Regulatory

iStock_000017431133SmallParrish Law Offices works closely with hospitals and health systems; physician practice groups and individual physicians; companies; and academic medical centers on various regulatory, contracting and billing issues.

 

 

We have counseled clients on:

  • Stark, Anti-Kickback, and False Claims issues. We have worked with both entities and individuals on civil and criminal matters relating to marketing and sales practices; ongoing operations; and partnerships, joint ventures, and additional financial transactions. We have provided prospective analysis and planning; responsive representation before agencies; and representation before federal courts, including in qui tam actions.
  • OIG investigations. As part of our efforts to address Stark, Anti-Kickback, and False Claims issues, we have worked with clients both to appropriately avoid and to respond to OIG investigations. We have a depth of familiarity with OIG advisory opinions, enforcement actions, and court cases and have worked with clients to address all parts of the OIG’s processes.
  • CLIA compliance. We have worked with numerous laboratories regarding legal requirements for clinical testing. Our experience encompasses assisting clients with certification processes; counseling them on a range of operational matters; and working with them both to prepare and to respond to inspections.
  • HIPAA issues. We have handled numerous issues regarding the protection of information, the use of EHR and conduct of electronic transactions, and HIPAA’s fraud and abuse provisions. We have worked both with providers and with researchers.
  • Sponsored research agreements. In connection with our research integrity and misconduct practice, we have experience with a significant number of sponsored research agreements. We have advised clients on virtually every aspect of these agreements, including drafting, negotiation, compliance review, and representation before multiple agencies.
  • FDA audits and agreements. We have expertise regarding the FDA’s good laboratory, good clinical, and good manufacturing practices, and we have counseled clients on research and production processes; relevant financial interests and agreements; and inspections.
  • Time and effort reporting. We have conducted and reviewed internal audits and self-reporting.
  • Human subject regulation compliance. We have particular expertise working with clients to help to ensure the safety and welfare of human research subjects, including creation and operation of IRBs, institution of and adherence to informed consent requirements, and appropriate conduct of testing.