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Feb 20 -- The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information through CMS–10110: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals. Comments must be received by April 22, 2024.

Section 1847A of the Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturers' average sales price data submitted quarterly to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR part 414 subpart J.

CMS, specifically, the Division of Data Analysis and Market-based Pricing (DDAMBP) will utilize the ASP data (ASP and number of units sold as specific in section 1847A of the Act) to determine the Medicare Part B drug payment amounts for CY 2005 and beyond. The manufacturers submit their ASP data for all of their National Drug Codes (NDC) for Part B drugs. DDAMBP compiles the data, analyzes the data and runs the data through software to calculate the volume-weighted ASP for all of the NDCs that are grouped within a given HCPCS code. The formula to calculate the volume-weighted ASP is the Sum (ASP * units) for all NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP payment amounts for several components within CMS that utilize 1847(A) payment methodologies to implement various payment policies including, but not limited to, ESRD, OPPS, OTP and payment models. CMS will also use reported ASP and units to calculate inflation adjusted coinsurance and rebates. The Department of Health and Human Services' Office of the Inspector General also uses the ASP data in conducting studies.

Medicare pays for some separately payable Medicare Part B-covered drugs and biologics using the average sales price (ASP) methodology. Medicare pays most separately payable drugs and biologics at a rate of ASP plus 6%. To calculate the ASP and payment of each drug and biologic, manufacturers submit sales data, including discounts. CMS publishes the payment amounts each quarter.

Medicare Part B Drug Average Sales Price: https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price
Draft data collection instrument and technical documentation: https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing-items/cms-10110
FRN: https://www.federalregister.gov/d/2024-03348

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