The Centers for Medicare and Medicaid Services (CMS) provided two webinar sessions on Open Payments, the CMS program to implement the Physician Payment Sunshine Act. CMS describes Open Payments as “a national disclosure program designed to promote transparency by publishing the financial relationships between the medical industry and healthcare providers on a publicly accessible website.” Open Payments requires applicable manufacturers and group purchasing organizations (GPOs) to report to CMS any payments or other transfers of value they make to physicians and teaching hospitals. The webinars presented technology-focused sessions directed at such manufacturers and GPOs designed to introduce features of the Open Payments system currently in development. We have included copies of the slides for interested parties.
It is interesting to note that instead of hard dates as stated in the final rule, CMS discussed their timeline during the webinar in terms of soft date targets, which include early 2014 submission, mid 2014 collection, and late 2014 publication of the data.
When asked about specific dates during the Question and Answer session, CMS stated that deadline questions “could not be answered at this time.” One could speculate this is to avoid malfunctions that may be involved in the website as CGI Federal, the same Montreal based agency that is running the health insurance exchanges, is also contracted to manage the open payments database. During the presentation, CMS’s representative stated that the health insurance marketplace issues would “not in any way” affect the rollout of the Open Payments system.
CMS encouraged listeners to sign up on their list serve for updates that would include deadlines, and to tune in to the December 3rd follow-up webinar session.
WEBINAR 1: OPEN PAYMENT REGISTRATION
The first webinar focused on Open Payments Registration. Registration consists of two steps. First, users must obtain authorization and secure access to CMS business applications through CMS’s Enterprise Identity Management (EIDM) registration, available at https://portal.cms.gov. Second, users must obtain authorization and secure access to Open Payments. Open Payments registration requires an Authorized Official to create an individual user profile and an entity profile. The information required at the entity and Authorized Official individual levels includes:
| Entity Identifiers | Individual Identifiers |
| Registering Entity Legal Name | First Name |
| Doing Business as (DBA) Name | Middle Name |
| Registering Business Address | Last Name |
| Registering Entity Business Telephone Number | Name Suffix |
| Food and Drug Administrator Establishment Identifier | Job Title |
| Uniform Resource Locator (URL) of Parent Company | Business Address |
| D&B D-U-N-S Number | Email Address |
| Taxpayer ID Number (TIN)/Employer ID Number (EIN) | |
| Consolidated Report Indicator (Y/N) (default to N) |
Applicable manufacturers and GPOs are required to annually submit data in the Open Payments system and electronically attest to the submitted data before the reporting deadline. Authorized Officials are in charge of nominating and approving Authorized Representatives as “Officers,” “Submitters,” and/or “Attesters” to fill these various roles. While one person may encompass all three user roles, an entity may have a maximum of ten users in a role. Most of the questions during the Question and Answer session focused on what constituted an “Authorized Official.” CMS stated that Authorized Officials are expected to be “C-level executives,” who may nominate user roles in the system after registration.
Registration is not complete until the entity and the authorized official have been successfully vetted. “Vetting” is the process of verifying that (1) the applicable manufacturer and GPO is an entity (determined through the entity’s stated D-U-N-S number), (2) the Authorized Official is linked to the vetted entity, and (3) the Authorized Official is significantly positioned to act on the entity’s behalf.
CMS recommends registering early to allow time for vetting. Successful vetting is required for registration and may take one to two weeks for CMS to process.
CMS concluded the first presentation with a list of recommendations for manufacturers to begin now:
- Determine or discuss user roles, including (1) who will register the entity and approve additional representative and (2) determine who will submit and/or attest to data on behalf of the entity.
- Review the resources available on the CMS Open Payments website: http://go.cms.gov/openpayments.
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Register on CMS list serve to receive email updates about the Open Payments, such as when registration will open in early 2014.
WEBINAR 2: OPEN PAYMENTS DATA SUBMISSION
The second webinar focused on Open Payments Data Submission. This session targeted data submitters, technology officers, and program developers who would be involved with data submission on behalf of applicable manufacturers or GPOs.
CMS listed three specific files that must be submitted: General Payments, Research Payments, and Ownership and Investment Interests.
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Submission File Specifications |
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Applicable Manufacturer |
Applicable GPO |
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| General Payment Submission File Specifications (non-research) | Used to report payments or other transfers of value to covered recipients (physicians and teaching hospitals) that are not made in connection with an activity that meets the definition of research in the final rule. | Used to report payments or other transfers of value to physician owners or investors that are not made in connection with an activity that meets the definition of research in the final rule. |
| Research Payment Submission File Specifications | Used to report payments or other transfers of value to covered recipients (physicians and teaching hospitals) made in connection with an activity that meets the definition of research in the final rule. | Used to report payments or other transfers of value to physician owners or investors made in connection with an activity that meets the definition of research in the final rule. |
| Ownership and Investment Interest Submission File Specifications | Used to report all ownership or investment interests that are held by physicians or their immediate family members. | Used to report all ownership or investment interests that are held by physicians or their immediate family members. |
CMS announced two resources that are available currently or will be shortly. Submission File Specifications list the data elements to be collected for each of the three payment types (i.e., general payments, research payments, ownership/investment interests). This information is currently available (and reprinted directly above). Second, Schema and Sample Files will provide the exact format and layout of the files that will be accepted by the Open Payments system. CMS stated that this information will be available in the next week or two and announced via the CMS Open Payments list serve.
The Open Payment system provides two options for data entry and submission: (1) Manual data entry via a Graphic User Interface, recommended for smaller volumes of data, and (2) Bulk data entry via XML and CSV file uploads. Schema and sample files for bulk uploads will be available potentially next week. CGI Federal’s representative noted that the maximum file size for bulk uploads will be 250MB, and that larger files need to be separated into multiple files.
When data is submitted to the Open Payment system, either through manual entry or bulk data upload, users will be notified immediately if there are entry/upload errors that need to be corrected. Additionally, payment records may be deleted from the Open Payments system on a per record basis or as a whole.
As with the first webinar, CMS offered recommendations for getting started as soon as possible:
- Decide on whether to enter data manually or through bulk upload.
- If choosing to bulk upload, decide between XML or CSV format.
- Access sample files, instructions document, and the mapping document from the Open Payments website.
- Review the resources available on the CMS Open Payments website: http://go.cms.gov/openpayments.
- Register on CMS list serve to receive email updates about the Open Payments, such as when registration will open in early 2014.
A third webinar is scheduled for December 3, 2013 entitled “Open Payments Registration and Data Submission Q&As.” CMS requests that questions be submitted by November 30.
CMS Open Payments Webinar Slides 11-19-2013