83_FR_49006 83 FR 48818 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

83 FR 48818 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 188 (September 27, 2018)

Page Range48818-48819
FR Document2018-20994

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 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 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.

Federal Register, Volume 83 Issue 188 (Thursday, September 27, 2018)
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48818-48819]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10599]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

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 (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 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 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 on the collection(s) of information must be received by 
the OMB desk officer by October 29, 2018.

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

[[Page 48819]]

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' 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: 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: Revision of a currently 
approved collection; Title of Information Collection: Pre-Claim Review 
Demonstration for Home Health Services; Use: Section 402(a)(1)(J) of 
the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)) 
authorizes the Secretary to ``develop or demonstrate improved methods 
for the investigation and prosecution of fraud in the provision of care 
or services under the health programs established by the Social 
Security Act (the Act).'' Pursuant to this authority, the CMS seeks to 
develop and implement a Medicare demonstration project, which CMS 
believes will help assist in developing improved procedures for the 
identification, investigation, and prosecution of Medicare fraud 
occurring among Home Health Agencies (HHA) providing services to 
Medicare beneficiaries.
    This revised demonstration would help assist in developing improved 
procedures for the identification, investigation, and prosecution of 
potential Medicare fraud. The demonstration would help make sure that 
payments for home health services are appropriate through either pre-
claim or postpayment review, thereby working towards the prevention and 
identification of potential fraud, waste, and abuse; the protection of 
Medicare Trust Funds from improper payments; and the reduction of 
Medicare appeals. CMS proposes initially implementing the demonstration 
in Illinois, Ohio, North Carolina, Florida, and Texas with the option 
to expand to other states in the Palmetto/JM jurisdiction. CMS proposes 
starting the demonstration in Illinois on December 10, 2018. Under this 
demonstration, CMS proposes to offer choices for providers to 
demonstrate their compliance with CMS' home health policies. Providers 
in the demonstration states may participate in either 100 percent pre-
claim review or 100 percent postpayment review. These providers will 
continue to be subject to a review method until the HHA reaches the 
target affirmation or claim approval rate. Once a HHA reaches the 
target pre-claim review affirmation or post-payment review claim 
approval rate, it may choose to be relieved from claim reviews, except 
for a spot check of their claims to ensure continued compliance. 
Providers who do not wish to participate in either 100 percent pre-
claim or postpayment reviews have the option to furnish home health 
services and submit the associated claim for payment without undergoing 
such reviews; however, they will receive a 25 percent payment reduction 
on all claims submitted for home health services and may be eligible 
for review by the Recovery Audit Contractor.
    The information required under this collection is required by 
Medicare contractors to determine proper payment or if there is a 
suspicion of fraud. Under the pre-claim review option, HHA will send 
the pre-claim review request along with all required documentation to 
the Medicare contractor for review prior to submitting the final claim 
for payment. If a claim is submitted without a pre-claim review 
decision on file, the Medicare contractor will request the information 
from the HHA to determine if payment is appropriate. For the 
postpayment review option, the Medicare contractor will also request 
the information from the HHA that submitted the claim for payment, to 
determine if payment was appropriate. Comments were received in 
response to the 60-day notice. Form Number: CMS-10599 (OMB control 
number: 0938-1311); Frequency: Occasionally; Affected Public: Private 
Sector (Business or other for-profits and Not-for-profits); Number of 
Respondents: 941,287; Total Annual Responses: 1,330,980; Total Annual 
Hours: 670,375. (For questions regarding this collection contact 
Jennifer McMullen (410) 786-7635).

    Dated: September 21, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-20994 Filed 9-26-18; 8:45 am]
BILLING CODE 4120-01-P



                                               48818                    Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices

