TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER D. DESIGNATING INCURABLE NEURODEGENERATIVE DISEASES

25 TAC §1.61

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts new §1.61, concerning designating incurable neurodegenerative diseases. The new section is adopted with changes to the proposed text as published in the September 27, 2019, issue of the Texas Register (44 TexReg 5541) and will be republished.

BACKGROUND AND JUSTIFICATION

The new section is necessary to comply with House Bill (H.B.) 3703, 86th Legislature, Regular Session, 2019, which amended Texas Occupations Code, Chapter 169, and requires the Executive Commissioner of HHSC to adopt a rule designating incurable neurodegenerative diseases. The new section designates incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169. The Executive Commissioner charged rule development for the designation of incurable neurodegenerative diseases to DSHS.

COMMENTS

The 31-day comment period ended October 28, 2019.

During this period, DSHS received comments regarding the proposed rule from two commenters, including Texas Neurology in Dallas, Texas, and Texas Star Alliance. A summary of the comments relating to new §1.61, and DSHS responses follows.

Comment: One commenter suggesting adding Cerebral Amyloid Angiopathy to the list of incurable neurodegenerative diseases eligible for prescription of low-THC cannabis.

Response: DSHS declines to make the suggested change at this time. DSHS will address the requested condition in a future rule project to ensure that the list of designated incurable neurodegenerative diseases is as comprehensive as possible and verified by subject-matter experts.

Comment: One commenter provided an extensive list of suggested conditions.

Response: DSHS declines to make the suggested change at this time. DSHS will address the requested condition in a future rule project to ensure that the list of designated incurable neurodegenerative diseases is as comprehensive as possible and verified by subject-matter experts.

There are minor revisions due to Texas Register formatting. The changes to §1.61(b)(2)(C)(v)(II) revise the numbering of "(I) Sepiapterin reductase" to "(II) Sepiapterin reductase;" remove the extra word "and" from the end of 1.61(b)(2)(E)(i)(III); and add the word "and" at the end of 1.61(b)(2)(E)(iv)(VIII).

There are also minor revisions to correct the spelling of diseases for §1.61(b)(1)(C) to "Freidreich's Ataxia;" §1.61(b)(1)(J)(ii)(II) to "Gerstmann-Straussler-Scheinker Disease," §1.61(b)(2)(A)(vi)(I) to "Alpers-Huttenlocher syndrome," and §1.61(b)(2)(A)(x)(II) to "SUCLG1-related mitochondrial DNA depletion syndrome, encephalomyopathic form with methylmalonic aciduria."

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; and H.B. 3703, which requires the Executive Commissioner of HHSC, in consultation with the National Institutes of Health, to adopt a rule designating incurable neurodegenerative diseases eligible for prescription of low-THC cannabis pursuant to Texas Occupations Code, Chapter 169.

§1.61.Incurable Neurodegenerative Diseases.

(a) An incurable neurodegenerative disease is a condition, injury, or illness:

(1) that occurs when nerve cells in the brain or peripheral nervous system lose function over time; and

(2) for which there is no known cure.

(b) A qualifying physician under Texas Occupations Code, Chapter 169, may prescribe low-THC cannabis to a patient with a documented diagnosis of one or more of the following incurable neurodegenerative diseases:

(1) Incurable Neurodegenerative Diseases with Adult Onset:

(A) Motor Neuron Disease:

(i) Amyotrophic lateral sclerosis;

(ii) Spinal-bulbar muscular atrophy; and

(iii) Spinal Muscular Atrophy.

(B) Muscular Dystrophies:

(i) Duchenne Muscular Dystrophy;

(ii) Central Core; and

(iii) Facioscapulohumeral Muscular Dystrophy.

(C) Freidreich's Ataxia.

(D) Vascular dementia.

(E) Charcot Marie Tooth and related hereditary neuropathies.

(F) Spinocerebellar ataxia.

(G) Familial Spastic Paraplegia.

(H) Progressive dystonias DYT genes 1 through 20.

(I) Progressive Choreas: Huntington's Disease.

(J) Amyloidoses:

(i) Alzheimer's Disease;

(ii) Prion Diseases:

(I) Creutzfeldt-Jakob Disease;

(II) Gerstmann-Straussler-Scheinker Disease;

(III) Familial or Sporadic Fatal Insomnia; and

(IV) Kuru.

(K) Tauopathies.

