; (bb) the request for such designation contained an untrue statement of material fact; or (cc) clinical or other information that was not available to the Secretary at the time such designation was made shows that— (AA) such drug or biological product is unsafe for use or not shown to be safe for use for individuals who are entitled to benefits under part A; or (BB) an alternative to such drug or biological product is an advance that substantially improves the diagnosis or treatment of such individuals. (III) Not later than October 1, 2021, and annually thereafter through October 1, 2025, the Secretary shall publish in the Federal Register a list of the DISARM antimicrobial drugs designated under this subparagraph pursuant to the process established under clause (iv)(I)(bb). (v) (I) For purposes of determining additional payment amounts under clause (i), a manufacturer or sponsor of a drug or biological product that submits a request described in clause (iv)(I)(aa) shall submit to the Secretary information described in section 1927(b)(3)(A)(iii). (II) The penalties for failure to provide timely information under clause (i) of subparagraph (C) of section 1927(b)(3) and for providing false information under clause (ii) of such subparagraph shall apply to manufacturers and sponsors of a drug or biological product under this section with respect to information under subclause (I) in the same manner as such penalties apply to manufacturers under such clauses with respect to information under subparagraph (A) of such section. (vi) The mechanism established pursuant to clause (i) shall provide that— (I) except as provided in subclause (II), no additional payment shall be made under this subparagraph for discharges involving a DISARM antimicrobial drug if any additional payments have been made for discharges involving such drug as a new medical service or technology under subparagraph (K)