Policy & Compliance

Expert Analysis

• What US Medicine Onshoring Means For Indian Life Sciences

  

  Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.

• FCA Working Group Reboot Signals EHR Compliance Risk

  

  The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.

• FDA's Hasty Policymaking Approach Faces APA Challenges

  

  Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

• The Metamorphosis Of The Major Questions Doctrine

  

  The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

• A Rapidly Evolving Landscape For Noncompetes In Healthcare

  

  A wave of new state laws regulating noncompete agreements in the healthcare sector, varying in scope, approach and enforceability, are shaped by several factors unique to the industry and are likely to distort the market, say attorneys at Seyfarth.

• Arguing The 8th Amendment For Reduction In FCA Penalties

  

  While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

• $95M Caremark Verdict Should Put PBMs On Notice

  

  A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.

• DOJ Actions Signal Rising Enforcement Risk For Health Cos.

  

  The U.S. Department of Justice's announcement of a new False Claims Act working group, together with the largest healthcare fraud takedown in history, underscore the importance of sophisticated compliance programs that align with the DOJ's data-driven approach, say attorneys at Debevoise.

• Spotlight On Medicare Marketing Practices Enforcement Trend

  

  Recent U.S. Department of Justice actions, including its recent Medicare kickback allegations in Shea v. eHealth, demonstrate increasing enforcement scrutiny on Medicare Advantage marketing practices, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Erica Hitchings at the Whistleblower Law Collaborative.

• Federal Regs Order May Spell Harsher FDCA Enforcement

  

  A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

• What High Court's Tenn. Trans Care Ruling Means Nationally

  

  The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

• High Court ACA Ruling May Harm Preventative Care

  

  The U.S. Supreme Court's decision in Kennedy v. Braidwood last week, ruling that the U.S. Department of Health and Human Services secretary has authority over an Affordable Care Act preventive care task force, risks harming the credibility of the task force and could open the door to politicians dictating clinical recommendations, says Michael Kolber at Manatt.

• Rising Enforcement Stakes For Pharma Telehealth Platforms

  

  Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.