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Health Law Highlights

Wade’s Health Law Highlights for July 22, 2025

Business of Healthcare

  • Healthcare organizations face financial losses from compliance failures, with non-compliance leading to penalties, reputational damage, and operational disruption. The company helped an academic institution save $310,000 using their Compliance Risk Analyzer software, which provides statistical analysis of audit risk for physician claims. VMG Health offers services including fair market value opinions, coding audits, transaction support, and staff training to help healthcare organizations navigate compliance challenges. The firm has developed FMV-MD software to standardize valuation management processes and reduce risks associated with physician compensation arrangements under Stark Law. With 30 years of experience focused on healthcare, VMG Health provides compliance services across all healthcare sectors. Source: VMG Health
  • Physician groups must evaluate tax efficiency, legal structure, and compliance issues before considering strategic transactions to avoid pitfalls and devaluation. Medical practice consolidation has increased in recent years with lucrative valuations, but groups need consensus before exploring transactions—full consensus for smaller groups of 2-4 physicians and substantial consensus of 80% or more for larger groups of 5-30+ physicians. Groups must agree on proceeds allocation early and address compliance issues including monthly exclusion checks, Stark/DHS compliance, HIPAA policies, co-pay waiver violations, and employee classification problems. Real estate leases between physician owners and practices should reflect fair market value terms rather than friendly arrangements. Engaging experienced healthcare transaction attorneys and advisors is crucial for proper advance planning and positioning. Source: Medical Economics

Clinical Laboratories

Cybersecurity & Data Breaches

Electronic Health Record

Emergency Preparedness

Emerging Tech

Fraud & Abuse

  • The HHS Office of Inspector General issued an unfavorable advisory opinion on July 7, 2025, ruling that flat fee payment structures do not protect healthcare arrangements from Anti-Kickback Statute violations. The Advisory Opinion 25-08 involved a proposed arrangement between a medical device company and a software vendor, where the device company would pay $395 per license annually (totaling $1.2 million) to access software that facilitates device sales to hospitals and surgical centers. The OIG determined the arrangement failed to meet the Personal Services and Management Contracts Safe Harbor because the software services were “redundant” to the company’s existing accounts receivable processes and provided no tangible benefits beyond accessing referrals from surgical providers. The opinion emphasized that payments primarily intended to access referrals rather than obtain legitimate services can violate the Anti-Kickback Statute regardless of whether compensation is structured as a flat fee. The OIG also expressed concerns about anti-competitive behavior, noting that such arrangements could inappropriately steer healthcare providers toward companies willing to pay these fees while disadvantaging competitors. Source: Holland & Knight
  • Medical practices must navigate two federal laws designed to prevent financial conflicts of interest that could influence patient referrals. The Stark Law prohibits physicians from referring Medicare patients for designated health services to entities with which they or their family members have financial relationships unless specific exceptions apply, and violations can occur regardless of intent since it is a strict liability statute. The Anti-Kickback Statute criminalizes exchanges of value to induce referrals for federal healthcare program services and requires proof of intent but applies more broadly to all federal programs. In 2024, the Department of Justice resolved multiple cases involving alleged violations, including a Delaware health system that paid $42.5 million to settle allegations it provided free clinical support to a neonatology practice that then billed for services performed by staff. The Office of Inspector General recommends medical practices implement a seven-element compliance framework that includes internal audits, written policies, designated compliance officers, training programs, prompt violation response, open communication, and disciplinary standards. Source: CSH Law

Medicare Reimbursement

  • CMS will require specialists in selected regions to participate in a new payment model targeting heart failure and low back pain starting January 1, 2027. The Ambulatory Specialty Model will run for five years through December 31, 2031, and initially cover specialists in roughly one-quarter of core-based statistical areas who treat Original Medicare patients. Participation will be mandatory for cardiologists treating heart failure and specialists in anesthesiology, pain management, neurosurgery, orthopedic surgery, and physical medicine treating low back pain, provided they have historically treated at least 20 episodes per year. The model rewards specialists for improving patient health outcomes and coordinating with primary care providers to reduce avoidable hospitalizations and unnecessary procedures. CMS expects the program to lower costs to Original Medicare while improving patient experience and outcomes. Source: CMS
  • CMS announced a proposed rule to slash Medicare reimbursement for skin substitutes by nearly 90% to combat what it calls “abusive pricing practices” in the wound care industry. The 2026 Medicare Physician Fee Schedule would pay for skin substitutes as incident-to-supplies at a flat rate of $125.38 per square cm instead of the current biologicals framework, which allows products to be priced as much as $2,000 per square inch. Medicare spending on these cellular and tissue-based products that treat chronic wounds jumped from $252 million in 2019 to more than $10 billion in 2024. The proposal would categorize skin substitutes by their FDA regulatory status and aims to incentivize products with clinical evidence while saving billions in taxpayer dollars. Industry stakeholders have until September 12 to provide comments, with manufacturers warning the cuts could limit patient access and reduce innovation while advocacy groups support the cost-control measures. Source: MedPage Today

Mergers & Acquisition

  • Healthcare mergers and acquisitions demonstrate resilience in 2025, with transaction levels nearly double pre-2020 volumes despite economic and regulatory challenges. Private equity participates in roughly 40% of healthcare transactions, driven by large reserves of undeployed capital and urgency to generate returns. Behavioral health and home health/hospice sectors remain top targets for deals, while revenue cycle management and infusion therapy show increased momentum due to their tech-enabled potential and operational scalability. The Federal Trade Commission and state attorneys general have heightened scrutiny around private equity ownership and market concentration, slowing deal timelines but not halting activity. Organizations now conduct annual strategic portfolio reviews instead of three- to five-year planning cycles, with many preparing to bring deals to market for the remainder of 2025. Source: Modern Healthcare

Transgender Care

  • Physician groups must evaluate tax efficiency, legal structure, and compliance issues before considering strategic transactions to avoid pitfalls and devaluation. Medical practice consolidation has increased in recent years with lucrative valuations, but groups need consensus before exploring transactions—full consensus for smaller groups of 2-4 physicians and substantial consensus of 80% or more for larger groups of 5-30+ physicians. Groups must agree on proceeds allocation early and address compliance issues including monthly exclusion checks, Stark/DHS compliance, HIPAA policies, co-pay waiver violations, and employee classification problems. Real estate leases between physician owners and practices should reflect fair market value terms rather than friendly arrangements. Engaging experienced healthcare transaction attorneys and advisors is crucial for proper advance planning and positioning. Source: Medical Economics