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Are payments provided to a consulting firm or third party, whom in turn provide the payment (in whole or pa...- Yes, Open Payments requires reporting of both direct and indirect payments and other transfers of value provided by an a... (more)
- Yes, Open Payments requires reporting of both direct and indirect payments and other transfers of value provided by an applicable manufacturer or applicable group purchasing organization to a covered recipient. An indirect payment is a payment or transfer of value made by an applicable manufacturer, or an applicable group purchasing organization, to a covered recipient, or a physician owner or investor, through a third party, where the applicable manufacturer, or applicable group purchasing organization, requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s), or a physician owner or investor. Key words: Open Payments, Sunshine Act
(FAQ8155)
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If an applicable manufacturer or applicable group purchasing organization (GPO) provides a payment or trans...- No. A payment or transfer of value as described above would not be subject to reporting under Open Payments for any cove... (more)
- No. A payment or transfer of value as described above would not be subject to reporting under Open Payments for any covered recipient physician speakers or faculty. As explained in the Calendar Year 2015 Physician Fee Schedule Final Rule, when an applicable manufacturer or GPO provides funding to a continuing education provider, but does not: 1) select or pay the covered recipient speaker directly, or (2) provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under § 403.904(i)(1) [revised as § 403.904(h)(i)]. This approach is consistent with our discussion in the preamble to the final rule, where we explained that if an applicable manufacturer conveys ”full discretion” to the continuing education provider, those payments are outside the scope of the rule (79 Fed. Reg. 67759). We continued by saying “[t]his is the case even if the applicable manufacturer or applicable GPO learns the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.”(79 Fed. Reg. 67760).
(FAQ8165)
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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 not ... (more)
- Educational materials and items that directly benefit patients, or are intended to be used by or with patients, are not reportable transfers of value. Additionally, the value of an applicable manufacturer’s services to educate patients regarding a covered drug, device, biological, or medical supply are not reportable transfers of value. For example, overhead expense, such as printing and time development of educational materials, which directly benefit patients or are intended for patient use are not reportable transfers of value. Key words: Open Payments, Sunshine Act
(FAQ8161)
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Does the exemption for reporting payments to medical residents also include payments to “Fellows”? - No. The final rule exempted payments to medical residents from the reporting requirements solely due to operational and ... (more)
- No. The final rule exempted payments to medical residents from the reporting requirements solely due to operational and data accuracy concerns regarding aggregation of payments or other transfers of value to residents, many of whom have neither a National Provider Identifier (NPI) nor a State professional license. Because these same concerns do not generally apply to physicians in Fellowship training, payments to Fellows are not exempt from the reporting requirements. Key words: Open Payments, Sunshine Act
(FAQ8372)
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Is an applicable manufacturer with both covered and non-covered products required to report payments or oth...- Yes, applicable manufacturers of at least one covered drug, device, biological or medical supply are required to report ... (more)
- Yes, applicable manufacturers of at least one covered drug, device, biological or medical supply are required to report all payments or other transfers of value, unless the applicable manufacturer meets one of the reporting limitations, as described in 42 C.F.R. § 403.904(b); in that case the applicable manufacturer is only required to report payments or other transfer of value related to covered drugs, devices, biological, or medical supplies. Reporting limitations include: (1) applicable manufacturers with total revenue from covered drugs, devices, biological, or medical supplies constituting less than 10 percent of total revenue during the fiscal year preceding the reporting year, (2) an entity meets the definition of an applicable manufacturer because it is under common ownership with such applicable manufacturer and provides assistance and support to such applicable manufacturer, (3) the applicable manufacturer has separate operating divisions that do not manufacture any covered drugs, devices, biologicals or medical supplies, and (4) the applicable manufacturer is only manufacturing a covered drug, device, biological, or medical supply because it is under written agreement to manufacture the covered drug, device, biological, or medical supply, does not hold the FDA approval, licensure, or clearance for the covered drugs, device, biological, or medical supply, and is not involved in the sale marketing, or distribution of the covered drugs, device, biological, or medical supply. In the instance of pre-clinical research, applicable manufacturers only need to report the research institution, principal investigator(s) (including their name, National Provider Identifier, State professional license number(s), specialty and business address) and total payment. See 78 FR 9484. Key words: Open Payments, Sunshine Act
(FAQ9132)
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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 ind... (more)
- Yes, the payment is reportable if the applicable manufacturer determines that the payment meets the definition of an indirect payment, and the applicable manufacturer knows or can determine the identity of the covered recipient by the end of the second quarter of the following reporting year. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. In accordance with 42 C.F.R. §403.904(i)(1), indirect payments or other transfers of value do not have to be reported if the applicable manufacturer is unaware of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. Keywords: Open Payments, Sunshine Act, CME, Physician Fee Schedule
(FAQ11638)
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Is a physician located outside of the United States considered a physician covered recipient for purposes o...- If a physician maintains a current state license to practice medicine in any state in the United States, the physician w... (more)
- If a physician maintains a current state license to practice medicine in any state in the United States, the physician will be considered a covered recipient for purposes of Open Payments. Within Open Payments, the term “physician” has the same meaning as under Section 1861(r) of the Social Security Act, which generally includes doctors of medicine, osteopathy, dentists, podiatrists, optometrists and chiropractors who are legally authorized to practice by a state. A current state license would render the physician “legally authorized” to practice medicine, regardless of the extent to which they do so. Therefore, a physician who maintains an active license to practice in the United States would be considered a covered recipient, and payments made to such a person would have to be reported, even for services rendered (such as speaking at a public seminar) outside of the U.S. An exception to this covered recipient classification is when a physician is a bona fide employee of an applicable manufacturer that is required to submit reporting information under subsection (a) of Section 1128G of the Social Security Act. Key words: Open Payments, Sunshine Act
(FAQ8984)
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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)
- Yes, payments or other transfers of value made in connection with an activity that meets the definition of research and that are subject to a written agreement, a research protocol or both should be included in the total amount of the research payment. Payments or other transfers of value that are not included in the written agreement or research protocol should be reported separately in the appropriate nature of payment category. Key words: Open Payments, Sunshine Act
(FAQ8264)
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Is a payment or other transfer of value considered indirect if an applicable manufacturer utilizes a market...- No, a payment or other transfer of value provided to a market research company to conduct double-blinded market research... (more)
- No, a payment or other transfer of value provided to a market research company to conduct double-blinded market research with physicians is not considered an indirect payment. The applicable manufacturer clearly intends a portion of the payment to be provided to physicians, but given that the reason for the third party’s involvement is specifically to maintain the anonymity of the respondents and sponsor, we do not intend this to be considered a reportable indirect payment or other transfer of value. Additionally, under section 1128G(e)(10)(A) of the Social Security Act, Open Payments excludes reporting of payments when an applicable manufacturer is unaware of the covered recipient, and the payment to the covered recipient is made indirectly through a third party, such as the market research company, in the above facts. Key words: Open Payments, Sunshine Act
(FAQ8992)
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Is a medical device considered eligible for payment by Medicare, Medicaid, or CHIP for purposes of Open Pay...- Yes, if a medical device is used to perform a service that is reimbursable under Medicare, Medicaid, or CHIP, the device... (more)
- Yes, if a medical device is used to perform a service that is reimbursable under Medicare, Medicaid, or CHIP, the device is considered a covered device for purposes of Open Payments, so long as it is of the type that by law requires premarket approval by or premarket notification to the FDA, per the definition in 42 C.F.R. § 403.902. Key words: Open Payments, Sunshine Act
(FAQ8258)
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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)
- Generally, no. Pursuant to 42 C.F.R. 403.906(a)(1), applicable manufacturers and applicable group purchasing organizations are required to report annually on ownership and investment interests held by a physician or an immediate family member of a physician. Such ownership and investment interests must be reported under the name of the physician -- even if it is the physician’s immediate family member that holds the ownership or investment interest -- with an indication of whether the interest is held by the physician or an immediate family member. Under § 403.906(b), however, applicable manufacturers and applicable group purchasing organizations must report the dollar amount invested by a physician or a physician’s immediate family member, but for payments or other transfers of value, they are only required to report those to a physician owner/investor (not to an immediate family member of a physician, who has an ownership/investment interest). Note -there are two exceptions: 1) when an applicable manufacturer or applicable group purchasing organization gives a payment/other transfer of value to an immediate family member of a physician on behalf of or at the request of a physician owner or investor (i.e., a third party payment to the family member), or 2) when the payment is provided to the immediate family member of a physician as an indirect payment to be passed through to the physician. In those two scenarios, the payment or transfer of value to the immediate family member of a physician owner/investor must be reported, regardless of whether or not the immediate family member is also an owner/investor. Key words: Open Payments, Sunshine Act
(FAQ8366)
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Are awards from specialty societies provided to physician covered recipients considered indirect payments i...- Yes. Open Payments requires reporting of direct and indirect payments or other transfers of value provided by an applica... (more)
