The Centers for Medicare and Medicaid Services (CMS) has been busy this month. All in preparation for the first set of disclosure reports as required by 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.” In an effort to get our readers caught up on the Sunshine Act reporting frenzy, we have prepared the following timeline of recent events:
February 1, 2013 – CMS announces the release of the final regulations implementing the Sunshine Act, which 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 forth in the final regulations, applicable manufacturers and GPOs must have begun data collection on August 1, 2013.
February 7, 2014 - CMS announces 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 the 2013 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.
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.
February 7, 2014 - In response to CMS’ announcement, Senator Charles Grassley, co-author of the Sunshine Act, stated that "[t]he Sunshine Act will help inform the public about the financial relationships between the drug and medical device industry and doctors. The disclosure of key items will be uniform. Consumers will get a much fuller picture of the industry’s financial presence in medicine than they have now. The trend toward payment transparency is good for the public and good for accountability.”
February 18, 2014 – Registration and data submission opens on CMS' Open Payments website for applicable manufacturers and GPOs. Phase 1, which will run through March 31, requires each entity's authorized official to register in CMS's Enterprise Identity Management system (EIDM) and receive an EIDM user ID. Next, registrants must complete a data file of specified 2013 Open Payments information and submit it to CMS via email to [email protected]. The authorized official should use the sample template, available for download following registration in the EIDM, to submit data. In addition to general information regarding the registering entity, the form requires the following aggregate information regarding the applicable manufacturer's or applicable GPO's 2013 payments:
General payments and research payments aggregate data, including for each report:
- The total aggregate amount of general payments and research payments the applicable manufacturer or applicable GPO has provided to covered recipients or physician owners/investors during the reporting period;
- The total number of general payments and research payments made; and
- The total number of covered recipients or physician owners/investors that were recipients of the general payments and research payments during the reporting period.
Ownership or investment interests aggregate data, including:
- The total number of instances of physician ownership or investment interests during the reporting period.
Once CMS has received data submissions, the Open Payments Help Desk will review the file. The Help Desk will reply directly to the submitter, and will indicate whether the submitted data meets all requirements or if there is a problem. CMS will use the submitted data within the Open Payments system to create the registering entity's profile and prepare for Phase 2 data submission. Phase 2 will begin in May and will extend for at least 30 days, and will require entities to submit detailed 2013 payment data.
February 24, 2014 – CMS posts the following resources on its Open Payments website to assist reporting entities:
- A slide deck containing step-by-step instructions for registration and data submission utilizing the CMS Enterprise Portal;
- A sample template to be used for Phase 1 aggregate data submission; and
- The addition of new frequently asked questions (FAQs) to address common questions on the two-phased approach.
February 25, 2014- CMS holds a webinar to explain requirements for Open Payments Phase 1 registration and data submission. The webinar was targeted to those primarily impacted by the registration and data submission requirements, including applicable manufacturers and GPOs, and the authorized official.