Life Science Compliance Update

February 04, 2016

Physician Payment Sunshine Act: Open Payments Final 2015 Data Submission and Attestation Help

In our latest endeavor to try to help you wade through the lengthy regulations known as Open Payments leading up to the March 31 submission deadline, we drafted the following article on the Final Submission and Attestation process.

In order to meet the requirements of Open Payments, officials from manufacturers and GPOs are required to submit final payment or other transfer of data value or ownership/investment interest data. In addition to the actual submission of the data, authorized officials must attest to the accuracy of the data.

Once the final data is submitted, the Open Payments system then matches your submitted information with physician and teaching hospital profiles. If your information is unable to be matched, you will be notified and given an opportunity to correct and re-submit the final data. It is important to realize that reporting under Open Payments is not considered complete until the official attestation is received.

Additionally, prior to final submission and attestation, the user must be registered in the Enterprise Identity Management System (EIDM) and the reporting entity must be registered in the Open Payments system. The user who submits the data is known as the submitter user, while the user who attests to the accuracy and truthfulness of the data is the attester for the reporting entity.

Final Data Submission

Prior to submission, you must make sure that all data within the selected payment type is in "Ready for Submission" status, which means that all validation and matching errors have been corrected on your end.

To complete the final submission, you should log into the Open Payments system through the CMS Enterprise Portal at https://portal.cms.gov, and select the "Submissions" tab. From there, utilize the drop down menu to select the reporting entity and the program year for which you want to complete the final submission, and select "Review Records."

Once on the records review page, select "View All" for one of the three payment types (general, research, and ownership/investment). On the "Payments Category" page for the selected payment type, the "Final Submission" button should be enabled, click it. On the "Confirm Final Submission" page, review the summary details and select "Submit as Final Submission" if the information is correct. If the displayed information is not correct, select "Cancel" to go back and make any necessary changes to the records.

If the "Final Submission" button above is not enabled, review the status column on the left side of the page. If any of the following statuses are listed for the records, you will not be able to perform the Final Submission for that payment type: System Processing, Failed Validation, Failed Matching Validation.

You will need to repeat the final data submission steps for each of the three payment types (general, research, and ownership/investment).

When you select "Submit as Final Submission," an email notification will automatically be sent to the attester letting them know that there are records ready for their attestation if (1) all records across payment categories are now in "Ready for Attestation" status; and (2) no records for that program year had previously undergone attestation.

If any records for the program year have already undergone attestation and re-attestation is required, select the "Notify Attester" button once all records are ready for the attester to review. This button will send the email notification to the attester that new records are ready for their attestation. Re-attestation will be required any time previously attested data is changed, including any data fields, delay in publication indicator, or deletion of records.

Attestation

Once the data has undergone final submission, the attester will be able to attest that the information is accurate and complete. Only individuals who are in the attester role may complete the attestation process.

Records that were previously attested to that were marked for deletion must be re-attested to for those records to be removed from the Open Payments system. A summary of records that are marked for deletion is provided during the attestation process.

To complete attestation, the attester needs to log into the Open Payments system via the CMS Enterprise Portal and select the "Submissions" tab. From there, select the reporting entity and program year for which you want to perform attestation and select "Review Records."

To view records in "Marked for Deletion" status, select "View All" next to the payment category for the records you wish to examine. On the following page, in the Record Status filter box, check the box for "Yes" under the heading "Marked for Deletion," and select "Search." When you are ready to attest, return to the "Review Records" page.

Once you're on the "Review Records" page, select "Begin Attestation of All Records." Attestation is conducted for all records for that program year, across all three payment types.

If the "Begin Attestation of All Records" button is not enabled, check that all records for that program year are in "Ready for Attestation" or "Attested" status. If they are not, reach out to a submitter for the reporting entity and let them know that there are records that still need to be advanced to the "Ready for Attestation" status before you can begin the attestation process.

On the "Confirm Payments" page, review the summary of records being attested to and continue to "Next."

If you have made any assumptions in either preparing or submitting the data, include that on the "Add Assumptions" page. If you do choose to include an assumptions statement, the assumptions are entered in a free-form text box with a 4,000 character limit. The assumptions statement can be edited at a later time.

On the "Agree to Attestations" page, review the attestation statements and select the checkbox next to all statements which apply to the submission. Checking the first two statements is required in order to proceed. Additionally, if you are attesting to the deletion of previously attested records, checking the sixth statement is highly recommended.

A summary of all records that are being attested to and deleted will be displayed. When finished, select "Continue," to move to the "Review and Attest" page. Once you have reviewed the information displayed, select "Attest" to complete the attestation.

The Final Submission and Attestation phases are now complete. If any disputes arise, both the submitter and the attester may need to review and resolve them as they arise.

