The Centers for Medicare & Medicaid Services (CMS) recently held two webinars regarding the 2021 Open Payments program expansion as well as the review and dispute resolution process.
CMS began by reviewing the data submitted by pharmaceutical and medical device manufacturers for the 2019 calendar year. In 2019, there were 10.98 million records published for a total amount of $10.03 billion in transfers of value to covered recipients. General payments accounted for $3.56 billion of the total, while $5.23 billion was for research and $1.24 billion was provided in ownership and investment interest.
The SUPPORT Act was passed in the fall of 2018 and included new Open Payments provisions for data collection beginning in 2021 for reporting by March 31, 2022. Most notably was the expansion of the definition of a covered recipient, the addition of new nature and purpose payment categories and the requirement for medical device and supply manufacturers to include the applicable device identifier for each transfer of value.
The covered recipient definition is expanded to include physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), certified registered nurse anesthetists & anesthesiologist assistants (CRNAs) and certified nurse-midwives (CNMs). To help with reporting, CMS has released a Preliminary Non-Physician Practitioner List (PnPPL). This list includes identifying information for providers registered in CMS systems and is designed to help reporting entities pre-validate their data before submitting it to CMS.
Non-physician practitioners are not required to obtain National Provider Identifiers (NPIs). Therefore, for non-physician practitioners without an NPI, reporting entities may include up to five state licenses on the payment record. Matching will be performed based on the combination of first name, last name and state license information. CMS will use a combination of data contained in the National Plan and Provider Enumeration System (NPPES) and Provider, Enrollment, Chain and Ownership System (PECOS), a commercial data source of aggregated data from state boards, and other sources to validate reported data on non-physician practitioners (PAs, NPs, CNSs, CRNAs, CNMs).
Beginning in January 2021, manufactures are now required to report the ‘device identifier’ component of the unique device identifier for devices and medical supplies. CMS has released preliminary resources to help comply with these new device requirements. These resources include a reference database of medical device and medical supply names and primary device identifier information for all the medical device and medical supplies listed in the Food and Drug Administration (FDA) Global Unique Device Identification Database Directory (GUDID) through June 30, 2020.
Additionally, the nature of payment updates include three new categories to be added to the general payments report. These include debt forgiveness, long term medical supply or device loan and acquisitions. Additionally, the two categories related to medical education programs will be combined into one single category. Unfortunately, CMS does not have guidance on the use of the new categories or detailed definitions. CMS stated that manufacturers are free to interpret them to fit their own business and reporting processes and should note those interpretations in their assumptions document. CMS also noted that there is likely to be additional guidance on the program expansion in the near future.
Finally, CMS affirmed that program year 2020 data submission closes March 31, 2021. On April 1, 2021 the pre-publication review & dispute period will open for covered recipients. During this time, covered recipients will have an opportunity to preview the data and dispute attributed transfers of value they believe to be inaccurate or incorrect in any way. Manufacturers have the responsibility of working with covered recipients to resolve disputes. The correction period ends on May 30th.
Disputes initiated within the review and dispute period and resolved by the end of the correction period will be published and identified as non-disputed in the June 2021 data publication. If an initiated dispute is not resolved by the end of the correction period, the record will be published and identified as disputed. Disputes initiated or resolved after May 30th will not be reflected in the initial data publication and will be published as the original attested-to data.
More information and details can be found on the CMS Open Payments Events page.
Lauren Howe
Compliance Attorney
March 25, 2021