82 FR 44416 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 82, Issue 183 (September 22, 2017)

Page Range		44416-44417
FR Document		2017-20290

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.

Federal Register, Volume 82 Issue 183 (Friday, September 22, 2017)

[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44416-44417]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20290]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-R-185, CMS-718-721, CMS-10123/-10124, CMS-
10142, and CMS-R-262]


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 November 21, 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: William Parham at (410) 786-4669.

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-185 Granting and Withdrawal of Deeming Authority to Private 
Nonprofit Accreditation Organizations and CLIA Exemption under State 
Laboratory Programs
CMS-718-721 Business Proposal Forms for Quality Improvement 
Organizations (QIOs)
CMS-10123/-10124 Fast Track Appeals Notices: NOMNC/DENC
CMS-10142 Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and 
Prescription Drug Plans (PDP)
CMS-R-262 Contract Year 2019 Plan Benefit Package (PBP) Software and 
Formulary Submission

    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 currently 
approved collection; Title of Information Collection: Granting and 
Withdrawal of Deeming Authority to Private Nonprofit Accreditation 
Organizations and CLIA Exemption Under State Laboratory Programs; Use: 
The information required is necessary to determine whether a private 
accreditation organization/State licensure program standards and 
accreditation/licensure process is at least equal to or more stringent 
than those of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). If an accreditation organization is approved, the laboratories 
that it

[[Page 44417]]

accredits are ``deemed'' to meet the CLIA requirements based on this 
accreditation. Similarly, if a State licensure program is determined to 
have requirements that are equal to or more stringent than those of 
CLIA, its laboratories are considered to be exempt from CLIA 
certification and requirements. The information collected will be used 
by HHS to: Determine comparability/equivalency of the accreditation 
organization standards and policies or State licensure program 
standards and policies to those of the CLIA program; to ensure the 
continued comparability/equivalency of the standards; and to fulfill 
certain statutory reporting requirements. Form No.: CMS-R-185 (OMB 
control number: 0938-0686); Frequency: Occasionally; Affected Public: 
Private Sector--Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 12; Total Annual Responses: 96; 
Total Annual Hours: 384. (For policy questions regarding this 
collection contact Arlene Lopez at 410-786-6782.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Business Proposal 
Forms for Quality Improvement Organizations (QIOs); Use: The submission 
of proposal information by current quality improvement associations 
(QIOs) and other bidders, on the appropriate forms, will satisfy our 
need for meaningful, consistent, and verifiable data with which to 
evaluate contract proposals. We use the data collected on the forms 
associated with this information collection request to negotiate QIO 
contracts. We will be able to compare the costs reported by the QIOs on 
the cost reports to the proposed costs noted on the business proposal 
forms. Subsequent contract and modification negotiations will be based 
on historic cost data. The business proposal forms will be one element 
of the historical cost data from which we can analyze future proposed 
costs. In addition, the business proposal format will standardize the 
cost proposing and pricing process among all QIOs. With well-defined 
cost centers and line items, proposals can be compared among QIOs for 
reasonableness and appropriateness. Form Number: CMS-718-721 (OMB 
control number: 0938-0579); Frequency: Annually; Affected Public: 
Business or other for-profits and Not-for-profit institutions; Number 
of Respondents: 20; Total Annual Responses: 20; Total Annual Hours: 
1,000. (For policy questions regarding this collection contact Benjamin 
Bernstein at 410-786-6570.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Fast Track 
Appeals Notices: NOMNC/DENC; Use: Providers shall deliver a Notice of 
Medicare (Provider) Non-Coverage (NOMNC) to beneficiaries, enrollees, 
or both beneficiaries and enrollees no later than two days prior to the 
end of Medicare-covered services in skilled nursing facilities, home 
health agencies, comprehensive outpatient rehabilitation facilities, 
and hospices. Beneficiaries, enrollees or both beneficiaries and 
enrollees will use this information to determine whether they want to 
appeal the service termination to their Quality Improvement 
Organization (QIO). If the beneficiaries, enrollees or both 
beneficiaries decide to appeal, the Medicare provider or health plan 
will send the QIO and appellant a Detailed Explanation of Non-Coverage 
(DENC) detailing the rationale for the termination decision. Form 
Number: CMS-10123 and CMS-10124 (OMB control number: 0938-0953); 
Frequency: Occasionally; Affected Public: Private sector--Business or 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 28,177; Total Annual Responses: 6,017,832; Total Annual 
Hours: 1,111,196. (For policy questions regarding this collection 
contact Janet Miller at 404-562-1799.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Bid Pricing Tool 
(BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans 
(PDP); Use: We require that Medicare Advantage organizations and 
Prescription Drug Plans complete the BPT as part of the annual bidding 
process. During this process, organizations prepare their proposed 
actuarial bid pricing for the upcoming contract year and submit them to 
us for review and approval. The purpose of the BPT is to collect the 
actuarial pricing information for each plan. The BPT calculates the 
plan's bid, enrollee premiums, and payment rates. We publish 
beneficiary premium information using a variety of formats 
(www.medicare.gov, the Medicare & You handbook, Summary of Benefits 
marketing information) for the purpose of beneficiary education and 
enrollment. Form Number: CMS-10142 (OMB control number: 0938-0944); 
Frequency: Yearly; Affected Public: Business or other for-profits and 
Not-for-profit institutions; Number of Respondents: 555; Total Annual 
Responses: 4,995; Total Annual Hours: 149,850. (For policy questions 
regarding this collection contact Rachel Shevland at 410-786-3026.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Contract Year 
2019 Plan Benefit Package (PBP) Software and Formulary Submission; Use: 
We require that Medicare Advantage and Prescription Drug Plan 
organizations submit a completed PBP and formulary as part of the 
annual bidding process. During this process, organizations prepare 
their proposed plan benefit packages for the upcoming contract year and 
submit them to us for review and approval. We publish beneficiary 
education information using a variety of formats. The specific 
education initiatives that utilize PBP and formulary data include web 
application tools on www.medicare.gov and the plan benefit insert in 
the Medicare & You handbook. In addition, organizations utilize the PBP 
data to generate their Summary of Benefits marketing information. Form 
Number: CMS-R-262 (OMB control number 0938-0763); Frequency: Yearly; 
Affected Public: Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 520; Total Annual Responses: 
5,675; Total Annual Hours: 54,550. (For policy questions regarding this 
collection contact Kristy Holtje at 410-786-2209.)

