Agency Information Collection Activities: Submission for OMB Review; Comment Request, 11037-11040 [2017-03235]
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
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circumstances. CMS also explained the steps
which the agency can and must follow under
regulations at 42 CFR 435.916(d) and 42 CFR
part 435 subpart E in the event that the
agency later discovers information that
suggests someone was not at application, or
is no longer, eligible for coverage. Again, if
the agency believes that an applicant
intentionally provided false information on
his or her application, referral to law
enforcement for investigation of fraud, or
institution of a full investigation by the
agency into potential abuse, are the only
appropriate next steps under the statute and
regulations.
The Alabama Medicaid agency’s
submission of its quarterly expenditure
reports through the CMS–64 includes a
certification that the Alabama Medicaid
agency is operating under the authority of its
approved Medicaid state plan. However, at
this time, CMS has not received information
from the agency providing evidence of
compliance with its approved state plan,
sections 1902(a)(8), 1902(a)(10) and 1128B(a)
of the Act or regulations at 42 CFR 455.15
and 455.16.
Determination of Non-Compliance and FFP
Withholding
The CMS has concluded that the Alabama
Medicaid agency is operating its program in
substantial noncompliance with federal
requirements described in sections 1902(a)(8)
and 1902(a)(10) of the Act, requiring states to
provide Medicaid to all individuals who
meet eligibility criteria required under the
state plan, and with section 1128B(a) of the
Act and regulations at 42 CFR 455.15 and
455.16, requiring that the agency refer cases
of suspected fraud to appropriate law
enforcement, conduct a full investigation of
suspected abuse, and limit sanctions to those
permitted under the regulations or specified
in its approved state plan. Subject to the
state’s opportunity for a hearing, CMS will
withhold a portion of federal financial
participation (FFP) from the Alabama
Medicaid agency’s quarterly claim of
expenditures for administrative costs until
such time as the Alabama Medicaid agency
is, and continues to be, in compliance with
the federal requirements.
The withholding will initially be one
percent of the federal share of the Alabama
Medicaid agency’s quarterly claim for
administrative expenditures, an amount that
was developed based on the proportion of
total state Medicaid expenditures that are
used for expenditures for eligibility
determinations, as reported on Form CMS–
64.10 Line 50. The withholding percentage
will increase by one percentage point for
every quarter in which the Alabama
Medicaid agency remains out of compliance.
The withholding will end when the Alabama
Medicaid agency fully and satisfactorily
implements a corrective action plan to bring
its eligibility policies and procedures under
its Medicaid program into compliance with
the federal requirements.
Opportunity To Request a Hearing
The state has 30 days from the date of this
letter to request a hearing. If a request for
hearing is submitted timely, the hearing will
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be convened by the designated hearing
officer below, no later than 60 days after the
date of the Federal Register notice, or a later
date by agreement of the parties and the
Hearing Officer, at the CMS Regional Office
in Atlanta, Georgia, in accordance with the
procedures set forth in federal regulations at
42 CFR part 430, subpart D. The Hearing
Officer also should be notified if the Alabama
Medicaid agency requests a hearing but
cannot meet the timeframe expressed in this
notice. The Hearing Officer designated for
this matter is:
Benjamin R. Cohen, Hearing Officer
Centers for Medicare & Medicaid Services
2520 Lord Baltimore Drive, Suite L
Baltimore, MD 21244
At issue in any such hearing will be:
1. Whether the penalties set forth in
Section 22–6–8 of the Alabama Code are
consistent with the requirements of sections
1902(a)(8) and 1902(a)(10) of the Act.
2. If so, whether an administrative finding
of the type described in section 22–6–8 of the
Alabama Code, without a conviction in a
court of law, is a sufficient basis to impose
such penalties consistent with the
requirements of sections 1902(a)(8) and
1902(a)(10) of the Act, and the remedies set
forth in sections 1128 and 1128B of the Act,
regulations at 42 CFR 455.15 and 455.16 and
the Alabama Medicaid state plan.
