Policy & Compliance

Expert Analysis

• 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.

• 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

  

  In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.

• How Providers Can Brace For Drug Pricing Policy Changes

  

  Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.

• Debunking 4 Misconceptions Around Texas' IV Therapy Law

  

  Despite industry confusion, an IV therapy law enacted in Texas last week may actually be the most business-friendly regulatory development the medical spa industry has seen in recent years, says Keith Lefkowitz at Hendershot Cowart.

• Legacy Of 3 Justices Should Guide Transgender Rights Ruling

  

  Three Republican-appointed U.S. Supreme Court justices — Anthony Kennedy, Sandra Day O'Connor and David Souter — gave rise to a jurisprudence of personal liberty that courts today invoke to protect gender-affirming care, and with the court now poised to decide U.S. v. Skrmetti, it must follow the path that they set, says Greg Fosheim at McDermott.

• 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.