The Centers for Medicare and Medicaid Services (CMS) just released a reminder for manufacturers to complete 2013 data submission and attestation by June 30th. They also released 27 new Frequently Asked Questions (FAQs) regarding the Phase 2 Submission process, registration, attestation and other nuances of the Sunshine Act.
As we have covered over the last few weeks, companies have been struggling with many aspects of the Open Payments system. In fact, the pharmaceutical industry trade group PhRMA just petitioned CMS to delay the data submission timeline by a month to make up for the system’s struggles. CMS seems to have decided to move forward with the current timeline, with industry data submission due June 30th. CMS also announced that physicians and teaching hospitals will have access to Open Payments “mid-July.”
The short deadline, problematic Open Payments system, and newly released FAQs underscore how difficult this process has been for companies. They are essentially required to learn new aspects of the Sunshine law every day.
Data Submission Process
Both phases of the Sunshine Act’s mandatory data submission are due by June 30th. Phase 2 was broken into two steps. As a review, in Step 1, authorized officials of applicable manufacturers and applicable GPOs are required to complete Open Payments system registration for themselves and their reporting entity; confirm the accuracy of the reporting entity profile data submitted for Phase 1; and delegate roles and responsibilities by nominating system users to fill specific user roles. Users in the role of Submitter should: (1) Perform test file uploads and submit data files to validate the file structure and contents of the file and (2) Utilize the error report produced by the Open Payments system to fix data errors (if any) in submitted files.
Once the test data files have been successfully uploaded and validated at this step, industry users can move on to Step 2. Submitters must perform final data submission (which includes a series of checks to match the reported data to the appropriate physicians and teaching hospitals); and Attesters must attest to the accuracy of their submitted detailed 2013 payment data, or ownership/investment interest data.
NEW Phase 2 Frequently Asked Questions
CMS states: “These FAQs are designed to answer basic to more advanced policy questions, and provide a detailed understanding of navigating through the Open Payments system.” The following FAQs deal heavily with technical aspects of the data submission process.
No, the Open Payments system will not accept a negative value for a payment or other transfer of value amount. Applicable manufacturers and applicable GPOs are responsible for submitting corrected information regarding their annual report in accordance with 42 C.F.R. § 403.908(h)(1).
How does CMS plan to handle the dispute process from an IT perspective?
Physicians and teaching hospitals will be able to initiate data reviews and disputes through the Open Payments system during the review and dispute period, which follows the data submission period (and will begin in mid-July, 2014). Applicable manufacturers and applicable GPOs will be able to review disputed records and take action to correct the records and resolve any issues directly with physicians and teaching hospitals.
Any discussions pertaining to the resolution of a disputed record must take place outside of the Open Payments system between the applicable manufacturer/applicable GPO and physician/teaching hospital. For more information on the review and dispute process and timing, review the Open Payments website.
How will data submissions be transferred to and received by CMS?
Data can be submitted to CMS through the Open Payments system via two data submission methods. The first submission method is bulk data file upload via CSV, XML, or ZIP file (ZIP files may only be uploaded if they contain either CSV or XML files). The second submission method is manual submission through the Graphical User Interface.
Can one attestation cover multiple individually submitted data files, with all of the files as part of the same submission?
Yes. When you attest to data, you attest to all of the successfully submitted data files for the selected program year. Regardless of how many files are submitted during the data submission process, users will attest at the same time to all of the data successfully submitted and ready for attestation. In other words, attestation does not occur for each individual data file; it occurs for all files submitted for the selected program year that are ready for attestation.
Including zip codes, how will data validation be performed on data elements to be validated? And, what checks will be performed on each?
The first level of validation is at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system). You will receive immediate feedback via an on-screen message letting you know the file upload was successful or not successful. If the file level checks are successful, the process will move to the second level of validation, which will be the record level check.
The second level of validation includes data validation performed on data elements as they are reviewed against the specifications described in the Data Submission Mapping Document. The Error Code File Document serves as the “go-to” reference for errors made during the data submission process. In the event an error is found in a data file uploaded to the Open Payments system, an error code will be displayed in the system-generated error report. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
Following successful data validation, the file is ready for Final Submission. After Final Submission, the Open Payments system will search to match each submitted record to a valid physician or teaching hospital.
What is the expected length of time for CMS to complete data validation on submitted data files?
First level of data validation: This happens immediately, when the submitter uploads a file into the system. The first level of validation is at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system). You will receive immediate feedback via an on-screen message letting you know the file upload was not successful. If the file level checks are successful, the process will move to the second level of validation.
Second level of data validation: For small data files, this second level of automated validation can happen in seconds. Larger data files could take up to several hours to validate. Once the data files are uploaded, the Open Payments system validates each individual record to ensure the data elements are in the proper format, and checks them against the specifications described in the Data Submission Mapping Document. The Error Code File Document serves as the “go-to” reference for errors made during the data submission process. In the event an error is found in a data file uploaded to the Open Payments system, an error code will be displayed in the system-generated error report. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
Following successful data validation, the file is ready for Final Submission. After Final Submission, the Open Payments system will search to match each submitted record to a valid physician or teaching hospital. This matching process may take up to several days, and timing will vary based upon the size of the data files.
