Open Payments Data Submission
- The Centers for Medicare & Medicaid Services (CMS) said today’s webinar would cover the data submission process.
- CMS said the target audience today was applicable manufacturers and GPOs, data submitters, technology officers, etc.
- CMS said its agenda was to provide a high-level understanding of the data submission process and data entry options and to provide information on file formats for bulk data uploads (XML, CSV, and XSD schemas). CMS said it would also review its available resources and answer Q&As at the end.
- Submission overview and data entry options: The program requires entities to annually submit data before the reporting deadline. Single or consolidated reports may be submitted. There will be two options for data entry and submission:
o Manual data entry via a graphic user interface
o Bulk data entry via XML and CSV file uploads
- There are 3 types of reports in the Open Payments program:
o General payments reports
o Research payments reports
o Ownership & investment interest reports
These must be submitted separately. These can be submitted individually or by consolidated report.
- Submission file specifications list data elements that will be collected for each of the 3 report types. 2013 file specification elements are available at http://go.cms.gov/openpayments.
- Schema and sample files define the exact format and layout that will be accepted. XML and CSV sample files will be available in November 2013 on the Open Payments website along with how to use the schema and sample files and a mapping of each data field in the sample files to the data elements listed in submission file specifications.
- Manual data entry: CMS said this is best suited for organizations with a small amount of data for reporting. First, log into the system. Navigate to the payments page and select “Enter Payments Manually.” Then, you would select the entity, program year, and payment type and enter data for each reportable payment. When you hit “submit” you will receive an on-screen message of online submission confirmation. If matching of the data is unsuccessful, then a follow-up email may be sent. After the data are submitted successfully, the entity must attest to their accuracy and completeness. Data reporting is only complete after attestation.
- Bulk data upload: This is best suited for organizations with a large volume of data for reporting. XML and CSV sample files and templates will be made available in November 2013. Determine whether your organization will use XML or the CSV format. Download the appropriate schema definition file (XML or CSV). This schema can be used to create and validate the XML data submission file. These will be available later this month.
o Once the XML schema is downloaded, files can be created using XMLSpy or other programmatic interfaces using the XSD schema or by using the XML sample files. Type of payment in the XSD determines the contents of the required submission file elements that need to be populated. The XSD schema is used to validate the XML. Further instructions will be provided.
o Once the CSV sample file is downloaded (3 files, one for each payment type will be available), create the .CSV file. The .CSV files are pipe-delimited, so ensure the list separator is set to pipe “I”. Open the appropriate sample file, clear any sample data, and follow the instructions CMS will make available.
o Upload the XML or CSV file to Open Payments: Log onto Open Payments, navigate to “Report Payments page”, select the file to upload, then select the organization, program year, and payment type, browse to select the appropriate file to upload, click to upload, and then receive an on-screen message as well as an email noting successful validation (or validation errors).
o File sizes may not exceed 250MB. Files LARGER than 250MB will need to be separated into multiple files. Processing time may vary depending on the file size.
o Testing of format will be available to users – a test submission can be submitted. This file will be deleted by CMS.
- Deleting submissions: Open Payments will allow users to delete payments recorded by searching for the file ID of the payment that needs to be deleted, then select the individual payment record or all records that need to be deleted. Click “delete selected” and confirm “yes” to delete the record(s).
- In short, the steps for submission are to use the graphic user interface for manual submission or to upload a CSV or XML file, then receive a report validating the successful file submission, then complete the attestation in order for the reporting to be considered complete.
- What can you do now? Review webinar 1 on registration and decide who will serve in the submitter and attester roles, decide on whether manual or bulk upload data submission will best suit your company, access the sample files and instructions available on the Open Payments website later this month, and monitor the Open Payments website for any additional updates that may become available.
- A follow-up webinar will occur on December 3rd with an in-depth Q&A on the data submission process. Questions can be submitted to OpenPayments@cms.hhs.gov by November 30.
- A Help desk with technical support and phone lines will be available in early 2014.
- CMS then opened up the Q&A segment:
o If one record is invalid for a submission, will the entire file get kicked out or just that record? CMS said just that record and you will have the opportunity to correct that record. CMS said you will have the opportunity to upload early and make corrections as necessary.
o When in November will the schema and sample files become available? CMS said it expects to post them within the next week.
o Are the sample file instructions and document available now? No, but they will be available on the CMS website hopefully within the next week.
o As a vendor responsible for data submission, will it be possible to run a test data submission that is NOT associated with an applicable manufacturer? No. CMS said if you are working on behalf of a manufacturer, then you can use the test submission function in the open payments system to test the files you will be uploading on their behalf (in their account). If you are testing your own system as an outside vendor to help facilitate compliance, then no CMS said there will be no separate testing function for that.
o For a consolidated report, is the $100 reporting threshold based on each individual entity or all of the entities combined in the report? The $100 threshold is based on each individual entity.
o For the 250MB maximum and millions of rows of data, is there a maximum to the number of files you can send? No there is no limit, but you can only upload one file at a time.
o Will there be FTP options available in the future for sending/transmitting this data? CMS said not at this time but it will consider those enhancements for the future.
