Frequently Asked Questions

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FAQ

By Topic: Open Payments


If an employee (non-physician) of a teaching hospital receives a transfer of value such as a meal, would th...
Non-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physic... (more)

What items or materials are considered education materials and are not reportable transfers of value?
Education materials and items that directly benefit patients or are intended to be used by or with patients are not repo... (more)

What is the difference between the “officer” and the “authorized official”?
The authorized official is an entity’s executive-level officer who can legally represent their entity and manage the ... (more)

Should an applicable manufacturer report a payment was made to a physician or to a clinic if the applicable...
This is considered an indirect payment.  Applicable manufacturers are required to report indirect payments to physi... (more)

What value should an applicable manufacturer assign to clinical study drugs that are provided to principal ...
Applicable manufacturers are not required to assign a specific value to clinical study drugs that are provided to princi... (more)

Are payments provided to a consulting firm or third party, whom in turn provide the payment (in whole or pa...
Yes, OPEN PAYMENTS requires reporting of both direct and indirect payments and other transfers of value provided by an a... (more)

Applicable manufacturers with less than 10% total (gross) revenue from covered drugs, devices, biologicals,...
Both domestic and global sales are included in the company’s total (gross) revenue. Applicable manufactures with less th... (more)

Why was research removed as a nature of payment category option from the general data specification? (poste...
The research nature of payment category was removed from the general data specification because all payments or other tr... (more)

Are payments provided to physicians for speaking at a continuing medical education event reportable?
Speaker compensation at continuing education event such as Continuing Medical Education (CME) conference is not required... (more)

Are payments for travel, lodging and meals to speakers and faculty of accredited or certified CME events th...
Yes. Lodging, travel and meals for speakers of an accredited or certified CME event meeting all three requirements in 42... (more)

Is study equipment, implantable devices, instrumentation, or other supplies provided to a covered recipient...
Yes, payments or other transfers of value made in connection with an activity that meets the definition of research and ... (more)

Are independent sales representatives that are responsible for taking product orders from covered recipient...
Independent sales representatives are only required to report payments or other transfers of value provided to covered r... (more)

Is an applicable manufacturer required to report the name of a third party, such as a clinical research org...
No, applicable manufacturers are not required to report the name of the third party, such as a CRO, that indirectly prov... (more)

Are payments for medical research writing and/or publication included in reporting research payments?
Under OPEN PAYMENTS, a payment reported as research falls within a research payment category if it is subject to either:... (more)

Is a contract research organization (CRO) that performs clinical trials according to protocols for pharmace...
A CRO that is not an applicable manufacturer is not required to report information under Open Payments. However, an appl... (more)

How should applicable manufacturers or applicable group purchasing organization determine the value of jour...
The value of a journal reprint should reflect the cost that an applicable manufacturer or applicable group purchasing or... (more)

Are items or materials used to educate physicians, which may indirectly benefit patients, included in the e...
No, the education material exclusion is limited to materials and items directly benefiting patients or intended for pati... (more)

Are applicable manufacturers required to report meals, travel, lodging, and other similar expenses made in ...
Yes, compensation paid by an applicable manufacturer to a physician for expenses made in connection with interviewing th... (more)

I am planning on submitting a consolidated report in Phase 2; how is this addressed in Phase 1?
Consolidated reporting is only applicable in Phase 2. In Phase 1, consolidated reports will not be accepted. Individual ... (more)

How should an applicable manufacturer report a payment or other transfer of value provided to a teaching ho...
An applicable manufacturer must report identifiers for a teaching hospital as they appear on the teaching hospital list.... (more)

Are entities currently in the research and development phase for drugs which, are at the time not approved ...
An applicable manufacturer, as defined by 42 CFR 403.902, is an entity that is engaged in the production, preparation, p... (more)

Is a donation provided to a teaching hospital’s foundation by an applicable manufacturer reportable? (poste...
Yes, if an applicable manufacturer provides a payment or other transfer of value to a teaching hospital’s foundation at ... (more)

If an applicable manufacturer supports an unaccredited educational program at a large annual conference and...
The question of whether an applicable manufacturer must report a buffet meal provided to physician attendees at an unacc... (more)

How should an applicable manufacturer determine which National Drug Code(s) (NDC) to report for a payment o...
Applicable manufacturers and applicable group purchasing organizations are required to report any 10-digit NDC correspon... (more)

