Policy & Compliance

Expert Analysis

• Recent Reports Shed Light On Section 340B's Effectiveness

  

  Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

• What Parity Rule Freeze Means For Plan Sponsors

  

  In light of a District of Columbia federal court’s recent decision to stay litigation challenging a Mental Health Parity and Addiction Equity Act final rule, as well as federal agencies' subsequent decision to hold off on enforcement, attorneys at Morgan Lewis discuss the statute’s evolution and what plan sponsors and participants can expect going forward.

• CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

  

  Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

• 3 Takeaways From Recent Cyberattacks On Healthcare Cos.

  

  For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.

• Most-Favored Nation Drug Pricing Could Shake Up US Pharma

  

  Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.

• How Focus On Menopause Care Is Fueling Innovation, Access

  

  Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

• FDA Commissioner Speech Suggests New Vision For Agency

  

  In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

• Customs Fraud Enforcement In The Age Of Tariffs

  

  In the wake of the Trump administration’s new approach toward tariffs, two recent Justice Department developments demonstrate aggressive customs fraud enforcement, with the DOJ emphasizing competitive harm to American businesses, and signaling that investigations will likely involve both civil and criminal enforcement tools, say attorneys at Bernstein Litowitz and London & Naor.

• Legal Risks For Providers Discussing Psychedelic Therapies

  

  The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.

• How NY's FAIR Act Mirrors CFPB State Recommendations

  

  New York's proposed FAIR Business Practices Act, which targets predatory lending and junk fees, reflects the Rohit Chopra-era Consumer Financial Protection Bureau's recommendations to states in a number of ways, including by defining "abusive" conduct and adding a new right to file class actions, says Christian Hancock at Bradley Arant.

• A Breakdown Of Trump's Order On Drug Pricing

  

  The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.

• Takeaways From DOJ's 1st Wage-Fixing Jury Conviction

  

  U.S. v. Lopez marked the U.S. Department of Justice's first labor market conviction at trial as a Nevada federal jury found a home healthcare staffing executive guilty of wage-fixing and wire fraud, signaling that improper agreements risk facing successful criminal prosecution, say attorneys at McGuireWoods.

• Deregulation Memo Presents Risks, Opportunities For Cos.

  

  A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.