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Texas Drafts Definition for Incurable Neurodegenerative Diseases That Qualify for Medical Cannabis

Texas Department of Health & Human Services Posts Draft Definition for “Incurable Neurodegenerative Diseases” to Qualify for Medical Cannabis Program AUSTIN, Texas—Nov. 6, 2019—In June of 2019 the Texas Legislature approved an expansion of the state’s medical cannabis program, known as the Compassionate Use Program (CUP), as signed into law by Governor Abbott. Previous to expansion, only patients with intractable epilepsy qualified for the program. The law’s expansion achieved multiple feats, including relaxing some barriers to obtaining prescriptions to those who previously qualified under the narrower version, and opening up accessibility to new patients by adding additional qualifying conditions to the approved list. Under the passage of HB 3703, patients with all forms of epilepsy and other seizure disorders, as well as patients with multiple sclerosis, amyotrophic lateral sclerosis (ALS), spasticity, autism, terminal cancer, and incurable neurodegenerative diseases can qualify for a medical cannabis prescription. At the time of the passage of the bill, “incurable neurodegenerative diseases” was yet to be clearly defined, with a deadline of December 1, 2019 to clarify the exact conditions that would qualify under this umbrella term. Recently, the Executive Commissioner of the Texas Department of Health & Human Services Commission posted a draft definition for what would qualify as “incurable neurodegenerative diseases.” To keep patients and physicians apprised of changes to Texas’s medical cannabis program, we are posting a copy of this draft below. Sign up for our email list here, to stay up-to-date with program updates as they unfold. Tip: To quickly check if a specific condition is covered on the draft, press “CTRL + F” (or “⌘ + F” for Mac) on your keyboard and begin typing the name of the condition. —————— DEPARTMENT OF STATE HEALTH SERVICES MISCELLANEOUS PROVISIONS DESIGNATING 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) Freidrich’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-Strausller-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-Huttenlodcher 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, encephalmyopathic 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;
    - (I) 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; and
    - (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;
  - (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. —————— Compassionate Cultivation made Texas history when it opened its doors in February 2018 as the state’s first retail dispensary. The Texas-based company is one of three businesses licensed by the Texas Department of Safety to grow cannabis and process it into low-THC formulations of medical cannabis products. ### About Compassionate Cultivation Compassionate Cultivation is the leading medical cannabis company in the state of Texas. Headquartered in Manchaca, southwest of Austin, the company is the only 100 percent Texan-owned and operated medical cannabis company serving patients throughout America’s second-most populous state. Compassionate Cultivation is dedicated to representing the integrity of this great state and helping patients and families in need—and the physicians prescribing their cannabis-based medicine. For more information, please visit texasoriginal.com. Follow us on Facebook, Instagram and Twitter for news and updates on Texas medical cannabis.

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