Frequently Asked Questions

  ADA/508 friendly site



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 va... (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 wit... (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... (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)

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 ... (more)

If an applicable manufacturer or applicable group purchasing organization (GPO) provides a payment or trans...
No, this payment or other transfer of value would not be reportable because it does not meet the def... (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-bli... (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... (more)

Is a medical device considered a covered product for purposes of the Open Payments reporting requirements i...
Yes, if a medical device is used to perform a service that is reimbursable under Medicare, Medicaid, or CHIP , the devic... (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 Sta... (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)

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, preparati... (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 prac... (more)

I’m a physician who is listed as a principal investigator on a research payment reported by an applicable...
Each research payment record submitted to the Open Payments system by an applica... (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 produc... (more)

Is the loan of a covered device by an applicable manufacturer for training purposes at a Continuing Medical...
No. A loan of a covered device by an applicable manufacturer for training purposes at a CME or non-C... (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 or... (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 distrib... (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 man... (more)

Are there minimum value thresholds that must be met in order for applicable manufacturers and applicable gr...
Yes, there are specific key (de minimis) thresholds for reporting for applicable manufacturers and applicable GPOs, whic... (more)

If an applicable manufacturer or applicable group purchasing organization (GPO) offers buffet meals, snacks...
The question of whether an applicable manufacturer must report buffet meals, snacks, or coffee provi... (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 Paymen... (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 gro... (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 ... (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 repo... (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)

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 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 pr... (more)

Does CMS have guidelines for how to determine the value of ownership and investment interests?
Applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report the cumulative valu... (more)

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

If an applicable manufacturer contracts with a clinic for consulting services, and the applicable manufactu...
This is considered an indirect payment. Applicable manufacturers are required to report indirect payments made to physic... (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... (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 ... (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 p... (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 patient... (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 enti... (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 rese... (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 a writt... (more)

How often is Open Payments data refreshed or updated?
Data publication is on June 30. CMS will also refresh the data once annually, after the initial publ... (more)

Does CMS notify covered recipients (physicians and teaching hospitals) when applicable manufacturers or app...
The Open Payments system does not generate individual notifications to covered recipients when attri... (more)

What is considered a timely submission of data under the Open Payments program, and can a data file be subm...
Reporting under the Open Payments program is not considered complete until the o... (more)

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

When correcting a payment or other transfer of value record that is in a “Ready for Attestation” or “...
Yes. If fields that identify the record’s covered recipient or principal inves... (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)

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... (more)

If several applicable manufacturers or group purchasing organizations (GPOs) contribute funding to a Contin...
In this scenario, each applicable manufacturer or GPO would need to determine for itself if their respective contributio... (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... (more)

How is data validation performed, and what data elements are checked?
Data validation occurs on several levels. The first level of validation is at th... (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)

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 th... (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 tran... (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 ... (more)

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

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

When an entity with no covered products becomes an applicable manufacturer or applicable group purchasing o...
When an applicable manufacturer or applicable GPO that did not previously have any other covered pro... (more)

Because the National Plan and Provider Enumeration System (NPPES) data can be updated by physicians on an o...
Applicable manufacturers and applicable GPOs should reference the Validated Physician List (VPL) fir... (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) rese... (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 ar... (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 comm... (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 ... (more)

Are applicable manufacturers or applicable group purchasing organizations expected to resubmit an entire re...
Applicable manufacturers and applicable group purchasing organizations submitting a report have the ability to retract a... (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 ge... (more)

How should an applicable manufacturer or applicable group purchasing organization (GPO) document the approp...
NDCs must be reported in the standard 10-digit NDC format with dashes placed in the appropriate posi... (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. § 403.90... (more)

Is a blood center an applicable manufacturer?
Yes, a blood center is considered to be an applicable manufacturer if the blood center operates i... (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)

Are applicable manufacturers required to report a physician’s name and taxonomy code as listed in the Nat...
Applicable manufacturers and applicable group purchasing organizations (GPOs) are encouraged to repo... (more)

What values must be reported when an applicable manufacturer or applicable group purchasing organization (G...
When reporting that a physician has an ownership or investment interest in an applicable manufacture... (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 ro... (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... (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 in... (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)

Are applicable manufacturers and group purchasing organizations (GPOs) required to report all taxonomy code...
Applicable manufacturers and GPOs should report only one taxonomy code per physician. CMS provides a Validated Physici... (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 ... (more)

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

Does CMS provide any type of summary data?
CMS provides summary graphics of key data points on ... (more)

Is a promotional newsletter that consists of journal abstracts and information on patient adherence, which ...
Yes, a promotional newsletter provided to a physician by an applicable manufacturer (either directly... (more)

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

What is the expected length of time for CMS to complete data validation on submitted data files?
The length of time depends upon file sizes and the number of files being process... (more)

Does CMS publish a covered recipient’s NPI on the Open Payments website?
No. As required by the statute, CMS does not publish a covered recipient’s NPI on the Open Payment... (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, bio... (more)