(i) Chronic Traumatic Encephalopathy:

(ii) Pick Disease;

(iii) Globular Glial Tauopathy;

(iv) Corticobasal Degeneration;

(v) Progressive Supranuclear Palsy;

(vi) Argyrophilic Grain Disease;

(vii) Neurofibrillary Tangle dementia, also known as Primary Age-related Tauopathy; and

(viii) Frontotemporal dementia and parkinsonism linked to chromosome 17 caused by mutations in MAPT gene.

(L) Synucleinopathies:

(i) Lewy Body Disorders:

(I) Dementia with Lewy Bodies; and

(II) Parkinson's Disease; and

(ii) Multiple System Atrophy.

(M) Transactive response DNA-binding protein-43 (TDP-43) Proteinopathies:

(i) Frontotemporal Lobar Degeneration;

(ii) Primary Lateral Sclerosis; and

(iii) Progressive Muscular Atrophy.

(2) Incurable Neurodegenerative Diseases with Pediatric Onset:

(A) Mitochondrial Conditions:

(i) Kearn Sayers Syndrome;

(ii) Mitochondrial Encephalopathy Ragged Red Fiber;

(iii) Mitochondrial Encephalopathy Lactic Acidosis Stroke;

(iv) Neuropathy, Ataxia, and Retinitis Pigmentosa;

(v) Mitochondrial neurogastrointestinal encephalopathy;

(vi) Polymerase G Related Disorders:

(I) Alpers-Huttenlocher syndrome;

(II) Childhood Myocerebrohepatopathy spectrum;

(III) Myoclonic epilepsy myopathy sensory ataxia; and

(IV) Ataxia neuropathy spectrum;

(vii) Subacute necrotizing encephalopathy, also known as Leigh syndrome;

(viii) Respiratory chain disorders complex 1 through 4 defects: Co Q biosynthesis defects;

(ix) Thymidine Kinase;

(x) Mitochondrial Depletion syndromes types 1 through 14:

(I) Deoxyguanisine kinase deficiency;

(II) SUCLG1-related mitochondrial DNA depletion syndrome, encephalomyopathic form with methylmalonic aciduria; and

(III) RRM2B-related mitochondrial disease.

(B) Creatine Disorders:

(i) Guanidinoacetate methytransferase deficiency;

(ii) L-Arginine/glycine amidinotransferase deficiency; and

(iii) Creatine Transporter Defect, also known as SLC 6A8.

(C) Neurotransmitter defects:

(i) Segawa Diease, also known as Dopamine Responsive Dystonia;

(ii) Guanosine triphosphate cyclohydrolase deficiency;

(iii) Aromatic L-amino acid decarboxylase deficiency;

(iv) Monoamine oxidase deficiency;

(v) Biopterin Defects:

(I) Pyruvoyl-tetahydropterin synthase;

(II) Sepiapterin reductase;

(III) Dihydropteridine reductase; and

(IV) Pterin-4-carbinolamine dehydratase.

(D) Congenital Disorders of Glycosylation.

(E) Lysosomal Storage Diseases:

(i) Mucopolysaccaridosis:

(I) Mucopolysaccharidosis Type I, also known as Hurler Syndrome or Scheie Syndrome;

(II) Mucopolysaccharidosis Type II, also known as Hunter Syndrome;

(III) Mucopolysaccharidosis Type III, also known as Sanfilippo A and B;

(IV) Mucopolysaccharidosis Type IV, also known as Maroteaux-Lamy; and

(V) Mucopolysaccharidosis Type VII, also known as Sly.

(ii) Oligosaccharidoses:

(I) Mannosidosis;

(II) Alpha-fucosidosis;

(III) Galactosialidosis;

(IV) Asparylglucosaminuria;

(V) Schindler; and

(VI) Sialidosis;

(iii) Mucolipidoses:

(I) Mucolipidoses Type II, also known as Inclusion Cell disease; and

(II) Mucolipidoses Type III, also known as pseudo-Hurler polydystrophy;

(iv) Sphingolipidoses:

(I) Gaucher Type 2 and Type 3;

(II) Neimann Pick Type A and B;

(III) Neimann Pick Type C;

(IV) Krabbe;

(V) GM1 gangliosidosis;

(VI) GM2 gangliosidosis also known as Tay-sachs and Sandhoff Disease;

(VII) Metachromatic leukodystrophy;

(VIII) Neuronal ceroid lipofuscinosis types 1-10 including Batten Disease; and

(IX) Farber Disease; and

(v) Glycogen Storage-Lysosomal: Pompe Disease.

