CMS Mandatory Reporting Program to Include Data on PAs

In June 2022, Information on PAs and APRNs will be Displayed on Open Payments Website

January 31, 2022

By AAPA Reimbursement Department

The Centers for Medicare and Medicaid Services’ (CMS) Open Payments program is a national disclosure database aimed at improving transparency by identifying financial relationships between the pharmaceutical and medical device manufacturing industries, and healthcare professionals and teaching hospitals on a public-facing website. Physicians have been part of the reporting program, originally known as the Sunshine Act, since 2015. Starting January 1, 2021, the Open Payments program began collecting information on PAs’ and advanced practice registered nurses’ (APRNs) reportable financial relationships with manufacturers.

The Open Payments program offers information to the public providing greater transparency regarding financial relationships. In reviewing this information, interested stakeholders may better understand such financial relationships and assess whether any might represent a potential conflict of interest. CMS makes it clear that the existence of a financial relationship between a health professional or teaching hospital and a medical device or pharmaceutical company or their distributors, also known as reporting entities, is not an indication of improper behavior or legal wrongdoing. In addition, CMS does not offer an official position or opinion regarding which financial relationships may cause conflicts of interest.

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Financial relationships
There are numerous situations where it is entirely appropriate for a medical device or pharmaceutical company to have a financial relationship with a health professional. The Open Payments program defines a financial relationship as certain payments or transfers of value made to PAs, physicians, and APRNs from applicable manufacturers of drugs, medical devices, biological, or medical supplies, and group purchasing organizations (GPOs). GPOs purchase, arrange for, or negotiate the purchase of a covered drug, device, biological, or medical supply for a group of individuals or entities.

Legitimate reasons for payments or transfers of value to health professionals captured on the Open Payments site may include:

• Serving as faculty or as a speaker for an accredited or certified continuing education program, such as speaking at a medical conference;
• Serving as faculty or as a speaker at an event other than a continuing education program, such as giving a medical talk to other health professionals at a local restaurant;
• Providing consulting services, advice, or expertise to a pharmaceutical or medical device company regarding the use of a particular drug, product or treatment regimen;
• Engaging in research activities including coordinating a study or enrolling patients into studies;
• Having an ownership or investment interests in an applicable manufacturer or applicable group purchasing organization.

Other items that may be an appropriate transfer of value include receiving gifts, promotional products, entertainment, food and beverage, or lodging and travel. CMS provides a more detailed, but not exhaustive, list of examples of applicable financial relationships.

Payments include those made directly to health professionals or indirect payments made to health professionals through a third party. A third-party transfer of payment occurs when the third party provides the payment or transfer of value, in whole or in part, to a health professional at the direction or instruction of the pharmaceutical, medical device company, or GPO.

Availability of information to the public
The 2021 calendar year was an information collection year for transactions related to PAs and APRNs – that is, no information on PA/APRN eligible financial transactions appeared on the Open Payments website in 2021. However, beginning June 2022, CMS will place PA/APRN financial relationship data from the 2021 calendar year on a searchable website.

Health professionals have early access to the Open Payments site
Medical device and pharmaceutical companies must collect the names and National Provider Identification (NPI) numbers of PAs and certain other health professionals when reportable financial transactions occur. The companies are then obligated to report that information directly to CMS.

It is important to register with the Open Payments program if you want to gain access to the information collected in the database. PAs and APRNs can register beginning February 1, 2022. Register through the CMS.gov Enterprise Portal (scroll down to new user registration). At Step #1 (Select Your Application) scroll down to “Open Payments” to continue the registration process. After registering, you will be able to request access to the Open Payments system to view any information reported under your name and NPI number.

Health professionals who register with Open Payments can get an early look at information collected under their name before it is available to the general public. This early look provides an opportunity to dispute or correct any erroneous information. There is also the opportunity for a health professional to proactively confirm information associated with their name if the information displayed is correct. Beginning April 1, through May 15, PAs and APRNs will be able to review and dispute payment or transfer of value information. Reporting entities then have until May 30 to resolve/correct any disputed data. Once the opportunity for correction has occurred, the data will be published in June for the general public to view the information.

Conclusion
Pharmaceutical and medical device companies are incentivized to track and report payments or transfers of value provided to health professionals. To encourage timely and accurate reporting, CMS has the legal authority to impose civil monetary penalties on those companies that do not collect and report required data to the Open Payments program.

It’s important for PAs to understand that the reporting of information to the Open Payments system will not generate individual notifications to the health professionals. Each health professional is responsible for accessing the Open Payments website to review and ensure the accuracy of published data associated with their name and NPI.

For more information, please view CMS’ Open Payment explanatory video.

For additional information contact Michael Powe, AAPA’s vice president of reimbursement and professional advocacy, at [email protected].

More Resources
Open Payments
Open Payments Summary

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