Agency Information Collection Activities: Submission for OMB Review; Comment Request, 23005-23007 [2017-10225]
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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
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organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of TJC’s request
for continued CMS-approval of its CAH
accreditation program. This notice also
solicits public comment on whether
TJC’s requirements meet or exceed the
Medicare conditions of participation for
CAHs.
III. Evaluation of Deeming Authority
Request
TJC submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its CAH
accreditation program. This application
was determined to be complete on
March 31, 2017. Under Section
1865(a)(2) of the Act and our regulations
at 42 CFR 488.5 (Application and reapplication procedures for national
accrediting organizations), our review
and evaluation of TJC will be conducted
in accordance with, but not necessarily
limited to, the following factors:
• The equivalency of TJC’s standards
for CAHs as compared with CMS’ CAH
conditions of participation.
• TJC’s survey process to determine
the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of TJC’s
processes to those of State agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ TJC’s processes and procedures
for monitoring a CAH is out of
compliance with TJC’s program
requirements. These monitoring
procedures are used only when TJC
identifies noncompliance. If
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noncompliance is identified through
validation reviews or complaint
surveys, the State survey agency
monitors corrections as specified at
§ 488.9(c).
++ TJC’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ TJC’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of TJC’s staff and
other resources, and its financial
viability.
++ TJC’s capacity to adequately fund
required surveys.
++ TJC’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ TJC’s agreement to provide CMS
with a copy of the most current
accreditation survey together with any
other information related to the survey
as CMS may require (including
corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the ‘‘DATES’’ section
of this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
Dated: April 25, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–10216 Filed 5–18–17; 8:45 am]
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23005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10175, CMS–
10220, CMS–10471 and CMS–10495]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by June 19, 2017.
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
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:
OIRA_submission@omb.eop.gov.
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’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
DATES:
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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
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: Extension of a currently
approved information collection; Title
of Information Collection: Certification
Statement for Electronic File
Interchange Organizations; Use: Health
care providers can currently obtain a
National Provider Identifier (NPI) via a
paper application or over the Internet
through the National Plan and Provider
Enumeration System (NPPES). These
applications must be submitted
individually, on a per-provider basis.
The Electronic File Interchange (EFI)
process allows provider-designated
organizations (EFIOs) to capture
multiple providers’ NPI application
information on a single electronic file
for submission to NPPES. This process
is also referred to as bulk enumeration.
To ensure that the EFIO has the
authority to act on behalf of each
provider and complies with other
federal requirements, an authorized
official of the EFIO must sign a
certification statement and mail it to us.
No comments were received during the
60-day comment period. Form Number:
CMS–10175 (OMB Control Number:
0938–0984). Frequency: Occasionally.
Affected Public: Private Sector; Number
of Respondents: 25; Total Annual
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Responses: 25; Total Annual Hours: 75.
(For policy questions regarding this
collection contact Kimberly McPhillips
at 410–786–5374.)
2. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Security
Consent and Surrogate Authorization
Form; Use: The primary function of the
Medicare enrollment application is to
obtain information about the Provider or
supplier and whether they meet the
Federal and/or State qualifications to
participate in the Medicare program. In
addition, the Medicare enrollment
application gathers information
regarding the provider or supplier’s
practice location, the identity of the
owners of the enrolling organization,
and information necessary to establish
the correct claims payment.
Enrollees have the option of
submitting either a CMS–855 form, or
submitting information via a web based
process. In establishing a web based
application process, we allow providers
and suppliers the ability to enroll in the
Medicare program, revalidate their
enrollment and make changes to their
enrollment information via Internetbased Provider Enrollment, Chain and
Ownership System (PECOS). Individual
providers/suppliers (hereinafter referred
to as ‘‘Individual Providers’’) log into
Internet-based PECOS using their User
IDs and passwords established when
they applied on-line to the National
Plan and Provider Enumeration System
(NPPES) for their National Provider
Identifiers (NPIs). Authorized Officials
(AOs) of the provider or supplier
organizations (hereinafter referred to as
‘‘Organizational Providers’’) must
register for a user account and
authenticate their identity and
connection to the organization they
represent before being able to log into
Internet-based PECOS. Once
authenticated, AOs for Organizational
Providers, receive complete access to
their enrollment information via
Internet-based PECOS. Individuals and
AOs of Organizational Providers are not
required to submit a Security Consent
and Surrogate Authorization Form to
enroll, revalidate or make changes to
their Medicare enrollment information.
