Policy & Compliance

Expert Analysis

• A Look At HHS' New Opinion On Patient Assistance Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

• 2 Anti-Kickback Developments Hold Lessons For Biopharma

  

  The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

• Tips For Pharma-Biotech Overlap Reporting In New HSR Form

  

  While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.

• A Look At Drug Price Negotiation Program's Ongoing Impact

  

  More than two years after the passage of the Inflation Reduction Act and the rapid implementation of the drug price negotiation program, attorneys at Ropes & Gray discuss how the IRA has influenced licensing strategies, and how maximum fair prices under the law have economically affected certain drugs.

• Preparing For A Possible End To The Subminimum Wage

  

  The U.S. Department of Labor's proposed rule to end the subminimum wage for employees with disabilities may significantly affect the community-based rehabilitation and training programs that employ these workers, so certified programs should be especially vigilant about compliance during this period of evaluation and scrutiny, say attorneys at Jackson Lewis.

• Drug Pricing Policy Trends To Expect In 2025 And Beyond

  

  Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.

• Top 10 Healthcare And Life Sciences Issues To Watch In 2025

  

  Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

• 4 Keys To Litigating In An Active Regulatory Environment

  

  For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

• How Views On Healthcare Price Transparency Are Changing

  

  Regulators' attitudes toward price transparency regulation have shifted over the past several years in ways that may seem contradictory, and research into detailed rate information published by hospitals and health plans has yielded mixed results, says Matthew List at Charles River Associates.

• EEOC Wearable Tech Guidance Highlights Monitoring Scrutiny

  

  The U.S. Equal Employment Opportunity Commission's recent fact sheet on wearable technologies cautions against potential issues with federal anti-discrimination laws and demonstrates growing concern from regulators and legislators about intrusive technologies in the workplace, say attorneys at Littler.

• Navigating The Potential End Of GLP-1 Drug Shortages

  

  The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.

• Politicized OIGs Could Target Federal Employees, Contractors

  

  After President Donald Trump fired nearly 20 inspectors general last week, it’s worth exploring how the administration could use Offices of Inspectors General to target federal employees and contractors, why it would be difficult to fight this effort, and one possible bulwark against the politicization of these watchdogs, says Sara Kropf at Kropf Moseley.

• Takeaways From DOJ Fraud Section's 2024 Year In Review

  

  Attorneys at Paul Weiss highlight notable developments in the U.S. Department of Justice Fraud Section’s recently released annual report, and discuss what the second Trump administration could mean for enforcement in the year to come.