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MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

USA - January 27 2016 MedPAC proposes changes that would reduce Medicare Part B spending on 340B drugs by 10 percent, reallocating almost $300 million to pay for…

Eric Zimmerman

Anticipated framework for regulatory oversight of laboratory developed tests

USA - August 6 2014 Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory-developed tests (LDTs)…

Paul W. Radensky, Michael W. Ryan, Eric Zimmerman

Sweeping changes to Medicare payment for clinical laboratory services

USA - April 1 2014 On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services.  The House approved the Act on March 27, and the president is expected to sign the legislation.

Paul W. Radensky, Eric Zimmerman

HHS and GAO reports highlight need to address drug shortages

USA - March 25 2014 Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively…

Michael W. Ryan

CMS take steps to modernize clinical lab policies

USA - February 11 2014 Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare…

Paul W. Radensky, Eric Zimmerman