Section 1927 of the Social Security
Act (the Act) requires drug labelers 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 fill in the
information on the related documents. The drug manufacturer must
also supply information within 30 days after the end of each
calendar quarter and month on the average manufacturer price of the
drugs. Under the Medicaid program, states may provide coverage of
prescribed drugs as an optional service under section 1905(a)(12)
of the Social Security Act (the Act). Section 1903(a) of the Act
provides for federal financial participation (FFP) in state
expenditures for these drugs. Section 1927 of the Act governs the
Medicaid Drug Rebate (MDR) Program and payment for covered
outpatient drugs (CODs), which are defined in section 1927(k)(2) of
the Act. In general, for payment to be made available under section
1903(a) of the Act for CODs, manufacturers must enter into a
National rebate agreement (agreement) as set forth in section
1927(a) of the Act. Section 1927 of the Act provides specific
requirements for rebate agreements, drug pricing submission and
confidentiality requirements, the formulas for calculating rebate
payments, and requirements for states for CODs.
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
In this iteration, two fields
(ACA Base AMP and DRA Base AMP) are being removed from Form 367c
because the fields are no longer collected. We also propose to
remove two one-time requirements. Additionally, several data
definitions as well as verbiage have been updated on all the forms
(367a-d) in order to provide better clarification for labelers. We
have also adjusted the number of respondents due to an increase in
the number of participating labelers. Overall, our total time
estimate has decreased by -3,082,033 hours from our active estimate
of 3,618,703 hours to our proposed estimate of 536,670 hours (see
section 15 of this Supporting Statement for details).
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-367d Supplemental Data Sheet (CMS-367d)
CMS-367 - Supporting Statement A (2019 version 3).docx
DDR Quarterly Pricing Data Specifications (CMS-367a)