The IPI model, as initially proposed, would only apply to drugs administered in physician offices and hospital outpatient departments (HOPD). HHS, however, has asked for comments on whether to include ASCs in the final proposed rulemaking, along with durable medical equipment (DME) suppliers and other providers that furnish the relevant drugs.
The model would start by focusing on single-source drugs and biologicals (including biosimilars), since drugs from a single manufacturer are easier to compare to international pricing. The model would phase in over a five-year period, with more drugs potentially being added in later years. Only about 50 percent of the country would be subject to participation, but the geographic areas selected for inclusion would be picked randomly.
It is important to note that this was an Advance Notice of Proposed Rulemaking (ANPRM), meaning that the proposal is still quite far from implementation. The actual proposed rule could come in spring 2019, and would be followed by a comment period and then a final rule. Actual implementation would not occur until late 2019 or early 2020 at the earliest.