What is the Sunshine Act?

On February 1, 2013, the U.S. Centers for Medicare & Medicaid Services (“CMS”) within the U.S. Department of Health and Human Services (HHS) announced the release of the final rule implementing Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act (“ACA”), commonly referred to as the Sunshine Act.

The Physician Payments Sunshine Act requires all U.S. drug and medical device manufacturers to report any gifts and payments made to physicians and teaching hospitals with a value totaling $100 annually or greater, as part of the Patient Protection and Affordable Car Act of 2009 (H.R. 3590, section 60002). Failure to stay in compliance may result in fines from $10,000 to $1,000,000 annually.

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Download The Sunshine Act: Increasing Transparency infographic

Who must comply?

In accordance with the new regulations, all applicable manufacturers of covered drugs, devices, biological products, and medical supplies must provide an annual report to the Centers for Medicare & Medicaid Services (CMS) of all information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. You must comply if you are a:

  • Medical device manufacturer
  • Drug manufacturer
  • Biological product manufacturer
  • Medical supplies manufacturer

What needs to be tracked?

Certify offers a simple solution for tracking all spending, in all required fields to ensure your organization stays in compliance with the new regulation. With Certify, your team can easily create reports anytime to meet federal reporting requirements. Certify is also integrated with the NPI (National Provider Identifier), which gives you the ability to track and link expenses with specific physician and organization NPI records. Just add Certify Mobile or on the go access to the NPI database.

  • Business Gifts
  • Direct Compensation
  • Food/Meals
  • Grants
  • Entertainment
  • Investment Interests
  • Education
  • Honoraria Services
  • Travel
  • Charity Contributions
  • Consulting Fees
  • Royalties and Fees
  • Services Outside of Consulting
  • Research
Articles on the Sunshine Act

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