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Congress
FDA Issues Guidance on REMS
With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did…
HHS Releases Regulations on Alternative Pay Models in Last Weeks of Current…
Despite Republicans’ call for a suspension on new rules, the Department of Health and Human Services (HHS) pushed regulations…
OIG Issues Semiannual Report to Congress
The Department of Health and Human Services (HHS) issued its Semiannual Report to Congress, covering April 1, 2016 to September…
AHR Holds Congressional Briefing Focused on Cost Growth
The Alliance for Health Reform recently held a Congressional briefing about cost growth of pharmaceuticals in the Medicare program…
Tandem Price Increases: Legal or Price Fixing?
An article by reporters at Bloomberg recently highlighted the way United States prosecutors are beginning to crack down on generic…
21st Century Bill Headed to President Obama’s Desk
Nearly three years after its initial introduction, the 21st Century Cures Act has finally passed both houses of the Congress, and…
21st Century Cures No Longer Includes Open Payments Exemption for Reprints,…
We previously wrote about the updated version of the 21st Century Cures bill – one that we, along with many others, thought would…
21st Century Cures Update – Includes Exemption for Education in Open…
When lawmakers head back to Washington, D.C. this week, one of the votes they have ahead of themselves is the 21st Century Cures…
Leahy, Wyden Send Letter to DOJ Regarding DEA Enforcement Actions
Recently, the ranking members of the Judiciary and Finance Committees, Senators Patrick Leahy and Ron Wyden, respectively, raised…
Congressional Leaders Question CMS Handling of Medicare Fraud
Leaders of three congressional committees have raised concerns about how the Centers for Medicare and Medicaid Services…