Frank Pallone,
H.R. 3 Title III
(2021)
“ MANUFACTURER.—The term ‘manufacturer’ means any entity which is engaged in the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. ”
Frank Pallone,
H.R. 3 Title III
(2021)
“ NOTIFICATION.—If a third party with a contract under subsection (d) (3) determines that the manufacturer is not in compliance with such agreement, the third party shall notify the Secretary of such noncompliance for appropriate enforcement under subsection (e) . “ (3) COLLECTION OF DATA FROM PRESCRIPTION DRUG PLANS AND MA–PD PLANS.—The Secretary may collect appropriate data from prescription drug plans and MA–PD plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section. ”
Frank Pallone,
H.R. 3 Title III
(2021)
“ CLAIMS SPANNING OUT-OF-POCKET THRESHOLD.—In the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall entirely below or entirely above the annual out-of-pocket threshold specified in section 1860D–2 (b) (4) (B) (i) for the year, the manufacturer of the applicable drug shall provide the discounted price— “ (I) in accordance with subparagraph (A) (i) on the portion of the negotiated price of the applicable drug that falls below such threshold ”
