Proposed Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

SUBCHAPTER Y. ADVERSE LICENSING, LISTING, OR REGISTRATION DECISIONS

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes an amendment to §1.601, concerning Decisions Based on Interagency Records.

BACKGROUND AND PURPOSE

House Bill 4611, 88th Legislature, Regular Session, 2023, made certain non-substantive revisions to Subtitle I, Title 4, Texas Government Code, which governs HHSC, Medicaid, and other social services as part of the legislature's ongoing statutory revision program. This proposal is necessary to update citations in the rule to Texas Government Code Chapter 526 that becomes effective on April 1, 2025. The proposed amendment updates the affected citations to Texas Government Code.

FISCAL NOTE

Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rule will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of HHSC employee positions;

(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;

(4) the proposed rule will not affect fees paid to HHSC;

(5) the proposed rule will not create a new regulation;

(6) the proposed rule will not expand, limit, or repeal existing regulations;

(7) the proposed rule will not change the number of individuals subject to the rule; and

(8) the proposed rule will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Trey Wood has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule because the amendment only updates references to existing laws.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to this rule because the rule does not impose a cost on regulated persons and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.

PUBLIC BENEFIT AND COSTS

Libby Elliott, Deputy Executive Commissioner, Office of Policy and Rules, has determined that for each year of the first five years the rule is in effect, the public will benefit from rules that accurately cite the laws governing HHSC, Medicaid, and other social services.

Trey Wood has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the amendment only updates references to existing laws.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 24R085" in the subject line.

STATUTORY AUTHORITY

The amendment 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, and Chapter 526.

The amendment affects Texas Government Code §531.0055 and Chapter 526.

§1.601.Decisions Based on Interagency Records.

(a) Scope of subchapter. In accordance with Health and Safety Code, Chapter 531, this subchapter applies to the final licensing or registration decisions of the Department of State Health Services (department) that resulted in a final order that was not reversed on appeal, for the following persons or entities regulated under the Health and Safety Code:

(1) a youth camp licensed under Chapter 141;

(2) a hospital licensed under Chapter 241;

(3) a special care facility licensed under Chapter 248;

(4) a chemical dependency treatment facility licensed under Chapter 464; and

(5) a mental hospital or mental health facility licensed under Chapter 577.

(b) Record of final decision. In accordance with Texas Government Code §526.0454[~~Government Code, §531.952~~], the department shall maintain a record:

(1) of each application for a license, including a renewal license or a registration that is denied by the department under the law authorizing the department to regulate the person or entity;

(2) of each license or registration that is revoked, suspended, or terminated by the department under the applicable law;

(3) until the 10th anniversary of the date of the denial, revocation, suspension, or termination;

(4) that includes:

(A) the name and address of the applicant for a license or registration that is denied by the department, and the name and address of each person named on the application for a license or registration that is denied;

(B) the name of each controlling person of an entity for which an application, license or registration is denied, revoked, suspended, or terminated as described in paragraphs (1) and (2) of this subsection and the specific type of license or registration that was denied, revoked, suspended, or terminated by the department;

(D) the period the denial, revocation, suspension, or termination was effective.

(5) The department shall provide a copy of the records maintained under this section, in a form determined by the department, to the Department of Aging and Disability Services and the Department of Family and Protective Services (each Health and Human Services agency that regulates a person described by Texas Government Code Chapter 526 [~~Government Code, Chapter 531~~]) on a monthly basis.

(c) Denial of application based on adverse agency decision. The department may deny an application for a license, including a renewal license or a registration of a person described in subsection (a) of this section if:

(1) the applicant, a person named on the application, or a person determined by the regulating agency to be a controlling person of an entity for which the license, listing, or registration is sought is listed in a record maintained by a Health and Human Services agency under Texas Government Code §526.0454[~~Government Code, §531.952~~]; and

(2) the agency's action that resulted in the person being listed in a record maintained under Texas Government Code §526.0454 [~~Government Code, §531.952~~], is based on:

(A) an act or omission that resulted in physical or mental harm to an individual in the care of the applicant or person;

(B) a threat to the health, safety, or well-being of an individual in the care of the applicant or person;

(D) a determination by the agency that the applicant or person has committed an act or omission that renders the applicant unqualified or unfit to fulfill the obligations of the license, listing, or registration.

(d) Required application information. An applicant submitting an initial or renewal application for a license, including a renewal license or a registration described in subsection (a) of this section must include with the application a written statement of:

(1) the name of any person who is or will be a controlling person of the entity for which the license or registration is sought; and

(2) any other relevant information required by law, rule, or department policy.

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 November 21, 2024.

TRD-202405679

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: January 5, 2025

For further information, please call: (512) 221-9021

PART 7. TEXAS MEDICAL DISCLOSURE PANEL

CHAPTER 602. PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A

25 TAC §§602.3, 602.5, 602.9, 602.16

The Texas Medical Disclosure Panel (Panel) proposes amendments to §602.3, concerning Digestive System Treatments and Procedures; §602.5, concerning Endocrine System Treatments and Procedures; §602.9, concerning Breast Surgery (non-cosmetic) Treatments and Procedures; and §602.16, concerning Urinary System Treatments and Procedures.

BACKGROUND AND PURPOSE

These amendments are proposed in accordance with Texas Civil Practice and Remedies Code §74.102, which created the Panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure.

The purpose of these amendments is to modify the list of procedures and risks and hazards in §§602.3, 602.5, 602.9, and 602.16 and update these sections using plain language when possible.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §602.3, Digestive System Treatments and Procedures, revises and lists additional types of digestive system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them, and includes plain language explanations, where necessary.

The proposed amendment to §602.5, Endocrine System Treatments and Procedures, revises and lists additional types of endocrine system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them, and includes plain language explanations, where necessary.

The proposed amendment to §602.9, Breast Surgery (Non-cosmetic) Treatments and Procedures, revises and lists additional types of breast surgery (non-cosmetic) treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them, and includes plain language explanations, where necessary.

The proposed amendment to §602.16, Urinary System Treatments and Procedures, revises and lists additional types of urinary system treatments and procedures that the Panel has determined require full disclosure of the risks and hazards associated with them, and includes plain language explanations, where necessary.

