FacultyFaculty/Author Profile

Robert J. Rossi, Esquire

Calloway Laboratories, Inc.
Vice President & Chief Compliance Officer
Woburn, MA, USA


ROBERT J. ROSSI, ESQUIRE
VICE PRESIDENT – CHIEF COMPLIANCE OFFICER

Serve as a trusted legal and business advisor to C-level leaders, the Board of Directors, and other members of executive management. As a key member of the senior leadership team, oversee legal, contracting, audit, regulatory and compliance activities. 15+ years of progressively responsible legal, managerial, and planning experience in a highly regulated industry; broad based knowledge of healthcare standards with demonstrated expertise in regulatory requirements and preparation of legal documents. Competently address sensitive situations in a dynamic and changing environment. Exceptional communicator who generates stakeholder consensus for the adoption of new ideas. Strong record of personal and professional accomplishments.

Strengths include:

  • Healthcare Compliance & Investigations
  • Commercial Transactions
  • Contract Drafting & Negotiations
  • Risk Analysis & Mitigation
  • Litigation Management
  • Outside Counsel Oversight
  • Foreign Corrupt Practices Act (FCPA)
  • EU Data Privacy
  • Gap Analysis
  • Board & Executive-Level Communications

PROFESSIONAL EXPERIENCE

CALLOWAY LABORATORIES, INC., Woburn,  MA
Vice President & Chief Compliance Officer
2013 - Present

  • Develop, initiate, maintain, and revise policies and procedures for the general operation of the Compliance Program and its related activities to help prevent illegal, unethical, or improper conduct.  Manage day-to-day operation of the Program.
  • Direct, oversee, and control legal activities and functions and help ensure protection of the organization from legal action.
  • Key member of leadership team in providing company officers and directors with guidance in identifying critical problems and applying legal principles to minimize risk.
  • Develop and periodically review and update Standards of Conduct to help ensure continuing currency and relevance in providing guidance to management, board, and employees.
  • Collaborate with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.
  • Manage outside counsel.
  • Respond to alleged violations of laws, rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develop and oversee a system for uniform handling of such violations.
  • Management of all external contracts, agreements, and language related to: licensing, counsel, leases, financing/loans, information technology/software, equity investment, suppliers, confidentiality, service, employment, corporate governance (board & shareholder matters),employment law, intellectual property, adherence to state law, consulting, marketing & sales materials, etc.
  • Act as an independent review and evaluation body to help ensure that compliance issues/concerns within the organization are being appropriately evaluated, investigated and resolved.
  • Monitor, and as necessary, coordinate compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Identify potential areas of compliance vulnerability and risk; developed/implemented corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
  • Provide reports on a regular basis, and as directed or requested, to keep the Board and senior management informed of the operation and progress of compliance efforts.
  • Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
  • Established and provide direction and management of the compliance Hotline.
  • Institute and maintain an effective compliance communication program for the organization, including promoting (a) use of the Compliance Hotline; (b) heightened awareness of Standards of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.
  • Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as on-going training for all employees and managers.
  • Monitor the performance of the Compliance Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness.

Highlighted Achievements:

  • Monitor the Company’s Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) and state settlement with the Massachusetts Office of Attorney General (OAG).

LAKEWOOD PATHOLOGY ASSOCIATES, INC., (dba PLUS Diagnostics), Collegeville, PA 
Senior Vice President, General Counsel
2010 - 2012

Direct the legal efforts and ensure regulatory compliance for this CLIA-certified cytology, histology, and molecular pathology laboratory. Provide ongoing legal guidance to finance, IT, operations, medical, sales and marketing, client service, and managed care departments. Serve as secretary at quarterly Board of Director meetings. Draft and negotiate various contracts, including non compete agreements, separation agreements, and technology contracts. Manage commercial transactions with vendors and physicians, and compliance audits. Oversee the outside counsel budget. Conduct legal research and analysis.

Highlighted Achievements:

  • Developed the legal function for the company, successfully eliminating the need for various outside counsel law firms. Efforts drove stability and improved the company’s ability to manage legal affairs more efficiently and effectively.
  • Substantially reduced outside counsel legal spend by $80K per month.
  • Engaged an external compliance consultant to facilitate an internal compliance audit.

