Insights & Resources

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over the past year, the U.S. Department of Health & Human Services (HHS) announced on December 2, 2025 that it repealed the minimum staffing standards for long-term care facilities participating in Medicare and Medicaid programs due to its burdensome impact on facilities,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.

Each year, the Centers for Medicare & Medicaid Services’ issuance of its proposed rule for the Medicare Physician Fee Schedule creates potentially significant changes to PFS payments and Part B in particular. The impact of these proposed changes can be widespread and complex, and it is important to understand how these changes may affect you or your practice.

In an increasingly competitive environment, many physicians seek creative ways to grow their personal brands, their practices, and their revenue. One common vehicle for achieving these goals involves physician-owned entities that derive revenue from selling, or arranging for the sale of, medical devices that the physician-owners order and use in procedures they perform at hospitals.

Although OIG has long-standing concerns about such arrangements, OIG recently issued a favorable advisory opinion (25-09) regarding a proposed arrangement involving physicians with an ownership interest in a medical device company.

On August 1, 2025, the Health Resources and Services Administration issued a new pilot initiative under the 340B Drug Pricing Program that may significantly reshape longstanding pricing and discount frameworks. The 340B Rebate Model Pilot Program will allow participating drug manufacturers to offer post-sale, rebates to eligible 340B Covered Entities for select drugs, rather than providing upfront discounts.

Applied Behavior Analysis therapy providers operating clinic-based environments in New York City and New York State have recently experienced increased scrutiny and enforcement actions from different regulatory authorities, including the New York State Office of Children and Family Services, and the New York City Department of Health and Mental Hygiene.

Garfunkel Wild’s Steven R. Antico presented “Navigating Compliance Considerations Relating to Patient Referrals and Recommendations to Affiliates” at the Council of Autism Service Providers’ CEO Section Meeting on August 14, 2025.

As a successful podiatrist treating complex wounds with skin substitutes, your growing reputation also brings increased risk of audits, investigations, and costly claw backs from Medicare, Medicaid, and insurers. With billions spent annually on these treatments, government scrutiny is intensifying. Protect your practice by building the right team—experienced health care attorneys, top medical experts, and skilled billing and documentation specialists—before issues arise. Garfunkel Wild focuses exclusively on health care law and offers the resources to safeguard your practice, reputation, and livelihood.

As part of Governor Kathy Hochul’s commitment “to transform the mental health care system (in New York) over the next several years,” the state has enacted new legislation and allotted $160 million dollars towards increasing the number of in-patient psychiatric beds in New York.