FISCAL NOTE

Dr. Noah Appel, Panel Chairman, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

The Panel has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to the agency;

(5) the proposed rules will not create new rules;

(6) the proposed rules will not expand, limit, or repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the Panel has insufficient information to determine the proposed rules' effect on the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Dr. Appel has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

The Panel is unable to provide an estimate of the number of small businesses and micro businesses affected.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Dr. Noah Appel, Panel Chairman, has determined that for each year of the first five years the rules are in effect, the public benefit will be that patients are better informed about the risks and hazards related to medical treatments and surgical procedures they are considering and there will be improved clarity in this chapter of the Texas Administrative Code.

Dr. Appel has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.

TAKINGS IMPACT ASSESSMENT

The Panel has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Debasmita Bhakta, TMDP Liaison, Health and Human Services Commission; P.O. Box 149030, Mail Code E-249, Austin, Texas, 78714-9030; fax (877) 438-5827; office (512) 438-2889, or by email to: hhsc_tmdp@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule" in the subject line.

STATUTORY AUTHORITY

The amendments to the sections are authorized under Texas Civil Practice and Remedies Code §74.102, which created the Panel to determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients and to establish the general form and substance of such disclosure, and §74.103, which requires the Panel to prepare lists of medical treatments and surgical procedures that do and do not require disclosure by physicians and health care providers of the possible risks and hazards, and to prepare the forms for the treatments and procedures which do require disclosure.

The amendments to the sections implement Texas Civil Practice and Remedies Code Chapter 74, Subchapter C.

The Panel hereby certifies that this proposal has been reviewed by legal counsel and found to be a valid exercise of the Panel's legal authority.

§602.3.Digestive System Treatments and Procedures.

(a) Cholecystectomy with or without common bile duct exploration.

(1) Pancreatitis (inflammation of the pancreas).

(2) Bile duct injury (Injury to the tube between the liver and the bowel) [~~Injury to the tube between the liver and the bowel~~].

(3) Retained bile duct stones (stones remaining in the tube between the liver and the bowel) [~~in the tube between the liver and the bowel~~].

(4) Bile duct stenosis or occlusion (narrowing or obstruction of the tube between the liver and the bowel) [~~Narrowing or obstruction of the tube between the liver and the bowel~~].

(5) Injury to the bowel and/or intestinal obstruction.

(6) Bile leak (leak of bile from end of gallbladder duct or variant duct from the liver).

(b) Bariatric surgery (including gastric bypass (Roux-en-Y), biliopancreatic diversion with duodenal switch, sleeve gastrectomy, gastric banding).

(1) Failure of wound to heal or wound dehiscence (separation of wound).

(2) Injury to organs.

(3) Failure of device, including slippage or erosion requiring additional surgical procedure (for surgeries with implanted devices such as gastric banding).

(4) Obstructive symptoms requiring additional surgical procedure.

(5) Development of gallstones (Roux-En-Y).

(6) Development of metabolic and vitamin disorders (Roux-En-Y, biliopancreatic diversion with duodenal switch).

(7) Dumping syndrome causing nausea, vomiting, diarrhea, dizziness, sweating (Roux-En-Y, biliopancreatic diversion with duodenal switch).

(1) Pancreatitis (inflammation of the pancreas) (subtotal).

(2) Diabetes (total).

(3) Lifelong requirement of enzyme and digestive medication.

(4) Anastomotic leaks (leak of bile or intestinal fluids at surgical site where ducts and intestines are joined).

(d) Colectomy - total or subtotal [~~Total colectomy~~].

(1) Permanent ileostomy.

(2) Injury to organs.

(3) Infection.

(4) Anastomotic leaks (leak of bowel contents at site where intestines reattached).

(5) Need for colostomy, permanent or temporary (subtotal colectomy).

(6) Incontinence (if ileoanal anastomosis)(unable to control bowel if small bowel attached directly to anus).

~~[(e) Subtotal colectomy.]~~

~~[(1) Anastomotic leaks.]~~

~~[(2) Temporary colostomy.]~~

~~[(3) Infection.]~~

~~[(4) Second surgery.]~~

~~[(5) Injury to organs.]~~

(e) [~~(f)~~] Hepatobiliary drainage/intervention including percutaneous transhepatic cholangiography, percutaneous biliary drainage, percutaneous cholecystostomy, biliary stent placement (temporary or permanent), biliary stone removal/therapy (bile duct, gallbladder, and gallstone related procedures).

(1) Leakage of bile at the skin site or into the abdomen with possible peritonitis (inflammation of the abdominal lining and pain or if severe can be life threatening).

(2) Pancreatitis (inflammation of the pancreas).

(3) Hemobilia (bleeding into the bile ducts).

(4) Cholangitis, cholecystitis, sepsis (inflammation/infection of the bile ducts, gallbladder or blood).

(5) Pneumothorax (collapsed lung) or other pleural complications (complication involving chest cavity).

(f) [~~(g)~~] Gastrointestinal tract stenting.

(1) Stent migration (stent moves from location in which it was placed).

(2) Esophageal/bowel perforation (creation of a hole or tear in the tube from the throat to the stomach or in the intestines).

(3) Tumor ingrowth or other obstruction of stent.

(4) For stent placement in the esophagus (tube from the throat to the stomach).

(A) Tracheal compression (narrowing of windpipe) with resulting or worsening of shortness of breath.

(B) Reflux (stomach contents passing up into esophagus or higher).

(D) Foreign body sensation (feeling like there is something in throat) (for stent placement in the upper esophagus).

(E) Tracheoesophageal fistula (formation of hole and connection between the windpipe and tube between mouth and stomach).

(g) Anti reflux procedures (surgical, endoscopic, including hiatal hernia repair).

(1) Dysphagia (difficulty swallowing).

(2) Stomach bloating, difficulty belching or vomiting.

(3) Esophageal perforation (hole in tube from mouth to stomach).

(4) Mediastinal abscess (infected collection in central portion of chest).

(5) Pneumothorax (collapsed lung).

(6) Device erosion into esophagus/surrounding tissues (procedures with implanted devices).

(h) Endoscopy simple (diagnostic endoscopy).

