Expert Analysis

• What's New In FDA's Latest Cell And Gene Therapy Guidance

  

  New draft guidance from the U.S. Food and Drug Administration, along with other recent initiatives, come together to promote cell and gene therapy product development by streamlining development and review pathways, say attorneys at Holland & Knight.

• Adapting To Enforcement Focus On Wound Care Fraud

  

  As federal agencies target wound care industry fraud as a top enforcement priority, attorneys advising industry stakeholders should evaluate business relationships for Anti-Kickback Statute violations, emphasize appropriate product use and documentation, and use internal data analytics to monitor billing patterns, say David Tarras at Tarras Defense and Jay McCormack at Verrill Dana.

• AG Watch: Illinois A Key Player In State-Level Enforcement

  

  Illinois Attorney General Kwame Raoul has systematically strengthened his office to fill federal enforcement gaps, oppose Trump administration mandates and advance state policy objectives, particularly by aggressively pursuing labor-related issues, say attorneys at Troutman.

• Organ Transplant System Reforms Mark Regulatory Overhaul

  

  Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.

• Federal Grantees May Soon Face More Limitations On Speech

  

  If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.

• HHS Wound Care Report Highlights Need For Payment Reform

  

  The U.S. Department of Health and Human Services' recent report on potential abuse in Medicare Part B payments for skin substitutes highlights specific fraud schemes, but more importantly emphasizes that broader changes are needed for the wound care sector's fundamentally flawed payment system, say attorneys at Paul Hastings.

• Assessing The Future Of The HIPAA Reproductive Health Rule

  

  In light of a Texas federal court's recent decision to strike down a U.S. Department of Health and Human Services rule aimed to protect the privacy of patients seeking abortions and gender-affirming care, entities are at least temporarily relieved from compliance obligations, but tensions are likely to continue for the foreseeable future, says Liz Heddleston at Woods Rogers.

• DOJ's Tracing Rule For Pandemic Loan Fraud Is Untenable

  

  In conducting investigations related to COVID-19 relief fraud, the government's assertion that loan proceeds are nonfungible and had to have been segregated from other funds is unsupported by underlying legislation, precedent or the language establishing similar federal relief programs, say Sharon McCarthy, Jay Nanavati and Lasya Ravulapati at Kostelanetz.

• New Health AI Guidance Features A Provider-Centric Approach

  

  New guidance from the Joint Commission and Coalition for Health AI regarding the responsible use of artificial intelligence in healthcare deviates from preexisting guidance by recommending a comprehensive framework for using AI tools, focusing on healthcare provider organizations rather than on AI developers, say attorneys at Ropes & Gray.

• Mass. Ruling May Pave New Avenue To Target Subpoenas

  

  A Massachusetts federal court’s recent decision to quash a subpoena seeking information on gender-affirming care at Boston Children’s Hospital is a significant departure from courts' deferential approach to subpoena enforcement, and may open a new pathway for practitioners challenging investigative tools in the future, say attorneys at Gibson Dunn.

• What To Expect After FDA Warnings To GLP-1 Compounders

  

  The U.S. Food and Drug Administration's recent warning letters to companies advertising compounded versions of GLP-1 medications raise questions not just about the enforcement outlook for marketing such products, but also about the future of drug compounding as a whole, say attorneys at Spencer Fane.

• How Financial Cos. Can Prep As NYDFS Cyber Changes Loom

  

  Financial institutions supervised by the New York State Department of Financial Services can prepare for two critical cybersecurity requirements relating to multifactor authentication and asset inventories, effective Nov. 1, by conducting gap analyses and allocating resources to high-risk assets, among other steps, say attorneys at Pillsbury.

• How Courts May Interpret Data-Driven Healthcare Fraud Suits

  

  As the U.S. Department of Justice and other agencies increasingly turn to data mining as an enforcement tool, courts will have to determine how far data alone can take a fraud case, and sound theory, clinical expertise and institutional context will play an important role, say Jaime Jones at Sidley and Andrée-Anne Fournier and Atang Gilika at Analysis Group.