Policy & Compliance

Expert Analysis

• PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB

  

  The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.

• Justices Face Tough Question On HHS Hospital Pay Formula

  

  In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.

• Key Healthcare Issues That Hinge On The Election Outcome

  

  The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.

• The Key To Solving High Drug Costs Is Understanding Causes

  

  One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.

• Next Steps For FCA Defendants After Fla. Qui Tam Ruling

  

  Because a Florida federal court's recent decision in Zafirov v. Florida Medical Associates could eventually prove to be a watershed event for False Claims Act suits, defendants should consider potential next steps to ensure that their litigation benefits from the court's reasoning and further developments, says Scott Gallisdorfer at Bass Berry.

• A Look At Calif.'s New AI Law For Health Insurers

  

  A newly enacted California law prohibits artificial intelligence tools from making medical necessity determinations for healthcare service plans or disability insurers, addressing core questions that have arisen around AI's role in coverage decisions, say attorneys at DLA Piper.

• New HHS Research Misconduct Rules Bring Seismic Changes

  

  The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.

• Fla. Ruling May Undermine FCA Whistleblowers' Authority

  

  A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.

• 11th Circ. Kickback Ruling May Widen Hearsay Exception

  

  In a $400 million fraud case, U.S. v. Holland, the Eleventh Circuit recently held that a conspiracy need not have an unlawful object to introduce co-conspirator statements under federal evidence rules, potentially broadening the application of the so-called co-conspirator hearsay exception, say attorneys at ArentFox Schiff.

• Navigating Complex Regulatory Terrain Amid State AG Races

  

  This year's 10 attorney general elections could usher in a wave of new enforcement priorities and regulatory uncertainty, but companies can stay ahead of the shifts by building strong relationships with AG offices, participating in industry coalitions and more, say Ketan Bhirud and Dustin McDaniel at Cozen O’Connor.

• Navigating HHS' New Reproductive Healthcare Privacy Rule

  

  The U.S. Department of Health and Human Services' new final rule regarding protections for the privacy of reproductive health information will require regulated entities to grapple with difficult questions about whether to comply with state law requirements or federal privacy prohibitions, says Christine Chasse at Spencer Fane.

• Mental Health Parity Rules: Tips For Plans And Issuers

  

  Following federal agencies' release of final mental health parity rules, plan sponsors and health insurance issuers should develop protocols for preparing compliant nonquantitative treatment limitation comparative analyses, say attorneys at Ropes & Gray.

• FTC's Report Criticizing Drug Middlemen Is Flawed

  

  The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.