                                               CDC announces the following meeting                     However, it is requested that comments                  The Chief Operating Officer, Centers
                                               for the Clinical Laboratory Improvement                 be submitted at least five business days              for Disease Control and Prevention, has
                                               Advisory Committee (CLIAC). This                        prior to the meeting date so that the                 been delegated the authority to sign
                                               meeting is open to the public, limited                  comments may be made available to the                 Federal Register notices pertaining to
                                               only by the space available. The meeting                Committee for their consideration and                 announcements of meetings and other
                                               room accommodates approximately 100                     public distribution. Written comments,                committee management activities, for
                                               people. The public is also welcome to                   one hard copy with original signature,                both the Centers for Disease Control and
                                               view the meeting by webcast. Check the                  should be provided to the contact                     Prevention and the Agency for Toxic
                                               CLIAC website on the day of the                         person at the mailing or email address                Substances and Disease Registry.
                                               meeting for the webcast link http://                    below, and will be included in the
                                                                                                                                                             Sherri Berger,
                                               cdclabtraining.adobeconnect.com/                        meeting’s Summary Report.
                                               cliac/.                                                                                                       Chief Operating Officer, Centers for Disease
                                                                                                          The CLIAC meeting materials will be                Control and Prevention.
                                               DATES: The meeting will be held on                      made available to the Committee and
                                                                                                                                                             [FR Doc. 2018–21083 Filed 9–26–18; 8:45 am]
                                               November 7, 2018, 8:30 a.m. to 5:30                     the public in electronic format (PDF) on
                                                                                                                                                             BILLING CODE 4163–19–P
                                               p.m., EST and November 8, 2018, 8:30                    the internet instead of by printed copy.
                                               a.m. to 1:00 p.m., EST.                                 Check the CLIAC website on the day of
                                               ADDRESSES: CDC, 2500 Century Parkway                    the meeting for materials: https://                   DEPARTMENT OF HEALTH AND
                                               NE, Rooms 1200/1201, Atlanta, Georgia                   wwwn.cdc.gov/cliac/.                                  HUMAN SERVICES
                                               30345 and http://cdclabtraining.adobe                      Purpose: This Committee is charged
                                               connect.com/                                            with providing scientific and technical               Centers for Medicare & Medicaid
                                               cliac/.                                                 advice and guidance to the Secretary of               Services
                                               FOR FURTHER INFORMATION CONTACT:                        Health and Human Services (HHS); the
                                                                                                                                                             [Document Identifier: CMS–10599]
                                               Nancy Anderson, MMSc, MT(ASCP),                         Assistant Secretary for Health; the
                                               Senior Advisor for Clinical Laboratories,               Director, Centers for Disease Control                 Agency Information Collection
                                               Division of Laboratory Systems, Center                  and Prevention; the Commissioner,                     Activities: Submission for OMB
                                               for Surveillance, Epidemiology and                      Food and Drug Administration (FDA);                   Review; Comment Request
                                               Laboratory Services, Office of Public                   and the Administrator, Centers for
                                               Health Scientific Services, Centers for                 Medicare and Medicaid Services (CMS).                 AGENCY: Centers for Medicare &
                                               Disease Control and Prevention, 1600                    The advice and guidance pertain to                    Medicaid Services, HHS.
                                               Clifton Road NE, Mailstop F–11,                         general issues related to improvement in              ACTION: Notice.
                                               Atlanta, Georgia 30329–4027, telephone                  clinical laboratory quality and
                                               (404) 498–2741; NAnderson@cdc.gov.                      laboratory medicine practice and                      SUMMARY:    The Centers for Medicare &
                                                                                                       specific questions related to possible                Medicaid Services (CMS) is announcing
                                               SUPPLEMENTARY INFORMATION: All people
                                                                                                       revision of the Clinical Laboratory                   an opportunity for the public to
                                               attending the CLIAC meeting in-person
                                                                                                       Improvement Amendment (CLIA)                          comment on CMS’ intention to collect
                                               are required to register for the meeting
                                                                                                       standards. Examples include providing                 information from the public. Under the
                                               online at least five business days in
                                                                                                       guidance on studies designed to                       Paperwork Reduction Act of 1995
                                               advance for U.S. citizens and at least 15
                                                                                                       improve safety, effectiveness, efficiency,            (PRA), federal agencies are required to
                                               business days in advance for
                                                                                                       timeliness, equity, and patient-                      publish notice in the Federal Register
                                               international registrants. Register at:
                                                                                                       centeredness of laboratory services;                  concerning each proposed collection of
                                               https://wwwn.cdc.gov/cliac/. Register by
                                                                                                       revisions to the standards under which                information, including each proposed
                                               scrolling down and clicking the
                                                                                                       clinical laboratories are regulated; the              extension or reinstatement of an existing
                                               ‘‘Register for this Meeting’’ button and
                                                                                                       impact of proposed revisions to the                   collection of information, and to allow
                                               completing all forms according to the
                                                                                                       standards on medical and laboratory                   a second opportunity for public
                                               instructions given. Please complete all
                                                                                                       practice; and the modification of the                 comment on the notice. Interested
                                               the required fields before submitting
                                                                                                       standards and provision of non-                       persons are invited to send comments
                                               your registration and submit no later
                                                                                                       regulatory guidelines to accommodate                  regarding the burden estimate or any
                                               than October 30, 2018 for U.S.
                                                                                                       technological advances, such as new                   other aspect of this collection of
                                               registrants and October 20, 2018 for
                                                                                                       test methods, the electronic                          information, including the necessity and
                                               international registrants.
                                                  It is the policy of CLIAC to accept                  transmission of laboratory information,               utility of the proposed information
                                               written public comments and provide a                   and mechanisms to improve the                         collection for the proper performance of
                                               brief period for oral public comments on                integration of public health and clinical             the agency’s functions, the accuracy of
                                               agenda items. Public comment periods                    laboratory practices.                                 the estimated burden, ways to enhance
                                               for each agenda item are scheduled                         Matters To Be Considered: The agenda               the quality, utility, and clarity of the
                                               immediately prior to the Committee                      will include agency updates from CDC,                 information to be collected, and the use
                                               discussion period for that item. In                     CMS, and FDA. Presentations and                       of automated collection techniques or
                                               general, each individual or group                       discussions will focus on an update                   other forms of information technology to
                                               requesting to make oral comments will                   from the CDC’s Office of Infectious                   minimize the information collection
                                               be limited to a total time of five minutes              Diseases Board of Scientific Counselors               burden.
                                               (unless otherwise indicated). To assure                 meeting; updates on laboratory                        DATES: Comments on the collection(s) of
                                               adequate time is scheduled for public                   interoperability; updates on antibiotic               information must be received by the
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                                               comments, speakers should notify the                    resistance activities; the Clinical                   OMB desk officer by October 29, 2018.
                                               contact person below at least five                      Laboratory Improvement Amendments                     ADDRESSES: When commenting on the
                                               business days prior to the meeting date.                personnel requirements; the role of the               proposed information collections,
                                               For individuals or groups unable to                     laboratory in the opioid crisis; and the              please reference the document identifier
                                               attend the meeting, CLIAC accepts                       role of the laboratory in improving                   or OMB control number. To be assured
                                               written comments until the date of the                  diagnoses. Agenda items are subject to                consideration, comments and
                                               meeting (unless otherwise stated).                      change as priorities dictate.                         recommendations must be received by


