Life Science Compliance Update

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.

 

June 30, 2015

Physician Payments Sunshine Act: CMS posts 2014 Open Payments Data Totaling $6.49 Billion

Open Payments

The Centers for Medicare & Medicaid Services (CMS) today published 2014 Open Payments data about transfers of value by drug and medical device makers to health care providers. The data includes information about 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals, totaling $6.49 billion. This is compared to 4.3 million records attributed to 470,000 physicians and 1,019 teaching hospitals covering $3.43 billion dollars, according to CMS’s summary data.

Like last year, the datasets are available in three separate spreadsheets—general payments, research payments, and ownership interests. Interestingly, it appears ownership interests in life science companies by physicians have dropped around 23 percent.  

Type of Payments

2013 – 5 months
(8/2013-12/2013)

2014 – 12 months  
(1/2014 – 12/2014)

General

$972 million

$2.56 billon

Research

$1.55 billion

$3.23 billion

Ownership

$908 million

$703 million

Total

$3.43 billion

$6.49 billion

Acting CMS Administrator Andy Slavitt said, “Consumer access to information is a key component of delivery system reform and making the health care system perform better. In year 2, Open Payments is now a highly searchable resource to provide transparency to over 1 1/2 years’ worth of financial transactions between drug and device companies and physicians and teaching hospitals. This is part of our larger effort to open up the health care system to consumers by providing more information to help in their decision making.”

Increased Validation Rates from the Rocky 2013 Roll-Out

For all 2014 and 2013 data, CMS was able to validate that 98.8% of all records submitted in the Open Payments system contained accurate identifying information about the associated covered recipient. Records that could not be verified to align to an individual covered recipient were rejected and were not processed by the system. CMS will continue to update the Open Payments website annually with data collected from the previous year.

Today’s data posting also includes a group of 2013 submissions that could not be verified before the first data publication last September, 2014, CMS states.

Dr. Shantanu Agrawal, CMS deputy administrator and director of the agency’s Center for Program Integrity, said the agency has improved the Open Payments’ user interface to highlight valuable information for people who want to view payments and other financial transactions involving doctors, hospitals, and drug and medical device makers. Other consumer website upgrades are expected in late summer.

“CMS’ role is to facilitate discussion and analysis of the data by making it publicly available for consumers and researchers,” Agrawal said. “CMS has improved our interfaces for both collecting and reporting this data about compensation and other payments between drug and medical device manufacturers and physicians and teaching hospitals.” 

“We expended a tremendous level of effort to resolve inconsistencies in the reporting of these 2013 transactions and are very pleased to be able to align them with the rest of the payments,” Agrawal stated. 

Review and Dispute Activity

The press release indicated that registered physicians and teaching hospitals reviewed nearly 30% of the total value of the reported data. “We are pleased that so many providers participated this year, but will continue to work with doctors and hospitals to increase their review rate,” Agrawal said.

An analysis of the physicians and teaching hospitals included in reported data reveals that there are distinct differences between those that have registered and those that have not. For example, the median value of total payments made to registered physicians is $3,644, compared to $747 made to non-registered covered recipient physicians. View our article on some difficulties that remain in the review and dispute process. 

"CMS will update the Open Payments data at least annually to include updates to data disputes and other data corrections made since the initial publication," the press release states. 

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We will provide continued coverage of Open Payments in the coming days as we delve into the database, though we will leave you with our favorite stat so far. The general database lists 590 payments of less than a penny and a whopping 158,402 payments of $1 or less. 

Detailed analysis of the Open Payments data, including useful trends and comparisons from 2013 to 2014 will be available in August's issue of Life Science Compliance Update

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