- Yes. Open Payments requires reporting of direct and indirect payments or other transfers of value provided by an applicable manufacturer to a covered recipient. An indirect payment, defined by 42 C.F.R. § 403.902, is a payment or transfer of value made by an applicable manufacturer (or an applicable group purchasing organization) to a covered recipient (or a physician owner or investor) through a third party, where the applicable manufacturer (or applicable group purchasing organization) requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient(s) (or a physician owner or investor). If the applicable manufacturer causes the specialty society, acting as a third party, to provide a payment or transfer of value in whole or in part to a covered recipient, then this may be considered an indirect payment or other transfer of value. In this scenario, the transfer of value is the portion of the grant that would be used to create an award for a covered recipient. However, an applicable manufacturer is not required to report an indirect payment/other transfer of value if, according to 42 C.F.R. § 403.904(i)(1), the applicable manufacturer is unaware of the identity of the covered recipient. An applicable manufacturer is unaware of the identity of a covered recipient if the applicable manufacturer does not know (as defined in §403.902) the identity of the covered recipient. The definition of “know” states that a person “knows” if he/she has actual knowledge of the information, or acts in deliberate ignorance or reckless disregard of the information. An example of an applicable manufacturer having the requisite knowledge that a covered recipient received an award from grant funds is if an applicable manufacturer allows a specialty society to use its name in an award for a covered recipient, the applicable manufacturer would easily be able to ascertain the identity of the award’s recipient. Therefore, the applicable manufacturer could be deemed to be acting with deliberate ignorance if it did not follow up with the specialty society regarding the identity of the recipient. Key words: Open Payments, Sunshine Act
(FAQ9004)
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Is a distributor required to report food and beverages that are provided during an open house for a new dis...- Yes. If the distributor meets the definition of an applicable manufacturer, as defined by 42 C.F.R § 403.902, food and ... (more)
- Yes. If the distributor meets the definition of an applicable manufacturer, as defined by 42 C.F.R § 403.902, food and beverages provided to covered recipients and physician owners or investors are required to be reported. The applicable manufacturer should divide the value of the food by the number of those who partook in the food. The value of the food still needs to be accounted for even if the event is a large scale event as long as the applicable manufacturer can identify the covered recipients of the food. Key words: Open Payments, Sunshine Act
(FAQ9140)
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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)
- An applicable manufacturer, as defined by 42 C.F.R § 403.902, is an entity that is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply, or is under common ownership with an applicable manufacturer and provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered product or a distributor or wholesaler (including, but not limited to, repackagers, relabelers, and kit assemblers) that do not hold title to any covered drug, device, biological or medical supply. A “covered device” (including a medical supply that is a device) is any device for which (1) payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP), either separately (such as through a fee schedule or formulary) or as part of a bundled payment, and (2) by law, requires premarket approval by or premarket notification to the FDA. The question of whether a distributor falls within the definition of an applicable manufacturer, as defined in 42 C.F.R. § 403.902, depends in part on whether payment is available for any of the distributor’s products under Medicare, Medicaid, or CHIP. A distributor is not considered an applicable manufacturer for purposes of Open Payments if the distributor only distributes and sells a manufacturer’s medical devices and drugs and payment is not available under Medicare, Medicaid, or CHIP. However, it is worth noting that under the final rule, if an entity manufactures at least one covered drug, device, biological, or medical supply, then it qualifies as an applicable manufacturer and must report all payments or transfers of value to covered recipients, regardless of whether or not they are related to a covered product. Similarly, if a distributor distributes at least one covered drug, device, biological or medical supply, then it qualifies as an applicable manufacturer and must report all payments or transfers of value to covered recipients, regardless of whether or not they are related to a covered product, except if a limitation on reporting applies as specified in § 403.904(b). Key words: Open Payments, Sunshine Act
(FAQ8968)
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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)
- Both domestic and global sales are included in the company’s total (gross) revenue. Applicable manufactures with less than 10 percent of total (gross) revenue from covered drugs, devices, biological or medical supplies during the previous fiscal year are required to report only payments or other transfers of value specifically related to covered drugs, devices, biologicals or medical supplies. Applicable manufacturers with less than 10 percent of total gross revenue from covered products during the previous year must register with CMS and attest that less than 10 percent of total (gross) revenues are from covered products, along with their attestation of the submitted data. Key words: Open Payments, Sunshine Act
(FAQ8163)
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Are payments from an applicable manufacturer to covered recipients in order to purchase products or materia...- Yes. There is no reporting exclusion for payments made by applicable manufacturers or applicable group purchasing organi... (more)
- Yes. There is no reporting exclusion for payments made by applicable manufacturers or applicable group purchasing organizations to covered recipients for the purpose of purchasing products or materials. Key words: Open Payments, Sunshine Act
(FAQ8374)
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Are distributions to physician owners of LLC units in a physician owned distributor (POD) considered report...- If a POD falls within the definition of an applicable manufacturer or applicable group purchasing organization (or both)... (more)
- If a POD falls within the definition of an applicable manufacturer or applicable group purchasing organization (or both), then they must report distributions provided to physician owners of LLC units in the POD for purposes of Open Payments. Key words: Open Payments, Sunshine Act
(FAQ8974)
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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)
- Repairs or services and/or additional training provided under a contractual warranty (including a service or maintenance agreement) will also be subject to the exclusion, where the terms of the warranty are set forth in the purchase or lease agreement. Key words: Open Payments, Sunshine Act
(FAQ8960)
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Is the loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME eve...- No. A loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME event is not cons... (more)
- No. A loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME event is not considered a payment or other transfer of value provided to a covered recipient if the device was loaned to the CME vendor for training covered recipients at a CME event and the covered recipient did not take possession of the covered device. Key words: Open Payments, Sunshine Act
(FAQ9154)
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If an employee (non-physician) of a teaching hospital receives a transfer of value such as a meal, would th...- Non-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physic... (more)
- Non-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physician-owned entity are not covered recipients for the purposes of Open Payments. Accordingly, payments or other transfers of value made to these non-physician employees generally do not need to be reported. However, note that such payments to non-physician employees would need to be reported pursuant to 42 C.F.R. §403.904(a) and (c)(10) if the payments were made to the non-physician employees at the request of or designated by the applicable manufacturer on behalf of a covered recipient. In addition, the payments to non-physician employees would need to be reported if they were in fact indirect payments (as defined at §403.902) to a covered recipient (physician or teaching hospital) being made through the non-physician employee. Indirect payments or other transfers of value occur when an applicable manufacturer or applicable group purchasing organization requires, instructs, directs or otherwise causes a third party to provide the payment or other transfer of value, in whole or in part, to a covered recipient. For example, an applicable manufacturer providing equipment to a non-physician employee of a teaching hospital that is intended to benefit the teaching hospital is considered an applicable manufacturer otherwise causing the employee to provide the equipment to the teaching hospital covered recipient. Key words: Open Payments, Sunshine Act
(FAQ8272)
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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 Pay... (more)
- Unrestricted donations to a medical conference as described in this FAQ would not be subject to reporting under Open Payments. Although there is no formal definition of an unrestricted donation, in this case we can take that term to mean a grant given by a reporting entity to a professional association for use without any restrictions, preconditions, or post-conditions in order to assist the professional or educational association with its administrative or educational needs. In accordance with the definition of an indirect payment at 42 C.F.R. §403.902, an applicable manufacturer that contributes funding to a medical/educational conference would be required to report the payment if the reporting entity determines that it meets the definition of an indirect payment at 42 C.F.R. §403.902. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. Keywords: Open Payments, Sunshine Act, CME, Physician Fee Schedule
(FAQ11602)
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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 requi... (more)
- Yes, research payments (meeting the definition of research at 42 C.F.R. § 403.902) from an NIH research grant are required to be reported as payment or other transfer of value for purposes of Open Payments according to the special rules for research payments at § 403.904(f). < Key words: Open Payments, Sunshine Act
(FAQ8996)
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Are applicable manufacturers or applicable group purchasing organizations responsible for reporting individ...- Applicable manufacturers and applicable group purchasing organizations are required to report to CMS on an annual basis ... (more)
- Applicable manufacturers and applicable group purchasing organizations are required to report to CMS on an annual basis all ownership and investment interest in the applicable manufacturer or applicable group purchasing organization that were held by a physician or an immediate family member of a physician during the preceding calendar year. An ownership or investment interest is not reportable if an applicable manufacturer or applicable group purchasing organization did not know about such ownership or investment interest (42 C.F.R. § 403.902). In this context, the word “know” means that a person, with respect to information: (1) has actual knowledge of the information, (2) acts in deliberate ignorance of the truth or falsity of the information, or (3) acts in reckless disregard of the truth or falsity of the information. Key words: Open Payments, Sunshine Act
(FAQ8380)
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Are drugs or biologicals that are reimbursed by Medicare, Medicaid, or CHIP but do not require a prescripti...- Yes, drugs and biologicals that are reimbursable under Medicare, Medicaid, or CHIP and that are not over-the-counter pro... (more)
- Yes, drugs and biologicals that are reimbursable under Medicare, Medicaid, or CHIP and that are not over-the-counter products are considered covered drugs or biologicals for Open Payments. The limiting clause requiring a “prescription to be dispensed” in order for a drug or biological to fall within the definition of a “covered drug, device, biological, or medical supply” in 42 C.F.R. § 403.902 is only intended to exclude over-the-counter (OTC) drugs, not those that require administration or authorization by a physician. 78 Fed. Reg. 9465. Key words: Open Payments, Sunshine Act
(FAQ8256)
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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, wh... (more)
- Reporting entities should only submit the newly corrected records. They should not re-upload an entire new data file, which includes the corrected record plus previously submitted records that did not need to be corrected. Re-uploading an entire new data file that includes records that did not need to be corrected may not be in compliance with 42 C.F.R. § 403.908(e), which pertains to attesting to each report, including subsequent corrections, and ensuring the submission is reported timely, accurately, and is a complete submission.