Should all physician covered recipient principal investigators who perform research for the research instit...
No, applicable manufacturers are only required to report the names of principal investigators, as that term is normally ... (more)

If an applicable manufacturer makes a payment or transfer of value to a group practice rather than a specif...
A payment or other transfer of value provided to a group practice (or multiple covered recipients generally) should be a... (more)

Which nature of payment category should applicable manufacturers report payments to physician covered recip...
Applicable manufacturers and applicable group purchasing organizations should consider the purpose and manner of the pay... (more)

Are all applicable manufacturers and applicable group purchasing organizations required to register for Ope...
No, only applicable manufacturers and applicable group purchasing organizations that have reportable payments or other t... (more)

Is a hospital that is not listed on the Open Payments teaching hospital list considered a teaching hospital...
No. A teaching hospital covered recipient for the purposes of Open Payments is defined at 42 C.F.R. § 403.902 as any ins... (more)

Is an applicable manufacturer with both covered and non-covered products required to report payments or oth...
Yes, applicable manufacturers of at least one covered drug, device, biological or medical supply are required to report ... (more)

Is a distributor required to report food and beverages that are provided during an open house for a new dis...
Yes. If the distributor meets the definition of an applicable manufacturer, as defined by 42 C.F.R § 403.902, food and b... (more)

Is the loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME eve...
No. A loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME event is not cons... (more)

Is a physician located outside of the United States considered a physician covered recipient for purposes o...
If a physician maintains a current state license to practice medicine in any state in the United States, the physician w... (more)

In which payment category should applicable manufacturers report payments to covered recipients for medical...
Applicable manufacturers must select the nature of payment category that they believe most accurately describes a paymen... (more)

Are applicable manufacturers required to report a physician’s name and taxonomy code as listed in the Natio...
Applicable manufacturers and applicable group purchasing organizations (GPO) are required to report a physician’s Nation... (more)

Does Open Payments require an entity to report payments or other transfers of value provided to covered rec...
No, Open Payments does not require retroactive reporting. Entities determined to be applicable manufacturers because the... (more)

Is a meeting a reportable event if an applicable manufacturer located in the United States conducts the mee...
Yes. Any payments or other transfers of value provided by an applicable manufacturer to covered recipients (or physician... (more)

If an applicable manufacturer provides compensation to a non-US speaker for a CME in the US, does the payme...
Yes. If the non-US speaker meets the definition of a physician covered recipient and the event does not meet the criteri... (more)

Do I need to provide my social security number to get an EIDM account?
This is an optional field, but providing your social security number can facilitate identity verification. ... (more)

When reporting ownership or investment interests; what should applicable manufacturers or applicable group ...
Applicable manufacturers and applicable group purchasing organizations reporting ownership or investment interests have ... (more)

Is an applicable manufacturer required to report payments provided to a physician covered recipient for a c...
No, legal proceedings that require physician involvements are excluded, including, legal defense, prosecutions, settleme... (more)

Is a medical device considered eligible for payment by Medicare, Medicaid, or CHIP for purposes of Open Pay...
Yes, if a medical device is used to perform a service that is reimbursable under Medicare, Medicaid, or CHIP, the device... (more)

An entity leases employees to an applicable manufacturer for operational purposes, and continues to pay all...
Yes, the act of an entity leasing employees to an applicable manufacturer that it is also under common ownership with ma... (more)

When requesting access to Open Payments, which user role should I select from the dropdown?
Select “Open Payments User”. ... (more)

The definition of an applicable manufacturer excludes distributors or wholesalers that do not hold title to...
A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and ... (more)

Are payments provided as compensation to speakers at CME events run by CME providers that that are accredit...
No, the list of accrediting or certifying bodies in the final rule at 42 CFR § 403.904(g)(1)(i) is exhaustive; in order ... (more)

Is an applicable manufacturer required to report all taxonomy codes for a physician or just the primary tax...
Applicable manufacturers will report only one taxonomy code per physician. Additionally, applicable manufacturers may us... (more)

Are Federal, state, and local taxes withheld from a physician owner or investor considered reportable payme...
No, Federal, state, and local taxes withheld from a physician owner or investor are not considered reportable payments o... (more)

If a medical professional society’s annual conference is held prior to August 1, 2013 and a physician recei...
Applicable manufacturers must report the date that a payment or transfer of value was provided to the covered recipient.... (more)

