New Sunshine Reporting FAQs Released by CMS

As announced last week, the Centers for Medicare & Medicaid Services (CMS) issued another round of FAQs related to the implementation of the Sunshine Act.  Below is a list of the 20 new CMS FAQs organized by category with a link to the answer from CMS for each.  Cooley’s CMS Sunshine FAQs trackers also have been updated, and can be located on the right side of the blog under “Trackers” or on the Resources page.

APPLICABLE MANUFACTURERS

9122 An entity leases employees to an applicable manufacturer for operational purposes, and continues to pay all salaries for the leased employees. Would this assistance and support be enough to consider the entity an applicable manufacturer if the entity is also under common ownership with the applicable manufacturer?
9124 Does Open Payments require an entity to report payments or other transfers of value provided to covered recipients or physician owners or investors retroactively once the entity becomes an applicable manufacturer, once the entity has a least one covered drug, biological, device or medical supply?
9126 Are independent sales representatives that are responsible for taking product orders from covered recipients and may receive a commission, but who do not hold title to any covered drugs, devices, biological, or medical supply and are not employees of applicable manufacturers required to report payments or other transfers of value provided to covered recipients or physician owners or investors?

EXCLUSIONS

9120 Is an applicable manufacturer required to report payments provided to a physician covered recipient for a claim settlement, for example, costs relating to a defective product?
9134 Are Federal, state, and local taxes withheld from a physician owner or investor considered reportable payments or other transfers of value?
9154 Is the loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME event considered a payment or other transfer of value to covered recipients?

INDIRECT PAYMENTS

9136 Is an applicable manufacturer required to report the name of a third party, such as a clinical research organization (CRO) providing an indirect research payment to a covered recipient?

REGISTRATION

9138 Are all applicable manufacturers and applicable group purchasing organizations required to register for Open Payments?

REPORTABLE PAYMENTS AND TRANSFERS OF VALUE

9132 Is an applicable manufacturer with both covered and non-covered products required to report payments or other transfers of value associated with a non-covered device, for example a device that is still in its development phase, which does not have pre-market approval by, nor required to have premarket notification to, the FDA and even when the device will only be used in the preclinical laboratory setting and not on humans?
9140 Is a distributor required to report food and beverages that are provided during an open house for a new distributorship center opened by a distributor?
9142 Is a donation provided to a teaching hospital’s foundation by an applicable manufacturer reportable?
9150 Is a meeting a reportable event if an applicable manufacturer located in the United States conducts the meeting in a foreign country?
9152 If an applicable manufacturer provides compensation to a non-US speaker for a CME in the US, does the payment or other transfer of value provided to the speaker need to be reported?

REPORTING (GENERAL)

9116 How should an applicable manufacturer determine which National Drug Code(s) (NDC) to report for a payment or other transfer of value that is associated with a covered drug or biological?
9128 Are applicable manufacturers required to report a physician’s name and taxonomy code as listed in the National Plan & Provider Enumeration System (NPPES)?
9144 Is a hospital that is not listed on the Open Payments teaching hospital list considered a teaching hospital covered recipient for purposes of Open Payments? 
9146 How should an applicable manufacturer report a payment or other transfer of value provided to a teaching hospital that is on the Open Payments teaching hospital list if the applicable manufacturer refers to the teaching hospital by a different name or the manufacturer’s internal records have a different address?
9148 Is an applicable manufacturer required to report all taxonomy codes for a physician or just the primary taxonomy codes?

RESEARCH

9130 Why was research removed as a nature of payment category option from the general data specification?

VALUE DETERMINATIONS

9118 What value should an applicable manufacturer assign to clinical study drugs that are provided to principal investigators as part of the research agreement? 

1 Comment

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One response to “New Sunshine Reporting FAQs Released by CMS

  1. Pingback: CMS Announces Certain Updates for 2014 Open Payments Data Collection | TheBeat @ CooleyHealth

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