Is leasing included in the actions that constitute “assistance or support” to determine if an entity is considered an applicable manufacturer under prong 2 of the definition for an applicable manufacturer at 42 C.F.R § 403.902?
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