Frequently Asked Questions

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FAQ

Is a manufacturer of dental alloys considered an applicable manufacturer for purposes of Open Payments? Are payments or other transfers of value provided to dental labs reportable or only payments or other transfers of value provided to dentists?

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.
(FAQ8978)

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