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.


January 26, 2016

CMS Final Rule on Covered Outpatient Drugs

The Centers for Medicare & Medicaid Services (CMS) issued the Covered Outpatient Drugs final rule with comment on January 21, 2016. The rule addresses important areas of Medicaid drug reimbursement, as well as some of the changes that were made to the Medicaid Drug Rebate Program by the Affordable Care Act. This final rule also requests comments on the definition of line extension, and that comment period expires on April 1, 2016.

This rule attempts to assist states and the federal government in managing drug costs and establishing a long-term framework for implementing the Medicaid drug rebate program.

Managing Drug Costs

While the Affordable Care Act increased the Medicaid rebates that are paid to the federal and state governments, this final rule went a step further in an attempt to ensure that the federal and state governments will save money in managing Medicare costs over the long term. One of those steps the final rule took was to create a regulatory definition for Average Manufacturer Price (AMP). The AMP is a key metric in the Medicaid drug rebate program, determining manufacturer rebates and pharmacy reimbursement for certain generic drugs that are subject to the Federal Upper Limit (FUL).

The new definition of AMP for inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs) will permit states to collect additional rebates on more expensive infused and injected drugs. Some of these 5i drugs are a constantly increasing expense to the Medicaid program and are not commonly dispensed through a retail community pharmacy.

The final rule also creates an incentive for pharmacies to utilize generic drugs by updating the FUL formula for the payment of certain generic drugs. The rule also implements the Affordable Care Act provision that extended rebates to covered outpatient drugs provided to beneficiaries that are enrolled in Medicaid managed care organizations.

Lastly, the final rule expanded the definition of "states" to include United States territories so that territories like Puerto Rico and Guam can receive savings in their drug expenditures.

Sustain Medicaid Drug Rebate Program

The final rule attempts to clarify many of the changes that were made to the Medicaid Drug Rebate Program under the Affordable Care Act and provides pharmaceutical manufacturers with clear regulatory guidance to help calculate and report drug product and pricing information.

In addition to clarifying the definition of what is considered a manufacturer's "best price" and aligning that definition with the definition of AMP, the final rule clarifies the definitions of Retail Community Pharmacy and Wholesaler in determining AMP.

Pharmacy Reimbursement System

The final rule also attempts to align pharmacy reimbursement with the acquisition cost of drugs and work to ensure that the states pay an "appropriate" professional dispensing fee.

The final rule also creates an exception to the FUL calculation, allowing for the use of a higher multiplier than 175% for certain multiple source drugs, and establishes actual acquisition cost (AAC) as the basis by which states determine their ingredient cost reimbursement. One of the impetuses behind AAC being the ingredient cost reimbursement basis is so that payments are "based on a more accurate estimate of the prices available in the marketplace."

In addition, a professional dispensing fee will be initiated so that the dispensing fee paid to pharmacies reflects the cost of the pharmacist's professional services and cost to dispense the pharmaceutical product to a Medicaid beneficiary.

Comments Sought After

While most portions of the rule are considered final, as previously mentioned, CMS is still considering comments received on the definition of line extension. For the time being, manufacturers should rely on the statutory definition of line extension found at 1927(c)(2)(C) of the Act, and are permitted to use reasonable assumptions in determining whether their drugs qualify as a line extension drug.

While the definition of line extension is not yet solidified in the final rule, CMS did finalize two aspects of the line extension provision: specifying the rebate calculation requirements and requiring the alternative rebate be calculated if there is a corporate relationship between the manufacturer of the line extension drug and the manufacturer of the initial brand name listed drug.


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).


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.


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