Life Science Compliance Update

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February 26, 2014

Physician Payments Sunshine Act: Open Payments Phase I Registration and Submission Webinar Provides More Details

As we previously reported, the Centers for Medicare and Medicaid Services (CMS) conducted a webinar to explain requirements for Open Payments, the implementation program for the Physician Payments Sunshine Act, Phase 1 registration and data submission. A recording of the event and PowerPoint slides will be posted this week on the Events page of the CMS website.

Some key takeaways from the webinar include that for Phase I, applicable manufacturers with multiple entities will have to register C level registrants for each entity. Registration will be limited to one registered person per entity, no one will be able to file for more than one entity. In addition, registrants who live outside of the US are having difficulty in registering on the CMS enterprise portal. CMS is asking X US companies to contact via email the help line.

Companies will need to register at least two weeks in advance of submission to ensure that they are verified in the CMS enterprise portal. The CMS enterprise portal requires changes to passwords every 60 days, so make a reminder for yourselves.

The Webinar

CMS started the webinar with general updates to the program. A few important pieces of information regarding Phase I registration from the presentation:

CMS also provided step-by-step instructions with screen shots to help in three areas: (1) Registering with CMS's Enterprise Portal; (2) Requesting Access to Open Payments; and (3) Logging into the Open Payments System. The instructions with screen shots can be located here.

However, during the webcast CMS also added in additional slides to the step-by-step instructions, should verification fail during the registration process. The additional information is as follows:

In the instructions there is also an error regarding EIDM formatting:

The webinar provided key information about Phase I data submissions:

In addition, CMS explained the three data elements that should be reported – the general reporting category, research reporting category, and ownership or investment interest category:

A sample calculation was provided:

Additional reminders were provided about Phase I data submissions:

Phase I resources:

Links: EIDM User Operations Guide

Open Payments Help Desk

CSV Data Element Template

Phase I Data Submission Instructions

More information about Phases I and II:

Finally, the webinar ended with CMS answering questions from the audience. We strongly encourage interested parties to download the webinar recording when it is published this week to get a complete run down of CMS's comments. The following are a few items that may be of interest to our readers:

  • During Phase II, you will be able to edit and correct information from Phase I submissions. In addition, CMS realizes that reporting aggregates in Phase I is a new requirement for entities, so CMS does not require the total to be reported during Phase I -- only during Phase II submissions.
  • During Phase I, CMS asks that the authorized official (often C-level executive) get an EIDM account and prepare the system to set up the entity. The email submitted with the aggregate information during Phase I can be sent by anyone as long it includes the C-level official's EIDM ID in the heading of the e-mail.
  • You may submit a consolidated report when two entities under common ownership use one data submission to represent both entities. In Phase I, consolidated reporting is not available but is applicable in Phase II. In Phase I, both of the two entities need a C-level official from each organization to establish registration within the system and submit the aggregate form on behalf of their organization.
  • CMS will process the data submitted during Phase I and repopulate it in the Open Payments system once it goes live. During Phase II, the entity will see what it submitted during Phase I and during this time they will be able to review and make corrections on the Phase I data before submitting Phase II information.
  • Foreign entities are having problems getting an EIDM account. CMS recommends contacting the help desk to resolve the issue and will lead foreign entities through the registration and submission part of Open Payments.
  • EIDM requires the use of a residential address, but you can use a company address if you do not have a United States location. However, CMS recommends using a residential address.
  • Phase I is an aggregation of the number of covered recipients, payments made or value transfers and their amounts, but the May, Phase II submission will be a granule level submission of values and transfers made using the Open Payments website.
  • More EIDM user ID questions will be addressed on the Open Payments FAQ page in the future.
  • CMS plans to publicly post payments or transfers of value by September 30th.
  • There is no separate template for physicians in teaching hospitals.
  • Sometime in the near future CMS will be adding live telephone help assistance to the Open Payments project.

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  • Companies should note that there is no requirement for submitting assumption documents to CMS and the upload of those documents into Open Payments will only be available in Phase II

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