Individual and Organizational
Providers may complete their Medicare
enrollment responsibilities on their own
or elect to delegate this task to a
Surrogate. A Surrogate is an individual
or organization identified by an
Individual or Organizational Provider as
someone authorized to access CMS
computer systems, such as Internetbased PECOS, National Provider Plan
and Enumeration System (NPPES) and
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the Medicare and Medicaid Electronic
Health Records (EHR) Incentive Program
Registration and Attestation System
(HITECH), on their behalf and to modify
or view any information contained
therein that the Individual or
Organizational Provider may have
permission or right to access in
accordance with Medicare statutes,
regulations, policies, and usage
guidelines for any CMS system.
Surrogates may consist of administrative
staff, independent contractors, 3rd party
consulting companies or credentialing
departments. In order for an Individual
or Organizational Provider to delegate
the Medicare credentialing process to a
Surrogate to access and update their
enrollment information in the above
mentioned CMS systems on their behalf,
it is required that a Security Consent
and Surrogate Authorization Form be
completed, or Individual and
Organizational Providers use an
equivalent online process via the
PECOS Identity and Access
Management (I&A) system. The Security
Consent and Surrogate Authorization
form replicates business service
agreements between Medicare
providers, suppliers or both and
Surrogates providing enrollment
services.
The form, once signed, mailed and
approved, grants a Surrogate access to
all current and future enrollment data
for the Individual or Organization
Provider. Form Number: CMS–10220
(OMB Control Number: 0938–1035);
Frequency: Occasionally; Affected
Public: Individuals and Private Sector;
Number of Respondents: 226,100; Total
Annual Responses: 226,100; Total
Annual Hours: 226,100. (For policy
questions regarding this collection
contact Kimberly McPhillips at 410–
786–5374.)
3. Type of Information Collection
Request: Extension of a currently
approved collection of information;
Title of Information Collection:
Medicare Prior Authorization of Power
Mobility Devices (PMDs)
Demonstration; Use: The purpose of the
Medicare Prior Authorization of Power
Mobility Devices Demonstration (the
Demonstration) is to ensure that
payments for PMDs are appropriate
before the claims are paid, thereby
preventing the fraud, waste, and abuse
in the seven states participating in the
Demonstration: California, Florida,
Illinois, Michigan, New York, North
Carolina and Texas. Additional benefits
of the Demonstration include ensuring
that a beneficiary’s medical condition
warrants their medical equipment under
existing coverage guidelines and
preserving their ability to receive
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quality products from accredited
suppliers. In order to gather qualitative
information for analysis, the evaluation
team will use semi-structured interview
guides that focus on the direct impact of
the Demonstration on stakeholder
groups. Stakeholders will be drawn
from advocacy organizations, power
mobility device supply companies, state
and local government, and healthcare
practitioners. This information
collection request explains the research
methodology and data collection
strategies designed to minimize the
burden placed on research participants,
while effectively gathering the data
needed for the evaluation of the
Demonstration. Form Number: CMS–
10471 (OMB Control Number: 0938–
1235); Frequency: Yearly; Affected
Public: Private sector (business or other
for-profit and not-for-profit institutions)
and State and Local Governments;
Number of Respondents: 254; Total
Annual Responses: 254; Total Annual
Hours: 288. (For policy questions
regarding this collection contact Debbie
Skinner at 410–786–7480.)
4. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Registration,
Attestation, Dispute & Resolution,
Assumptions Document and Data
Retention Requirements for Open
Payments; Use: Section 6002 of the
Affordable Care Act added section
1128G to the Social Security Act (Act),
which requires applicable
manufacturers and applicable group
purchasing organizations (GPOs) of
covered drugs, devices, biologicals, or
medical supplies to report annually to
CMS certain payments or other transfers
of value to physicians and teaching
hospitals, as well as, certain information
regarding the ownership or investment
interests held by physicians or their
immediate family members in
applicable manufacturers or applicable
GPOs.
Specifically, applicable manufacturers
of covered drugs, devices, biologicals,
and medical supplies are required to
submit on an annual basis the
information required in section
1128G(a)(1) of the Act about certain
payments or other transfers of value
made to physicians and teaching
hospitals (collectively called covered
recipients) during the course of the
preceding calendar year. Similarly,
section 1128G(a)(2) of the Act requires
applicable manufacturers and
applicable GPOs to disclose any
ownership or investment interests in
such entities held by physicians or their
immediate family members, as well as
information on any payments or other
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transfers of value provided to such
physician owners or investors.
Applicable manufacturers must report
the required payment and other transfer
of value information annually to CMS in
an electronic format. The statute also
provides that applicable manufacturers
and applicable GPOs must report
annually to CMS the required
information about physician ownership
and investment interests, including
information on any payments or other
transfers of value provided to physician
owners or investors, in an electronic
format by the same date. Applicable
manufacturers and applicable GPOs are
subject to civil monetary penalties
(CMPs) for failing to comply with the
reporting requirements of the statute.
