Compliance

Commercialize products in a lawful fashion.

We help clients assess and mitigate regulatory risk.

Aggressive government enforcement continues. Whistleblower cases are on the rise due to economic incentives for qui tam plaintiffs. Off-label promotion, anti-kickback, and false claims prosecutions continue to be popular. Failure to comply can drive a manufacturer out of business and put employees in jail.

We assess commercial activities for compliance with the following laws:
Food, Drug and Cosmetic Act
Anti-Kickback Statute
False Claims Act
Physician Payments Sunshine Act
HIPAA & HITECH
Federal Trade Commission Act
Foreign Corrupt Practices Act
Stark Law
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Looking for a place to start?

Utilize our compliance checklist.

Learn more about compliance auditing and monitoring:

Compliance

For more information about personal liability:

Paying HCPs, product discounting, providing reimbursement support and similar activities present legal exposure. Mitigate risk through an effective compliance program.

Representative matters:

  • Outsourced Compliance Function
  • Designing and implementing compliance programs
  • Monitoring and auditing
  • Training management teams and staff on compliance laws and regulations
  • Analyzing Sales and Marketing programs for compliance with FDA, CMS, OIG requirements
  • Assisting companies subject to Corporate Integrity Agreements (CIA)
  • Investigating allegations and hotline reports
  • Reviewing discounting practices for Discount Safe Harbor compliance
  • Analyzing transfers of value to HCPs for compliance with the Personal Services and Management Contracts Safe Harbor
  • Reviewing reimbursement support services and program hubs
  • Conducting compliance audits and compliance risk assessments of commercial activities
  • Helping to mitigate, wind-down, and/or terminate risky practices
  • Performing healthcare and FDA regulatory due diligence for buyers and sellers
  • Reviewing research activities, e.g., advertising and recruitment practices
  • Training on best documentation practices
  • Reviewing contracts
  • Reviewing privacy policies
  • Auditing against the PhRMA and AdvaMed Codes