If the Alabama Medicaid agency plans to
come into compliance with the approved
state plan, the Alabama Medicaid agency
should submit, within 30 days of the date of
this letter, an explanation of how the
Alabama Medicaid agency plans to come into
compliance with federal requirements and
the timeframe for doing so. If that
explanation is satisfactory, CMS may
consider postponing any requested hearing,
which could also delay the imposition of the
withholding of funds as described above. Our
goal is to have the Alabama Medicaid agency
come into compliance, and CMS continues to
be available to provide technical assistance to
the Alabama Medicaid agency in achieving
this outcome. However, if CMS does not find
the Alabama Medicaid agency’s plan or
explanation satisfactory, CMS will not
postpone any requested hearing.
Should you not request a hearing within 30
days, a notice of withholding will be sent to
you and the withholding of federal funds will
begin as described above.
If you have any questions or wish to
discuss this determination further, please
contact:
Jackie Glaze
Associate Regional Administrator
Division of Medicaid and Children’s Health
Operations
CMS Atlanta Regional Office, 61 Forsyth
Street, Suite 4T20
Atlanta, Georgia 30303
404–562–7417
Sincerely,
Patrick H. Conway
Acting Administrator
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program.)
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11037
Dated: February 14, 2017.
Patrick H. Conway,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2017–03292 Filed 2–16–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–10, CMS–
10116, CMS–R–26, CMS–10069, CMS–10629,
CMS–10266, CMS–8003, CMS–4040, CMS–
10156, CMS–10170, CMS–10198, CMS–
10227, CMS–10344, CMS–416, CMS–R–244,
and CMS–10219]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
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 March 20, 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
SUMMARY:
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
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
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
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.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
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 previously
approved collection; Title of
Information Collection: Advance
Directives (Medicare and Medicaid) and
Supporting Regulations; Use: The
advance directives requirement was
enacted because Congress wanted
individuals to know that they have a
right to make health care decisions and
to refuse treatment even when they are
unable to communicate. Steps have
been taken at both the Federal and State
level, to afford greater opportunity for
the individual to participate in
decisions made concerning the medical
treatment to be received by an adult
patient in the event that the patient is
unable to communicate to others, a
preference about medical treatment. The
individual may make his preference
known through the use of an advance
directive, which is a written instruction
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SUPPLEMENTARY INFORMATION:
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prepared in advance, such as a living
will or durable power of attorney. This
information is documented in a
prominent part of the individual’s
medical record. Advance directives as
described in the Patient SelfDetermination Act have increased the
individual’s control over decisions
concerning medical treatment. Sections
4206 of the Omnibus Budget
Reconciliation Act of 1990 defined an
advance directive as a written
instruction recognized under State law
relating to the provision of health care
when an individual is incapacitated
(those persons unable to communicate
their wishes regarding medical
treatment).
All states have enacted legislation
defining a patient’s right to make
decisions regarding medical care,
including the right to accept or refuse
medical or surgical treatment and the
right to formulate advance directives.
Participating hospitals, skilled nursing
facilities, nursing facilities, home health
agencies, providers of home health care,
hospices, religious nonmedical health
care institutions, and prepaid or eligible
organizations (including Health Care
Prepayment Plans (HCPPs) and
Medicare Advantage Organizations
(MAOs) such as Coordinated Care Plans,
Demonstration Projects, Chronic Care
Demonstration Projects, Program of All
Inclusive Care for the Elderly, Private
Fee for Service, and Medical Savings
Accounts must provide written
information, at explicit time frames, to
all adult individuals about: (a) The right
to accept or refuse medical or surgical
treatments; (b) the right to formulate an
advance directive; (c) a description of
applicable State law (provided by the
State); and (d) the provider’s or
organization’s policies and procedures
for implementing an advance directive.
