[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.

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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 (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: 
[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' 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 [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: 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

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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 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