; (ii) lower prices that exceed a standard of cost per health benefit achieved; or (iii) lower prices that constitute significant barriers to access or fiscal burdens on patients; or (B) a combination of mechanisms listed in subparagraph (A) or other mechanisms. (d) Waiver (1) In general The Secretary may waive part or all of a reasonable pricing obligation under this section upon a demonstration that such a waiver is in the public interest. A decision to grant such a waiver shall set out the Secretary’s finding that the waiver is in the public interest. (2) Required process No waiver under paragraph (1) shall take effect before— (A) the public is given notice of the proposed waiver and provided a reasonable opportunity to comment in writing and at a public hearing on the proposed waiver; and (B) the Secretary publishes an economic analysis to justify the waiver. (e) Transparency (1) Reporting In order to evaluate additional requirements promulgated under subsection (c), agreements subject to subsection (a) shall include a requirement that the manufacturer or other companies commercializing the biomedical product or service involved report to the Secretary in formats determined by the Secretary— (A) the costs of each clinical trial undertaken to support the Federal regulatory approval of the biomedical product or service involved; (B) subsidies of those costs by the Federal Government; and (C) the annual revenues generated by the biomedical product or service involved, by county of sale. (2) Public availability The Secretary shall make all reports under paragraph (1) publicly available. (f) No effect on other requirements The reasonable pricing requirements imposed under this section are in addition to any other requirements to limit the price of biomedical products or services, including such requirements imposed— (1) through standards or negotiated provisions on pricing in contracts