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Results: 1-10 of 905

CMS Revises Medicare Part B Biosimilar Coding and Payment Policies
  • Covington & Burling LLP
  • USA
  • November 8 2017

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services ("CMS") released two final rules addressing changes to Medicare Part B


FDA Improving Regulatory Oversight of Stem Cell Therapies and Regenerative Medicine Products
  • Haynes and Boone LLP
  • USA
  • November 8 2017

Regenerative medicine is a burgeoning interdisciplinary research field aiming to offer new therapies that replace or regenerate human cells, tissues


OIG Wants CMS to Track Medicare Costs from Device Failures
  • Reed Smith LLP
  • USA
  • October 27 2017

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates


OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement
  • Cooley LLP
  • USA
  • October 17 2017

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications


CNN Investigates Expanding Use of Nuedexta in Nursing Homes
  • Stark & Stark
  • USA
  • October 16 2017

A recent investigation by CNN brought to light the expanding and allegedly inappropriate use of the prescription drug Nuedexta in nursing homes


Life Sciences: Compliance and enforcement in the USA
  • Perkins Coie LLP
  • USA
  • October 11 2017

A structured guide to compliance and dishonest practices in the USA


FDA Requires Pharma Companies to Certify Drug Listing Info
  • Arent Fox LLP
  • USA
  • October 6 2017

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The


Washington Healthcare Update - Sep 25, 2017
  • McGuireWoods LLP
  • USA
  • September 25 2017

On Sept. 20, the Congressional Diabetes Caucus Chairs Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) sent a letter to FDA Commissioner Scott Gottlieb


Open Season for FCA Relators? Ninth Circuit Finds Falsity in Gilead Case Despite Possible Discrepancy with Sister Court
  • Vinson & Elkins LLP
  • USA
  • September 5 2017

We’re back with our second installment on the Ninth Circuit’s decision in United States ex. Rel. Campie v. Gilead Sciences, Inc., No. 15-16380, 2017


Washington Healthcare Update - Aug 14, 2017
  • McGuireWoods LLP
  • USA
  • August 14 2017

Thirty-one Democratic Senators have written CMS Administrator Seema Verma urging her to drop a proposed rule that would require prospective patients