When submitting a consolidated report for separate applicable manufacturers and group purchasing organizati...
No. The attester of a consolidated report is required to hold an Officer position only within the en... (more)

Who can register in EIDM to access the Open Payments system?
Applicable manufacturers, group purchasing organizations (GPOs), physicians, and... (more)

How does a covered recipient complete the review and dispute process?
Physicians and teaching hospitals are able to initiate disputes through the Open... (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 th... (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 sep... (more)

Are there any submitted records that CMS does not publish?
Yes. The Open Payments final rule allows some research payments related to new product development o... (more)

When may an applicable manufacturer or applicable GPO request a delay in publication for a general payment ...
Applicable manufacturers and applicable GPOs may request a delay in publication for a research-related and the payment o... (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 submi... (more)

Why am I receiving a "Failed Matching" message for payment records that were successfully processed in a pr...
Payment records that were successfully matched in a prior year may appear as "Failed Matching" in fu... (more)

Are tax and payments for shipping and handling included in calculating value for a payment or other transfe...
Yes, tax and payments for shipping and handling are included in the total paymen... (more)

What does CMS publish annually on June 30th?
CMS publishes data reported by applicable manufactures and group purchasing organizations (GPOs) for... (more)

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

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

Is there a methodology guide available providing technical details about the published data?
Yes, the Methodology Overview & Data Dictionary, available on the Resources page (... (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... (more)

To determine if an applicable manufacturer or applicable group purchasing organization (GPO) has met the ag...
Yes. To determine if small payments or other transfers of value made to a physician or teaching hosp... (more)

What resources should applicable manufacturers and applicable group purchasing organizations (GPOs) use to ...
To accurately identify physicians for Open Payments reporting, applicable manufacturers and applicab... (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 pa... (more)

The final rule states in 42 CFR 403.902 that an “applicable group purchasing organization” is one that ...
Regarding the definition of “applicable group purchasing organization,” a ‘group’ consists o... (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 t... (more)

Do applicable manufacturers and applicable group purchasing organizations (GPOs) need to recertify their Op...
Yes. Each calendar year, applicable manufacturers and applicable GPOs need to recertify their profil... (more)

On the Open Payments “Review and Dispute” page, how do I view all of the fields in the Review and Dispu...
To view all columns in the table, use the scroll bar at the bottom of the table to scroll left and r... (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, pr... (more)

In what formats is the data presented?
CMS delivers Open Payments data in a number of ways to accommodate different ... (more)

How do I renew a record’s delay in publication status?
Payment records may be delayed in publication if the payment or other transfer of value is related t... (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 repo... (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... (more)

Are attestations required as part of corrected record resubmissions?
If any records are resubmitted, the entirety of the data for the program year mu... (more)

Can one attestation cover multiple individually submitted data files, with all of the files as part of the ...
Yes. When attesters attest to data for a reporting entity, they attest to all of the successfully su... (more)

What should applicable manufacturers and applicable group purchasing organizations include when reporting t...
When reporting the terms of an ownership or investment interest, applicable manufacturers and applicable group purchasin... (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, ... (more)

When calculating number of payments a doctor received, should users count entries (rows) or tally the numbe...
Each payment record (row) for a physician does not necessarily constitute a single payment or other transfer of value. ... (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 purchasin... (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 reci... (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)

Why does the Open Payments data change over time?
Current data publications include a refreshed publication of all records from previous program years... (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 § ... (more)

How can disputes initiated by physicians and teaching hospitals be resolved?
Once the dispute is initiated, it can be resolved in one of three ways: 1. Resolved - Disputed ... (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 o... (more)

What happens if an applicable manufacturer or applicable group purchasing organization (GPO) does not renew...
A request for a delay in publication must be renewed each year by the end of the data submission pe... (more)

How is a delay in publication request removed for a previously submitted record?
To remove a delay in publication request on a record, the user may update the delay in publication f... (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 r... (more)

Do applicable manufacturers and group purchasing organizations (GPOs) need to report National Provider Iden...
No. Applicable manufacturers and applicable GPOs are only required to provide NPIs for physician cov... (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... (more)

Including data lines and rows per file submission, what is the total allowable size for the data files?
The maximum file submission size for each data file is 250 megabytes (MB). There... (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 purc... (more)

How will CMS ensure Open Payments information remains user-friendly for consumers?
CMS provides stakeholders the opportunity to submit feedback on the Open Payments program and system... (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 ... (more)

Do physicians and teaching hospitals have a chance to review the financial data reported about them prior t...
Yes. During the 45-day physician and teaching hospital review and dispute period, the dollar values and information abou... (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 t... (more)

How will an applicable manufacturer or applicable GPO be notified if any portion of their submitted data fi...
Data validation occurs on several levels. The first level of validation is at th... (more)

What if a physician or teaching hospital registered (or tried to register) prior to review and dispute peri...
Any disputes initiated after review and dispute period ends will not be reflected in the June 30 dat... (more)