(1) Perforation (hole) of the esophagus (tube from mouth to stomach), stomach, small intestine (with leakage of contents into chest or abdomen), possibly requiring additional procedures including open surgery.

(2) Need for inclusion of or conversion to advanced endoscopy procedures with those risks (see subsection (i) of this section).

(i) Advanced upper endoscopic procedures (anything more than simple, diagnostic endoscopy) (ERCP, POEM, ESD, pancreatic fluid collection drainage/necrosectomy).

(1) Perforation (hole) of the esophagus, stomach, small intestine (with leakage of contents into chest or abdomen).

(2) Pancreatitis (inflammation of the pancreas) (for any procedures involving pancreas/pancreatic duct).

(3) Hemorrhage (Severe bleeding).

(4) Adjacent organ injury for transluminal procedures (e.g. liver biopsy, fluid drainage).

(5) Biliary peritonitis (bile leakage causing inflammation of the abdominal cavity).

(6) Sepsis (severe infection).

(j) Appendectomy.

(1) Injury to nearby organs.

(2) Infectious collection of fluid (abscess) requiring additional procedure(s).

(3) Normal appendix.

(k) Hemorrhoidectomy with/without fistulectomy or fissurectomy.

(1) Fecal incontinence (unable to control bowel).

(2) Anal stenosis (narrowing of the anus).

(3) Damage to bowel.

(4) Recurrent or new hemorrhoid(s).

(l) Repair and plastic operations on anus and rectum (anal fistula repair, rectovaginal fistula repair, rectal prolapse repair, anal sphincter repair, perineal reconstruction).

(1) Fecal incontinence (unable to control bowel).

(2) Anal stenosis (narrowing of the anus).

(3) Damage to bowel.

(m) Hernia repair (for example inguinal or ventral) (for hiatal hernia repair see subsection (g) of this section).

(1) Injury to adjacent structures (bowel, bladder, blood vessels, nerves).

(2) Seroma (fluid) or hematoma (blood) collection at surgical site.

(3) Chronic pain.

(4) Testicular injury (for those of male sex).

(5) If mesh used, infection, failure, migration, or rejection of the mesh.

(6) Recurrence.

(n) Esophageal dilatation (opening a narrowing of the tube between the mouth and the stomach).

(1) Perforation of the esophagus (creation of hole in tube from mouth to stomach), with possible need for additional procedures including open surgery.

(2) Recurrent stenosis (return of narrowing of the tube from the mouth to the stomach).

(o) Gastrostomy/gastrojejunostomy open, percutaneous, or endoscopic (placement of tube directly between the skin and the stomach with surgical incision, puncture from the skin into the stomach, or puncture from the stomach out towards the skin with endoscopy (camera)).

(1) Damage to surrounding organs.

(2) Hemorrhage (severe bleeding).

(3) Peritonitis (irritation of the abdominal compartment).

(p) Pyloromyotomy (cutting of the muscle at the end of the stomach to treat blockage of the stomach outlet).

(1) Perforation (creation of a hole from the mucosa (inside of the stomach) to the outside of the stomach) possible requiring additional procedures or surgeries.

(2) Incomplete myotomy (incomplete cutting of the muscle) possibly requiring repeat procedure/surgery.

(3) Delayed gastric emptying (food takes longer to leave the stomach than normal).

(q) Colonoscopy. Perforation (creation of a hole in the intestine) possibly requiring additional procedures or open surgery.

§602.5.Endocrine System Treatments and Procedures.

(a) Thyroidectomy.

(1) Acute airway obstruction requiring temporary tracheostomy (creation of hole in neck to breathe).

(2) Injury to nerves resulting in hoarseness or impairment of speech.

(3) Injury to parathyroid glands resulting in low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness and muscle irritability.

(4) Lifelong requirement of thyroid medication.

(b) For scarless/minimally invasive thyroidectomy.

(1) All risks of standard thyroidectomy.

(2) For axillary approach.

(A) Injury to brachial plexus (nerves in shoulder/neck) which can affect function of muscles and sensation in the affected extremity.

(B) Tract seeding of thyroid tissue (thyroid tissue can deposit and grow along the surgical tract).

(D) Great vessel injury (injury to large blood vessels of the upper chest and neck).

(3) Transoral/transoral vestibular approach (TOETVA)).

(A) CO2 embolism (gas bubbles enter bloodstream) (Transoral/transoral vestibular approach (TOETVA)).

(B) Mental nerve injury (nerve injury causing paresthesias (pins and needles sensation) of the lower lip and/or chin) (Transoral/transoral vestibular approach (TOETVA)).

(D) Burns (Transoral/transoral vestibular approach (TOETVA)).

(E) Surgical space infection (Transoral/transoral vestibular approach (TOETVA)).

(1) Acute airway obstruction requiring temporary tracheostomy (creation of hole in neck to breathe).

(2) Injury to nerves resulting in hoarseness or impairment of speech.

(3) Low blood calcium levels that require extensive medication to avoid serious degenerative conditions, such as cataracts, brittle bones, muscle weakness, and muscle irritability.

(4) Persistent high calcium level with need for additional treatment/surgery.

(d) [~~(c)~~] Adrenalectomy.

(1) Loss of endocrine functions (lifelong requirement for hormone replacement therapy and steroid medication).

~~[(2) Lifelong requirement for hormone replacement therapy and steroid medication.]~~

(2) [~~(3)~~] Damage to kidneys.

(d) Other procedures.

(e) For pituitary surgery, see §602.13 of this chapter (relating to Nervous System Treatments and Procedures).

(f) [~~(e)~~] For pancreatic surgery, see [~~See also Pancreatectomy under~~] §602.3 of this chapter (relating to Digestive System Treatments and Procedures).

§602.9.Breast Surgery (non-cosmetic) Treatments and Procedures.

(a) Radical or modified radical mastectomy (removal of the breast, possible removal of other chest wall tissues, and possible removal of lymph nodes in the chest and/or under the arm).

(1) Limitation of movement of shoulder and arm.

(2) Permanent swelling of the arm.

(3) Loss of the skin of the chest requiring skin graft.

(4) Residual or recurrent [~~Recurrence of~~] malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).

