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
The current ICR (approved April
4, 2016) had set out one IC. This July 2016 iteration breaks out
the requirements and burden into six ICs. This is intended to
provide a clearer picture of the components within this information
collection request. The only program/burden change is specific to
CMS-367c which adds 6,100 hours for the narrow exception process
(see Supporting Statement section 15). There are no program/burden
changes with regard to CMS-367a, CMS-367b, CMS-367d, the
reconfiguration of labeler drug pricing systems, and the training
of drug manufacturer staff.
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-367a DDR Quarterly Pricing Data Specifications (CMS-367a)
CMS-367 - Supporting Statement A [rev 07-17-2016 by OSORA PRA].docx
DDR Quarterly Pricing Data Specifications (CMS-367a)