Program Participants
There are two groups of participants in the Open Payments program. Reporting entities and Covered recipients.
• Reporting entities – applicable manufacturers and group purchasing organizations – must submit yearly reports of payments made to covered recipients.
• Covered Recipients - as a covered recipient, you have the opportunity to review and dispute information reported about you in the Open Payments System.
Reporting Entities
Reporting entities are required to report payments and other transfers of value they make to covered recipients, which includes ownership or investment interests that physicians or physicians’ immediate family members hold with the reporting entity.
Reporting entities report this information to the Centers for Medicare & Medicaid Services (CMS) on an annual basis, and it becomes publicly available via the Open Payments data site.
Again, this is applicable manufacturers and group purchasing organizations.
You’re an Applicable Manufacturer If…
• Your physical location and/or your activities are within the United States. This includes any territory, possession, or commonwealth of the United States.
• You produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program (CHIP). And if the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer or if the product is a device or medical supply, and it requires premarket approval or premarket notification by the Food and Drug Administration (FDA).
• Type 1 Manufacturer: You engage in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological or medical supply. This includes distributors or wholesalers that hold title to a covered drug, device, biological, or medical supply.
• Type 2 Manufacturer: You exist under common ownership with a Type 1 applicable manufacturer AND You provide assistance or support to such an entity with respect to the production, preparation, propagation, compounding, sale, or distribution of a covered drug, device, biological, or medical supply.
EXEMPTIONS:
• Applicable manufacturers and GPOs with less than 10 percent of revenues from covered products do not need to report all payments or other transfers of value. They are, however, required to report payments or other transfer of value that are related to one or more covered drugs, devices, biologicals or medical supplies
• Foreign entities that may contribute to the manufacturing process of a covered product are exempt if they have no business presence in the United States.
• Entities that only manufacture raw materials or components, which are not themselves covered products, are not required to report unless the entity are under common ownership with an applicable manufacturer and assist such manufacturer with the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply.
• Entities such as hospitals, hospital-based pharmacies, and laboratories are exempt if they manufacture a covered product solely for use by or within the entity itself or by an entity’s own patients.
• Wholesalers or distributors that do not hold the title of a covered product are not subject to the reporting requirements, unless they are under common ownership with an applicable manufacturer and provide assistance or support with respect to a covered drug, device, biological, or medical supply.
• If an applicable manufacturer does not manufacture a covered drug, device, biological, or medical supply (except pursuant to a written agreement to manufacture the covered product for another entity), does not hold the FDA approval, licensure or clearance for the product, and is not involved in the sale, marketing or distribution of the product, then the manufacturer is only required to report payments or other transfers of value related to the covered product.
You’re an Applicable GPO If…
• Your organization’s physical location is within the United States and/or if you conduct activities within the United States. This includes any territory, possession, or commonwealth of the United States.
• You purchase, arrange, or negotiate the purchase of a covered drug, device, biological or medical supply for a group of individuals or entities, but not solely for use by the entity itself.
• At least one product is reimbursed by Medicare, Medicaid or CHIP and if the product is a drug or biological and it requires a prescription (or a physician’s authorization) to administer or if the product is a device or medical supply and it requires pre-market approval or premarket notification by the FDA.
How Does Your Organization Participate in Open Payments?
To participate in Open Payments as a reporting entity, you will need to:
• Register in the Open Payments system.
• Collect and submit data into the system.
• Verify and attest to the accuracy of the data.
• Respond to disputed payments.
All Open Payments program cycles consist of a full calendar year during which data must be collected and reported to CMS. It is then published on the Open Payments data site each year on or by June 30.
Registration for Reporting Entities
Get Started with Open Payments
To submit data for your organization and perform other functions within the Open Payments system, you must be registered in both the CMS Identity Management System (IDM) and the Open Payments system. This registration requires two steps:
STEP 1 Register in IDM via the IDM portal. Use the IDM Registration Quick Reference Guide (PDF) to help you through the process. IDM will automatically deactivate any user that has not logged in for 180 days or more. Users must call the Open Payments Help Desk at 1-855-326-8366 or TTY line call 1-844-649-2766 to reinstate an account after 180 days of inactivity.
