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)

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)

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)

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)

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)

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)

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 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)

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)

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)

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)

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)

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)

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)

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)

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)

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 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)

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)

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)

"NEW" What data is CMS publishing on June 30, 2015?
This is the second reporting cycle for Open Payments, and first full calendar year of reporting. It covers payments, ... (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 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 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 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)

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)

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 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)

"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 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)

"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)

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)

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)

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)

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 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)

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)

"NEW" Is there a way to get a crosswalk between the specialties listed for providers and the taxonomy codes...
The crosswalk for physician specialties is posted on the resource section of the Open Payments website. People can us... (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)

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)

Is there a minimum value threshold that needs to be met in order for applicable manufacturers and applicabl...
The Open Payments reporting thresholds are adjusted annually based on the consumer price index. This means that for 2... (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)

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)

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)

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)

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)

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)

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)

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 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)

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)

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)

"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)

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)

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)

"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)

"NEW" How many records did CMS release on June 30, 2015? What is the value of those records?
For 2014, the data contains 11.4 million records, totaling $6.49 billion. That means that over the program’s entire l... (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)

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)

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)

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)

"NEW" Is CMS planning to provide any type of data summary sheets?
CMS is providing summary graphics of key data points on ... (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)

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)

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)

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)

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)

"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)

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)

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)

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)

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)

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)

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)

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)

"NEW" How often is Open Payments data refreshed or updated?
CMS will collect and publish this data every year. September 30, 2014, was the first publication of this data; it was... (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)

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)

"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)

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 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)

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" What is CMS doing to make sure this information is friendly for consumers?
Since first publishing Open Payments data in September 2013, CMS has made many enhancements to the tools available to... (more)

"NEW" Is there a methodology guide available providing technical details about the published data?
Yes, the Meth... (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)

"NEW" My organization already downloaded the 2013 data last year; should we download just the new 2014 data...
CMS recommends that you re-download the 2013 data this year, in addition to downloading the new 2014 data. The 2013 d... (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)

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)

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)

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)

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)

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)

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)

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)

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)

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 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)

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)

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)

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)

"NEW" 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: Resolved - Disp... (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)

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)

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)

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)

"NEW" When calculating number of payments a doctor received, should users count entries (rows) or tally the...
Each row indicates one payment, transfer of value, or ownership amount per doctor; counting rows should provide the t... (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)

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)

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)

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)

"NEW" What happens if physicians or teaching hospitals initiated disputes with the reported data before/aft...
The status of a dispute on a record has several effects on what data is published. Details of how disputes are shown ... (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)

"NEW" In what formats is the data presented?
CMS delivers Open Payments data in a number of ways to accommodate different users and their interests: ... (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)

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)

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)

"NEW" Are there any records that you are not publishing?
Yes. The Open Payments final rule provides that some research payments related to new product development, or new use... (more)

There are some differences between the data published in the initial 2013 data publication and the 2013 dat...
The June 30, 2015 data publication includes a refreshed publication of 2013 program year records. This refresh includ... (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)

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)

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)

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)

"NEW" What if a physician or teaching hospital registered (or tried to register) prior to May 20, 2015, but...
Review and dispute officially ended on May 20, 2015 for the 2014 reporting cycle. Any disputes initiated after this d... (more)

"NEW" Can a physician or teaching hospital still register in the Open Payments system and initiate a disput...
Physicians and teaching hospitals can register in CMS’ Enterprise Portal and the Open Payments system, and initiate d... (more)

"NEW" How is “de-identified” 2013 data being treated?
2013 data published last year included a set of “de-identified” records which removed payment recipients’ identifying... (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)