A bill

TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ADDING SECTION 44-6-120 SO AS TO REQUIRE THE SOUTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES, subject to federal approval, TO incluDE COVERAGE OF RAPID WHOLE GENOME SEQUENCING as a separately payable service FOR certain MEDICAID recipients; to require that the genetic data generated as a result of the sequencing be used only for specified purposes, with exceptions; to require the department to seek federal approval as needed to accomplish the purposes of this section; and for other purposes.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION 1.  Article 1, Chapter 6, Title 44 of the S.C. Code is amended by adding:

    Section 44-6-120.  (A) As used in this section, "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 which yields preliminary results within five days and the final results within fourteen days. The term includes patient-only whole genome sequencing and duo and trio whole genome sequencing of the patient and biological parent or parents.

    (B) Subject to any required approval of the Centers for Medicare and Medicaid Services, the department shall include coverage of rapid whole genome sequencing as a separately payable service for a Medicaid recipient who:

       (1) is twenty-one years of age or younger;

       (2) has a complex or acute illness of unknown etiology which is confirmed not to have been caused by an environmental exposure, a toxic ingestion, an infection with normal response to therapy, or trauma; and

       (3) is receiving inpatient hospital services in an intensive care unit or a high-acuity pediatric care unit.

    (C)(1) Except as specified in item (2), genetic data generated as a result of performing rapid whole-genome sequencing covered by this section must be used only to assist the ordering health care professional and treating care team in diagnosing and treating the patient. As protected health information, this patient genetic data is subject to the privacy provisions of the federal Health Insurance Portability and Accountability Act of 1996 and its implementing regulations.

       (2) Genetic data generated from rapid whole genome sequencing covered under this section may be used in scientific research if the patient, or the patient's legal guardian if the patient is a minor, has given express consent for that use of the data. A patient or patient's legal guardian, as applicable, has the right to rescind the original consent to the use of the data in scientific research at any time, and upon receipt of a written revocation of the consent, the health care provider or other entity using the data must cease its use of the data and expunge the data from any data repository where it is held.

    (D) The department shall seek approval to amend current waivers, request a new waiver, and amend contracts as necessary to provide for coverage of services under this section.

    (E) The department may promulgate regulations to implement this section.

SECTION 2.  This act takes effect upon approval by the Governor.

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