[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11921-11923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03809]
[[Page 11921]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-65, CMS-1572, CMS-10175, CMS-10220, CMS-
10471, and CMS-10495]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by April 28, 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
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.
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 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: Reports Clearance Office at (410) 786-
1326.
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-65 Final Peer Review Organizations Sanction Regulations in 42 CFR
Sections 1004.40, 1004.50, 1004.60, and 1004.70
CMS-1572 Home Health Agency Survey and Deficiencies Report
CMS-10175 Certification Statement for Electronic File Interchange
Organizations
CMS-10220 Security Consent and Surrogate Authorization Form
CMS-10471 Medicare Prior Authorization of Power Mobility Devices (PMDs)
Demonstration
CMS-10495 Registration, Attestation, Dispute & Resolution, Assumptions
Document and Data Retention Requirements for Open Payments
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: Final Peer Review
Organizations Sanction Regulations in 42 CFR Sections 1004.40, 1004.50,
1004.60, and 1004.70; Use: The Peer Review Improvement Act of 1982
amended Title XI of the Social Security Act (the Act), creating the
Utilization and Quality Control Peer Review Organization Program.
Section 1156 of the Act imposes obligations on health care
practitioners and others who furnish or order services or items under
Medicare. This section also provides for sanction actions, if the
Secretary determines that the obligations as stated by this section are
not met. Quality Improvement Organizations (QIOs) are responsible for
identifying violations. The QIOs may allow practitioners or other
entities, opportunities to submit relevant information before
determining that a violation has occurred. The information collection
requirements contained in this information collection request are used
by the QIOs to collect the information necessary to make their
decision. Form Number: CMS-R-65 (OMB Control Number: 0938-0444);
Frequency: Occasionally; Affected Public: Private sector--Business or
other for-profit and Not-for-profit institutions; Number of
Respondents: 18; Total Annual Responses: 18; Total Annual Hours: 4,716.
(For policy questions regarding this collection contact Tiffany
Jackson-Dickey at 410-786-1124.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Home Health
Agency Survey and Deficiencies Report; Use: In order to participate in
the Medicare Program as a Home Health Agency (HHA) provider, the HHA
must meet federal standards. This form is used to record information
and patients' health and provider compliance with requirements and to
report the information to the federal government. Form Number: CMS-1572
(OMB Control Number: 0938-0355); Frequency: Yearly; Affected Public:
State, Local or Tribal Government; Number of Respondents: 3,830; Total
Annual Responses: 3,830; Total Annual Hours: 958. (For policy questions
regarding this collection contact Sarah Fahrendorf at 410-786-3112.)
3. 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
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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. 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.)
4. 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 online 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.)
5. 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 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.)
6. Type of Information Collection Request: Revision of a currently
approved 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
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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: February 22, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-03809 Filed 2-24-17; 8:45 am]
BILLING CODE 4120-01-P