(5) Decreased sensation or numbness of the inner aspect of the arm and chest wall.

(b) Simple mastectomy (removal of the breast).

(1) Loss of skin of the chest requiring skin graft.

(2) Residual or recurrent [~~Recurrence of~~] malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).

(3) Decreased sensation or numbness of the nipple.

(1) Loss of skin of the chest requiring skin graft.

(2) Residual or recurrent [~~Recurrence of~~] malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).

(3) Decreased sensation or numbness of the nipple.

(d) Open biopsy of the breast.

(1) Loss of skin of the chest requiring skin graft.

(2) Residual or recurrent [~~Recurrence of~~] malignancy, if present (cancer remaining or comes back after the surgery, if cancer present before the surgery).

(3) Decreased sensation or numbness of the nipple.

§602.16.Urinary System Treatments and Procedures.

(a) Nephrectomy [~~Partial nephrectomy~~] (removal of part or all of the kidney).

(1) Incomplete removal of stone(s) or tumor, if present.

(2) Blockage of urine (risk of partial nephrectomy).

(3) Leakage of urine at surgical site.

(4) Injury to or loss of the entire kidney (risk of partial nephrectomy, intentional for total or radical nephrectomy)

(5) Loss of the adrenal gland (gland on top of the kidney that makes certain hormones/chemicals the body needs) - intentional in the case of radical nephrectomy.

(6) [~~(5)~~] Damage to organs next to kidney.

~~[(b) Radical nephrectomy (removal of kidney and adrenal gland for cancer).]~~

~~[(1) Loss of the adrenal gland (gland on top of kidney that makes certain hormones/chemicals the body needs).]~~

~~[(2) Incomplete removal of tumor.]~~

~~[(3) Damage to organs next to kidney.]~~

~~[(c) Nephrectomy (removal of kidney).]~~

~~[(1) Incomplete removal of tumor if present.]~~

~~[(2) Damage to organs next to kidney.]~~

~~[(3) Injury to or loss of the kidney.]~~

(b) [~~(d)~~] Nephrolithotomy and pyelolithotomy (removal of kidney stone(s)).

(1) Incomplete removal of stone(s).

(2) Blockage of urine.

(3) Leakage of urine at surgical site.

(4) Injury or loss of the kidney.

(5) Damage to organs next to kidney.

(c) [~~(e)~~] Pyeloureteroplasty (pyeloplasty or reconstruction of the kidney drainage system). Ureteroplasty (reconstruction of ureter (tube between kidney and bladder)).

(1) Blockage of urine.

(2) Leakage of urine at surgical site.

(3) Injury to or loss of the kidney (pyeloureteroplasty) or ureter (ureterolithotomy).

(4) Damage to organs next to kidney.

(5) Incomplete removal of the stone or tumor (when applicable).

~~[(f) Exploration of kidney or perinephric mass.]~~

~~[(1) Incomplete removal of stone(s) or tumor, if present.]~~

~~[(2) Leakage of urine at surgical site.]~~

~~[(3) Injury to or loss of the kidney.]~~

~~[(4) Damage to organs next to kidney.]~~

~~[(g) Ureteroplasty (reconstruction of ureter (tube between kidney and bladder)).]~~

~~[(1) Leakage of urine at surgical site.]~~

~~[(2) Incomplete removal of the stone or tumor (when applicable).]~~

~~[(3) Blockage of urine.]~~

~~[(4) Damage to organs next to ureter.]~~

~~[(5) Damage to or loss of the ureter.]~~

(d) [~~(h)~~] Ureterolithotomy (surgical removal of stone(s) from ureter (tube between kidney and bladder)).

(1) Leakage of urine at surgical site.

(2) Incomplete removal of stone.

(3) Blockage of urine.

(4) Damage to organs next to ureter (tube that carries urine from kidney to bladder).

(5) Damage to or loss of ureter (tube that carries urine from kidney to bladder).

(e) [~~(i)~~] Ureterectomy (partial/complete removal of ureter tube that carries urine from kidney to bladder), Ureterolysis (partial/complete removal of ureter (tube that carries urine from kidney to bladder) from adjacent tissue [~~(tube between kidney and bladder)~~]).

(1) Leakage of urine at surgical site.

(2) Incomplete removal of stone (if stone present).

(3) Blockage of urine.

(4) Damage to organs next to ureter.

(5) Damage to or loss of ureter (ureterolysis).

~~[(j) Ureterolysis (partial/complete removal of ureter (tube between kidney and bladder from adjacent tissue)).]~~

~~[(1) Leakage of urine at surgical site.]~~

~~[(2) Blockage of urine.]~~

~~[(3) Damage to organs next to ureter.]~~

~~[(4) Damage to or loss of ureter.]~~

(f) [~~(k)~~] Ureteral reimplantation (reinserting ureter (tube between kidney and bladder) into the bladder).

(1) Leakage of urine at surgical site.

(2) Blockage of urine.

(3) Damage to or loss of ureter.

(4) Backward flow of urine from bladder into ureter.

(5) Damage to organs next to ureter.

(g) [~~(l)~~] Prostatectomy (partial or total removal of prostate).

(1) Leakage of urine at surgical site.

(2) Blockage of urine.

(3) Incontinence (difficulty with control of urine flow).

(4) Semen passing backward into bladder.

(5) Difficulty with penile erection (possible with partial and probable with total prostatectomy).

(h) [~~(m)~~] Total cystectomy (removal of bladder).

(1) Probable loss of penile erection and ejaculation in the male.

(2) Damage to organs next to bladder.

(3) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).

(i) [~~(n)~~] Radical cystectomy.

(1) Probable loss of penile erection and ejaculation in the male.

(2) Damage to organs next to bladder.

(3) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).

(4) Chronic (continuing) swelling of thighs, legs and feet.

(5) Recurrence or spread of cancer if present.

(j) [~~(o)~~] Partial cystectomy (removal of a portion of the bladder [~~partial removal of bladder~~]).

(1) Leakage of urine at surgical site.

(2) Incontinence (difficulty with control of urine flow).

(3) Backward flow of urine from bladder into ureter (tube between kidney and bladder).

