びびなび : ワシントンDC : (アメリカ合衆国) Washington DC

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ASP Newsletter




*January 13, 2025*

Happy New Year! 

Have an idea for something you would like to see featured in the next newsletter? Email us at sec303aspdata@cms.hhs.gov. 

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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 fourth calendar quarter of 2024. Sales data of Medicare Part B drugs, and biologicals separately payable under Medicare Part B, for the months of October, November and December 2024, are due to CMS on *Thursday, January 30, 2025*. 

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 42 CFR 414 Subpart J. 

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ASP Data Collection System Updates

*New Fields*

When requesting a new manufacturer name, users will now be prompted to enter the manufacturer Employer Identification Number (EIN) and Data Universal Numbering System (DUNS) number at the time of the request. The following hover-over tips have been added as well to provide data entry guidance: 


* EIN: A 9-digit number assigned to employers, sole proprietors, corporations, partnerships, estates, trusts, certain individuals, and other entities for tax filing purposes. Example: 12-3456789. 

* DUNS: A unique 9-digit number that identifies a business entity. Example: 123456789. 

*Data Entry Tips*


* When submitting a request for a new generic name, enter only the new name in the *New Generic Name* field. Please do not include any other product information such as volume or strength dosage in the name field. The ASP Data Collection System will only accept the generic name of the product. 

* If you are a manufacturer of certain drugs that contain variable amounts of product, such as radiopharmaceuticals and blood clotting factors, your data should be reported to CMS at the HCPCS level rather than the NDC level. CMS maintains and publishes a list of these drugs on a quarterly basis on the ASP Reporting page [ https://www.cms.gov/medicare/payment/part-b-drugs/asp-reporting ] under the Reporting Resources section. If you are a manufacturer of a drug that contains variable amounts of product, please check the “ASP Report in Units Other than NDC” document prior to submitting your financial data for the quarter. Should you have any questions, please contact sec303aspdata@cms.hhs.gov. 

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What's New?

CMS has made several updates to the information found on the Medicare Part B Drug ASP website [ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price ]. 


* *Updated Website Content* 
* Discarded Drug page [ https://www.cms.gov/medicare/payment/part-b-drugs/discarded-drugs ]: Content was added to answer frequently asked questions about the Medicare Part B Discarded Drug Program and support manufacturers as CMS released Refund Reports for Calendar Year 2023 in December.
* Vaccine Pricing page [ https://www.cms.gov/medicare/payment/part-b-drugs/vaccine-pricing ]: Existing content was reorganized to help visitors more easily find the information they are looking for. 

* *New Fact Sheets *
* Discarded Drug Program Overview [ https://www.cms.gov/files/document/discarded-drug-program-overview.pdf ]: An overview of the Discarded Drug Program that requires manufacturers of certain Part B Drugs to pay a refund to CMS for the portion of the drug that is discarded. 
* Discarded Drug Manufacturer Quick Reference [ https://www.cms.gov/medicare/payment/part-b-drugs/asp-education-outreach/discarded-drug-program-manufacturer-quick-reference ]: A quick reference guide of high-level steps designed to aid manufacturers during the discarded drug refund calculation process and to ensure compliance. 

* *Webinar Recording:* The links to the recording and presentation of the December 05, 2024, Medicare Part B Discarded Drug Webinar are available on the ASP Events page [ https://www.cms.gov/medicare/payment/medicare-part-b-drug-average-sales-price/asp-events ]. 

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Upcoming Events

There are currently no events scheduled at this time. Please continue to check the ASP Events page [ https://www.cms.gov/medicare/payment/medicare-part-b-drug-average-sales-price/asp-events ] for events as they become available. 



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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