(FAQ11956)
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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. § 403.902 if it is ... (more)
- An entity can be considered an applicable manufacturer under prong 2 of the definition at 42 C.F.R. § 403.902 if it is under common ownership with an applicable manufacturer under prong 1 of the definition, and it provides assistance or support to the prong 1 applicable manufacturer with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological or medical supply. “Common ownership” refers to circumstances where the same individual, individuals, entity, or entities directly or indirectly own 5 percent or more total ownership of two entities, including, but not limited to, parent corporations, direct and indirect subsidiaries, and brother or sister corporations. A prong 2 applicable manufacturer is only required to report payments or other transfers of value that are related to a covered drug, device, biological, or medical supply for which it provided assistance or support to the prong 1 applicable manufacturer under common ownership. Key Words: Open Payments, Sunshine Act
(FAQ8270)
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Is information regarding a physician principal investigator required for reporting if he/she is a military ...- Yes, if a military physician is a physician covered recipient principal investigator for a research study that is identi... (more)
- Yes, if a military physician is a physician covered recipient principal investigator for a research study that is identified according to 42 C.F.R. § 403.904(f) then information about the physician covered recipient principal investigator is required to be reported as indicated at § 403.904(f)(1)(v). Key words: Open Payments, Sunshine Act
(FAQ9000)
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Is a distributor for an applicable manufacturer responsible for reporting to CMS payments or other transfer...- If a distributor holds title to any covered drug, device, biological, or medical supply, the distributor meets the defin... (more)
- If a distributor holds title to any covered drug, device, biological, or medical supply, the distributor meets the definition of an applicable manufacturer as defined at 42 C.F.R. § 403.902, and is subject to Open Payments reporting requirements. A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and possesses the right to re-sell the inventory of the products that it has purchased. Applicable manufacturers that have products with titles held by distributors do not need to report payments or other transfers of value made by the distributor to covered recipients. The distributor that holds title will be subject to the same reporting requirements as applicable manufacturers, and thus will be responsible for reporting the transfer of value. Key words: Open Payments, Sunshine Act
(FAQ8982)
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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 pa... (more)
- No, the educational material exclusion is limited to materials and items directly benefiting patients or intended for patient use as required by the Affordable Care Act Section 6002. Educational materials, such as medical textbooks or journal reprints, which are educational to covered recipients but are not intended for patient use or directly beneficial to patients are not included in the exclusion. Key words: Open Payments, Sunshine Act
(FAQ8171)
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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 GPOs. The Open Paymen... (more)
- Yes, there are specific key (de minimis) thresholds for reporting for applicable manufacturers and GPOs. The Open Payments key (de minimis) thresholds for reporting are adjusted based on the consumer price index. This means that for a calendar year (January 1 – December 31), if a small payment or other transfer of value is less than a certain minimum amount, it is excluded from the reporting requirements under Open Payments. However if the amount transferred to, requested by, or designated on behalf of a physician or teaching hospital exceeds an aggregate total annual amount for the calendar year (see table below) all payments or other transfers of value must be reported. For information on the de minimum amounts for specific program years, see: https://www.cms.gov/OpenPayments/Program-Participants/Applicable-Manufacturers-and-GPOs/Data-Collection.html. Key words: Open Payments, Sunshine Act
(FAQ10090)
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Is a contract research organization (CRO) that performs clinical trials according to protocols for pharmace...- A CRO that is not an applicable manufacturer is not required to report information under Open Payments. However, an appl... (more)
- A CRO that is not an applicable manufacturer is not required to report information under Open Payments. However, an applicable manufacturer providing a payment that meets the definition of research, as defined at 42 C.F.R. § 403.902, to a CRO which is ultimately paid in whole or in part to a covered recipient (physician or teaching hospital), is required to report, as outlined in §403.904(f), the name of the research institution, individual or entity receiving the payment, total amount of the research payment, name of the research study, names of any related covered drugs, devices, biological, or medical supplies, and information about each physician covered recipient principal investigator. The research agreement may include an unbroken chain of agreements as long as they link the applicable manufacturer with the recipient. If the employee of a CRO who is conducting medical safety for clinical trials for a research study is also a physician covered recipient principal investigator then information regarding the physician is required to be reported by the applicable manufacturer under Open Payments. Key words: Open Payments, Sunshine Act
(FAQ8988)
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How should applicable manufacturers or applicable group purchasing organization determine the value of jour...- The value of a journal reprint should reflect the cost that an applicable manufacturer or applicable group purchasing or... (more)
- The value of a journal reprint should reflect the cost that an applicable manufacturer or applicable group purchasing organization paid to acquire the reprint from the publisher or other distributor. Applicable manufacturers and applicable group purchasing organizations may submit an assumptions document clarifying any assumptions made to determine the value of journal reprints. Key words: Open Payments, Sunshine Act
(FAQ8370)
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Which nature of payment category should applicable manufacturers report payments to physician covered recip...- Applicable manufacturers and applicable group purchasing organizations should consider the purpose and manner of the pay... (more)
- Applicable manufacturers and applicable group purchasing organizations should consider the purpose and manner of the payment or other transfer of value and make a reasonable determination. A payment for promotional speaking may be included in the “compensation for services other than consulting” or “honorarium” nature of payment category depending on the specific facts. Applicable manufacturers and applicable group purchasing organizations may submit an assumptions document clarifying any assumptions made to determine the nature of payment category. Key words: Open Payments, Sunshine Act
(FAQ8382)
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Should all physician covered recipient principal investigators who perform research for the research instit...- No, applicable manufacturers are only required to report the names of principal investigators, as that term is normally ... (more)
- No, applicable manufacturers are only required to report the names of principal investigators, as that term is normally used in industry, not sub-researchers. Applicable manufacturers reporting research payments may report up to five covered recipient principal investigators for each research payment reported. Key words: Open Payments, Sunshine Act
(FAQ8266)
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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 applicable manufacturer or applicable GPO is at... (more)
- Each research payment record submitted to the Open Payments system by an applicable manufacturer or applicable GPO is attributed to the physician, teaching hospital, or non-covered recipient that received the payment. As appropriate, the names of physician principal investigators associated with the research payment are also provided. If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name. This does not necessarily mean the payments are attributed to you. The dollar amount of the record corresponds to the total payment; the amounts are not attributed to each individual on the record. For example, if an applicable manufacturer submits a $1000 research payment made to a teaching hospital and reports that there are three associated physician principal investigators, all three principal investigators would be listed in the Open Payments system; but the teaching hospital would be listed as the entity that received the $1000 research payment. As a principal investigator, you may only dispute your own association with the payment or other transfer of value. You should not dispute any other information about the transaction, such as payment amount, nature of payment, etc. Key words: Open Payments, Sunshine Act
(FAQ12224)
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Does CMS notify physicians and teaching hospitals when applicable manufacturers or applicable group purchas...- If physicians, teaching hospitals, and physician owners or investors have previously registered in the Open Payments sys... (more)
- If physicians, teaching hospitals, and physician owners or investors have previously registered in the Open Payments system, they will receive a general notification when information has been reported about them and is ready for review. We encourage physicians, teaching hospitals, and physician owners or physician investors to register with CMS so that they receive this notification. Key words: Open Payments, Sunshine Act
(FAQ8147)
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Does CMS have a definition of what constitutes an ownership or investment interest for purposes of Open Pay...- Applicable manufacturers and applicable group purchasing organizations reporting ownership or investment interests have ... (more)
- Applicable manufacturers and applicable group purchasing organizations reporting ownership or investment interests have some flexibility to decide how to report the “value” of such interests. However, they must document the method used to estimate the value of the ownership or investment and may include such documentation if they submit an assumptions document with their annual report. Applicable manufacturers and applicable group purchasing organizations are required to report the cumulative value of an ownership or investment interest, therefore applicable manufacturers and applicable group purchasing organizations need to report the total value a physician owner or investor or physician owner or investor’s immediate family member holds in an applicable manufacturer or applicable group purchasing organization at the end of preceding calendar year. When reporting the terms of an ownership or investment interest, applicable manufacturers and applicable group purchasing organizations should report the type of ownership or investment interest (as defined in 42 CFR § 403.902), including but not limited to stock, stock options, partnership shares, loans, bonds, or other financial instruments that are secured with an entity’s property or revenue or a portion of that property or revenue. Key words: Open Payments, Sunshine Act
(FAQ8376)
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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 provided to physician att... (more)
- The question of whether an applicable manufacturer must report buffet meals, snacks, or coffee provided to physician attendees at a large annual conference requires a fact-specific inquiry as to whether it is difficult for the manufacturer “to definitively establish the identities of the physicians who partake in the food or beverage” (78 Fed. Reg. 9479). Reporting is not required when an applicable manufacturer provides buffet meals, snacks, or coffee in settings where it would be difficult to establish the identity of the physicians who partook in the meal or snack, such as when the food and beverages are made available to all conference attendees. This reporting exception does not apply to meals provided to select attendees at conferences where the sponsoring applicable manufacturer can establish the identity of the attendees that partake in the food or beverage. Key words: Open Payments, Sunshine Act
(FAQ8390)
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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)
- Stock options granted prior to August 1, 2013 are not considered payments or other transfers of value in Open Payments for the data collection period beginning on August 1, 2013 to December 31, 2013. Stock options granted after August 1, 2013 are required to be reported as payments or other transfers of value if provided to a covered recipient. Once the stock option is exercised, causing the physician to become an owner or investor in an applicable manufacturer or applicable group purchasing organization, those investment or ownership interests are required to be reported annually according to the reporting requirements in the Physician Ownership data specification. Key words: Open Payments, Sunshine Act
(FAQ8378)
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Are applicable manufacturers or applicable group purchasing expected to resubmit an entire report with corr...- Applicable manufacturers and applicable group purchasing organizations submitting a report will have the ability to retr... (more)
- Applicable manufacturers and applicable group purchasing organizations submitting a report will have the ability to retract and resubmit an entire report, submit corrections to a group of records, retract a group of records, or append a group of records that were omitted from the original report submission. Applicable manufacturers and applicable group purchasing organizations will have the ability to make corrections and additions after the data submission deadline; however, they may be subject to penalties for submitting data after the deadline. Therefore, applicable manufacturers should register and submit data early to ensure correction activities are completed prior to the deadline. Key words: Open Payments, Sunshine Act
(FAQ8360)
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An entity leases employees to an applicable manufacturer for operational purposes, and continues to pay all...- Yes, the act of an entity leasing employees to an applicable manufacturer that it is also under common ownership with ma... (more)
