[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