Policy & Compliance

Expert Analysis

• Mapping Philly US Atty's White Collar Enforcement Push

  

  Attorneys at Blank Rome discuss the U.S. Attorney for the Eastern District of Pennsylvania David Metcalf’s commitments and priorities, survey early results from his first year, and suggest practical action items for companies operating under the office's jurisdiction.

• How The Coming Months Will Shape State Drug Price Boards

  

  The future of state prescription drug affordability boards may be determined in the next few months, between an upcoming court decision in a challenge against state authority to set drug prices, and pending state decisions about whether to use federal Medicare maximum fair prices as reference, say Michael Kolber, Steven Chen and Kelechi Ezealaji at Manatt.

• Steps To Consider As DOJ Launches Fraud Division

  

  The establishment this month of the National Fraud Enforcement Division within the U.S. Department of Justice is a significant reorganization that suggests an increase in enforcement activity involving federally funded programs but leaves a number of important questions unanswered, say attorneys at Crowell & Moring.

• Court's HRSA Policy Reversal Leaves 340B Rules Murky

  

  A D.C. federal court's recent decision in Premier v. U.S. Department of Health limits the Health Resources and Services Administration's ability to enforce long-standing Section 340B interpretations through subregulatory guidance, leaving open core statutory questions about purchasing models, inventory classification and program oversight, says Martha Cramer at Hooper Lundy.

• Fresenius Ruling May Shift Anti-Kickback Enforcement

  

  The Ninth Circuit's recent decision in Fresenius v. Bonta suggests that businesses have a First Amendment right to donate to certain charities, even if those donations are motivated by economic self-interest, potentially calling into question years of Anti-Kickback Statute proceedings against pharmaceutical manufacturers for making similar donations, says Jonah Knobler at Patterson Belknap.

• The Challenge Of Stabilizing Rural Hospitals On The Brink

  

  The outlook for rural hospitals has grown more concerning, as recent policy and regulatory developments are decreasing hospital revenues and increasing the cost of uncompensated care, which may result in additional hospital closures, service reductions, or mergers and acquisitions, say Omur Celmanbet, Kristy Piccinini and Sabiha Quddus at FTI Consulting.

• Fraud Enforcement, Sentencing Face Unusual Convergence

  

  The Trump administration’s newly created task force to eliminate fraud and the U.S. Sentencing Commission’s recent proposals to scale back certain elements of the federal sentencing framework seem to point in opposite directions, creating a collision of policy priorities that may reshape how fraud cases are charged, negotiated and sentenced for years to come, says David Tarras at Tarras Defense.

• Peptide Policy Is Shifting Toward Sanctioned Compounding

  

  The policy landscape for peptides is undergoing a significant shift under the Trump administration, moving toward a complex system of verified compounding and complementary enforcement that will likely bring peptides firmly back into the sphere of legitimate consumer products, say attorneys at Sheppard.

• Trump Order Signals Tougher Benefits Fraud Probes

  

  A recent order from President Donald Trump establishing a federal taskforce for addressing fraud in federally funded benefit programs emphasizes interagency information sharing, potentially affecting a broad range of areas including government contracts, administrative law considerations and False Claims Act cases, say attorneys at Morgan Lewis.

• The Evolution Of States' Workplace Violence Prevention Laws

  

  Utah's new law requiring hospitals to implement comprehensive workplace violence reporting systems continues a broader trend of state efforts to expand workplace protections in the absence of sufficient federal regulations, say attorneys at Ogletree.

• FDA Guidance May Move Goalposts For Form 483 Responses

  

  New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about the agency's timelines and expectations, say attorneys at Cooley.

• 2 Strands Of Patent Law In High Court's 'Skinny Label' Case

  

  Amarin v. Hikma, which is set for oral argument in the U.S. Supreme Court this month, highlights the distinction between two different strands of intellectual property law — analogizing a patent to either a property deed or a home, says Jonas McDavit at Spencer West.

• A Check-Up On HHS' Push To Implement AI Infrastructure

  

  The U.S. Department of Health and Human Services has made some headway in its efforts to implement artificial intelligence across its agencies, but will have to overcome a number of near-term tests in order to be successful, says Theodore Thompson at Stinson.