Today, CMS held two follow-up webinars on Open Payments registration and data submission. CMS has made slides from its webinars available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Events.html. Following is a summary of the items CMS presented and discussed today:
(1) Follow-up Questions on Open Payments Registration
· CMS explained that on November 19 CMS hosted two webinars on registration and data submission and said that today’s first webinar will include an overview of the November 19 webinar recap followed by a live question and answer session.
· What is an entity or a reporting entity? CMS explained that these are not intended to be specialized terms but are just referring to the applicable manufacturer or applicable GPO.
· Registration is a two-step process. Registration is required but only if you have payments or transfers of value to report. Also, if the entity is physician-owned, then that is considered a payment or transfer of value under Open Payments and registration will be required. There is no cost to register.
· EIDM registration is “Step 1” of the process. Users should obtain authorization and secure access to EIDM for registration, authentication, authorization, and identity lifecycle management. Open Payments will be available in early 2014 and so while EIDM registration may be available now, accounts can go “inactive” in the interim so CMS recommends waiting until early 2014 to register on EIDM.
· Who needs to register the entity? An individual significantly positioned within the entity to allow Open Payments to successfully vet the affiliation between the Authorized Official and the entity. This was referred to in the last webinar as a “C-level” officer. CMS said specific titles may vary based on the organizational structure of a company, so the Authorized Official may not always be a C-level officer, but will have similar functional roles. There can only be ONE Authorized Official per entity per calendar year.
· One attestation is required per consolidated report. One submission is also required.
· Is registration different for entities outside the US? CMS said that it cannot answer this question as the functionality is currently under investigation. CMS said that the final rule should be consulted for additional information on which foreign entities are required to register and are subject to reporting.
· Who accesses the Open Payments System:
o Up to 10 users per entity, including its Authorized Official are allowed, but a minimum of 2 are required per the final rule
§ Authorized Official – required to register the entity. Can only be ONE per entity. This individual holds the Officer Role by default but can delegate that duty. The Authorized Official will be able to use Open Payments to: Manage the entity in the Open Payments system, including registering the entity, nominating and approving the authorized representative (may include external parties) submitting and attesting to the data; May delegate these functions to another Officer; May assume all roles within the Open Payments system; User vetting is required.
o Authorized Representatives –
§ Officer Role – up to 5 officers can be listed among the 10 total users. Must be an Officer of the applicable manufacturer or GPO; May be the Authorized Official; May manage other Authorized Representatives and their user roles (includes nominate others, delete users); Must accept nomination
§ Submitter Role
§ Attester Role
§ Registration for nominated Authorized Representatives: Nomination notification is sent; Step 1 is to register self in EIDM by selecting “New User Registration” and entering personal information; then Step 2 is to register in Open Payments.
o Vetting Process: Includes verifying (1) applicable manufacturer/GPO is an entity; AO is linked to vetted entity; and AO is significantly positioned to act on the entity’s behalf. Successful vetting is required for successful registration. Register early to allow time for vetting (which can take up to 2 weeks). The AO will receive additional information if vetting is not successful.
o Tips for Completing Registration: Ensure accuracy of registration information; If you have a D&B number, confirm that AO is also listed on your D&B registration.
(2) Follow-up Questions on Open Payments Data Submission
· Available submission resources:
o Submission Data Mapping Document: Will be available later this week on Open Payments and will have mapping data elements listed in the submission file specifications to the specific data fields in the XML and CSV sample files;
o Bulk Data Upload Instructions: Detailed instructions on how to use the XML schema and XML and CSV sample files to bulk upload data
· Data can be entered (submitted) into the submission by manual entry, bulk file upload, or a combination of manual and bulk uploads. All payment records can be edited via the Graphic User Interface.
· Bulk Data Upload Requirements:
o Maximum file size is 250MB for both CSV and XML files. Files larger than 250MB need to be separated into multiple files. There are no limits on the number of files that can be uploaded.
o CMS is analyzing other options such as FTP to increase the maximum upload size for future system releases.
o There are no naming conventions for the uploaded files, but they cannot contain special characters prohibited/reserved in a UNIX system and cannot exceed 50 characters.
o There is no preferred format as between XML and CSV; however, XML files tend to be larger so for companies with a lot of records, CSV would be recommended.
o CSV files accepted by Open Payments are pipe delimited. Sample files and submission instructions provide information related to using the pipe delimiter and headers. No control totals are recorded.
o Excel format is not accepted; only pipe delimited text files or XML files are accepted. Excel can be used to create CSV files, however. The order in which files are uploaded is not important. Records without prepopulated IDs will be treated as new records.
o Each payment record when uploaded is assigned an Open Payment ID. IDs will be sent in an email notification and can be viewed online and downloaded. If a user wishes to print a summary of submitted data, printing can be done using the web browser’s printing functionality. No extract functionality is currently planned.
o Submission of test files is not required. Entities can test bulk uploads after the system goes live. Test submission will not validate data for accuracy, only for format.
o Submitted records can be deleted any time before and after the reporting deadline for as long as they are retained in the system; currently, the system will retain records for 10 years from date of data publication. Users can delete individual records or entire files in the system. The user with the Submitter role can search by the File ID, Open Payments ID, and/or Home System Payment ID. Changes to the data can be made through either bulk file uploads or graphic user interface regardless of original data entry method used.