(F) Peroxisomal Disorders:

(i) X-linked adrenoleukodystrophy;

(ii) Peroxisomal biosynthesis defects:

(I) Zellweger syndrome:

(II) Neonatal Adrenoleukodystrophy; and

(iii) D Bidirectional enzyme deficiency.

(G) Leukodystrophy:

(i) Canavan disease;

(ii) Pelizaeus-Merzbacher disease;

(iii) Alexander disease;

(iv) Multiple Sulfatase deficiency;

(v) Polyol disorders;

(vi) Glycine encephalopathy, also known as non-ketotic hyperglycinemia;

(vii) Maple Syrup Urine Disease;

(viii) Homocysteine re-methylation defects;

(ix) Methylenetetrahydrofolate reductase deficiency severe variant;

(x) L-2-hydroxyglutaric aciduria;

(xi) Glutaric acidemia type 1;

(xii) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;

(xiii) Galactosemia;

(xiv) Manosidosis alpha and beta;

(xv) Salidosis;

(xvi) Peripheral neuropathy types 1 through 4;

(xvii) Pyruvate Dehydrogenase Deficiency;

(xviii) Pyruvate Carboxylase Deficiency;

(xix) Refsum Disease; and

(xx) Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy.

(H) Fatty Acid Oxidation:

(i) Trifunctional protein deficiency; and

(ii) Long-chain L-3 hydroxyacyl-CoA dehydrogenase deficiency.

(I) Metal Metabolism:

(i) Wilson Disease;

(ii) Pantothenate Kinase Associated Neurodegeneration; and

(iii) Neurodegeneration with brain iron accumulation.

(J) Purine and Pyrimidine Defects:

(i) Adenylosuccinate synthase Deficiency;

(ii) 5-aminoimidazole-4-carboxamide ribonucleotide transformylase deficiency;

(iii) Hypoxanthine-guanine phosophoribosyltransferase Deficiency also known as Lesch-Nyhan disease;

(iv) Dihydropyrimidine dehydrogenase Deficiency; and

(v) Dihydropirimidinase Deficiency.

(c) A treating physician of a patient suffering from an incurable neurodegenerative disease not listed in subsection (b) of this section may submit a request to the department to have a disease added.

(d) A request under subsection (c) of this section shall be submitted to the department on a form prescribed by the department, which can be found on the department's website at https://www.dshs.texas.gov/chronic/default.shtm.

(e) After review of the submitted documentation, the department may request additional information or make a determination.

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 November 15, 2019.

TRD-201904262

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: December 5, 2019

Proposal publication date: September 27, 2019

For further information, please call: (512) 776-3829


SUBCHAPTER F. LICENSURE EXEMPTIONS

25 TAC §1.81

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts new §1.81, concerning Recognition of Out-of-State License of Military Spouse. New §1.81 is adopted with changes to the proposed text as published in the August 30, 2019, issue of the Texas Register (44 TexReg 4657) and will be republished.

BACKGROUND AND JUSTIFICATION

The adopted rule complies with Senate Bill (S.B.) 1200, 86th Legislature, Regular Session, 2019, to implement the legislation.

S.B. 1200 amended Texas Occupations Code, Chapter 55, by adding §55.0041 to authorize certain military spouses to engage in a business or occupation in the State of Texas without having a license issued in Texas. The rule requires the military spouse to be currently licensed and in good standing in another jurisdiction that has licensing requirements substantially equivalent to the requirements of a license in this state. State agencies are directed to adopt rules not later than December 1, 2019.

COMMENTS

The 31-day comment period following publication of the proposed changes ended on September 30, 2019. During this period, DSHS received two comments by email from individuals supporting the proposed rule.

Due to a DSHS' staff comment, §1.81(b) and (g) are revised to include "Texas Occupations Code" to include references to licenses issued under that Code subject to new §55.0041.

STATUTORY AUTHORITY

The new section is authorized by Texas Occupations Code, §55.0041 and Texas Government Code, §531.0055, which provides the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction.

§1.81.Recognition of Out-of-State License of Military Spouse.

(a) For the purposes of this section, the definitions in Texas Occupations Code, Chapter 55 are hereby adopted by reference.

(b) This section applies to all licenses issued by the Department of State Health Services (department) under authority granted by the applicable chapter of the Texas Health and Safety Code or Texas Occupations Code.