- Yes, the act of an entity leasing employees to an applicable manufacturer that it is also under common ownership with may constitute assistance and support necessary to consider the entity an applicable manufacturer if the service or services provided by the employees that are leased are necessary or integral to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered drug, device, biological or medical supply. Key words: Open Payments, Sunshine Act
(FAQ9122)
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How should an applicable manufacturer report a payment or other transfer of value provided to a teaching ho...- An applicable manufacturer must report identifiers for a teaching hospital as they appear on the teaching hospital list ... (more)
- An applicable manufacturer must report identifiers for a teaching hospital as they appear on the teaching hospital list provided by CMS. If there are minor discrepancies between the hospital name and/or address in your records anf the hospital name and/or address provided on the teaching hospital list, the information on the teaching hospital list should be used. The reported Taxpayer Identification Number (TIN) must match exactly the TIN provided on the teaching hospital list. If you are submitting a record of a payment or other transfer of value for the 2013 program year, the hospital name in the record must be the name given as the hospital’s “PECOS Legal Business Name” on the 2013 supplemental teaching hospital list. The address to be used for 2013 reporting should be the “NPPES Business Address” that appears in the 2013 supplemental teaching hospital list. For the 2014 program year and all subsequent years, the hospital name in a submitted record must be the name given in the “Hospital Name” field (also known as the “Doing Business As” (DBA) name) on the teaching hospital list, and the address should be the “NPPES Business Address.” When preparing records, you must refer to the teaching hospital list for the year in which you made the payment or other transfer of value. For example, if you are re-submitting a 2013 program year payment record, you must refer to the 2013 reporting cycle teaching hospital list. All teaching hospital lists can be found on the Resources page of the Open Payments website. Key words: Open Payments, Sunshine Act
(FAQ9146)
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Is leasing included in the actions that constitute “assistance or support” to determine if an entity is...- Assistance or support, as defined at 42 C.F.R § 403.902, is conduct that is necessary or integral to the production, pr... (more)
- Assistance or support, as defined at 42 C.F.R § 403.902, is conduct that is necessary or integral to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered product. An example of assistance or support considered necessary or integral, would be an entity that produces the active ingredient for a covered drug, which is then included in the final product. (78 Fed. Reg. 9463) A case-by-case analysis is necessary to determine whether the provision of a leasing device constitutes assistance or support. However, leasing a device may constitute assistance or support if supplying the device would be necessary or integral to the applicable manufacturer who could not produce the product without the leased device. Key words: Open Payments, Sunshine Act
(FAQ8990)
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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)
- Applicable manufacturers must select the nature of payment category that they believe most accurately describes a payment or other transfer of value. 42 C.F.R. § 403.904(e)(2). Therefore, applicable manufacturers must select the nature of payment category that best describes the provision of a medical textbook or journal reprint to a covered recipient. Possible natures of payment applicable to medical textbooks include “education” and “gift,” depending on the circumstances of the transfer of value. The “education” category generally includes payments or other transfers of value that involve the imparting or acquiring of particular knowledge or skills, which can include medical textbooks provided to covered recipients. Key words: Open Payments, Sunshine Act
(FAQ8254)
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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)
Yes, a blood center is considered to be an applicable manufacturer if the blood center operates in the United States and is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply covered by Medicare, Medicaid, or CHIP. Additionally, a blood center is considered to be an applicable manufacturer if the blood center is under common ownership, as defined in 42 CFR 403.902 with an applicable manufacturer, and the blood center provides assistance or support to the applicable manufacturer. Assistance and support provided by the blood center to the entity must pertain to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered drug, device, biological, or medical supply. A covered drug or biological is any drug or biological for which: (1) Payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP), either separately (such as through a fee schedule or formulary) or as part of a bundled payment (such as under a hospital inpatient /outpatient prospective payment system; and (2) Requires a prescription to be dispensed. Key words: Open Payments, Sunshine Act
(FAQ8157)
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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)
- Some payments or other transfers of value are excluded from reporting; however, no exclusion exists for payments or transfers of value that are later reimbursed. Please review 42 C.F.R. §403.904(i)(1) for information on possible exclusions. Key words: Open Payments, Sunshine Act
(FAQ10084)
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Are entities currently in the research and development phase for drugs which, are at the time not approved ...- An applicable manufacturer, as defined by 42 CFR 403.902, is an entity that is engaged in the production, preparation, p... (more)
- An applicable manufacturer, as defined by 42 CFR 403.902, is an entity that is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply, or is under common ownership with an applicable manufacturer and provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered product. A covered drug is any drug for which (1) payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP), either separately (such as through a fee schedule or formulary) or as part of a bundled payment, and (2) requires a prescription to be dispensed. The question of whether you fall within the definition of an “applicable manufacturer” depends in part on whether payment is available for any of your products under Medicare, Medicaid, or CHIP. While most products for which payment is available under these programs will have already received FDA clearance or approval, there are some exceptions. See 78 FR 9465. For that reason, we did not set FDA approval or clearance as a bright line test for determining whether a product is considered to be a “covered” product. If payment is not currently available under Medicare, Medicaid, or CHIP for your product at this time, then you would not be considered an applicable manufacturer for purposes of the reporting requirements; however, if payment is available (for example, under the Medicare Clinical Trial Policy), then you would be considered an applicable manufacturer. Note that the preamble addresses the situation where an entity with no covered products becomes an applicable manufacturer because, for example, its only product receives FDA approval. See 78 FR 9463. In that situation, an entity has a grace period of 180 days following its product becoming “covered” to begin complying with the data collection and reporting requirements. Key words: Open Payments, Sunshine Act
(FAQ8392)
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For purposes of the 90-day exclusion for a loan of a covered device, does the loan begin when an applicable...- The Open Payments reporting exclusion for providing a covered device or device under development for 90 days to permit e... (more)
- The Open Payments reporting exclusion for providing a covered device or device under development for 90 days to permit evaluation of the device or medical supply by the covered recipient begins when an applicable manufacturer provides the covered device to a covered recipient. Key words: Open Payments, Sunshine Act
(FAQ8956)
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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 physicians.... (more)
- This is considered an indirect payment. Applicable manufacturers are required to report indirect payments to physicians. A payment is considered indirect if an applicable manufacturer requires, instructs, directs or otherwise causes the third party to provide the payment in whole or in part to a physician. An indirect payment was made to the physician since the applicable manufacturer requested a certain physician at the clinic perform the services. The payment made to the clinic was ultimately transmitted in part to the physician through the clinic. Key words: Open Payments, Sunshine Act
(FAQ8169)
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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 contribut... (more)
- In accordance with the definition of an indirect payment at 42 C.F.R. §403.902, applicable manufacturers that contribute funding to a CME program with several speakers are required to report the payments provided to physician speakers if they determine that the payments meet the definition of an indirect payment. An indirect payment is defined at 42 C.F.R. §403.902 as a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. Consistent with the CMS Final Rule (CMS-5060-F), there are instances where indirect payments provided by an applicable manufacturer to a CME program are not reportable. In accordance with 42 C.F.R. §403.904(i)(1), indirect payments or other transfers of value are excluded from reporting where the applicable manufacturer is unaware of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. If the payment is a reportable payment, then the amount should be equally divided among the known covered recipient speakers. Keywords: Open Payments, CME, Physician Fee Schedule
(FAQ11600)
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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, that indirectly prov... (more)
- No, applicable manufacturers are not required to report the name of the third party, such as a CRO, that indirectly provides a research payment to a covered recipient. Applicable manufacturers are required to report information regarding the covered recipients that ultimately receive the research payments, as specified in 42 C.F.R § 403.904(f). Key words: Open Payments, Sunshine Act
(FAQ9136)
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Are payments for medical research writing and/or publication included in reporting research payments?- Under Open Payments, a payment reported as research falls within a research payment category if it is subject to either:... (more)
- Under Open Payments, a payment reported as research falls within a research payment category if it is subject to either: 1) a written agreement; 2) a contract; or 3) a research protocol. Payments for medical research writing and/or publication would be included in the research payment, if the activity (here, medical research writing/publication) was included in the written agreement or research protocol and paid as a part of the research payment. Key words: Open Payments, Sunshine Act
(FAQ8159)
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Are applicable manufacturers required to report uncollected payments for a covered device owed by a covered...- Yes, debt forgiveness by an applicable manufacturer for the remaining balance of a covered drug, biological, device or m... (more)
- Yes, debt forgiveness by an applicable manufacturer for the remaining balance of a covered drug, biological, device or medical supply purchased by a covered recipient is considered a payment or transfer of value and reportable for purposes of Open Payments. Key words: Open Payments, Sunshine Act
(FAQ8962)
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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 hospital’s foundation a... (more)
- Yes, if an applicable manufacturer provides a payment or other transfer of value to a teaching hospital’s foundation at the request of or designated on behalf of the teaching hospital covered recipient. An applicable manufacturer will also need to report the donation as a payment or other transfer of value made to a teaching hospital covered recipient if the applicable manufacturer requires, instructs, directs, or otherwise causes the teaching hospital’s foundation to provide the donation, in whole or in part, to the teaching hospital covered recipient. Key words: Open Payments, Sunshine Act
(FAQ9142)
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Are applicable manufacturers required to report meals, travel, lodging, and other similar expenses made in ...- Yes, compensation paid by an applicable manufacturer to a physician for expenses made in connection with interviewing th... (more)
- Yes, compensation paid by an applicable manufacturer to a physician for expenses made in connection with interviewing the physician for possible employment is considered a reportable payment or other transfer of value. Key words: Open payments, Sunshine Act
(FAQ8260)
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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)
- The teaching hospital list compiled by CMS is a complete list of teaching hospital covered recipients. Applicable manufacturers and applicable group purchasing organizations should collect the TIN from a hospital, or in this case, dental school, that they believe is affiliated with a teaching hospital in order to correctly identify the teaching hospital’s name and address from the list. Additionally, as discussed in the proposed and final rule, a teaching hospital is any institution that received payments under sections 1886(d)(5)(B), 1886(h) or 1886(s) of the Act. Key words: Open Payments, Sunshine Act
(FAQ9002)
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The definition of an applicable manufacturer excludes distributors or wholesalers that do not hold title to...- A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and ... (more)
- A distributor holds title to products once it takes ownership of a particular inventory of products from the seller and possesses the right to re-sell the inventory of the products that it has purchased. Holding title to a covered product in this context is distinct from holding FDA approval, licensure or clearance for a covered product. Distributors and wholesalers (which include repackagers, relabelers, and kit assemblers) that hold title to a covered drug, device, biological or medical supply meets the definition of an applicable manufacturer. Distributors and wholesalers that do not hold title of a covered product will not be subject to the reporting requirements, unless they are under common ownership with an applicable manufacturer and provide assistance or support with respect to a covered drug, device, biological, or medical supply. Key words: Open Payments, Sunshine Act
