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May 12, 2014

Physician Payments Sunshine Act: Inside Look at the Open Payments Phase 2 Uploads, Assumptions Documents, and the Attestation Process

The Office of Management and Budget (OMB) posted documents that provide a lot of insight into the next steps of the Open Payments System for implementing the Physician Payments Sunshine Act. The Centers for Medicare and Medicaid (CMS) have not yet released detailed information on the Submission and Attestation process, but the OMB Information Collection Request sheds light on important aspects of Phase 2.

Entitled "Screen Shots Submission Flow," the documents contain screen shots of a sample user submitting a "General payments" record (as opposed to Research payments or Investment/Ownership Interests).

As we've covered, Open Payments registration and data submission for applicable manufacturers and applicable GPOs opened with a two-phased approach for the 2013 reporting year:

  • Phase 1 (February 18 - March 31) included user registration in CMS' Enterprise Portal and submission of corporate profile information and aggregate 2013 payment data.
  • Phase 2 (begins in May and extends for no fewer than 30 days) includes industry registration in the Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data.'

 

Uploading Instructions:

CMS states that companies: "Report payments (transfers of value) either by uploading a file or by entering a single payment manually. After you upload the file and submit the file, you will see a confirmation message. You can then go to View Records to see your recently uploaded files when they have finished uploading."

First, perform a test of the file by selecting Test File Submission.

Second, you can then proceed to upload the appropriate file for the payment category (Research, Nonresearch, and Ownership/Investment Interest).

Third, to successfully upload the data,

  • 1) Make sure each file you are submitting is in a valid file format (CSV or XML). If needed, you may download the latest Open Payments submissions sample files from the sample files link.
  • 2) Fill out and review your data for accuracy, completion, and valid field formatting.
  • 3) Browse and upload the correct file, then click "Submit File to Open Payments."
  • 4) Repeat steps 1-4 if you are uploading multiple files.

The Sample Screen Shots for Uploading are as follows:

Select Criteria for Upload: You must first identify the payment category (General, Research, and Ownership/Investment Interests). No one file can be larger than 250 MB.

Successful File Upload Page:

Once your payments have passed the file level validation check and are ready for final submission, CMS summarizes the payments by category: (1) General; (2) Research; (3) Ownership/Investment Interests:

Once you have viewed the separate payments, the Final Submission button is enabled:

Final Submission Confirmation page:

Submission Confirmation:

Below are the records reported by the entity and categorized by status. Each status has a corresponding action related to it.

 

Attestation

Once you have submitted your records, the attestation process begins.

First, companies are able to add assumptions to the attestation.

CMS states: "Applicable manufacturers and applicable GPOs may submit assumptions, which explain the reasonable assumptions made and the methodologies used when reporting payments or other transfers of value or ownership or investment interests.

Note: Assumptions for an entity can only be entered and edited by a user with an attester role. Assumptions entered during the initial attestation can be updated and additional assumptions can be entered at any time, but doing so will require re-attestation. If no assumptions were entered during initial attestation, the user will not be able to add assumptions later."

The Assumptions Document is essentially a text box for which companies can provide information to CMS on how they, for example, interpreted various terms and calculated transfers of value. "By default," CMS states, "the assumptions statement applies to all payments (transfers of value) being attested to."

After adding assumptions, users select "Agree to Attestation." Officers must attest to a list five things:

  1. They are a "C-Level" Officer, with the authority to attest to the information submitted to Open Payments
  2. The information reported in timely, accurate, and complete to the best of your knowledge
  3. Companies with less than 10% of their gross revenues coming from covered products must attest to that fact in order to avail themselves of the special exclusion of only reporting payments related to covered products.
  4. Companies delaying publication due to the development or research of new drugs/devices must attest to that fact.
  5. The officer must attest that his or her entity is submitting a consolidated report because it is under common ownership with a separate entity or entities that are also applicable manufacturers.

Finally, officers must review and agree to the attestation, which summarizes the agreement. Attesters can go back to make corrections as well:

After you attest, the records will reflect that the payments are attested to (35 General Payments in CMS' sample):

The following documents are available on the OMB website:

Assumptions Submission Screenshots

Attestation Submission Screenshots

CMS has promised additional Phase 2 information in the coming weeks, and we are expecting the documents to look very similar to the screenshots currently available.

 

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