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, 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.


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 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.


December 08, 2014

Physician Payments Sunshine Act: List of Open Payments Resources

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2014 has been a big year for the Physician Payments Sunshine Act. Applicable manufacturers submitted their 2013 payment data in two phases, then physicians and teaching hospitals were able to engage in review and dispute during the summer, and on September 30, the Centers for Medicare and Medicaid Services (CMS) published the Open Payments data. While this timeline glosses over the technical difficulties, data problems, and missing payments in the system, companies don’t have time to dwell on Open Payments’ rocky rollout—reporting obligations have not stopped. Companies must move forward to submit their 2014 reports to CMS next year.

Policy and Medicine has been writing about the Physician Payments Sunshine Act for a long time now. Below is a summary of our articles about the Act since CMS announced the final rule. This will serve as an ongoing reference for articles related to the Sunshine Act.


Physician Payment Sunshine Act Final Rule: Quick Reference Guide

In light of the significant complexity the rule presents to many stakeholders, we provide a condensed chart or quick reference guide for readers to know many of the key details for reporting.

Physician Payment Sunshine Act: Final Rule Top 50 Things to Know

A brief overview of key areas of Sunshine compliance

Physician Payment Sunshine Act: Sunshine Alerts and Analysis

A listing of client alerts and other analysis from law firms and industry regarding the final regulations. 

Questions and Answers

Open Payment - Questions and Answers by Topic Category

A complete list of up to date Questions and Answers for Open Payments compiled by topic category in an easy to access format. According to CMS they have received over 500 Q&A that they are hoping to answer.

We have also provided analysis of many of the FAQs as they have been released:

CMS Post Round 1 of FAQ's

CMS Updates FAQ's –Textbooks, Imaging, Biologics and Employee Recruitment

CMS Posts Round 3 of Q&A Exempts Accredited Speaker Expenses and Educational Materials, Clarify Meals and Journal Reprints

CMS Posts Round 4 of FAQs: CME Exemption for Only the Five Accreditation Systems Listed, Promotional Speaking Listed as Honorarium or Services other than Consulting

CMS Posts Round 5 of FAQ's Adds Newsletters and Taxes Reportable

CMS Posts Round 6 of Frequently Asked Questions

CMS Posts Submission and Attestation FAQs


Open Payments Data Release

Open Payments Search Tool

Search for physicians, teaching hospitals, and applicable manufacturers. Currently, the database is missing a fair amount of physician-identified information. However, this is poised to change in 2015.

Majority of Open Payments Transactions Are Less Than $20

Out of the 2.6 million lines of identifiable general payments that manufacturers collected and reported to CMS about their interactions with physicians and teaching hospitals, approximately 1.7 million "transfers of value" were for less than $20. More than 1.2 million were for less than $15.   

Top Doctors Provide Context to Their Payments

With the release of the Open Payments database, many were concerned that the benefits of this partnership would be lost in the discussion. After all, Open Payments provides little room for context, and is essentially just a spreadsheet of payment transactions. While some media outlets did take the Open Payments release as an opportunity for a witch hunt, others dug deeper into the numbers. A Michigan news source interviewed the five Michigan doctors with the highest payment totals, and gave each an opportunity to discuss the fruits of collaboration. 

Initial Media Coverage of the Open Payments Data Release

The media surrounding the release for the most part focused on the deficiencies in the roll out of the system. This article also lists resources that analyzed the payment data. We followed up this initial publication review with another round-up on October 30, a month after the initial data release.  

Breakdown of Research Payments, Including Top Manufacturers

Research payments from manufacturers to teaching hospitals and physicians in the first database were around $1.5 billion. While about 90 percent of this research data was de-identified, so as to cover the recipient of these payments, the information provides a useful look into the collaborations between companies and physicians and teaching hospitals. 

Continuing Medical Education

Physician Payments Sunshine Act: CMS Removes CME Language from the Final Rule and Effectively Incorporates the Accredited CME Exemption Into Its Other Definitions

On October 31, CMS released their updated final rule containing modifications to the Open Payments program. The rule eliminated the continuing education exclusion formerly located at 42 C.F.R. Section 403.904(g)(1). However, this change effectively incorporates the exclusion into other language in the rule, and may actually broaden the exclusion for continuing education payments because the now-eliminated provision had required that the event be accredited or certified by certain organizations. Read a simple breakdown of the new CME treatment here.

Hundreds of Organizations Respond to CMS Over CME Exemption

The tremendous support for a CME exemption in the Sunshine Act was evident in the rulemaking process where hundreds of comments were submitted encouraging the agency to either maintain or expand the current exclusion. This article compiles the organizations comments on the issue.

Bipartisan Members of Congress Introduce Bill to Exclude Educational Materials From Reporting, Including CME and Medical Texts

Reps. Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements.

Representative Burgess Addresses New Bill to Exempt Medical Texts and CME

At a November 2014 meeting in Washington, D.C., Rep. Michael Burgess, M.D. (R-TX) spoke to the importance of H.R. 5539, bipartisan legislation he co-sponsored that would exempt peer-reviewed medical journal reprints and independent continuing medical education from Sunshine Act reporting.

CME Coalition's Sunshine Act Compliance Guide for CME Providers and Supporters

The CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities.


CMS Resources: Reporting Requirements and Data Submission Information

Who Must Report?

CMS outlines the entities that must report under the Open Payments system.

Open Payments System User Guide

CMS’s 361-page user guide to using Open Payments.

