Policy & Compliance

Expert Analysis

• 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.

• 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.