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
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)