Form Number: CMS–R–10 (OMB control
number: 0938–0610); Frequency: Yearly;
Affected Public: Business or other forprofits; Number of Respondents: 39,479;
Total Annual Responses: 39,479; Total
Annual Hours: 2,836,441. (For policy
questions regarding this collection
contact Jeannine Cramer at 410–786–
5664.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions for
Payment of Power Mobility Devices,
including Power Wheelchairs and
Power-Operated Vehicles; Use: We are
renewing our request for approval for
the collection requirements associated
with the final rule, CMS–3017–F (71 FR
17021), which published on April 5,
2006, and required a face-to-face
examination of the beneficiary by the
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physician or treating practitioner, a
written prescription, and receipt of
pertinent parts of the medical record by
the supplier within 45 days after the
face-to-face examination that the
durable medical equipment (DME)
suppliers maintain in their records and
make available to CMS and its agents
upon request. Form Number: CMS–
10116 (OMB control number: 0938–
0971); Frequency: Yearly; Affected
Public: Business or other for-profits;
Number of Respondents: 46,000;
Number of Responses: 72,500; Total
Annual Hours: 14,434. (For policy
questions regarding this collection
contact Stuart Caplan at 410–786–8564)
3. Type of Information Collection
Request: Revision 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 (OMB Control Number: 0938–0612);
Frequency: Monthly, occasionally;
Affected Public: Business or other forprofits and Not-for-profit institutions,
State, Local or Tribal Governments, and
the Federal government; Number of
Respondents: 70,861; Total Annual
Responses: 1,979,300; Total Annual
Hours: 14,975,785. (For policy questions
regarding this collection contact Raelene
Perfetto at 410–786–6876).
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare/
Medicaid Demonstration/Model
Application; Use: The application is
used for solicitation of proposals that
are either congressionally mandated or
Administration high priority
demonstration initiatives which would
be used to strengthen and modernize the
Medicare and/or Medicaid programs.
The standardized proposal format is not
controversial and will reduce burden on
applicants and reviewers. Responses are
strictly voluntary. The standard format
will enable CMS to select proposals that
meet CMS objectives and show the best
potential for success. Form Number:
CMS–10069 (OMB control number:
0938–0880); Frequency: Once; Affected
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Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 75; Total Annual
Responses: 75; Total Annual Hours:
6,000. (For policy questions regarding
this collection contact John Amoh at
410–786–4910).
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Waiver
Application for Providers and Suppliers
Subject to an Enrollment Moratorium;
Use: This demonstration, in conjunction
with an expansion of the existing
provider enrollment moratoria, will
allow CMS to mitigate known
vulnerabilities within the existing
moratoria and will lead to increased
investigations of fraud. Section
402(a)(l)(J) of the Social Security
Amendments of 1967 (42 U.S.C. 1395b–
l(a)(l)(J)) permits the Secretary to
‘‘develop or demonstrate improved
methods for the investigation and
prosecution of fraud in the provision of
care or services under the health
programs established by the Social
Security Act.’’ In addition to the
development and demonstration of
improved methods for investigations,
CMS will utilize this demonstration to
address beneficiary access to care
issues. CMS received one comment
during the 60-day comment period (81
FR 75408). Form Number: CMS–10629
(OMB control number: 0938–1313);
Frequency: Occasionally; Affected
Public: Business or other for-profit, Notfor-profit institutions; Number of
Respondents: 800; Total Annual
Responses: 800; Total Annual Hours:
4,800. (For policy questions regarding
this information collection contact Kim
Jung at 410–786–9370).
6. Type of Information Collection
Request: Extension of a previously
approved collection; Title of
Information Collection: Conditions of
Participation: Requirements for
Approval and Reapproval of Transplant
Centers to Perform Organ Transplants;
Use: The Conditions of Participation
and accompanying requirements
specified in the regulations are used by
our surveyors as a basis for determining
whether a transplant center qualifies for
approval or re-approval under Medicare.
We, along with the healthcare industry,
believe that the availability to the
facility of the type of records and
general content of records 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–10266 (OMB Control Number:
0938–1069); Frequency: Yearly; Affected
Public: Business or other for-profits and
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Not-for-profit institutions; Number of
Respondents: 165; Total Annual
Responses: 425; Total Annual Hours:
2,593. (For policy questions regarding
this collection contact Diane Corning at
410–786–8486.)
7. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: 1915(c)
Home and Community Based Services
(HCBS) Waiver; Use: We will use the
web-based application to review and
adjudicate individual waiver actions.
The web-based application will also be
used by states to submit and revise their
waiver requests. Form Number: CMS–
8003 (OMB control number 0938–0449);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 47; Total
Annual Responses: 71; Total Annual
Hours: 6,005. (For policy questions
regarding this collection contact Kathy
Poisal at 410–786–5940.)
8. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Request for
Enrollment in Supplementary Medical
Insurance; Use: Form CMS–4040 is used
to establish entitlement to and
enrollment in Medicare Part B for
beneficiaries who file for Part B only.
