Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations

ICR 201710-0938-002

OMB: 0938-0921

Federal Form Document

ICR Details
0938-0921 201710-0938-002
Active 201603-0938-002
HHS/CMS CMS-10110
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations
Revision of a currently approved collection   No
Regular
Approved with change 02/27/2018
Retrieve Notice of Action (NOA) 10/05/2017
  Inventory as of this Action Requested Previously Approved
02/28/2021 36 Months From Approved 08/31/2019
720 0 720
9,360 0 8,640
0 0 0

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 of 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. In the CY2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. We also initiated additional changes to the template in 2008 (73 FR 76032). In order to facilitate more accurate and consistent ASP data reporting from manufacturers, we are now proposing revisions to the Addendum A template. Specifically, we propose to revise existing reporting fields and add new fields to the Addendum A template, as follows: o To split the current NDC column into three separate reporting fields, corresponding to the three segments of an NDC: the labeler, product, and trade package size; o To add a new field to collect an Alternate ID for products without an NDC; and o To expand the current FDA approval number column to account for multiple entries and supplemental numbers. We have also added a macro to the Addendum A template that will allow manufacturers to validate the format of their data prior to submission. This will help verify that data are complete and submitted to CMS in the correct format, thereby minimizing time and resources spent on identifying mistakes or errors. A User Guide containing general instructions on the use of the template and instructions for the reporting of dermal grafting products has also been created.

US Code: 42 USC 1395u(o) Name of Law: null
   US Code: 42 USC 1395(a)(1)(S) Name of Law: null
   US Code: 42 USC 1395w-3 Name of Law: null
   PL: Pub.L. 108 - 17 303 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   Statute at Large: 18 Stat. 1847 Name of Statute: null
   Statute at Large: 19 Stat. 1927 Name of Statute: null
  
None

Not associated with rulemaking

  82 FR 35530 07/31/2017
82 FR 46245 10/04/2017
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 720 720 0 0 0 0
Annual Time Burden (Hours) 9,360 8,640 0 0 720 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.

$2,239,300
No
    No
    No
No
No
No
Uncollected
Kayla Williams 410 786-5887 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
10/05/2017


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