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[Federal Register Volume 78, Number 193 (Friday, October 4, 2013)]
[Notices]
[Pages 61848-61851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-37, CMS-64, CMS-10052, CMS-10141, CMS-10142, 
CMS-10227, CMS-10311, CMS-10344, CMS-10500, CMS-R-26, CMS-R-138, CMS-R-
244, and CMS-R-308]

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 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 December 3, 2013:

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). 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 Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

[[Page 61849]]

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-37 Medicaid Program Budget Report
CMS-64 Medicaid Program Budget Report
CMS-10052 Recognition of Pass-Through Payment for Additional (New) 
Categories of Devices Under the Outpatient Prospective Payment 
System and Supporting Regulations
CMS-10141 Medicare Prescription Drug Benefit Program
CMS-10142 Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans 
and Prescription Drug Plans (PDP)
CMS-10227 PACE State Plan Amendment Preprint
CMS-10311 Medicare Program/Home Health Prospective Payment System 
Rate Update for Calendar Year 2010: Physician Narrative Requirement 
and Supporting Regulation
CMS-10344 Elimination of Cost-Sharing for full benefit dual-eligible 
Individuals Receiving Home and Community-Based Services
CMS-10500 Outpatient and Ambulatory Surgery Experience of Care 
Survey
CMS-R-26 Clinical Laboratory Improvement Amendments (CLIA) 
Regulations
CMS-R-138 Medicare Geographic Classification Review Board (MGCRB) 
Procedures and Supporting Regulations
CMS-R-244 Programs for All-inclusive Care of the Elderly (PACE) and 
Supporting Regulations
CMS-R-308 State Children's Health Insurance Program and Supporting 
Regulations

    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 Collections

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Program 
Budget Report; Use: We require that each State Medicaid agency 
quarterly submit the Form CMS-37 via the web-based Medicaid and State 
Children's Health Insurance Program Budget and Expenditure System 
(MBES/CBES). Due dates are November 15, February 15, May 15 and August 
15 of each fiscal year. The addendum provides a description of forms 
contained in this package. All submissions represent equally important 
components of the grant award cycle, but the May and November 
submissions are particularly significant for budget formulation. The 
November submission introduces a new fiscal year to the budget cycle 
and serves as the basis for the formulation of the Medicaid portion of 
the President's Budget, which is presented to Congress in January. The 
February and August submissions are used primarily for budget execution 
in providing interim updates to CMS' Office of Financial Management, 
the Department of Health and Human Services, the Office of Management 
and Budget and Congress depending on the scheduling of the national 
budget review process in a given fiscal year. These submissions provide 
us with base information necessary to track current year obligations 
and expenditures in relation to the current year appropriation and to 
notify senior managers of any impending surpluses or deficits; Form 
Number: CMS-37 (OCN: 0938-0101); Frequency: Quarterly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 56; Total 
Annual Responses: 224; Total Annual Hours: 7,616 (For policy questions 
regarding this collection contact Abraham John at 410-786-4519).
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Program 
Budget Report; Use: Section 1903 of the Social Security Act provides 
the authority for collecting this information. States are required to 
submit the form CMS-64 quarterly to us no later than 30 days after the 
end of the quarter being reported. These submissions provide us with 
the information necessary to issue the quarterly grant awards, monitor 
current year expenditure levels, determine the allow ability of State 
claims for reimbursement, develop Medicaid financial management 
information provide for State reporting of waiver expenditures, ensure 
that the federally-established limit is not exceeded for HCBS waivers, 
and to allow for the implementation of the Assignment of Rights and 
Part A and Part B Premium (i.e., accounting for overdue Part A and Part 
B Premiums under State buy-in agreements)--Billing Offsets. Form 
Number: CMS-64 (OCN: 0938-0067); Frequency: Quarterly; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 56; Total 
Annual Responses: 224; Total Annual Hours: 16,464. (For policy 
questions regarding this collection contact Abraham John at 410-786-
4519).
    3. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Recognition of Pass-Through Payment for Additional (New) Categories of 
Devices Under the Outpatient Prospective Payment System and Supporting 
Regulations; Use: Interested parties such as hospitals, device 
manufacturers, pharmaceutical companies, and physicians apply for 
transitional pass-through payment for certain items used with services 
covered in the outpatient prospective payment system (PPS). After we 
receive all requested information, we evaluate the information to 
determine if the creation of an additional category of medical devices 
for transitional pass-through payments is justified. We may request 
additional information related to the proposed new device category, as 
needed. We advise the applicant of our decision, and update the 
outpatient PPS during its next scheduled quarterly payment update cycle 
to reflect any newly approved device categories. We list below the 
information that we require from all applicants. Form Number: CMS-10052 
(OCN: 0938-0857); Frequency: Once; Affected Public: Business or other 
for-profits; Number of Respondents: 10; Total Annual Responses: 10; 
Total Annual Hours: 160. (For policy questions regarding this 
collection contact Barry Levi at 410-786-4529).
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Prescription Drug Benefit Program; Use: Part D plans use the 
information to comply with the eligibility and associated Part D 
participating requirements. We use the information to approve contract 
applications, monitor compliance with contract requirements, make 
proper payment to plans, and to ensure that correct information is 
disclosed to potential and current enrollees. Form Number: CMS-10141

