Beginning January 1, 2021 the Open Payments program expansion will go into effect. This expansion which is a result of the SUPPORT Act, includes additional Open Payments reporting requirements as well as updates to the Nature of Payment categories. The program is impacted in the following ways:
- The definition of a “covered recipient” is expanded to include five additional provider types: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists (including anesthesiologist assistants), and certified nurse midwives. This is in response to statutory changes included in the SUPPORT Act.
- Standardization of data on reported products by adding reporting requirements for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
- The Nature of Payment categories will be updated to include three new categories: debt forgiveness, long term medical supply or device loan, and acquisitions. In addition, the two categories related to education programs will be combined into one.
We know there are many questions around these changes and that your organization is preparing for the 2021 data collection. We are working on providing resources related to each area of the expansion in order to give you the information needed for a smooth transition.
At this time, we are pleased to offer the preliminary resources for the device reporting requirements. There are two new resources currently available to get you started on this reporting requirement:
Preliminary Medical Device and Medical Supply Reference data
This preliminary reference data includes medical device and medical supply names and Primary Device Identifier Information for all the medical device and medical supplies listed in the Food & Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID) through June 30, 2020. Our preliminary Device Name and Preliminary Device Identifier Dataset is available on the CMS Open Payments Resources Page. This should be used as reference data only and you should consult the instructions document described below for details on how to use this preliminary data.
Medical Device and Medical Supply Name and Primary Device Identifier Preliminary Dataset Instructions Document
The instructions document, also available on the Open Payments Resources page, provides details about the use of the Device Name and Primary Device Identifier (PDI) dataset.
In addition to these resources, we have added a new FAQ (#2007) to the Open Payments FAQ document and identified a selection of existing FAQs related to the device reporting requirements that are available within our FAQ document. The FAQs you might find helpful for device reporting requirements are: FAQ #2007, FAQ #8258, FAQ #8392, FAQ #9124 and FAQ #9132.