The Medicare Prescription Drug,
Improvement, and Modernization Act (MMA) of 2003 created section
1847A of the Social Security Act (SSA), enacting the Average Sales
Price (ASP) payment methodology for the vast majority of separately
payable Medicare Part B drugs. The MMA also amended section
1927(b)(3)(A) to include a provision for drug manufacturers to
report Average Sales Price (ASP) data for certain drugs. This
information collection implements these provisions. The Centers for
Medicare and Medicaid Services (CMS) began collecting ASP data from
manufacturers in 2004. This information specifies the data elements
and forms that manufacturers will use to submit the required data
and to certify the accuracy of the submitted data. In addition to
sales data, this form collects descriptive data elements that are
used to convert the ASP data to the Medicare billing codes and
payment amounts, and to determine the applicable payment
methodology. The collected data will be used as permitted by
section 1847A and section 1927 of the SSA as amended.
The increase in reporting
burden arises from the CMS's need to apply appropriate payments for
single source drugs and biologicals. This need is not new; the
original ASP statute requires a calculation of separate payment
amounts for single source drugs and biologicals. Section 1847A
specifies that the payment amount for single source drugs and
biologicals is determined based on the ASP for the single source
drug or biological product. Single source drugs and biologicals, as
defined in the ASP statute, are identified by their FDA approval
status, which is shown by a number assigned by the DHHS Food and
Drug Administration (FDA). Therefore, to appropriately identify
single source drugs and biologicals for purposes of calculating
payment, CMS must identify and associate the FDA approval number of
a product with the applicable ASP data. These data are not
available to CMS from an existing source. Therefore, CMS must
collect these data directly from manufacturers.
$200,000
No
No
Uncollected
Uncollected
No
Uncollected
Bonnie Harkless
4107865666
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.
CROSSWALK DOCUMENT FOR CMS 10110 110708.doc
ASPData revised _AddendumA revised 2009 with example data 112108.xls
ASPData revised _AddendumA revised 2009 with example data 110108.csv
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)