The Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act,” requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. As set forthin the final regulations issued by the Centers for Medicare and Medicaid Services (CMS), applicable manufacturers and GPOs must have begun data collection on August 1, 2013.
Today, February 7, 2014, CMS announced that Open Payments registration and data submission for applicable manufacturers and GPOs will open on February 18, 2014. There will be a two-phased approach for this first reporting year.
- Phase 1, which will run from February 18 through March 31, includes “user registra[t]ion in CMS' Enterprise Portal and submission of corporate profile information and aggregate 2013 payment data.”
- Phase 2, which begins in May and will extend for at least 30 days, includes “industry registration in the Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data.”
Both phases will be completed by August 1, 2014, and healthcare providers and manufacturers will then have an opportunity to review and correct inaccuracies in the submitted data. Click here to view the Phase 1 instructions.
CMS has indicated that for the 2013 reporting year it will not enforce penalties for reporting non-compliance until after the close of Phase 2 registration and data submission. CMS has also indicated that it will announce additional information in the Spring of 2014 regarding the review and correction phase, which begins on August 1. Please note that this phased approach to Open Payments registration and data submission is only for the 2013 reporting year, which includes data that was collected between August 1 and December 31, 2013.
Next week, CMS will announce the date and registration information for an industry-focused webinar discussing the phased approach to Open Payments registration and data submission. Stay tuned!