    Dated: September 19, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2017-20290 Filed 9-21-17; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44417

accredits are ‘‘deemed’’ to meet the contact Benjamin Bernstein at 410–786– Responses: 4,995; Total Annual Hours:
CLIA requirements based on this 6570.) 149,850. (For policy questions regarding
accreditation. Similarly, if a State 3. Type of Information Collection this collection contact Rachel Shevland
licensure program is determined to have Request: Extension of a currently at 410–786–3026.)
requirements that are equal to or more approved collection; Title of 5. Type of Information Collection
stringent than those of CLIA, its Information Collection: Fast Track Request: Revision of a currently
laboratories are considered to be exempt Appeals Notices: NOMNC/DENC; Use: approved collection; Title of
from CLIA certification and Providers shall deliver a Notice of Information Collection: Contract Year
requirements. The information collected Medicare (Provider) Non-Coverage 2019 Plan Benefit Package (PBP)
will be used by HHS to: Determine (NOMNC) to beneficiaries, enrollees, or Software and Formulary Submission;
comparability/equivalency of the both beneficiaries and enrollees no later Use: We require that Medicare
accreditation organization standards than two days prior to the end of Advantage and Prescription Drug Plan
and policies or State licensure program Medicare-covered services in skilled organizations submit a completed PBP
nursing facilities, home health agencies, and formulary as part of the annual
standards and policies to those of the
comprehensive outpatient rehabilitation bidding process. During this process,
CLIA program; to ensure the continued
facilities, and hospices. Beneficiaries, organizations prepare their proposed
comparability/equivalency of the
enrollees or both beneficiaries and plan benefit packages for the upcoming
standards; and to fulfill certain statutory enrollees will use this information to contract year and submit them to us for
reporting requirements. Form No.: determine whether they want to appeal review and approval. We publish
CMS–R–185 (OMB control number: the service termination to their Quality beneficiary education information using
0938–0686); Frequency: Occasionally; Improvement Organization (QIO). If the a variety of formats. The specific
Affected Public: Private Sector— beneficiaries, enrollees or both education initiatives that utilize PBP
Business or other for-profits and Not- beneficiaries decide to appeal, the and formulary data include web
for-profit institutions; Number of Medicare provider or health plan will application tools on www.medicare.gov
Respondents: 12; Total Annual send the QIO and appellant a Detailed and the plan benefit insert in the
Responses: 96; Total Annual Hours: Explanation of Non-Coverage (DENC) Medicare & You handbook. In addition,
384. (For policy questions regarding this detailing the rationale for the organizations utilize the PBP data to
collection contact Arlene Lopez at 410– termination decision. Form Number: generate their Summary of Benefits
786–6782.) CMS–10123 and CMS–10124 (OMB marketing information. Form Number:
2. Type of Information Collection control number: 0938–0953); Frequency: CMS–R–262 (OMB control number
Request: Revision of a currently Occasionally; Affected Public: Private 0938–0763); Frequency: Yearly; Affected
approved collection; Title of sector—Business or other for-profits and Public: Business or other for-profits and
Information Collection: Business Not-for-profit institutions; Number of Not-for-profit institutions; Number of
Proposal Forms for Quality Respondents: 28,177; Total Annual Respondents: 520; Total Annual
