Health Care Compliance / Fraud and Abuse

The Robinson+Cole Health Law Group has extensive experience with all facets of health care compliance and fraud and abuse issues. We have provided compliance counsel and assistance and representation for publicly traded, privately held, nonprofit, for-profit, and other health care provider entities, including hospitals, physician hospital organizations, physician groups and individual practices, home health care and nursing home providers, dialysis suppliers, and others involved in health care delivery. Robinson+Cole lawyers have extensive experience assisting health care providers with the full spectrum of health care compliance, audits, self-reporting, and fraud and abuse analysis and defense issues. We have assisted a broad range of clients with the development and ongoing operation and review of compliance programs, compliance initiatives, and other responses to the rapidly changing health care regulatory landscape. Such assistance ranges from providing advice and counsel on health care compliance on specific issues to determine whether an appropriate compliance response or corrective action may be necessary to responding to fraud and abuse investigations.

Robinson+Cole assists clients in establishing and evaluating compliance programs with particular focus on federal and state fraud and abuse false claims acts, the Stark law, and other compliance-related matters. Such counseling includes internal counseling and review in a preemptive manner, as well as responding to investigations and other enforcement initiatives. Robinson+Cole has assisted clients to assess appropriate structures for compliance programs, including development of written policies and procedures, development of compliance training programs and initiatives, and periodic review and redesign of monitoring and reporting systems.

Given the broad depth of experience of our health care lawyers, we have assisted clients with reviewing and developing of a number of voluntary self-disclosure matters as well as responding to investigative subpoenae and other enforcement actions. While focused on prevention before issues arise, Robinson+Cole is also well positioned to respond to government investigations and audits that are becoming increasingly prevalent in the highly regulated health care marketplace.

In addition, Robinson+Cole counsels clients in transactions to ensure compliance with federal, state, antikickback, and physician self-referral laws. Such experience and background allows us to counsel clients on structuring compliant arrangements at the start of negotiations and as transactions proceed.

    • Experience
      • Regular representation of hospitals, integrated delivery systems, nursing homes, continuing care retirement communities, physician groups, outpatient clinics and other health care providers as outside general counsel. Regularly advise these clients in matters of corporate governance, contracts, regulatory compliance, corporate compliance, risk management, policies, fundraising and tax exemption, employment, labor and litigation. Work closely with senior management and/or general counsel in transactional and day-to-day risk management and operational issues.
      • Representation of tissue bank in connection with negotiations and drafting of distribution, supply, licensing, representation and other agreements; acquisition of substantially all of the assets of another tissue bank; creation of domestic and international joint venture; subsidiary arrangements for the provision of certain tissue products and services; and certain regulatory matters.
      • Regular representation of hospitals in connection with physician recruitment and retention matters, including advice regarding Stark exceptions, Anti-kickback safe harbors and tax exemption restrictions and drafting of income guarantees, loan forgiveness arrangements and employment agreements.
      • Representation of hospital in connection with formation of professional corporation for employment of physicians in private practice model.
      • Regular representation of hospitals and physician groups in connection with physician and mid-level provider employment agreements, including advice regarding Stark and Anti-kickback statute compliance, incentive compensation and gainsharing issues.
      • Regular advice to and representation of clients in proceedings before the Connecticut Department of Social Services regarding financial audits, administrative sanctions and Title XIX appeals.
      • Representation of one of Connecticut’s largest providers of home health services in connection with a multi-agency federal and state investigation into the company’s billing practices. Worked closely with the client to conduct an internal investigation of the agency’s billing processes to identify potential areas of exposure and to develop a comprehensive corporate compliance program. Successfully persuaded the United States Attorney’s Office not to pursue charges and to issue a formal declination letter.
      • Representation of a hospital network and behavioral health center in an investigation of billing practices brought by the Federal Bureau of Investigation and the Office of the Inspector General.
      • Representation of a Connecticut hospital in connection with quality of care investigation by the Connecticut Department of Public Health. Prepared and defended witnesses in interviews with state investigators, coordinated all aspects of compliance with document demands, and appeared in related individual licensure hearings on behalf of the facility.
      • Regular representation of hospitals, outpatient clinics, nursing homes and physician groups in connection with service contracts, including without limitation, contracts with providers of durable medical equipment, pharmacy, clinical laboratory, infusion services and staffing services.
      • Representation of an emergency medical service corporation and principals in criminal investigation involving potential Medicare fraud. Avoided prosecution and termination of Medicare participation status through negotiated resolution of civil monetary penalties.
      • Regular representation of institutional health care providers in connection with financial audits and quality of care investigations relating to the Medicaid and Medicare programs conducted by the Connecticut Department of Social Services and the Connecticut Department of Public Health.
      • Regular representation of not-for-profit health care providers in connection with corporate reorganizations, governance issues and revisions to corporate governance documents.
      • Representation of home care agency in connection with acquisition of the assets of another home health care agency.
      • Representation of hospital in the development of a managed residential community and the licensing of an assisted living services agency, including without limitation, development of the assisted living services agreement, development and negotiation of a management agreement and development of policies.
      • Representation of joint venture between tax exempt hospital and physicians in connection with development and operation of ambulatory surgery center, including drafting Operating Agreement, drafting private placement memorandum and subscription agreements, fraud and abuse analysis, and drafting and negotiating land option agreement and lease, management agreement and anesthesiology service agreement.
      • Representation of physician group in the formation of a joint venture with a hospital for outpatient radiology services, including drafting and negotiation of an Operating Agreement, management agreement, billing services agreement, imaging services agreement and lease agreement.
      • Regular representation of hospitals in connection with exclusive professional service agreements for radiology, anesthesiology, pathology and radiation oncology.
      • Regular representation of hospitals, community providers and physician groups in connection with corporate compliance plans.
      • Regular advice to hospitals regarding issues involving EMTALA, including compliance and EMTALA’s physician on call requirements.
      • Representation of a nursing home in connection with a complete revision of its Medical Staff Bylaws and Rules and Regulations, including revisions to ensure compliance with applicable statutes, regulations and accreditation standards of agencies such as Joint Commission on Accreditation of Health Care Organizations, Centers for Medicare and Medicaid Services and the Connecticut Department of Public Health.
      • Representation of a continuing care retirement community in connection with restructuring and revising their continuing care contracts.
      • Representation of physician hospital organization in connection with purchase of electronic medical record hardware and software, including fraud and abuse and tax exemption advice regarding donation of electronic medical record software and services by a hospital to physicians, structuring the transactions between the physician hospital organizations and the physician users and hospital donor and drafting and negotiating all contracts with the electronic medical record vendor and the physician users.
      • Representation of hospital in connection with acquisition of middleware software for electronic health records, including fraud and abuse and tax exemption advice in connection with the donation of such software to physicians.
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    • News
      • September 21, 2022