We are required by statute to publish
the reported data on a public Web site.
The data must be downloadable, easily
searchable, and aggregated. In addition,
we must submit annual reports to the
Congress and each state summarizing
the data reported. Finally, section
1128G of the Act generally preempts
state laws that require disclosure of the
same type of information by
manufacturers. Form Number: CMS–
10495 (OMB Control Number: 0938–
1237); Frequency: Once; Affected
Public: Private sector—Business or other
for-profits; Number of Respondents:
227,157; Total Annual Responses:
457,454; Total Annual Hours: 3,099,297.
(For policy questions regarding this
collection contact Veronika Peleshchuk
Fradlin at 410–786–3323.)
Dated: May 16, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–10225 Filed 5–18–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10371 and CMS–
10507]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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
SUMMARY:
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23007
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
July 18, 2017.
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 https://
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 lll, 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’ Web site address at
https://www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23005-23007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10225]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10175, CMS-10220, CMS-10471 and CMS-10495]
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 June 19, 2017.
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
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:
OIRA_submission@omb.eop.gov.
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' Web site address at Web site address at https://
www.cms.gov/Regulations-and-Guidance/Legislation/
[[Page 23006]]
PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
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: Extension of a currently
approved information collection; Title of Information Collection:
Certification Statement for Electronic File Interchange Organizations;
Use: Health care providers can currently obtain a National Provider
Identifier (NPI) via a paper application or over the Internet through
the National Plan and Provider Enumeration System (NPPES). These
applications must be submitted individually, on a per-provider basis.
The Electronic File Interchange (EFI) process allows provider-
designated organizations (EFIOs) to capture multiple providers' NPI
application information on a single electronic file for submission to
NPPES. This process is also referred to as bulk enumeration. To ensure
that the EFIO has the authority to act on behalf of each provider and
complies with other federal requirements, an authorized official of the
EFIO must sign a certification statement and mail it to us. No comments
were received during the 60-day comment period. Form Number: CMS-10175
(OMB Control Number: 0938-0984). Frequency: Occasionally. Affected
Public: Private Sector; Number of Respondents: 25; Total Annual
Responses: 25; Total Annual Hours: 75. (For policy questions regarding
this collection contact Kimberly McPhillips at 410-786-5374.)
2. Type of Information Collection Request: Revision of a currently
approved information collection; Title of Information Collection:
Security Consent and Surrogate Authorization Form; Use: The primary
function of the Medicare enrollment application is to obtain
information about the Provider or supplier and whether they meet the
Federal and/or State qualifications to participate in the Medicare
program. In addition, the Medicare enrollment application gathers
information regarding the provider or supplier's practice location, the
identity of the owners of the enrolling organization, and information
necessary to establish the correct claims payment.
Enrollees have the option of submitting either a CMS-855 form, or
submitting information via a web based process. In establishing a web
based application process, we allow providers and suppliers the ability
to enroll in the Medicare program, revalidate their enrollment and make
changes to their enrollment information via Internet-based Provider
Enrollment, Chain and Ownership System (PECOS). Individual providers/
suppliers (hereinafter referred to as ``Individual Providers'') log
into Internet-based PECOS using their User IDs and passwords
established when they applied on-line to the National Plan and Provider
Enumeration System (NPPES) for their National Provider Identifiers
(NPIs). Authorized Officials (AOs) of the provider or supplier
organizations (hereinafter referred to as ``Organizational Providers'')
must register for a user account and authenticate their identity and
connection to the organization they represent before being able to log
into Internet-based PECOS. Once authenticated, AOs for Organizational
Providers, receive complete access to their enrollment information via
Internet-based PECOS. Individuals and AOs of Organizational Providers
are not required to submit a Security Consent and Surrogate
Authorization Form to enroll, revalidate or make changes to their
Medicare enrollment information.
Individual and Organizational Providers may complete their Medicare
enrollment responsibilities on their own or elect to delegate this task
to a Surrogate. A Surrogate is an individual or organization identified
by an Individual or Organizational Provider as someone authorized to
access CMS computer systems, such as Internet-based PECOS, National
Provider Plan and Enumeration System (NPPES) and the Medicare and
Medicaid Electronic Health Records (EHR) Incentive Program Registration
and Attestation System (HITECH), on their behalf and to modify or view
any information contained therein that the Individual or Organizational
Provider may have permission or right to access in accordance with
Medicare statutes, regulations, policies, and usage guidelines for any
CMS system. Surrogates may consist of administrative staff, independent
contractors, 3rd party consulting companies or credentialing
departments. In order for an Individual or Organizational Provider to
delegate the Medicare credentialing process to a Surrogate to access
and update their enrollment information in the above mentioned CMS
systems on their behalf, it is required that a Security Consent and
Surrogate Authorization Form be completed, or Individual and
Organizational Providers use an equivalent online process via the PECOS
Identity and Access Management (I&A) system. The Security Consent and
Surrogate Authorization form replicates business service agreements
between Medicare providers, suppliers or both and Surrogates providing
enrollment services.