o How will entities receive a resubmission ID number? Once you submit a file, CMS said you will get a submission ID for that file you uploaded. If you need to make corrections on any individual records in that submission ID, then you will pull that file backup based on the submission ID. If you submit 10 250MB files for the “general payment” category, then you will only get ONE submission ID. You will get one per payment category.
o If you upload 1000 records and receive a notice that there were issues with 10, then will companies receive an email saying that these are the 10 with issues? And will CMS provide upload examples with screenshots of troubleshooting, etc.? CMS said you will see all of the issues at once. CMS said that if a request is sent to openpayments@cms.hhs.gov, then yes CMS will ensure screenshots are provided, etc.
o For the cross-check, other than the NPI number, what other fields will be cross-checked and what system is CMS cross-checking the records with for matching purposes? CMS said it will use NPI and state license numbers, name and address information, and most physician identifier fields that companies will be providing for matching purposes to attribute transactions to physicians.
o If an investigator hasn’t updated his new business address in the NPI database, then will a record submission come back with an error? CMS said if it can’t match a record with a good degree of confidence then the company can provide additional information to see if the submission will go through.
o For the resubmission process, if there are 1000 records which were submitted and 10 had errors, then would the company receive the submission ID for all of the 10 records and how would the company identify which 10 records had an error to fix those records? CMS said that you should include a home systems record ID with each record so that when an error occurs CMS will provide the submission ID and home systems record ID to identify which have errors.
o We haven’t seen the field for home record ID on any of the information provided so far – can CMS provide more information since this was not part of the original CMS templates? CMS said that information will be provided in the sample file schemas that will be provided later this month. The home systems record ID is a data field to assist with tracking in error reports.
o Are there any additional significant changes that will be made in the schemas that will be released because we have already built our system? CMS said there are no other significant changes and to the extent there are any, companies will be able to identify them quickly.
o When will the system design be frozen from further CMS changes? CMS does not yet know.
o Will you be sending out a complete set of business rules? CMS said that they are going to get back to entities on that as it was not planning to make those business rules available. However, if industry considers those valuable, they will consider making them available.
o What types of errors will come back? If there are rejection errors, then there is likely an invalid file format. If the file format is valid but contents of the files are not, then you will receive information on which records are invalid in the error report. If your data cannot be attributed with a good degree of confidence with a covered recipient, then CMS will provide that information in a “feedback report.”
§ Ensure each payment is only reported once as CMS will not be able to validate systematically whether a duplicate record is submitted if multiple of the same files are accidentally submitted.
o Confirm that each record a company submits will need to include a company unique identifier? CMS said that field is an optional field to help companies link back records to their home system. If an identifier is provided in that field, then CMS will report that home ID as having an issue if an error is present. It is intended as a convenience in helping companies link those IDs back to their systems.
§ CMS said a list of error codes will be published.
§ CMS said the sample files can be used as templates if sample data is cleared; those files will be provided later in November.
§ Any changes that have been made are minor. After posted, CMS does not plan to make any further changes for the 2013 reporting year to the data templates.
o If there is a dispute of a record by a physician, what will a manufacturer/GPO receive? What will that look like? CMS said to stay tuned that there will be future webinars explaining that information.
o Does the XML data restrict only to valid data? CMS expects industry to validate that the XML is well-formed prior to submission.
o Earlier in the discussion, CMS stated that an actual vendor can submit this data to CMS on behalf of a manufacturer? If so, then who is responsible for signing an attestation? CMS said third party vendors can submit data on behalf of manufacturers/GPOs so long as an officer of the manufacturer/GPO approves the submitter role by nomination through the Open Payments system. Then, that third party can perform the submission role. However, the attestation still must come afterward from an officer at the company.
o One row of data or record of data could have multiple errors – will CMS in its error codes be able to indicate multiple error codes per record or row of data? CMS said there will be no limit on error codes shown per record.
o For the functionality reviewed for deleting a file submission? Is there a window of opportunity for an applicable manufacturer/GPO to delete a submitted file or could they do so at any time? CMS said an applicable manufacturer or GPO could change a record at any time. If that occurs post-attestation then that could impact the data for that year. (As a side note, there was suggestion by CMS that this might trigger action by CMS due to company attestation to an incomplete report, so companies should take care to ensure the accuracy and completeness of data before attesting to the accuracy and completeness of their submissions). If modification is made to any data that has been attested, then CMS said the system will require re-attestation of the data but wants to confirm that with its technology folks and provide additional information at a later date.
o Will companies be able to test volume in the test environment that CMS makes available? CMS said there will not be a separate test environment but that there will be a test function for uploading files in the production environment.
o Does CMS foresee in the future having a functionality that says you have already uploaded this file name to ensure against duplication of file upload? CMS said that the system will send out email notifications for files submitted, so that will be the best way for companies to keep track of files submitted. CMS said that the email notification may have record count included but it needs to confirm.
- CMS concluded its webinar having reached the end of the hour. Additional questions to be addressed at the follow-up webinar on December 3rd can be sent by November 30th to CMS at the email address provided above.
Julie Tibbets is a partner in the Food, Drug & Device practice at Alston & Bird LLP where she focuses her practice advising manufacturers and marketers of drugs, biologics, and medical devices on marketing, medical affairs, and health care professional related interactions as well as Sunshine Act compliance. This posting is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions. Julie can be reached at julie.tibbets@alston.com or at 202.239.3444.