81 FR 23705 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range		23705-23706
FR Document		2016-09425

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 require; 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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016)

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23705-23706]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-1490S and CMS-10458]


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 require; 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by June 21, 2016.

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-1490S Patient's Request for Medicare Payment

CMS-10458 Consumer Research Supporting Outreach for Health Insurance 
Marketplace

    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.
    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Patient's Request for Medicare Payment; Use: The Form CMS-1490S form 
provides beneficiaries with a relatively easy form to use when filing 
their claims. Without the collection of this information, claims for 
reimbursement relating to the provision of Part B medical services/
supplies could not be acted upon. This would result in a nationwide 
paralysis of the operation of the Federal Government's Part B Medicare 
program, and major problems for the patients/beneficiaries inflicting 
severe physical and financial hardship on beneficiaries. This form was 
explicitly developed for easy use by beneficiaries who file their own 
claims. The CMS-1490S form can be obtained from any Social Security 
office or Medicare Administrative Contractors or CMS. When the CMS-
1490S is used, the beneficiary must attach to it his/her bills from 
physicians or suppliers. The form is, therefore, designed specifically 
to aid beneficiaries who cannot get assistance from their physicians or 
suppliers for completing claim forms. The form is currently approved 
under 0938-1197; however, we are submitting for approval as a 
standalone information collection request. Once a new OMB control 
number is issued, we will remove the burden for the CMS-1490S that is 
currently approved under OMB control number 0938-1197. Form Number: 
CMS-1490 (OMB control number: 0938-NEW); Frequency: Occasionally 
Affected Public: Individuals and Households; Number of Respondents: 
167,839; Total Annual Responses: 167,839; Total Annual Hours: 83,920. 
(For policy questions regarding this collection contact Sumita Sen at 
410-786-5755.)

[[Page 23706]]

    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Consumer Research 
Supporting Outreach for Health Insurance Marketplace; Use: The Centers 
for Medicare and Medicaid Services is requesting reapproval for two 
surveys that aid in understanding levels of awareness and customer 
service needs associated with the Health Insurance Marketplace 
established by the Affordable Care Act. Because the Marketplace will 
provide coverage to the almost 50 million uninsured in the United 
States through individual and small employer programs, we have 
developed one survey to be administered to individual consumers most 
likely to use the Marketplace and another to be administered to small 
employers most likely to use the Small Business Health Options portion 
of the Marketplace. These brief surveys, designed to be conducted 
quarterly, give CMS the ability to obtain a rough indication of the 
types of outreach and marketing that will be needed to enhance 
awareness of and knowledge about the Marketplace for individual and 
business customers. CMS' biggest customer service need is likely to be 
providing sufficient education so consumers: (a) Can take advantage of 
the Marketplace and (b) know how to access CMS' customer service 
channels. The surveys will provide information on media use, concept 
awareness, and conceptual or content areas where education for customer 
service delivery can be improved. Awareness and knowledge gaps are 
likely to change over time based not only on effectiveness of CMS' 
marketing efforts, but also of those of state, local, private sector, 
and nongovernmental organizations. Form Number: CMS-10458 (OMB control 
number: 0938-1203): Frequency: Quarterly; Affected Public: Individuals 
or households, Private Sector (business or other for-profits); Number 
of Respondents: 40,200; Total Annual Responses: 40,200; Total Annual 
Hours: 2,480. (For policy questions regarding this collection contact 
Frank Funderburk at 410-786-1820.)

    Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-09425 Filed 4-21-16; 8:45 am]
 BILLING CODE 4120-01-P