(FAQ8151)
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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 report physician identif... (more)
- Applicable manufacturers and applicable group purchasing organizations (GPOs) are encouraged to report physician identifiers exactly as they are listed on the latest available Validated Physician List (VPL) to avoid any matching errors. The VPL contains information from the NPPES System as well as other CMS data sources in order to accurately identify physicians that are subject to Open Payments reporting. Please note, however, that physicians not listed on the VPL may still be considered covered recipients under the Open Payments program. If the reporting entity believes that a physician who is not listed on the VPL meets the definition of a covered recipient, they are responsible for reporting any covered payments made to such physician using the best available information to identify them. The VPL contains only information on physicians with a National Provider Identifier (NPI) who have been reported on in the Open Payments system; it is not an exhaustive list of all physicians who should be included in Open Payments reporting. In the event that the information presented on the VPL differs from information in NPPES, reporting entities may use the information from the VPL. This list can only be accessed within the Open Payments system, on the “Payments Overview” page on the “Submissions” tab. Key words: Open Payments, Sunshine Act
(FAQ9128)
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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)
- No. A teaching hospital covered recipient for the purposes of Open Payments is defined at 42 C.F.R. § 403.902 as any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Social Security Act during the last calendar year for which such information is available. The teaching hospital list posted at http://go.cms.gov/openpayments is the final list of all teaching hospital covered recipients for the purposes of Open Payments for the reporting year specified on the list, and the list will be refreshed every year. Key words: Open Payments, Sunshine Act
(FAQ9144)
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What is the relationship between Open Payments and the Federal Anti-Kickback statute, False Claims Act or s...- Compliance with Open Payments reporting requirements does not exempt applicable manufacturers, applicable group purchasi... (more)
- Compliance with Open Payments reporting requirements does not exempt applicable manufacturers, applicable group purchasing organizations, covered recipients, physician owners or investors, immediate family members, other entities, and other persons from any potential liability associated with payments or other transfers of value, or ownership or investment interests under the Federal Anti-Kickback statute, False Claims Act or similar laws. As noted in the preamble of the rule, however, the inclusion of a payment or other transfer of value or ownership or investment interest in Open Payments is not, by itself, an indicator of wrongdoing or illegal conduct. Key Words: Open Payments, Sunshine Act
(FAQ8384)
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What value should an applicable manufacturer assign to clinical study drugs that are provided to principal ...- Applicable manufacturers are not required to assign a specific value to clinical study drugs that are provided to princi... (more)
- Applicable manufacturers are not required to assign a specific value to clinical study drugs that are provided to principal investigators, rather applicable manufacturers should report the total amount of the research payment, including all research-related costs for activities outlined in a written agreement, research protocol or both, as specified in 42 C.F.R. § 403.904(f)(1)(ii). Key words: Open Payments, Sunshine Act
(FAQ9118)
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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 developme... (more)
- Publication of a payment or other transfer of value is delayed when made in connection with (1) research on or development of a new drug, device, biological, or medical supply, or a new application of an existing drug, device, biological, or medical supply; or (2) clinical investigations regarding a new drug, device, biological, or medical supply. An applicable manufacturer must indicate on its research report to CMS whether a payment or other transfer of value is eligible for a delay in publication. The absence of this indication in the report will result in CMS posting all payments publicly. If this indication is made, the publication of the payment will be delayed in accordance with 42 C.F.R. §403.910. CMS will not send publication delay approval to the applicable manufacturer. Key words: Open Payments, Sunshine Act
(FAQ10080)
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Because the National Plan and Provider Enumeration System (NPPES) data may be updated by physicians on an o...- Applicable manufactures and GPOs should reference the Validated Physician List (VPL) first. This list can only be access... (more)
- Applicable manufactures and GPOs should reference the Validated Physician List (VPL) first. This list can only be accessed within the Open Payments system on the “Payments Overview” page under the “Submissions” tab. Physicians who do not appear on the VPL may still be successfully matched. Applicable manufacturers and GPOs should check NPPES for NPI information on physicians not included on the VPL. If applicable manufacturers and GPOs still cannot find physicians’ information, they should contact those physicians directly. Key words: Open Payments, Sunshine Act
(FAQ10094)
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Is an applicable manufacturer required to report payments provided to a physician covered recipient for a c...- No, legal proceedings that require physician involvements are excluded, including, legal defense, prosecutions, settleme... (more)
- No, legal proceedings that require physician involvements are excluded, including, legal defense, prosecutions, settlement or judgment of a civil or criminal action and arbitration or other legal action. Key words: Open Payments, Sunshine Act
(FAQ9120)
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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 hospital exceed the aggr... (more)
- Yes. To determine if small payments or other transfers of value made to a physician or teaching hospital exceed the aggregate threshold and must be reported, applicable manufacturers and applicable GPOs must combine all payments made across the multiple nature of payment categories. For example, if an applicable manufacturer or applicable GPO made payments to a physician for: (1) six hot dog lunches for $9 each, (2) three cab fares for $9 each, and (3) three sporting event tickets for $9 each, the total payment amount would be calculated to be $108 and all of these payments must be reported. Key words: Open Payments, Sunshine Act
(FAQ8364)
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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 position (e.g., 9999-999... (more)
- NDCs must be reported in the standard 10-digit NDC format with dashes placed in the appropriate position (e.g., 9999-9999-99, 99999-999-99, or 99999-9999-9). The unique NDCs must be reported for each record and must match the number and order of named drugs or biologicals associated with the record. If no NDC exists for any named drug or biological (for example, if the product is in pre-market trial stages), the NDC field may be left blank. Key words: Open Payments, Sunshine Act
(FAQ9116)
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Are independent sales representatives that are responsible for taking product orders from covered recipient...- Independent sales representatives are only required to report payments or other transfers of value provided to covered r... (more)
- Independent sales representatives are only required to report payments or other transfers of value provided to covered recipients or physician owners or investors if they meet the definition of an applicable manufacturer, as defined by 42 C.F.R § 403.902 or if they are under common ownership with an applicable manufacturer and provide assistance and support to such applicable manufacturer with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale or distribution of a covered drug, device, biological or medical supply. However, applicable manufacturers requiring, instructing, directing or otherwise causing independent sales representatives to provide payments or other transfers of value, in whole or in part, to a covered recipient or physician owner or investor, known as indirect payments defined at § 403.902, are required to be reported by the applicable manufacturer. Key words: Open Payments, Sunshine Act
(FAQ9126)
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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)
First level of data validation: This happens immediately, when the submitter uploads a file into the system. The first level of validation is at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system). You will receive immediate feedback via an on-screen message letting you know the file upload was not successful. If the file level checks are successful, the process will move to the second level of validation.
Second level of data validation: For small data files, this second level of automated validation can happen in seconds. Larger data files could take up to several hours to validate. Once the data files are uploaded, the Open Payments system validates each individual record to ensure the data elements are in the proper format, and checks them against the specifications described in the Data Submission Mapping Document. The Error Code File Document serves as the “go-to” reference for errors made during the data submission process. In the event an error is found in a data file uploaded to the Open Payments system, an error code will be displayed in the system-generated error report. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
Following successful data validation, the file is ready for Final Submission. After Final Submission, the Open Payments system will search to match each submitted record to a valid physician or teaching hospital. This matching process may take up to several days, and timing will vary based upon the size of the data files.
Key words: Open Payments, Sunshine Act
(FAQ10110)
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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 publication. Key words: ... (more)
- Data publication is on June 30. CMS will also refresh the data once annually, after the initial publication. Key words: Open Payments, Sunshine Act
(FAQ12380)
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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)
- The research nature of payment category was removed from the general data specification because all payments or other transfers of value made in connection with an activity that meets the definition of research, as defined at 42 C.F.R § 403.902, are required to be reported using the research data specification according to § 403.904(f). As discussed in the preamble to the final rule research-related payments, which do not meet the definition of research, should be reported using the other nature of payment categories available. (42 Fed Reg. 9482) Key words: Open Payments, Sunshine Act
(FAQ9130)
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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)
- Yes, if the applicable manufacturer requires, instructs, directs, or otherwise causes the distributor to provide the payment or transfer of value, in whole or in part, to a covered recipient or a physician owner or investor. Key words: Open Payments, Sunshine Act
(FAQ8976)
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If an applicable manufacturer makes a payment or transfer of value to a group practice rather than a specif...- A payment or other transfer of value provided to a group practice (or multiple covered recipients generally) should be a... (more)
- A payment or other transfer of value provided to a group practice (or multiple covered recipients generally) should be attributed to each individual physician covered recipient who requested the payment, on whose behalf the payment was made, or who are intended to benefit from the payment or other transfer of value. Payments or other transfers of value do not necessarily need to be reported in the name of all members of a practice, rather, applicable manufacturers should divide payments or other transfers of value in a manner that most fairly represents the situation. For example, many payments or other transfers of value may need to be divided evenly, others may need to be divided in a different manner to represent who requested the payment, on whose behalf the payment was made, or who was intended to benefit from the payment or other transfer of value. Key words: Open Payments, Sunshine Act
(FAQ8167)
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Are tax and payments for shipping and handling including in calculating value for a payment or other transf...- Yes, tax and payments for shipping and handling are included in the total payment or other transfer of value for Open Pa... (more)
- Yes, tax and payments for shipping and handling are included in the total payment or other transfer of value for Open Payments. Key words: Open Payments, Sunshine Act
(FAQ8964)
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With respect to the 90-day supplies of single-use/disposable evaluation products that are exempted from rep...- The 90-day supply should be calculated for exclusion purposes not on a per-patient basis but rather on a per-covered rec... (more)
- The 90-day supply should be calculated for exclusion purposes not on a per-patient basis but rather on a per-covered recipient usage basis regardless of the number of patients that are treated during that 90-day period. The Open Payments reporting exclusion for providing a 90-day supply of single-use/disposable devices for the purpose of enabling covered recipients to evaluate the items is limited to the aggregate supply that covered recipients would be expected to use during 90 days of average use. Key words: Open Payments, Sunshine Act
(FAQ8358)
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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 or indirectly throu... (more)
- Yes, a promotional newsletter provided to a physician by an applicable manufacturer (either directly or indirectly through an advertising agency) is considered a reportable transfer of value for purposes of Open Payments if the promotional newsletter is valued at the aggregated threshold or more, or if the aggregate amount of payments and transfers of value provided to a covered recipient exceeds the aggregated threshold in a calendar year (see CMS website for current key reporting thresholds). Applicable manufacturers or applicable GPOs must select the “nature of payment” category that best describes the provision of the newsletter to a covered recipient (42 C.F.R. § 403.904(e)(2)). Key words: Open Payments, Sunshine Act
