On May 17, 2016, FDA issued Draft Guidance for Industry on Use of Electronic Health Record Data in Clinical Investigations (“Draft Guidance”). This Draft Guidance builds on prior FDA guidance on Computerized Systems Used in Clinical Investigations and Electronic Source Data in Clinical Investigations, and provides information on FDA’s expectations for the use of
Life Sciences
House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation
By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady
The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from…
HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to Court Vacating Final Rule
By Constance Wilkinson, Alan Arville, and Jonathan Hoerner
On July 23, 2014, the Health Resources and Services Administration (“HRSA”) issued an “interpretive rule” entitled “Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities under the 340B Program” (the “Interpretive Rule”).[1] The Interpretive Rule follows the ruling by the U.S. District…
The Sunshine Act Also Rises: One More Chance for Medical Device Manufacturers to Prepare
By Robert E. Wanerman on
The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during…
Five Wishes for the Medicare Shared Savings Program Regulations
By Doug Hastings on
As the health care world awaits the Medicare Shared Savings Program regulations expected to be issued soon by CMS, below is a wish list for key attributes that I hope the regulations evidence:
1. Flexibility.
"Transforming health care everywhere starts with transforming it somewhere." I hope that CMS takes Atul Gawande’s advice and …