What is considered a timely re-submission of data? And can corrected data file resubmissions extend past the deadline?
Data submissions to Open Payments for program year 2013 must be made from June 1 – June 30, 2014. All submissions, corrected data file re-submissions, and attestations must occur during this time period. Re-submissions and re-attestations made past the 2013 submission deadline of June 30 will be considered late submissions and will not be publicly posted until the next data refresh.
In the event of any data errors, will the applicable manufacturer or applicable GPO be returned their whole data file submission, or only the data lines failing validation?
It depends on the level of data error that is discovered:
If the error is at the file level (i.e., the file is in incorrect format, or does not adhere to the accepted schema – headings are wrong, incorrect number of data elements, etc.), then the entire data submission will be rejected and needs to be re-submitted after it is re-formatted.
However, if the error is found in an individual record, only the record(s) containing errors need to be re-submitted.
Applicable manufacturers and applicable GPOs will be notified via onscreen text of file level errors; they will be notified via email of record level data validation errors. The email will direct the user to the system-generated error report available in the Open Payments system, which will provide a list of all errors the submission has generated and error codes that explain the source of the errors. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
Are attestations required as part of corrected record resubmissions?
If any records are resubmitted, the entirety of the data for the program year must be attested to again.
Including data lines and rows per file submission, what is the total allowable size for the data files to be submitted in Phase 2?
The maximum file submission size for each data file is 250 megabytes (MB). There is no limit to the number of data files that can be submitted, as long as each one is under 250MB. Zipped data files that are under 250MB when zipped and larger than 250MB when unzipped are acceptable.
There is no system limitation on the number of data lines or rows allowed in each file.
How will an applicable manufacturer or applicable GPO be notified if any portion of their submitted data file has failed data validation or contains any data errors?
For the first level of data validation which is performed at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system), the submitter will receive immediate feedback via an on-screen message letting them know the file upload was successful or not successful.
For the second level of data validation (which checks the record level specifications described in the Data Submission Mapping Document), applicable manufacturers and applicable GPOs will be notified via email of any data validation errors. The email will direct the user to the system-generated error report available in the Open Payments system. The error report will provide a list of all errors the submission has generated and error codes that explain the source of the errors. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
After Final Submission, the Open Payments system will search to match submitted records to a valid physician or teaching hospital. This matching process may take up to several days, and timing will vary based upon the size of the data files. Email notification that contains the results of the matching process will be sent to the data submitter upon completion of this step.
What is the resubmission process for an applicable manufacturer or applicable GPO to resubmit their corrected data files?
After making corrections to the records to be resubmitted, indicate a record is a resubmission by setting the Resubmission Indicator to “Y,” and include the original Payment Record ID in the “Resubmitted Payment Record ID” field. Then upload the file to the system as with any other bulk file upload, including the original Payment Record ID.
You may also correct and re-submit data using the Graphic User Interface (instead of bulk file upload) if the number of records to be re-submitted is small. You must correct and resubmit corrected records for all records that failed. Records with no errors do not need to be resubmitted.
You may also delete your entire original submission from the Open Payments system and replace it with a new submission if you prefer.
If multiple records in a submitted data file have been rejected, can an applicable manufacturer or applicable GPO replace and submit an entirely new data file?
Yes, an applicable manufacturer or applicable GPO may submit an entirely new data file to replace an earlier submission if the earlier submission contains extensive errors. To do so, delete the earlier file from the Open Payments system and submit the corrected file.
Yes, applicable manufacturers and applicable GPOs may submit a dummy test data file through the “Submit as Test File” button. The test will validate that the file is a CSV or XML file, or a ZIP file containing a CSV or XML file; if the file size is under 250MB; if the file header is present and is correct; and if the file template and payment category match. The results of the test will be displayed onscreen. Please note that this test does not upload the file to the system. The file is checked and discarded.
Are large amounts of corrected data files capable of being resubmitted?
Yes, corrected data files can be submitted through bulk file upload. Note that the 250MB size limit also applies to corrected data files.
Can a data file submission be broken down and submitted in multiple files based on the number of line items?
Yes. Data files can be separated and uploaded into multiple files for submission. However, each individual file should not be larger than 250MB in size. There are no system limitations for the number of records allowed in each file or the total number of files that can be uploaded.
Will every data error in each line item be identified to eliminate resubmissions regarding the same line items?
Yes. Applicable manufacturers and applicable GPOs will be notified via email of any record level data validation errors. The email will direct the user to the system-generated error report in the Open Payments system, which will provide a list of all errors the submission has generated and error codes that explain the source of the errors. The Open Payments error code document provides explanations of the error codes and suggested fixes. All errors in all records in the file will be captured in the error report.
