Common use of SECRETARY’S RESPONSIBILITIES Clause in Contracts

SECRETARY’S RESPONSIBILITIES. (a) The Secretary shall require Part D sponsors to make applicable discounts available to applicable beneficiaries at the pharmacy, by mail order service, or at any other point of sale for applicable drugs beginning January 1, 2012. The Secretary shall also require Part D sponsors to make applicable discounts available to applicable beneficiaries after the point-of-sale if it is later determined that a drug dispensed to a beneficiary was an applicable drug dispensed to an applicable beneficiary. (b) The Secretary is responsible for monitoring compliance by the Manufacturer with the terms of this Agreement and with monitoring compliance by Part D sponsors and the TPA with their respective obligations in connection with the Discount Program. (c) The Secretary is responsible for collecting PDE information from Part D sponsors, for monitoring and tracking the applicable discounts provided by Part D sponsors and reimbursed by Manufacturers for applicable drugs, , and for implementing internal control measures designed to ensure the accuracy and appropriateness of discount payments provided by Part D sponsors. (d) In accordance with section V, the Secretary may audit the Manufacturer periodically with respect to the Manufacturer's labeler codes, expiration date of NDCs, and utilization and pricing information relied on by the Manufacturer to dispute the invoices and Medicare Part D Discount Information, and any other data the Secretary determines are necessary to carry out the Discount Program. (e) The Secretary shall directly or through a contract with one or more third parties (the TPA): 1. Receive and transmit information, including Medicare Part D Discount Information (as defined in section I (k) of this Agreement), among the Secretary, Manufacturer, Part D sponsors and other individuals or entities the Secretary determines appropriate; 2. Receive, distribute, or facilitate the distribution of funds of the Manufacturer to appropriate individuals or entities; 3. Provide adequate and timely information to the Manufacturer as necessary for the Manufacturer to fulfill its obligations under this Agreement; 4. Calculate the invoice and reconcile any discrepancies with applicable discounts reported by Part D sponsors prior to invoicing Manufacturers; 5. Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; 6. Permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used to determine the applicable discounts for applicable drugs of the Manufacturer under the Discount Program in accordance with section V of this Agreement. (f) The Secretary shall not disclose any identifying beneficiary information in these reports or otherwise under this Discount Program except as may be required by a court with competent jurisdiction. (g) The Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretary’s determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer. (h) The Secretary shall make public a list of Manufacturers’ and their reported labeler codes that are subject to an existing Discount Program Agreement. (i) The Secretary shall ensure that adjustments are made to invoices as a result of any information obtained relating to errors, including information obtained as a result of the Secretary’s audit of a Part D sponsor or the TPA or an audit of data and information made available by the TPA as specified in section V performed by a Manufacturer. In the event a systemic error is discovered, the Secretary shall ensure that either CMS or the TPA identify all invoices affected by the error, notify the Manufacturer and determine the impact of the error on invoiced discounts, and adjust the invoices of the affected Manufacturers (or implement an alternative reimbursement process if determined necessary by the Secretary) to correct any underpayment or overpayment that was requested on prior invoices.

