Policy & Compliance

Expert Analysis

• High Court Must Acknowledge US History Of Anti-Trans Laws

  

  Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.

• The Fate Of Biden-Era Clinical Study Guidance Under Trump

  

  Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

• 10 Issues To Watch In Aerospace And Defense Contracting

  

  This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

• Dispelling 10 Myths About Health Provider-Based Compliance

  

  Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.

• 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.