Instruments (at
minimum, the first data entry screen) must display the OMB control
number, the expiration date, and the public burden statement.
Inventory as of this Action
Requested
Previously Approved
06/30/2017
36 Months From Approved
09/30/2016
10,370
0
9,440
156,343
0
139,712
0
0
0
Section 1927 requires drug
manufactures to enter into and have in effect a rebate agreement
with the Federal Government for States to receive funding for drugs
dispensed to Medicaid recipients. In order for payment to be made
under Medicaid, the drug labeler must complete and sign a drug
rebate agreement and fillin the information on the related
documents. The Affordable Care Act (ACA) added two new data
elements to potentially be reported by manufacturers, a Pediatric
Exclusivity product indicator and a new optional "ACA base AMP"
field. Additionally, per the ACA, the Federal upper limit (FUL)
will be calculated as no less than 175 percent of the weighted
average of the most recently reported monthly AMP. Section 1927 of
the Act requires manufacturers to report the total number of units
that are used to calculate monthly AMP for each covered outpatient
drug no later than 30 days after the last day of the month. We plan
to require manufacturers to report these units by the same unit
type used to calculate the AMP and to use these units to calculate
the weighted-AMP-based FULs prices.
Statute at
Large: 19
Stat. 1927 Name of Statute: null
PL: Pub.L. 111 - 148 2503 Name of Law:
Patient Protection and Affordable Care Act
PL: Pub.L. 111 - 226 202 Name of Law: Education Jobs and Medicaid
Assistance Act
We have adjusted the number of
respondents from 590 to 610 (or +20 respondents). We are also
adding one field to form CMS-367b (5i Threshold); five fields to
form CMS-367c (5i Drug Indicator, 5i Route of Administration,
Covered Outpatient Drug (COD) Status, FDA Application Number/OTC
Monograph Number, and optional ACA Base AMP); and two optional
e-mail address fields on CMS-367d for the legal contact and the
invoice contact. As a result of the new fields added to form 367c,
we are removing the DESI Indicator field, which is no longer
needed. The new optional e-mail fields, the Reactivation Date and
the ACA Baseline AMP field are voluntary. The burden associated
with the reporting of each of these fields is negligible;
therefore, no explicit burden increase is expected. The increased
burden associated with adjusting the number of respondents amounts
to +320 responses/year or +4,736 hr (aggregate). The increased
burden associated with each of the other new fields amounts to +610
responses or +11,895 hr (aggregate).
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-367 Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)
CMS-367 - Supporting Statement A [rev 4-11-2014 by OSORA PRA].docx
Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)