The collected information is used to
determine entitlement for individuals
who meet the requirements in section
1836(2) of the Social Security Act as
well as the entitlement of the applicant
(or their spouses) to an annuity paid by
OPM for premium deduction purposes.
Form Number: CMS–4040 (OMB control
number: 0938–0245); Frequency: Once;
Affected Public: Individuals or
households; Number of Respondents:
10,000; Total Annual Responses:
10,000; Total Annual Hours: 2,500. (For
policy questions regarding this
collection contact Carla Patterson at
410–786–8911.)
9. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Retiree Drug
Subsidy (RDS) Application and
Instructions; Use: Plan sponsors (e.g.,
employers, unions) who offer
prescription drug coverage to their
qualified covered retirees are eligible to
receive a 28 percent tax-free subsidy for
allowable drug costs. To qualify, plan
sponsors must submit a complete
application with a list of retirees for
whom it intends to collect the subsidy.
Once we review and analyze the
information on the application and the
retiree list, notification will be sent to
the plan sponsor about its eligibility to
participate in the RDS program. Form
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Number: CMS–10156 (OMB control
number: 0938–0957); Frequency: Yearly
and monthly; Affected Public: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
2,482; Total Annual Responses: 2,482;
Total Annual Hours: 158,848. (For
policy questions regarding this
collection contact Ivan Iveljic at 410–
786–3312.)
10. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Retiree Drug
Subsidy (RDS) Payment Request and
Instructions; Use: Plan sponsors (e.g.,
employers, unions) who offer
prescription drug coverage meeting
specified criteria to their qualified
covered retirees are eligible to receive a
28 percent tax-free subsidy for allowable
drug costs. Plan sponsors must submit
required prescription drug cost data and
other information in order to receive the
subsidy. Plan sponsors may elect to
submit RDS payment requests on a
monthly, quarterly, interim annual, or
annual basis; once selected, the
payment frequency may not be changed
during the plan year. Form Number:
CMS–10170 (OMB control number:
0938–0977); Frequency: Occasionally;
Affected Public: Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 2,482; Total
Annual Responses: 2,482; Total Annual
Hours: 374,782. (For policy questions
regarding this collection contact Ivan
Iveljic at 410–786–3312.)
11. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Creditable
Coverage Disclosure to CMS On-Line
Form and Instructions; Use: Most
entities that currently provide
prescription drug benefits to any
Medicare Part D eligible individual
must disclose whether their prescription
drug benefit is creditable (expected to
pay at least as much, on average, as the
standard prescription drug plan under
Medicare). The disclosure must be
provided annually and upon any change
that affects whether the coverage is
creditable prescription drug coverage.
Form Number: CMS–10198 (OMB
control number: 0938–1013); Frequency:
Yearly and semi-annually; Affected
Public: Business or other for-profits and
Not-for-profit institutions, and State,
Local, or Tribal Governments; Number
of Respondents: 85,635; Total Annual
Responses: 87,265; Total Annual Hours:
7,272. (For policy questions regarding
this collection contact Tammie Wall at
410–786–3317.)
12. Type of Information Collection
Request: Extension of a currently
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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.’’ CMS will review the information
provided in order to determine if the
state has properly elected to cover PACE
services as a state plan option. In the
event that the state changes something
in the state plan, only the affected page
must be updated. Form Number: CMS–
10227 (OMB control number: 0938–
1027); Frequency: Once and
occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 7; Total Annual
Responses: 2; Total Annual Hours: 140.
(For policy questions regarding this
collection contact Angela Cimino at
410–786–2638.)
13. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Elimination of
Cost-Sharing for Full Benefit DualEligible Individuals Receiving Home
and Community-Based Services; Use:
This collection eliminates Part D costsharing for full benefit dual-eligible
beneficiaries who are receiving home
and community based services. In this
regard, states are required to identify the
affected beneficiaries in their monthly
Medicare Modernization Act Phase
Down reports. Form Number: CMS–
10344 (OMB control number: 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 Roland Herrera at
410–786–0668.)
14. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual Early
and Periodic Screening, Diagnostic and
Treatment (EPSDT) Participation
Report; Use: The collected baseline data
is used to assess the effectiveness of
state early and periodic screening,
diagnostic and treatment (EPSDT)
programs in reaching eligible children
(by age group and basis of Medicaid
eligibility) who are provided initial and
periodic child health screening services,
referred for corrective treatment, and
receiving dental, hearing, and vision
services. This assessment is coupled
with the state’s results in attaining the
participation goals set for the state. The
information gathered from this report,
permits federal and state managers to
evaluate the effectiveness of the EPSDT
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law on the basic aspects of the program.
Form Number: CMS–416 (OMB control
number 0938–0354); Frequency: Yearly
and on occasion; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Annual
Responses: 168; Total Annual Hours:
1,624. (For policy questions regarding
this collection contact Kimberly Perrault
at 410–786–2482.)
15. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Programs for
All-inclusive Care of the Elderly (PACE)
and Supporting Regulations in 42 CFR
part 460; Use: This information
collection addresses all operational
components of the PACE program (as
defined in 42 CFR part 460) with the
exception of the application process
(§ 460.12). We are removing the
application requirements and burden
since this CMS–R–244 package is
lengthy and we recognize that it can be
somewhat time consuming to review.
We believe the change will help
streamline the public and OMB’s review
of the application as well as the
remaining requirements and burden
under the CMS–R–244 package.
The application is being moved under
a new information collection request
with a new CMS identification number
(CMS–10631). An OMB control number
specific to the application process is
pending. The CMS–10631 information
collection request was submitted to
OMB on October 6, 2016, under ICR
Reference No: 201610–0938–001. When
approved, the control number can be
found on www.reginfo.gov/public/.
Form Number: CMS–R–244 (OMB
control number: 0938–0790); Frequency:
Once and occasionally; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 130; Total
Annual Responses: 145,455; Total
Annual Hours: 61,350. (For policy
questions regarding this collection
contact Debbie Van Hoven at 410–786–
6625).
16. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Healthcare
Effectiveness Data and Information Set
(HEDIS®) Data Collection for Medicare
Advantage; Use: We use the collected
data to: monitor Medicare Advantage
organization performance, inform audit
strategies, and inform beneficiary choice
through their display in our consumeroriented public compare tools and Web
sites. Medicare Advantage organizations
use the data for quality assessment and
as part of their quality improvement
programs and activities. Quality
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Improvement Organizations and our
contractors use HEDIS® data in
conjunction with their statutory
authority to improve quality of care.
Consumers use the information to help
make informed health care choices. In
addition, the data is made available to
researchers and others as public use
files at www.cms.hhs.gov. Form
Number: CMS–10219 (OMB control
number: 0938–1028); Frequency: Yearly;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 576; Total
Annual Responses: 576; Total Annual
Hours: 184,320. (For policy questions
regarding this collection contact Lori
Teichman at 410–786–6684.)
Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–03235 Filed 2–16–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/304a,
CMS–368/CMS–R–144, CMS–R–308, CMS–
10151, CMS–10199, CMS–R–13, and CMS–
10279]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
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
SUMMARY:
E:\FR\FM\17FEN1.SGM
17FEN1
Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11037-11040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-10, CMS-10116, CMS-R-26, CMS-10069, CMS-
10629, CMS-10266, CMS-8003, CMS-4040, CMS-10156, CMS-10170, CMS-10198,
CMS-10227, CMS-10344, CMS-416, CMS-R-244, and CMS-10219]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 March 20, 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
[[Page 11038]]
Number: (202) 395-5806 OR, Email: OIRA_submission@omb.eop.gov.
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 https://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.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
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
previously approved collection; Title of Information Collection:
Advance Directives (Medicare and Medicaid) and Supporting Regulations;
Use: The advance directives requirement was enacted because Congress
wanted individuals to know that they have a right to make health care
decisions and to refuse treatment even when they are unable to
communicate. Steps have been taken at both the Federal and State level,
to afford greater opportunity for the individual to participate in
decisions made concerning the medical treatment to be received by an
adult patient in the event that the patient is unable to communicate to
others, a preference about medical treatment. The individual may make
his preference known through the use of an advance directive, which is
a written instruction prepared in advance, such as a living will or
durable power of attorney. This information is documented in a
prominent part of the individual's medical record. Advance directives
as described in the Patient Self-Determination Act have increased the
individual's control over decisions concerning medical treatment.
