[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8679-8681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04061]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-70, CMS-R-72, CMS-1557, and CMS-10185]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services.

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 April 30, 2018.

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.

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    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 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: William 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-R-70 Information Collection Requirements in HSQ-110, Acquisition, 
Protection and Disclosure of Peer review Organization Information and 
Supporting Regulations
CMS-R-72 Information Collection Requirements in 42 CFR 478.18, 478.34, 
478.36, 478.42, QIO Reconsiderations and Appeals
CMS-1557 Survey Report Form for Clinical Laboratory Improvement 
Amendments (CLIA) and Suporting Regulations
CMS-10185 Medicare Part D Reporting Requirements and Supporting 
Regulations

    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: Extension of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements in HSQ-110, Acquisition, Protection and 
Disclosure of Peer review Organization Information and Supporting 
Regulations; Use: The Peer Review Improvement Act of 1982 authorizes 
quality improvement organizations (QIOs), formally known as peer review 
organizations (PROs), to acquire information necessary to fulfill their 
duties and functions and places limits on disclosure of the 
information. The QIOs are required to provide notices to the affected 
parties when disclosing information about them. These requirements 
serve to protect the rights of the affected parties. The information 
provided in these notices is used by the patients, practitioners and 
providers to: Obtain access to the data maintained and collected on 
them by the QIOs; add additional data or make changes to existing QIO 
data; and reflect in the QIO's record the reasons for the QIO's 
disagreeing with an individual's or provider's request for amendment. 
Form Number: CMS-R-70 (OMB control number: 0938-0426); Frequency: 
Reporting--On occasion; Affected Public: Business or other for-profits; 
Number of Respondents: 400; Total Annual Responses: 21,200; Total 
Annual Hours: 42,400. (For policy questions regarding this collection 
contact Tennille Coombs at 410-786-3472.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements in 42 CFR 478.18, 478.34, 478.36, 478.42, QIO 
Reconsiderations and Appeals; Use: In the event that a beneficiary, 
provider, physician, or other practitioner does not agree with the 
initial determination of a Quality Improvement Organization (QIO) or a 
QIO subcontractor, it is within that party's rights to request 
reconsideration. The information collection requirements 42 CFR 478.18, 
478.34, 478.36, and 478.42, contain procedures for QIOs to use in 
reconsideration of initial determinations. The information requirements 
contained in these regulations are on QIOs to provide information to 
parties requesting the reconsideration. These parties will use the 
information as guidelines for appeal rights in instances where issues 
are actively being disputed. Form Number: CMS-R-72 (OMB control number: 
0938-0443); Frequency: Reporting--On occasion; Affected Public: 
Individuals or Households and Business or other for-profit 
institutions; Number of Respondents: 2,590; Total Annual Responses: 
5,228; Total Annual Hours: 2,822. (For policy questions regarding this 
collection contact Tennille Coombs at 410-786-3472).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Survey Report 
Form for Clinical Laboratory Improvement Amendments (CLIA) and 
Supporting Regulations; Use: The form is used to report surveyor 
findings during a CLIA survey. For each type of survey conducted (i.e., 
initial certification, recertification, validation, complaint, 
addition/deletion of specialty/subspecialty, transfusion fatality 
investigation, or revisit inspections) the Survey Report Form 
incorporates the requirements specified in the CLIA regulations. Form 
Number: CMS-1557 (OMB control number: 0938-0544); Frequency: 
Biennially; Affected Public: Private sector (Business or other for-
profit and Not-for-profit institutions, State, Local or Tribal 
Governments and Federal Government); Number of Respondents: 19,183; 
Total Annual Responses: 9,592; Total Annual Hours: 4,796. (For policy 
questions regarding this collection contact Kathleen Todd at 410-786-
3385).
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements and Supporting Regulations; Use: Data collected 
via Medicare Part D Reporting Requirements is an integral resource for 
oversight, monitoring, compliance and auditing activities necessary to 
ensure quality provision of the Medicare Prescription Drug Benefit to 
beneficiaries. Each section is reported at one of the following levels: 
Contract (data should be entered at the H#, S#, R#, or E# level) or 
Plan (data should be entered at the Plan Benefit Package (PBP level, 
e.g. Plan 001 for contract H#, R#, S#, or E). Sponsors should retain 
documentation and data records related to their data submissions. Data 
will be validated, analyzed, and utilized for trend reporting by the 
Division of Clinical and Operational Performance (DCOP) within the 
Medicare Drug Benefit and C & D Data Group. If outliers or other data 
anomalies are detected, DCOP will work in collaboration with other 
Divisions within CMS for follow-up and resolution.
    For CY2019 Reporting Requirements, the following 6 reporting 
sections will be reported and collected at the

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Contract-level or Plan-level: (1) Enrollment and Disenrollment--to 
evaluate sponsors' processing of enrollment, disenrollment, and 
reinstatement requests in accordance with CMS requirements. (2) 
Medication Therapy Management (MTM) Programs--to evaluate Part D MTM 
programs, and sponsors' adherence to CMS requirements. (3) Grievances--
to assess sponsors' compliance with timely and appropriate resolution 
of grievances filed by their enrollees. (4) Improving Drug Utilization 
Review Controls--to determine the impact of formulary-level edits at 
point of sale in sponsors' processing of opioid prescriptions. (5) 
Coverage Determinations and Redeterminations--to assess sponsors' 
compliance with appropriate resolution of coverage determinations and 
redeterminations requested by their enrollees. (6) Employer/Union 
Sponsored Sponsors--to ensure PDPs and the employer groups that 
contract with the PDPs properly utilize appropriate waivers and 
modifications.
    Form Number: CMS-10185 (OMB control number: 0938-0992); Frequency: 
Annually and semi-annually; Affected Public: Private sector (Business 
or other for-profits); Number of Respondents: 627; Total Annual 
Responses: 13,603; Total Annual Hours: 14,748. (For policy questions 
regarding this collection contact Chanelle Jones at 410-786-8008.)

    Dated: February 23, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-04061 Filed 2-27-18; 8:45 am]
 BILLING CODE 4120-01-P