A blog by attorneys for anyone interested in or affected by The Sunshine Act.

CMS Announces Two-Phase Registration Process

March 17, 2014
Ruselle W. Robinson

CMS recently announced a two-phase process for registering “applicable manufacturers” who must report 2013 payment data to CMS. The CMS announcement can be found at www.cms.gov/regulations-and-guidance/legislation/national-physician-payment-transparency-program/program-registration.htr. The announcement includes step-by-step instructions for the Phase 1 registration process I describe below.

The definition of an “applicable manufacturer” is an entity that operates in the United States and (1) is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply, but not if such covered drug, device, biological or medical supply is solely for use by or within the entity itself or by the entity’s own patients (this definition does not include distributors or wholesalers (including, but not limited to, repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological or medical supply); or (2) is an entity under common ownership with an entity described in part (1) of this definition, which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological or medical supply.

Phase 1 began February 18 and will continue through March 31. Applicable manufacturers are required to register during this six-week period if they have 2013 payment data to report. Phase 2 will be for the submission of 2013 payment data. CMS has not decided on the exact dates for Phase 2, but the agency is targeting May 2014 and says Phase 2 will run at least 30 days. See below for more detailed information on Phase 1 and Phase 2.

Physicians (broadly defined to include dentists and other health care providers) and teaching hospitals are not required to take any action at this time. CMS will begin its open-ended registration of physicians and teaching hospitals after applicable manufacturers finish submitting their 2013 payment data at the end of Phase 2. Registration should begin around August 1, 2014 and is voluntary.

A physician or teaching hospital should register with CMS if (i) you received reportable payments from an applicable manufacturer during 2013, and (ii) you want to review and possibly dispute the payment data pertinent to you before CMS makes that payment data public. CMS says that it intends to publish the 2013 payment data on its website by September 30, 2014.

Here is the detailed Phase 1 and Phase 2 information that I promised:

Phase 1

From February 18 through March 31, applicable manufacturers can use the secure CMS Enterprise Portal (https://portal.cms.gov) to register for Phase 1 submission of aggregate 2013 payment data. Registration will include submitting corporate profile information and obtaining a user ID and password.

The authorized person creating the user ID and password must be an executive-level official who can legally represent the applicable manufacturer. Subsequent submissions can be delegated to others within the organization. The applicable manufacturer will need the user ID and password in order to submit any 2013 data to CMS.

CMS notes that the registration and identity vetting of an applicable manufacturer may take up to a week to complete, so applicable manufacturers are encouraged to begin the registration process early to avoid delays in data submission.

An applicable manufacturer with a user ID and password that has completed the registration process will be able to log on to the CMS Enterprise Portal and access instructions for submitting aggregate 2013 data, as well as a sample reporting template. CMS also has posted a sample reporting template on its website (www.cms.gov/regulations-and-guidance/legislation/national-physician-payment-transparency-program/index.html) on the Data Submission and Attestation page.

After an applicable manufacturer completes its aggregate data submission, CMS will reply to the submitter and confirm that the data meets all applicable standards. If corrections are necessary, CMS will provide additional instructions.

Phase 2

In May (for at least a 30-day period), applicable manufacturers will complete industry registration in the Open Payments system, submit detailed 2013 payment data and attest to the accuracy of their submissions. Additional details about Phase 2 will become available later this Spring. I will post the Phase 2 information on this Blog when it becomes available.
CMS reports that it expects Phase 1 and Phase 2 to be completed by August 1, 2014.

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