PRA Disclosure Statement The purpose of the PRA package is to collect specific information from states regarding CMS-authorized supplemental rebate agreements that include value-based payment arrangements (VBP). The reporting is mandatory as required by 42 CFR 447.518(d). Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to the extent of the law. |
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-1385 (Expires: TBD). The time required to complete this information collection is estimated to average 6 hours per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. |
Product FDA List Name |
NDC for drugs covered by VBP |
Number of Prescriptions |
Cost to State to Administer VBP (need standard computation) |
Total Savings generated by supplemental rebate under VBP |
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Year 1 (10/1/2021 - 9/30/2022) |
|
Drug A Name |
NDC - 1, NDC - 2, NDC - 3, NDC - 4 |
250 |
$75,000 |
$225,000 |
|
Drug B Name |
NDC - 1, NDC - 2 |
100 |
$50,000 |
$350,000 |
|
Year 1 (10/1/2021 - 9/30/2022) |
350 |
$125,000 |
$575,000 |
Year 1 total for all |
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Year 2 (10/1/2022 - 9/30/2023) |
|
Drug A Name |
NDC - 1, NDC - 2, NDC - 3, NDC - 4 |
400 |
$75,000 |
$225,000 |
|
Drug B Name |
NDC - 1, NDC - 2 |
50 |
$50,000 |
$350,000 |
|
Year 2 (10/1/2022 - 9/30/2023) |
450 |
$125,000 |
$575,000 |
Year 2 total for all |
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CUMULATIVE TO DATE |
|
CUMULATIVE DRUG A |
650 |
$150,000 |
$450,000 |
Year 1 and Year 2 total for drug A |
CUMULATIVE DRUG B |
150 |
$100,000 |
$700,000 |
Year 1 and Year 2 total for drug B |
CUMULATIVE ALL |
800 |
$250,000 |
$1,150,000 |
Year 1 and Year 2 total for all |
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Data Element Definitions |
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Product FDA List Name |
For each VBP arrangement. |
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NDC |
NDC 9s used in arrangement (at dosage form and strength level). Example: 00001-1234, 1244, 1254, |
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# of Prescriptions |
The # of prescriptions should reflect the # of Medicaid beneficiaries receiving the prescribed treatment whether single or multiple doses under the state's VBP for the NDC 9s listed. State should reflect # of beneficiaries receiving treatment over the year. |
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Cost to the State to Administer VBP (Estimated to the nearest dollar. States may approximate the amount of administrative costs for a single administrative contract used for multiple arrangements.) |
Calculated as the estimated administrative costs to the state to enter into and administer each VBP arrangement. Examples of administrative costs states may incur: The costs applicable to negotiating the contract, the applicable cost of collecting data, the applicable cost of a contract with a fiscal agent to develop, invoice and collect rebates, applicable costs to entities collecting and verification of patient or population data, state cost of filling out this survey. *We understand that there may be start-up costs only reflected in the first year. |
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Total Savings generated by the supplemental rebate due to VBP (Estimated to the nearest dollar) |
Calculated as the Supplemental rebate collected minus the Costs to state to administer VBP |
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Annual report due |
The period for the VBP reporting will be on CY. Therefore, the first period will include VBP arrangements in effect during CY 2022 (1/1/2022 through 12/31/22). The submission of reports for the CY 22 will take place 60 days after the end of CY or March 1, 2023. |
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