CMS-10110_Supporting_Statement_A_(2025 version_16)

Supporting Statement – Part A

Manufacturer Submission of Average Sales Price (ASP)

Data for Medicare Part B Drugs and Biologicals and Supporting

Regulations in 42 CFR 414.800-806

(CMS-10110, OMB 0938-0921)

Background

In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price (ASP) of the drug or biological, beginning in Calendar Year (CY) 2005. The ASP data reporting requirements are specified in Section 1927 of the Act. Manufacturers that have a Medicaid Rebate Agreement are required to report ASP data of Part B drugs. Section 401 of Division CC of Title IV of the Consolidated Appropriations Act (CAA), 2021 amended section 1847A of the Social Security Act (the Act) to add new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreement to report average sales price (ASP) information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. The reported ASP data are used to establish the Medicare payment amounts.

The revisions in this iteration are associated with our November 5, 2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F, OMB 0938-AV50).

The rule finalized that skin substitute products are paid as incident-to supplies beginning January 1, 2026, which are not required to be paid under section 1847A of the Act. Accordingly, manufacturers of skins substitutes will no longer be required to report ASP data to CMS. Instead, ASP data reporting for manufacturers of skin substitutes will become voluntary. Although shifting the payment of skin substitutes to incident-to supplies will remove the requirement for their manufacturers to report ASP data to CMS, we are not going to decrease the overall number of manufacturers reporting data in the burden calculations to account for the maximum potential overall burden.

Second, 42 CFR 414.804(a)(5) sets out additional submission requirements for the reporting of ASP data. As such, the submission requirement is being expanded to include a (1) reasonable assumptions form and (2) warranty/certification that a bona fide service fee is not passed on.

The reasonable assumptions explain the methodology used by the manufacturer to calculate ASP and, in the absence of specific guidance in the Act or Federal regulations, the manufacturer may make reasonable assumptions in its calculations of the manufacturer’s ASP, consistent with the general requirements and intent of the Act, Federal regulations, and its customary business practices. While the document is currently optional and is submitted voluntarily by some manufacturers along with ASP data, the rule’s reasonable assumptions form is a required component of the ASP data submission. The warranty/certification form provides an attestation that the recipient of a bona fide service fee is not pass on.

A. Justification

1. Need and Legal Basis

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.

2. Information Users

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 limits 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.

3. Use of Information Technology

CMS migrated the submission of ASP data and signatures to an internet-based automated system in July 2020. ASP data is manually entered via data entry screens or uploaded via product and financial templates into the ASP automated system. The data that is being collected will not change. However, some new data is being requested so that DDAMBP can accurately calculate payment amounts for the components within CMS that utilize 1847(A) payment methodologies to implement various payment policies, calculate the inflation adjusted coinsurance and rebates, and apply the drug wastage provision.

A CMS User ID is required to access the ASP Application. To obtain a CMS User ID, you must complete the Application for Access to the Centers for Medicare & Medicaid Services (CMS) Computer Systems (Form CMS-20037). If you already have a CMS User ID, then you must submit a request to access the ASP Application. The Application for Access to the Centers for Medicare & Medicaid Services (CMS) Computer Systems (Form CMS-20037) can be downloaded from the CMS Website at: http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Downloads/EUAaccessform.pdf

Users that have been approved for access to the ASP application are assigned a CMS user ID and a password. Users are required to access the CMS Portal @ https://portal.cms.gov/ to begin the authentication and role assignment process. Users enter their assigned user ID in the User ID field and enter ASP User in the Request field in the CMS portal. Users are then directed to the EIdM (Enterprise Identity Management) Authentication System. The EIdM Authentication System performs identity proofing on the user. The EIdM Authentication System will prompt the user to create a username and password that conforms to the system’s policies; this user ID and password are not affiliated with the user’s CMS user ID and password. After the user successfully creates a username and password, the EIdM Authentication System will begin the identity proofing process. After the user’s identity is verified, the CMS Portal will push the user’s data to the ASP application. Users are assigned a role, assigned organization codes, and the NDCI contact is applied to the user.

Once granted access to the ASP application, users can log into the ASP application and set up NDC1s they will use, enter ASP data into data entry screens or upload their ASP data using the product and financial data templates.  The submitter then saves the data and the system generates a one-time password (OTP) for the submitter to send to the certifier.  The certifier then logs onto the system using the OTP (first time only), reviews the data, and certifies the data each quarter.

4. Duplication of Efforts

This information collection does not duplicate any other effort and the information cannot be obtained from any other source.

