82 FR 23005 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 96 (May 19, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 96 (May 19, 2017)
| Page Range | 23005-23007 | |
| FR Document | 2017-10225 |
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)] [Notices] [Pages 23005-23007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10225] ----------------------------------------------------------------------- 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: [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 [[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
![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23005
organization’s requirements consider, noncompliance is identified through DEPARTMENT OF HEALTH AND
among other factors, the applying validation reviews or complaint HUMAN SERVICES
accrediting organization’s requirements surveys, the State survey agency
for accreditation; survey procedures; monitors corrections as specified at Centers for Medicare & Medicaid
resources for conducting required § 488.9(c). Services
surveys; capacity to furnish information ++ TJC’s capacity to report [Document Identifiers: CMS–10175, CMS–
for use in enforcement activities; deficiencies to the surveyed facilities 10220, CMS–10471 and CMS–10495]
monitoring procedures for provider and respond to the facility’s plan of
entities found not in compliance with correction in a timely manner. Agency Information Collection
the conditions or requirements; and ++ TJC’s capacity to provide CMS Activities: Submission for OMB
ability to provide CMS with the with electronic data and reports Review; Comment Request
necessary data for validation. necessary for effective validation and
Section 1865(a)(3)(A) of the Act AGENCY: Centers for Medicare &
assessment of the organization’s survey Medicaid Services, HHS.
further requires that we publish, within
process.
60 days of receipt of an organization’s ACTION: Notice.
complete application, a notice ++ The adequacy of TJC’s staff and
identifying the national accrediting other resources, and its financial SUMMARY: The Centers for Medicare &
body making the request, describing the viability. Medicaid Services (CMS) is announcing
nature of the request, and providing at ++ TJC’s capacity to adequately fund an opportunity for the public to
least a 30-day public comment period. required surveys. comment on CMS’ intention to collect
We have 210 days from the receipt of a ++ TJC’s policies with respect to information from the public. Under the
complete application to publish notice whether surveys are announced or Paperwork Reduction Act of 1995
of approval or denial of the application. unannounced, to assure that surveys are (PRA), federal agencies are required to
The purpose of this proposed notice unannounced. publish notice in the Federal Register
is to inform the public of TJC’s request concerning each proposed collection of
++ TJC’s agreement to provide CMS information, including each proposed
for continued CMS-approval of its CAH with a copy of the most current
accreditation program. This notice also extension or reinstatement of an existing
accreditation survey together with any collection of information, and to allow
solicits public comment on whether other information related to the survey
TJC’s requirements meet or exceed the a second opportunity for public
as CMS may require (including comment on the notice. Interested
Medicare conditions of participation for corrective action plans).
CAHs. persons are invited to send comments
IV. Collection of Information regarding the burden estimate or any
III. Evaluation of Deeming Authority Requirements other aspect of this collection of
Request information, including the necessity and
TJC submitted all the necessary This document does not impose utility of the proposed information
materials to enable us to make a information collection requirements, collection for the proper performance of
determination concerning its request for that is, reporting, recordkeeping or the agency’s functions, the accuracy of
continued approval of its CAH third-party disclosure requirements. the estimated burden, ways to enhance
accreditation program. This application Consequently, there is no need for the quality, utility, and clarity of the
was determined to be complete on review by the Office of Management and information to be collected; and the use
March 31, 2017. Under Section Budget under the authority of the of automated collection techniques or
1865(a)(2) of the Act and our regulations Paperwork Reduction Act of 1995 (44 other forms of information technology to
at 42 CFR 488.5 (Application and re- U.S.C. 3501 et seq.). minimize the information collection
application procedures for national V. Response to Public Comments burden.
accrediting organizations), our review DATES: Comments on the collection(s) of
and evaluation of TJC will be conducted Because of the large number of public
comments we normally receive on information must be received by the
in accordance with, but not necessarily OMB desk officer by June 19, 2017.
