Frequently Asked Questions

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FAQ

By Topic: Open Payments


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 a... (more)

If an applicable manufacturer gave a contribution to support a medical conference, but did not have any say...
Unrestricted donations to a medical conference as described in this FAQ would not be subject to reporting under Open ... (more)

Starting with 2016 Open Payments data collection and reporting to CMS in 2017, are payments provided by an ...
Yes, the payment is reportable if the applicable manufacturer determines that the payment meets the definition of an ... (more)

What items or materials are considered educational materials and are not reportable transfers of value?
Educational materials and items that directly benefit patients, or are intended to be used by or with patients, are n... (more)

If several applicable manufacturers contribute funding to a continuing medical education (CME) program and ...
In accordance with the definition of an indirect payment at 42 C.F.R. §403.902, applicable manufacturers that contrib... (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 a... (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 a... (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 report... (more)

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 phy... (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 resea... (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 repo... (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 physicia... (more)

When correcting a payment or other transfer of value record, should the reporting entity submit just the co...
Reporting entities should only submit the newly corrected records. They should not re-upload an entire new data file,... (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 organiza... (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 an... (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 dev... (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 r... (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, prepara... (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 meet... (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 ... (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 maintena... (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... (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 org... (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 c... (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 normal... (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 ... (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)

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 a... (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 appl... (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... (more)

Can a physician reimburse an applicable manufacturer for payments so that no information is reported about ...
Some payments or other transfers of value are excluded from reporting; however, no exclusion exists for payments or t... (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 bas... (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 physicia... (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 bo... (more)

Are payments provided to physicians for speaking at a continuing medical education event reportable?
Yes. Starting in 2016, when an applicable manufacturer provides an indirect payment or transfer of value to a continu... (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 de... (more)

"Revised" How should an applicable manufacturer report a payment or other transfer of value provided to a t...
An applicable manufacturer must report identifiers for a teaching hospital as they appear on the teaching hospital li... (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 req... (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 ... (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 i... (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 ha... (more)

"NEW" Why am I receiving a "Failed Matching Validation" message for payment records that were accepted last...
Payment records that were successfully matched in 2014 may now appear as "Failed Matching Validation" in 2015 because... (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... (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 co... (more)

Is there a minimum value threshold that needs to be met in order for applicable manufacturers and applicabl...
There is no minimum value threshold for reporting. However, for CY 2013, payments or other transfers of value less th... (more)

What is considered a timely re-submission of data? And can corrected data file resubmissions extend past th...
Data submissions to Open Payments for program year 2013 must be made from June 1 - June 30, 2014. All submissions, co... (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 p... (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 ide... (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 pay... (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 eith... (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... (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 ... (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 un... (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, ... (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... (more)

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

I am a physician trying to initiate a dispute for a record that I see published in the Open Payments public...
If you see a record published in the Open Payments public data and attributed to you, but you do not see it on your R... (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 man... (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 b... (more)

On the Open Payments “Review and Dispute” page, how do I view all of the fields in the Review and Dispute t...
To view all columns in the table, use the scroll bar at the bottom of the table to scroll left and right. Some column... (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)) ... (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 pri... (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 permi... (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 purch... (more)

Since NPPES data may be updated by physicians on an ongoing basis, at what point in time may applicable man...
Applicable manufacturers may rely on NPI information in NPPES as of 90 days before the beginning of the reporting yea... (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 ... (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 o... (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 Payment... (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 a... (more)

How can an applicable manufacturer request a delay in publication for a research-related payment, and how w...
Publication of a payment or other transfer of value is delayed when made in connection with (1) research on or develo... (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... (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 ... (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... (more)

"NEW" How do I re-new a record’s delay in publication status?
Payment records may be delayed in publication if the payment or other transfer of value is related to: ... (more)

What is the resubmission process for an applicable manufacturer or applicable GPO to resubmit their correct...
After making corrections to the records to be resubmitted, indicate a record is a resubmission by setting the Resubmi... (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 ... (more)

What is the expected length of time for CMS to complete data validation on submitted data files?
First level of data validation: This happens immediately, when the submitter uploads a file into the system. The firs... (more)

I’m a physician who is listed as a principal investigator on a research payment reported by an applicable m...
Each research payment record submitted to the Open Payments system by an applicable manufacturer or applicable GPO is... (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 Nat... (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 d... (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 othe... (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 covere... (more)

How will data submissions be transferred to and received by CMS?
Data can be submitted to CMS through the Open Payments system via two data submission methods. The first submission m... (more)

"NEW" Do applicable manufacturers and applicable GPOs need to re-certify their Open Payments system registr...
Yes. Each calendar year, reporting entities (applicable manufacturers or applicable GPOs) need to re-certify their pr... (more)

