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ASP Newsletter




*October 1, 2024 *

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Current Reporting Window

The ASP Data Collection System [ https://portal.cms.gov/portal/ ] is now open to receive ASP data for the third calendar quarter of 2024. Sales data of drugs and biologicals separately payable under Medicare Part B for the months of July, August, and September 2024 are due to CMS by Wednesday, October 30, 2024.

As a reminder, manufacturers of drugs and biologicals separately payable under Medicare Part B must report accurate ASP data to CMS, as described in Sections 1927(b)(3), 1847A(d)(4), and 1847A(f) of the Social Security Act and in regulation at 42 CFR 414 Subpart J.

User guides and templates for easy upload into the system are available on the Education and Outreach page [ https://www.cms.gov/medicare/payment/part-b-drugs/asp-education-outreach ] of the ASP website [ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price ].

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ASP Data Collection System Updates

This summer, a few hover-over fields were updated to provide further clarification on several data fields. These definitions have also been updated in the Financial Data Templates:


* *Manufacturer’s ASP*: A manufacturer’s average sales price for each National Drug Code (NDC) assigned to the drug or biological product.
* *Number of ASP Units*: Units of the product represented by the NDC, unless otherwise specified by CMS to account for situations where labeling indicates that the amount of drug product represented by an NDC varies.
* *Average Wholesale Price*: The price for a drug or biological to retail pharmacies, physicians, and other entities from the wholesaler, as reflected in published compendia.

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From the ASP Help Desk

Here are the top three Frequently Asked Questions from the ASP Help Desk this quarter:

*Q:* "How can I correct a mistake I made while submitting ASP data?"

*A:* There are two types of data we collect in the ASP Data Collection System: product data and financial data. Product data are typically entered only once when a new drug is available. After product data has been entered, some fields may not be changed online. To correct product data for an existing product, please contact the ASP Help Desk at asphelpdesk@dcca.com for assistance. Financial data are entered quarterly for all drugs and biologicals separately payable under Medicare Part B. If you made an error while entering financial data before it is certified, you can reupload or reenter the information. If the financial data has been certified, you will need to re-submit the financial data in the ASP Data Collection System on the Restatement Tab.

*Q:* "My drug is no longer being produced but is showing on the Active Tab and on the Compliance Summary as data that I owe. How can I correct this?"

*A:* To update a drug that is no longer being sold or produced, go to the Product Data section, and on the Add/Update Product Data page, select the Update Product tab. Next, select the product and enter an Expiration Date of Final Lot Sold. Then, click “Save” to update the product to expired status.

*Q:* "When I view the Compliance Summary, I do not see previously certified ASP financial data. How can I view historical financial data?"

*A:* Unfortunately, financial data are suppressed and may not be retrieved once entered into the system. We advise that each submitter maintain their own financial records.

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What’s New?

* The webinar held in July for manufacturers of skin substitute products is available on the ASP Events page [ https://www.cms.gov/medicare/payment/medicare-part-b-drug-average-sales-price/asp-events ]. Under the Materials From Past Events heading, click on 2024 to reveal the web session, password, and the accompanying slides.
* In an effort to keep our content up-to-date and user friendly, several pages of the ASP website [ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price ] were recently updated. You may notice some minor reorganization of content and new features. We hope that this page remains your primary resource for ASP and Medicare Part B Drug information. Your feedback is always welcome at sec303aspdata@cms.hhs.gov.
* CMS is preparing to implement the Discarded Drug Refund Program as required by Section 90004 of the Infrastructure Investment and Jobs Act (IIJA), which requires manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug. CMS has partnered with a contractor, Palmetto GBA, to serve as a third-party administrator (TPA) of the invoicing and payment processing module in the Health Plan Management System (HPMS). In addition to the Discarded Drug Refund Program, HPMS is used to manage several other programs for CMS, such as the Inflation Reduction Act’s Rebate Program. Representatives from the TPA Support Center will be reaching out to manufacturers who are not yet onboarded into HPMS to begin the HPMS onboarding process for calendar year 2023 refund reports. Questions about the Discarded Drugs Program should be directed to DiscardedDrugs@cms.hhs.gov.

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Upcoming Events

In November, CMS will host a webinar for manufacturers of Part B Drugs in the Discarded Drug Program. If you are a manufacturer of a single source drug or biologicals or a biosimilar biological products for which payment is made under Medicare Part B and are furnished from a single-dose container or single-use package based on FDA-approved labeling or product information not including exceptions as defined in § 414.902 [ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-414/subpart-K/section-414.902 ], you may be a manufacturer of a refundable drug and should plan to attend. This webinar will provide additional information on how to access Discarded Drug Refund Reports as well as how to pay any refund amounts due in the Health Plan Management System (HPMS). Stay tuned for a Save the Date email announcement coming soon. For additional information regarding the Discarded Drug Program, please visit the Discarded Drugs page [ https://www.cms.gov/medicare/payment/part-b-drugs/discarded-drugs ] on the ASP website [ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price ].

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Give Us Your Feedback

* *How are We Doing?* We are looking for feedback on our website content, the resources and fact sheets posted on the Education and Outreach page [ https://www.cms.gov/medicare/payment/part-b-drugs/asp-education-outreach ], and communication preferences. If you are interested in participating in a session with CMS to provide feedback on our available resources, please contact sec303aspdata@cms.hhs.gov.
* If you have an idea for something you would like to see featured in the next edition of the Medicare Part B ASP Newsletter, email us at sec303aspdata@cms.hhs.gov.


Centers for Medicare & Medicaid Services




You're receiving this message because you subscribed to get email updates from the Centers for Medicare & Medicaid Services (CMS) [ http://www.cms.gov/ ] and to receive Medicare Part B Average Sales Price (ASP) information. Update your subscriptions, modify your password or email address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://public.govdelivery.com/accounts/USCMS/subscriber/edit?preferences=true#tab1 ]. You will need to use your email address to log in. If you have questions or problems with the subscription service, please contact subscriberhelp.govdelivery.com [ https://subscriberhelp.govdelivery.com/ ].

For questions related to the Medicare Part B ASP process, related policies, and other general questions, please contact sec303aspdata@cms.hhs.gov.

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