The form, once signed, mailed and approved, grants a Surrogate
access to all current and future enrollment data for the Individual or
Organization Provider. Form Number: CMS-10220 (OMB Control Number:
0938-1035); Frequency: Occasionally; Affected Public: Individuals and
Private Sector; Number of Respondents: 226,100; Total Annual Responses:
226,100; Total Annual Hours: 226,100. (For policy questions regarding
this collection contact Kimberly McPhillips at 410-786-5374.)
3. Type of Information Collection Request: Extension of a currently
approved collection of information; Title of Information Collection:
Medicare Prior Authorization of Power Mobility Devices (PMDs)
Demonstration; Use: The purpose of the Medicare Prior Authorization of
Power Mobility Devices Demonstration (the Demonstration) is to ensure
that payments for PMDs are appropriate before the claims are paid,
thereby preventing the fraud, waste, and abuse in the seven states
participating in the Demonstration: California, Florida, Illinois,
Michigan, New York, North Carolina and Texas. Additional benefits of
the Demonstration include ensuring that a beneficiary's medical
condition warrants their medical equipment under existing coverage
guidelines and preserving their ability to receive
[[Page 23007]]
quality products from accredited suppliers. In order to gather
qualitative information for analysis, the evaluation team will use
semi-structured interview guides that focus on the direct impact of the
Demonstration on stakeholder groups. Stakeholders will be drawn from
advocacy organizations, power mobility device supply companies, state
and local government, and healthcare practitioners. This information
collection request explains the research methodology and data
collection strategies designed to minimize the burden placed on
research participants, while effectively gathering the data needed for
the evaluation of the Demonstration. Form Number: CMS-10471 (OMB
Control Number: 0938-1235); Frequency: Yearly; Affected Public: Private
sector (business or other for-profit and not-for-profit institutions)
and State and Local Governments; Number of Respondents: 254; Total
Annual Responses: 254; Total Annual Hours: 288. (For policy questions
regarding this collection contact Debbie Skinner at 410-786-7480.)
4. Type of Information Collection Request: Revision of a currently
approved information collection; Title of Information Collection:
Registration, Attestation, Dispute & Resolution, Assumptions Document
and Data Retention Requirements for Open Payments; Use: Section 6002 of
the Affordable Care Act added section 1128G to the Social Security Act
(Act), which requires applicable manufacturers and applicable group
purchasing organizations (GPOs) of covered drugs, devices, biologicals,
or medical supplies to report annually to CMS certain payments or other
transfers of value to physicians and teaching hospitals, as well as,
certain information regarding the ownership or investment interests
held by physicians or their immediate family members in applicable
manufacturers or applicable GPOs.
Specifically, applicable manufacturers of covered drugs, devices,
biologicals, and medical supplies are required to submit on an annual
basis the information required in section 1128G(a)(1) of the Act about
certain payments or other transfers of value made to physicians and
teaching hospitals (collectively called covered recipients) during the
course of the preceding calendar year. Similarly, section 1128G(a)(2)
of the Act requires applicable manufacturers and applicable GPOs to
disclose any ownership or investment interests in such entities held by
physicians or their immediate family members, as well as information on
any payments or other transfers of value provided to such physician
owners or investors. Applicable manufacturers must report the required
payment and other transfer of value information annually to CMS in an
electronic format. The statute also provides that applicable
manufacturers and applicable GPOs must report annually to CMS the
required information about physician ownership and investment
interests, including information on any payments or other transfers of
value provided to physician owners or investors, in an electronic
format by the same date. Applicable manufacturers and applicable GPOs
are subject to civil monetary penalties (CMPs) for failing to comply
with the reporting requirements of the statute. We are required by
statute to publish the reported data on a public Web site. The data
must be downloadable, easily searchable, and aggregated. In addition,
we must submit annual reports to the Congress and each state
summarizing the data reported. Finally, section 1128G of the Act
generally preempts state laws that require disclosure of the same type
of information by manufacturers. Form Number: CMS-10495 (OMB Control
Number: 0938-1237); Frequency: Once; Affected Public: Private sector--
Business or other for-profits; Number of Respondents: 227,157; Total
Annual Responses: 457,454; Total Annual Hours: 3,099,297. (For policy
questions regarding this collection contact Veronika Peleshchuk Fradlin
at 410-786-3323.)
Dated: May 16, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-10225 Filed 5-18-17; 8:45 am]
BILLING CODE 4120-01-P