(4) Blockage of urine.

(5) Damage to organs next to bladder.

(k) Cystolithotomy (surgical removal of stone(s) from the bladder).

(1) Injury to bladder or surrounding organs.

(2) Urinary incontinence (inability to control release of urine from bladder).

(l) Cystolitholapaxy (cystoscopic crushing and removal of bladder stone(s)).

(1) Injury to bladder.

(2) Scarring/injury of urethra (tube from bladder to outside).

(m) Cystostomy (placement of tube into the bladder). Injury to bladder or surrounding organs.

(n) Diverticulectomy of the bladder (removal of outpouching of the bladder).

(1) Injury to bladder or surrounding organs.

(2) Urinary incontinence (inability to control release of urine from bladder).

(o) [~~(p)~~] Urinary diversion (ileal conduit, colon conduit).

(1) Blood chemistry abnormalities requiring medication.

(2) Development of stones, strictures (scars or narrowings) or infection in the kidneys, ureter or bowel (intestine).

(3) Leakage of urine at surgical site.

(4) This procedure will require an alternate method of urinary drainage (urine will need a new place to collect or empty from the body).

(p) [~~(q)~~] Ureterosigmoidostomy attachment of ureters (tubes between kidney and bladder to the colon (large intestine))[~~(placement of kidney drainage tubes into the large bowel (intestine))~~].

(1) Blood chemistry abnormalities requiring medication.

(2) Development of stones, strictures or infection in the kidneys, ureter or bowel (intestine).

(3) Leakage of urine at surgical site.

(4) Difficulty in holding urine in the rectum.

(q) [~~(r)~~] Urethroplasty (construction/reconstruction/dilation [~~construction/reconstruction~~] of drainage tube from bladder to the outside).

(1) Leakage of urine at surgical site.

(2) Stricture formation (narrowing of urethra (tube from bladder to outside)).

(3) Need for additional surgery.

(r) Diverticulectomy or diverticulotomy of the urethra (repair or drainage of outpouching of the urethra).

(1) Injury to urethra (tube from bladder to outside) with leak of urine or narrowing of urethra.

(2) Fistula formation (connection between urethra and other pelvic structure).

(3) Sexual dysfunction (pain with sexual intercourse, change in sensation with sex).

(s) Percutaneous nephrostomy/stenting/stone removal.

(1) Pneumothorax or other pleural complications (collapsed lung or filling of the chest cavity on the same side with fluid).

(2) Septic shock/bacteremia (infection of the blood stream with possible shock/severe lowering of blood pressure) when pyonephrosis (infected urine in the kidney) present.

(3) Bowel (intestinal) injury.

(4) Blood vessel injury with or without significant bleeding.

(t) Lithotripsy ("Shockwave Lithotripsy") (sound wave removal of stones from kidney and ureter).

(1) Injury to kidney, ureter (tube between kidney and bladder), or other nearby organs.

(2) Stone fragments blocking ureter.

(3) Bleeding in or around kidney or ureter.

(u) [~~(t)~~] Dialysis (technique to replace functions of kidney and clean blood of toxins).

(1) Hemodialysis.

(A) Hypotension (low blood pressure).

(B) Hypertension (high blood pressure).

(D) Cardiac arrhythmias (irregular heart rhythms).

(E) Infections of blood stream, access site, or blood borne (for example: Hepatitis B, C, or HIV).

(F) Hemorrhage (severe bleeding as a result of clotting problems or due to disconnection of the bloodline).

(G) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis.

(H) Allergic reactions.

(I) Chemical imbalances and metabolic disorders (unintended change in blood minerals).

(J) Pyrogenic reactions (fever).

(K) Hemolysis (rupture of red blood cells).

(L) Graft/fistula damage including bleeding, aneurysm, formation (ballooning of vessel), clotting (closure) of graft/fistula.

(2) Peritoneal dialysis.

(A) Infections, including peritonitis (inflammation or irritation of the tissue lining the inside wall of abdomen and covering organs), catheter infection and catheter exit site infection.

(B) Development of hernias of umbilicus (weakening of abdominal wall or muscle).

(D) Hypotension (low blood pressure).

(E) Hydrothorax (fluid in chest cavity).

(F) Arrhythmia (irregular heart rhythm).

(G) Perforation of the bowel (hole in intestine).

(H) Sclerosis or scarring of the peritoneum (lining of the abdomen) with loss of dialysis function.

(I) Weight gain leading to obesity.

(J) Abdominal discomfort/distension.

(K) Heartburn or reflux.

(L) Increase in need for anti-diabetic medication.

(M) Muscle weakness.

(N) Dehydration (extreme loss of body fluid).

(O) Chemical imbalances and metabolic disorders (unintended change in blood minerals).

(P) Allergic reactions.

(Q) Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis.

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 November 20, 2024.

TRD-202405661

Dr. Noah Appel

Panel Chairman

Texas Medical Disclosure Panel

Earliest possible date of adoption: January 5, 2025

For further information, please call: (512) 438-2889

CHAPTER 603. PROCEDURES REQUIRING NO DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST B

25 TAC §603.3, §603.16

The Texas Medical Disclosure Panel (Panel) proposes amendments to §603.3, concerning Digestive System Treatments and Procedures; and §603.16, concerning Urinary System Treatments and Procedures.

BACKGROUND AND PURPOSE

The purpose of these amendments is to modify the list of procedures and risks and hazards in §603.3 and §603.16 and update these sections using plain language when possible.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §603.3, Digestive System Treatments and Procedures, revises and lists additional types of digestive system treatments and procedures that the Panel has determined require no disclosure of specific risks and hazards associated with them, and includes plain language explanations, where necessary.

The proposed amendment to §603.16, Urinary System Treatments and Procedures, revises and lists additional types of urinary system treatments and procedures that the Panel has determined require no disclosure of specific risks and hazards associated with them, and includes plain language explanations, where necessary.

FISCAL NOTE

GOVERNMENT GROWTH IMPACT STATEMENT

The Panel has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to the agency;

(5) the proposed rules will not create new rules;

(6) the proposed rules will not expand, limit, or repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the Panel has insufficient information to determine the proposed rules' effect on the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Dr. Appel has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

The Panel is unable to provide an estimate of the number of small businesses and micro businesses affected.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

PUBLIC BENEFIT AND COSTS

Dr. Appel has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.

