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.
The burden hours were increased due to agency discretion to include collection of additional data elements. The increase in reporting burden arises from the Agency's (CMS's) need to apply appropriate payments for drugs and biologicals. This need is not new; the original ASP statute requires a calculation of payment amounts for drugs and biologicals. Section 1847A specifies that the payment amount for drugs and biologicals is determined based on the ASP for the products as submitted by manufacturers. These data are proprietary. Therefore, CMS must collect these data directly from manufacturers.
$200,000
No
No
No
No
No
Uncollected
William Parham 4107864669
Reginfo record details
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.
Form CMS-10110 Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
Disclosure Statement FINAL.docx
CMS-10110 Supporting Statement part A [rev 12-05-2011].doc
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)