Policy & Compliance

Expert Analysis

• What To Expect From Calif.'s Incoming Health AI Laws

  

  California's new statewide ground rules for artificial intelligence in clinical care, set to take effect on Jan. 1, reveal the Legislature's choice to regulate healthcare AI primarily though institutions, rather than direct product regulation, and providers should shape their compliance plans accordingly, say attorneys at Reed Smith.

• DOL Association Health Plan Rule Could Cut Employer Costs

  

  The U.S. Department of Labor's proposed rule would redefine who may act as an employer for purposes of sponsoring a group health plan under the Employee Retirement Income Security Act, potentially extending cost relief to many more businesses, says W. James Hamilton at Bose McKinney.

• FDA Classification Setback Bodes Well For Wound Care Cos.

  

  A Georgia federal court's recent decision in MiMedx v. U.S. Food and Drug Administration constrains the FDA's analytical framework for classifying certain wound care products as biological products, carrying important ramifications for manufacturers seeking to avoid heightened regulatory requirements, say attorneys at Hyman Phelps.

• Defending Hospital Antisteering Clauses From DOJ Scrutiny

  

  The Trump administration has recently made clear that pursuing antitrust challenges to antisteering provisions in hospital-insurer contracts is a priority — but a review of similar cases against hospital systems and important precedent from the U.S. Supreme Court illuminates some potential defenses in such cases, says Derek Moore at Rule Garza.

• What Expanded CMS Authority Means For Health Compliance

  

  A recent delegation gives the Centers for Medicare & Medicaid Services independent authority to impose permissive exclusions, creating a more active federal enforcement system with heightened risks for healthcare organizations, says Jose Vela at Clark Hill.

• DOJ Directive Gives Contractors A Fraud Risk Road Map

  

  For government contractors, the 10 factors described in the U.S. Department of Justice's recent corporate fraud enforcement directive function as a de facto scoring rubric for internal audits that mirrors what prosecutors will prioritize, say attorneys at Spencer Fane.

• A Nuanced Reading Of DOL's Mental Health Parity Guidance

  

  Though a recent U.S. Department of Labor bulletin may suggest that agency enforcement pressure on group health plans with respect to mental health parity is easing, the takeaways are more complex, and plan sponsors should not relax compliance efforts, say attorneys at Proskauer.

• Where DOJ's Fraud Directive May Actually Affect Enforcement

  

  The U.S. Department of Justice’s recent directive outlining corporate fraud enforcement priorities is mostly a management document instead of a policy, but one part may actually undermine the directive's goals by leading to worse outcomes for organizational defendants and less corporate self-disclosure, says Zachary Warren at Williams & Connolly.

• Importer Risk Rises As AI Enters Trade Fraud Enforcement

  

  The Trump administration's new data-driven and artificial intelligence-enabled push against tariff evasion raises the stakes for companies with global supply chains, making it crucial that they consider strengthening response protocols, documentation and internal reporting mechanisms, say attorneys at Cooley.

• What CMS Audit Rule Means For Medicare Advantage Plans

  

  Despite ongoing legal challenges, the Centers for Medicare & Medicaid Services is moving forward with implementation of its risk adjustment data validation audits, raising statistical concerns around overpayments indicated by variance in unbalanced samples, say Stephen Fink, Brad Rice and Igor Karagodsky at Analysis Group.

• What To Know As State 'Neural Data' Privacy Laws Emerge

  

  Attorneys at Goodwin discuss new state laws aimed at regulating consumer data generated from nervous system activity, explain why neurotechnology is attracting state and federal legislators’ attention, and highlight the compliance obligations that industry players should address now.

• Health Plan Takeaways After 2nd Circ. No Surprises Act Ruling

  

  While the Second Circuit's recent ruling in East Coast Advanced Plastic Surgery v. Cigna gives health plans breathing room in finding that healthcare providers cannot enforce out-of-network billing dispute resolution awards in court, sponsors should not assume that declining to pay awards will go unaddressed by regulators, say attorneys at Thompson Hine.

• Contact Lens Rule's Evolution Steers FTC Guidance Program

  

  The history of the Federal Trade Commission's Contact Lens Rule illustrates the goals of the FTC's recently announced guidance program, which aims to strengthen consumer protection and safeguard competition, say attorneys at Wilson Sonsini.