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42 U.S. Code § 1395w-153. Condition for coverage of drugs under this part
(a) In generalIn order for coverage to be available under this part for covered part D drugs (as defined in section 1395w–102(e) of this title) of a manufacturer, the manufacturer must—
(1) participate in—
(A)
for 2011 through 2024, the Medicare coverage gap discount program under section 1395w–114a of this title; and
(B)
for 2025 and each subsequent year, the manufacturer discount program under section 1395w–114c of this title;
(2) have entered into and have in effect—
(A)
for 2011 through 2024, an agreement described in subsection (b) of section 1395w–114a of this title with the Secretary; and
(B)
for 2025 and each subsequent year, an agreement described in subsection (b) of section 1395w–114c of this title with the Secretary; and