TAKINGS IMPACT ASSESSMENT

PUBLIC COMMENT

STATUTORY AUTHORITY

The amendments to the sections implement Texas Civil Practice and Remedies Code Chapter 74, Subchapter C.

The Panel hereby certifies that this proposal has been reviewed by legal counsel and found to be a valid exercise of the Panel's legal authority.

§603.3.Digestive System Treatments and Procedures.

~~[(a) Appendectomy.]~~

~~[(b) Hemorrhoidectomy with fistulectomy or fissurectomy.]~~

~~[(c) Hemorrhoidectomy.]~~

(a) [~~(d)~~] Incision (cutting into) or excision (removal) of perirectal tissue.

(b) [~~(e)~~] Local excision (removal) and/or [~~and~~] destruction of a lesion of anus and/or rectum [~~lesion, anus and rectum~~].

~~[(f) Operations for correction of cleft palate.]~~

~~[(g) Repair of inguinal or ventral hernia.]~~

~~[(h) Repair and plastic operations on anus and rectum.]~~

~~[(i) Colonoscopy.]~~

~~[(j) Tonsillectomy with adenoidectomy.]~~

§603.16.Urinary System Treatments and Procedures.

~~[(a) Nephrotomy (placement of drainage tubes).]~~

(a) [~~(b)~~] Biopsy of prostrate, bladder or urethra.

(b) Urethrotomy (incision of the urethra).

~~[(c) Cystolithotomy (surgical removal of stone(s) from the bladder).]~~

~~[(d) Cystolitholapaxy (cystoscopic crushing and removal of bladder stone(s)).]~~

~~[(e) Cystostomy (placement of tube into the bladder).]~~

~~[(f) Urethrotomy (incision of the urethra).]~~

~~[(g) Diverticulectomy of the bladder (removal of outpouching of the bladder).]~~

~~[(h) Diverticulectomy or diverticulotomy of the urethra (repair or drainage of outpouching of the urethra).]~~

~~[(i) Lithotripsy (sound wave removal of stones from kidney and ureter).]~~

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 November 20, 2024.

TRD-202405662

Dr. Noah Appel

Panel Chairman

Texas Medical Disclosure Panel

Earliest possible date of adoption: January 5, 2025

For further information, please call: (512) 438-2889

PART 11. CANCER PREVENTION AND RESEARCH INSTITUTE OF TEXAS

CHAPTER 703. GRANTS FOR CANCER PREVENTION AND RESEARCH

25 TAC §703.13, §703.26

The Cancer Prevention and Research Institute of Texas ("CPRIT" or "the Institute") proposes amending 25 Texas Administrative Code §703.13 and §703.26 relating the grant recipient audit threshold, unallowable grant recipient expenses, and a reference to Texas Grant Management Standards.

Background and Justification

The proposed amendment to §703.13(b) increases the grant recipient audit threshold from $750,000 to $1 million. The amendment harmonizes CPRIT's administrative rules with recent changes to the Texas Grant Management Standards (TxGMS) published by the Comptroller of Public Accounts. Currently, CPRIT grantees who expend $750,000 or more in state funds must obtain either an annual single independent audit, a program specific independent audit, or an agreed upon procedures engagement. CPRIT follows the guidance in TxGMS to determine the audit threshold. On October 1, 2024, the Comptroller's of Public Accounts released a new version of TxGMS that increased the threshold to $1 million.

CPRIT proposes amending §703.26(e) to add the following as an unallowable expense for grant recipients, "Reimbursements to employees for their out-of-pocket health insurance premium or other health care expenses which are not made through an employer-sponsored plan established under Section 105 of the Internal Revenue Code." For these expenses to be considered fringe benefits that are reimbursable from CPRIT grant funds, the employer must have an established health reimbursement arrangement program under Section 105 of the Internal Revenue Code. Thus, this amendment clarifies that CPRIT program standards for reimbursements conform to other relevant laws.

Lastly, the Institute proposes a non-substantive, technical amendment to § 703.26(b). This amendment proposes replacing an outdated reference to the Uniform Grant Management Standards (UGMS) with a reference to TxGMS. CPRIT relied on UGMS, the predecessor to TxGMS, as guidance for grant recipients and referred to it in the Institute's administrative rules. When TxGMS went into effect, CPRIT updated its administrative rules to replace references to UGMS with references to TxGMS. The proposed amendment to § 703.26(b) corrects a reference that was inadvertently excluded from the previous update.

Fiscal Note

John Ellis, General Counsel for the Cancer Prevention and Research Institute of Texas, has determined that for the first five-year period the rule change is in effect, there will be no foreseeable implications relating to costs or revenues for state or local government due to enforcing or administering the rules.

Public Benefit and Costs

Mr. Ellis has determined that for each year of the first five years the rule change is in effect the public benefit anticipated due to enforcing the rule will be clarifying grantee reporting obligations and consequences.

Small Business, Micro-Business, and Rural Communities Impact Analysis

Mr. Ellis has determined that the rule change will not affect small businesses, micro businesses, or rural communities.

Government Growth Impact Statement

The Institute, in accordance with 34 Texas Administrative Code §11.1, has determined that during the first five years that the proposed rule change will be in effect:

(1) the proposed rule change will not create or eliminate a government program;

(2) implementation of the proposed rule change will not affect the number of employee positions;

(3) implementation of the proposed rule change will not require an increase or decrease in future legislative appropriations;

(4) the proposed rule change will not affect fees paid to the agency;

(5) the proposed rule change will not create new rule;

(6) the proposed rule change will not expand existing rule;

(7) the proposed rule change will not change the number of individuals subject to the rule; and

(8) The rule change is unlikely to have an impact on the state's economy. Although the change is likely to have a neutral impact on the state's economy, the Institute lacks enough data to predict the impact with certainty.

