Common use of CMS Responsibilities Clause in Contracts

CMS Responsibilities. ‌ (a) CMS shall administer the Part D Manufacturer Discount Program, including the determination of the amount of the Applicable Discount for an Applicable Drug of the Manufacturer pursuant to section 1860D-14C(c)(1)(A) of the Act. (b) CMS shall establish procedures pursuant to section 1860D-14C(c)(1)(B) of the Act that require Part D Sponsors to pay Applicable Discounts on behalf of the Manufacturer for Applicable Drugs dispensed by a pharmacy, mail order service, or other dispenser within the Applicable Number of Calendar Days beginning January 1, 2025. (c) CMS shall establish procedures pursuant to section 1860D-14C(c)(1)(C) of the Act to ensure that the Applicable Discount for an Applicable Drug is applied before any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of Applicable Beneficiaries. (d) CMS shall provide a reasonable dispute resolution mechanism to resolve disagreements between manufacturers, Part D Sponsors, and CMS. (e) CMS shall monitor compliance by the Manufacturer with the terms of this Agreement, sections 1860D-14C and 1860D-43 of the Act, and any applicable regulations and guidance related to the Part D Manufacturer Discount Program pursuant to section 1860D- 14C(c)(2) of the Act. CMS shall monitor compliance by Part D Sponsors and the TPA with their respective obligations in connection with the Part D Manufacturer Discount Program. (f) CMS shall use PDE information reported by Part D Sponsors for monitoring and tracking the Applicable Discounts for Applicable Drugs paid by Part D Sponsors and reimbursed by the Manufacturer for Applicable Drugs, and for implementing internal control measures designed to ensure the accuracy and appropriateness of Applicable Discount payments provided by Part D Sponsors. (g) CMS shall, or shall ensure that its TPA shall, do each of the following:‌ (1) Receive and transmit information, including Medicare Part D Discount Information, among CMS, the Manufacturer, Part D Sponsors and other individuals or entities CMS determines appropriate; (2) Provide adequate and timely information to the Manufacturer as necessary for the Manufacturer to fulfill its obligations under this Agreement; (3) Calculate the invoice quarterly based upon PDEs reported to CMS by Part D Sponsors on a flow basis, which invoices may include PDEs with Dates of Dispensing from prior quarters, and reconcile any discrepancies with Applicable Discounts reported by Part D Sponsors prior to invoicing the Manufacturer; (4) Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; and (5) Permit the Manufacturer to conduct periodic audits of the data and information used to determine the Applicable Discounts for Applicable Drugs of the Manufacturer under the Part D Manufacturer Discount Program in accordance with section V of this Agreement. (h) CMS shall contract with a TPA to receive, distribute, and facilitate the distribution of funds of the Manufacturer to appropriate individuals or entities. (i) In accordance with section V of this Agreement, CMS may audit the Manufacturer periodically as necessary to carry out the Part D Manufacturer Discount Program. (j) CMS shall make public a list of participating manufacturers and the Labeler Codes each such manufacturer has provided to CMS in accordance with section II(c). (k) CMS shall ensure that adjustments are made to invoices as necessary to correct errors, including information obtained as a result of CMS’s audit of a Part D Sponsor or the TPA or from an audit performed by the Manufacturer of data and information made available by the TPA, as specified in section V. In the event a systemic error is discovered, CMS shall ensure that either CMS or the TPA identifies all invoices affected by the error, determines the impact of the error on invoiced discounts, notifies the Manufacturer, and adjusts the invoices of the Manufacturer if warranted (or implements an alternative reimbursement process if determined necessary by CMS) to correct any underpayment or overpayment that was requested on prior invoices. (l) CMS shall specify the form and manner for the Manufacturer to provide and attest to the completeness, accuracy, and truthfulness of information necessary for CMS to determine eligibility for and implement the Specified Manufacturer and Specified Small Manufacturer phase-ins pursuant to sections 1860D- 14C(g)(4)(B)(ii) and (g)(4)(C)(ii) of the Act, respectively, and any applicable regulations and guidance. (m) CMS shall determine whether the Manufacturer qualifies as a Specified Manufacturer or Specified Small Manufacturer in accordance with sections 1860D- 14C(g)(4)(B)(ii) and (g)(4)(C)(ii) of the Act, respectively, and any applicable regulations and guidance. (n) In the event that the Manufacturer declares bankruptcy, as described in Title 11 of the United States Code, and does not pay all invoiced amounts due for Applicable Discounts for Applicable Drugs, including the total sum of any civil money penalties (CMPs) imposed, if necessary, CMS will file a proof of claim with the bankruptcy court to recover the unpaid amounts from the Manufacturer.