About three weeks ago, on November 15th, the compliance industry had another “Oh God, not again!!!” moment. Because CMS had issued changes in the scope of the Open Payments program.

For the compliance professionals already struggling with data collection and compilation following the first set of changes issued in August 2019, these latest changes in November 2019 might WILL bring in a lot more workload.

The updated scope of Open Payments will be effective January 1st, 2020; however, according to the CMS website, the expanded definition of a covered recipient implemented in the SUPPORT Act applies to information that is required to be submitted on or after January 1, 2022, which is why this and other changes will also be effective on data collected from January 2021 through December 2021.

Phew!

Now that’s a relief, no?

But you still need to be on top of your game.

Now, we know you are busy with the Open Payments 2020 reports compilation and have absolutely no time even to scratch your head, let alone read out the recent changes in the CMS Open Payments rule, so we have come up with a quick run down for you.

Number of rules changed: 4

Applicable from: January 2021- December 2021 data

To be submitted: On or after January 1st, 2022

What are these rules that have been changed?

List of “Covered Recipients” has been broadened: Starting with data collection for the year 2021, manufacturers are required to track and report payments and transfers of value made to not just physicians but also to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

Three new Nature of Payments categories have been added:

These include debt forgiveness, long-term medical supply or device loan, and acquisitions.

Two payment categories consolidated into one: 

The two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – which were previously separated, have now been consolidated into one payment category for all continuing education programs. That means one less column in your report, perhaps!

Addition of a reporting requirement for the ‘device identifier’ component

Now, this doesn’t sound good for medical device manufacturers. CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies. This change is expected to put up substantial burden on medical device manufacturers; just giving you all a heads up!

That’s all about the latest changes in the CMS Open Payments Program.

To assure adherence with the changing Sunshine Act reporting requirements, qordata provides CMS Open Payments Reporting solution.

This solution is designed to help life sciences companies and compliance officers to timely submit accurate and complete spend reports to the CMS.