For purposes of reporting physician ownership under section 1128(G)(a)(2) of the Social Security Act, does ...
Yes. “Immediate family member” is defined in the implementing regulations at 42 C.F.R. § 403.902 as any of the follow... (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 or 1-855-326-8366 for support with registratio... (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 ... (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 requi... (more)

What is the difference between the Review and Dispute statuses of “Resolved No Change” and “Resolved”?
Records may have a Review and Dispute status of “Resolved, No Change,” which means that the reporting entity and phys... (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 o... (more)

Do applicable manufacturers need to report NPIs for teaching hospitals?
The NPI is not a required field if the covered recipient is a teaching hospital. As stated in 78 FR 9498, reporting t... (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 ... (more)

Can all payments made to a covered recipient during a reporting period for the same Nature of Payment categ...
Applicable manufacturers have the flexibility to report payments made over multiple dates either separately or as a s... (more)

Are attesters for applicable manufacturers and applicable GPOs submitting a consolidated report required to...
No. The attester for the reporting entity submitting a consolidated report is only required to be a Chief Executive O... (more)

"NEW" How do I remove a delay in publication request for a previously submitted record?
A request for a delay in publication must be renewed each year. So, if the record was previously submitted in a prior... (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 ent... (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)

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.Key wor... (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, settl... (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 corres... (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 recipi... (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 physic... (more)

Is an applicable manufacturer company that dissolves or is purchased by another company responsible for rep...
If a company meeting the definition of an applicable manufacturer dissolves, it is still responsible for reporting in... (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, biologic... (more)

"NEW" What happens if I do not re-new a record’s delay in publication status?
A request for a delay in publication must be re-newed each year. If this request is not re-newed each year, the recor... (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 m... (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’ u... (more)

How does CMS plan to handle the dispute process from an IT perspective?
Physicians and teaching hospitals will be able to initiate data reviews and disputes through the Open Payments system... (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... (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... (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 crit... (more)

If an entity registered for Phase 1 in Open Payments but later determined that it is not an applicable manu...
If an entity determines that it is not an applicable manufacturer or applicable GPO, as defined by 42 C.F.R. §403.902... (more)

Including zip codes, how will data validation be performed on data elements to be validated? And, what chec...
The first level of validation is at the file level (i.e., checking the file broadly to make sure it is formatted corr... (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 recipie... (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 ... (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... (more)

In the event of any data errors, will the applicable manufacturer or applicable GPO be returned their whole...
It depends on the level of data error that is discovered: If the error is at the file level (i.e., the file ... (more)

If two or more entities plan to submit a consolidated report, do all entities need to register in Open Paym...
Yes. Any entity that fits the definition of an applicable manufacturer or applicable group purchasing organization an... (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 payment... (more)

If an applicable manufacturer or applicable GPO later determines an error across all payments or other tran...
No, the Open Payments system will not accept a negative value for a payment or other transfer of value amount. Applic... (more)

Are attestations required as part of corrected record resubmissions?
If any records are resubmitted, the entirety of the data for the program year must be attested to again. Key ... (more)

When requesting access to Open Payments, which user role should I select from the dropdown?
Select “Applicable Manufacturer, GPO, Physician, or Teaching Hospital user role”.Key words: Open Payments, Sunshi... (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 organizati... (more)

Can one attestation cover multiple individually submitted data files, with all of the files as part of the ...
Yes. When you attest to data, you attest to all of the successfully submitted data files for the selected program yea... (more)

Can an applicable manufacturer or applicable GPO submit a dummy test data file submission to verify if thei...
Yes, applicable manufacturers and applicable GPOs may submit a dummy test data file through the "Submit as Test File"... (more)

How will an applicable manufacturer or applicable GPO be notified if any portion of their submitted data fi...
For the first level of data validation which is performed at the file level (i.e., checking the file broadly to make ... (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 su... (more)

Are large amounts of corrected data files capable of being resubmitted?
Yes, corrected data files can be submitted through bulk file upload. Note that the 250MB size limit also applies to c... (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. Individu... (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 ... (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 es... (more)

Can a data file submission be broken down and submitted in multiple files based on the number of line items?
Yes. Data files can be separated and uploaded into multiple files for submission. However, each individual file shoul... (more)

Will every data error in each line item be identified to eliminate resubmissions regarding the same line it...
Yes. Applicable manufacturers and applicable GPOs will be notified via email of any record level data validation erro... (more)

If multiple records in a submitted data file have been rejected, can an applicable manufacturer or applicab...
Yes, an applicable manufacturer or applicable GPO may submit an entirely new data file to replace an earlier submissi... (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 e... (more)

Including data lines and rows per file submission, what is the total allowable size for the data files to b...
The maximum file submission size for each data file is 250 megabytes (MB). There is no limit to the number of data fi... (more)