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ARIZONA STATE SENATE
Fifty-Sixth Legislature, First Regular Session
AHCCCS; rapid genome sequencing
Purpose
Requires the Arizona Health Care Cost Containment System (AHCCCS) to provide coverage of rapid whole genome sequencing as a separately payable service for members if the member meets all outlined criteria, subject to any required approval by the Centers for Medicare and Medicaid Services (CMS).
Background
AHCCCS contracts
with health professionals to provide medically necessary health and medical
services to eligible members. Currently, AHCCCS contractors are required to
provide:
1) inpatient and outpatient hospital services; 2) laboratory and X-ray
services; 3) prescription medications; 4) medical supplies, durable medical
equipment, insulin pumps and prosthetic devices, excluding cochlear implants;
5) treatment of medical conditions of the eye; 6) early and periodic health
screening and diagnostic services; 7) family planning services; 8) podiatry
services; 9) nonexperimental transplants; 10) emergency dental care; 11)
ambulance and nonambulance transportation; 12) hospice care; 13) orthotics; and
14) diabetes outpatient self-management training services (A.R.S.
§ 36-2907).
Whole genome sequencing is increasingly being used in healthcare and research to identify genetic variations and additionally allows for rapid sequencing of large amounts of DNA. Research has found that DNA variations can affect gene activity and protein production that may lead to genetic disorders. Whole genome sequencing determines the order of all the nucleotides in an individual's DNA and can determine variations in any part of the genome (National Library of Medicine).
If there is a cost associated with providing rapid whole genome sequencing through AHCCCS, there may be a fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Requires AHCCCS to provide coverage of rapid whole genome sequencing, subject to any required CMS approval, as a separately payable service if the member:
a) is under one year of age;
b) has a complex or acute illness of unknown etiology that is not confirmed to be caused by an environmental exposure, toxic ingestion, infection with normal response to therapy or trauma; and
c) is receiving inpatient hospital services in an intensive care unit or a high acuity pediatric care unit.
2. Specifies
the rapid whole genome sequencing coverage may be subject to applicable
evidence-based medical necessity criteria that are based on whether:
a) the patient has symptoms that suggest a broad differential diagnosis that would require an evaluation by multiple genetic tests if rapid whole genome sequencing is not performed;
b) the patient's treating health care provider determines that timely identification of a molecular diagnosis is necessary to guide clinical decision-making and that testing results may guide the treatment or management of the patient's condition; or
c) the patient has a complex or acute illness of unknown etiology, including outlined conditions.
3. Lists the following conditions as complex or acute illnesses of unknown etiology that may qualify a patient for rapid whole genome sequencing coverage:
a) congenital anomalies involving at least two organ systems or complex or multiple congenital anomalies in one organ system;
b) specific organ malformations suggestive of a genetic etiology;
c) abnormal laboratory tests or abnormal chemistry profiles suggesting the presence of a genetic disease, complex metabolic disorder or inborn error of metabolism;
d) refractory or severe hypoglycemia or hyperglycemia;
e) an 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) a high-risk stratification on evaluation for a brief resolved unexplained event, including a recurrent event without respiratory infection, a recurrent seizure-like event or 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 or physiologic function studies suggestive of an underlying genetic condition or etiology; and
k) family genetic history related to the patient's condition.
4. Requires the genetic data generated as a result of performing rapid whole genome sequencing to have a primary use of assisting the ordering health care professional and treating care team to diagnose and treat the patient.
5. Specifies that genetic data generated as a result of performing rapid whole genome sequencing is protected health information that is subject to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health Act and their attendant regulations, including HIPAA Privacy Standards.
6. Requires the AHCCCS Director to submit any new waiver application, amendment to an existing waiver or Medicaid state plan amendment necessary for CMS approval of rapid whole genome sequencing coverage.
7. Allows the AHCCCS Director to adopt any rules or take any other administrative action necessary to implement rapid whole genome sequencing coverage.
8. Defines rapid whole genome sequencing as an investigation of the entire human genome, including coding and noncoding regions and mitochondrial deoxyribonucleic acid that identifies disease-causing genetic changes and returns the preliminary positive results within five days and final results within 14 days.
9. Specifies that rapid whole genome sequencing includes patient-only whole genome sequencing and duo and trio whole genome sequencing of the patient and the patient's biological parent or parents.
10. Becomes effective on the general effective date.
House Action
HHS 2/6/23 DP 9-0-0-0
3rd Read 2/22/23 59-0-1
Prepared by Senate Research
March 10, 2023
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