Submit written comments on the proposed rule changes to Mr. John Ellis, General Counsel, Cancer Prevention and Research Institute of Texas, P.O. Box 12097, Austin, Texas 78711, no later than January 7, 2025. The Institute asks parties filing comments to indicate whether they support the rule revision proposed by the Institute and, if the party requests a change, to provide specific text for the proposed change. Parties may submit comments electronically to jellis@cprit.texas.gov or by facsimile transmission to 512/475-2563.

Statutory Authority

The Institute proposes the rule changes under the authority of the Texas Health and Safety Code Annotated, §102.108, which provides the Institute with broad rule-making authority to administer the chapter. Mr. Ellis has reviewed the proposed amendments and certifies the proposal to be within the Institute's authority to adopt.

There is no other statute, article, or code affected by these rules.

§703.13.Audits and Investigations.

(a) Upon request and with reasonable notice, an entity receiving Grant Award funds directly under the Grant Contract or indirectly through a subcontract under the Grant Contract shall allow, or shall cause the entity that is maintaining such items to allow the Institute, or auditors or investigators working on behalf of the Institute, including the State Auditor and/or the Comptroller of Public Accounts for the State of Texas, to review, inspect, audit, copy or abstract its records pertaining to the specific Grant Contract during the term of the Grant Contract and for the three year period following the date the last disbursement of funds is made by the Institute or all reports required pursuant to the Grant Contract are submitted and approved, whichever date is later.

(1) A Grant Recipient shall maintain its records pertaining to the specific Grant Contract for a period of three years following the date the last disbursement of funds is made by the Institute or all reports required pursuant to the Grant Contract are submitted and approved, whichever date is later.

(2) The Grant Recipient may maintain its records in either electronic or paper format.

(b) Notwithstanding the foregoing, the Grant Recipient shall submit a single audit determination form no later than 60 days following the close of the Grant Recipient's fiscal year. The Grant Recipient shall report whether the Grant Recipient has expended $1 million [~~$750,000~~] or more in state awards during the Grant Recipient's fiscal year. If the Grant Recipient has expended $1 million [~~$750,000~~] or more in state awards in its fiscal year, the Grant Recipient shall obtain either an annual single independent audit, a program specific independent audit, or an agreed upon procedures engagement as defined by the American Institute of Certified Public Accountants and pursuant to guidance provided in subsection (e) of this section.

(1) The audited time period is the Grant Recipient's fiscal year.

(2) The audit must be submitted to the Institute within thirty (30) days of receipt by the Grant Recipient but no later than nine (9) months following the close of the Grant Recipient's fiscal year and shall include a corrective action plan that addresses any weaknesses, deficiencies, wrongdoings, or other concerns raised by the audit report and a summary of the action taken by the Grant Recipient to address the concerns, if any, raised by the audit report.

(A) The Grant Recipient may seek additional time to submit the required audit and corrective action plan by providing a written explanation for its failure to timely comply and providing an expected time for the submission.

(B) The Grant Recipient's request for additional time must be submitted on or before the due date of the required audit and corrective action plan. For purposes of this rule, the "due date of the required audit" is no later than nine (9) months following the close of the Grant Recipient's fiscal year.

(C) Approval of the Grant Recipient's request for additional time is at the discretion of the Institute. Such approval must be granted by the Chief Executive Officer.

(c) No reimbursements or advances of Grant Award funds shall be made to the Grant Recipient if the Grant Recipient is delinquent in filing the required audit and corrective action plan. A Grant Recipient that has received approval from the Institute for additional time to file the required audit and corrective action plan may receive reimbursements or advances of Grant Award funds during the pendency of the delinquency unless the Institute's approval declines to permit reimbursements or advances of Grant Award funds until the delinquency is addressed.

(d) A Grant Recipient that is delinquent in submitting to the Institute the audit and corrective action plan required by this section is not eligible to be awarded a new Grant Award or a continuation Grant Award until the required audit and corrective action plan are submitted. A Grant Recipient that has received approval from the Institute for additional time to file the required audit and corrective action plan may remain eligible to be awarded a new Grant Award or a continuation Grant Award unless the Institute's approval declines to continue eligibility during the pendency of the delinquency.

(e) For purposes of this rule, an agreed upon procedures engagement is one in which an independent certified public accountant is hired by the Grant Recipient to issue a report of findings based on specific procedures to be performed on a subject matter.

(1) The option to perform an agreed upon procedures engagement is intended for a non-profit or for-profit Grant Recipient that is not subject to Generally Accepted Government Audit Standards (also known as the Yellow Book) published by the U.S. Government Accountability Office.

(2) The agreed upon procedures engagement will be conducted in accordance with attestation standards established by the American Institute of Certified Public Accountants.

(3) The certified public accountant is to perform procedures prescribed by the Institute and to report his or her findings attesting to whether the Grant Recipient records are in agreement with stated criteria.

(4) The agreed upon procedures apply to all current year expenditures for Grant Awards received by the Grant Recipient. Nothing herein prohibits the use of a statistical sample consistent with the American Institute of Certified Public Accountants' guidance regarding government auditing standards and 2 CFR Part 200, Subpart F, "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards."

(5) At a minimum, the agreed upon procedures report should address:

(A) Processes and controls;

(B) The Grant Contract;

(D) Matching Funds, if appropriate;

(E) Grant Award expenditures (payroll and non-payroll related transactions);

(F) Equipment;

(G) Revenue Sharing and Program Income;

(H) Reporting; and

(I) Grant Award closeout.

(6) The certified public accountant should consider the specific Grant Mechanism and update or modify the procedures accordingly to meet the requirements of each Grant Award and the Grant Contract reviewed.

(f) For purposes of this rule, a program specific audit should address:

(1) Sample of awards;

(2) Reporting;

(3) Indirect costs;

(4) Matching funds, if appropriate;

(5) Expenditures;

(6) Expenditure Reporting;

(7) Personnel Level of Effort Reporting;

(8) Grant Closeout;

(9) Performance Measures;

(10) Publications and Acknowledgements;

(11) Title to equipment;

(12) Contract certifications;

(13) Changes in Principal Investigator or Program Director;

(14) Intellectual Property and revenue sharing;

(15) Early termination and event of default; and

(16) Any other issue identified by the Institute, the Grant Recipient, or the person performing the program specific audit.

