Ober|Kaler’s Health Law Group represents numerous large and small independent clinical laboratories as well as hospitals that offer laboratory services to individuals who are not hospital patients. Our practice also serves laboratories that only offer highly specialized pathology services.
Our attorneys – several of whom have been active in this area since Medicare fee schedules were established as part of the Deficit Reduction Act of 1984 – are extremely knowledgeable regarding legal, regulatory and business issues related to both clinical laboratory and anatomic pathology services.
We assist laboratories on compliance with Medicare, Medicaid and other third-party payment rules, including issues related to Medicare carrier jurisdiction, “bundling” requirements, federal and state direct billing requirements, “shell laboratory” rules, advanced beneficiary notices of non-coverage (ABNs), reassignment issues and Medicaid payment limitations. We also advise clients on compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Medicare enrollment issues. In addition, we represent clients in regulatory disputes related to those issues, including Medicare recoupment actions, CLIA sanctions and revocation of Medicare billing privileges.
Our attorneys review and prepare contract documents related to provision of laboratory and pathology services, and we also advise clients regarding compliance issues related to marketing and financial arrangements with referral sources. We look at compliance issues under the Stark Law, the Federal Anti-Kickback Statute and related state statutes. Our firm also represents laboratory clients who are subject to federal or state investigations.