Dan Fundakowski helps health care and life sciences organizations turn complex regulatory, compliance and enforcement issues into clear, actionable strategy. Hospitals, health systems, academic medical centers and life sciences companies rely on his guidance to manage risk, respond to regulatory scrutiny and keep operations aligned with evolving legal requirements.

Dan’s practice spans day-to-day regulatory counseling, compliance program development, government investigations and transactional regulatory strategy. His practice includes:

Regulatory and Compliance Counseling

• Anti-Kickback Statute, Stark Law, False Claims Act and Civil Monetary Penalties Law
• Human subjects research regulations and the Food, Drug and Cosmetic Act
• State fraud, pricing transparency and marketing laws
• Value-based care arrangements, provider compensation models and population health collaborations
• Compliance program design, training, Corporate Integrity Agreements and post-resolution monitoring
• Licensure, telehealth and scope-of-practice issues, including advocacy before state boards and oversight agencies

Government Investigations, Audits and Enforcement

• Internal investigations and audits involving compliance, billing practices and risk adjustment integrity
• Overpayment self-disclosures and responses to government inquiries
• Investigations and enforcement actions involving the Anti-Kickback Statute, False Claims Act, Controlled Substances Act and other fraud and abuse laws
• DOJ, HHS, CMS, FDA, state attorney general and government contractor inquiries
• Reimbursement and coverage disputes, RADV audits and CMS program integrity reviews
• Matters involving off-label promotion, kickback allegations, research misconduct, billing fraud, cost mischarging and pricing data reporting

Transactional Regulatory Counseling

• Regulatory strategy and risk assessment in mergers, acquisitions, joint ventures, affiliations and other transactions
• Transactions involving providers, payors and private equity sponsors
• Structuring collaborations and arrangements to align with federal health care program requirements