14 Aug 2025

🩺HRSA Considers Adding MLD to Newborn Screening Panel

Notice With Request for Comment: Consideration of Adding Metachromatic Leukodystrophy to the Recommended Uniform Screening Panel

Summary

HRSA is considering recommending to the Secretary the addition of Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non- grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, co-insurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of MLD within the newborn period, the ability of state newborn screening programs to screen for MLD, and the availability of effective treatments for MLD. In deciding whether to provide recommendations to the Secretary supporting the addition of MLD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.

Agencies

  • Health and Human Services Department
  • Health Resources and Services Administration

Business Impact ?

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The notice involves potential regulatory changes requiring health plans to cover screenings for Metachromatic Leukodystrophy (MLD) without cost-sharing, which could lead to increased operational costs for businesses offering health insurance. Compliance with new screening mandates could impact profitability and operational procedures for healthcare providers and insurers.

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