[Federal Register Volume 78, Number 193 (Friday, October 4, 2013)]
[Notices]
[Pages 61848-61851]
From the Federal Register Online via the Government Publishing 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 [email protected].
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