[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76577-76578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25890]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifiers: CMS-304/-304a, CMS-367a--d, and CMS-368/-R-144]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare and Medicaid Services, Health and Human 
Services (HHS).

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by January 29, 2021.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development Attention: Document Identifier/OMB 
Control Number ____, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html
    2. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-304/-304a Reconciliation of State Invoice (ROSI) and Prior Quarter 
Adjustment Statement (PQAS)
CMS-367a-d Medicaid Drug Rebate Program Labeler Reporting Format
CMS-368/-R-144 Medicaid Drug Rebate Program State Reporting Forms

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Reconciliation of 
State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQAS); 
Use: Form CMS-304 (ROSI) is used by manufacturers to respond to the 
state's rebate invoice for current quarter utilization. Form CMS-304a 
(PQAS) is required only in those instances where a change to the 
original rebate data submittal is necessary. Effective July 1, 2021, 
the Medicaid Drug Rebate Program (MDRP) is updating to a new Medicaid 
Drug Programs (MDP) system which will now accept a delimited text file 
format, Comma Separated Values (.CSV), in addition to the current Text 
(.TXT) file format. We have also increased several file format data 
field sizes in order to accommodate the higher priced drugs that are 
entering the market. These changes in conjunction with numerous edits 
to verbiage are applicable to Forms CMS-304 and -304a. Separately, we 
are also updating corresponding collection of information requests (OMB 
0938-0578 and OMB 0938-0582) so that all the MDP file formats, field 
sizes, and verbiage will align across the MDRP. 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: 749; Total Annual Responses: 5,841; Total Annual Hours: 
248,584. (For policy questions regarding this collection contact Andrea 
Wellington at 410-786-3490.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program Labeler Reporting Format; Use: Labelers transmit drug 
product and pricing data to CMS within 30 days after the end of each 
calendar month and quarter. CMS calculates the unit rebate amount (URA) 
and the unit rebate offset amount (UROA) for each new drug application 
(NDC) and distributes to all State Medicaid agencies. States use the 
URA to invoice the labeler for rebates and the UROA to report onto CMS-
64. The monthly data is used to calculate Federal Upper Limit (FUL) 
prices for applicable drugs and for states that opt to use this data to 
establish their pharmacy reimbursement methodology. Effective July 1, 
2021, the MDRP is updating to a new Medicaid Drug Programs (MDP) system 
which will now accept a delimited text file format, Comma Separated 
Values (.CSV), in addition to the current Text

[[Page 76578]]

(.TXT) file format. We have also increased several file format data 
field sizes in order to accommodate the higher priced drugs that are 
entering the market. These changes in conjunction with numerous edits 
to verbiage are applicable to Forms CMS-367a (Quarterly Pricing), CMS-
367b (Monthly Pricing), CMS-367c (Product Data), and CMS-367d 
(Manufacturer Contact Form). Separately, we are also updating 
corresponding collection of information requests (OMB 0938-0582 and OMB 
0938-0676) so that all the MDP file formats, field sizes, and verbiage 
will align across the MDRP. Form Number: CMS-367a, b, c, and d (OMB 
control number: 0938-0578); Frequency: Monthly, quarterly, and on 
occasion; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 749; Total Annual Responses: 14,980; 
Total Annual Hours: 558,979. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate Program State Reporting Forms; Use: Form CMS 368 is a report of 
contact for the State to name the individuals involved in the Medicaid 
Drug Rebate Program (MDRP) and is required only in those instances 
where a change to the originally submitted data is necessary. The 
ability to require the reporting of any changes to these data is 
necessary to the efficient operation of these programs. Form CMS-R-144 
is required from States quarterly to report utilization for any drugs 
paid for during that quarter. Effective July 1, 2021, the MDRP is 
updating to a new Medicaid Drug Programs (MDP) system which will now 
accept a delimited text file format, Comma Separated Values (.CSV), in 
addition to the current Text (.TXT) file format. We have also increased 
several file format data field sizes in order to accommodate the higher 
priced drugs that are entering the market. These changes in conjunction 
with numerous edits to verbiage are applicable to Form CMS-R-144. 
Separately, we are also updating corresponding collection of 
information requests (OMB 0938-0578 and OMB 0938-0676) so that all the 
MDP file formats, field sizes, and verbiage will align across the MDRP. 
Form CMS-368 has been revised by removing the DUR State Contact 
information and description ``Drug Utilization Review (DUR) Program.'' 
This information is now accounted for under OMB 0938-0659. Form Number: 
CMS-368 and -R-144 (OMB control number: 0938-0582); Frequency: 
Quarterly and on occasion; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 56; Total Annual Responses: 290; 
Total Annual Hours: 13,669. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)

    Dated: November 18, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-25890 Filed 11-27-20; 8:45 am]
BILLING CODE 4120-01-P