SUNSHINE

Gardner Law has extensive experience with new state and federal transparency requirements.

Clients turn to Gardner Law for assistance with the Physician Payments Sunshine Act (“Sunshine Act”) and similar state laws found in Minnesota, D.C., Massachusetts, Vermont, and Connecticut. Other states have special rules for sales and marketing compliance. These include California, Nevada, Louisiana, as well as the federal 20/50 Rule which limits gifts to federal employees, including health care professionals working for the government.

The Sunshine Act and state laws are complex and change frequently. You can rely on Gardner Law to provide the help you need with these laws, including interpretation of whether or not something is reportable, as well as registering and reporting requirements on both the federal and state levels. Depending on your needs, Gardner Law can play an oversight role or dig in and help make the submissions with you. It is important to get these filings correct because several states have started to enforce these laws. The Centers for Medicare and Medicaid Services, who enforce the Sunshine Act, have also stated that they intend to start auditing manufacturers for compliance with the new law.


Sunshine Reporting Related Services offered include:
  • Sunshine Act registration and reporting
  • Counsel on state law registration, reporting and compliance requirements
  • Policy development and implementation
  • Training
  • Guiding companies on how the Final Rule to the Sunshine Act impacts tracking and reporting requirements
  • Counseling on exclusions from reporting
  • Addressing disputes and corrections
Sunshine
ABOUT THE FIRM
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Gardner Law specializes in laws and regulations that govern the development and commercialization of pharmaceuticals and medical technologies. The firm provides practical and responsive counsel to company leaders navigating the regulatory minefield which they face today.

CONTACT
  • 423 Main Street South
    Stillwater, MN 55082
  • 612.382.7584
  • 651.430.7150
  • office@gardner.law
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