Life Science Compliance Update

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May 08, 2014

Physician Payments Sunshine Act: CMS Releases Submission of Phase 2 Data Webinar

The Centers for Medicare and Medicaid Services (CMS) posted a webinar outlining the procedures that companies will need to follow as they embark into Phase 2 of Open Payments. CMS expects to begin Phase 2 of Open Payments registration and data submission for industry in "late May/June 2014," and Phase 2 will run for no fewer than 30 days.

According to a CMS announcement, the agency is developing a series of tutorial videos to explain three Phase 2 topics. The first educational tutorial is now available, and it explains how to prepare submissions using the data submission resources, which CMS recently updated (see the technical changes here), using the CSV and XML Sample Files and XML Schema Definition (XSD document) to format data for upload into the Open Payments system.

Polaris consolidated CMS' technical updates, most of which pertain to field size-related issues in the report template, into a convenient and easy-to-read table


Phase 2

Applicable Manufacturers and Applicable Group Purchasing Organizations (GPOs) have two options when it comes to submitting data: Manual Data Entry and Bulk File Upload. Manual data entry will be available in Open Payments via a Graphic User Interface. This option requires users to enter data manually as the Open Payments system guides them through the various mandatory fields. Right now, CMS advises that companies intending to use manual data entry should simply focus on collecting 2013 data, as detailed step-by-step instructions will be forthcoming in a webinar focusing on data submission and attestation.

CMS also went through the Bulk File Upload process, the recommended method for data submission for applicable manufacturers and applicable GPOs with large volumes of reportable data. Manufacturers can choose between CSV and XML. CMS went through a number of easy-to-follow demonstrations about how companies should submit their data, depending on whether they were using Windows or Macintosh.

For CSV, companies using excel must change from comma delimited to pipe delimited, but then save the excel file as a .csv file. Finally, companies must check that data rows are not contained within quotation marks, as this renders an entire row of data into a single data element, which will be rejected by the system. Users pursuing CSV should watch the webinar at (5:00).

For XML files, CMS suggests companies refer to the Submission Data Mapping Document for the data elements, data element description, and the expected size, format, and name of each XSD element. Also of note, files must not exceed 250MB—companies must split their data into multiple files if their data exceeds that. Also, XML file names should be unique across submissions and not exceed 50 characters. CMS recommends that users compare their files with those provided as sample XML files in order to check for errors.

Open Payments allows users to submit test files to test for submission errors before formally submitting their data. To submit data files, just select "Submit as Test Submission." The Open Payments system, however, will only check the file format and perform basic field validations. Detailed instructions on validation rules, error reporting, and correcting records, CMS states, will be available on the Open Payments page "in the near future."

CMS concluded the Open Payments tutorial with the top error codes in data file submission and how to avoid them. Those with large files may find themselves with several errors amongst thousands of records. It is recommended that you run the test with real data before actual submission.

Future Webinars:

Following CMS webinars will cover how to register in the Open Payments system, explained through step-by-step screenshots, and finally how to formally submit data files in the acceptable file formats to the Open Payments system, and attest to the accuracy of the data.

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