83 FR 8679 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 40 (February 28, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 40 (February 28, 2018)
| Page Range | 8679-8681 | |
| FR Document | 2018-04061 |
[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)] [Notices] [Pages 8679-8681] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04061] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. [[Page 8680]] 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 [[Page 8681]] 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
![Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices 8679
based on which state issued the driver’s We cannot assume responsibility for DEPARTMENT OF HEALTH AND
license. For detailed information, please coordinating the receipt, transfer, HUMAN SERVICES
refer to the Department of Homeland transport, storage, set-up, safety, or
Security (DHS) website: At http:// timely arrival of any personal Centers for Medicare & Medicaid
www.dhs.gov. When planning a visit to belongings or items used for Services
a federal facility, visitors who have demonstration or to support a [Document Identifiers: CMS–R–70, CMS–R–
further questions about acceptable forms presentation. Special arrangements and 72, CMS–1557, and CMS–10185]
of identification are encouraged to approvals are required at least 2 weeks
contact the facility to determine prior to each public meeting to bring Agency Information Collection
acceptable identification. pieces of equipment or medical devices. Activities: Proposed Collection;
Participants will also be subject to a Comment Request
These arrangements need to be made
vehicle security inspection before access with the public meeting coordinator. It AGENCY: Centers for Medicare &
to the complex is granted. Participants is possible that certain requests made in Medicaid Services, Department of
not in possession of a valid advance of the public meeting could be Health and Human Services.
identification or who are in possession
denied because of unique safety, ACTION: Notice.
of prohibited items will be denied
security or handling issues related to the
access to the complex. Prohibited items SUMMARY: The Centers for Medicare &
on federal property include but are not equipment. A minimum of 2 weeks is
Medicaid Services (CMS) is announcing
limited to, alcoholic beverages, illegal required for approvals and security
an opportunity for the public to
narcotics, explosives, firearms or other procedures. Any request not submitted comment on CMS’ intention to collect
dangerous weapons (including pocket at least 2 weeks in advance of the public information from the public. Under the
knives), dogs or other animals except meeting will be denied. Paperwork Reduction Act of 1995 (the
service animals. Once cleared for entry Foreign National Visitors are defined PRA), federal agencies are required to
to the complex participants will be as Non-US Citizens, and non-lawful publish notice in the Federal Register
directed to visitor parking by a security permanent residents, non-resident concerning each proposed collection of
officer. aliens or non-green-card holders. information (including each proposed
To ensure expedited entry into the Attendees that are foreign nationals extension or reinstatement of an existing
building it is recommended that collection of information) and to allow
must identify themselves as such, and
participants have their ID and a copy of 60 days for public comment on the
provide the following information for
their written meeting registration proposed action. Interested persons are
security clearance to the public meeting invited to send comments regarding our
confirmation readily available and that
they do not bring large/bulky items into coordinator by the date specified in the burden estimates or any other aspect of
DATES section of this notice: this collection of information, including
the building. Participants are reminded
that photography on the CMS complex • Building to Visit/Destination. the necessity and utility of the proposed
is prohibited. We have also been • Visit start date, start time, end date, information collection for the proper
declared a tobacco free campus and end time. performance of the agency’s functions,
violators are subject to legal action. In the accuracy of the estimated burden,
planning arrival time, we recommend • Visitor full name. ways to enhance the quality, utility, and
allowing additional time to clear • Gender. clarity of the information to be
security. Individuals who are not • Visitor Title. collected, and the use of automated
registered in advance will not be collection techniques or other forms of
permitted to enter the building and will • Visitor Organization/Employer. information technology to minimize the
be unable to attend the meeting. The • Citizenship. information collection burden.
invited guests may not enter the • Birth Place (City, Country). DATES: Comments must be received by
building earlier than 45 minutes before April 30, 2018.
• Date of Birth.
the convening of the meeting each day. ADDRESSES: When commenting, please
Guest access to the complex is limited • ID Type (Passport or State reference the document identifier or
to the meeting area, the main entrance Department ID). OMB control number. To be assured
lobby, and the cafeteria. If a visitor is • Passport issued by Country. consideration, comments and
found outside of those areas without recommendations must be submitted in
• ID (passport) Number.
proper escort they may be escorted off any one of the following ways:
of the premises. Also be mindful that • ID (passport) issue date. 1. Electronically. You may send your
there will be an opportunity for • ID (passport) expiration date. comments electronically to http://
everyone to speak and we request that • Visa Type. www.regulations.gov. Follow the
everyone waits for the appropriate time instructions for ‘‘Comment or
to present their product or opinions. • Visa Number. Submission’’ or ‘‘More Search Options’’
Disruptive behavior will not be tolerated • Purpose of Visit. to find the information collection
and may result in removal from the document(s) that are accepting
Dated: February 21, 2018.
meetings and escort from the complex. comments.
No visitor is allowed to attach USB Seema Verma, 2. By regular mail. You may mail
cables, thumb drives or any other Administrator, Centers for Medicare & written comments to the following
sradovich on DSK3GMQ082PROD with NOTICES
equipment to any CMS information Medicaid Services. address: CMS, Office of Strategic
technology (IT) system or hardware for [FR Doc. 2018–04105 Filed 2–27–18; 8:45 am] Operations and Regulatory Affairs
any purpose at any time. Additionally, BILLING CODE 4120–01–P Division of Regulations Development,
our staff is prohibited from taking such Attention: Document Identifier/OMB
actions on behalf of a visitor or utilizing Control Number, Room C4–26–05, 7500
any removable media provided by a Security Boulevard, Baltimore,
visitor. Maryland 21244–1850.
VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\28FEN1.SGM 28FEN1](https://thefederalregister.org/doc/83_FR_8719/page/1.svg)
![Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices 8681
Contract-level or Plan-level: (1) DEPARTMENT OF HEALTH AND from all respondents, data collection
Enrollment and Disenrollment—to HUMAN SERVICES will include: (1) A survey of parent
evaluate sponsors’ processing of program participants at enrollment
enrollment, disenrollment, and Administration for Children and (baseline), (2) a follow-up survey of
reinstatement requests in accordance Families parent program participants at 6 and 12
with CMS requirements. (2) Medication months, (3) the MUSE Family Resources
Proposed Information Collection Check-in administered to parent
Therapy Management (MTM) Activity; Comment Request
Programs—to evaluate Part D MTM program participants at baseline and 12
programs, and sponsors’ adherence to Title: Multi-site Implementation months (4) a Rapid Reflect self-
CMS requirements. (3) Grievances—to Evaluation of Tribal Home Visiting completed questionnaire completed by
assess sponsors’ compliance with timely (MUSE). parent program participants after
and appropriate resolution of grievances OMB No.: New Collection. selected home visits; (5) a Rapid Reflect
Description: The Administration for self-completed questionnaire completed
filed by their enrollees. (4) Improving
Children and Families (ACF) within the by home visitors after selected home
Drug Utilization Review Controls—to U.S. Department of Health and Human visits; (6) a one-time survey of home
determine the impact of formulary-level Services has launched a national multi- visitors; (7) a one-time survey of
edits at point of sale in sponsors’ site evaluation of Tribal Maternal, program coordinators/managers; (8) a
processing of opioid prescriptions. (5) Infant, and Early Childhood Home one-time survey of program directors;
Coverage Determinations and Visiting (TMIECHV) programs. MUSE is (9) a one-time survey of local program
Redeterminations—to assess sponsors’ the first multi-site, multi-model study evaluators; (10) qualitative interviews of
compliance with appropriate resolution that will systematically explore how home visitors at each site; (11)
of coverage determinations and home visiting programs are operating qualitative interviews of program
redeterminations requested by their across diverse tribal contexts and coordinators/managers and program
enrollees. (6) Employer/Union identify factors that lead to programs’ directors at each site; (12) qualitative
Sponsored Sponsors—to ensure PDPs success. The evaluation will provide interviews of local program evaluators
and the employer groups that contract information that will help the federal at each site; (13) qualitative interviews
with the PDPs properly utilize government design and support federal of program participants; (14) a log of
appropriate waivers and modifications. home visiting initiatives in tribal implementation activities completed by
communities and similar populations. program coordinators/managers on
Form Number: CMS–10185 (OMB Evaluation findings will also assist
control number: 0938–0992); Frequency: staffing, training, family group
programs with improving home visiting activities, and supervision; and (15)
Annually and semi-annually; Affected services for children and families. The electronic compilation and submission
Public: Private sector (Business or other aims of MUSE are to (1) identify and of administrative program data.
for-profits); Number of Respondents: describe the primary influences shaping
627; Total Annual Responses: 13,603; All data collection will be used to
tribal home visiting program planning;
Total Annual Hours: 14,748. (For policy generate information about how tribal
(2) identify and describe how home
questions regarding this collection home visiting program services are
visiting programs are being
planned and delivered, and about what
contact Chanelle Jones at 410–786– implemented; and (3) explore supports
individual, organizational, community,
8008.) to home visiting implementation in
and external factors support successful
Dated: February 23, 2018. tribal communities. To address these
program implementation.
aims, the evaluation will gather data
William N. Parham, III, Respondents: Parent participants
about participating home visiting
Director, Paperwork Reduction Staff, Office programs from program staff and parent enrolled in TMIECHV programs and
of Strategic Operations and Regulatory program participants and utilize TMIECHV program staff (program
Affairs. administrative program data. directors, program coordinators/
[FR Doc. 2018–04061 Filed 2–27–18; 8:45 am] The current Notice is specific to data managers, home visitors, and local
BILLING CODE 4120–01–P collection efforts needed to address the program evaluators).
MUSE aims. Quantitative and Annual Burden Estimates
qualitative data will be collected from
program staff and parent program We will request approval for three
participants at each program site. years, which will accommodate an
Program sites will also submit local approximate two-year data collection
administrative data to the evaluation period and any potential delays in the
team. After obtaining informed consent data collection timeline.
Annual Number of Average
Total number of Annual
Instrument number of responses per burden hours
respondents burden hours
respondents respondent per response
Participant Survey—Baseline ........................................ 423 141 1 .25 35
Participant Survey—6 & 12 Month Follow-up ............... 312 104 2 .50 104
Family Resources Check-in—Baseline and 12 Month
sradovich on DSK3GMQ082PROD with NOTICES
Follow-up .................................................................... 354 118 2 .25 59
Rapid Reflect Self-Completed Home Visit Question-
naire for Participants .................................................. 1,394 1 697 12 .08 669
Rapid Reflect Self Completed Home Visit Question-
naire for Home Visitors .............................................. 93 1 47 180 .2 1,692
Home Visitor Survey ...................................................... 81 27 1 1.17 32
Program Coordinator/Manager Survey .......................... 21 7 1 1 7
Program Director Survey ............................................... 21 7 1 1 7
VerDate Sep<11>2014 17:25 Feb 27, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\28FEN1.SGM 28FEN1](https://thefederalregister.org/doc/83_FR_8719/page/3.svg)
Document Created: 2018-02-28 03:20:05
Document Modified: 2018-02-28 03:20:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by April 30, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 8679 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR