88R8031 JG-D
By: A. Johnson of Harris H.B. No. 2641
A BILL TO BE ENTITLED
AN ACT
relating to Medicaid coverage and reimbursement for the provision
of rapid whole genome sequencing to certain infants with acute or
complex illnesses.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter B, Chapter 32, Human Resources Code,
is amended by adding Section 32.03125 to read as follows:
Sec. 32.03125. REIMBURSEMENT FOR RAPID WHOLE GENOME
SEQUENCING. (a) In this section:
(1) "Rapid whole genome sequencing" means an
investigation of the entire human genome, including coding and
noncoding regions and mitochondrial deoxyribonucleic acid, to
identify disease-causing genetic changes that returns preliminary
positive results not later than the fifth day after the date the
sequencing is ordered and final results not later than the 14th day
after the date the sequencing is ordered. The term includes
patient-only whole genome sequencing and duo and trio whole genome
sequencing of the patient and a biological parent or parents of the
patient.
(2) "Recipient" means a medical assistance recipient.
(b) The commission shall ensure medical assistance
reimbursement is provided for the provision of rapid whole genome
sequencing in accordance with this section to a recipient who:
(1) is younger than one year of age;
(2) has a complex or acute illness of unknown origin
that is not confirmed to be caused by:
(A) an environmental exposure;
(B) a toxic ingestion;
(C) an infection with a normal response to
therapy; or
(D) trauma; and
(3) is receiving inpatient hospital treatment in an
intensive care unit or high acuity pediatric care unit.
(c) The executive commissioner by rule shall establish a
medical assistance program reimbursement rate for the provision of
rapid whole genome sequencing to a recipient by a genome sequencing
provider.
(d) The provision of rapid whole genome sequencing may be
subject to applicable evidence-based utilization review required
by the commission that is based on whether:
(1) the recipient's symptoms suggest a broad
differential diagnosis that would require an evaluation by multiple
genetic tests if comprehensive genetic testing is not performed;
(2) the recipient's treating genome sequencing
provider determines that a timely identification of a molecular
diagnosis is necessary to guide clinical decision-making and
testing results may guide the treatment or management of the
recipient's condition; and
(3) the recipient has a complex or acute illness of
unknown origin that includes at least one of the following:
(A) congenital anomalies involving at least two
organ systems or complex or multiple congenital anomalies in one
organ system;
(B) specific organ malformations highly
suggestive of a genetic origin;
(C) abnormal laboratory tests or abnormal
chemistry profiles suggesting the presence of a genetic disease,
complex metabolic disorder, or inborn error of metabolism,
including an abnormal newborn screen, hyperammonemia, or severe
lactic acidosis not due to poor perfusion;
(D) refractory or severe hypoglycemia or
hyperglycemia;
(E) abnormal response to therapy related to an
underlying medical condition affecting vital organs or bodily
systems;
(F) severe muscle weakness, rigidity, or
spasticity;
(G) refractory seizures;
(H) high-risk stratification on evaluation for a
brief resolved unexplained event with:
(i) a lack of coordination;
(ii) a recurrent event without respiratory
infection;
(iii) a recurrent witnessed seizure-like
event; or
(iv) a recurrent cardiopulmonary
resuscitation;
(I) abnormal cardiac diagnostic testing results
suggestive of possible channelopathies, arrhythmias,
cardiomyopathies, myocarditis, or structural heart disease;
(J) abnormal diagnostic imaging studies
suggestive of an underlying genetic condition such as a storage
disorder or brain white matter disease;
(K) abnormal physiologic function studies
suggestive of an underlying genetic origin such as a bleeding
disorder or immune deficiency disorder; or
(L) family genetic history related to the
recipient's condition.
(e) Except as provided by Subsection (g), genetic data
created as a result of rapid whole genome sequencing provided in
accordance with this section must primarily be used to assist the
genome sequencing provider who ordered the test and other health
care providers treating the recipient who is the subject of the
sequencing in the diagnosis and treatment of the recipient.
(f) Genetic data described by Subsection (e) is subject to
the requirements applicable to protected health information under
the Health Insurance Portability and Accountability Act of 1996
(Pub. L. No. 104-191), the American Recovery and Reinvestment Act
of 2009 (Pub. L. No. 111-5), and the rules adopted under those laws,
including 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subparts A and
E.
(g) A person may use genetic data described by Subsection (e)
in scientific research if the person receives express consent for
that use by the recipient or the recipient's parent, legal
guardian, or managing conservator if the recipient is a minor. The
recipient or recipient's parent, legal guardian, or managing
conservator may provide a written revocation of that consent to the
person at any time, and the person shall cease using the data and
expunge the data from the person's data repository immediately on
receipt of the revocation.
(h) A recipient or the recipient's parent, legal guardian,
or managing conservator if the recipient is a minor may request
access to the results of rapid whole genome sequencing authorized
under this section for use in other clinical settings.
SECTION 2. If before implementing any provision of this Act
a state agency determines that a waiver or authorization from a
federal agency is necessary for implementation of that provision,
the agency affected by the provision shall request the waiver or
authorization and may delay implementing that provision until the
waiver or authorization is granted.
SECTION 3. This Act takes effect September 1, 2023.