[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40106-40107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-304/CMS-304a, CMS-368/CMS-R-144 and CMS-
10517]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow

[[Page 40107]]

a second opportunity for public comment on the notice. Interested 
persons are invited to send comments regarding the burden estimate or 
any other aspect of this collection of information, including any of 
the following subjects: (1) The necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions; (2) the accuracy of the estimated burden; (3) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and (4) the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by August 11, 2014.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions:
    OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, Fax Number: (202) 395-5806 OR, Email: [email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Reconciliation of 
State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304 
(Reconciliation of State Invoice) is used by manufacturers to respond 
to the state's rebate invoice for current quarter utilization. Form 
CMS-304a (Prior Quarter Adjustment Statement) is required only in those 
instances where a change to the original rebate data submittal is 
necessary. Form Number: CMS-304 and -304a (OMB control number: 0938-
0676); Frequency: Quarterly; Affected Public: Private sector--Business 
or other for-profits; Number of Respondents: 1,037; Total Annual 
Responses: 4,148; Total Annual Hours: 187,880. (For policy questions 
regarding this collection contact Andrea Wellington at 410-786-3490.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program Forms; Use: We develop the rebate amount per drug unit 
from information supplied by the drug manufacturers and distributes 
these data to the states. States then must report quarterly to the drug 
manufacturers and report to us the total number of units of each dosage 
form/strength of their covered outpatient drugs reimbursed during a 
quarter and the rebate amount to be refunded. This report is due within 
60 days of the end of each calendar quarter. The information in the 
report is based on claims paid by the state Medicaid agency during a 
calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required 
from states quarterly to report utilization for any drugs paid for 
during that quarter. Form CMS-368 (Administrative Data) is required 
only in those instances where a change to the original data submittal 
is necessary. Form Number: CMS-368 and -R-144 (OMB control number: 
0938-0582); Frequency: Quarterly; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 56; Total Annual Responses: 
224; Total Annual Hours: 12,101. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)
    3. Type of Information Collection Request: New collection (Request 
for a new control number); Title of Information Collection: The 
Predictive Learning Analytics Tracking Outcome (PLATOTM); 
Use: The Predictive Learning Analytics Tracking Outcome (PLATO\TM\) is 
a web-based application tool that will serve as the centerpiece of the 
advanced analytics initiative with the Centers for Medicare & Medicaid 
Services (CMS) and Health Integrity, LLC, the National Benefit 
Integrity Medicare Integrity Contractor (NBI MEDIC). Developed by 
Health Integrity, LLC and licensed for one of its contracts--the NBI 
MEDIC--PLATO\TM\ utilizes a cutting-edge advanced analytics fraud 
detection process in conjunction with a state-of-the-art web-based user 
interface tool to present fraud and abuse lead information visually to 
Medicare Part D plan sponsors. Summary data, based on National 
Prescription Drug Event Data and actions from all Part D plan sponsors, 
is shared with law enforcement, CMS, NBI MEDIC, and Part D plan 
sponsors to review historic actions taken against providers who are 
enrolled in the Medicare Part D program, which will assist in detecting 
and preventing fraud, waste, and abuse. Form Number: CMS-10517 (OMB 
control number: 0938--New); Frequency: Monthly; Affected Public: 
Private sector--Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 1,550; Total Annual Responses: 
1,550; Total Annual Hours: 18,600. (For policy questions regarding this 
collection contact Delois Newkirk at 410-786-1247.)

    Dated: July 3, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2014-16083 Filed 7-10-14; 8:45 am]
BILLING CODE 4120-01-P