5. Small Businesses

This collection will not have a significant economic impact on small businesses. We do not believe the respondents to this collection (that is, manufacturers that produce drugs and biologicals that are typically administered by injection in the physician’s office) are small businesses.

6. Less Frequent Collection

Quarterly data collection is required to meet the objectives of market-based pricing. If the collection is not conducted quarterly, CMS will be unable to develop updated quarterly drug payment pricing files. As stated in section 1847A of the Social Security Act, the ASP payment limits are adjusted based on actual marketplace prices submitted each quarter by manufacturers to the CMS.

7. Special Circumstances

As indicated below in section 10, the reported information may contain proprietary, sensitive, or other confidential information. Otherwise, this information collection request does not include any other special circumstances. Specifically, this information collection does not require respondents to:

• Report information to the agency more often than quarterly;

• Prepare a written response to a collection of information in fewer than 30 days after receipt of it;

• Submit more than an original and two copies of any document;

• Retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;

• Collect data in connection with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study,

• Use a statistical data classification that has not been reviewed and approved by OMB;

• Include a pledge of confidentiality that is not supported by authority established in statute or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

• Submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

8. Federal Register/Outside Consultation

The initial 60-day comment period was associated with our July 16, 2025 (90 FR 32352) CY 2026 Physician Fee Schedule (PFS) NPRM (CMS-1832-P, OMB 0938-AV50)..

We did not receive public comments on the rule’s proposed requirements or burden estimates. However, following publication of the proposed rule, we identified that we should account for burden for a chief executive to certify the data.

The subsequent final rule (CMS–1832–F, OMB 0938–AV50) published in the Federal Register on November 5, 2025 (90 FR 49266).

We also published a 60-day non-rule collection of information notice on December 30, 2025 (90 FR 61154) to provide the public with an additional 60-day comment period for the ASP provisions that published in our November 5 final rule. The comment period will not be supplemented with a subsequent 30-day notice or comment period. Comments are due on/by March 2, 2026.

9. Payments/Gifts to Respondents

There will be no payments or gifts to respondents.

10. Confidentiality

CMS would keep the information collected confidential, according to statutory requirements. Information provided as part of this information collection request that the submitter indicates is confidential commercial or financial information would be protected from disclosure if the information meets the requirements set forth under Exemptions 3 and/or 4 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(3), (4)).¹

Additionally, section 1847A(f)(2) of the Social Security Act requires manufacturers without a Medicaid drug rebate agreement to report their ASP data for certain Part B drugs to CMS. Section 1847A(f)(2)(D) specifies that this information is confidential and will not be disclosed by the Secretary except as specifically authorized by law.

Section 1927(b)(3)(D) of the Act protects drug pricing data submitted by drug manufacturers to CMS under the MDRP. The protection applies to information such as the AMP, which is needed to calculate Medicaid rebates and to determine federal payment rates. The provision ensures that the sensitive pricing data is not disclosed publicly, though certain government entities may be granted access for specific purposes, like audits or oversight.

11. Sensitive Questions

There are no sensitive questions associated with this collection. Specifically, the collection does not solicit questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

12. Burden Estimates

Wage Estimates

To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ (BLS) May 2024 National Occupational Employment and Wage Estimates for all salary estimates (https://www.bls.gov/oes/2024/may/oes_nat.htm). In this regard, the following table sets out BLS’ mean hourly wage, our estimated cost of fringe benefits and other indirect costs (calculated at 100 percent of salary), and our adjusted hourly wage.

Occupation Title	Occupation Code	Mean Hourly Wage ($/hr)	Fringe Benefits and Other Indirect Costs ($/hr)	Adjusted Hourly Wage ($/hr)
Chief Executives	11-1011	126.41	126.41	252.82
Secretaries and Administrative Assistants	43-6014	22.90	22.90	45.80

There are many sources of variance in the average cost estimates, both because fringe benefits and other indirect costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Therefore, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

We believe that secretaries/administrative assistants will be responding to the information collection requirements. The secretary/administrative assistant compiles the data and submits it to the CEO/COO who certifies the data. Some manufacturers use contractors to compile their ASP reports.

Information Collection Requirements and Associated Burden Estimates

Reporting of Drug Pricing Information for Part B (§§ 414.802 and 414.902)

The burden associated with the information collection is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to register to the CMS portal, and to prepare and submit the required data to CMS.

We believe that secretaries/administrative assistants and chief executives will be responding to the information collection requirements. The secretary/administrative assistant compiles the data and submits it to the CEO/COO who certifies the data.

