Topic: Transparency

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Changes proposed to Sunshine Act reporting would remove CME exclusion, may broaden availability of “indirect-payments” exclusion

On Friday, July 11, the Centers for Medicare & Medicaid Services (CMS) proposed potentially significant revisions to the federal Sunshine Act rules. Among other changes, CMS suggested eliminating the rule section that explicitly excludes certain continuing medical education (CME) speaker compensation from manufacturers’ transparency reports. The life-sciences industry had pushed hard for this exclusion prior to the … Continue reading

Phase 2 reporting opens June 1

By listserv message, CMS announced that applicable manufacturers and applicable group purchasing organizations (“GPOs”) can start Phase 2 of Open Payments registration and detailed data submission process on June 1. Phase 2 itself has two steps and Phase 2 closes on June 30, 2014: Step 1: Starting June 1 Applicable manufacturers and applicable GPOs must complete system registration and confirm … Continue reading

CMS offers new resources and guidance on two-phase approach to Sunshine Act reporting

The CMS has posted new resources to its “Open Payments” website to clarify its recently announced two-stage approach to registration and data submission.  These resources include: Step-by-step instructions for completing new user registration with the CMS Enterprise Portal, A sample template to be used for Phase 1 aggregate data submission, and New frequently asked questions (FAQs) on … Continue reading

Vermont AG offers limited penalty for failure to report data

Today, the Vermont Attorney General’s Office announced an offer to accept a limited penalty from medical device and biologic manufacturers to resolve failure to report expenses related to health care providers under Vermont’s Prescribed Products Gift Ban and Disclosure Law during any of the law’s reporting periods. This offer does not apply to other violations … Continue reading

FY 2014 OIG Work Plan summary

On January 31, 2014, the US Department of Health and Human Services Office of Inspector General (OIG) published its Work Plan for fiscal year 2014. The OIG announced that in the upcoming year, it will continue to investigate various Medicare and Medicaid claims made to nearly every type of provider group. Below is a brief … Continue reading