At O’Connell & Aronowitz, we provide legal advice and representation to all laboratories including clinical, toxicology, anatomic pathology, physician office and IVF laboratories throughout the country. Our seasoned team handles the full array of laboratory legal matters from the routine to complex and guides clients through federal and state laws and regulations. Laboratories must constantly adapt to new legal and competitive challenges and respond to new developments in technology and science. Attorneys in our firm have been representing laboratories for almost 40 years.
Contracts, Corporate Formation and Relationships
We have assisted laboratories in structuring business relationships to best suit their needs, goals, and resources, developing sales and marketing practices and providing compliance advice regarding the federal Anti-Kickback Statute, the Stark Law, the False Claims Act, Eliminating Kickbacks in Recovery Act, and corollary state laws. We regularly advise clients regarding corporate compliance and prepare compliance manuals and policies and procedures. We represent laboratories in various transactional matters, including sales, purchases, mergers and affiliations and performing necessary due diligence.
Litigation and Audits
We regularly represent laboratories in state and federal criminal proceedings, civil litigation, and administrative proceedings, as well as payor and governmental investigations and audits. We counsel clients in the preparation and submission of self-disclosures to the OIG, CMS and state prosecutorial agencies.
Data and Privacy Security
We regularly advise clients on HIPAA, as well as other applicable state and federal privacy and data security laws.