Will CMS notify physicians and teaching hospitals that applicable manufactures or applicable GPO’s reported...
Physicians, teaching hospitals, and physician owners or investors will receive a general notification when the reported ... (more)

Are payments from an applicable manufacturer to covered recipients in order to purchase products or materia...
Yes. There is no reporting exclusion for payments made by applicable manufacturers or applicable group purchasing organi... (more)

What are the requirements for reporting stock options granted by an applicable manufacturer to a covered re...
Stock options granted prior to August 1, 2013 are not considered payments or other transfers of value in Open Payments f... (more)

Is a payment or other transfer of value considered indirect if an applicable manufacturer utilizes a market...
No, a payment or other transfer of value provided to a market research company to conduct double-blinded market research... (more)

To determine if an applicable manufacture (or applicable group purchasing organization) has met the $100 ag...
Yes. To determine if payments or other transfers of value exceed the $100 threshold and must be reported, applicable man... (more)

Are payments or other transfers of value made, by an applicable manufacturer or applicable group purchasing...
Generally, no. Pursuant to 42 C.F.R. 403.906(a)(1), applicable manufacturers and applicable group purchasing organizatio... (more)

Does the exemption for reporting payments to medical residents also include payments to “Fellows”?
No. The final rule exempted payments to medical residents from the reporting requirements solely due to operational and ... (more)

Are educational materials or items associated with an accredited or certified CME program that meets all th...
Yes. Educational materials that are included in the tuition fees for an accredited or certified CME program that meets a... (more)

What is the relationship between Open Payments and the Federal Anti-Kickback statute, False Claims Act or s...
Compliance with Open Payments reporting requirements does not exempt applicable manufacturers, applicable group purchasi... (more)

With respect to the 90-day supplies of single-use/disposable evaluation products that are exempted from rep...
The 90-day supply should be calculated for exclusion purposes not on a per-patient basis but rather on a per-covered rec... (more)

What information does an applicable manufacturer or applicable group purchasing organization need to provid...
Applicable manufacturers and applicable group purchasing organizations need to register with CMS in order to submit data... (more)

For purposes of the 90-day exclusion for a loan of a covered device, does the loan begin when an applicable...
The Open Payments reporting exclusion for providing a covered device or device under development for 90 days to permit e... (more)

Are free repairs or services, and/or additional training offered by applicable manufacturers included in th...
Repairs or services and/or additional training provided under a contractual warranty (including a service or maintenance... (more)

When can covered recipients and physician owners or investors initiate a dispute?
Covered recipients and physician owners or investors may initiate disputes at any time after the 45 day review and corre... (more)

Are applicable manufacturers required to report uncollected payments for a covered device owed by a covered...
Yes, debt forgiveness by an applicable manufacturer for the remaining balance of a covered drug, biological, device or m... (more)

Are applicable manufacturers or applicable group purchasing expected to resubmit an entire report with corr...
Applicable manufacturers and applicable group purchasing organizations submitting a report will have the ability to retr... (more)

Are applicable manufacturers or applicable group purchasing organizations responsible for reporting individ...
Applicable manufacturers and applicable group purchasing organizations are required to report to CMS on an annual basis ... (more)

Is a distributor considered an applicable manufacturer if it holds title to devices and drugs and distribut...
An applicable manufacturer, as defined by 42 C.F.R § 403.902, is an entity that is engaged in the production, preparatio... (more)

Are awards from specialty societies provided to physician covered recipients considered indirect payments i...
Yes. Open Payments requires reporting of direct and indirect payments or other transfers of value provided by an applica... (more)

Is a newsletter created by an ad agency on behalf of a pharmaceutical client that is an applicable manufact...
Yes, a newsletter consisting of a few journal abstracts provided to physician covered recipients from an applicable manu... (more)

If a covered recipient does not accept an offered payment or other transfer of value from an applicable man...
The applicable manufacturer should report the payment or other transfer of value under the name of the covered recipient... (more)

Is there a required relationship between the “applicable manufacturer” of a covered device and the entity t...
An entity can be considered an applicable manufacturer under prong 2 of the definition at 42 C.F.R. § 403.902 if it is u... (more)

What if the automated identity verification function does not work for me?
A manual work-around will be available, but please be aware that this manual process could take up to two weeks, so earl... (more)

Are dental schools that are affiliated with universities and health care institutions, but do not match the...
The teaching hospital list compiled by CMS is a complete list of teaching hospital covered recipients. Applicable manufa... (more)

