1. (a) An end stage renal disease (ESRD) facility may request the following types of exceptions from a requirement in this chapter.

   1. (1) An ESRD facility may request a temporary exception related to alternative concepts, methods, procedures, or techniques, or for conducting pilot projects or research.
   2. (2) An ESRD facility may request a permanent exception related to United States Food and Drug Administration-approved equipment.
2. (b) Exceptions related to operating a facility during an emergency or disaster situation are governed by §507.22 of this subchapter (relating to Exceptions During Emergency or Disaster Situations).

3. (c) To request an exception to a requirement in this chapter, a facility shall submit a form to the Texas Health and Human Services Commission (HHSC) that includes:

   1. (1) the specific rule for which the facility requests an exception;
   2. (2) a detailed description of the specific circumstances the facility administration believe justify the exception;
   3. (3) a detailed description of what alternatives the facility considered, if any, and why the facility did not select any of the identified alternatives, including compliance with the rule;
   4. (4) a detailed description of how the proposed exception is desirable to maintain or improve the health and safety of the patients, will not jeopardize patient health and safety, and will maintain patient access to care; and
   5. (5) the proposed duration of the exception, if the facility submits a request for a temporary exception.
4. (d) HHSC may conduct an inspection and may consult with the medical review board before approving an exception.
5. (e) HHSC responds to an exception request within 90 calendar days after the date HHSC receives the request. On finding that the facility satisfied the conditions of this section, HHSC may grant a temporary or permanent exception and shall specify the exception duration when notifying the facility that HHSC granted the exception.
6. (f) The facility may implement an exception only after the date the facility receives written approval from HHSC.
7. (g) Granting of an exception is public information, is subject to disclosure, and may be posted on the HHSC website.

Source Note:The provisions of this §507.21 adopted to be effective December 23, 2025, 50 TexReg 8289.