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Lilly Addresses AHA Concerns on 340B Program Changes

Key highlights
  • Lilly extends claims data collection to all pharmacy purchases as of January 15.
  • The change aims to prevent fraud, waste, and abuse in the 340B program.
  • Lilly's actions align with agency guidance and federal court rulings.
  • The data collection uses existing data, imposing no new burdens on 340B entities.

Claims Data Collection Expansion

On January 15, Lilly announced the extension of its claims data collection to encompass all pharmacy purchases. This move is part of Lilly's effort to ensure that the 340B program's reduced prices benefit vulnerable patients and are not misused by hospitals and their for-profit partners.

Addressing Fraud and Abuse

The expanded data collection aims to combat fraud, waste, and abuse within the 340B program, which negatively impacts employers, state and federal governments, and patients. Lilly's approach aligns with longstanding agency guidance and rulings from two federal courts of appeals, affirming that manufacturers can lawfully collect claims data to identify fraud, abuse, and unlawful duplicate discounts.

Impact on 340B Entities

This data collection initiative does not impose new burdens on 340B entities, as it utilizes data that is already available and routinely submitted to insurers by these entities.

Response to AHA's Criticism

The American Hospital Association (AHA) has criticized Lilly's change, claiming it is illegal and burdensome. However, Lilly argues that AHA's opposition is an attempt to conceal abuse within the 340B program, from which hospitals profit. Lilly urges AHA to support policies that enhance compliance, transparency, and the sustainability of the 340B program, prioritizing patient care over profit.