(FAQ8966)
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If a covered recipient does not accept an offered payment or other transfer of value from an applicable man...- The applicable manufacturer should report the payment or other transfer of value under the name of the covered recipient... (more)
- The applicable manufacturer should report the payment or other transfer of value under the name of the covered recipient who accepted the payment or other transfer of value. Key words: Open Payments, Sunshine Act
(FAQ8262)
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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, oth... (more)
- This is the second reporting cycle for Open Payments, and first full calendar year of reporting. It covers payments, other transfers of value made to physicians and teaching hospitals, and ownership or investment interests held by physicians (or their immediate family members) in applicable manufacturers and applicable group purchasing organizations (GPOs) throughout the entire 2014 calendar year. This reporting cycle also publishes a group of 2013 records with all relevant recipients included; these select 2013 records were previously only available in their de-identified form. Key words: Open Payments, Sunshine Act
(FAQ12360)
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What should distributors, which offer a multitude of covered and non-covered products, report in the Produc...- Distributors that are considered applicable manufacturers because they hold title to a covered drug, device, biological ... (more)
- Distributors that are considered applicable manufacturers because they hold title to a covered drug, device, biological or medical supply may report “None” in the Product Indicator indicating that the payment or other transfer of value was not associated with any covered drugs, device, biological or medical supply if the payment or other transfer of value was related to the distributor’s full line of products, rather than any specific covered products. Key words: Open Payments, Sunshine Act
(FAQ8980)
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Do applicable manufacturers and group purchasing organizations (GPOs) need to report National Provider Iden...- No. Applicable manufacturers and GPOs are only required to provide a NPIs for physician covered recipients (if the physi... (more)
- No. Applicable manufacturers and GPOs are only required to provide a NPIs for physician covered recipients (if the physician has an NPI). Key words: Open Payments, Sunshine Act
(FAQ10082)
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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 products becomes subjec... (more)
- When an applicable manufacturer or applicable GPO that did not previously have any other covered products becomes subject to the Open Payments data collection and reporting requirements, they will be granted a grace period of 180 days following a product becoming ‘‘covered’’ to begin complying with the data collection and reporting requirements. Therefore, retroactive reporting is not required. Key words: Open Payments, Sunshine Act
(FAQ9124)
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What resources should applicable manufacturers and applicable group purchasing organizations (GPOs) use to ...- Applicable manufacturers and applicable GPOs should obtain the Validated Physician List (VPL), which is available for do... (more)
- Applicable manufacturers and applicable GPOs should obtain the Validated Physician List (VPL), which is available for download in the Open Payments system to registered and successfully vetted applicable manufacturers and GPOs. The VPL contains information from NPPES and other CMS data sources to accurately identify physicians that are subject to Open Payments reporting. Applicable manufacturers and GPOs are encouraged to report physician identifiers exactly as they are listed on the latest available VPL to avoid any matching errors. The VPL can only be accessed within the Open Payments system, on the “Payments Overview” page on the “Submissions” tab. Please note, however, that the VPL is not an exhaustive list of all physicians who are subject to Open Payments reporting, and therefore physicians not listed on the VPL may still be considered covered recipients or physician owners or investors under the Open Payments program. If the applicable manufacturer or applicable GPO believes that a physician who is not listed on the VPL meets the definition of a covered recipient or physician owner or investor, they are responsible for reporting the best information that the applicable manufacturer or applicable GPO has available to identify the physician. Key words: Open Payments, Sunshine Act
(FAQ8994)
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How should applicable manufacturers and applicable group purchasing organizations report transfer royalties...- Transfer royalties are reportable payments or other transfer of value for Open Payments. Transfer royalties are required... (more)
- Transfer royalties are reportable payments or other transfer of value for Open Payments. Transfer royalties are required to be reported using the general payment data specification. The appropriate “nature of payment” category for the payment or transfer of value would be “royalty or license.” The value of a transfer royalty should reflect the cost of the intellectual property that an applicable manufacturer or applicable group purchasing organization would pay to acquire the intellectual property from a covered recipient. Key words: Open Payments, Sunshine Act
(FAQ8970)
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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 uses o... (more)
- Yes. The Open Payments final rule provides that some research payments related to new product development, or new uses of an existing product, may be granted a delay in publication for up to four years, or until Food and Drug Administration (FDA) approval is received. Key words: Open Payments, Sunshine Act
(FAQ12374)
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Is a textbook donation to a medical center library for the general use of all employees reportable? - The textbook donation would be considered a reportable event if: 1) The medical center library is part of a teaching hos... (more)
- The textbook donation would be considered a reportable event if: 1) The medical center library is part of a teaching hospital; or 2) The donation was an indirect payment or transfer of value to a designated physician or group of physicians. Payments or other transfers of value provided to a third party at the request of or designated by the applicable manufacturer on behalf of a covered recipient, must be reported in the name of the covered recipient, as well as the name of the entity that received the payment at the covered recipient’s request or designated on the covered recipient’s behalf according to 42 C.F.R. § 403.904(c)(10). Additionally, an indirect payment, defined at § 403.902, is a payment or other transfer of value made by an applicable manufacturer to a covered recipient through a third party, where the applicable manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient. However, CMS does not believe that a payment that ultimately is passed on to a covered recipient has to be reported if the applicable manufacturer “did not intend or expect that a covered recipient would receive any portion of the payment or other transfer of value.” (78 Fed. Reg. 9489). Key words: Open Payments, Sunshine Act
(FAQ8986)
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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 Resubmissi... (more)
- After making corrections to the records to be resubmitted, indicate a record is a resubmission by setting the Resubmission Indicator to "Y," and include the original Payment Record ID in the "Resubmitted Payment Record ID" field. Then upload the file to the system as with any other bulk file upload, including the original Payment Record ID. You may also correct and re-submit data using the Graphic User Interface (instead of bulk file upload) if the number of records to be re-submitted is small. You must correct and resubmit corrected records for all records that failed. Records with no errors do not need to be resubmitted. You may also delete your entire original submission from the Open Payments system and replace it with a new submission if you prefer. Key words: Open Payments, Sunshine Act
(FAQ10118)
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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 Revi... (more)
- If you see a record published in the Open Payments public data and attributed to you, but you do not see it on your Review and Dispute page in the Open Payments system, that indicates that the record was available for your review in a prior calendar year and is no longer available for review. Records are only made available for review and dispute in the calendar year that they were submitted and attested to. For example, if a reporting entity submitted and attested to a record during the submission window in calendar year 2014, the covered recipient has until December 31, 2014 to review and, if necessary, initiate a dispute on the payment or transfer of value. After the end of the calendar year in which the record was submitted, if you do not see the record on your Review and Dispute page in the Open Payments system but have a concern about the data, you will need to reach out to the reporting entity directly to resolve the dispute. In the event that a reporting entity makes edits to a published record, the covered recipient will have an opportunity to review the edits made on the Review and Dispute page within the Open Payments system, and initiate a dispute if needed. Key words: Open Payments, Sunshine Act
(FAQ12208)
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Are Federal, state, and local taxes withheld from a physician owner or investor considered reportable payme...- No, Federal, state, and local taxes withheld from a physician owner or investor are not considered reportable payments o... (more)
- No, Federal, state, and local taxes withheld from a physician owner or investor are not considered reportable payments or other transfer of value. Key words: Open Payments, Sunshine Act
(FAQ9134)
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Is there a methodology guide available providing technical details about the published data?- Yes, the Methodology Overv... (more)
- Yes, the Methodology Overview & Data Dictionary explains all of the technical specifications of the published data. Key words: Open Payments, Sunshine Act
(FAQ12386)
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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 foll... (more)
- Yes. “Immediate family member” is defined in the implementing regulations at 42 C.F.R. § 403.902 as any of the following: (1) Spouse; (2) Natural or adoptive parent, child, or sibling; (3) Stepparent, stepchild, stepbrother, or stepsister; (4) Father-, mother-, daughter-, son-, brother-, or sister-in-law; (5) Grandparent or grandchild; (6) Spouse of a grandparent or grandchild. The term “spouse” is gender-neutral, and is properly read to include lawfully married spouses, including same-sex spouses. In United States v. Windsor, 570 U.S. __, 113 S. Ct. 2675 (2013), the Supreme Court ruled that section 3 of the Defense of Marriage Act, which had defined marriage for federal purposes as between opposite sex spouses, is unconstitutional. In light of this decision, the Department has instituted a policy of treating same-sex marriages on the same terms as opposite-sex marriages to the greatest extent reasonably possible. This FAQ clarifies Windsor’s application to the requirement to report physician ownership under section 1128(G)(a)(2) of the SSA. For purposes of this reporting requirement, the same-sex spouse of a physician and the family members that result from same-sex marriages are considered “immediate family members” if the marriage was celebrated in a state or other jurisdiction, whether foreign or domestic, that permitted the marriage under its laws, or if the states(s) or other jurisdiction(s) where the couple lives recognizes the marriage as a legally valid marriage. Key words: Open Payments, Sunshine Act
(FAQ10014)
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When submitting a consolidated report for separate applicable manufacturers and group purchasing organizati...- No. The attester submitting a consolidated report is required to hold an Officer position only within the entity that is... (more)
- No. The attester submitting a consolidated report is required to hold an Officer position only within the entity that is submitting the consolidated report. The attester is not required to hold an Officer position in the other entities included in the consolidated report. Key words: Open Payments, Sunshine Act
(FAQ10074)
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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)
Payment records may be delayed in publication if the payment or other transfer of value is related to:
- Research or development of a new drug, device, biological, or medical supply;
- Research or development of a new application of an existing drug, device, biological, or medical supply; or
- Clinical investigations regarding a new drug, device, biological, or medical supply.
Payment records can be delayed in publication for up to four years after the date of payment. The request for a delay must be renewed each year. If this request is not renewed each year by the end of the data submission period, the record will automatically be flagged for publication in the next publication cycle.
For instructions on re-newing a record’s delay in publication status, refer to the Open Payments System Quick Reference Guide: Payment Category Page and Delay in Publication located on the Resources page of the Open Payments website.
Keywords: Open Payments, Sunshine Act
(FAQ11972)
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In what formats is the data presented?- CMS delivers Open Payments data in a number of ways to accommodate different users and their interests:
&nbs... (more)
CMS delivers Open Payments data in a number of ways to accommodate different users and their interests:
Search Tool: Site visitors can get immediate results using this standard search interface to find detailed information on individual physicians, teaching hospitals, or companies making payments. Data Explorer: Users can select a dataset then customize the view using filters, sorts, and other actions to create their own, targeted views of the data and visualizations such as charts and graphs.
Data downloads: Users can download the data in comma-separated values (.csv) format, which allows users to open and explore the data using their own software on their own computer. With this option, the user must have robust data viewing software that allows for downloading and viewing data in large datasets.