Sections 4206 of the Omnibus Budget Reconciliation Act of 1990 defined
an advance directive as a written instruction recognized under State
law relating to the provision of health care when an individual is
incapacitated (those persons unable to communicate their wishes
regarding medical treatment).
All states have enacted legislation defining a patient's right to
make decisions regarding medical care, including the right to accept or
refuse medical or surgical treatment and the right to formulate advance
directives. Participating hospitals, skilled nursing facilities,
nursing facilities, home health agencies, providers of home health
care, hospices, religious nonmedical health care institutions, and
prepaid or eligible organizations (including Health Care Prepayment
Plans (HCPPs) and Medicare Advantage Organizations (MAOs) such as
Coordinated Care Plans, Demonstration Projects, Chronic Care
Demonstration Projects, Program of All Inclusive Care for the Elderly,
Private Fee for Service, and Medical Savings Accounts must provide
written information, at explicit time frames, to all adult individuals
about: (a) The right to accept or refuse medical or surgical
treatments; (b) the right to formulate an advance directive; (c) a
description of applicable State law (provided by the State); and (d)
the provider's or organization's policies and procedures for
implementing an advance directive. Form Number: CMS-R-10 (OMB control
number: 0938-0610); Frequency: Yearly; Affected Public: Business or
other for-profits; Number of Respondents: 39,479; Total Annual
Responses: 39,479; Total Annual Hours: 2,836,441. (For policy questions
regarding this collection contact Jeannine Cramer at 410-786-5664.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Conditions for
Payment of Power Mobility Devices, including Power Wheelchairs and
Power-Operated Vehicles; Use: We are renewing our request for approval
for the collection requirements associated with the final rule, CMS-
3017-F (71 FR 17021), which published on April 5, 2006, and required a
face-to-face examination of the beneficiary by the physician or
treating practitioner, a written prescription, and receipt of pertinent
parts of the medical record by the supplier within 45 days after the
face-to-face examination that the durable medical equipment (DME)
suppliers maintain in their records and make available to CMS and its
agents upon request. Form Number: CMS-10116 (OMB control number: 0938-
0971); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 46,000; Number of Responses: 72,500;
Total Annual Hours: 14,434. (For policy questions regarding this
collection contact Stuart Caplan at 410-786-8564)
3. Type of Information Collection Request: Revision 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 (OMB Control Number: 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: 70,861; Total Annual
Responses: 1,979,300; Total Annual Hours: 14,975,785. (For policy
questions regarding this collection contact Raelene Perfetto at 410-
786-6876).
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare/Medicaid
Demonstration/Model Application; Use: The application is used for
solicitation of proposals that are either congressionally mandated or
Administration high priority demonstration initiatives which would be
used to strengthen and modernize the Medicare and/or Medicaid programs.
The standardized proposal format is not controversial and will reduce
burden on applicants and reviewers. Responses are strictly voluntary.
The standard format will enable CMS to select proposals that meet CMS
objectives and show the best potential for success. Form Number: CMS-
10069 (OMB control number: 0938-0880); Frequency: Once; Affected
[[Page 11039]]
Public: Business or other for-profits and Not-for-profit institutions;
Number of Respondents: 75; Total Annual Responses: 75; Total Annual
Hours: 6,000. (For policy questions regarding this collection contact
John Amoh at 410-786-4910).
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Waiver
Application for Providers and Suppliers Subject to an Enrollment
Moratorium; Use: This demonstration, in conjunction with an expansion
of the existing provider enrollment moratoria, will allow CMS to
mitigate known vulnerabilities within the existing moratoria and will
lead to increased investigations of fraud. Section 402(a)(l)(J) of the
Social Security Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) permits
the Secretary to ``develop or demonstrate improved methods for the
investigation and prosecution of fraud in the provision of care or
services under the health programs established by the Social Security
Act.'' In addition to the development and demonstration of improved
methods for investigations, CMS will utilize this demonstration to
address beneficiary access to care issues. CMS received one comment
during the 60-day comment period (81 FR 75408). Form Number: CMS-10629
(OMB control number: 0938-1313); Frequency: Occasionally; Affected
Public: Business or other for-profit, Not-for-profit institutions;
Number of Respondents: 800; Total Annual Responses: 800; Total Annual
Hours: 4,800. (For policy questions regarding this information
collection contact Kim Jung at 410-786-9370).