23706 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices

2. Type of Information Collection DEPARTMENT OF HEALTH AND II. Notice of Approval of ASHI as an
Request: Extension of a currently HUMAN SERVICES Accreditation Organization
approved collection; Title of
Information Collection: Consumer Centers for Medicare & Medicaid In this notice, we approve ASHI as an
Research Supporting Outreach for Services organization that may accredit
Health Insurance Marketplace; Use: The laboratories for purposes of establishing
[CMS–3330–N]
Centers for Medicare and Medicaid its compliance with CLIA requirements
Announcement of the Re-Approval of for the subspecialty of General
Services is requesting reapproval for
the American Society of Immunology, the specialty of
two surveys that aid in understanding
Histocompatibility and Histocompatibility, and the subspecialty
levels of awareness and customer
Immunogenetics (ASHI) as an of ABO/Rh typing. We have examined
service needs associated with the Health
Accreditation Organization Under the the initial ASHI application and all
Insurance Marketplace established by
Clinical Laboratory Improvement subsequent submissions to determine its
the Affordable Care Act. Because the
Amendments of 1988 accreditation program’s equivalency
Marketplace will provide coverage to with the requirements for approval of an
the almost 50 million uninsured in the AGENCY: Centers for Medicare & accreditation organization under
United States through individual and Medicaid Services (CMS), HHS.
subpart E of part 493. We have
small employer programs, we have ACTION: Notice. determined that ASHI meets or exceeds
developed one survey to be the applicable CLIA requirements. We
administered to individual consumers SUMMARY: This notice announces the
application of the American Society for have also determined that ASHI will
most likely to use the Marketplace and ensure that its accredited laboratories
Histocompatibility and Immunogenetics
another to be administered to small will meet or exceed the applicable
(ASHI) for approval as an accreditation
employers most likely to use the Small organization for clinical laboratories requirements in subparts H, I, J, K, M,
Business Health Options portion of the under the Clinical Laboratory Q, and the applicable sections of R.
Marketplace. These brief surveys, Improvement Amendments of 1988 Therefore, we grant ASHI approval as an
designed to be conducted quarterly, give (CLIA) program for the following accreditation organization under
CMS the ability to obtain a rough specialty and subspecialty areas: subpart E of part 493, for the period
indication of the types of outreach and General Immunology; stated in the DATES section of this notice
marketing that will be needed to Histocompatibility; and ABO/Rh typing. for the subspecialty of General
enhance awareness of and knowledge We have determined that the ASHI Immunology, the specialty of
about the Marketplace for individual accreditation meets or exceeds the Histocompatibility, and the subspecialty
and business customers. CMS’ biggest applicable CLIA requirements. We are of ABO/Rh typing. As a result of this
customer service need is likely to be announcing the approval and grant determination, any laboratory that is
providing sufficient education so ASHI deeming authority for a period of accredited by ASHI during the time
consumers: (a) Can take advantage of the 6 years. period stated in the DATES section of this
Marketplace and (b) know how to access DATES: Effective Date: This notice is notice will be deemed to meet the CLIA
CMS’ customer service channels. The effective from April 22, 2016 to April requirements for the listed
surveys will provide information on 21, 2022. subspecialties and specialties, and
media use, concept awareness, and FOR FURTHER INFORMATION CONTACT: therefore, will generally not be subject
conceptual or content areas where Penelope Meyers, (410) 786–3366. to routine inspections by a state survey
education for customer service delivery SUPPLEMENTARY INFORMATION: agency to determine its compliance with
can be improved. Awareness and I. Background and Legislative CLIA requirements. The accredited
knowledge gaps are likely to change Authority laboratory, however, is subject to
over time based not only on validation and complaint investigation
On October 31, 1988, the Congress surveys performed by CMS, or its
effectiveness of CMS’ marketing efforts,
enacted the Clinical Laboratory agent(s).
but also of those of state, local, private
Improvement Amendments of 1988
sector, and nongovernmental (CLIA) (Pub. L. 100–578). CLIA III. Evaluation of ASHI Commission
organizations. Form Number: CMS– amended section 353 of the Public Request for Approval as an
10458 (OMB control number: 0938– Health Service Act. We issued a final Accreditation Organization Under
1203): Frequency: Quarterly; Affected rule implementing the accreditation CLIA
Public: Individuals or households, provisions of CLIA on July 31, 1992 (57
Private Sector (business or other for- FR 33992). Under those provisions, we The following describes the process
profits); Number of Respondents: may grant deeming authority to an used to determine that ASHI
40,200; Total Annual Responses: accreditation organization if its accreditation program meets the
40,200; Total Annual Hours: 2,480. (For requirements for laboratories accredited necessary requirements to be approved
policy questions regarding this under its program are equal to or more by us and that, as such, we may approve
collection contact Frank Funderburk at stringent than the applicable CLIA ASHI as an accreditation program with
410–786–1820.) program requirements in 42 CFR part deeming authority under the CLIA
493 (Laboratory Requirements). Subpart program. ASHI formally applied to us
Dated: April 19, 2016.
for approval as an accreditation
mstockstill on DSK4VPTVN1PROD with NOTICES

E of part 493 (Accreditation by a Private,
William N. Parham, III, Nonprofit Accreditation Organization or organization under CLIA for the
Director, Paperwork Reduction Staff, Office Exemption Under an Approved State subspecialty of General Immunology,
of Strategic Operations and Regulatory Laboratory Program) specifies the the specialty of Histocompatibility, and
Affairs. requirements an accreditation the subspecialty of ABO/Rh typing. In
[FR Doc. 2016–09425 Filed 4–21–16; 8:45 am] organization must meet to be approved reviewing these materials, we reached
BILLING CODE 4120–01–P by us as an accreditation organization the following determinations for each
under CLIA. applicable part of the CLIA regulations:

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Document Created: 2017-08-22 23:36:55
Document Modified: 2017-08-22 23:36:55

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 must be received by June 21, 2016.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 23705

81 FR 23705 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 78 (April 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services