Additional Help

If you need further assistance, data submission resources can be found on the Resources page of the CMS Open Payments website at http://www.cms.gov/OpenPayments/About/Resources.html. The Open Payments User Guide also has a chapter on the Data Submission and Attestation processes, Chapter 4, which provides step-by-step instructions for various potential scenarios.

 

January 20, 2016

CMS Updates 2014 Open Payments Data

Breaking months of silence on Open Payments data, Centers for Medicare and Medicaid Services (CMS) updated some of the Open Payments data available on its website.

CMS still plans to update the Open Payments data at least once a year to include updates from disputes and other data corrections that were made since the initial publication of the data. The updates by CMS affect all types of payments or transfers of value to physicians, teaching hospitals, and physician ownership and investment interests.

This updated Open Payments dataset reflects changes that were made to records, changes to delays in publication flags, changes to disputed records, and records that were deleted. The updated data was submitted by the applicable manufacturers and applicable group purchasing organizations (GPOs), and the accuracy of all data included in the update was attested to by the submitting applicable manufacturer or GPO.

Not only did CMS update the actual data, but the Open Payments data website itself was updated and enhanced with new added features. The new added features include: a homepage tool where you can search for physicians by name, a snapshot of Open Payment facts, and sections to explore and download data.

Updated Data Information

While CMS did a data refresh, that does not mean that all of the data on the Open Payments website is undisputed now. Currently, of the $3.49 billion in general payments, $5.94 million is in dispute; of the $4.81 billion in research payments, $19.07 million is in dispute; and of the $1.02 billion in investments, $1.19 million are in dispute.

For the 14.84 million records of general payments, 2,672 of them are under dispute; and of the 823,000 records of research payments, 1,378 of them are disputed.

New Interface – Sort of

In addition to updating the data CMS updated the opening page of Open Payment Data. Now the page goes directly to a picture which reads find your doctors payments, this is an updated version of the old screen in which you would also enter in the city, state, country and specialty. Now if your doctor's last name is Khan or Smith the patient gets to scroll through hundreds of pages of names. Though the old interface is still available if one presses the option to select by teaching hospital or company name, There is still little context on the home page as to what those payments are for, or why a patient would want to know about them. Overall the interface and subsequent data is still very confusing for a patient.

New Interface                         

    Old Interface

Open Payments System Down

From Thursday, January 21, 2016 through Tuesday, January 26, 2016, the Open Payments system will be unavailable as CMS works to update and improve upon how the system works. While the Open Payments system will not be available for use during that time, you will still be able to see Open Payments data and use the data search tool on the website, and register at the Enterprise Portal (EIDM).

Conclusion

It is promising that CMS is yearly updating their data. Publishing outdated or incorrect data is not being transparent, but instead, can be considered to be unknowingly misleading.

As we have previously written, the push for transparency can have concerning ramifications for patients and physicians alike. Patients who rely on Open Payments data, and the doctors who serve those patients, deserve to, at the very least, have reliable information presented through the Open Payments website. We continue to advocate for life science companies and physicians keeping track of their reporting for Open Payments, to help cut down on the confusion for patients.

November 10, 2015

2016 Data Collection and Submittal Changes under the Open Payments System

A representative of the Open Payments Team at CMS, hosted a Webinar on Thursday, October 29, 2015 about Open Payments and the new submittal and data collection changes for CY2015 data and CY 2016 data, respectively. This webinar comes on the heels of a presentation by Mr. Brown, presented at the Sixteenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, in late October.

Both presentations shed light on the progress CMS has made on data submission and answered some open questions, a summary of which is laid out below.

Stakeholder Feedback Changes

The representative mentioned that they had received a lot of stakeholder feedback and were working on making some responsive changes, including the ability to exchange reporting entity and covered recipient contact information to help facilitate the review and dispute process. The system will now ask you what contact information you want shared with the individuals/organizations reviewing your records, and you can input the most convenient way to contact you.

CMS also received a lot of comments on the special character restrictions; most of the unnecessary special character restrictions have now been removed.

The ability to download reported records will also be enhanced in the update: the downloaded records will now be enhanced to include dispute information and be extended to covered recipient uses. Each download is limited to 400,000 records, which stands in contrast to the upload limit of 250MB. Therefore, CMS recommends that your uploaded data be less than 250MB and 400,000 records so the same files that are uploaded can be downloaded all at once.

One more change CMS has made from stakeholder feedback is that the covered recipient interface will allow users to distinguish whether a record identifies them as a covered recipient or a principal investigator.

Help Desk Feedback Changes

In addition to stakeholder feedback, CMS received feedback from their help desk. One of the new updates will be that reporting entities may delete records that have a status of "system processing."

