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Sarah Beth Smith


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Alternative Payment Models (APMs) Under MACRA Proposed Rule

USA - May 6 2016 Continuing our blog series on CMS's massive proposed rule for the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)...

Lauren Moldawer, Jordan T. Cohen, Thomas S. Crane.

Biosimilar Developments Continue at a Rapid Pace

USA - April 1 2016 As our regular readers know, we've been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments...

Joanne Hawana.

Recent HIPAA Updates from OCR

USA - March 7 2016 The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has been busy lately, issuing three news releases on the HIPAA...

Provider Confusion and Interoperability Concerns Prompt OCR and ONC to Release Guidance on PHI Sharing

USA - February 22 2016 Last Friday, the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT ("ONC") and the Office for Civil...

FDA Legal and Regulatory - 2015 Year In Review

USA - December 14 2015 Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight...

Joanne Hawana.