Life Science Compliance Update

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April 20, 2016

CMS Update Call on Open Payments

Recently, the Centers for Medicare & Medicaid Services (CMS) held a National Provider Call on Open Payments: Program Overview and Prepare to Review Reported Data. Robin Usi and Erin Skinner took turns educating participants how to identify the parts of the review, dispute, and correction process and how to take appropriate actions in the Open Payments system.

What is Reported?

As a reminder, any direct or indirect payments, or other transfers of value, that are made to covered recipients (i.e., physicians, teaching hospitals, physician owners, investors). Certain ownership or investment interests that are held by physician owners or investors, or their immediate family members are also reported.

Who is Responsible for Reporting?

Applicable manufacturers of covered products and entities under common ownership with applicable manufacturers who also provide assistance and support, as well as applicable Group Purchasing Organizations (GPOs), are required to annually report to CMS.

Who is Reported On?

There are three categories of individuals and entities that are reported on – covered recipient physicians, covered recipient teaching hospitals, and physician owners or investors. Covered recipient physicians cover individuals, such as: doctors of medicine or osteopathy legally authorized to practice medicine or surgery by the state; doctors of dental medicine or dental surgery legally authorized to practice dentistry in the state; doctors of podiatric medicine legally authorized to perform by the state; doctors of optometry legally authorized to perform as a doctor of optometry by the state; and chiropractors licensed by the state and legally authorized to perform by the state. Covered recipient teaching hospitals can change from year to year and each year, Open Payments publishes a list of these teaching hospitals on their website.

Program Year Timelines

For the 2015 program year, data collection ran from January 1, 2015 through December 31, 2015. Payment data was submitted by applicable manufacturers and GPOs from February 1, 2016 through March 31, 2016. Therefore, the review and dispute period for physicians and teaching hospitals is April 1 through May 15, 2016, and the period for applicable manufacturers and GPOs to review and correct the data runs fifteen days after that close, to June 1, 2016. The data is scheduled to be displayed on the website on June 30, 2016.

Registration Process

In order to be able to review and dispute any data reported in the Open Payments system prior to its publication, users must register for the Open Payments system using the two-step registration process. Physicians and teaching hospitals who registered during 2013 or 2014 do not need to register again. Additionally, a physician may nominate one authorized representative to perform system functions on their behalf and teaching hospitals can designate up to ten authorized representatives and authorized officials to act on its behalf in the Open Payments system.

Review, Dispute, and Correction Record Statuses

There are several different status' that can show for each record. A status of "initiated" means the dispute has been initiated by a physician, teaching hospital, or principal investigator. Once the reporting entity acknowledges the dispute, the status will change to "acknowledged." If the reporting entity and physician, teaching hospital, or principal investigator have resolved the dispute in accordance with the Final Rule and no changes were made to the disputed record, the status will change to "Resolved No Change." If the dispute was resolved by the reporting entity with updates made to the record, the status will change to "Resolved." If the physician, teaching hospital, or principal investigator has withdrawn the dispute, the status will reflect that.

Question and Answer Session

At the end of the call, the presenters allotted time for questioners who had previously submitted questions and for those who were on the call and had specific questions.

The first question was whether or not every physician in a particular practice need to register for the Open Payments system. The answer was yes, each physician needs to register since all payments are reported to physicians individually. Once a physician has registered, they can appoint an authorized representative, but each physician needs their own account.

It is also important to note that CMS does not send an email of alleged payments to physicians, making it important for physicians to register for Open Payments so they can see what payments are being assigned to them.

Another question was asked about whether there are any plans for an institutional reviewer role in the future to allow compliance officers to review data for teaching hospital faculty process review and dispute. While CMS cannot speak to any current plans, they took comments under advisement for future improvements to the program.

For any other help or issues, CMS recommends that you contact the CMS Open Payments Help Desk.

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