; or (B) affect the application and approval process for pass-through payment status under section 1833(t)(6) or for an additional payment under section 1886(d)(5)(K) in the case of a medical device that is not approved by the Food and Drug Administration as a breakthrough device. (c) Coding (1) Prompt assignment Not later than three months after the date of approval or clearance of a breakthrough device by the Food and Drug Administration, subject to subparagraph (B), the Secretary shall assign a unique temporary or permanent code or codes for purposes of coverage and payment for such breakthrough device under the applicable payment systems (described in paragraph (4)). (2) Updates (A) IPPS The Secretary shall provide for semiannual updates under the applicable payment system described in paragraph (4)(A) (relating to the inpatient hospital prospective payment system) to recognize the code or codes assigned under paragraph (1). (B) OPPS The Secretary shall provide for quarterly updates under the applicable payment system described in paragraph (4)(B) (relating to the outpatient hospital prospective payment system) to recognize the code or codes assigned under paragraph (1). (3) Transparency The process for the assignment of a code or codes under this subsection shall provide for public notice and a meaningful opportunity for public comment from affected parties. (4) Applicable payment systems described For purposes of this subsection, the term applicable payment systems means— (A) with respect to inpatient hospital services, the prospective payment system for inpatient hospital services established under section 1886(d); (B) with respect to outpatient hospital services, the prospective payment system for covered OPD services established under section 1833(t); (C) with respect to ambulatory surgical center services, the fee schedule for such services established under 1833(i); (D) with respect to physicians’ services, the physician fee schedules established under section 1848