Section 1 Short title
This Act may be cited as the “No Big Blockbuster Bailouts Act”.
No Big Blockbuster Bailouts Act
A BILL
To amend title XI of the Social Security Act to provide for the treatment of orphan drugs under the Medicare Drug Price Negotiation Program.
Sec. 2 Treatment of orphan drugs under the Medicare Drug Price Negotiation Program
in paragraph (1), in the matter preceding subparagraph (A), by striking “through (4)” and inserting “and (3)”;
in paragraph (3)—
by striking subparagraph (A);
by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively; and
in subparagraph (A)(iii), as redesignated by subparagraph (B) of this paragraph, by striking “with respect to” and inserting “subject to paragraph (4), with respect to”; and
by striking paragraph (4) and inserting the following new paragraph:
“(4) Treatment of orphan drugs—In the case of a drug that is designated as a drug for one or more rare diseases or conditions and for which the only approved indication (or indications) is for one or more such rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act), paragraph (3)(A) shall be applied by substituting “$400,000,000” for “$200,000,000” in clause (i) of such paragraph.”
Application— The amendments made by subsection (a) shall apply with respect to initial price applicability years (as defined in section 1191(b) of the Social Security Act (42 U.S.C. 1320f(b))) beginning on or after January 1, 2028.