Life Science Compliance Update

February 06, 2018

Tomorrow: CMS To Host Open Payments Webinar/Q&A

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Tomorrow, February 7, 2018, the Centers for Medicare and Medicaid Services (CMS) will be hosting a Webinar and Question and Answer session with CMS Open Payments program experts from 2:00 pm to 3:00 pm EST. CMS has been hosting these every few months for stakeholders to get some of their important questions answered.

During this webinar/Q&A session, the Open Payments team will present an overview of system enhancements and data submission activities and will then be able to respond to your questions about the 2017 Open Payments program year.

If you have a question, you must go online and register at least fifteen minutes prior to the webinar here. Once you are registered, you will receive an email with instructions on how to join the call and ask a question.

If you do not have a question, but want to listen to the call to gain insightful information, you can dial in to (844) 396-8222 and enter meeting number 900 984 780 when prompted.

February 17, 2016

Open Payments 2016 Updates: Companies Should Report Retired and Deceased Doctors

In politics it is sometimes noted that death does not necessarily prevent you from voting, in the case of Open Payments it doesn't stop you from being reported on either.

On Tuesday, February 16, 2016, the Centers for Medicare & Medicaid Services (CMS) hosted the first webinar in a series of webinars on the Open Payments program. Upcoming question and answer sessions have been announced via the Open Payments listserv and will be listed on the Open Payments website as they get closer.

At the outset of the question and answer session, the Open Payments team presented a PowerPoint going over the system enhancements for the year. While the PowerPoint presentation will not be made public, the Open Payments team recommended visiting the 2015 Open Payments Overview and Enhancement resource online.

2016 Timeline

This year, in order to be included in the June refresh, changes must be made prior to March 31, 2016. One Q&A attendee was concerned that reporting is supposed to be completed 90 days within January 1 of each year, which usually lands the deadline on March 31. This year, however, is a leap year, messing up conventional wisdom a bit. According to CMS, this year, companies who must report payments have an extra day to do so – the deadline is still March 31, 2016.

The final timeline for 2016 should be coming out relatively soon.

Trending Help Desk Questions

Before getting into individual questions of Q&A Session attendees, the Open Payments team went through some of the trending help questions. Questions such as what happens when it has been over 180 days you last logged into the CMS Enterprise Portal and your account has been deactivated? Or how do you remove a user role in the Open Payment system? Both of those questions can be answered in real time by members of the Open Payments Help Desk.

Another frequently asked question is what steps must be taken before one can complete submission? One of the important things is that if this is the first reporting year for Open Payments for you, you must register your entity. On the other hand, if you have submitted data before, you must complete recertification before taking any action in the system for 2015, and the officer role must be complete in order to be recertified. It is important to note that while providing contact information in the recertification process, do not hit the "enter" key, as it could cause an error code.

Guidance Documents

Several questions focused on guidance documents. One person wondered if there was a new error code guide. There is, and it can be found here. Another wondered if there is an updated Open Payments 2015 System Enhancement Document. It can be found here.

Additionally, the current listing of teaching hospitals can be found here.

Reporting Requirements

Retired Physicians

According to the Open Payments team, physician retirement status doesn't matter when it comes to the required reporting of payments or ownership interests. The definition of physician as applicable is found in the Social Security Act, and is essentially defined as one who is legally authorized to practice medicine. Therefore, as long as the retired physician can still practice medicine if they so choose, their ownership interest should be reported.

Deceased Physicians

Generally, there is no exclusion for deceased physicians. Payments should be reported as usual.

Cash and In-Kind Items Reporting

At least one attendee was concerned about a manufacturer who has provided both a cash payment and a supply for free products to a covered recipient, under the same research agreement. Since you cannot report both cash and in-kind items in a single report, you would need to report them as two or more separate payments.

Reporting Form Templates

Once concern voiced was if a manufacturer is submitting data for the 2013 or 2014 program year, can they use the current reporting form. The answer is yes, the templates that are posted online should be used for all payment years – 2013, 2014, and 2015. Additionally, the edits that are now in place for this reporting year are effective to any new reports that should have been made in previous years. The template you use depends on which type of payment records you are submitting.

Old, Unreported Payments

If you discover payments that were not previously reported, you may submit payments for prior program years. When doing so, make sure that you submit the payment under the correct program year.

Physicians Being Rejected for Not Being on Validated Physician List

There are evidently a number of specialists who are not currently on the VPL, were accepted in prior years, and are now being rejected. This could be in part to "enhanced system matching logic," by CMS. Only physicians who are covered recipients under the program final rule will be accepted into the system. As such, certain specialties and physicians no longer match, possibly because CMS determined that they are not considered to be a covered recipient for purposes of Open Payments. If you believe that payments should be reported, CMS suggests that you attempt to submit them. If they do not match, and you cannot make appropriate adjustments to make them match, CMS recommends that you delete the records and do not resubmit them. CMS keeps record of deleted statements and will analyze all deleted statements later.

Taxonomies

Several attendees were curious as to whether or not taxonomies are drivers or if they can singly determine whether or not a recipient is a covered recipient. CMS assured everyone that taxonomies are not drivers for determining whether someone is a covered recipient – that determination is made based on definitions found in the Final Rule. CMS also informed us that the taxonomies are based on a list – or several lists – that might actually be out of date. (Surprise, surprise. Transparency leads to miscommunication and misunderstanding yet again.)

Unmatched Data

If you find that you have unmatched transactions, go back and make sure everything is accurate. According to CMS, the majority of unmatched transactions last year were because of one single mistake. They suggest that you use the Validated Physician List to avoid problems. As a last resort, you can delete the payment from the system, as you will have to have all payments in attested status for reporting to be completed.

Dispute Process

If someone initiates a dispute, you will receive an email notification. You can also monitor disputes under the "Review and Dispute" tab when you're logged into the system.

There is no change to the dispute resolution process itself, the only change is your company's contact information being displayed to covered recipients, who can then reach out to you directly.

Deleted Transactions

If a company deletes some of their transactions, they will then be unable to view them in the system. If you delete a record that was already attested to, you will have to re-attest to the deletion before it can be removed.

 

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.

 

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