If an entity registered for Phase 1 in Open Payments but later determined that it is not an applicable manufacturer or applicable group purchasing organization (GPO), what action should be taken, if any?
If an entity determines that it is not an applicable manufacturer or applicable GPO, as defined by 42 C.F.R. §403.902, but has inadvertently registered in Open Payments and completed a Phase 1 submission, the entity does not need to take any further action. The aggregate payment amounts reported in Phase 1 will not be made public.
Attestation
No. The attester for the reporting entity submitting a consolidated report is only required to be a Chief Executive Officer, Chief Financial Officer, Chief Compliance Officer, or other Officer for that entity that is submitting the consolidated report. While the attester for the consolidated report must hold the attester role for all entities included in the consolidated report (so that attester is able to attest on behalf of the entities included in the consolidated report, in accordance with 42 C.F.R § 403.908(e)), that attester does not need to hold an Officer role in the other entities included in the consolidated report.
How can an applicable manufacturer request a delay in publication for a research-related payment, and how will CMS notify the applicable manufacturer if the delay is approved?
Publication of a payment or other transfer of value is delayed when made in connection with (1) research on or development of a new drug, device, biological, or medical supply, or a new application of an existing drug, device, biological, or medical supply; or (2) clinical investigations regarding a new drug, device, biological, or medical supply. An applicable manufacturer must indicate on its research report to CMS whether a payment or other transfer of value is eligible for a delay in publication. The absence of this indication in the report will result in CMS posting all payments publicly. If this indication is made, the publication of the payment will be delayed in accordance with 42 C.F.R. §403.910. CMS will not send publication delay approval to the applicable manufacturer.
Participation in Open Payments:
If a company meeting the definition of an applicable manufacturer dissolves, it is still responsible for reporting in Open Payments for the period when it was an applicable manufacturer.
For example, if Company A meets the definition of an applicable manufacturer and is purchased by Company B, then Company A is responsible for reporting in Open Payments for the period prior to the purchase. However, if Company B meets the definition of an applicable manufacturer upon the purchase of Company A, it too is responsible for reporting in Open Payments beginning with the date of the purchase.
Registration
If two or more entities plan to submit a consolidated report, do all entities need to register in Open Payments?
Yes. Any entity that fits the definition of an applicable manufacturer or applicable group purchasing organization and has payments or other transfers of value to report must register in the Open Payments System.
Data Collections: CMS also added six new FAQs to its Data Collection subject.
Can a physician reimburse an applicable manufacturer for payments so that no information is reported about them in Open Payments?
Some payments or other transfers of value are excluded from reporting; however, no exclusion exists for payments or transfers of value that are later reimbursed. Please review 42 C.F.R. §403.904(i)(1) for information on possible exclusions.
If a physician covered recipient is indicated in the Covered Recipient Demographic section of the Research Payment submission template (including data elements 10-13) and is also a Principal Investigator for the research study, then data element 43 must be used to indicate that the Principal Investigator of the research study is a covered recipient. If the Principal Investigator covered recipient is the covered recipient physician receiving the payment (identified in data elements 10-13), please indicate “Y” in data element 43. It is not necessary to duplicate the information for the previously indicated Principal Investigator covered recipient in data elements 45-60.
If there are multiple Principal Investigators who are covered recipients and who are not indicated in data elements 10-13, please follow the instructions in the Research Payments submission template and provide the identifiers for each of these individuals in data elements 45-60.
Can all payments made to a covered recipient during a reporting period for the same Nature of Payment category be combined into one payment?
Applicable manufacturers have the flexibility to report payments made over multiple dates either separately or as a single line item for the first payment date. In addition, CMS will allow flexibility for what specific date to report for a nature of payment category. For more information, please review 78 FR 9473.
Applicable manufacturers must provide the date of payment or other transfer of value. If the payment or other transfer of value is a series of payments (e.g., a consulting fee that is paid every month for three months) or an aggregated set of payments, applicable manufacturers should report the date of the first payment or other transfer of value.
Since NPPES data may be updated by physicians on an ongoing basis, at what point in time may applicable manufacturers rely on the data?
Applicable manufacturers may rely on NPI information in NPPES as of 90 days before the beginning of the reporting year. While it is not possible to keep past “versions” of NPPES due to the continual updates, each provider entry is date-stamped to include the date the entry was created, as well as the date of each update, which establishes the information available at any given time.
Is there a minimum value threshold that needs to be met in order for applicable manufacturers and applicable group purchasing organizations to be required to report?
There is no minimum value threshold for reporting. However, for CY 2013, payments or other transfers of value less than $10 are excluded from reporting unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient exceeds $100 in the calendar year.
Do applicable manufacturers need to report NPIs for teaching hospitals?
The NPI is not a required field if the covered recipient is a teaching hospital. As stated in 78 FR 9498, reporting the NPI (as listed in NPPES) is required for physicians only. It is the applicable manufacturers’ responsibility to demonstrate a good faith effort to obtain an NPI for a physician.