Überblick
Dave Gacioch focuses his practice on healthcare litigation and enforcement defense. Dave counsels hospitals, health systems, physician practices, and other providers, along with payors, private equity sponsors, pharmaceutical and medical device manufacturers, and others involved in the US healthcare system, on compliance and risk mitigation issues. He conducts internal investigations for clients, and represents them in government investigations, enforcement actions, and civil and criminal litigation.
Dave has deep experience across a number of key substantive issues, including:
- False Claims Act matters pursued by whistleblowers (qui tam cases) or government authorities;
- Fraud and abuse issues arising under the Anti-Kickback Statute, the Stark Law, and other laws governing federal healthcare programs such as Medicare and Medicaid—especially fair market value (business valuation and professional services compensation) issues;
- Federal and state oversight of controlled substance laws, including defending Drug Enforcement Administration (DEA) investigations;
- Information privacy, cybersecurity and data breach response issues arising under the Health Insurance Portability and Accountability Act (HIPAA), 42 C.F.R. Part 2, and other US federal and state laws;
- Conscience and religious freedom-based investigations of providers by the US Department of Health & Human Services, Office for Civil Rights (HHS-OCR);
- Negotiation of, and compliance with, corporate integrity agreements (CIAs) and corrective action plans (CAPs);
- Response to sentinel events, such as allegations of provider staff abuse of patients— including compliance with real-time administrative and criminal reporting obligations while planning for potential investigative, civil litigation, and community relations impacts downstream; and
- Response to civil investigative demands (CIDs) and subpoenas.
Dave works closely with McDermott’s best-in-class Health Industry Advisory team to provide litigation and enforcement defense representation informed by leading-edge thinking on complex healthcare regulatory issues. As a recent example, Dave is partnering with an expert healthcare regulatory team to counsel clients on their approaches to the many new federal and state funding programs, and other changes in law and regulation, occasioned by the COVID-19/coronavirus public health emergency—including the Provider Relief Fund and accelerated/advance Medicare payments. The team’s work is designed to maximize clients’ ability to participate in appropriate programs, while mitigating downstream audit, enforcement, and litigation risks.
Dave is one of the leading lawyers in the United States in the area of responding to HHS-OCR investigations, whether based upon HIPAA or upon conscience and religious freedom laws, and negotiating favorable resolutions when such investigations result in allegations of non-compliance by covered entities or business associates.
As a former advanced emergency medical technician and ambulance service officer, Dave brings a provider’s perspective to the practicalities of healthcare compliance and risk mitigation, which allows him to grasp issues quickly and to communicate them effectively both to and on behalf of providers.
Additionally, Dave serves as national coordinating counsel for a building products manufacturer in the asbestos product liability litigation.
Dave regularly writes and lectures on the issues referenced above. Dave also has significant trial, hearing, 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.
Ausgewählte Referenzmandate
- Successfully defending the first private healthcare provider against which HHS-OCR tried to take enforcement action over employee conscience and religious freedom issues
- Securing dismissal of a payor/Medicare Advantage organization client from a qui tam False Claims Act case
- Convincing US Attorney’s Offices not to intervene or otherwise pursue healthcare provider and life sciences clients in multiple False Claims Act investigations
- 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 a leading global healthcare 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 multiple healthcare providers facing threats of HIPAA civil monetary penalties from HHS-OCR and negotiating favorable resolutions to such matters
- 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
- 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
Auszeichnungen
- Acritas Stars 2020, listed among independently rated lawyers
- Cornell University, received the Baccalaureate Service Award for academic excellence and contributions to the community as a volunteer firefighter and emergency medical technician while in law school
- Super Lawyers 2013 to 2017, Rising Star
Mitgliedschaften
- Dartmouth Skiway Ski Patrol, Lyme Center, NH, volunteer alpine ski patroller
- Dana Farber Cancer Institute, Boston, MA, volunteer fundraiser and blood donor
- Town Meeting Member, Brookline, MA
- All Saints Parish, Brookline, MA, member of the Stewardship Committee
- Cayuga Heights (NY) Fire Department, former volunteer firefighter and emergency medical technician
Qualifikation
Education
Cornell Law School, JD, cum laude, 2004
Dartmouth College, AB, 2001
Admissions
Massachusetts
Courts / Agencies
US Court of Appeals for the First Circuit
US District Court for the District of Massachusetts