; or (ii) permitting the Secretary to make proprietary data available to the public. (E) Definitions In this paragraph: (i) Drug manufacturer The term drug manufacturer has the meaning given the term manufacturer in section 1860D–14A(g)(5). (ii) Single source drug or biological The term single source drug or biological has the meaning given such term in section 1847A(c)(6)(D). . (b) Requiring participation in negotiation process as condition of part D drug coverage Section 1860D–14A(b) of the Social Security Act (42 U.S.C. 1395w–114a(b)) is amended by adding at the end the following new paragraph: (5) Participation in negotiation process Each agreement under this subsection shall include, with respect to plans years beginning with plan year 2019, an agreement by the manufacturer, with respect to each specified drug of such manufacturer under section 1860d–11(i)(2), to participate in the negotiation process under such section for such drug, including accepting the price resulting from the negotiation (or, in the case that such negotiation does not result in a price for such drug that is agreed to by the Secretary and the manufacturer, the price resulting from the application of subparagraph (B)(ii) of such section) as the maximum price for such drug for the period provided under such section. . 3. Study and report (a) Study The Secretary of Health and Human Services shall conduct a study examining— (1) the impact of the amendments made by section 2 on— (A) the cost of single source drugs and biologicals (as defined in section 1847A(c)(6)(D) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(D))) for which payment is made under part B of title XVIII of such Act; and (B) the accessibility of such drugs and biologicals for individuals entitled to benefits under part A of such title or enrolled under part B of such title