STEP 2 Register in the Open Payments system (accessible via the IDM portal). Refer to the Registration and Recertification Quick Reference Guide (PDF) for assistance.
Tips to Streamline Registration in the Open Payments System
• Please use Internet Explorer 10 or 11 or the latest version of Microsoft Edge or Firefox. The Open Payments system isn’t currently optimized for Safari or Chrome browsers.
• The entire registration process usually takes about 30 minutes to complete and must be finished in a single session. Users cannot save entries or complete their profiles at later times. Note: Using your browser’s navigation buttons during the registration process may delete information you have entered.
• Identify User Roles before registration.
• The Open Payments Help Desk is available to address any questions or challenges in the registration and vetting process.
User Roles for Reporting Entities
There are four user roles for reporting entities: Officer, Submitter, Attester, and Compliance.
Reporting entities must have individuals assigned to these roles within the Open Payments system before they can use the system. Users may have multiple roles. Each reporting entity can have up to 10 users, but no more than 5 users can hold an officer role.
The person registering your organization must select the role of officer. They can also select the role of submitter and/or attester or choose others for these roles. At least one person must be identified for each of the four roles in the Open Payments system during initial registration, whether it is the individual registering in all four roles or others that they choose. The system will not allow you to proceed without at least one person chosen for each user role.
More information about the functions and requirements of each role below:
1. OFFICER
FUNCTIONS:
• Manages the reporting entity’s profile in the Open Payments system
• Nominates/approves other individuals for user roles
• May self-select the role of submitter and/or attester
REQUIREMENTS
• Must be an officer as designated by the reporting entity
• If nominated, must either accept or reject the nomination
• Must select role of officer when registering a new reporting entity
• You won’t be able to proceed if this role isn’t selected for a reporting entity
2. SUBMITTER
FUNCTIONS:
• Submits data to the Open Payments system
• Receives emails regarding data disputed by covered recipients
• May edit their respective reporting entity's data when necessary
REQUIREMENTS
• Not required to be an officer
• If nominated, must either accept or reject the nomination
3. ATTESTER
FUNCTIONS:
• Attests to the accuracy of the data in the Open Payments system on behalf of the reporting entity
REQUIREMENTS
• Must be an officer of the reporting entity
• If nominated must either accept or reject the nomination
4. COMPLIANCE
FUNCTIONS:
• Has the ability to view and download any compliance related communication placed in the Open Payments System for the reporting entity
REQUIREMENTS
• Does not have to be an officer of the reporting entity
• If nominated, must either accept or reject the nomination
Covered Recipients
Covered recipients are any physicians (excluding medical residents) who are not employees of the applicable manufacturer that is reporting the payment; or teaching hospitals that receive payment for Medicare direct graduate medical education (GME), inpatient prospective payment system (IPPS) indirect medical education (IME), or psychiatric hospital IME programs during the last calendar year for which such information is available.
Every year, reporting entities are required to submit data to the Centers for Medicare & Medicaid Services (CMS) reflecting payments made to covered recipients. These payments include certain financial transactions and transfers of value made during the year unless an exclusion applies. CMS publishes this data annually, exactly as it is received, on the Open Payments data site.
Since Open Payments began, CMS has published $53.06 billion in payments from more than 2,000 reporting entities to over 1.08 million physicians.
You should check your data every year. Even if you don’t think data will be reported about you, reporting entities could submit data from previous years. Once data is reported, the pre-publication review and dispute period will give you time to review and/or dispute the data before it becomes public.
Register as a Covered Recipient
Covered recipients must register to review and dispute information reported to Open Payments. If you’re a physician, you can also nominate an authorized representative to review and dispute data on your behalf once you’ve registered.
