This bill requires TennCare, subject to any required approval of the federal centers for medicare and medicaid services (CMS), to cover rapid whole genome sequencing as a separately payable service for beneficiaries when the following conditions are met:
(1) The beneficiary is under 21;
(2) The beneficiary has a complex or acute illness of unknown etiology, that is not confirmed to be caused by an environmental exposure, a toxic ingestion, an infection with normal response to therapy, or trauma; and
(3) The beneficiary is receiving hospital services in an intensive care unit or other high-acuity care unit within a hospital.
As used in this bill, "rapid whole genome sequencing" means an investigation of the entire human genome to identify disease-causing genetic changes that returns the preliminary positive results within seven days and final results within 15 days from the date of receipt of the sample by the lab performing the test.
COVERAGE SUBJECT TO EVIDENCE-BASED MEDICAL NECESSITY CRITERIA
Coverage provided pursuant to this bill is subject to applicable evidence-based medical necessity criteria that must include the following:
(1) 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;
(2) The patient has a determination from the patient's treating healthcare provider that timely identification of a molecular diagnosis is necessary to guide clinical decision-making and testing results may guide the treatment or management of the patient's condition; and
(3) The patient has a complex or acute illness of unknown etiology, including 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 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) 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 with: a recurrent event without respiratory infection, recurrent witnessed 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 suggestive of an underlying genetic condition;
(K) Abnormal physiologic function studies suggestive of an underlying genetic etiology; or
(L) Family genetic history related to the patient's condition.
This bill allows the bureau of TennCare to add additional conditions to those mentioned in (3) above, based upon new medical evidence or from providing additional coverage for rapid whole genome sequencing or other next-generation sequencing and genetic testing for medicaid beneficiaries.
GENETIC DATA SUBJECT TO FEDERAL LAW RELATIVE TO HEALTH AND PRIVACY
Genetic data generated from rapid whole genome sequencing covered pursuant to this bill has a primary use of assisting the ordering healthcare provider and treating care team to diagnose and treat the patient, and as protected health information, is subject to the requirements set forth in HIPAA and the federal Health Information Technology for Economic and Clinical Health Act (HITECH).
Notwithstanding the foregoing provision, genetic data generated from rapid whole genome sequencing covered pursuant to this bill may be used in scientific research if consent for use of the data has been expressly given by the patient, or the patient's legal guardian in the case of a minor. The patient, the patient's legal guardian, or the patient's healthcare provider with the patient's consent may request access to the results of the testing covered by this bill for use in other clinical settings. A healthcare provider may charge a fee based on the costs of producing the results to the extent allowed under the law relative to medical records. A patient or patient's legal guardian has the right to rescind consent given pursuant to this provision for use of the data in scientific research at any time, and upon receipt of a written revocation of the consent, the healthcare provider or other entity using the data must cease use and expunge the data from each data repository where the data is held.
TENNCARE AUTHORITY TO EFFECTUATE THIS BILL
This bill authorizes the bureau of TennCare to promulgate rules and take necessary administrative action to effectuate this bill. The bureau of TennCare is authorized to submit to CMS new waiver applications and amendments to existing waivers necessary to ensure federal financial participation for medicaid coverage pursuant to this bill.
ON APRIL 15, 2024, THE SENATE ADOPTED AMENDMENT #1 AND PASSED SENATE BILL 1762, AS AMENDED.
AMENDMENT #1 rewrites this bill to make changes to the present law with regard to approved medical assistance to be provided to those classes of individuals eligible under TennCare.
Present law requires medical assistance, including demonstration projects and programs designed to enhance the efficient and economic operation of the TennCare program, to be provided to those classes of individuals determined to be eligible under TennCare. Present law provides a number of specific kinds of services that constitute such medical assistance, in the amount, scope, and duration determined by the commissioner of health and to the extent permitted by federal law. This amendment adds rapid whole genome sequencing to such list in present law.
As used in this amendment, "rapid whole genome sequencing" means an investigation of the entire human genome, including coding and non-coding regions and mitochondrial deoxyribonucleic acid, to identify disease-causing genetic changes that returns the preliminary positive results within seven days and final results within 15 days from the date of receipt of the sample by the lab performing the test. The term also includes patient-only whole genome sequencing, duo whole genome sequencing of the patient and one biological parent, and trio whole genome sequencing of the patient and both biological parents.