Health Law Advisor

Veloxis Pharmaceuticals, Inc. (“Veloxis”) recently agreed to pay more than $46 million to resolve criminal and civil allegations that it paid kickbacks to health care professionals to encourage prescriptions and sales of a brand-name immunosuppression drug to kidney transplant recipients instead of a generic drug. What makes this settlement noteworthy is that it includes a civil penalty of $1.55 million to address claims that Veloxis knowingly failed to report to the Centers for Medicare and Medicaid Services payments to health care professionals (“HCPs”) under the federal Open Payments Program (also known as the Physician Payments Sunshine Act or “Sunshine Act”). This civil penalty is the largest penalty ever imposed under the Sunshine Act.

On November 13, 2014, CMS published the 2015 Medicare Physician Fee Schedule ("MPFS") finalizing the following changes to the Sunshine Open Payments regulations.  The MPFS:

1. Deleted  the provision exempting certain payments to CME providers from the reporting requirements;
2. Added  three new forms of payment designations;
3. Made  the reporting of the marketed name of a covered device no longer optional; and
4. Deleted the definition of covered device.

These changes will be effective January 1, 2016, with reports to CMS in 2017.

(A summary of the final Open Payment regulations can be accessed ...

by Sarah K. Giesting, Wendy C. Goldstein, Kathleen A. Peterson, and Natasha F. Thoren

On December 14, 2011, the Centers for Medicare & Medicaid Services issued long-awaited proposed rules (“Proposed Rules”) related to the federal Physician Payment Sunshine Act applicable to pharmaceutical, medical device, biological and medical supply manufacturers and group purchasing organizations (“GPOs”). The Proposed Rules outline CMS’s proposals regarding implementation of the Physician Payment Sunshine Act and seek comments regarding these proposals. This health ...