Agency Information Collection Activities: Proposed Collection; Comment Request, 36516-36518 [2014-15075]
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
PICOTS (Population, Interventions,
Comparators, Outcomes, Timing,
Setting)
V. Multifaceted approaches that
include numerous elements of one or
more of the above strategies.
Populations
Comparators
I. Adult and pediatric patients with an
acute RTI and no clear indication for
antibiotic treatment. Respiratory tract
infections of interest include: acute
bronchitis; otitis media; sore throat/
pharyngitis/tonsillitis; rhinitis; sinusitis;
cough and common cold.
II. Parents of pediatric patients with
acute RTI and no clear indication for
antibiotic treatment.
III. Healthy adults and/or children
without a current acute RTI, who may
develop an acute RTI in the future.
IV. Clinicians and others who care for
patients with acute RTI in outpatient
settings.
V. Groups whose attendance policies
may indirectly affect the use of
antibiotics, such as employers or school
officials.
I. Different strategies for improving
appropriate use of antibiotics when not
indicated for acute RTI.
II. Standard care without a strategy for
improving appropriate use of
antibiotics.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Interventions
Any strategy for improving
appropriate use of antibiotics when not
indicated for acute RTI, which may fall
into various categories, including:
I. Educational, behavioral and
psychological interventions that target
clinicians, patients, or both.
II. Strategies to improve
communication between clinicians and
patients, such as those designed to
improve shared decision making.
III. Clinical strategies, such as delayed
prescribing of antibiotics, clinical
prediction rules, use of risk assessment
or diagnostic prediction, use of nonantibiotic alternatives, or use of relevant
point-of-care (POC) diagnostic tests.
A. EPC will include any POC test that
is available and used in primary care
settings for diagnostic purposes with the
ability to provide results within a
reasonable period (e.g. during the clinic
visit). Examples include inflammatory
tests (e.g., procalcitonin, c-reactive
protein [CRP], white blood cell, etc.),
rapid multiplex polymerase chain
reaction (PCR) tests used to rule in/out
organisms (e.g. rapid strep test,
influenza, RSV), routine diagnostic
tests, such as chest x-ray, pulse
oximetry, and blood gasses, when they
are specifically evaluated as an
intervention for improving antibiotic
use.
IV. System level strategies, such as
clinician reminders (paper-based or
electronic), clinician audit and
feedback, financial or regulatory
incentives for clinicians or patients,
antimicrobial stewardship programs,
pharmacist review.
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Outcomes
Key Question 1
• Increased appropriate prescription of
antibiotics (primary outcome)
• Increased appropriate use of
antibiotics (primary outcome)
Note: Studies may vary in how
appropriateness is defined or determined. We
will accept and record any definition of
appropriateness. We will group together
studies that use similar definitions of
appropriateness and categorize the different
groups based on concordance with (e.g., high,
medium, low) select clinical practice
guidelines (e.g., AAP, ACCP, AAFP). We will
then evaluate whether the comparative
effectiveness of strategies differ across
categories. We may also find that overall
reduction in antibiotic prescription or use is
reported, without a determination of
appropriateness. While this is not a direct
measure of the primary outcomes, we will
report these as indirect measures of the
impact of the intervention.
Key Question 2
•
•
•
•
Mortality
Antibiotic resistance
Medical complications
Adverse drug effects, including
clostridium difficile infections
Key Question 3
• Admission to hospital
• Clinic visits (Index, return and
subsequent episodes), ED visits
• Time to return to work and/or school
• Patient satisfaction
• Quality of life
• Improvement in patient symptoms,
speed of improvement
• Use of non-antibiotic treatments, such
as over-the-counter medications
• Utilization of vaccinations
• Quality metrics
Key Question 4
Intermediate outcomes, such as
improved knowledge regarding use of
antibiotics for acute RTI (clinician
and/or patient), or improved shared
decision making
Key Question 5
Adverse effects of the strategy, such as
increased time burden on clinicians,
sustainability of intervention (e.g.
measures of continued effectiveness
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over time), diagnostic resource use
associated with POC testing,
diagnostic coding (e.g. ICD billing
codes) according to desired action
(prescribe/not prescribe)
Timing
Any duration of follow-up.