We estimate that it will take 12 hours per quarter at $45.80/hr for a secretary/administrative assistant to review instructions and search existing data resources, gather the data, compile the data, manually input or upload the data into the automated system; this estimate also includes the time to register with the CMS Portal. We previously estimated these tasks to take 13 hours. However, after further evaluation, we shifted one hour from the secretary/administrative assistant to the CEO/COO to account for the total burden of certification the ASP data, the reasonable assumptions, and the warranty/certification letter and signature as discussed below in the next section. We estimate it will take 1 hour per quarter at $252.82/hr for a chief executive to complete these tasks.

In aggregate based on the current number of manufacturers reporting ASP data to CMS, we estimate an annual burden of 22,620 hours (500 respondents x 4 responses/year x 13 hr/response) at a cost of $1,396,211 (1,740 responses x [(12 hr x $45.80/hr) + (1 hr x $252.82/hr)].

Reporting of Drug Pricing Information for Part B	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Secretary/Administrative Assistant	500	2,000 (500 x 4 responses/yr)	12	24,000	45.80	1,099,200
Chief Executive	500	2,000 (500 x 4 responses/yr)	1	2,000	252.82	505,640
Total	500	2,000	varies	26,000	varies	1,604,840

Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.802 and 414.804)

Section 414.804(a)(5) expands the ASP data reporting requirement to include: (1) reasonable assumptions for calculating the manufacturer’s ASP and (2) warranty or certification letter from the recipient of a fee from a manufacturer as evidence that a fee was not passed on in accordance with the definition of “bona fide service fee” at § 414.802 and the submission requirements at § 414.804.

The burden is comprised of the time and effort required by manufacturers of drugs and biologicals to prepare and submit the reasonable assumption document and warranty/certification​ letter to CMS.

Although overestimated, we anticipate that all 500 manufacturers will submit reasonable assumptions and warranty/certification letters to accompany their ASP data submissions​.

Reasonable Assumptions: The reasonable assumptions explain the methodology used by the manufacturer to calculate ASP. It is a required component of the quarterly ASP data submission.

Reasonable assumptions may vary in terms of the exact information that is provided and are generally updated by each manufacturer every 1 to 3 years depending on changes in the product line and various contract terms and conditions with intermediaries or consultants.

Based on our review of voluntarily submitted reasonable assumption data, we estimate that it will take 19 hours annually at $45.80/hr for a secretary/administrative assistant ​ including signature from the certifier, to CMS via ASP Data Collection System.

Our 19-hour estimate is comprised of: 10 hr to compile and/or update the information, 5 hr to review the information approximately once annually, and 4 hr annually (at 1 hr per quarter) to submit the reasonable assumptions to CMS.

Warranty or Certification Letter: The warranty or certification from the recipient of a bona fide service fee is required as evidence of whether or not a fee is passed on.

We estimate the submission of the warranty/certification letter from the recipient of a bona fide service fee is 8 hours annually at $45.80/hr for a secretary/administrative assistant to submit the warranty/certification letter including signature from the certifier, to CMS via the ASP Data Collection System. Our 8-hour estimate consists of: 4 hr to review the warranty/certification letter approximately once per year and 4 hr annually (at 1 hr per quarter) to submit to the ASP data collection portal.

A warranty/certification letter could be renewed up to every three years depending on the specific terms of each contract and not all manufacturers will submit a warranty/certification each quarter. For the purposes of the burden calculation, we will estimate the maximum burden by assuming that all manufacturers will submit this document each quarter.

As described above, the ASP data submission must be certified by the CEO/COO. The certifier must also sign the warranty/certification as described above. We estimate that the total burden of the certifier (accounting for all certification and signature tasks) is 1 hour per quarter at a rate of $ 252.82 per hour as discussed above in the previous section.

Average Sales Price: Price Concessions and Bona Fide Service Fees	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Reasonable Assumptions	500	500 (500 x 1 response/yr)	19	9,500	45.80	435,100
Disclosure and Submission of the Certification Letter	500	500 (500 x 4 responses/yr)	6	3,000	45.80	137,400
Total	500	1,000	25	12,500	45.80	572,500

Burden Summary

Section(s) Under Title 42 of the CFR	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Reporting of Drug Pricing Information for Part B	500	2,000	13	26,000	varies	1,604,840
Average Sales Price: Price Concessions and Bona Fide Service Fees (CMS-1832-F)	500	1,000	25	12,500	45.80	572,500
TOTAL	500	3,000	varies	38,500	varies	2,177,340

Collection of Information Instruments and Instruction/Guidance Documents

• Medicare Part B Average Sales Price (ASP) Module Submitter User Guide (Revised)

• Medicare Part B Average Sales Price (ASP) Module Certifier User Guide (Revised)

• Medicare Part B Average Sales Price (ASP) Module Registration User Guide (Revised)

• Reasonable Assumptions form (New)

• Bona Fide Service Fee Certification form (New)

13. Capital Costs

There are no capital costs associated with this collection.

