Clinical Laboratories

Our attorneys are well versed in the unique challenges facing clinical laboratories.  We understand that the Clinical Laboratory Improvement Amendments (CLIA), which address laboratory practices, are only the beginning of the many requirements for laboratories, and that with the increase in laboratory testing (Medicare reports a 92% increase in payment for lab tests between 1998 and 2008) labs will likely see a rise in scrutiny.

Our healthcare attorneys are experienced at working with clinical laboratories on a variety of issues.  We understand the reimbursement and documentation challenges faced by labs because physicians can order any tests they believe are appropriate, but Medicare will only pay for those tests which are covered, reasonable and necessary.  Our healthcare attorneys are experienced in working with laboratories on a variety of issues including:

  • Compliance

  • Under arrangement issues

  • Physician office laboratories

  • Interpretation of laboratory conditions of participation

  • Corrective action plans in response to deficiencies

  • DAB appeals for licensure revocation issues

  • Medicare reimbursement and appeals

  • Audits

  • Contract issues

  • Anti-Kickback, Stark, and False Claims Act

  • HIPAA compliance

By working now to ensure compliance with federal laws and regulations and staying abreast of changes, it can lessen the effect of an audit or investigation.