QUEST DIAGNOSTICS INCORPORATED, Collegeville, PA 1999-2010
Senior Corporate Counsel (2005-2010); Corporate Counsel (2001-2005); Compliance Attorney
1999 - 2001

Assumed increasing levels of responsibility via promotion during an 11-year tenure for this Fortune 500 provider of clinical laboratory services with more than $7.5B in revenue. Advised internal clients on healthcare matters, including complex commercial transactions, and regulatory and compliance reviews. Handled federal government contracts, including Department of Defense (DoD) and Veteran’s Administration. Provided guidance as part of supporting the national contracts team with group purchasing organizations, hospital accounts, and hospital lab management arrangements. Managed high profile litigation and investigations in connection with Major League Baseball and Olympic athletes. Led compliance audits and performed internal investigations. Provided legal advice on international trade regulations and the Foreign Corrupt Practices Act (FCPA). Supervised 2 attorneys.

Highlighted Achievements:

  • Developed and implemented an international compliance program, including EU data privacy, export controls, and FCPA. Customized compliance policies for facilities in India and Mexico, and created compliance policies for medical device subsidiaries.
  • Assisted the company with enrollment onto the Federal Supply Schedule (FSS).
  • Assisted with due diligence for company acquisitions and provided post-acquisition support.
  • Advised on federal and state healthcare fraud and abuse laws, including federal and state Anti-Kickback statutes, Discount Safe-Harbor, GPO Safe-Harbor, Stark Self-Referral, Personal Services Safe-Harbor, Antitrust, Medicare/Medicaid billing and reimbursement issues, Data Privacy, EU Data Privacy, and HIPAA.
  • Traveled domestically and internationally to audit company laboratories and business practices in collaboration with the internal audit team and external auditors.
  • Trained sales staff regarding legal and compliance guidelines and policies, including contract, FCPA, export controls, antitrust, and fraud and abuse.
  • Advised and provided legal support to the Hospital Services Division, a billion dollar segment of the company; counseled leadership on complex commercial transactions.

OFFICE OF ATTORNEY GENERAL PENNSYLVANIA, Harrisburg, PA + Philadelphia, PA
1996-1999

Chief Deputy Attorney General – Director of Medicaid Fraud (1998 - 1999)

Originally contributed as the Deputy Attorney General in the asset forfeiture unit ultimately promoted to Chief Deputy Attorney General of Medicaid fraud. Managed 4 fraud auditors, 8 attorneys, special agents, and administrative staff. Investigated and prosecuted Medicaid fraud, as well as patient abuse and neglect cases. Conducted training for care dependent healthcare organizations on the Neglect of a Care Dependent Person Act.

Highlighted Achievements:

  • Achieved the first successful prosecution in the State of Pennsylvania under the Neglect and Abuse of a Care Dependent Person statute.
  • Arrested and prosecuted 6 state employed physicians at the Polk Center, the state's largest of 8 institutions for the mentally retarded for negligent care that led to the deaths of 3 patients.

Deputy Attorney General, Attorney-In-Charge – Eastern Regional Office
Medicaid Fraud Control Section (1998); Deputy Attorney General (1997 - 1998)

Supervised Eastern Region attorneys, conducted investigations, and handled resulting prosecutions. Worked with special agents and fraud auditors in the development of criminal cases, including investigations into abuse and neglect of care dependent persons. Facilitated statewide abuse and neglect training. Utilized the statewide investigatory grand jury.

Asset Forfeiture and Money Laundering Section (1996-1997)

Handled civil litigation of asset forfeiture cases pursuant to the Controlled Substances Forfeitures Act throughout a 10-county Pennsylvania assigned region. Utilized the civil discovery rules, providing for depositions, interrogatories, and production of documents. Supervised money laundering investigations and resulting prosecutions.

OFFICE OF THE DISTRICT ATTORNEY, DELAWARE COUNTY COURTHOUSE, Media, PA
1990 - 1996

Supervising Assistant District Attorney, Juvenile Division (1996); Assistant District Attorney, Trial Team Assistant (1991-1996)

Prosecuted criminal matters in the Juvenile Division. Supervised and delegated cases to Assistant District Attorneys in prosecuting juveniles. As a trial team assistant, prosecuted felony and misdemeanor jury and non-jury trials. Tried over 50 jury trials, which included homicides. Utilized county investigatory grand jury. Legal Intern (’90-’91)

EDUCATION & ADDITIONAL INFORMATION

TEMPLE LAW SCHOOL, Philadelphia, PA
Juris DoctorDean’s List

TEMPLE UNIVERSITY, Philadelphia, PA
Bachelor of Arts, Criminal Justice
Former Board Member, College of Liberal Arts Alumni Association

Admissions:
Pennsylvania Bar; US District Court, Eastern District of Pennsylvania

Certification:
Six Sigma Green Belt

Affiliations:
American Health Lawyers Association; Association of Corporate Counsel; Pennsylvania Bar Association; Montgomery County Pennsylvania Bar Association

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