Policy & Compliance

Expert Analysis

• Remote Patient Monitoring Is At Regulatory Inflection Point

  

  With remote patient monitoring at the center of new federal pilot programs and a recent report from the U.S. Department of Health and Human Services' Office of Inspector General examining Medicare billing for those services, it is clear that balancing innovation and risk will be a central challenge ahead for digital health stakeholders, say attorneys at Morgan Lewis.

• Utah's AI Prescription Renewal Pilot Could Inform Policy

  

  Utah recently became the first state to approve an artificial intelligence system for autonomously renewing certain prescription medicines, providing a test case for how regulators may be able to draw boundaries between administrative automation and medical judgment, say Jashaswi Ghosh at Holon Law Partners and Bryant Godfrey at Foley Hoag.

• Ramped Up Psychedelic Production Carries Opportunity, Risk

  

  Kimberly Chew at Husch Blackwell discusses the key legal implications of the U.S. Drug Enforcement Administration's recent dramatic increases in the production quotas for a range of psychedelic substances, offering guidance on compliance, risk management and strategic opportunities for practitioners navigating this rapidly evolving landscape.

• New Biotech Nat'l Security Controls May Have Blunted Impact

  

  While the newly enacted federal prohibition against contracting with certain biotechnology providers associated with countries of concern may have consequences on U.S. companies' ability to develop drugs, the restrictions may prove to be less problematic for the industry than the significant publicity around their passage would suggest, say attorneys at Wilson Sonsini.

• Takeaways From The DOJ Fraud Section's 2025 Year In Review

  

  Former acting Principal Deputy Chief Sean Tonolli of the U.S. Department of Justice's Fraud Section, now at Cahill Gordon, analyzes key findings from the section’s annual report — including the changes implemented to adapt to the new administration’s priorities — and lays out what to watch for this year.

• Traditional FCA Enforcement Surges Amid Shifting Priorities

  

  The U.S. Department of Justice’s January report on False Claims Act enforcement in fiscal year 2025 reveals that while the administration signaled its intent to expand FCA enforcement into new areas such as tariffs, for now the greatest exposure remains in traditional areas like healthcare — in which the risk is growing, say attorneys at Debevoise.

• 3 Key Ohio Financial Services Developments From 2025

  

  Ohio's banking and financial services sector saw particularly notable developments in 2025, including a significant Ohio Supreme Court decision on creditor disclosure duties to guarantors in Huntington National Bank v. Schneider, and some major proposed changes to the state's Homebuyer Plus program, says Alex Durst at Durst Kerridge.

• Rescheduling Cannabis Marks New Tax Era For Operators

  

  As the attorney general takes steps to move cannabis from Schedule I to Schedule III of the Controlled Substances Act, operators and advisers should prepare by considering the significant changes this will bring from tax, state, industry and market perspectives, says Michael Harlow at CohnReznick.

• Justices' Med Mal Ruling May Spur Huge Shift For Litigators

  

  The U.S. Supreme Court’s recent decision in the medical malpractice suit Berk v. Choy, holding that a Florida procedural requirement does not apply to medical malpractice claims filed in federal court, is likely to encourage eligible parties to file claims in federal court, speed the adjudicatory process and create both opportunities and challenges for litigators, says Thomas Kroeger at Colson Hicks.

• 5 Drug Pricing Policy Developments To Watch In 2026

  

  2026 may prove to be a critical year for drug pricing in the U.S., with potential major shifts including several legislative initiatives moving forward after being in the works for years, and more experimentation on the horizon concerning GLP-1s and Section 340B pricing, say attorneys at Manatt.

• Regulatory Uncertainty Ahead For Organ Transplant System

  

  Pending court cases against a Centers for Medicare and Medicaid Services final rule that introduced a competition-centric model for assessing organ procurement organizations' performance will significantly influence the path forward for such organizations and transplant hospitals, say attorneys at Crowell & Moring.

• Key False Claims Act Trends From The Last Year

  

  The False Claims Act remains a powerful enforcement tool after some record verdicts and settlements in 2025, and while traditional fraud areas remain a priority, new initiatives are raising questions about its expanding application, says Veronica Nannis at Joseph Greenwald.

• It's Too Soon To Remove Suicide Warnings From GLP-1 Drugs

  

  The U.S. Food and Drug Administration's decision this month to order removal of warnings about the risk of suicidal thoughts from GLP-1 weight-loss drugs is premature — and from a safety and legal standpoint, the downside of acting too soon could be profound, says Sean Domnick at Rafferty Domnick.