SECRETARY’S RESPONSIBILITIES. (a) The Secretary shall require Part D sponsors to make applicable discounts available to applicable beneficiaries at the pharmacy, by mail order service, or at any other point of point-of-sale for applicable drugs beginning January 1, 20122020. The Secretary shall also require Part D sponsors to make applicable discounts available to applicable beneficiaries after the point-of-sale if it is later determined that a drug dispensed to a beneficiary was an applicable drug dispensed to an applicable beneficiary. (b) The Secretary is responsible for monitoring compliance by the Manufacturer with the terms of this Agreement and with monitoring compliance by Part D sponsors and the TPA with their respective obligations in connection with the Discount Program. (c) The Secretary is responsible for collecting PDE information from Part D sponsors, sponsors for monitoring and tracking the applicable discounts provided by Part D sponsors and reimbursed by Manufacturers for applicable drugs, , and for implementing internal control measures designed to ensure the accuracy and appropriateness of discount payments provided by Part D sponsors. (d) In accordance with section VV of this Agreement and as described in in 42 CFR § 423.2330, the Secretary may audit the Manufacturer periodically with respect to the Manufacturer's labeler codes, NDC last lot expiration date of NDCsdates, and utilization and pricing information relied on by the Manufacturer to dispute the invoices and Medicare Part D Discount Informationquarterly invoices, and any other data the Secretary determines are necessary to carry out the Discount Program. (e) The Secretary shall directly or through a contract with one or more third parties (the TPA): 1. Receive and transmit information, including Medicare Part D Discount Information (as defined in section I (k) of this Agreement), among the Secretary, Manufacturer, Part D sponsors and other individuals or entities the Secretary determines appropriate; 2. Receive, distribute, or facilitate the distribution of funds of the Manufacturer to appropriate individuals or entities; 3. Provide adequate and timely information to the Manufacturer as necessary for the Manufacturer to fulfill its obligations under this Agreement; 4. Calculate the invoice and reconcile any discrepancies with applicable discounts reported by Part D sponsors prior to invoicing Manufacturers; 5. Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; 6. Permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used to determine the applicable discounts for applicable drugs of the Manufacturer under the Discount Program in accordance with section V of this Agreement. (f) The Secretary shall not disclose any identifying beneficiary information in these reports or otherwise under this Discount Program except as may be required by a court with competent jurisdiction. (g) The Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretary’s determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer. (h) The Secretary shall make public a list of Manufacturers’ Manufacturers and their reported labeler codes that are subject to an existing Discount Program Agreement. (i) The Secretary shall ensure that adjustments are made to invoices as a result of any information obtained relating to errors, including information obtained as a result of the Secretary’s audit of a Part D sponsor or the TPA or an audit of data and information made available by the TPA as specified in section V performed by a Manufacturer. In the event a systemic error is discovered, the Secretary shall ensure that either CMS or the TPA identify all invoices affected by the error, notify the Manufacturer and determine the impact of the error on invoiced discounts, and adjust the invoices of the affected Manufacturers (or implement an alternative reimbursement process if determined necessary by the Secretary) to correct any underpayment or overpayment that was requested on prior invoices.

SECRETARY’S RESPONSIBILITIES. (a) The Secretary shall require Part D sponsors to make applicable discounts available to applicable beneficiaries at the pharmacy, by mail order service, or at any other point of sale for applicable drugs beginning January 1, 2012. The Secretary shall also require Part D sponsors to make applicable discounts available to applicable beneficiaries after the point-of-sale if it is later determined that a drug dispensed to a beneficiary was an applicable drug dispensed to an applicable beneficiary2011. (b) The Secretary is responsible for monitoring compliance by the Manufacturer with the terms of this Agreement and with monitoring compliance by Part D sponsors and the TPA with their respective obligations in connection with the Discount ProgramAgreement. (c) The Secretary is responsible for collecting PDE information from Part D sponsors, sponsors for monitoring and tracking the applicable discounts provided by Part D sponsors and reimbursed by on behalf of Manufacturers for applicable drugs, , drugs and for implementing internal control measures designed to ensure the accuracy and appropriateness of discount payments provided by Part D sponsors. (d) In accordance with section V, the The Secretary may audit the Manufacturer periodically with respect to the Manufacturer's labeler codes, expiration date of NDCs, and utilization and pricing information relied on by the Manufacturer to dispute the invoices and Medicare Part D Discount InformationCMS contractor’s discount calculations, and any other data the Secretary determines are is necessary to carry out the Discount Programprogram. (e) The Secretary shall directly or through a contract with one or more third parties (the TPA):contractor) to: 1. Receive and transmit information, including Medicare Part D Discount Information (as defined in section I (k) of this Agreement), among between the Secretary, Manufacturermanufacturers, Part D sponsors and other individuals or entities the Secretary determines appropriate; 2. Receive, distribute, or facilitate the distribution of funds of the Manufacturer manufacturers to appropriate individuals or entitiesentities in order to meet the obligations of manufacturers under this agreement; 3. Provide adequate and timely information to the Manufacturer manufacturers as necessary for the Manufacturer manufacturer to fulfill its obligations under this Agreement; 4. Calculate the invoice and reconcile any discrepancies with applicable discounts reported by Part D sponsors prior to invoicing Manufacturers; 5. Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; 6. Permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used by the contractor to determine the applicable discounts for applicable drugs of the Manufacturer manufacturer under the Discount Program in accordance with section V of this AgreementProgram. (f) The Secretary shall not disclose any identifying beneficiary information in these reports or otherwise under this Discount Program except as may be required by a court with competent jurisdiction. (g) The Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretary’s determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer. (h) The Secretary shall make public a list of Manufacturers’ and their reported Manufacturer's labeler codes that are subject to an existing Discount Program Agreement. (i) The Secretary shall ensure that adjustments are made to invoices as a result of any information obtained relating to errors, including information obtained as a result of the Secretary’s audit of a Part D sponsor or the TPA or an audit of data and information made available by the TPA as specified in section V performed by a Manufacturer. In the event a systemic error is discovered, the Secretary shall ensure that either CMS or the TPA identify all invoices affected by the error, notify the Manufacturer and determine the impact of the error on invoiced discounts, and adjust the invoices of the affected Manufacturers (or implement an alternative reimbursement process if determined necessary by the Secretary) to correct any underpayment or overpayment that was requested on prior invoices.

SECRETARY’S RESPONSIBILITIES. (a) The Secretary shall require Part D sponsors to make applicable discounts available to applicable beneficiaries at the pharmacy, by mail order service, or at any other point of point-of-sale for applicable drugs beginning January 1, 20122011. The Secretary shall also require Part D sponsors to make applicable discounts available to applicable beneficiaries after the point-of-sale if it is later determined that a drug dispensed to a beneficiary was an applicable drug dispensed to an applicable beneficiary. (b) The Secretary is responsible for monitoring compliance by the Manufacturer with the terms of this Agreement and with monitoring compliance by Part D sponsors and the TPA with their respective obligations in connection with the Discount Program. (c) The Secretary is responsible for collecting PDE information from Part D sponsors, for monitoring and tracking the applicable discounts provided by Part D sponsors and reimbursed by Manufacturers for applicable drugs, , and for implementing internal control measures designed to ensure the accuracy and appropriateness of discount payments provided by Part D sponsors. (d) In accordance with section VV of this Agreement and as described in in 42 CFR §423.2330, the Secretary may audit the Manufacturer periodically with respect to the Manufacturer's labeler codes, NDC last lot expiration date of NDCsdates, and utilization and pricing information relied on by the Manufacturer to dispute the invoices and Medicare Part D Discount Informationquarterly invoices, and any other data the Secretary determines are necessary to carry out the Discount Program. (e) The Secretary shall directly or through a contract with one or more third parties (the TPA): 1. Receive and transmit information, including Medicare Part D Discount Information (as defined in section I (k) of this Agreement), among the Secretary, Manufacturer, Part D sponsors and other individuals or entities the Secretary determines appropriate; 2. Receive, distribute, or facilitate the distribution of funds of the Manufacturer to appropriate individuals or entities; 3. Provide adequate and timely information to the Manufacturer as necessary for the Manufacturer to fulfill its obligations under this Agreement; 4. Calculate the invoice and reconcile any discrepancies with applicable discounts reported by Part D sponsors prior to invoicing Manufacturers; 5. Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; 6. Permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used to determine the applicable discounts for applicable drugs of the Manufacturer under the Discount Program in accordance with section V of this Agreement. (f) The Secretary shall not disclose any identifying beneficiary information in these reports or otherwise under this Discount Program except as may be required by a court with competent jurisdiction. (g) The Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretary’s determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer. (h) The Secretary shall make public a list of Manufacturers’ and their reported labeler codes that are subject to an existing Discount Program Agreement. (i) The Secretary shall ensure that adjustments are made to invoices as a result of any information obtained relating to errors, including information obtained as a result of the Secretary’s audit of a Part D sponsor or the TPA or an audit of data and information made available by the TPA as specified in section V performed by a Manufacturer. In the event a systemic error is discovered, the Secretary shall ensure that either CMS or the TPA identify all invoices affected by the error, notify the Manufacturer and determine the impact of the error on invoiced discounts, and adjust the invoices of the affected Manufacturers (or implement an alternative reimbursement process if determined necessary by the Secretary) to correct any underpayment or overpayment that was requested on prior invoices.