6. Type of Information Collection Request: Extension of a
previously approved collection; Title of Information Collection:
Conditions of Participation: Requirements for Approval and Reapproval
of Transplant Centers to Perform Organ Transplants; Use: The Conditions
of Participation and accompanying requirements specified in the
regulations are used by our surveyors as a basis for determining
whether a transplant center qualifies for approval or re-approval under
Medicare. We, along with the healthcare industry, believe that the
availability to the facility of the type of records and general content
of records 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-10266 (OMB Control Number: 0938-1069);
Frequency: Yearly; Affected Public: Business or other for-profits and
Not-for-profit institutions; Number of Respondents: 165; Total Annual
Responses: 425; Total Annual Hours: 2,593. (For policy questions
regarding this collection contact Diane Corning at 410-786-8486.)
7. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: 1915(c) Home and Community Based Services (HCBS) Waiver;
Use: We will use the web-based application to review and adjudicate
individual waiver actions. The web-based application will also be used
by states to submit and revise their waiver requests. Form Number: CMS-
8003 (OMB control number 0938-0449); Frequency: Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents: 47;
Total Annual Responses: 71; Total Annual Hours: 6,005. (For policy
questions regarding this collection contact Kathy Poisal at 410-786-
5940.)
8. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Request for
Enrollment in Supplementary Medical Insurance; Use: Form CMS-4040 is
used to establish entitlement to and enrollment in Medicare Part B for
beneficiaries who file for Part B only. The collected information is
used to determine entitlement for individuals who meet the requirements
in section 1836(2) of the Social Security Act as well as the
entitlement of the applicant (or their spouses) to an annuity paid by
OPM for premium deduction purposes. Form Number: CMS-4040 (OMB control
number: 0938-0245); Frequency: Once; Affected Public: Individuals or
households; Number of Respondents: 10,000; Total Annual Responses:
10,000; Total Annual Hours: 2,500. (For policy questions regarding this
collection contact Carla Patterson at 410-786-8911.)
9. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Retiree Drug
Subsidy (RDS) Application and Instructions; Use: Plan sponsors (e.g.,
employers, unions) who offer prescription drug coverage to their
qualified covered retirees are eligible to receive a 28 percent tax-
free subsidy for allowable drug costs. To qualify, plan sponsors must
submit a complete application with a list of retirees for whom it
intends to collect the subsidy. Once we review and analyze the
information on the application and the retiree list, notification will
be sent to the plan sponsor about its eligibility to participate in the
RDS program. Form Number: CMS-10156 (OMB control number: 0938-0957);
Frequency: Yearly and monthly; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 2,482;
Total Annual Responses: 2,482; Total Annual Hours: 158,848. (For policy
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)
10. Type of Information Collection Request: Extension of a
currently approved collection; Title of Information Collection: Retiree
Drug Subsidy (RDS) Payment Request and Instructions; Use: Plan sponsors
(e.g., employers, unions) who offer prescription drug coverage meeting
specified criteria to their qualified covered retirees are eligible to
receive a 28 percent tax-free subsidy for allowable drug costs. Plan
sponsors must submit required prescription drug cost data and other
information in order to receive the subsidy. Plan sponsors may elect to
submit RDS payment requests on a monthly, quarterly, interim annual, or
annual basis; once selected, the payment frequency may not be changed
during the plan year. Form Number: CMS-10170 (OMB control number: 0938-
0977); Frequency: Occasionally; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 2,482;
Total Annual Responses: 2,482; Total Annual Hours: 374,782. (For policy
questions regarding this collection contact Ivan Iveljic at 410-786-
3312.)
11. Type of Information Collection Request: Extension of a
currently approved collection; Title of Information Collection:
Creditable Coverage Disclosure to CMS On-Line Form and Instructions;
Use: Most entities that currently provide prescription drug benefits to
any Medicare Part D eligible individual must disclose whether their
prescription drug benefit is creditable (expected to pay at least as
much, on average, as the standard prescription drug plan under
Medicare). The disclosure must be provided annually and upon any change
that affects whether the coverage is creditable prescription drug
coverage. Form Number: CMS-10198 (OMB control number: 0938-1013);
Frequency: Yearly and semi-annually; Affected Public: Business or other
for-profits and Not-for-profit institutions, and State, Local, or
Tribal Governments; Number of Respondents: 85,635; Total Annual
Responses: 87,265; Total Annual Hours: 7,272. (For policy questions
regarding this collection contact Tammie Wall at 410-786-3317.)
