Dave Gacioch counsels clients across the healthcare industry and beyond on compliance and risk management issues. He also assists clients in conducting internal investigations and represents them in matters involving government investigations, enforcement actions and civil litigation.
Dave focuses his practice on three key areas: (1) information privacy, cybersecurity and data breach response issues arising under the Health Insurance Portability and Accountability Act (HIPAA) and other laws; (2) fraud and abuse issues arising under the Anti-Kickback Statute and other laws governing federal healthcare programs such as Medicare and Medicaid; and (3) False Claims Act cases brought by whistleblowers or government authorities. Notably, Dave has significant experience helping clients to negotiate, and to operate under, corporate integrity agreements (CIAs) and corrective action plans (CAPs).
Dave is one of the leading lawyers in the United States in the area of responding to HIPAA investigations by the US Department of Health & Human Services, Office for Civil Rights or state attorneys general, and negotiating favorable resolutions when such investigations result in allegations of non-compliance by covered entities or business associates.
Dave also has particularly deep knowledge of the fair market value issues that frequently arise in healthcare compliance and other contexts. He has worked extensively alongside (and opposite) experts from numerous leading valuation firms in the contexts of compliance counseling, investigations, litigation and arbitration, including with respect to „remuneration“ issues under the Anti-Kickback Statute and litigation/arbitration damages issues.
As a former advanced emergency medical technician and ambulance service officer, Dave brings a provider’s perspective to the practicalities of healthcare compliance, which allows him to grasp issues quickly and to communicate them effectively both to and on behalf of providers.
Dave regularly writes and lectures on issues such as breach response, enforcement and litigation issues related to privacy and data protection. Dave also has significant trial, litigation and arbitration experience, and has performed extensive pro bono work.
Previously, Dave served as law clerk to the Honorable Ernest C. Torres, Chief Judge of the US District Court for the District of Rhode Island.
Representing a leading global healthcare company in responding to and successfully resolving a four-year multifaceted federal investigation into alleged kickbacks to patient referral sources and false claims for reimbursement, along with parallel civil qui tam action under the False Claims Act
Helping the same company to negotiate, implement and operate under the terms of a corporate integrity agreement with the Office of Inspector General for the US Department of Health & Human Services (HHS)
Counseling a major healthcare services company with respect to fair market value and other issues on hundreds of millions of dollars‘ worth of mergers and acquisitions (M&A) transactions with potential sources of patient referrals
Representing an academic medical center in responding to two HIPAA compliance investigations conducted by the HHS, Office for Civil Rights and negotiating a favorable settlement resolving both investigations
Securing very favorable (including „no-action“ and „technical assistance only“) outcomes for several hospitals and other healthcare providers facing data breach-related investigations by state attorneys general and/or the HHS, Office for Civil Rights
Serving as trial counsel for an information technology company in a multimillion-dollar breach of contract, fraud and unfair business practices litigation against one of its vendors
Defending a leading global medical products manufacturer at the London Court of International Arbitration and a Turkish entrepreneur at the International Chamber of Commerce (ICC) International Court of Arbitration in London against multimillion-dollar breach of contract and related claims brought by business partners
Serving as national coordinating counsel for two building products manufacturers with respect to thousands of asbestos product liability claims filed in jurisdictions across the United States
Defending on appeal an order of the US District Court for the District of Massachusetts directing the Massachusetts Department of Corrections to provide inmates with access to weekly religious services (Crawford v. Clarke, 578 F. 3d 39 (1st Cir. 2009))
Obtaining compensation from the Commonwealth of Massachusetts for an individual who had served a 40-month prison sentence in the mid-1980s for an armed robbery that he did not actually commit
Securing favorable outcomes for several indigent federal criminal defendants facing charges related to narcotics distribution, gun possession and tax evasion
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