limited to, the following factors: Federal Register documents, we are not
• The equivalency of TJC’s standards able to acknowledge or respond to them ADDRESSES: When commenting on the
for CAHs as compared with CMS’ CAH individually. We will consider all proposed information collections,
conditions of participation. comments we receive by the date and please reference the document identifier
• TJC’s survey process to determine time specified in the ‘‘DATES’’ section or OMB control number. To be assured
the following: of this preamble, and, when we proceed consideration, comments and
++ The composition of the survey with a subsequent document, we will recommendations must be received by
team, surveyor qualifications, and the respond to the comments in the the OMB desk officer via one of the
ability of the organization to provide preamble to that document. following transmissions: OMB, Office of
continuing surveyor training. Upon completion of our evaluation, Information and Regulatory Affairs,
++ The comparability of TJC’s including evaluation of comments Attention: CMS Desk Officer, Fax
processes to those of State agencies, received as a result of this notice, we Number: (202) 395–5806 OR, Email:
including survey frequency, and the will publish a final notice in the Federal OIRA_submission@omb.eop.gov.
ability to investigate and respond To obtain copies of a supporting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Register announcing the result of our
appropriately to complaints against evaluation. statement and any related forms for the
accredited facilities. proposed collection(s) summarized in
++ TJC’s processes and procedures Dated: April 25, 2017. this notice, you may make your request
for monitoring a CAH is out of Seema Verma, using one of following:
compliance with TJC’s program Administrator, Centers for Medicare & 1. Access CMS’ Web site address at
requirements. These monitoring Medicaid Services. Web site address at https://
procedures are used only when TJC [FR Doc. 2017–10216 Filed 5–18–17; 8:45 am] www.cms.gov/Regulations-and-
identifies noncompliance. If BILLING CODE 4120–01–P Guidance/Legislation/
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![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23007
quality products from accredited transfers of value provided to such Paperwork Reduction Act of 1995 (the
suppliers. In order to gather qualitative physician owners or investors. PRA), federal agencies are required to
information for analysis, the evaluation Applicable manufacturers must report publish notice in the Federal Register
team will use semi-structured interview the required payment and other transfer concerning each proposed collection of
guides that focus on the direct impact of of value information annually to CMS in information (including each proposed
the Demonstration on stakeholder an electronic format. The statute also extension or reinstatement of an existing
groups. Stakeholders will be drawn provides that applicable manufacturers collection of information) and to allow
from advocacy organizations, power and applicable GPOs must report 60 days for public comment on the
mobility device supply companies, state annually to CMS the required proposed action. Interested persons are
and local government, and healthcare information about physician ownership invited to send comments regarding our
practitioners. This information and investment interests, including burden estimates or any other aspect of
collection request explains the research information on any payments or other this collection of information, including
methodology and data collection transfers of value provided to physician the necessity and utility of the proposed
strategies designed to minimize the owners or investors, in an electronic information collection for the proper
burden placed on research participants, format by the same date. Applicable performance of the agency’s functions,
while effectively gathering the data manufacturers and applicable GPOs are the accuracy of the estimated burden,
needed for the evaluation of the subject to civil monetary penalties ways to enhance the quality, utility, and
Demonstration. Form Number: CMS– (CMPs) for failing to comply with the clarity of the information to be
10471 (OMB Control Number: 0938– reporting requirements of the statute. collected, and the use of automated
1235); Frequency: Yearly; Affected We are required by statute to publish collection techniques or other forms of
Public: Private sector (business or other the reported data on a public Web site. information technology to minimize the
for-profit and not-for-profit institutions) The data must be downloadable, easily information collection burden.
and State and Local Governments; searchable, and aggregated. In addition, DATES: Comments must be received by
Number of Respondents: 254; Total we must submit annual reports to the July 18, 2017.