Improvement Organizations (QIOs); Use: Responses: 6,017,832; Total Annual Responses: 5,675; Total Annual Hours:
The submission of proposal information Hours: 1,111,196. (For policy questions 54,550. (For policy questions regarding
by current quality improvement regarding this collection contact Janet this collection contact Kristy Holtje at
associations (QIOs) and other bidders, Miller at 404–562–1799.) 410–786–2209.)
on the appropriate forms, will satisfy 4. Type of Information Collection
Dated: September 19, 2017.
Request: Revision of a currently
our need for meaningful, consistent, and William N. Parham, III,
approved collection; Title of
verifiable data with which to evaluate Director, Paperwork Reduction Staff, Office
Information Collection: Bid Pricing Tool
contract proposals. We use the data of Strategic Operations and Regulatory
(BPT) for Medicare Advantage (MA)
collected on the forms associated with Affairs.
Plans and Prescription Drug Plans
this information collection request to [FR Doc. 2017–20290 Filed 9–21–17; 8:45 am]
(PDP); Use: We require that Medicare
negotiate QIO contracts. We will be able Advantage organizations and BILLING CODE 4120–01–P
to compare the costs reported by the Prescription Drug Plans complete the
QIOs on the cost reports to the proposed BPT as part of the annual bidding
costs noted on the business proposal process. During this process, DEPARTMENT OF HEALTH AND
forms. Subsequent contract and organizations prepare their proposed HUMAN SERVICES
modification negotiations will be based actuarial bid pricing for the upcoming
on historic cost data. The business Food and Drug Administration
contract year and submit them to us for
proposal forms will be one element of review and approval. The purpose of the [Docket No. FDA–2011–N–0275]
the historical cost data from which we BPT is to collect the actuarial pricing
can analyze future proposed costs. In information for each plan. The BPT Agency Information Collection
addition, the business proposal format calculates the plan’s bid, enrollee Activities; Proposed Collection;
will standardize the cost proposing and premiums, and payment rates. We Comment Request; Certification To
pricing process among all QIOs. With publish beneficiary premium Accompany Drug, Biological Product,
well-defined cost centers and line items, information using a variety of formats and Device Applications or
proposals can be compared among QIOs (www.medicare.gov, the Medicare & You Submissions
for reasonableness and appropriateness. handbook, Summary of Benefits AGENCY: Food and Drug Administration,
Form Number: CMS–718–721 (OMB marketing information) for the purpose HHS.
control number: 0938–0579); Frequency: of beneficiary education and ACTION: Notice.
Annually; Affected Public: Business or enrollment. Form Number: CMS–10142
other for-profits and Not-for-profit (OMB control number: 0938–0944); SUMMARY: The Food and Drug
institutions; Number of Respondents: Frequency: Yearly; Affected Public: Administration (FDA) is announcing an
20; Total Annual Responses: 20; Total Business or other for-profits and Not- opportunity for public comment on the
Annual Hours: 1,000. (For policy for-profit institutions; Number of proposed collection of certain
questions regarding this collection Respondents: 555; Total Annual information by the Agency. Under the

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Document Created: 2017-09-22 01:52:59
Document Modified: 2017-09-22 01:52:59

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 November 21, 2017.
Contact		William Parham at (410) 786-4669.
FR Citation		82 FR 44416

82 FR 44416 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 82, Issue 183 (September 22, 2017)

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