        Conor Duffy and Ben Daniels Author Article on Second Circuit Interpretation of the Anti-Kickback Statute for Physicians Practice

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      • June 12, 2017

        Pam Del Negro Writes Article for Compliance Today

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      • December 11, 2013

        Robinson & Cole Elects Four New Partners and Promotes Six Counsel

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      • November 1, 2013

        Robinson & Cole Receives 34 First-Tier Metropolitan Rankings and Three National Rankings in U.S. News – Best Lawyers Survey

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      • October 21, 2013

        Super Lawyers® Names 61 Robinson & Cole Attorneys to 2013 List

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      • September 3, 2013

        Hartford Office Lawyers Elected to Executive Committee of CBA's Young Lawyers Section

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      • August 16, 2013

        Robinson & Cole Receives Top Listing in Connecticut Attorney Count in Best Lawyers National Peer Review Survey

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      • June 10, 2013

        Chambers USA Ranks Robinson & Cole in Five Practices, Names 17 Attorneys as Leading Lawyers

      • February 11, 2013

        Ted Tucci Quoted in Law360 Article for Health Law

      • December 21, 2012

        Robinson & Cole Attorneys Appointed to Board of Directors of Nonprofits

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      • November 7, 2012

        Robinson & Cole Receives 32 First-Tier Metropolitan Rankings and Four National Rankings in U.S.News - Best Lawyers Survey

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      • October 22, 2012

        Super Lawyers® Names 49 Robinson & Cole Attorneys to 2012 List and Recognizes 26 as Rising Stars

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      • August 28, 2012

        Robinson & Cole Receives Top Listing in Connecticut Attorney Count in Best Lawyers National Peer Review Survey

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      • August 2, 2012

        Ted Tucci on Panel Discussion about the Supreme Court’s Ruling on Health Care

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      • June 30, 2012

        Theodore J. Tucci to Participate in the Metro Hartford Alliance’s Panel Discussion on the U.S. Supreme Court’s Ruling on Health Care Reform

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      • June 7, 2012

        Chambers USA Ranks Robinson & Cole in Five Practices, Names 16 Attorneys as Leading Lawyers

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      • January 19, 2012

        Robinson & Cole Welcomes New Health Law Attorneys

      • October 19, 2011

        Class Dismissed! Appellate Team Wins Summary Judgment for Health Insurer

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      • June 17, 2011

        Chambers USA Ranks Robinson & Cole in Six Practices, Names 12 Attorneys as Leading Lawyers

      • June 14, 2011

        Health Law Attorneys Publish ACO Regulations Article in Connecticut Law Tribune

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      • June 8, 2011

        Robinson & Cole Attorneys Present Webinar on Accountable Care Organizations (ACOs)

