[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]



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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