Daniel C. Fundakowski

Regulatory and Compliance Strategy

• Led regulatory strategy for a multibillion-dollar hospital system in connection with a DOJ investigation and lawsuit alleging violations of the Stark Law, the AKS, and the FCA. Dan guided leadership on physician compensation realignment, compliance infrastructure enhancements, and the negotiation and implementation of a Corporate Integrity Agreement.
• Supported hospitals and health systems on compliance with federal rules governing human subjects research, CME and grant-funded collaborations, and implementation of regulatory safeguards under HHS and FDA rules.
• Guided health system on Stark Law and CMP Law compliance in the context of population health initiatives and community-based care programs. Dan conducted internal policy audits and trained executives on referral risk mitigation and safe harbor frameworks.
• Counseled regional and national health insurers on compliance with CMS marketing and sales regulations, risk adjustment program integrity, HIPAA interoperability rules, and RADV audit preparedness. Dan supported enterprise-wide policy development, compliance training, and internal audit strategy across Medicare Advantage and Medicaid lines of business.
• Advised integrated health systems and provider groups on MACRA and Quality Payment Program participation, including MIPS reporting, alternative payment models, and compliance risks related to shared savings, care coordination incentives, and quality-linked compensation.
• Structured provider compensation models and clinical collaborations that align with commercial goals and regulatory risk frameworks (e.g., the Stark Law and the AKS), including value-based care, co-management, and clinical support services.
• Supported enterprise risk assessments related to provider reimbursement and audit exposure, including RADV audits, MAC overpayment findings, and pre-/post-payment review strategy. Dan advised on strengthening compliance auditing functions and documentation workflows.
• Conducted HIPAA compliance reviews and enterprise security risk assessments for integrated delivery networks, with attention to EHR interoperability, data-sharing protocols, and incident response planning.
• Resolved a federal investigation into a pharmaceutical manufacturer's promotional practices without any admission of wrongdoing, by aligning internal policy changes with FDA promotional guidelines and AKS safe harbor principles.
• Advised on regulatory risks under the FDCA, the AKS, and the Sunshine Act related to FDA-regulated product promotion, co-branded communications, patient education, and peer-to-peer marketing strategies.

Investigations and Disputes

• Represented health systems and pharmaceutical manufacturers in FCA, AKS, and FDCA investigations. Dan led internal investigations and prepared self-disclosures to CMS, the OIG, and the DOJ.
• Advised a research university in responding to a lawsuit involving the alleged falsification of federally funded research data. Dan guided internal compliance strategy and risk mitigation tied to research integrity requirements.
• Advised a health system on Medicare reimbursement strategy and audit defense, including appeals before the Provider Reimbursement Review Board. Dan provided counsel on regulatory positioning, documentation standards, and administrative appeal rights involving disallowed cost report items and overpayment recoupment.
• Supported health systems and health insurers in responding to audit findings from UPICs, MACs, and RADV contractors. Dan advised on corrective action planning, documentation improvements, and legal strategy across all phases of the audit and appeal process.
• Counseled a health system through a multi-defendant FCA matter involving alleged violations of the Stark Law, the AKS, and the FCA. Dan advised on institutional exposure, compliance remediation, and parallel strategic affiliations.
• Resolved a federal investigation into a pharmaceutical manufacturer's promotional practices without any admission of wrongdoing.
• Secured a dismissal with prejudice in an FCA lawsuit involving alleged noncompliance with Paycheck Protection Program loan requirements.
• Defended a medical device manufacturer against FCA allegations of fraudulent billing practices and pursued breach-of-contract counterclaims against relators.
• Defended an operator of skilled nursing facilities in parallel investigations by Congress, the OIG, and state attorneys general involving long-term care billing practices.
• Counseled a supplier of wound care products on audit defense and appeal strategy for UPIC audits, including representation through the administrative law judge hearing phase.

Transactional Regulatory Counsel

• Served as regulatory counsel in mergers, joint ventures, and strategic affiliations involving hospitals, academic medical centers, and drug/device manufacturers. Dan evaluated licensure, billing compliance, research regulations, and fraud and abuse exposure.
• Counseled on structuring collaborations to support digital health, research infrastructure, and patient engagement technologies, with attention to federal health program requirements.