Additionally, recipient type and details on payment records and principal investigator information on research records cannot be changed after final submission. Changes require the original record to be deleted and a new record with updated information to be submitted. CMS wanted to draw attention to the fact, however, that while reporting entities can delete old records and replace them with new records, the Open Payments system will treat them as new submissions and it may appear as though the records were submitted late.

The final change being made in response to help desk feedback is the character limit for physician/principal investigator state license number has been increased. The character limit will now be twenty-five characters for manual submission and 28 characters for bulk file upload (25 license, 1 hyphen, 2 state code).

Validation Edits

In the 2015 program year, CMS will reject records that are submitted with an NDC (National Drug Code) but without a marketed name. NDCs will also be validated for proper format – dashes must be included in the appropriate positions. The drug name is required in addition to the NDC for several reasons, (1) it is a requirement in the Open Payments Final Rule, and (2) as a more technical point, Open Payments data is not connected to the drug data directly, so for consumers to understand the publicly available information, the marketed name is an important component.

Also, in the next year, research and general payment amounts may not contain a "$0" value amount. For ownership records, "$0" may only be entered in "Total Amount Invested" or "Value of Interest" field, but not both at the same time. If both the total amount invested and the value of interest are equal to zero, there is nothing to report.

For records that contain data in physician-specific fields and hospital-specific fields simultaneously, those records will now be rejected. CMS only wants either the hospital reported or the physician-covered recipient, not both.

Teaching Hospital Complications

Last year, there was some confusion as to which organization should be listed in the Open Payments database: the teaching hospital on the list is the organization that you make the research or general payment to directly. CMS provided this slide during the webinar in hopes that it would shed some light on the confusing hierarchy.

 

Also related to Teaching Hospitals, CMS provided the below flow chart to use in determining when and how to report payments to Teaching Hospitals.

 

Stock as a Form of Payment

CMS also touched upon how to handle stock as a form of payment. Essentially, if the stock is publicly traded, it should be reported as a General Payment, Form: Stock. If the stock is not publicly traded, it should be reported as a General Payment and as Ownership.

Stock Options as a Form of Payment

Stock Options as a form of payment is a little trickier. If the stock is publicly traded, payment of transfer of value in the form of stock options should be reported as a General Payment, Form: Stock Options. If the stock is not publicly traded, it should also be reported as a General Payment, Form: Stock Options, but if the options are exercised also need to be reported as Ownership or Investment Interest. If the options are not exercised, they are just reported as General Payment, Form: Stock Options.

Ownership and Investment: Stock

If you have an ownership interest in stock and it is publicly traded, there is nothing more to report. If you have an ownership interest in the form of stock, and it is not publicly traded, new holdings need to be reported in "Dollar Amount Invested" and total holdings should be reported as of the last feasible valuation date in "Value of Interest."

GPOs and PODs

A manufacturer must report each payment to a physician owned distributor (POD) (e.g., LLC, etc.) as an indirect payment to a covered recipient physician. PODs, as a subset of GPOs, must report their physician ownership interests annually.

2015 Physician Fee Schedule Reminders

The 2015 Physician Fee Schedule, implemented November 13, 2014, made some regulation changes to allow for consistency in reporting. For data collected in CY2016, the device and medical supply names will be required and therapeutic area and product category will be optional. CMS wants to move to a more uniform way of reporting medical devices and drugs, making it easier on consumers and patients to read and understand their physicians' reports.

CME Payments

Additionally, with regard to CME payments, compensation (either direct or indirect payments) for physician speakers at accredited or certified continuing education events must be reported if the payment was directed towards a specific physician. However, CMS did update their section on CME payments because they would like for patients to be able to understand their physicians' reports. CMS states that if you are making a direct or an indirect payment to a covered recipient physician, within the context of providing the CME, then that is a reportable event. If by virtue of the relationship you have with the CME organization, it does not meet the definition of a direct or indirect payment, then it is not a reportable event.

Essentially, when determining whether to report a CME payment or not, always review whether it fits into the definition of a direct or indirect payment. If it does, it is reportable; if not, do not report. CMS has outlined in several FAQ's the criteria for determining if the CME payment qualifies as a payment.

Compliance

Failure to timely, accurately, or completely report each payment or transfer of value, or ownership or investment interest is subject to a penalty of $1,000 - $10,000 per payment/interest, with a maximum annual penalty of $150,000.

Knowingly failing to timely, accurately, or completely report each payment or transfer of value, or ownership or investment interest is subject to a penalty of $10,000 to $100,000 per payment/interest, with a maximum penalty of $1,000,000.

Resources Available

CMS announces periodic webinars and Q&A sessions for industry professionals and offers a Help Desk email: openpayments@cms.hhs.gov.

 

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