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New Federal Right To Try Act Poses Practical and Ethical Dilemmas for Physicians
  • Dykema Gossett PLLC
  • USA
  • June 29 2018

On May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right To Try Act,” or “Act”


GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005
  • Cooley LLP
  • USA
  • May 16 2018

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and


Boots on the Ground: PIL Task Force Targeting Opioid Providers in the War on Drugs
  • K&L Gates
  • USA
  • April 30 2018

Attorney General Jeff Sessions announced the creation of the Prescription Interdiction & Litigation (“PIL”) Task Force -- which Sessions described as


First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer
  • Arent Fox LLP
  • USA
  • March 29 2018

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS


Top 7 Legal Challenges Facing Physicians and Hospitals
  • Jackson Lewis PC
  • USA
  • February 21 2018

The American Health Lawyers Association’s 2018 Physicians and Hospitals Law Institute in New Orleans focused on the legal challenges faced by


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


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


Balancing State and Federal Informed Consent Law
  • Epstein Becker Green
  • USA
  • October 5 2017

The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated


How Companies Should Prep for Enforcement Shift to State AGs
  • Foley & Lardner LLP
  • USA
  • August 23 2017

“Top Cop” is how every state Attorney General wants to be known. In reality, state AGs have far more authority for civil enforcement than they do for


Ohio Attorney General Sues Pharmaceutical Companies Over Opioid Marketing - Yet Another Sign of Government Focus on Recovering Financial Cost of Opioid Epidemic
  • Pietragallo Gordon Alfano Bosick & Raspanti LLP
  • USA
  • June 9 2017

Last week, Ohio Attorney General Mike DeWine filed a lawsuit against multiple pharmaceutical companies, including Purdue, Teva, Johnson & Johnson