Reconciliation Tasks

A Reconciliation Task is created when the application detects a discrepancy between the manufacturer’s data points and HRSA’s data points for a specific ClosedNDC A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes. after instrument file upload. A reconciliation task requires the manufacturer to reconcile the pricing data points for the NDC. Failure to reconcile the data prior to the end of the upload period will result in HRSA data points being selected.

  1. Select the Edit option on the top menu to access your Reconciliation tasks. Alternatively, select the shortcut link under the Product Data Reconciliation Required section to navigate to the Reconciliation tasks, or select the hyperlink on the NDC requiring MFR Reconciliation displayed under the Manufacturer Remaining Work list.

    Reconciliation Task Listing

  1. When the user selects the Edit option, the tasks that require reconciliation by the manufacturer are displayed as shown below.

    Reconciliation Tasks Assigned to Manufacturer

    • Select the link for an NDC to edit its data points. The manufacturer will only be able to update the four data points in each record or accept the HRSA data displayed. When a task that requires reconciliation is selected, the NDC details with the data points on record will display on the reconciliation pop up window. The user updates the correct values, and the ceiling price recalculates automatically.

  1. Selecting an NDC displays the Product Reconciliation page with all manufacturer data points as follows:

    • The Average Manufacturer Price

    • Unit Rebate Amount

    • Package Size

    • Case Package Size

    • Corresponding ceiling price (if it can be calculated)

    • After the manufacturer upload, if a manufacturer does not reconcile a price discrepancy, then HRSA will defer to CMS for the AMP and URA data points, and the commercial data broker for PS and CSP data points.

    • Package Adjusted Price of HRSA (displayed under HRSA Data Points)

  1. The Product Reconciliation page will highlight the Manufacturer data points that are different from the HRSA data points. The page will also display the Inner NDC value from HRSA (ClosedFDB First Databank, Inc., is the publisher of pharmaceutical information that is used within healthcare information systems serving hospitals, physician practices, other providers, payers, retail pharmacies, state health programs, and others for the purpose of medication decision support and negotiating reimbursement rates paid to pharmacies and other providers.). The Inner NDC Value for Manufacturers has two options – Yes or No. Before clicking on "Save MFR Data", please select the appropriate Inner NDC value for the Product. Click on "Accept HRSA Data" to submit the data points and Inner NDC value under HRSA data points.

    Product Reconciliation page highlighting data points different from HRSA

  1. When one or more of the Manufacturer data points do no match the HRSA data points, the manufacturer must enter a justification in the Notes section. Select standard notes from the Notes drop-down to populate pre-defined justifications in the Notes. Manufacturers may edit the standard note selected in the Note text box. If Other is selected from the drop-down, the Manufacturer must enter a custom note.

    Product Reconciliation page justification notes

  1. During the product reconciliation, if the product was not reported to Closed340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA). for the previous three quarters, then manufacturers will have to answer the New Drug Price Estimate questions.

    1. Is this a new drug (i.e., not previously reported to DDR for the previous four quarters)?

    2. Is this a new drug price estimate (i.e., AMP not yet established; therefore, the ceiling price is estimated as WAC is less than the appropriate rebate percentage)?

    • Manufacturers will have a reconciliation task to answer the New Drug Price Estimate questions even if the manufacturer pricing data matches with the HRSA data for the product.

    • Based on the answers, the product may be flagged as a “New Drug Price Estimate” and the questions may be asked again during subsequent quarters.

    • New Drug Price Estimate question Business Rules

      • If the manufacturer answers no to both question A and B, then they will not be prompted in the future for reconciliation.

      • If the manufacturer answers yes to question A, but no to question B, then they will not be prompted in the future for reconciliation.

      • If the manufacturer answers yes to both questions, then they will be required to answer for up to 4 consecutive quarters or until they answer no to the drug estimate.

  1. Manufacturers will be able to review the Notes from the previous quarters for the selected NDC, in the Notes section during the Product Reconciliation. The Notes are sorted in descending order with the note from the latest sales year and sales quarter on top. Manufacturers can click on the columns to sort the fields.

    Product Reconciliation notes from previous quarters

    Product Reconciliation New Drug Price Estimate questions

Product Reconciliation Controls
Control Description
New Drug Price Estimate

Select “Yes” or “No” to answer the Questions. 2nd Question will be disabled if your answer to the 1st question was “No”.

You need to answer both the questions to save and exit the page.
Supplied ClosedCeiling Price Manufacturers who participate in the Medicaid Drug Rebate Program (MDRP) enter into an agreement with the Secretary of Health and Human Services under which the manufacturer must agree to charge a price no greater than the statutory pricing formula (340B ceiling price) when selling covered outpatient drugs to 340B covered entities. In order to calculate the 340B ceiling price, the Unit Rebate Amount (URA) is subtracted from the Average Manufacturer Price (AMP) for the smallest unit of measure [340B Ceiling Price = (AMP – URA)]. Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC). To ensure that the final price is operational in the marketplace, HRSA then multiplies this amount by drug's package size (PS), defined as the number of billing units in the labeled quantity from which the pharmacist dispenses, and the case pack size (CSP), defined as the number of salable units in the shipping container [340B Ceiling Price = (AMP-URA) x PS x CSP]. The ceiling price supplied by the manufacturer via the file instrument upload.
Notes

A manufacturer must provide a note to justify if the data provided does not match HRSA data. Enter up to 1000 characters to explain discrepancies. Use the drop-down to select a standard Note. Additional comments may be added to the standard text in the note text box.

You will be required to add additional comments if you selected “Other” from the Notes drop-down. If there are no suitable standard Notes, you can select the “Other” option and add your justification.
Save MFR Data Click Save MFR Data to save your entries. This option will not be active if the manufacturer failed to provide a note to justify data entries that do not match HRSA data. Accepting changes removes the record from the Reconciliation Task List.
Accept HRSA Data This button allows the manufacturer user to accept HRSA data in one click. Any changes to manufacturer’s data points will not be saved and the record will be removed from the Reconciliation Task List.
Cancel Click to cancel any changes and keep the record in the Reconciliation Task List.
Standard Manufacturer Note Options
Drop down box Pre-populated text
Restated AMP (edit note as needed) AMP has been restated; ClosedCMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit.’ DDR has been updated.
Baseline AMP correction (edit note as needed) Baseline AMP has been updated; CMS’ DDR has been updated.
Best Price updated (edit note as needed) Best Price was restated; CMS’s DDR has been updated.
Drug category change (edit note as needed) Drug category is pending a change request with CMS.
New drug price estimate (edit note as needed) New drug price estimate using WAC in the AMP field with appropriate rebate percentage.
Package size reporting update (edit note as needed) UPPS reflect the unit of measure for which AMP is reported.
Other (provide detailed note)