Key words: Open Payments, Sunshine Act
(FAQ12362)
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Is an applicable manufacturer required to report all taxonomy codes for a physician or just the primary tax...- Applicable manufacturers will report only one taxonomy code per physician. Additionally, applicable manufacturers may us... (more)
- Applicable manufacturers will report only one taxonomy code per physician. Additionally, applicable manufacturers may use their internal data to determine a physician’s taxonomy code. However, the National Plan Provider Enumeration System provider taxonomy code list should be used as the list of accepted specialties. Key words: Open Payments, Sunshine Act
(FAQ9148)
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Are research payments provided to a Military Medical Center that is not a teaching hospital covered recipie...- Yes, for research payments, the reporting entity must provide the name of the research institution, individual or entity... (more)
- Yes, for research payments, the reporting entity must provide the name of the research institution, individual or entity receiving the payment or other transfer of value as outlined in §403.904(f). If the Military Medical Center receives a research-related payment or other transfer of value, which is ultimately paid in whole or in part to a covered recipient (physician or teaching hospital), it must report information on the payment as indicated at § 403.904(f)(1)(i)(C). Key words: Open Payments, Sunshine Act
(FAQ8998)
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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 sing... (more)
- Applicable manufacturers have the flexibility to report payments made over multiple dates either separately or as a single line item for the first payment date. In addition, CMS will allow flexibility for what specific date to report for a nature of payment category. For more information, please review 78 FR 9473. Applicable manufacturers must provide the date of payment or other transfer of value. If the payment or other transfer of value is a series of payments (e.g., a consulting fee that is paid every month for three months) or an aggregated set of payments, applicable manufacturers should report the date of the first payment or other transfer of value. Key words: Open Payments, Sunshine Act
(FAQ10086)
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When calculating number of payments a doctor received, should users count entries (rows) or tally the numbe...- Each row indicates one payment, transfer of value, or ownership amount per doctor; counting rows should provide the tota... (more)
- Each row indicates one payment, transfer of value, or ownership amount per doctor; counting rows should provide the total number of payments. Key words: Open Payments, Sunshine Act
(FAQ12368)
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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 data is updated and then ... (more)
- Once the dispute is initiated, it can be resolved in one of three ways: 1. Resolved - Disputed data is updated and then resubmitted and re-attested to by the applicable manufacturer or GPO. 2. Resolved, no change - Indicates that both the applicable manufacturer or GPO discussed the dispute with the physician or teaching hospital, and both parties determined that no change in the data was necessary. Physicians and teaching hospitals can initiate a new dispute if they disagree with the “resolved, no change” status. 3. Withdrawn – A physician or teaching hospital can remove a dispute opened on a record.
(FAQ12388)
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Is a meeting a reportable event if an applicable manufacturer located in the United States conducts the mee...- Yes. Any payments or other transfers of value provided by an applicable manufacturer to covered recipients (or physician... (more)
- Yes. Any payments or other transfers of value provided by an applicable manufacturer to covered recipients (or physician owners or investors), wherever made, are required to be reported. Key words: Open Payments, Sunshine Act
(FAQ9150)
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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 official attestation is received. All dat... (more)
- Reporting under the Open Payments program is not considered complete until the official attestation is received. All data for the program year must be submitted and attested to by the 90th day of the following calendar year. Any data submitted after this time will be not be posted publicly until the next data publication and will be considered late. Applicable manufacturers and GPOs that submit late data may be subject to civil monetary penalties for noncompliance with program requirements.. Key words: Open Payments, Sunshine Act
(FAQ10126)
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Why am I receiving a "Failed Matching Validation" message for payment records that were accepted last year?- Payment records that were successfully matched in 2014 may now appear as "Failed Matching Validation" in 2015 because al... (more)
- Payment records that were successfully matched in 2014 may now appear as "Failed Matching Validation" in 2015 because all records are now subject to a more stringent matching process that was implemented in early 2015. These records will need to be reviewed and corrected. For additional guidance, refer to the Open Payments System Quick Reference Guide: Identifying and Correcting Validation and Matching Errors located on the Resources page of the Open Payments website. After consulting this resource, if you are having trouble moving your records out of "Failed Matching Validation" status, contact the CMS Open Payments Help Desk at openpayments@cms.hhs.gov or 1-855-326-8366 for assistance. Keywords: Open Payments, Sunshine Act
(FAQ11970)
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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 of two or more indivi... (more)
- Regarding the definition of “applicable group purchasing organization,” a ‘group’ consists of two or more individuals and/or entities. Key words: Open Payments, Sunshine Act
(FAQ8368)
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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)
- The short term loan exclusion to permit evaluation of the device or medical supply by the covered recipient applies on a per-covered recipient basis. Therefore, if a manufacturer loans a medical device (whether the same device or not) to different teaching hospital recipients, each for a period of 90 days or less, each loan would be eligible for the exclusion in 42 C.F.R. 403.904(i)(5). Key words: Open Payments, Sunshine Act
(FAQ8958)
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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 data publication. These... (more)
- Any disputes initiated after review and dispute period ends will not be reflected in the June 30 data publication. These disputes and any subsequent correction to those data will be reflected in the next data refresh. Key words: Open Payments, Sunshine Act
(FAQ12378)
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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 during each program... (more)
- CMS provides stakeholders the opportunity to submit feedback on the Open Payments program and system during each program year. CMS takes this feedback into consideration when making system and data display enhancements. CMS also meets with various program stakeholders regularly throughout the program year to collect feedback on how to improve consumer-friendliness, and CMS monitors and tests the Open Payments system for consumer usefulness and ease of navigation. Key words: Open Payments, Sunshine Act
(FAQ12394)
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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)
A request for a delay in publication must be renewed each year. So, if the record was previously submitted in a prior year and the request is not renewed each year by the end of the data submission period, the record will automatically be flagged for publication in the next publication cycle. That means the user doesn’t have to do anything to remove the delay in publication request.
However, if the previously submitted record was submitted in the current reporting year, follow the instructions in the Open Payments System Quick Reference Guide: Payment Category Page and Delay in Publication located on the Resources page of the Open Payments website.
Keywords: Open Payments, Sunshine Act
(FAQ11974)
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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 meth... (more)
- Data can be submitted to CMS through the Open Payments system via two data submission methods. The first submission method is bulk data file upload via CSV or ZIP file. The second submission method is manual submission through the Graphical User Interface. Key words: Open Payments, Sunshine Act
(FAQ10102)
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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)
- Applicable manufacturers and applicable group purchasing organizations need to register with CMS in order to submit data. Personnel representing applicable manufacturers and applicable group purchasing organizations should be prepared to provide information necessary to identify themselves and establish their roles (both within the Open Payments System and the organizations they represent). This data includes, for example, the name of the primary point of contact, the name of the secondary point of contact, and the name of the individual that will attest to the accuracy of the data submitted. Additional guidance regarding the registration process is forthcoming. Key words: Open Payments, Sunshine Act
(FAQ8145)
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What happens if an applicable manufacturer or group purchasing organization (GPO) does not renew a record�...- A request for a delay in publication must be renewed each year by the end of the data submission period. If this request... (more)
- A request for a delay in publication must be renewed each year by the end of the data submission period. If this request is not renewed within this timeframe, the record will automatically be flagged for publication in the next publication cycle. For example, Program Year 2015 records that were not published on June 30, 2016 due to a publication delay request will be published on June 30, 2017 unless the delay in publication request is renewed by the end of the data submission window. Key words: Open Payments, Sunshine Act
(FAQ11968)
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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)
The first level of validation is at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system). You will receive immediate feedback via an on-screen message letting you know the file upload was successful or not successful. If the file level checks are successful, the process will move to the second level of validation, which will be the record level check. The second level of validation includes data validation performed on data elements as they are reviewed against the specifications described in the Data Submission Mapping Document. The Error Code File Document serves as the “go-to” reference for errors made during the data submission process. In the event an error is found in a data file uploaded to the Open Payments system, an error code will be displayed in the system-generated error report. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error. Following successful data validation, the file is ready for Final Submission. After Final Submission, the Open Payments system will search to match each submitted record to a valid physician or teaching hospital.
Key words: Open Payments, Sunshine Act
(FAQ10108)
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Do physicians and teaching hospitals have a chance to review the financial data reported about them?- Yes. During the 45-day physician and teaching hospital review and dispute period, the dollar values and information abou... (more)
- Yes. During the 45-day physician and teaching hospital review and dispute period, the dollar values and information about each transaction listed are available for review by doctors and teaching hospitals registered in the Open Payments system. They can confirm the information as correct or pursue corrections, via the dispute option, to remove, clarify, or adjust the information that had been attributed to them. This required 45-day review and dispute process affords the opportunity for physicians and teaching hospitals to review and dispute any data they feel is inaccurate or incomplete. Key words: Open Payments, Sunshine Act
(FAQ12376)
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Why does the Open Payments data change over time?- Current data publications include a refreshed publication of all records from previous program years. This refresh inclu... (more)
- Current data publications include a refreshed publication of all records from previous program years. This refresh includes records that were not included in previous publications of that year’s data due to the delay in publication flag not being renewed or has expired, revisions, deletions, and additions resulting from data dispute resolution and other data maintenance. These data updates are reflected in the most current data publication, along with all unedited records previously published. Key words: Open Payments, Sunshine Act
(FAQ12304)
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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)
It depends on the level of data error that is discovered:
If the error is at the file level (i.e., the file is in incorrect format, or does not adhere to the accepted schema - headings are wrong, incorrect number of data elements, etc.), then the entire data submission will be rejected and needs to be re-submitted after it is re-formatted.
However, if the error is found in an individual record, only the record(s) containing errors need to be re-submitted.
