RD154 - The Virginia Newborn Screening Advisory Committee’s Report to the State Health Commissioner and Virginia Board of Health on the Addition of Krabbe Disease to the Virginia Newborn Screening Panel – December 29, 2020

Executive Summary:

During the 2020 General Assembly Session, HB97 (Patron: Delegate Jason Miyares) was introduced proposing the addition of “…Krabbe Disease and all other lysosomal storage disorders for which a screening test is available…" to the Virginia Newborn Screening Panel. The proposed language was to be added to the Code of Virginia, specifically section 32.1-65. The estimated fiscal impact was $3,551,838 for Year 1 and $3,379,838 each year thereafter. HB97 was amended with a substitute, which required the Virginia Department of Health (VDH) to initiate a review of Krabbe Disease and provide recommendations to the Board of Health regarding whether Krabbe Disease should be included on Virginia’s newborn screening panel. The substitute bill was adopted and passed in both the House and the Senate.

Section 32.1-65 of the Code of Virginia states that “every infant who is born in the Commonwealth shall be subjected to screening tests for various disorders consistent with, but not necessarily identical to, the uniform condition panel recommended by the U.S. Secretary of Health and Human Services and the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children" (ACHDNC). For future reference in this document, the uniform screening panel is also known and referred to as the Recommended Uniform Screening Panel (RUSP).

The specific screening tests that are included in Virginia’s panel are defined in the Virginia Administrative Code 12VAC5-71-30 Core Panel of Heritable Disorders and Genetic Diseases. Currently, the Virginia newborn screening regulations cover 31 of 33 dried blood spot (DBS) disorders that are included in the RUSP. The remaining two disorders of the 33 DBS disorders on the RUSP, spinal muscular atrophy (SMA) and X-linked adrenoleukodystrophy (X-ALD), are currently in the regulatory process to be added to Virginia’s core newborn screening panel with implementation planned for 2021.

Section 12VAC5-71-30 also outlines the process by which disorders are added to Virginia’s panel. This process requires disorders being considered for addition to Virginia’s core panel to be reviewed by the Virginia Genetics Advisory Committee (VAGAC), also known at this time as the Virginia Newborn Screening Advisory Committee. This process results in a formal report to the Board of Health through the State Health Commissioner. VDH staff informed Delegate Miyares of this process at the start of the 2020 General Assembly Session.