; (ii) Federal laws affecting these pharmaceutical manufacturer distribution models; and (iii) whether hub services could improperly incentivize health care providers to deem a drug or biological as medically necessary under section 423.578 of title 42, Code of Federal Regulations. (B) Other areas determined appropriate by the Secretary. (b) Report Not later than January 1, 2021, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with recommendations for such legislation and administrative action as the Secretary determines appropriate. (c) Consultation In conducting the study under subsection (a) and preparing the report under subsection (b), the Secretary shall consult with the Attorney General. C Miscellaneous 141. Drug manufacturer price transparency Title XI of the Social Security Act ( 42 U.S.C. 1301 et seq.) is amended by inserting after section 1128K the following new section: 1128L. Drug manufacturer price transparency (a) In general (1) Determinations Beginning July 1, 2022, the Secretary shall make determinations as to whether a drug is an applicable drug as described in subsection (b). (2) Required justification If the Secretary determines under paragraph (1) that an applicable drug is described in subsection (b), the manufacturer of the applicable drug shall submit to the Secretary the justification described in subsection (c) in accordance with the timing described in subsection (d). (b) Applicable drug described (1) In general An applicable drug is described in this subsection if it meets any of the following at the time of the determination: (A) Large increase The drug (per dose)— (i) has a wholesale acquisition cost of at least $10; and (ii) had an increase in the wholesale acquisition cost, with respect to determinations made— (I) during 2020, of at least 100 percent since the date of the enactment of this section; (II) during 2021, of at least 100 percent in the preceding 12 months or of at least 150 percent in the preceding 24 months