CMS Breaks Down the “Nature of Payment” Category with Examples

CMS offers insight into the Nature of Payments category that manufacturers must classify payments as. 

2015 Reporting Year: Teaching Hospital list for 2014 Data Submission

CMS's annual list of reportable teaching hospitals. 

CMS Addresses Open Payments at Pharmaceutical Regulatory and Compliance Congress, November 2014

Doug Brown, the acting director of the data sharing and partnership group within the Center for Program Integrity at CMS, spoke on a number of topics that compliance professionals have spent the last year working through. He also touched on what to expect in 2015.

Physician Payment Sunshine Act: CMS Releases Fact Sheets

Payments website to include fact sheets for applicable manufacturers, applicable group purchasing organizations (GPOs), teaching hospitals and physicians who will be affected by the Open Payments, commonly known as Sunshine, final rule. 

Physician Resources and Dispute Resolution

Registration for Physicians and Teaching Hospitals

CMS outlines the registration process for covered recipients interested in viewing and potentially disputing payments before they are published. 

Physicians and Teaching Hospitals Review and Dispute Quick Reference Guide

View the Dispute Resolution Comments CMS Received

This summer, the Centers for Medicare and Medicaid Services (CMS) issued a call for comments on the Dispute Resolution process for Open Payments, the program to implement the Physician Payments Sunshine Act. CMS received 38 responses, many of which revealed the tension inherent in the Act between doctors and pharmaceutical and device manufacturers.

Cost, Impact, and Controversy

Physician Payment Sunshine Act: HHS OIG Reports the NPPES Database as Largely Inaccurate

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a report titled Improvements Needed to Ensure Provider Enumeration and Medicare Enrollment Data Are Accurate, Complete, and Consistent. The report cites multiple failings in the reliability of the data contained in the National Plan and Provider Enumeration System (NPPES) and the Provider Enrollment, Chain and Ownership System (PECOS).This report is of particular interest because one of the main requirements under the reporting provisions of the Sunshine Act is that manufacturers and GPOs report a physician's name, address, NPI number, and other identifying information all based on information in the NPPS database.

Physician Payment Sunshine Act: Effect on Smaller Companies

The Sunshine Act's administrative burdens add yet another hurdle for life science companies, especially those smaller in size, in their efforts to save lives.

Physician Payment Sunshine Final Rule: Cost and Impact of Regulation

We looked at the costs CMS has estimated the Sunshine Act will have on affected stakeholders—doctors, hospitals, and manufacturers—as well as the regulatory impact analysis CMS conducted in issuing the regulation. 

Global Transparency

EFPIA Code on Disclosure of Transfers of Value

This article outlines the Disclosure Code, approved by EFPIA on June 24, 2013.

Japan Pharmaceutical Companies Release Their Own "Sunshine" Data

The Japanese pharmaceutical industry has been tracking and reporting transfers of value to healthcare professionals and academic centers based in Japan. In this article, we walk through the provisions of the Japanese transparency guideline before looking at the payment data and corresponding news stories surrounding the recent release of that data. 

Columbia Seeks To Join Transparency Trend

The Colombia Ministry of Health and Social Protection recently published a draft law which would require pharmaceutical and device manufacturers to disclose their payments and in-kind transfers to “those who participate in any manner in the provision, insurance, or education in the health sector.” The reports will be made public on a searchable database. 

Medicines Australia Code of Conduct: Payment Reporting Starts October 1, 2015

Medicines Australia, Australia's industry body, recently revamped the disclosure provisions of its Code of Conduct, and sent the reforms to the Australian Competition and Consumer Commission (ACCC) for approval. The new Code will require Medicines Australia's member companies to report on an individual basis a wide range of payments and transfers of value to healthcare professionals, as well as sponsorships of third party educational meetings and symposia. The Australian requirements are similar to the United States' Physician Payments Sunshine Act, but there are notable differences in the policies.

French Sunshine Act: Public Database Published

The Loi Bertrand, or the French Sunshine Act, is similar in many ways to the US Physician Payments Sunshine Act, but even more expansive. These differences pose significant hurdles for companies attempting to build uniform programs to comply with these laws. Furthermore, the French Sunshine Act's disclosure obligations are retroactive to transactions occurring in 2012.

State Reporting

Minnesota Board of Pharmacy: Manufacturers Must Be Tracking 2014 Payments to PAs and Nurse Practitioners; Reports Due May 1, 2015 

Minnesota had updated its statute to require manufacturers report their payments to physician assistants, nurse practitioners, veterinarians, and dental therapists.

Connecticut Disclosure Law update

A new Connecticut law requires pharmaceutical and device companies to report payments made to advance practice registered nurses. 

Review of Individual State Reporting Requirements

We run down the list of reporting requirements for the unique state disclosure laws that are out there. Minnesota and Connecticut have since been updated.


Notice of System of Records Shows that CMS may Share Sunshine Data With Department of Justice

CMS stated that they may share their information with other government bodies if CMS determines that "the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court, or adjudicatory body is compatible with the purpose for which the agency collected the records."

Will Sunshine Data Help Qui Tam Attorneys?

The Sunshine Act requires data to be searchable and "easily aggregated and downloaded." Sunshine data could instantly provides qui tam attorneys a host of information that would have been impossible or very difficult to find before the Act.

Tools and Systems

Physician Payment Sunshine Act: CMS Launches Open Payment Apps for Physicians and Manufacturers, and Contest to Develop Future Apps

Physician Payment Sunshine Act: AMA Reminds Members to Update Their Disclosures



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