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)