SECRETARY’S RESPONSIBILITIES. (a) The Secretary shall require Part D sponsors to make applicable discounts available to applicable beneficiaries at the pharmacy, by mail order service, or at any other point of sale for applicable drugs beginning January 1, 20122011. The Secretary shall also require Part D sponsors to make applicable discounts available to applicable beneficiaries after the point-of-sale if it is later determined that a drug dispensed to a beneficiary was an applicable drug dispensed to an applicable beneficiary. (b) The Secretary is responsible for monitoring compliance by the Manufacturer with the terms of this Agreement and with monitoring compliance by Part D sponsors and the TPA with their respective obligations in connection with the Discount Program. (c) The Secretary is responsible for collecting PDE information from Part D sponsors, for monitoring and tracking the applicable discounts provided by Part D sponsors and reimbursed by Manufacturers for applicable drugs, , and for implementing internal control measures designed to ensure the accuracy and appropriateness of discount payments provided by Part D sponsors. (d) In accordance with section V, the Secretary may audit the Manufacturer periodically with respect to the Manufacturer's labeler codes, expiration date of NDCs, and utilization and pricing information relied on by the Manufacturer to dispute the invoices and Medicare Part D Discount Information, and any other data the Secretary determines are necessary to carry out the Discount Program. (e) The Secretary shall directly or through a contract with one or more third parties (the TPA): 1. Receive and transmit information, including Medicare Part D Discount Information (as defined in section I (k) of this Agreement), among the Secretary, Manufacturer, Part D sponsors and other individuals or entities the Secretary determines appropriate; 2. Receive, distribute, or facilitate the distribution of funds of the Manufacturer to appropriate individuals or entities; 3. Provide adequate and timely information to the Manufacturer as necessary for the Manufacturer to fulfill its obligations under this Agreement; 4. Calculate the invoice and reconcile any discrepancies with applicable discounts reported by Part D sponsors prior to invoicing Manufacturers; 5. Notify the Manufacturer of invoice errors or retroactive adjustments and make any necessary adjustments to subsequent invoices; 6. Permit manufacturers to conduct periodic audits, directly or through contracts, of the data and information used to determine the applicable discounts for applicable drugs of the Manufacturer under the Discount Program in accordance with section V of this Agreement. (f) The Secretary shall not disclose any identifying beneficiary information in these reports or otherwise under this Discount Program except as may be required by a court with competent jurisdiction. (g) The Secretary shall be the sole source of information regarding beneficiary eligibility to receive the applicable discount and the Secretary’s determination regarding beneficiary eligibility is not subject to audit or dispute by Manufacturer. (h) The Secretary shall make public a list of Manufacturers’ and their reported labeler codes that are subject to an existing Discount Program Agreement. (i) The Secretary shall ensure that adjustments are made to invoices as a result of any information obtained relating to errors, including information obtained as a result of the Secretary’s audit of a Part D sponsor or the TPA or an audit of data and information made available by the TPA as specified in section V performed by a Manufacturer. In the event a systemic error is discovered, the Secretary shall ensure that either CMS or the TPA identify all invoices affected by the error, notify the Manufacturer and determine the impact of the error on invoiced discounts, and adjust the invoices of the affected Manufacturers (or implement an alternative reimbursement process if determined necessary by the Secretary) to correct any underpayment or overpayment that was requested on prior invoices.