Applicable manufacturers and applicable GPOs will be notified via onscreen text of file level errors; they will be notified via email of record level data validation errors. The email will direct the user to the system-generated error report available in the Open Payments system, which will provide a list of all errors the submission has generated and error codes that explain the source of the errors. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error. Key words: Open Payments, Sunshine Act
(FAQ10114)
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Are all applicable manufacturers and applicable group purchasing organizations required to register for Ope...- No, only applicable manufacturers and applicable group purchasing organizations that have reportable payments or other t... (more)
- No, only applicable manufacturers and applicable group purchasing organizations that have reportable payments or other transfers of value, ownership or investment interest, or both are required to register. Key words: Open Payments, Sunshine Act
(FAQ9138)
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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 manufacturer or applicable G... (more)
When reporting that a physician has an ownership or investment interest in an applicable manufacturer or applicable GPO, this information must be reported in two fields: (1) “Dollar Amount Invested” and (2) “Value of Ownership or Investment Interest.” “Dollar Amount Invested” is defined as the total amount (in US dollars) of the ownership interest in the applicable manufacturer or applicable GPO that was gained by the physician (or the physician’s immediate family members) during the reporting year only. “Value of Ownership or Investment Interest” is defined as the cumulative value (in US dollars) of ownership or investment interest in the applicable manufacturer or applicable GPO that is held by the physician (or the physician’s immediate family members) as of the most recent feasible valuation date preceding the reporting date. Key Words: Sunshine Act, Open Payments
(FAQ18289)
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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. Applicabl... (more)
- No, the Open Payments system will not accept a negative value for a payment or other transfer of value amount. Applicable manufacturers and applicable GPOs are responsible for submitting corrected information regarding their annual report in accordance with 42 C.F.R. § 403.908(h)(1). Key words: Open Payments, Sunshine Act
(FAQ10054)
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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 Op... (more)
- If a company meeting the definition of an applicable manufacturer dissolves, it is still responsible for reporting in Open Payments for the period when it was an applicable manufacturer. For example, if Company A meets the definition of an applicable manufacturer and is purchased by Company B, then Company A is responsible for reporting in Open Payments for the period prior to the purchase. However, if Company B meets the definition of an applicable manufacturer upon the purchase of Company A, it too is responsible for reporting in Open Payments beginning with the date of the purchase. Key words: Open Payments, Sunshine Act
(FAQ10076)
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Is CMS planning to provide any type of data summary sheets?- CMS is providing summary graphics of key data points on h... (more)
- CMS is providing summary graphics of key data points on https://openpaymentsdata.cms.gov/. This new data dashboard will also be available in printable format. Besides that, CMS is not providing any other summary presentations of the data. The data is publically accessible and available for consumers and researchers to extract as they see fit. Key words: Open Payments, Sunshine Act
(FAQ12364)
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Is a manufacturer of dental alloys considered an applicable manufacturer for purposes of Open Payments? Are...- A manufacturer of dental alloys is considered an applicable manufacturer, as defined by 42 C.F.R § 403.902, if it is an... (more)
- A manufacturer of dental alloys is considered an applicable manufacturer, as defined by 42 C.F.R § 403.902, if it is an entity that is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (prong 1 of the definition). Additionally, a manufacturer of dental alloys is considered an applicable manufacturer if all of the following criteria are met: the manufacturer of dental alloys provides assistance or support to an entity that meets prong 1 of the definition of an applicable manufacturer of a covered drug, device, biological, or medical supply; the manufacturer of dental alloys and the entity are under “common ownership” (as defined in 42 C.F.R. § 403.902); and the manufacturer of dental alloys’ act of providing alloys to the entity constitutes “assistance or support” to the entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological or medical supply. The final rule defines assistance or support as being necessary or integral to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered product. As an example of assistance or support that would be considered necessary or integral, the preamble mentions an entity that produces the active ingredient for a covered drug, which is then included in the final product. (78 Fed. Reg. 9463.) It seems likely that a manufacturer of dental alloys under common ownership with an applicable manufacturer, which provides alloys that is included in the final product, would be considered to be providing necessary and integral support with respect to the production of that product. Similar to the example in the preamble, supplying alloys would be necessary or integral since the applicable manufacturer could not produce the product without it. Key words: Open Payments, Sunshine Act
(FAQ8978)
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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)
- Covered recipients and physician owners or investors may initiate disputes at any time after the 45 day review and correction period begins, but before the end of the calendar year. Note that any changes resulting from disputes initiated after the 45 day review period may not be made until the next time the data is refreshed. If a dispute is not resolved by 15 days after the end of the 45 day period, we will report the applicable manufacturer or applicable GPO’s version of the payment or other transfer of value (or ownership or investment interest), but will mark it as disputed. Key words: Open Payments, Sunshine Act
(FAQ8268)
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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 words: Op... (more)
- This is an optional field, but providing your social security number can facilitate identity verification. Key words: Open Payments, Sunshine Act
(FAQ9724)
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Do covered recipients have two years from the date the review and correction period begins to initiate a di...- No, covered recipients have only until the end of the calendar year to initiate a dispute. (42 CFR 403.908(g)(3)(v)) For... (more)
- No, covered recipients have only until the end of the calendar year to initiate a dispute. (42 CFR 403.908(g)(3)(v)) For example, if an applicable manufacturer reports to CMS on March 31, 2014 all reportable payments or other transfers it provided to covered recipients during the previous year, covered recipients only have until December 31, 2014 to initiate a dispute. Key words: Open Payments, Sunshine Act
(FAQ8362)
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How does a covered recipient complete the review and dispute process?- Physicians and teaching hospitals are able to initiate disputes through the Open Payments system during the review and d... (more)
- Physicians and teaching hospitals are able to initiate disputes through the Open Payments system during the review and dispute period, which follows the data submission period each program year. Applicable manufacturers and group purchasing organizations (GPOs) are able to review disputed records and take action to correct the records and resolve any issues directly with physicians and teaching hospitals. Any discussions pertaining to the resolution of a disputed record must take place outside of the Open Payments system between the applicable manufacturer or GPO and the disputing physician or, teaching hospital. Key words: Open Payments, Sunshine Act
(FAQ10130)
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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 words: Open... (more)
- If any records are resubmitted, the entirety of the data for the program year must be attested to again. Key words: Open Payments, Sunshine Act
(FAQ10124)
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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 Payments website.... (more)
- No. As required by the statute, CMS does not publish a covered recipient’s NPI on the Open Payments website.
(FAQ18357)
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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 the first level of data validation which is performed at the file level (i.e., checking the file broadly to make sure it is formatted correctly for the Open Payments system), the submitter will receive immediate feedback via an on-screen message letting them know the file upload was successful or not successful.
For the second level of data validation (which checks the record level specifications described in the Data Submission Mapping Document), applicable manufacturers and applicable GPOs will be notified via email of any data validation errors. The email will direct the user to the system-generated error report available in the Open Payments system. The error report will provide a list of all errors the submission has generated and error codes that explain the source of the errors. Users should then refer to the Error Code File Document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
After Final Submission, the Open Payments system will search to match submitted records to a valid physician or teaching hospital. This matching process may take up to several days, and timing will vary based upon the size of the data files. Email notification that contains the results of the matching process will be sent to the data submitter upon completion of this step. Key words: Open Payments, Sunshine Act
(FAQ10112)
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Do applicable manufacturers and group purchasing organizations (GPOs) need to recertify their Open Payments...- Yes. Each calendar year, applicable manufacturers and GPOs need to recertify their profile information. During recertifi... (more)
- Yes. Each calendar year, applicable manufacturers and GPOs need to recertify their profile information. During recertification, the user must either confirm that the identifying details in the entity’s Open Payments profile are accurate or make updates if any information is inaccurate. Note that only those who hold the user role of “Officer” in the Open Payments system for that reporting entity can recertify the entity. If there is no active Officer for the reporting entity, contact the CMS Open Payments Help Desk at openpayments@cms.hhs.gov or 1-855-326-8366 for assistance with recertification and nominating/approving a new Officer. For additional guidance on how to recertify, refer to the “Applicable Manufacturer and Applicable GPO Registration and Re-Certification – Quick Reference Guide” located at https://www.cms.gov/OpenPayments/Downloads/Quick-Reference-Guide-Applicable-Manufacturer-and-GPO-Registration-and-Recertification.pdf. Key words: Open Payments, Sunshine Act
(FAQ11966)
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Who can register in EIDM to access the Open Payments system?- Applicable manufacturers, group purchasing organizations (GPOs), physicians, and teaching hospitals can register in EIDM... (more)
- Applicable manufacturers, group purchasing organizations (GPOs), physicians, and teaching hospitals can register in EIDM to access the Open Payment system. Select the appropriate role when registering in EIDM. Access to the Open Payments System will not be granted to anyone who does not meet one of these designated roles. Key words: Open Payments, Sunshine Act
(FAQ9722)
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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 and h... (more)
- Yes. Any entity that fits the definition of an applicable manufacturer or applicable group purchasing organization and has payments or other transfers of value to report must register in the Open Payments System. Key words: Open Payments, Sunshine Act
(FAQ10088)
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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 year. ... (more)
- Yes. When you attest to data, you attest to all of the successfully submitted data files for the selected program year. Regardless of how many files are submitted during the data submission process, users will attest at the same time to all of the data successfully submitted and ready for attestation. In other words, attestation does not occur for each individual data file; it occurs for all files submitted for the selected program year that are ready for attestation. Key words: Open Payments, Sunshine Act
(FAQ10106)
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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 should n... (more)
- Yes. Data files can be separated and uploaded into multiple files for submission. However, each individual file should not be larger than 250MB in size. There are no system limitations for the number of records allowed in each file or the total number of files that can be uploaded. Key words: Open Payments, Sunshine Act
(FAQ10104)
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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)
Yes, an applicable manufacturer or applicable GPO may submit an entirely new data file to replace an earlier submission if the earlier submission contains extensive errors. To do so, delete the earlier file from the Open Payments system and submit the corrected file. Key words: Open Payments, Sunshine Act
(FAQ10122)
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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 corr... (more)
- Yes, corrected data files can be submitted through bulk file upload. Note that the 250MB size limit also applies to corrected data files. Key words: Open Payments, Sunshine Act
(FAQ10120)
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Will CMS issue opinions exempting applicable manufacturers or applicable group purchasing organizations fro...- No, CMS is not issuing advisory opinions exempting applicable manufacturers or applicable group purchasing organizations... (more)
- No, CMS is not issuing advisory opinions exempting applicable manufacturers or applicable group purchasing organizations from Open Payments reporting requirements. Key words: Open Payments, Sunshine Act
(FAQ8972)
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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 right. Some columns c... (more)
- To view all columns in the table, use the scroll bar at the bottom of the table to scroll left and right. Some columns contain hyperlinks which, when selected, will allow you to view additional information related to the selected record. Key words: Open Payments, Sunshine Act
(FAQ10264)
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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 is no limit to the number of data files... (more)
- The maximum file submission size for each data file is 250 megabytes (MB). There is no limit to the number of data files that can be submitted, as long as each one is under 250MB. Zipped data files that are under 250MB when zipped and larger than 250MB when unzipped are acceptable. There is no system limitation on the number of data lines or rows allowed in each file. Key words: Open Payments, Sunshine Act
(FAQ10100)
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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 phy... (more)
- Records may have a Review and Dispute status of “Resolved, No Change,” which means that the reporting entity and physician or teaching hospital have resolved the dispute in accordance with the Final Rule and no changes were made to the disputed record. If a record has a status of “Resolved,” the disputed record was updated by the reporting entity and resubmitted in the Open Payments system. Key words: Open Payments, Sunshine Act
(FAQ10268)
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