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                                                                        Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices                                                 48819

                                               the OMB desk officer via one of the                     identification, investigation, and                    review option, the Medicare contractor
                                               following transmissions: OMB, Office of                 prosecution of Medicare fraud occurring               will also request the information from
                                               Information and Regulatory Affairs,                     among Home Health Agencies (HHA)                      the HHA that submitted the claim for
                                               Attention: CMS Desk Officer, Fax                        providing services to Medicare                        payment, to determine if payment was
                                               Number: (202) 395–5806 OR,                              beneficiaries.                                        appropriate. Comments were received in
                                                 Email: OIRA_submission@                                  This revised demonstration would                   response to the 60-day notice. Form
                                               omb.eop.gov.                                            help assist in developing improved                    Number: CMS–10599 (OMB control
                                                 To obtain copies of a supporting                      procedures for the identification,                    number: 0938–1311); Frequency:
                                               statement and any related forms for the                 investigation, and prosecution of                     Occasionally; Affected Public: Private
                                               proposed collection(s) summarized in                    potential Medicare fraud. The                         Sector (Business or other for-profits and
                                               this notice, you may make your request                  demonstration would help make sure                    Not-for-profits); Number of
                                               using one of following:                                 that payments for home health services                Respondents: 941,287; Total Annual
                                                 1. Access CMS’ website address at                     are appropriate through either pre-claim              Responses: 1,330,980; Total Annual
                                               http://www.cms.hhs.gov/                                 or postpayment review, thereby working                Hours: 670,375. (For questions regarding
                                               PaperworkReductionActof1995.                            towards the prevention and                            this collection contact Jennifer
                                                 2. Email your request, including your                 identification of potential fraud, waste,             McMullen (410) 786–7635).
                                               address, phone number, OMB number,                      and abuse; the protection of Medicare
                                                                                                                                                                Dated: September 21, 2018.
                                               and CMS document identifier, to                         Trust Funds from improper payments;
                                                                                                       and the reduction of Medicare appeals.                William N. Parham, III,
                                               Paperwork@cms.hhs.gov.
                                                 3. Call the Reports Clearance Office at               CMS proposes initially implementing                   Director, Paperwork Reduction Staff, Office
                                                                                                       the demonstration in Illinois, Ohio,                  of Strategic Operations and Regulatory
                                               (410) 786–1326.                                                                                               Affairs.
                                               FOR FURTHER INFORMATION CONTACT:                        North Carolina, Florida, and Texas with
                                                                                                       the option to expand to other states in               [FR Doc. 2018–20994 Filed 9–26–18; 8:45 am]
                                               William Parham at (410) 786–4669.
                                                                                                       the Palmetto/JM jurisdiction. CMS                     BILLING CODE 4120–01–P
                                               SUPPLEMENTARY INFORMATION: Under the
                                                                                                       proposes starting the demonstration in
                                               Paperwork Reduction Act of 1995 (PRA)
                                                                                                       Illinois on December 10, 2018. Under
                                               (44 U.S.C. 3501–3520), federal agencies                 this demonstration, CMS proposes to                   DEPARTMENT OF HEALTH AND
                                               must obtain approval from the Office of                 offer choices for providers to                        HUMAN SERVICES
                                               Management and Budget (OMB) for each                    demonstrate their compliance with
                                               collection of information they conduct                                                                        Food and Drug Administration
                                                                                                       CMS’ home health policies. Providers in
                                               or sponsor. The term ‘‘collection of                    the demonstration states may participate              [Docket No. FDA–2012–N–0280]
                                               information’’ is defined in 44 U.S.C.                   in either 100 percent pre-claim review
                                               3502(3) and 5 CFR 1320.3(c) and                         or 100 percent postpayment review.                    Agency Information Collection
                                               includes agency requests or                             These providers will continue to be                   Activities; Proposed Collection;
                                               requirements that members of the public                 subject to a review method until the                  Comment Request; Financial
                                               submit reports, keep records, or provide                HHA reaches the target affirmation or                 Disclosure by Clinical Investigators
                                               information to a third party. Section                   claim approval rate. Once a HHA
                                               3506(c)(2)(A) of the PRA (44 U.S.C.                                                                           AGENCY:    Food and Drug Administration,
