Yesterday, February 25th, CMS hosted a webinar titled, “Open Payments Phase 1 of 2 - Overview of Industry Data Registration & Data Submission.” As the name implies, it discussed the various aspects of the Phase I, which requires applicable manufacturers to submit aggregate data on transfers of value to …
CMS and OIG Announce Plan To Exclude “Recalcitrant Providers”
In a move that made little immediate splash, but has since received considerable media attention, including a recent article in the New York Times, the Department of Health & Human Services announced that it will take additional steps against “recalcitrant providers,” including exclusion from participation …
Invoking Anti-Kickback Statute Can Backfire
An Advisory Opinion issued last week by the Department of Health & Human Services' Office of Inspector General highlights the danger of invoking the Anti-Kickback Statute as a contract negotiating strategy. OIG Advisory Opinion 13-15 was issued in response to a request by an anesthesiology group, which had …
Sunshine – Lessons From the First Two Months of Tracking Payments
The first two-plus months of tracking payments under the Physician Payment Sunshine Act are now in the rearview mirror. Though novel questions continue to arise (albeit with less frequency), CMS has attempted to keep up, offering additional FAQs. Several of the more recent FAQs are of particular interest to …
Physicians – Are You Ready for Sunshine Act Reporting?
In just two weeks, drug and device manufacturers will be required to start tracking and collecting data in connection with the Physician Payments Sunshine Act, which CMS refers to as the Open Payments program. Available data suggests that while manufacturers are generally prepared, physicians may not be aware of …
OIG Provides Insight Into New Self-Disclosure Protocol
In April, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG) released an updated Provider Self-Disclosure Protocol (SDP) (here). The revised SDP supersedes the original SDP issued in 1998 (here), and incorporates a series of open letters issued by OIG in 2006 (here), 2008 …