{"data":{"id":"us-ok/okla.-stat.-tit.-56-56-4005","jurisdiction":"us-ok","citation":"Okla. Stat. tit. 56, § 56-4005","heading":"Rapid whole genome sequencing coverage","body":"A. For purposes of this section, \"rapid whole genome\n\nsequencing\" is defined as an investigation of the entire human\n\ngenome, including coding and non-coding regions and mitochondrial\n\ndeoxyribonucleic acid, to identify disease-causing genetic changes\n\nthat returns the preliminary positive results within seven (7) days\n\nand final results within fifteen (15) to twenty-one (21) days from\n\nthe date of receipt of the sample by the lab performing the test,\n\nand includes patient-only whole genome sequencing (WGS) and duo and\n\ntrio whole genome sequencing of the patient and biological parent or\n\nparents.\n\nB. Subject to any required approval of the Centers for Medicare\n\nand Medicaid Services, the Oklahoma Health Care Authority shall\n\ninclude coverage of rapid whole genome sequencing as a separately\n\npayable service for Medicaid beneficiaries when all of the following\n\ncriteria are met:\n\n1. Beneficiary is under twenty-one (21) years of age;\n\n2. Beneficiary has a complex or acute illness of unknown\n\netiology, that is not confirmed to be caused by an environmental\n\nexposure, toxic ingestion, infection with normal response to\n\ntherapy, or trauma; and\n\n3. Beneficiary is receiving hospital services in an intensive\n\ncare unit or other high acuity care unit within a hospital.\n\nC. The coverage provided pursuant to this section may be\n\nsubject to applicable evidence-based medical necessity criteria that\n\nshall be based on all of the following:\n\n1. The patient has symptoms that suggest a broad differential\n\ndiagnosis that would require an evaluation by multiple genetic tests\n\nif rapid whole genome sequencing is not performed;\n\n2. The patient's treating health care provider has determined\n\nthat timely identification of a molecular diagnosis is necessary to\n\nguide clinical decision-making and testing results may guide the\n\ntreatment or management of the patient's condition; and\n\n3. The patient has a complex or acute illness of unknown\n\netiology, including at least one of the following conditions:\n\na. congenital anomalies involving at least two organ\n\nsystems or complex and multiple congenital anomalies\n\nin one organ system,\n\nb. specific organ malformations highly suggestive of a\n\ngenetic etiology,\n\nc. abnormal laboratory tests or abnormal chemistry\n\nprofiles suggesting the presence of a genetic disease,\n\ncomplex metabolic disorder, or inborn error of\n\nmetabolism,\n\nd. refractory or severe hypoglycemia or hyperglycemia,\n\ne. abnormal response to therapy related to an underlying\n\nmedical condition affecting vital organs or bodily\n\nsystems,\n\nf. severe muscle weakness, rigidity, or spasticity,\n\ng. refractory seizures,\n\nh. a high-risk stratification on evaluation for a brief\n\nresolved unexplained event with any of the following:\n\n(1) a recurrent event without respiratory infection,\n\n(2) a recurrent event witnessed seizure-like event,\n\nor\ne to therapy related to an underlying\n\nmedical condition affecting vital organs or bodily\n\nsystems,\n\nf. severe muscle weakness, rigidity, or spasticity,\n\ng. refractory seizures,\n\nh. a high-risk stratification on evaluation for a brief\n\nresolved unexplained event with any of the following:\n\n(1) a recurrent event without respiratory infection,\n\n(2) a recurrent event witnessed seizure-like event,\n\nor\n\n(3) a recurrent cardiopulmonary resuscitation,\n\ni. abnormal cardiac diagnostic testing results suggestive\n\nof possible channelopathies, arrhythmias,\n\ncardiomyopathies, myocarditis, or structural heart\n\ndisease,\n\nj. abnormal diagnostic imaging studies suggestive of an\n\nunderlying genetic condition,\n\nk. abnormal physiologic function studies suggestive of an\n\nunderlying genetic etiology, or\n\nl. family genetic history related to the patient's\n\ncondition.\n\nD. Nothing in this section prohibits the Chief Operating\n\nOfficer of the Oklahoma Health Care Authority from adding additional\n\nconditions to those contained in paragraph 3 of subsection C of this\n\nsection based upon new medical evidence or from providing coverage\n\nfor rapid whole genome sequencing or other next generation\n\nsequencing (NGS) and genetic testing for Medicaid beneficiaries that\n\nis in addition to the coverage required under this section.\n\nE. Genetic data generated as a result of performing rapid whole\n\ngenome sequencing, covered pursuant to this section, shall have a\n\nprimary use of assisting the ordering health care professional and\n\ntreating care team to diagnose and treat the patient, and as\n\nprotected health information, it shall be subject to the\n\nrequirements applicable to protected health information as set forth\n\nin the Health Information Portability and Accountability Act\n\n(HIPAA), the Health Information Technology for Economic and Clinical\n\nHealth Act, and their attendant regulations, including, but not\n\nlimited to, the HIPAA privacy rule as promulgated at 45 CFR, Part\n\n160 and Subparts A and E of 45 CFR, Part 164.\n\nF. Genetic data generated from rapid whole genome sequencing,\n\ncovered pursuant to this section, can be used in scientific research\n\nif consent for such use of the data has been expressly given by the\n\npatient, or the patient's legal guardian in the case of a minor.\n\nThe patient, the patient's legal guardian in the case of a minor, or\n\nthe patient's health care provider with the patient's consent, may\n\nrequest access to the results of the testing covered by this section\n\nfor use in other clinical settings. A health care provider may only\n\ncharge a small fee to the patient based on the direct costs of\n\nproducing the results in a format usable in other clinical settings.\n\nA patient, or patient's legal guardian in the case of a minor, shall\n\nhave the right to rescind the original consent to the use of the\n\ndata in scientific research at any time, and upon receipt of a\n\nwritten revocation of the consent, the health care provider or other\n\nentity using the data shall cease use and expunge the data from any\n\ndata repository where it is held.\n\nG. The Chief Operating Officer of the Oklahoma Health Care\n\nAuthority shall take any actions necessary to implement the\n\nprovisions of this section, which may include, if deemed necessary,\n\nthe following:\n\n1. Promulgation of rules and regulations to provide for\n\nMedicaid coverage pursuant to this section;\n\n2. Submission to the Centers for Medicare and Medicaid Services\n\nof any new waiver application, amendment to an existing waiver, or\n\nMedicaid state plan amendment necessary to ensure federal financial\n\nparticipation for Medicaid coverage pursuant to this section; or\n\n3. Any other administrative action determined by the Chief\n\nOperating Officer as necessary to implement the requirements of this\n\nsection.","path":["OK Code","Title 56"],"source_url":"https://www.oklegislature.gov/OK_Statutes/CompleteTitles/os56.pdf","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:36Z","sha256":"fc7da193c4f300e6c5e1fca87b2fda125540c319a0594d51cb086139817310c3","source_id":"us-ok","stale":false,"prev":"us-ok/okla.-stat.-tit.-56-56-4004","next":"us-ok/okla.-stat.-tit.-56-56-4006"},"notice":"GroundRules: Original legal text. Not legal advice."}