[[Page 61850]]

(OCN: 0938-0964); Frequency: Occasionally; Affected Public: Individuals 
or households, Business or other for-profits and Not-for-profit 
institutions, and State, Local, or Tribal Governments; Number of 
Respondents: 4,100,953; Total Annual Responses: 26,301,339; Total 
Annual Hours: 7,572,243. (For policy questions regarding this 
collection contact Deborah Larwood at 410-786-9500).
    5. 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 Medicare Advantage organizations (MAOs) and 
prescription drug plans (PDPs) to 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 (OCN-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).
    6. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
PACE State Plan Amendment Preprint; Use: If a state elects to offer 
PACE as an optional Medicaid benefit, it must complete a state plan 
amendment preprint packet described as ``Enclosures 3,4,5,6 
and 7.'' The information, collected from the state on a one-time basis 
is needed in order to determine if the state has properly elected to 
cover PACE services as a state plan option. Form Number: CMS-10227 
(OCN: 0938-1027); Frequency: Once and occasionally; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 21; Total 
Annual Responses: 7; Total Annual Hours: 240. (For policy questions 
regarding this collection contact Angela Taube at 410-786-2638).
    7. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare 
Program--Home Health Prospective Payment System Rate Update for 
Calendar Year 2010: Physician Narrative Requirement and Supporting 
Regulation; Use: The conditions of participation and accompanying 
requirements specified in the regulations are used by Federal or state 
surveyors as a basis for determining whether a home health agency 
qualifies for approval or re-approval under Medicare. The Physician's 
certification and recertification of each patient's need for skilled 
care services; homebound status and the physician's clinical 
justification for skilled nursing management and evaluation of the care 
plan specified in the regulations at 42 CFR 424.22 are to be used by 
contractors and by us when reviewing the patient's medical record as a 
basis for determining whether the patient is eligible for the Medicare 
home health benefit and whether the medical record meets the criteria 
for coverage and Medicare payment. We, along with the healthcare 
industry believe that the availability to the home health agency of the 
type of records and general content of records, which this regulation 
specifies, is standard medical practice, and is necessary in order to 
ensure the well-being and safety of patients and professional treatment 
accountability. Form Number: CMS-10311 (OCN: 0938-1083; Frequency: 
Occasionally; Affected Public: Business or other for-profits and Not-
for-profit institutions); Number of Respondents: 9,354; Total Annual 
Responses: 345,600; Total Annual Hours: 28,800. (For policy questions 
regarding this collection contact Randy Throndset at 410-786-0131).
    8. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Elimination of Cost-Sharing for full benefit dual-eligible Individuals 
Receiving Home and Community-Based Services; Use: This provision 
eliminates Part D cost-sharing for full benefit dual-eligible 
beneficiaries who are receiving home and community based services. To 
implement this provision, States are required to identify the affected 
beneficiaries in their monthly Medicare Modernization Act Phase Down 
reports. Form Number: CMS-10344 (OCN: 0938-1127); Frequency: Monthly; 
Affected Public: Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 51; Total Annual Responses: 612; 
Total Annual Hours: 612. (For policy questions regarding this 
collection contact Katherine Pokrzywa at 410-786-5530).
    9. Type of Information Collection Request: New collection (Request 
for a new control number); Title of Information Collection: Outpatient 
and Ambulatory Surgery Experience of Care Survey; Use: We will use the 
information collected through the field test to inform the development 
of a larger national survey effort, including development of the final 
survey instrument and data collection procedures. Looking toward the 
survey development specifically, the data collected in this survey 
effort will be used to conduct a rigorous psychometric analysis of the 
survey content. The goal of such an analysis is to assess the 
measurement properties of the proposed instrument and sub-domain 
composites created from item subsets, to assure the information 
reported from any future administrations of the survey is well-defined. 
Such careful definition will prevent data distortion or misinformation 
if they are publicly reported. Data collection procedures will also be 
fine-tuned during this field test. Form Number: CMS-10500 (OCN: 0938-
New); Frequency: Once; Affected Public: Individuals and households; 
Number of Respondents: 2,304; Total Annual Responses: 2,304; Total 
Annual Hours: 384. (For policy questions regarding this collection 
contact Caren Ginsberg at 410-786-0713).
    10. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: 
Clinical Laboratory Improvement Amendments (CLIA) Regulations; Use: The 
information is necessary to determine an entity's compliance with the 
Congressionally-mandated program with respect to the regulation of 
laboratory testing (CLIA). In addition, laboratories participating in 
the Medicare program must comply with CLIA requirements as required by 
section 6141 of OBRA 89. Medicaid, under the authority of section 
1902(a)(9)(C) of the Social Security Act, pays for services furnished 
only by laboratories that meet Medicare (CLIA) requirements. Form 
Number: CMS-R-26 (OCN: 0938-0612); Frequency: Monthly, occasionally; 
Affected Public: Business or other for-profits and not-for-profit 
institutions, State, Local or Tribal Governments, and the Federal 
government; Number of Respondents: 79,175; Total Annual Responses: 
88,886,364; Total Annual Hours: 15,613,299. (For policy questions 
regarding this collection contact Raelene Perfetto at 410-786-6876).