I do not see the yellow “Open Payments” button on the portal. Where is it?
You must first request access to Open Payments in order for the yellow button labeled “Open Payments” to appear on th... (more)

What should distributors, which offer a multitude of covered and non-covered products, report in the Produc...
Distributors that are considered applicable manufacturers because they hold title to a covered drug, device, biological ... (more)

Should applicable manufacturers and applicable group purchasing organizations use the information found in ...
Applicable manufacturers and applicable group purchasing organizations may obtain information regarding physicians’ uniq... (more)

If the same medical device is loaned to three different teaching hospitals for a period of 30 days each is ...
The short term loan exclusion to permit evaluation of the device or medical supply by the covered recipient applies on a... (more)

My EIDM user ID is not formatted as ##-######-### - does it have to be?
No, it does not. We are correcting this error where it appeared in our original instruction document. The user can estab... (more)

Are distributions to physician owners of LLC units in a physician owned distributor (POD) considered report...
If a POD falls within the definition of an applicable manufacturer or applicable group purchasing organization (or both)... (more)

Do covered recipients have two years from the date the review and correction period begins to initiate a di...
No, covered recipients have only until the end of the calendar year to initiate a dispute. (42 CFR 403.908(g)(3)(v)) For... (more)

Are research payments provided to a Military Medical Center that is not a teaching hospital covered recipie...
Yes, for research payments, the reporting entity must provide the name of the research institution, individual or entity... (more)

Is a payment or other transfer of value provided by an applicable manufacturer’s distributor to a covered r...
Yes, if the applicable manufacturer requires, instructs, directs, or otherwise causes the distributor to provide the pay... (more)

Are drugs or biologicals that are reimbursed by Medicare, Medicaid, or CHIP but do not require a prescripti...
Yes, drugs and biologicals that are reimbursable under Medicare, Medicaid, or CHIP and that are not over-the-counter pro... (more)

We have received several questions about foreign nationals representing foreign entities with a foreign add...
Please contact the Open Payments help desk at OpenPayments@cms.hhs.gov for support with registration and data submission... (more)

The final rule states in 42 CFR 403.902 that an “applicable group purchasing organization” is one that purc...
Regarding the definition of “applicable group purchasing organization,” a ‘group’ consists of two or more individuals an... (more)

Are tax and payments for shipping and handling including in calculating value for a payment or other transf...
Yes, tax and payments for shipping and handling are included in the total payment or other transfer of value for Open Pa... (more)

Are applicable manufacturers that receive research grants from National Institute of Health (NIH) required ...
Yes, research payments (meeting the definition of research at 42 C.F.R. § 403.902) from an NIH research grant are requir... (more)

How should applicable manufacturers and applicable group purchasing organizations report transfer royalties...
Transfer royalties are reportable payments or other transfer of value for Open Payments. Transfer royalties are required... (more)

Is a distributor for an applicable manufacturer responsible for reporting to CMS payments or other transfer...
If a distributor holds title to any covered drug, device, biological, or medical supply, the distributor meets the defin... (more)

Is a textbook donation to a medical center library for the general use of all employees reportable?
The textbook donation would be considered a reportable event if: 1) The medical center library is part of a teaching hos... (more)

Is leasing included in the actions that constitute “assistance or support” to determine if an entity is con...
Assistance or support, as defined at 42 C.F.R § 403.902, is conduct that is necessary or integral to the production, pre... (more)

Is a blood center an applicable manufacturer?
Yes, a blood center is considered to be an applicable manufacturer if the blood center operates in the United States and... (more)

Will CMS issue opinions exempting applicable manufacturers or applicable group purchasing organizations fro...
No, CMS is not issuing advisory opinions exempting applicable manufacturers or applicable group purchasing organizations... (more)

Is information regarding a physician principal investigator required for reporting if he/she is a military ...
Yes, if a military physician is a physician covered recipient principal investigator for a research study that is identi... (more)

For individuals with a US address who even upon contacting Experian Verification services are experiencing ...
Please send an email to Open Payments help desk at OpenPayments@cms.hhs.gov for support with registration and data submi... (more)

Is a manufacturer of dental alloys considered an applicable manufacturer for purposes of Open Payments? Are...
A manufacturer of dental alloys is considered an applicable manufacturer, as defined by 42 C.F.R § 403.902, if it is an ... (more)