because this requirement may limit program participation. THOT and THA recommended removing this paragraph and following current hospital complaint investigation and survey procedures, which typically do not require entry into a patient's home. THOT alternatively suggested amending this paragraph to provide more details about the survey process when entering a patient's home.

Response: HHSC revises §133.54(f)(6), renumbered to §133.54(g)(5), to replace the requirement for a hospital to obtain consent to allow HHSC staff to enter the patient's home with a requirement that the informed consent must include a notice that HHSC may request to accompany hospital staff when entering the patient's home to ensure the hospital's compliance with §133.54.

STATUTORY AUTHORITY

The new section is authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies; HSC §241.026, which requires HHSC to develop, establish, and enforce standards for the construction, maintenance, and operation of licensed hospitals; and HSC §241.403, which requires HHSC to adopt rules establishing minimum standards for the operation of a hospital at home program by a hospital.

§133.54.Hospital at Home Program Application and Operational Requirements.

(a) As defined by Texas Health and Safety Code §241.401, and when used in this subchapter, the following words and terms have the following meanings.

(1) "Acute hospital care at home waiver program" means:

(A) the program established by the Centers for Medicare and Medicaid Services under United States Code Title 42 Section 1320b-5 that waives the requirements of 42 CFR Sections 482.23(b) and (b)(1); and

(B) a successor program to the program described by subparagraph (A) of this paragraph that is established by the United States Congress or the Centers for Medicare & Medicaid Services.

(2) "Hospital at home program" means a program operated by a hospital to provide in a home setting health care services that are considered to be acute hospital care for purposes of the acute hospital care at home waiver program.

(b) Notwithstanding hospital functions and services requirements in §133.41 of this subchapter (relating to Hospital Functions and Services) and hospital physical plant and construction requirements in Subchapter I of this chapter (relating to Physical Plant and Construction Requirements), a hospital may operate a hospital at home program and treat an eligible patient at that patient's home if the hospital:

(1) obtains approval from the Centers for Medicare & Medicaid Services (CMS) to participate in the acute hospital care at home waiver program; and

(2) receives written approval from the Texas Health and Human Services Commission (HHSC) to operate a hospital at home program.

(c) To apply for HHSC approval to operate a hospital at home program, an applicant shall submit the following to HHSC:

(1) a complete application to operate the program as indicated on the HHSC website;

(2) a nonrefundable application fee of $350;

(3) a copy of the CMS approval to participate in the acute hospital care at home waiver program; and

(4) any additional information requested by HHSC.

(d) A hospital shall reapply for HHSC approval to operate the hospital's hospital at home program when applying to renew the hospital's license under §133.23 of this chapter (relating to Application and Issuance of Renewal License).

(e) A hospital shall pay a nonrefundable renewal application fee of $390 per 10 beds the hospital designates for the hospital at home program in the renewal application. This fee is in addition to the hospital's license renewal fee.

(f) When a hospital increases the number of beds designated for its hospital at home program between license renewal periods, the hospital shall notify HHSC and pay a nonrefundable fee of $390 per block of 10 beds the hospital adds to their program.

(g) A hospital that is approved by HHSC to operate a hospital at home program shall:

(1) maintain CMS approval to participate in the acute hospital care at home waiver program;

(2) comply with the CMS acute hospital care at home waiver program requirements and all other applicable statutes and regulations;

(3) develop, implement, and enforce policies and procedures to ensure:

(A) the patient's health and safety;

(B) the safety of hospital staff entering the patient's home; and

(C) the safety of the patient's home;

(4) ensure the hospital's policies and procedures adopted under paragraph (3) of this subsection at a minimum:

(A) require the patient's home to:

(i) be located at a physical address;

(ii) allow hospital staff entry into the home as needed;

(iii) have animals separated securely away from the patient care area while hospital staff is on site, except for service animals as allowed by the Americans with Disabilities Act of 1990; and

(iv) maintain a safe route from the entrance and exit to the patient area within in the home;

(B) require the patient's home maintain electricity, water, and wastewater service and identify how the hospital addresses any disruptions in these services in an emergency; and

(C) require the patient maintain access to telephone service;

(5) obtain a patient's written and informed consent to participate before the patient participates in the hospital's hospital at home program, including notice that HHSC may request to accompany hospital staff when entering the patient's home to ensure a hospital's compliance with this rule; and

(6) notify HHSC in writing no later than five business days if the hospital:

(A) chooses to no longer operate a hospital at home program; or

(B) loses CMS approval to participate in the acute hospital care at home waiver program.

(h) At any time, HHSC may withdraw its approval for a hospital to operate a hospital at home program if HHSC finds a threat to patient health or safety. Any patient being treated under the hospital at home program at the time HHSC withdraws its approval shall be safely relocated as soon as practicable and according to the hospital's policies and procedures.

(i) To the extent this section may conflict with a requirement in §133.21(c)(4)(B) or (C) of this chapter (relating to General), this section controls.

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

Filed with the Office of the Secretary of State on December 28, 2023.

TRD-202305001

Karen Ray

Chief Counsel

Department of State Health Services

Effective date: January 25, 2024

Proposal publication date: October 20, 2023

For further information, please call: (512) 834-4591