Laboratories

Laboratories are under intense scrutiny by payors, as well as state and federal governmental regulators. Arrangements that involve payor-exclusive and/or preferred provider relationships, and payor efforts to steer members to “preferred” labs, must be carefully weighed in order to protect their client base and ensure viability. In order to secure, maintain and grow market share, Laboratories must not only evolve to adopt innovative structures and pursue compliant alignments with physicians and hospitals, but also remember to pay attention to a myriad of legal pitfalls.

Frier Levitt attorneys have significant experience representing independent, physician-office and hospital-affiliated Laboratories and are able to guide them in all aspects of business, including:

  • Laboratories doctor looking into microscopeFormation, Structuring, Licensing, Financing, and Billing
  • Regulatory Compliance including: Health Insurance Portability and Accountability Act (HIPAA), Stark Law, Anti-Kickback Statute, False Claims Act, Clinical Laboratory Improvement Amendments (CLIA), and Civil Monetary Penalties Law
  • Food and Drug Administration (FDA) compliance
  • Audits
  • Criminal matters
  • Anti-trust matters
  • Commercial litigation
  • Payor relations, contracting, and litigation
  • Government relations
  • Group Purchasing Organization (GPO) relationships
  • Business arrangements, Mergers and Acquisitions
  • Employment and Personnel matters
  • Marketer relationships
  • Physician/Hospital alignment
  • Real Estate matters
  • Draw Stations/Patient Service centers
  • Intellectual Property

Frier Levitt attorneys carefully monitor industry trends and governmental initiatives, including prosecutorial focuses, in order to apprise their Laboratory clients of ways in which they can remain competitive, exploit business opportunities, and avoid/reduce the likelihood of scrutiny and prosecutions. Contact us today to speak to an attorney.