Policy & Compliance

Expert Analysis

• 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.

• Plan Sponsors Must Prep For New Mental Health, Drug Rules

  

  To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.

• A Primer On Navigating The Conrad 30 Immigration Program

  

  As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.

• Class Actions At The Circuit Courts: September Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.

• Proposed Legislation May Crack Down On Online Drug Ads

  

  A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.

• What To Expect From Calif. Bill Regulating PE In Healthcare

  

  A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.

• Vertex Suit Highlights Issues For Pharma Fertility Support

  

  Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.