(g) If a deadline set by this rule falls on a Saturday, Sunday, or federal holiday as designated by the U.S. Office of Personnel Management, the required filing may be submitted on the next business day. The Institute will not consider a required filing delinquent if the Grant Recipient complies with this subsection.

§703.26.Allowable Costs.

(a) A cost is an Allowable Cost and may be charged to the Grant Award if it is reasonable, allocable, and adequately documented.

(1) A cost is reasonable if the cost does not exceed that which would be incurred by a prudent individual or organization under the circumstances prevailing at the time the decision was made to incur the cost; and is necessary for the performance of the Grant Award defined in the Scope of Work in the Grant Contract.

(2) A cost is allocable if the cost:

(A) Benefits the Grant Award either directly or indirectly, subject to Indirect Cost limits stated in the Grant Contract;

(B) Is assigned the Grant Award in accordance with the relative benefit received;

(D) Is not included as a cost or used to meet Matching Fund requirements for any other Grant Award in either the current or a prior period; and

(E) Conforms to any limitations or exclusions set forth in the applicable cost principles, administrative rules, state laws, and terms of the Grant Contract.

(3) A cost is adequately documented if the cost is supported by the organization's accounting records and documented consistent with §703.24 of this title (relating to Financial Status Reports).

(b) Grant Award funds must be used for Allowable Costs as provided by the terms of the Grant Contract, Chapter 102, Texas Health and Safety Code, the Institute's administrative rules, and the Texas Grant Management Standards (TxGMS) adopted by the Comptroller's Office. If guidance from TxGMS [~~the Uniform Grant Management Standards~~] on a particular issue conflicts with a specific provision of the Grant Contract, Chapter 102, Texas Health and Safety Code or the Institute's administrative rules, then the Grant Contract, statute, or Institute administrative rule shall prevail.

(c) An otherwise Allowable Cost will not be eligible for reimbursement if the Grant Recipient incurred the expense outside of the Grant Contract term, unless the Grant Recipient has received written approval from the Institute's Chief Executive Officer to receive reimbursement for expenses incurred prior to the effective date of the Grant Contract.

(d) An otherwise Allowable Cost will not be eligible for reimbursement if the benefit from the cost of goods or services charged to the Grant Award is not realized within the applicable term of the Grant Award. The Grant Award should not be charged for the cost of goods or services that benefit another Grant Award or benefit a period prior to the Grant Contract effective date or after the termination of the Grant Contract.

(e) Grant Award funds shall not be used to reimburse unallowable expenses, including, but not limited to:

(1) Bad debt, such as losses arising from uncollectible accounts and other claims and related costs.

(2) Contributions to a contingency reserve or any similar provision for unforeseen events.

(3) Contributions and donations made to any individual or organization.

(4) Costs of entertainment, amusements, social activities, and incidental costs relating thereto, including tickets to shows or sports events, meals, alcoholic beverages, lodging, rentals, transportation and gratuities.

(5) Costs relating to food and beverage items, unless the food item is related to the issue studied by the project that is the subject of the Grant Award.

(6) Fines, penalties, or other costs resulting from violations of or failure to comply with federal, state, local or Indian tribal laws and regulations.

(7) An honorary gift or a gratuitous payment.

(8) Interest and other financial costs related to borrowing and the cost of financing.

(9) Legislative expenses such as salaries and other expenses associated with lobbying the state or federal legislature or similar local governmental bodies, whether incurred for purposes of legislation or executive direction.

(10) Liability insurance coverage.

(11) Benefit replacement pay or legislatively-mandated pay increases for eligible general revenue-funded state employees at Grant Recipient state agencies or universities.

(12) Professional association fees or dues for an individual employed by the Grant Recipient. Professional association fees or dues for the Grant Recipient's membership in business, technical, and professional organizations may be allowed, with prior approval from the Institute, if:

(A) the professional association is not involved in lobbying efforts; and

(B) the Grant Recipient demonstrates how membership in the professional association benefits the Grant Award project(s).

(13) Promotional items and costs relating to items such as T-shirts, coffee mugs, buttons, pencils, and candy that advertise or promote the project or Grant Recipient.

(14) Fees for visa services.

(15) Payments to a subcontractor if the subcontractor working on a Grant Award project employs an individual who is a Relative of the Principal Investigator, Program Director, Company Representative, Authorized Signing Official, or any person designated as Key Personnel for the same Grant Award project (collectively referred to as "affected Relative"), and the Grant Recipient will be paying the subcontractor with Grant Award funds for any portion of the affected Relative's salary or the Relative submits payment requests on behalf of the subcontractor to the Grant Recipient for payment with Grant Award funds.

(A) For exceptional circumstances, the Institute's Chief Executive Office may grant an exception to allow payment of Grant Award funds if the Grant Recipient notifies the Institute prior to finalizing the subcontract. The Chief Executive Officer must notify the Oversight Committee in writing of the decision to allow reimbursement for the otherwise unallowable expense.

(B) Nothing herein is intended to supersede a Grant Recipient's internal policies, to the extent that such policies are stricter.

(16) Fundraising.

(17) Tips or gratuities.

(18) Reimbursements to employees for their out-of-pocket health insurance premium or other health care expenses which are not made through an employer-sponsored plan established under Section 105 of the Internal Revenue Code.

(f) Pursuant to Texas Health and Safety Code Section 102.203(b) the Institute may authorize reimbursement for one or more of the following expenses incurred by a cancer clinical trial participant that are associated with participating in a clinical trial and included in the Grant Recipient's Approved Budget:

(1) transportation, including car mileage, parking, bus fare, taxi or ride hailing fare exclusive of tips, and commercial economy class airfare within the borders of the State of Texas;

(2) lodging; and

(3) any cost reimbursed under a cancer clinical trial participation program established pursuant to Texas Health and Safety Code Chapter 51 (relating to Cancer Clinical Trial Participation Program).

(g) The Institute is responsible for making the final determination regarding whether an expense shall be considered an Allowable Cost.

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 November 21, 2024.

TRD-202405674

Heidi McConnell

Deputy Executive Officer / Chief Operating Officer

Cancer Prevention and Research Institute of Texas

Earliest possible date of adoption: January 5, 2025

For further information, please call: (512) 463-3190