o Resubmitted data may also be made through bulk upload by making sure the Resubmission file indicator data element is set to “Y” to identify that all information in the file will be resubmitted for processing. If there are multiple resubmissions for the same payment record, the same original Open Payments Payment ID needs to be referenced.
o Open Payments will reject an entire file only where: the file is in an invalid format and if the structure of the file does not align with the required schema. If errors are only on the record level (unpopulated fields, etc.), then only those records will be rejected.
o Records entered manually online are validated in real time.
o For bulk uploads, simple file format validations are performed right after the upload and more in-depth validations are performed offline. All records submitted will be processed, not just up to the first error.
o After the file is processed, users will receive an email notification stating: acceptance or validation errors that prevented acceptance (giving error codes to explain the rejections). The error listing will include the Home System Payment ID and Open Payments Payment ID to enable location of the offending records.
o Matching: After processing of records, the records are matched. If any records cannot be matched, i.e. a reported payment cannot be matched to a covered recipient, with a sufficient degree of confidence then reporting entities will receive an email with information about the unmatched records.
o Attestation: Reporting is not considered complete until formal attestation is received. Does not have to occur at the point of submission but must occur before the submission deadline. Attestation should only occur when all submissions are complete. Data can be modified any time before or after attestation but changes made after attestation will need to be reattested.
o Consolidated Reporting: Each entity included needs to be separately registered in Open Payments and the consolidated report must reference the registration IDs of those entities.
o Third-Party Submission: Submitter role in Open Payments can be filled by a 3rd party not affiliated with the entity but 3rd party must be nominated/approved by an officer in the same fashion as internal submitters.
o Review and dispute functionality is still under development. CMS envisions that disputed items will be resubmitted and reattested as individual line items rather than as entire resubmissions.
o If a reporting entity has multiple transactions for a physician, each transaction should be reported separately rather than aggregated into a single entry.
o At least one state license number is required for a physician even if NPI is provided.
o If a covered recipient does not have a NPI, the NPI field may be left blank.
o The NPI listed in NPPES is the official record that the Open Payments system uses for matching.
o Reporting entities do not need to submit a blank file if they don’t have any transactions for a particular payment type to report.
o There will be a phone line dedicated to answering technical questions next year.
o There will be another technical webinar in January 2014.
(3) Questions from Audience
· What information entered in the entity profiles will be available on the public database? Information submitted through the XML and CSV data schemas, generally, using the matching process.
· Do entities have to register annually? CMS said users will register through the two-step process only once. The entity profile information should be reviewed annually and recertification of that information will occur annually.
· Will registration IDs change year to year? No, CMS said they will stay the same and will not be impacted by annual recertification.
· Do we need to report a payment to a physician if the only payment is for serving on the Board of Directors? CMS said this is reportable unless an exception applies such as when the Board of Director member is an employee.
· Does each applicable manufacturer on a consolidated report have to assign the 3 roles when registering? Yes.
· CMS next verified that third parties can submit data on behalf of entities so long as those entities nominated them for data submission and they accepted the nomination.
· CMS next explained the difference between an Authorized Official and an Officer role. The distinction is that the Authorized Official has to be of sufficient level in the company to be vetted using CMS’s process. The AO has to be able to represent the organization with the registration process and setting up the entity profile. It is to the discretion of the company who they name in the officer roles, but need to be of a sufficient rank to take action on behalf of the entity.
· CMS plans to have a walk-through with screenshots of how to upload a file in a future webinar.
· Can CMS clarify what the legal entity name is for registration purposes? What if multiple entities share the same legal entity name? CMS said each entity should have a legal entity name and if more than one entity shares the same name then each should be registered.
· The identify of individuals in each of the three roles will not be made public.
· Can third parties be assigned as submitters for multiple companies? Yes, so long as they are nominated and accept the nomination from each such entity.
· If physicians or teaching hospitals do not register and review data submitted about them in the Open Payments system, will it be published publicly anyway? CMS said yes per the final rule.
· For dispute initiation, who will receive notification? CMS said that functionality is still under development. For submission errors, the submitter role individual will receive notification.
· If an entity does not have an establishment ID from FDA, what should that entity do? CMS said resolution of that remains in development.
· For the Home Payment System ID, what is the format? CMS said that it cannot be longer than 50 characters and has alphanumeric capabilities.
· How should payments to the same physician on the same day for the same category be reported? CMS said they should be reported separately as 2 entries/records.
· What if there are no active state licenses for a physician to report? CMS said to refer to the final rule – that payments/transfers do not have to reported for physicians with no active licenses, but that there could be other reporting requirements such as if that physician is an owner or investor [Note: this is what CMS stated, however, we found this to be somewhat confusing since it would seem that any such physician would not be a “covered recipient” under the Sunshine Act].
· Will physicians have to dispute payments through Open Payments? CMS said it will provide some functionality for doing so but that the dispute will, once flagged, have to be taken up and resolved with the applicable reporting entity.
· Vendors submitting for companies must identify a specific individual name rather than the vendor name when submitting or receiving a nomination.
· Assumptions documents can be submitted once per attestation rather than once per file and the assumptions can encompass multiple submitted files.
o CMS does not have the number of characters allowed in the assumptions submission – CMS said that information will be provided in an Open Payments User Guide and they expect it will be the equivalent of 5 pages.
· Test submissions can only be made by those acting/performing in the “submitter” role.