                                                                                                       reaches the target pre-claim review                   HHS.
                                               3506(c)(2)(A)) requires federal agencies                affirmation or post-payment review
                                               to publish a 30-day notice in the                       claim approval rate, it may choose to be              ACTION:   Notice.
                                               Federal Register concerning each                        relieved from claim reviews, except for
                                               proposed collection of information,                                                                           SUMMARY:   The Food and Drug
                                                                                                       a spot check of their claims to ensure                Administration (FDA or Agency) is
                                               including each proposed extension or                    continued compliance. Providers who
                                               reinstatement of an existing collection                                                                       announcing an opportunity for public
                                                                                                       do not wish to participate in either 100              comment on the proposed collection of
                                               of information, before submitting the                   percent pre-claim or postpayment
                                               collection to OMB for approval. To                                                                            certain information by the Agency.
                                                                                                       reviews have the option to furnish home               Under the Paperwork Reduction Act of
                                               comply with this requirement, CMS is                    health services and submit the
                                               publishing this notice that summarizes                                                                        1995 (PRA), Federal Agencies are
                                                                                                       associated claim for payment without                  required to publish notice in the
                                               the following proposed collection(s) of                 undergoing such reviews; however, they
                                               information for public comment:                                                                               Federal Register concerning each
                                                                                                       will receive a 25 percent payment                     proposed collection of information,
                                                 1. Type of Information Collection                     reduction on all claims submitted for
                                               Request: Revision of a currently                                                                              including each proposed extension of an
                                                                                                       home health services and may be                       existing collection of information, and
                                               approved collection; Title of                           eligible for review by the Recovery
                                               Information Collection: Pre-Claim                                                                             to allow 60 days for public comment in
                                                                                                       Audit Contractor.                                     response to the notice. This notice
                                               Review Demonstration for Home Health                       The information required under this
                                               Services; Use: Section 402(a)(1)(J) of the                                                                    solicits comments on information
                                                                                                       collection is required by Medicare
                                               Social Security Amendments of 1967                                                                            collections regarding financial
                                                                                                       contractors to determine proper
                                               (42 U.S.C. 1395b–1(a)(1)(J)) authorizes                 payment or if there is a suspicion of                 disclosure by clinical investigators.
                                               the Secretary to ‘‘develop or                           fraud. Under the pre-claim review                     DATES: Submit either electronic or
                                               demonstrate improved methods for the                    option, HHA will send the pre-claim                   written comments on the collection of
                                               investigation and prosecution of fraud                  review request along with all required                information by November 26, 2018.
                                               in the provision of care or services                    documentation to the Medicare                         ADDRESSES: You may submit comments
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                                               under the health programs established                   contractor for review prior to submitting             as follows. Please note that late,
                                               by the Social Security Act (the Act).’’                 the final claim for payment. If a claim               untimely filed comments will not be
                                               Pursuant to this authority, the CMS                     is submitted without a pre-claim review               considered. Electronic comments must
                                               seeks to develop and implement a                        decision on file, the Medicare contractor             be submitted on or before November 26,
                                               Medicare demonstration project, which                   will request the information from the                 2018. The https://www.regulations.gov
                                               CMS believes will help assist in                        HHA to determine if payment is                        electronic filing system will accept
                                               developing improved procedures for the                  appropriate. For the postpayment                      comments until midnight Eastern Time


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Document Created: 2018-09-27 01:04:13
Document Modified: 2018-09-27 01:04:13
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the collection(s) of information must be received by the OMB desk officer by October 29, 2018.
ContactWilliam Parham at (410) 786-4669.
FR Citation83 FR 48818 

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