Life Science Compliance Update

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February 20, 2014

Physician Payments Sunshine Act: Open Payments Phase I Registration and Submission Explained

On Tuesday, February 18th, CMS opened applicable manufacturer registration for phase I for Open Payments, the CMS program to administer the Physician Payments Sunshine Act.

First, company officers at applicable manufacturers in charge of submission will register on the CMS Enterprise Portal. It should be noted again that this step requires significant personal information from the company officer, including social security number, date of birth, and home address. Additionally, Internet Explorer 11 and a number of browsers are not supported by this website.

Once this data is submitted, after 5 minutes the officer will have to reenter the site and register for Open Payments.

Once Phase I Registration for Open Payments is complete, the officer will be able to download the CMS Phase I Data Submission Instructions and the Phase I sample reporting template.

Phase I submission requirements must be submitted to CMS by March 31st, sent via email to OPdata@cms.hhs.gov. Included in the submission must be the aggregate data and the reporting template.

Information required in the sample reporting template includes:

EIDM User ID

Registering Entity Legal Name

Registering Entity Business Name

Registering Entity Business Type

Parent Company Website URL

Registering Entity Business Address Line 1

Registering Entity Business Address Line 2

Registering Entity City

Registering Entity State

Registering Entity Zip code

Registering Entity Country

Registering Entity Province

Registering Entity Postal Code

Registering Entity Telephone Number

Total Amount for Research Category

Total Number of Records for Research Category

Total Number of Covered Recipients for Research Category

Total Amount for General Category

Total Number of Records for General Category

Total Number of Recipients for General Category

Total Number of Physician Owner Investors

 Analysis

There was no mention of how to register the company, only individuals. This is different than what CMS has stated in the past. We can assume that sometime in the future, after the company officer is vetted, there will be some process for submitting company information.

There is also no information on registration for Phase II. Phase II probably uses a different, yet-to-be-developed, registration system. The current schedule for Phase II data submissions is sometime between May 1st and August 1st, 2014, and will include the detailed reporting data.  

We believe CMS and their vendor CGI Federal are not ready to receive detailed data at this time, which accounts for the two phase process.  

Consistent with the statute itself, CMS is obtaining aggregate totals so they can comply with the requirement to report to Congress and have some data to give the media and the public by September 31st 2014. They have been consistent on that date. Our estimates are that the detailed reporting data will be publicly reported sometime on or after January 30th, 2015.

Here is the exact language from the Affordable Care Act Section 6002:

''(1) ANNUAL REPORT TO CONGRESS.—Not later than April 1 of each year beginning with 2013, the Secretary shall submit to Congress a report that includes the following:

''(A) The information submitted under subsection (a) during the preceding year, aggregated for each applicable manufacturer and applicable group purchasing organization that submitted such information during such year (except, in the case of information submitted with respect to a payment or other transfer of value described in subsection (c)(1)(E)(i), such information shall be included in the first report submitted to Congress after the date on which such information is made available to the public under such subsection).

''(B) A description of any enforcement actions taken to carry out this section, including any penalties imposed under subsection (b), during the preceding year

Final Thoughts

Because CMS is utilizing this spreadsheet reporting system, a person at the help desk will manually review each submission and send a confirmation of receipt for the information.  The process has been bumpy, but this does show that CMS is dedicated to implementing this program on a timely basis.

CMS has stated there will not be penalties for data submitted before the end of Phase II, which is August 1st, 2014.

Polaris Management Partners helped provide access to some of the information provided in this story.

CMS promises to answer questions and explain more in a webcast on Tuesday February 25th at 2:00pm.

Important Documents

CMS Open Payments Phase I Data Submission Instructions

CMS Phase I Sample Reporting Template.

Email Address to Submit March 31st Aggregate Report OPdata@cms.hhs.gov

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