Annual Responses: 254; Total Annual Congress and each state summarizing
Hours: 288. (For policy questions ADDRESSES: When commenting, please
the data reported. Finally, section
regarding this collection contact Debbie 1128G of the Act generally preempts reference the document identifier or
Skinner at 410–786–7480.) state laws that require disclosure of the OMB control number. To be assured
4. Type of Information Collection same type of information by consideration, comments and
Request: Revision of a currently manufacturers. Form Number: CMS– recommendations must be submitted in
approved information collection; Title 10495 (OMB Control Number: 0938– any one of the following ways:
of Information Collection: Registration, 1237); Frequency: Once; Affected 1. Electronically. You may send your
Attestation, Dispute & Resolution, Public: Private sector—Business or other comments electronically to http://
Assumptions Document and Data for-profits; Number of Respondents: www.regulations.gov. Follow the
Retention Requirements for Open 227,157; Total Annual Responses: instructions for ‘‘Comment or
Payments; Use: Section 6002 of the 457,454; Total Annual Hours: 3,099,297. Submission’’ or ‘‘More Search Options’’
Affordable Care Act added section (For policy questions regarding this to find the information collection
1128G to the Social Security Act (Act), collection contact Veronika Peleshchuk document(s) that are accepting
which requires applicable Fradlin at 410–786–3323.) comments.
manufacturers and applicable group 2. By regular mail. You may mail
Dated: May 16, 2017. written comments to the following
purchasing organizations (GPOs) of
covered drugs, devices, biologicals, or William N. Parham, III, address: CMS, Office of Strategic
medical supplies to report annually to Director, Paperwork Reduction Staff, Office Operations and Regulatory Affairs,
CMS certain payments or other transfers of Strategic Operations and Regulatory Division of Regulations Development,
Affairs.
of value to physicians and teaching Attention: Document Identifier/OMB
hospitals, as well as, certain information [FR Doc. 2017–10225 Filed 5–18–17; 8:45 am] Control Number lll, Room C4–26–
regarding the ownership or investment BILLING CODE 4120–01–P 05, 7500 Security Boulevard, Baltimore,
interests held by physicians or their Maryland 21244–1850.
immediate family members in To obtain copies of a supporting
applicable manufacturers or applicable DEPARTMENT OF HEALTH AND statement and any related forms for the
GPOs. HUMAN SERVICES proposed collection(s) summarized in
Specifically, applicable manufacturers this notice, you may make your request
Centers for Medicare & Medicaid
of covered drugs, devices, biologicals, using one of following:
Services
and medical supplies are required to 1. Access CMS’ Web site address at
submit on an annual basis the [Document Identifier: CMS–10371 and CMS– https://www.cms.gov/Regulations-and-
information required in section 10507] Guidance/Legislation/
1128G(a)(1) of the Act about certain PaperworkReductionActof1995/PRA-
payments or other transfers of value Agency Information Collection
Activities: Proposed Collection; Listing.html.
made to physicians and teaching 2. Email your request, including your
hospitals (collectively called covered Comment Request
address, phone number, OMB number,
recipients) during the course of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Centers for Medicare & and CMS document identifier, to
preceding calendar year. Similarly, Medicaid Services, HHS. Paperwork@cms.hhs.gov.
section 1128G(a)(2) of the Act requires ACTION: Notice. 3. Call the Reports Clearance Office at
applicable manufacturers and (410) 786–1326.
applicable GPOs to disclose any SUMMARY: The Centers for Medicare &
FOR FURTHER INFORMATION CONTACT:
ownership or investment interests in Medicaid Services (CMS) is announcing
such entities held by physicians or their an opportunity for the public to Reports Clearance Office at (410) 786–
immediate family members, as well as comment on CMS’ intention to collect 1326.
information on any payments or other information from the public. Under the SUPPLEMENTARY INFORMATION:
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Document Created: 2018-11-08 08:47:45
Document Modified: 2018-11-08 08:47:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by June 19, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 23005 |
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