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      • May 13, 2011

        Attorneys Present Webinar on Accountable Care Organizations

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      • May 5, 2011

        Robinson & Cole Attorneys Present Medicaid Audit Defense Seminar

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      • December 15, 2010

        Health and Benefits Litigators Win “Appropriate Care” Disability Insurance Case

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      • December 6, 2010

        Health Care Attorneys Talk Strategy with Hospitals

      • November 1, 2010

        VNA Health Care Elects Attorney to Board of Directors

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      • September 17, 2010

        Robinson & Cole LLP Receives Most Connecticut First-Tier Rankings in Inaugural U.S.News - Best Lawyers Survey

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      • August 12, 2010

        Health Law Group Hosted Webinar on New Electronic Health Record Requirements

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      • June 14, 2010

        Robinson & Cole Partner Quoted in Hartford Business Journal on Health Care Reform Impact to Local Businesses

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      • June 4, 2010

        Robinson & Cole Attorneys Author CT Law Tribune Article on Expansion of Fraud and Abuse Laws Under Reform Legislation

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      • May 20, 2010

        Robinson & Cole Attorneys Featured in Health Care Reform Book

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      • April 28, 2010

        Robinson & Cole Attorney Speaks at Regional Economic Development Forum

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      • October 12, 2009

        Connecticut Governor Appoints Robinson & Cole Attorney to Advisory Committee

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    • Publications + Presentations
    • "DOJ Guidance: Focus on Integrating Compliance and Business Operations," published in Compliance Today, authored by Pamela H. Del Negro (June 2017)
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      "CMS Releases Statement on Progress of EHR Incentive Programs" (12/13/2013)

      "OIG Report Outlines Concerns Regarding Use of Spinal Devices Provided by Physician-Owned Distributors" (12/11/2013)

      "Developing an Accountable Care Organization; Participating in the Medicare Shared Savings Program," presented at Connecticut Healthcare Financial Management Association Seminar, co-presented by Brian D. Nichols and Meaghan Mary Cooper (11/20/2013)

      "Compliance Date of HIPAA Omnibus Rule Approaching" (08/08/2013)

      "CT DSS Notifies Providers They Must Enroll in Medicaid to Serve Medicaid Beneficiaries" (08/01/2013)

      "OIG Issues Advisory Opinion Permitting Podiatrist-Owned Orthotics Business" (07/30/2013)

      "CT Health Law Legislative Update" (07/16/2013)

      "CT Health Law Legislative Update Supplement" (07/16/2013)

      "Health Law Pulse" (06/26/2013)

      "OIG Releases Revised Provider Self-Disclosure Protocol" (05/07/2013)

      "OIG Releases Special Fraud Alert and EHR Donation Sunset Date" (04/12/2013)

      "CMS Releases Final Sunshine Act Rule" (03/12/2013)

      "Implications of the Final HIPAA Omnibus Rule," co-presented by Brian D. Nichols, Meaghan Mary Cooper and Michael J. Kolosky, webinar (3/5/2013)

      "FTC Issues Favorable Advisory Opinion to Clinically Integrated PHO" (02/28/2013)

      "OIG Issues Advisory Opinions" (02/20/2013)

      "HIPAA Omnibus Rule Released" (02/13/2013)

      "CT AG Consolidates Antitrust and Health Care Fraud Units" (01/22/2013)

      "HHS-OCR Guidance for De-identifying PHI Under HIPAA" (12/18/2012)

      "OIG: Per Diem Call Coverage Payment Not Subject to Sanctions" (12/06/2012)

      "OIG Workplan for Fiscal Year 2013" (10/30/2012)

      "CT DSS Issues Proposed Audit Regulations" (10/18/2012)

      "Service Line Co-Management Arrangements: Models & Practicalities," published in ABA Health eSource, authored by Pamela H. Del Negro (10/2012)

      "Health Law Pulse" (09/27/2012)

      "CT Health Law Special Legislative Session Update" (07/25/2012)

      "NLRB Finds Hospital's No-Access Policy for Off-Duty Employees Unlawful" (07/16/2012)

      "Patient Protection and Affordable Care Act," presented by Theodore J. Tucci (7/10/2012)
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      "New Regulations for Hospital Conditions of Participation" (07/09/2012)

      "Supreme Court Holds Patient Protection and Affordable Care Act Constitutional" (06/29/2012)

      "CT Health Law Legislative Update" (06/11/2012)

      "Health Law Pulse" (06/01/2012)

      "OSHA Focuses on Nursing and Residential Care Facilities" (04/23/2012)

      "CMS Issues Proposed Rule on Stage Two Meaningful Use" (03/13/2012)

