Regulatory Transactions

From: Vox

Two new rules could make sure more kidneys go to recipients who need them.

By Dylan Matthews

From: The Hill

By Peter Sullivan

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The Department of Health and Human Services (HHS) sent to the White House for review a proposal to lower certain drug prices in Medicare by linking them to the lower prices paid in other countries, an idea called the international pricing index.

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It is unclear how long the process of White House review will take, and whether the White House will seek to make significant changes to the proposal

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Editor’s Note: For a history of the use of the DQA to seek relief from federal dissemination of inaccurate information concerning the medical use of cannabis, see Americans for Safe Access Data Quality Act Briefs and Replies. To see the power of the DQA to change a DEA scheduling decision, see Jim Tozzi’s Role in Stopping the DEA from Classifying Drug in Schedule 1 Status.

From: Marijuana Moment

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From: Lexology

Elizabeth B. Carder-Thompson and Debra A. McCurdy | Reed Smith LLP

The White House Office of Management and Budget (OMB) is reviewing a long-awaited Trump Administration proposed rule to amend the safe harbors to the Anti-Kickback Statute (AKS) and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute to better support coordinated care. The proposed rule presumably builds on the related request for information (RFI) on this topic issued by the Office of Inspector General (OIG) of the Department of Health Human Services (HHS) in August 2018. As discussed in a Reed Smith client alert, the RFI sought information on, among other things, changes needed in current safe harbors and beneficiary inducement CMPs to promote beneficial care coordination, patient engagement, and value-based arrangements.