Representative Clients Include
pharmacy chains
hospitals
physician practices
Durable medical equipment suppliers
long-term care providers
pharmaceutical companies
biotech companies
medical device companies
healthcare information technology companies
pharmaceutical distribution companies
Experience
Counsel on defense team in DOJ health care fraud investigation of patient assistance program.
Regulatory counsel on defense team for nationwide pharmacy chain in health care fraud investigation by HHS/OIG and DOJ.
Counsel on defense team for medical device company in health care fraud investigation by DOJ. Negotiated and helped client manage obligations of Corporate Integrity Agreement.
Represented pharmaceutical company in a qui tam False Claims Act investigation and persuaded government not to intervene.
Counsel on defense team for hospital system in qui tam False Claims Act litigation.
Represent clients in ZPIC and other Medicare audits, pre-pay reviews, billing number deactivations and other enforcement actions.
Obtained a favorable advisory opinion from the OIG regarding a hospital’s contracting arrangements with physicians in the ER.
Negotiate, implement and work closely with clients in managing obligations under Corporate Integrity Agreements including ongoing advice regarding IRO audits and reviews.
Develop, implement, and maintain healthcare compliance programs for several pharmaceutical companies, medical device companies, physician practices, and healthcare technology companies, including developing corporate policies, conducting training and education of management and sales forces, and conducting compliance reviews.
Serve on client compliance committees.
Advise clients on day to day regulatory issues in federal health care programs including fraud and abuse, reimbursement and compliance.
Independent compliance consultant, approved by the U.S. Securities and Exchange Commission, to a biotechnology company found by the SEC to have violated Section 16 of the Securities and Exchange Act. Responsibilities included conducting a comprehensive review of existing systems and procedures, making recommendations to prevent future problems, and reporting findings to the SEC annually for two years.