Expert Analysis

• 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.

• How Gov't Shutdown Will Affect Federal Health Agencies

  

  Federal health agencies' contingency plans indicate that many major programs will remain insulated from disruption during the ongoing government shutdown, but significant policy proposals will likely be delayed and the Trump administration's emphasis on reduction-in-force plans distinguishes this shutdown from past lapses, says Miranda Franco at Holland & Knight.

• Assessing Legal, Regulatory Hurdles Of Healthcare Offshoring

  

  The offshoring of administrative, nonclinical functions has emerged as an increasingly attractive option for healthcare companies seeking to reduce costs, but this presents challenges in navigating the web of state restrictions on the access or storage of patient data outside the U.S., say attorneys at McDermott.

• 5 Years In, COVID-19 Fraud Enforcement Landscape Is Shifting

  

  As the government moves pandemic fraud enforcement from small-dollar individual prosecutions to high-value corporate cases, and billions of dollars remain unaccounted for, companies and defense attorneys must take steps now to prepare for the next five years of scrutiny, says attorney David Tarras.