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
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. The reported ASP data are used to establish the Medicare payment amounts.
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 to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J.
Information Users
CMS, specifically, the Division of Ambulatory Services (DAS), 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 NDCs for Part B drugs. DAS compiles the data, analyzes the data and runs the data through the SAS program 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. The Department of Health and Human Services’ Office of the Inspector General also uses the ASP data in conducting statutorily mandated studies.
Use of Information Technology
This collection of information will continue to utilize Microsoft Excel spreadsheets that are typically submitted to CMS via electronic media, such as: CDs and DVDs. In addition, CMS is migrating the submission of ASP data and signatures to an internet-based automated system. The data that is being collected will not change.
This information collection does not duplicate any other effort and the information cannot be obtained from any other source. However, DAS will be requiring the manufacturer to submit the ASP data simultaneously via electronic media and the internet-based automated system.
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.
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
There are no Special Circumstances.
8. Federal Register/Outside Consultation
The 60-day Federal Register notice published on July 31. 2017(82FR35530) and received no comments. The 30-day Federal register notice published on October 4, 2017(82FR46245) with no comments. We are proposing to continue to collect ASP data based on our experience under the approved collection and based on our discussions with respondents.
9. Payments/Gifts to Respondents
There will be no payments or gifts to respondents. Manufacturers that have a Medicaid Rebate Agreement are required to report ASP data of Part B drugs. All other manufacturers can submit voluntarily.
10. Confidentiality
This information collection is authorized under Section 1927 of the Act. Confidentiality requirements appear in Section 1927(b)(3)(D) which states that the ASP data “is confidential and shall not be disclosed by the Secretary …in a form which discloses the identity of a specific manufacturer or wholesaler, prices charged for drugs by such manufacturer or wholesaler, except—
as the Secretary determines to be necessary to carry out this section,
to permit the Comptroller General to review the information provided, and
to permit the Director of the Congressional Budget Office to review the information provided.”
11. Sensitive Questions
There are no sensitive questions.
The burden associated with the information collection is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to prepare and submit the required data to CMS. The current information collection is approved for 720 responses. Based on the number of ASP submissions currently received, we estimate that this requirement will affect approximately 180 manufacturers who will submit each quarter. Therefore, there are 180 respondents, which report 4 times per year, equal to 720 responses.
We estimate the total annual reporting burden for the number of respondents to be approximately 9,360 hours (720 x13 annual hours per response). We estimate the total quarterly reporting burden for the number of respondents to be approximately 2,340 (180 x 13 quarterly hours per response). We believe that administrative assistants will be responding to the information collection requirements. Based on the most recent Bureau of Labor and Statistics Occupational and Employment Data (May 2016)
http://www.bls.gov/oes/current/oes_md.htm for Category 43-6014 (Secretaries and Administrative Assistants), the mean hourly wage for an administrative assistant is $18.89. [1] We have added
100% of the mean hourly wage to account for fringe and overhead benefits, which calculates to
$37.78 ($18.89 + $18.89). We estimate the total annual cost to be $353,620.80 (9,360 hours x $37.78/hour) and the quarterly burden cost to be $88,405.20 (2,340 hours x $37.78/hour).This estimate includes labor costs for manufacturers to extract data from their information systems and to compile and submit the ASP data, including signature, to CMS via the internet-based automated system and electronic media. We estimate that it will take 10 hours to review instructions and search existing data resources; and 3 hours to gather the data, compile the data, submit via electronic media and upload to the automated system. This estimate also includes the cost of the CD and overnight mail service used to report the data.
Time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection.
We estimate capital costs to be $2,000,000 for the operation and maintenance costs for the automated internet-based data intake system.
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.
The burden hours were changed from 12 to 13 hours. The additional hour is needed for the respondent to upload the ASP data to the internet-based automated system. There will be no changes to the electronic media submission. However, the respondents will be required to submit ASP data through both, the electronic media submission and the automated internet-based data intake system, simultaneously until we have fully transitioned to the automated internet-based data intake system. Screenshots of the automated internet-based system are located within the ASP Data Collection Validation Macro User Guide.
Publication/Tabulation Dates
N/A Manufacturer reporting requirements are described in section 1847A(f) of the Social Security Act which points to section 1927(b)(3). ASP data is considered confidential as described in subparagraph (D). We are not permitted to release manufacturers’ ASP data.
The Medicare Part B ASP website lists the calculated ASP+6% that includes ASP data from all manufacturers (once CMS calculates prices for products categorized into the same HCPCS code). The published data is the volume weighted average of manufacturer submitted data for products within the same HCPCS code. The reported ASP for an individual manufacturer’s product is not listed.
Expiration Date
We plan to display the expiration date on both applications internet based and electronic based.
Certification Statement
There are no exceptions for the certification statement.
There will be no statistical methods employed in the collection of information. The universe for the data collection is all Medicare Part B drug manufacturers.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement – Part A |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-21 |