Definitions
As used in this subpart and for purposes of the Manufacturer Discount Program, unless otherwise specified—
Agreement holder means a manufacturer that has executed and has in effect its own Manufacturer Discount Program agreement in accordance with § 423.2708(b)(1).
Applicable discount has the meaning set forth at § 423.2712.
Applicable LIS percent has the meaning set forth at § 423.2712(d)(1).
Applicable small manufacturer percent has the meaning set forth at § 423.2712(d)(2).
Covered Part D drug has the meaning set forth at § 423.100.
Dispute submission deadline means the date that is 60 calendar days from the date of the invoice containing the information that is the subject of the agreement holder's dispute.
Negotiated price has the meaning set forth at § 423.100, and with respect to an applicable drug under the Manufacturer Discount Program, such negotiated price includes any dispensing fee and, if applicable, any vaccine administration fee and sales tax.
Network pharmacy has the meaning set forth at § 423.100.
Part D drug has the meaning set forth at § 423.100.
Primary manufacturer has the meaning given such term pursuant to applicable regulations and guidance for the Medicare Drug Price Negotiation Program.
Specified drug means, with respect to a specified manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the specified manufacturer.
Specified small manufacturer drug means, with respect to a specified small manufacturer, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by the specified small manufacturer.
Total expenditures means with respect to—
(1) Part D, the total gross covered prescription drug costs, as defined in § 423.308; and
(2) Part B, the total Medicare allowed amount (i.e., total allowed charges), inclusive of beneficiary cost sharing, for Part B drugs and biologicals, except that expenditures for a drug or biological that are bundled or packaged into the payment for another service are excluded.