November 30, 2020
CMS Mandatory Reporting Program to Include PAs
For the First Time, PAs and APRNs to be Displayed on Open Payments Website
November 18, 2020
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 publicly-facing, searchable website. Physicians have been part of the reporting program since 2015. Starting January 1, 2020, the Open Payments website will display PAs’ and advanced practice registered nurses’ (APRNs) financial relationships with manufacturers.
The Open Payments program provides information to the public and other interested parties to assess whether any of these financial relationships are beneficial or 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.
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 coordination a study or enrolling patients into studies; or,
- 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 will be an information collection year for transactions on PAs and APRNs. That is, no information on PA/APRN eligible financial transactions will appear on the Open Payments website in 2021. Beginning on approximately June 30, 2022, CMS will place financial relationship data collected during 2021 on the site.
Health professionals have early access to the Open Payments site
PAs are not required to enroll in the Open Payments program. 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 information directly to CMS.
However, it is important to register with the Open Payments program to gain access to the information collected and stored in the database. The first step is to register with the CMS.gov Enterprise Portal. After registering through the Enterprise Portal, you will be able to request access to the Open Payments system to view your information. After reviewing the information, health professionals have a window of opportunity to dispute reported entries believed to be incorrect before any information is made available to the public.
Expect pharmaceutical and medical device companies to be diligent in tracking and reporting payments or transfers of value provided to health professionals. To encourage timely and accurate reporting, CMS has the legal ability to impose civil monetary penalties on companies that do not collect and report applicable data to the Open Payments program.
The reporting of information from manufacturers to the Open Payments system does not generate individual notifications to the attributed health professionals. Each health professional is responsible for ensuring the accuracy of data contained on the Open Payments site.
For additional information contact Michael Powe, AAPA’s vice president of reimbursement and professional advocacy, at [email protected].
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