12. Type of Information Collection Request: Extension of a
currently
[[Page 11040]]
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.'' CMS will review
the information provided in order to determine if the state has
properly elected to cover PACE services as a state plan option. In the
event that the state changes something in the state plan, only the
affected page must be updated. Form Number: CMS-10227 (OMB control
number: 0938-1027); Frequency: Once and occasionally; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 7; Total
Annual Responses: 2; Total Annual Hours: 140. (For policy questions
regarding this collection contact Angela Cimino at 410-786-2638.)
13. Type of Information Collection Request: Extension 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 collection
eliminates Part D cost-sharing for full benefit dual-eligible
beneficiaries who are receiving home and community based services. In
this regard, states are required to identify the affected beneficiaries
in their monthly Medicare Modernization Act Phase Down reports. Form
Number: CMS-10344 (OMB control number: 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 Roland Herrera at 410-786-0668.)
14. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Participation
Report; Use: The collected baseline data is used to assess the
effectiveness of state early and periodic screening, diagnostic and
treatment (EPSDT) programs in reaching eligible children (by age group
and basis of Medicaid eligibility) who are provided initial and
periodic child health screening services, referred for corrective
treatment, and receiving dental, hearing, and vision services. This
assessment is coupled with the state's results in attaining the
participation goals set for the state. The information gathered from
this report, permits federal and state managers to evaluate the
effectiveness of the EPSDT law on the basic aspects of the program.
Form Number: CMS-416 (OMB control number 0938-0354); Frequency: Yearly
and on occasion; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 56; Total Annual Responses: 168; Total Annual
Hours: 1,624. (For policy questions regarding this collection contact
Kimberly Perrault at 410-786-2482.)
15. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Programs for All-
inclusive Care of the Elderly (PACE) and Supporting Regulations in 42
CFR part 460; Use: This information collection addresses all
operational components of the PACE program (as defined in 42 CFR part
460) with the exception of the application process (Sec. 460.12). We
are removing the application requirements and burden since this CMS-R-
244 package is lengthy and we recognize that it can be somewhat time
consuming to review. We believe the change will help streamline the
public and OMB's review of the application as well as the remaining
requirements and burden under the CMS-R-244 package.
The application is being moved under a new information collection
request with a new CMS identification number (CMS-10631). An OMB
control number specific to the application process is pending. The CMS-
10631 information collection request was submitted to OMB on October 6,
2016, under ICR Reference No: 201610-0938-001. When approved, the
control number can be found on www.reginfo.gov/public/.
Form Number: CMS-R-244 (OMB control number: 0938-0790); Frequency:
Once and occasionally; Affected Public: Private sector (Business or
other for-profits and Not-for-profit institutions); Number of
Respondents: 130; Total Annual Responses: 145,455; Total Annual Hours:
61,350. (For policy questions regarding this collection contact Debbie
Van Hoven at 410-786-6625).
16. Type of Information Collection Request: Extension of a
currently approved collection; Title of Information Collection:
Healthcare Effectiveness Data and Information Set (HEDIS[supreg]) Data
Collection for Medicare Advantage; Use: We use the collected data to:
monitor Medicare Advantage organization performance, inform audit
strategies, and inform beneficiary choice through their display in our
consumer-oriented public compare tools and Web sites. Medicare
Advantage organizations use the data for quality assessment and as part
of their quality improvement programs and activities. Quality
Improvement Organizations and our contractors use HEDIS[supreg] data in
conjunction with their statutory authority to improve quality of care.
Consumers use the information to help make informed health care
choices. In addition, the data is made available to researchers and
others as public use files at www.cms.hhs.gov. Form Number: CMS-10219
(OMB control number: 0938-1028); Frequency: Yearly; Affected Public:
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 576; Total Annual Responses: 576; Total Annual Hours:
184,320. (For policy questions regarding this collection contact Lori
Teichman at 410-786-6684.)
Dated: February 14, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-03235 Filed 2-16-17; 8:45 am]
BILLING CODE 4120-01-P