Policy & Compliance

Expert Analysis

• Mass. UHC Fraud Suit Signals States' Medicaid FCA Push

  

  Massachusetts' recently filed False Claims Act suit alleging UnitedHealthcare misrepresented the health status of enrollees in a Medicaid senior care organization plan it managed pushes forward a new phase of state-level scrutiny of managed care data and Medicaid payment mechanisms, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwendolyn Stamper at Vogel Slade.

• FDA Draft Guidance Maps Payor Strategy For Psychedelics

  

  Recently revised guidance from the U.S. Food and Drug Administration will operationalize a framework permitting drug developers to share product information with insurance companies, giving psychedelic therapeutics developers a road map for building a successful payor infrastructure before approval, says Kimberly Chew at Husch Blackwell.

• Denying Emergency Abortion Care Is A Liability Oversight

  

  Health systems in states with abortion bans should consider that refusing to provide emergency abortion care carries greater legal risk than the risk of prosecution under post-Dobbs laws for providing treatment, say Kimberly Chernoby at FemInEM and Rachel Rebouché at the University of Texas, Austin School of Law.

• Carbon Health Settlement Highlights Why Evidence Is Key

  

  The California Attorney General's Office's first-of-its-kind settlement with Carbon Health, imposing penalties for alleged corporate practice of medicine violations, shows that friendly professional corporation challenges usually hinge not on the parties' management services agreement, but on whether the operational record matches it, says Ben Dubin at VC Expert Services.

• Remote Work Rulings Show ADA Fights Hinge On Process

  

  Two opposite outcomes in recent Fifth Circuit and D.C. federal court cases underscore that the legality of denying employees' disability accommodation requests for remote work depends less on broad policy and more on how it's applied, says Paul Sweeney at Ice Miller.

• How Justices' TPS Ruling Affects Workforce Planning

  

  The U.S. Supreme Court’s recent holding in Mullin v. Doe that courts lack jurisdiction to review temporary protected status determinations greenlights the end of TPS for thousands of Syrian and Haitian nationals, and means employers must reevaluate TPS-designees' employability while avoiding discriminatory document practices, says attorney Richard Herman.

• A New Regulatory Environment For PE In Calif. Healthcare

  

  The California Office of Health Care Affordability's proposed revisions to its cost and market impact review regulations, amid broader state scrutiny of private equity-backed healthcare arrangements, represent a qualitative shift in California's regulatory posture toward institutional healthcare investment, say attorneys at Ropes & Gray.

• FDA Moves Leave Peptides In A Legal Gray Zone

  

  While the U.S. Food and Drug Administration has taken a concrete step forward on reclassifying certain peptides, the practical consequence of their interim status cannot be overstated — these substances are no longer designated as posing a significant safety risk, but they have not been affirmatively authorized for compounding, say attorneys at Sheppard.

• NY Banking Brief: All The Notable Legal Updates In Q2

  

  The year's second quarter brought several notable banking law developments to New York, including a proposal to align state stablecoin rules with the federal Genius Act, fresh fair lending and cybersecurity guidance from state regulators, and a significant Second Circuit holding on preemption, say attorneys at Ashurst Perkins Coie.

• A New Defense For Medicaid Fraud Cases In Texas

  

  The Texas Supreme Court decision in LabCorp v. Texas last month, finding that the state's False Claims Act requires proof that an omission is material, is among the first to establish that the government's lack of reaction to the defendant's disclosures rendered alleged omissions immaterial, say attorneys at Sheppard.

• Pregnancy Bias Suits Highlight EEOC's Expanding Reach

  

  Recent U.S. Equal Employment Opportunity Commission suits show that enactment of the Pregnant Workers Fairness Act has drawn scrutiny to a wider range of employment decisions and an increasing focus on individual decisions as indicators of whether an employer's policies comply with evolving federal requirements, say attorneys at Krevolin Horst.

• Legal Risks Of Using AI To Screen Psychedelic Trial Patients

  

  Though using artificial intelligence to preemptively identify drug trial participants likely to experience placebo effects could produce clearer research results, sponsors will need to be ready for the new legal questions these methods raise about informed consent, accountability for algorithmically derived criteria, and potential bias in data training sets, says Kimberly Chew at Husch Blackwell.

• How 6th Circ. Tightened NLRB Injunction Standard

  

  The Sixth Circuit's recent ruling in Kerwin v. Trinity Health Grand Haven Hospital, dissolving a Section 10(j) injunction obtained by the National Labor Relations Board against an employer that refused to bargain, will make it harder for the NLRB to obtain injunctions while prosecuting unfair labor practice proceedings, say attorneys at Bass Berry.