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Reminder: Pharma Manufacturers Now Required to Report Average Sales Price (ASP) Data for Part B Drugs Via New System
  • Arent Fox LLP
  • USA
  • April 23 2018

As discussed in a prior blog post, pharmaceutical manufacturers whose drugs are reimbursed under Medicare Part B must now report certain product and

HRSA Seeks Fifth Delay of Final Rule on 340B Pricing and Manufacturer CMPs; Budget Document Sheds Light on 340B User Fee and Other HRSA Priorities
  • K&L Gates
  • USA
  • April 10 2018

The 340B Drug Pricing Program (“340B Program”) remains in the regulatory spotlight. Most recently, on March 27, 2018, the Health Resources and

Hospitals Face Sizable Overpayment Liability for Not Reporting Medical Device Credits
  • Nelson Mullins Riley & Scarborough LLP
  • USA
  • April 9 2018

The Office of Inspector General (OIG) continues to unearth widespread noncompliance by hospitals with requirements for reporting the receipt of

"Impossibility Preemption" Remains Alive and Well in Missouri for Generic Drug Manufacturers
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • April 6 2018

“Impossibility preemption” applies to bar tort claims where it is impossible for a party to comply with both state and federal law. In the recent

New CMS Guidance for ADLT Lab Tests and ADLT Application Released
  • Reed Smith LLP
  • USA
  • April 6 2018

CMS is still rolling out policies and procedures to fully implement the major clinical laboratory payment reforms mandated by the Protecting Access to

IVC Inconsistent Verdict Created
  • Reed Smith LLP
  • USA
  • April 3 2018

We don’t normally comment on verdicts, whether they favor our side or the plaintiffs, because the bare fact of a verdict doesn’t give us much to

No Novelty in crocs clog shoe Design
  • RNA Technology and IP Attorneys
  • USA, India
  • March 29 2018

Ms Crocs Inc. (Crocs) brought Design Infringement action against seven local manufacturers, Ms Liberty Shoes Ltd, Ms Relaxo Footwear & Anr. Ltd

Rafferty v. Merck Expands Potential Liability for Drug Manufacturers in Massachusetts
  • Wilson Elser
  • USA
  • March 28 2018

On March 16, 2018, Massachusetts’s highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability

Mattress Manufacturer Won’t Sleep on Made-in-USA Complaint
  • Baker & Hostetler LLP
  • USA
  • March 27 2018

Nectar Brand (aka Nectar Sleep and DreamCloud) boasts a great tagline for its mattresses: “The Bed Other Mattresses Dream About.” As in all dreams

Brazilian Administrative Council for Economic Defense reaches a decision on longstanding procedure against car manufacturers
  • Di Blasi, Parente & Associados
  • Brazil, European Union
  • March 26 2018

The Brazilian Administrative Council for Economic Defense (CADE) has moved to shelve an administrative prosecution action against Volkswagen, Fiat and