Registration Instructions
These instructions are for physicians and teaching hospitals. Newly added covered recipients will be able to register by 2022.
Step 1: Register in the Identity Management System. This step confirms your identity and makes sure others can’t get your information. IDM will automatically deactivate any user that has not logged in for 180 days or more. Users must call the Open Payments Help Desk at 1-855-326-8366 or TTY line call 1-844-649-2766 to reinstate an account after 180 days of inactivity.
Step 2: Register for the Open Payments system in the CMS Portal. This step lets you see the data reported about you.
Step 3 (Optional): Nominate an authorized representative.
You can nominate a member of your staff to act as your authorized representative. If you provide the appropriate access level your authorized representative will be able to review and dispute your data. Find more information in this reference guide (PDF).
To Nominate an Authorized Representative:
Log in to the Open Payments system via the CMS Enterprise Portal and select the “My Profile” tab.
• Select the “My Profile Details” tab. Select “Update Profile.”
• Select “Yes, designate an authorized representative.” The fields required to nominate an authorized representative will appear on the screen.
• Enter information on the nominee for all required fields. The default level of access is “Read.” For other levels, select “Modify Profile” and/or “Dispute Records.” When done, select “Save Updates.”
Registration Instructions for Office Managers and Staff
A physician must first nominate you to be an authorized representative. Once you’ve been nominated, you’ll receive an email notification that contains a Nomination ID, which you’ll need to accept or reject the nomination. You have 10 calendar days to accept or reject a nomination before the request becomes inactive.
To Register:
Log in to or register in the Open Payments system via the CMS Enterprise Portal. For more detailed information on registration, view the IDM Registration Quick Reference Guide (PDF). IDM will automatically deactivate any user that has not logged in for 180 days or more. Users must call the Open Payments Help Desk at 1-855-326-8366 or TTY line call 1-844-649-2766 to reinstate an account after 180 days of inactivity.
Once registered in the CMS Portal:
• If you are a first-time Open Payments system user, select “Create My Profile.” Select “Start Profile” at the bottom of the screen. Select the “I have a Nomination ID and Registration ID” link on the “Select Profile Type” page.
• If you are a returning user, select the “My Profile” tab. Select “My Roles and Nominations,” then select “Accept/Reject Nominations.”
• Select the user type “Physician” from the drop-down list and enter the nomination ID from the nomination notification email.
Non-Physician Practitioner Covered Recipient
Health care providers who practice either in collaboration with or under the supervision of a physician, including physician assistants, nurse practitioners, and clinical nurse specialists, are referred to as non-physician practitioners (NPPs).
Newly Added Covered Recipients
Open Payments expanded in January 2021 to include five new provider types: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists & anesthesiologist assistants, and certified nurse-midwives.
Open Payments now includes these five new provider types in response to statutory changes outlined in the SUPPORT Act. Effective January 1, 2021, reporting entities' data collection includes these additional program participants.
Data collected in 2021 will be submitted to CMS and published in 2022.
Your Role
Be mindful of the Open Payments Program expansion, knowing that in 2021 certain payments or transfers of value made to you by a company that meets the definition of a reporting entity (applicable manufacturer or applicable GPO) will be reportable for the purpose of Open Payments.
Stay connected with the program so you are ready to register to review your data in calendar year 2022. Registration and review of your data is voluntary and encouraged as this ensures accuracy of the Open Payments data.
What healthcare providers should know?
Open Payments is a national disclosure program from the Centers for Medicare & Medicaid Services (CMS) that promotes a more financially transparent and accountable healthcare system.
Drug and medical device companies must report to CMS payments or transfers of value they make to certain healthcare providers and teaching hospitals for research, meals, travel, gifts, speaking fees, and more.
Each year, CMS makes the data available so the public can see it at openpaymentsdata.cms.gov.
CMS’s role is to collect and publish information submitted by reporting entities. CMS does not offer an opinion on what financial relationships may cause conflicts of interests. Simply, CMS publishes the data for public use and interpretation.