      "Health Law Pulse" (03/01/2012)

      "Federal Agency Guidance on ACOs Released" (11/22/2011)

      "Accountable Care Organizations Final Regulations Released" (11/09/2011)

      "Health Law Pulse" (10/18/2011)

      "CT Health Law Legislative Update Part 2" (08/19/2011)

      "CT Health Law Legislative Update Part 1" (07/14/2011)

      "Health Law Pulse" (06/24/2011)

      "New Entities Will Coordinate Medicare Coverage," published in Connecticut Law Tribune, co-authored by Pamela H. Del Negro and Meaghan Mary Cooper (5/16/2011)

      "Guidance Released on Accountable Care Organizations Participating in the Medicare Shared Savings Program" (05/13/2011)

      "Finally! Some Enlightenment on Accountable Care Organizations: Proposed Rules Issued," co-presented by Lisa M. Boyle and Kimberly E. Troland and Moses Vargas (4/27/2011 and 5/4/2011)

      "Legal and Strategic Considerations in Defending Medicaid Audits," at Connecticut Community Providers Association, co-presented by Theodore J. Tucci and Michael J. Kolosky (4/27/2011)

      "Federal Agencies Release Guidance on Accountable Care Organizations" (04/21/2011)

      "Health Law Pulse" (03/10/2011)

      "Horizontal Merger Guidelines Revised" (10/19/2010)

      "Health Law 2010 Legislative Update" (07/15/2010)

      "New "Patient's Bill of Rights" Issued under Patient Protection and Affordable Care Act" (07/07/2010)

      "Health Care Reform Update" (04/12/2010)

      "President Obama Announces New Efforts to Crack Down on Fraud" (03/22/2010)

      "Vermont Supreme Court Upholds Suspension of Physician's License Despite Due Process" (02/12/2010)

      "Recovery Audit Contractor (RAC) Program" (12/28/2009)

      "CMS Issues Memorandum on Compliance with EMTALA During a Potential H1N1 Emergency" (12/28/2009)

      "Massachusetts Court Interprets Mental Health Professional "Duty to Warn Statute"" (12/28/2009)

      "Enforcement of Red Flags Rule Has Been Delayed Again" (11/09/2009)

      "New Connecticut False Claims Act" (11/09/2009)

      "Health Law 2009 Legislative Update" (09/21/2009)

      "Interim Final Regulations Clarify HITECH's Breach of Health Information Notification Requirements" (09/03/2009)

      "Enforcement of Red Flags Rule Has Been Delayed" (07/30/2009)

      "HHS Issues Guidance on Technologies and Methodologies that Render Protected Health Information Secure" (07/29/2009)

      "Enforcement of Federal Trade Commission Red Flag Rules Delayed" (05/19/2009)

      "Health Care Entities that Extend Credit to Patients Must Implement Identity Theft Prevention Program" (04/27/2009)

      "Health Care Implications of Federal Stimulus Plan" (03/09/2009)

      "Red Flag Rules' Effective Date Has Been Delayed" (10/24/2008)

      "Health Law 2008 Legislative Update" (09/03/2008)

      "A Guide to Connecticut’s Certificate-of-Need Process," published in Connecticut Medicine Magazine, co-authored by Brian D. Nichols and Theodore J. Tucci (June/July 2008)

      "Health Law Pulse" (06/11/2008)

      "The Joint Commission Suspends the Implementation of Revised Standard MS 1.20" (06/11/2008)

      "CT Department of Public Health Adopts New Regulations for Reporting Adverse Events within Hospitals and Outpatient Surgical Facilities" (02/29/2008)

      "Health Law Pulse" (11/06/2007)

      "Health Law Pulse" (08/09/2007)

      "Health Law Pulse" (06/27/2007)

      "Health Law Pulse" (04/19/2007)

      "Health Law Pulse" (03/26/2007)

      "Health Law Pulse" (02/15/2007)

      "Health Law Pulse" (11/27/2006)

      "Health Law Pulse" (07/31/2006)

      "Health Law Pulse" (06/20/2006)

      "Health Law Pulse" (05/24/2006)

      "e-News" (08/24/2005)

      "e-News" (06/10/2005)

      "e-News" (03/29/2005)

      "e-News" (11/22/2004)

      "e-News" (10/08/2004)

      "e-News" (09/20/2004)

      "e-News" (08/09/2004)

      "e-News" (04/06/2004)

      "e-News" (11/10/2003)

      "e-News" (09/25/2003)

      "Confidentiality," at Mental Health and the Law, A Health Education Network program, presented by Meaghan Mary Cooper

      "Medical Records Law," at Lorman Education Services program, presented by Meaghan Mary Cooper (3/14/2013; 4/11/2012)

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