(c) Notwithstanding any other rule, a military spouse may engage in a business or occupation as if licensed in the State of Texas without obtaining the applicable license in Texas, if the spouse:

(1) is currently licensed in good standing by another jurisdiction that has licensing requirements substantially equivalent to the requirements of a license in this state;

(2) notifies the department of the spouse's intent to practice in this state;

(3) submits to the department proof of the spouse's residency in this state and a copy of the spouse's military identification card; and

(4) receives from the department a verification letter that:

(A) the department has verified the spouse's license in the other jurisdiction; and

(B) the spouse is authorized to engage in the business or occupation in accordance with the Texas Statutes and rules for that business or occupation.

(d) To receive a verification letter, the military spouse must submit:

(1) a request to the department for recognition, on a form prescribed by the department;

(2) proof of residency in this state;

(3) a copy of the military spouse's identification card; and

(4) proof the military service member is stationed at a military installation in Texas.

(e) Upon verification from the licensing jurisdiction of the military spouse's license and if the license is substantially equivalent to a Texas license, the department shall issue a verification letter recognizing the licensure as the equivalent license in this state.

(f) The verification letter will expire three years from date of issuance or when the military service member is no longer stationed at a military installation in Texas, whichever comes first. The verification letter may not be renewed.

(g) The military spouse shall comply with all applicable laws, rules, and standards of this state, including applicable Texas Health and Safety Code or Texas Occupations Code Chapters and all relevant Texas Administrative Code provisions.

(h) The department may revoke the verification letter at its discretion. Basis for revocation include:

(1) the military spouse fails to comply with subsection (g) of this section; or

(2) the military spouse's license required under subsection (c)(1) of this section expires or is suspended or revoked in another jurisdiction.

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 November 15, 2019.

TRD-201904263

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: December 5, 2019

Proposal publication date: August 30, 2019

For further information, please call: (512) 834-6748


CHAPTER 157. EMERGENCY MEDICAL CARE

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §157.33, concerning Certification; §157.34, concerning Recertification; and §157.125, concerning Requirements for Trauma Facility Designation. The amendments to §§157.33, 157.34, and 157.125 are adopted without changes to the proposed text as published in the September 20, 2019, issue of the Texas Register (44 TexReg 5361), and therefore will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments are necessary to comply with House Bill (H.B.) 871 and H.B. 1418, 86th Legislature, Regular Session, 2019, which requires HHSC to adopt rules to implement the legislation. H.B. 871 requires adoption of rules not later than December 1, 2019.

H.B. 871 amended Texas Health and Safety Code, §773.1151, which authorizes a hospital located in a county with a population of less than 30,000 to utilize telemedicine medical services to comply with the physician requirement for Level IV Trauma Designation. Section 157.125 adds text to comply with this legislation in the basic Level IV trauma facility criteria in the Figure for §157.125(y).

H.B. 1418 amended Texas Health and Safety Code, §773.0551, by requiring emergency medical services personnel receive up-to-date information about their immunization status during certification or recertification and also information about certain risks posed when responding to an emergency.

During Hurricane Harvey, lack of clarity for first responders concerning their vaccine history caused certain individuals to either duplicate previous vaccinations or be required to wait for vaccinations due to high demand for the vaccines in the disaster-declared region. Sections 157.33(l) and 157.34(d) add the applicant's immunization history, which require DSHS to provide the emergency medical services personnel their immunization status during certification or recertification. The amendments add that DSHS will provide information about the risks of exposure to certain vaccine preventable diseases when responding to an emergency that an immunization may prevent. The rule references in §157.33 and §157.34 are also revised to reflect the addition of new text.

COMMENTS

The 31-day comment period ended October 21, 2019.

During this period, DSHS did not receive any comments regarding the proposed rules.

SUBCHAPTER C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL

25 TAC §157.33, §157.34

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code, Chapter 773; and Texas Government Code §531.0055, which provides the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction.

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 November 15, 2019.

TRD-201904264

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: December 5, 2019

Proposal publication date: September 20, 2019

For further information, please call: (512) 834-6748


SUBCHAPTER G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS

25 TAC §157.125

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code, Chapter 773; and Texas Government Code §531.0055, which provides the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction.

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 November 15, 2019.

TRD-201904265

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: December 5, 2019

Proposal publication date: September 20, 2019

For further information, please call: (512) 834-6748