14. Cost to Federal Government

The estimated annualized cost to the Federal Government is $2,239,300. This cost includes $239,300 for the operational expense of processing and receiving the data using the existing submission process. This cost estimate also includes $2,000,000 for the operation and maintenance costs for the automated internet-based data intake.

15. Changes to Burden

The revisions in this iteration are associated with our November 5, 2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F, OMB 0938-AV50).

This iteration revises the following user guides:

• Medicare Part B Average Sales Price (ASP) Module Submitter User Guide

• Medicare Part B Average Sales Price (ASP) Module Certifier User Guide

• Medicare Part B Average Sales Price (ASP) Module Registration User Guide

This iteration also adds the following collection of information instruments:

• Reasonable Assumptions Form

• Bona Fide Service Fee Certification Form

Reporting of Drug Pricing Information for Part B (§§ 414.802 and 414.902)

Our CY 2022 PFS final rule, estimated that an additional 568 respondents had products for which they would be required to report ASP data to CMS beginning January 1, 2022 (86 FR 65560), some of which are manufacturers of skin substitutes. Following the implementation of section 401, we estimated 500 respondents, 2,000 responses (500 respondents x 4 responses/yr), 26,000 hours (2,000 responses x 13 hr/response).

Our CY 2026 PFS final rule, skin substitutes are to be paid as incident-to supplies, which are not required to be paid under section 1847A of the Act. Accordingly, manufacturers of skin substitutes are no longer required to report ASP data to CMS. Instead, ASP data reporting for manufacturers of skin substitutes is now voluntary.

Based on ASP data for the July 2025 pricing file, 65 skin substitute manufacturers are reporting ASP data. However, to maximize our burden estimates, we continue to use 500 respondents instead of accounting for our expected decrease of minus 65 manufacturers or 435 manufacturers (500 current – 65 manufacturers).

Although our 13 hr/response is unchanged, we now estimate 12 hours by an Secretary/Administrative Assistant (@ minus 1 hr/response) and 1 hour (@ plus 1 hr/response) by a Chief Executive to log into the system, review the data, and certify the data and maximize burden by including all possible voluntary reporters.

Section(s) Under Title 42 of the CFR	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Current (Active) Burden	500	2,000 (500 x 4 responses/yr)	13	26,000	39.42	1,024,920
CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F)	500	2,000 (500 x 4 responses/yr	13	26,000	Varies*	1,604,840
Change	No change	No change	No Change	No Change	Varies	+579,920

*See section 12., above.

Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.802 and 414.804)

When combined, the burden for manufacturers of drugs and biologicals to prepare and submit the reasonable assumption document and warranty/certification​ letter to CMS is estimated to take 10,875 hours (500 responses x [19 hr per response + 6 hr per response]) and $498,075 (10,875 hr x $45.80/hr).

Average Sales Price: Price Concessions and Bona Fide Service Fees	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Current (Active) Burden	n/a	n/a	n/a	n/a	n/a	n/a
Reasonable Assumptions	500	500 (500 x 1 response/yr)	19	9,500	45.80	435,100
Disclosure and Submission of the Certification Letter	500	500 (500 x 1 response/yr)	6	3,000	45.80	137,400
Total	No Change	+1,000	25	+12,500	45.80	+572,500

Summary of Changes

Section(s) Under Title 42 of the CFR	No. Respondents	Total Annual Responses	Time per Response (hours)	Total Annual Time (hours)	Labor  Cost  ($/hr)	Total Cost  ($)
Reporting of Drug Pricing Information for Part B	No Change	No Change)	No Change	No Change	varies	+579,920
Average Sales Price: Price Concessions and Bona Fide Service Fees (CMS-1832-F)	No Change	+1,000	varies	+12,500	45.80	+572,500
TOTAL	No Change	+1,000	varies	+12,500	varies	+1,152,420

16. Publication/Tabulation Dates

The Medicare Part B ASP website lists the calculated payment limits for most drugs and biologicals payable under Medicare Part B. Typically, the payment limit is ASP+6% of the volume-weighted average of all individual products cross walked to a particular billing and payment code (HCPCS code). The reported ASP for an individual manufacturer’s product is not published.

17. Expiration Date

We plan to display the expiration date.

17. Certification Statement

There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

There will be no statistical methods employed in the collection of information.

1 See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.

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