Insights & Resources

Garfunkel Wild will be a sponsor at the eCap Healthcare Summit 2026 in Miami, Florida from February 9-11, 2026.

Recently finalized in the Federal Register, the USPS’s addition of Section 608.11—“Postmarks and Postal Possession”—to the Domestic Mail Manual quietly reshapes a foundational assumption about how postmarks function.

The U.S. Department of Health & Human Services, Office of Inspector General issued a favorable advisory opinion (25-11) regarding an arrangement under which a vaccine manufacturer proposed to offer four types of discounts and rebates on three selected vaccines to its retail and non-retail customers.

On December 19, 2025, the U.S. District Court for the District of Minnesota issued a significant decision in the Change Healthcare cybersecurity multidistrict class action, largely denying defendants’ motion to dismiss claims brought by health care providers nationwide. The Court permitted core negligence and breach-of-contract claims to proceed against Change Healthcare, UnitedHealth Group, and affiliated Optum entities, dismissing only narrower negligence-per-se theories premised on HIPAA and the Federal Trade Commission Act.

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly issued a fourth temporary extension (the “Extension”) permitting health care practitioners to prescribe Schedule II–V controlled substances via audio-video telemedicine encounters without first conducting an in-person evaluation. The Extension, effective through December 31, 2026, continues to afford the DEA time to finalize permanent regulations governing controlled substance prescribing through telemedicine.

Effective July 1, 2025, however, the State of Florida passed legislation allowing physicians to use non-FDA approved stem cell therapies for certain treatments or procedures related to orthopedics, wound care, or pain management, provided that the performance of such is within the physician’s scope of practice.

In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s D.C. office, to talk about what makes for an effective compliance program.  In the sixth of seven episodes exploring this topic, we discuss the importance of risk assessments, proactive auditing, and monitoring. 

After considerable legal and legislative wrangling over the past year, the U.S. Department of Health & Human Services (HHS) announced on December 2, 2025 that it repealed the minimum staffing standards for long-term care facilities participating in Medicare and Medicaid programs due to its burdensome impact on facilities, “especially those serving rural and Tribal communities”, and concerns over patient access to care.

Last week, the New York State Court of Appeals addressed this issue of whether an insurer can deny paying no-fault benefits to a provider if they claim the provider violated licensing requirements by paying for patient referrals in Government Employees Insurance Company (GEICO) v. Igor Mayzenberg.

As we explained in our previous client alert, at the time the government shutdown ended, it was unclear whether Medicare telehealth services provided during that time (October 1 through November 12, 2025) would be reimbursed. CMS has since issued updated guidance.

Congress has once again temporarily extended key Medicare telehealth flexibilities, this time through January 30, 2026.

Join us on October 29, 2025 for the Garfunkel Wild Health Care Conference from 8:50am to 5:00pm. Our complimentary virtual conference is dedicated to the most important business, legal, clinical, and operational issues facing the health care community.

As part of our “Employment Law – What Employers Need to Know Now” webinar series, Garfunkel Wild’s Marianne Monroy and Andy Zwerling will present “How to Become a Better Supervisor to Promote Employee Engagement and Reduce Risk” on October 22, 2025, from 12:00 pm – 1:00 pm (ET).

The U.S. Food and Drug Administration (FDA) has issued a Request for Public Comment to gather feedback on practical approaches for measuring and evaluating the performance of AI-enabled medical devices in real-world clinical settings to help the FDA ensure such medical devices remain safe and effective throughout their life cycle. This move underscores the FDA’s increasing focus on post-market oversight of AI technologies, including generative AI, and their evolving behavior in dynamic healthcare environments.

In press releases on September 4 & 5, 2025, the Federal Trade Commission (FTC) announced that it would no longer pursue appeals to the cases that blocked its nationwide ban on employee non-competes. While this move was expected with the change of administration, the FTC was quick to stress that it is not backing away from the issue of non-competes.

Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.

Garfunkel Wild’s Andrew Blustein will present “Role of the Healthcare CPA” at the NYCPA – The New York State Society of CPAs’s Healthcare Conference on September 18, 2025.

As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.

As part of our “Employment Law – What Employers Need to Know Now” webinar series, Garfunkel Wild’s Andy Zwerling and Sal Puccio will present “Best Practices For Conducting Effective Performance Evaluations” on September 16, 2025, from 12:00 pm – 1:00 pm (ET).

Garfunkel Wild’s David M. Traskey will present “Compliance Trends in Assisted Living/Skilled Nursing and an Inside Look at HHS-OIG” at the LifeSpan Network Conference and Expo on September 17, 2025.