[[Page 61851]]

    11. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Medicare Geographic Classification Review Board (MGCRB) 
Procedures and Supporting Regulations; Use: The information submitted 
by the hospitals is used to determine the validity of the hospitals' 
requests and the discretion used by the Medicare Geographic 
Classification Review Board (MGCRB) in reviewing and making decisions 
regarding hospitals' requests for geographic reclassification. Form 
Number: CMS-R-138 (OCN: 0938-0573); Frequency: Yearly; Affected Public: 
Business or other for-profits and Not-for-profit institutions, and 
State, Local, or Tribal Governments; Number of Respondents: 300; Total 
Annual Responses: 300; Total Annual Hours: 300. (For policy questions 
regarding this collection contact Geri Mondowney at 410-786-1172).
    12. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: 
Programs for All-inclusive Care of the Elderly (PACE) and Supporting 
Regulations; Use: The PACE organizations must demonstrate their ability 
to provide quality community-based care for the frail elderly who meet 
their state's nursing home eligibility standards using capitated 
payments from Medicare and the state. The model of care includes as 
core services the provision of adult day health care and 
multidisciplinary team case management, through which access to and 
allocation of all health services is controlled. Physician, 
therapeutic, ancillary, and social support services are provided in the 
participant's residence or on-site at the adult day health center. The 
PACE programs must provide all Medicare and Medicaid covered services 
including hospital, nursing home, home health, and other specialized 
services. Financing of this model is accomplished through prospective 
capitation of both Medicare and Medicaid payments. The information 
collection requirements are necessary to ensure that only appropriate 
organizations are selected to become PACE organizations and that we 
have the information necessary to monitor the care provided to the 
frail, vulnerable population served. Form Number: CMS-R-244 (OCN: 0938-
0790; Frequency: Once and occasionally; Affected Public: Private Sector 
(Not-for-profit institutions); Number of Respondents: 99; Total Annual 
Responses: 99; Total Annual Hours: 81,912. (For policy questions 
regarding this collection contact Anitra Johnson at 410-786-0609).
    13. Type of Information Collection Request: Extension of a 
currently approved collection; Title of Information Collection: State 
Children's Health Insurance Program and Supporting Regulations; Use: 
States must submit title XXI plans and amendments for approval by the 
Secretary. We use the plan and its subsequent amendments to determine 
if the state has met the requirements of title XXI. Information 
provided in the state plan, state plan amendments, and from the other 
information we are collecting will be used by advocacy groups, 
beneficiaries, applicants, other governmental agencies, providers 
groups, research organizations, health care corporations, health care 
consultants. States will use the information collected to assess state 
plan performance, health outcomes and an evaluation of the amount of 
substitution of private coverage that occurs as a result of the 
subsidies and the effect of the subsidies on access to coverage. Form 
Number: CMS-R-308 (OCN: 0938-0841; Frequency: Yearly, once, and 
occasionally; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 56; Total Annual Responses: 400; Total Annual 
Hours: 1,489,092. (For policy questions regarding this collection 
contact Judith Cash at 410-786-4473).

    Dated: September 30, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-24250 Filed 10-3-13; 8:45 am]
BILLING CODE 4120-01-P
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