Life Science Compliance Update

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July 16, 2013

Physician Payment Sunshine Act: CMS Launches Open Payment Apps for Physicians and Manufacturers, and Contest to Develop Future Apps

The Centers for Medicare and Medicaid Services (CMS) released their Open Payments Apps for Physicians and Manufacturers/GPO's to help keep records for Physician Payment Sunshine Act reporting.

The Open Payment Mobile for Physicians, provided free by CMS (IPhone and Android) is intended to help both physicians and members from industry keep track of, store, and view financial payments and other transfers of value as required by the Physician Payment Sunshine Act and its implementing regulations.

The privacy statement on the Apps say that "this app does not communicate with CMS, and the data stored using the app is owned by the user. CMS will not validate the accuracy of individual transfers of value stored in the app, nor will it be responsible for protecting the data stored in the app". This is reassuring, but it is not clear the country of origin for the developer of the app, and there is always the possibility that an App maker could encrypt the application or use a code that pings out payment data to an unknown or secret source.

The app also raises significant legal implications. If a doctor or sales rep uses this app, and the physician or company is later under investigation, it is possible that DOJ, FDA, or HHS-OIG, the SEC, and other federal agencies and law enforcement officials could subpoena the phone records on this app from a physician or industry rep. The phone records could also be subject to subpoena or requests from plaintiff's attorney's or in qui tam suits by whistleblowers.


In the setup mode for the Physician application, we noticed that the program asks for a significant amount of information on each vendor. For example, the App has placeholders for not only the name of the vendor (pfizer or GSK), but also the first name, last name, phone number, email, primary business address, city state and zip code. It is unclear why a physician would invest the time and effort to enter in all this data for every sales rep that visits him or provides a meal. This is extremely time consuming, and if the only purpose is for the physician to check his record against the manufacturer, physician's will either have no time to track all this information on their own, will have to hire additional staff to enter in such data, or they will stop collaborating with industry.

The other interesting feature on the Apps is a QR Code reader, which we are not certain how that becomes useful or what the purpose of that feature is. If our readers can figure it out please include a comment. It might be that manufacturers begin to issue receipts for certain transactions, and rather than have to manually enter in all of the information, the printed out receipt may already include such information and that way the sales rep or the doctor can just scan the "receipt" which will populate the app, rather then manually entering it.

Open Payment Mobile for Industry

The free mobile App for industry, applicable manufacturers and applicable Group Purchasing Organizations, is very similar. It allows them to keep track of, store, and view financial payments and other transfers of value.

This program is for those with really small fingers, requires extensive data entry, and the NPI lookup is only available when one is online. This is perhaps a solution for really small companies, and will help to provide other developers a look at improvements that could be made.

These apps may be version 1.0 and not linked from the "open payments" website, so CMS may be in the beginning engineering of these apps.

CMS Challenge Contest for Future Apps

In addition to their current apps, CMS is hosting a global contest to create applications for the iPhone 5, iPAD, and iPAD mini. Prizes range from:

  • 1st Place $2,100
  • 2nd Place $1,050
  • Reliability Bonus $420
  • DR Points 600

Contests include:

  • Mobile Application Wireframes (2)
  • Data Host Wire Frames
  • System Architecture
  • Mobile Application Screen Design (3)
  • Data Host – UI Specification
  • Mobile Application Prototype
  • Mobile Application Assembly
  • Data Host Prototype
  • Data Host Module Architecture

Requirements to qualify include:

  • You must be a TopCoder member (go on a website and sign up),
  • at least 18 years of age,
  • meeting all of the membership requirements.
  • In addition, you must fit into one of the following categories.
    • `If you reside in the United States, you must be either:
    • A US Citizen
    • A Lawful Permanent Resident of the US
    • A temporary resident, asylee, refugee of the U.S., or have a lawfully issued work authorization card permitting unrestricted employment in the U.S.
    • If you do not reside in the United States:
    • You must be authorized to perform services as an independent contractor.
      (Note: In most cases you will not need to do anything to become authorized)

A review of previous contest results reveals that the winners thus far have been from China (2), Morocco, Canada and Ukraine. The top winner a contestant from Canada named Argolite has won $1,370,009 from CMS. It is interesting to note that not a single listed winner was from the United States.

At least one contest has started the prize for mobile architecture.

  • Posted On:07/06/2013 09:22 PM EDT
  • Register By:07/09/2013 09:22 AM EDT
  • Submit By:07/14/2013 09:27 PM EDT

Final Submission: 07/20/2013 06:10 AM EDT

We asked a data security expert about the new Open Payment App for Industry and Physicians and they pointed out that a few red flags pop up. First of all the Apps keep track of all records and payments on your phone. Because phones are easy to steal, keeping any financially related records on a phone may not be the best idea. The app also utilizes international servers so you are trusting that they have the same security standards as most American financial institutes. Also this is a "free" new app that was just released and there are few details about the app. For example, there are no Security details, the question remains how will they protect your information, one may want to wait before utilizing these apps, the main reason to use it may be convenience.

The Medical App Journal a website for medical apps, took down this application from their website stating that "It has been determined that this app does not meet the medical app criteria established by Medical App Journal and therefore has not been included in this database." CMS also has no link to security protocols from the open payments website.

The concept of an app for physicians and industry may be a good idea, but this app and those created from the contest may serve more as a framework for future commercial applications than something utilized by industry and physicians. This week at least one group Infuse Medical announced plans for their own Open Payments for Industry App claiming their app is better than the CMS App.

If you are interested in participating in the CMS contest to design the killer sunshine app:

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