Setting
I. Outpatient care settings including
institutional settings
II. Emergency care settings
III. Other settings, such as school or
workplace
Study Design
We will prioritize comparative studies
with concurrent control groups (e.g.
randomized controlled trial, prospective
and retrospective cohort studies
including database studies). For areas in
which direct comparative evidence is
lacking, we will include before-after
studies, with or without a control group
and with or without repeated measures.
Dated: June 16 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–14962 Filed 6–26–14; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10526, CMS–
2540–10, CMS–265–11, CMS–10106 and
CMS–R–235]
Agency Information Collection
Activities: Proposed Collection;
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 (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
SUMMARY:
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
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.
Comments must be received by
August 26, 2014.
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 https://
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 Numberlll, 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
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.
DATES:
SUPPLEMENTARY INFORMATION:
wreier-aviles on DSK5TPTVN1PROD with NOTICES
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–10526 Cost Sharing Reduction
Reconciliation
CMS–2540–10 Skilled Nursing Facility
and Skilled Nursing Facility Health
Care Complex Cost Report
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15:30 Jun 26, 2014
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CMS–265–11 Independent Renal
Dialysis Facility Cost Report and
Supporting Regulations
CMS–10106 Medicare Authorization
to Disclose Personal Health
Information
CMS–R–235 Data Use Agreement
(DUA) for Data Acquired from the
Centers for Medicare & Medicaid
Services (CMS)
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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Cost Sharing
Reduction Reconciliation; Use: Under
established Department of Health and
Human Services (HHS) regulations,
qualified health plan (QHP) issuers will
receive estimated advance payments of
cost-sharing reductions throughout the
year. Each issuer will then be subject to
a reconciliation process at the end of the
benefit year to ensure that HHS
reimburses each issuer only for actual
cost sharing. This information collection
establishes the data elements that a QHP
issuer would be required to report to
HHS in order to establish the costsharing reductions provided on behalf
of enrollees for the benefit year.
Form Number: CMS–10526 (OMB
control number: 0938–NEW);
Frequency: Annually; Affected Public:
Private Sector—Business or other forprofits; Number of Respondents: 295;
Total Annual Responses: 4,000,000;
Total Annual Hours: 2,469. (For policy
questions regarding this collection
contact Patricia Meisol at 410–786–
1917.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Skilled Nursing
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36517
Facility and Skilled Nursing Facility
Health Care Complex Cost Report; Use:
Providers of services participating in the
Medicare program are required under
sections 1815(a), 1833(e) and
1861(v)(1)(A) of the Social Security Act
(42 U.S.C. 1395g) to submit annual
information to achieve settlement of
costs for health care services rendered to
Medicare beneficiaries. In addition,
regulations at 42 CFR 413.20 and 413.24
require adequate cost data and cost
reports from providers on an annual
basis. Form CMS–2540–10 is used by
Skilled Nursing Facilities (SNFs) and
Skilled Nursing Facility Complexes
participating in the Medicare program to
report health care costs to determine the
amount of reimbursable costs for
services rendered to Medicare
beneficiaries.
Form Number: CMS–2540–10 (OMB
control number: 0938–0463); Frequency:
Yearly; Affected Public: Private Sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 14,185; Total Annual
Responses: 14,185; Total Annual Hours:
2,865,370. (For policy questions
regarding this collection contact Amelia
Citerone at 410–786–3901.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Independent
Renal Dialysis Facility Cost Report and
Supporting Regulations; Use: Providers
of services participating in the Medicare
program are required under sections
1815(a) and 1861(v)(1)(A) of the Social
Security Act (42 U.S.C. 1395g) to submit
annual information to achieve
settlement of costs for health care
services rendered to Medicare
beneficiaries. In addition, regulations at
42 CFR 413.20 and 413.24 require
adequate cost data and cost reports from
providers on an annual basis. The Form
CMS–265–11 cost report is needed to
determine a provider’s reasonable costs
incurred in furnishing medical services
to Medicare beneficiaries.
Form Number: CMS–265–11 (OMB
control number: 0938–0263); Frequency:
Yearly; Affected Public: Private Sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 5,677; Total Annual
Responses: 5,677; Total Annual Hours:
369,005. (For policy questions regarding
this collection contact Gail Duncan at
410–786–7278.)
4. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Medicare Authorization to Disclose
Personal Health Information; Use:
Unless permitted or required by law, the
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Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices
Health Insurance Portability and
Accountability Act (HIPAA) prohibits
Medicare (a HIPAA covered entity) from
disclosing an individual’s protected
health information without a valid
authorization. In order to be valid, an
authorization must include specified
core elements and statements. Medicare
will make available to Medicare
beneficiaries a standard, valid
authorization to enable beneficiaries to
request the disclosure of their protected
health information. This standard
authorization will simplify the process
of requesting information disclosure for
beneficiaries and minimize the response
time for Medicare. Form CMS–10106,
the Medicare Authorization to Disclose
Personal Health Information, will be
used by Medicare beneficiaries to
authorize Medicare to disclose their
protected health information to a third
party. Form Number: CMS–10106 (OMB
control number: 0938–0930); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 1,298,329; Total Annual
Responses: 1,298,329; Total Annual
Hours: 324,582. (For policy questions
regarding this collection contact Sam
Jenkins at 410–786–3261.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Use
Agreement (DUA) for Data Acquired
from the Centers for Medicare &
Medicaid Services (CMS); Use: The
Privacy Act of 1974 allows for
discretionary releases of data
maintained in Privacy Act protected
systems of records under § 552a(b)
(Conditions of Disclosure). The mandate
to account for disclosures of data under
the Privacy Act is found at
§ 552a(c)(Accounting of Certain
Disclosures). This section states that
certain information must be maintained
regarding disclosures made by each
agency. This information is: Date,
Nature, Purpose, and Name/Address of
Recipient. Section 552a(e) sets the
overall requirements that each agency
must meet in order to maintain records
under the Privacy Act. The Data Use
Agreement (DUA) form is needed as part
of the review of each CMS data request
to ensure compliance with the
requirements of the Privacy Act for
disclosures that contain personally
identifiable information (PII). The DUA
form also provides data requestors and
custodians with a formal means to agree
to the data protection and destruction
statutory and regulatory requirements of
CMS’ PII data. The Health Insurance
Portability and Accountability Act
(HIPAA) of 1996, § 1173(d) (Security
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15:30 Jun 26, 2014
Jkt 232001
Standards for Health Information)
requires us to protect PII. Additionally,
the Federal Information Security
Management Act (FISMA) of 2002,
§ 3544 (b) (Federal Agency
Responsibilities—Agency Program) also
requires us to develop policies and
procedures for the protection and
destruction of sensitive data to include
PII. We use the information collected by
the DUA to track disclosures, conditions
for disclosure, accounting of disclosures
and agency requirements dictated by the
Privacy Act, HIPAA and FISMA.
Form Number: CMS–R–235 (OMB
control number: 0938–0734); Frequency:
Annually; Affected Public: Private
sector—business or other for-profits and
not-for-profit institutions; Number of
Respondents: 9,220; Total Annual
Responses: 9,220; Total Annual Hours:
2,740. (For policy questions regarding
this collection contact Sharon Kavanagh
at 410–786–5441.)
Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–15075 Filed 6–26–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–370 and CMS–
377, CMS 437, CMS–10510, CMS–216–94,
CMS–10494, CMS–10224, CMS–10472 and
CMS–10499]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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 any of the
following subjects: (1) The necessity and
utility of the proposed information
SUMMARY:
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Frm 00063
Fmt 4703
Sfmt 4703
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 on the collection(s) of
information must be received by the
OMB desk officer by July 28, 2014.
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
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.
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:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27JNN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36516-36518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15075]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10526, CMS-2540-10, CMS-265-11, CMS-10106
and CMS-R-235]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
[[Page 36517]]
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 August 26, 2014.
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
https://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 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:
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-10526 Cost Sharing Reduction Reconciliation
CMS-2540-10 Skilled Nursing Facility and Skilled Nursing Facility
Health Care Complex Cost Report
CMS-265-11 Independent Renal Dialysis Facility Cost Report and
Supporting Regulations
CMS-10106 Medicare Authorization to Disclose Personal Health
Information
CMS-R-235 Data Use Agreement (DUA) for Data Acquired from the Centers
for Medicare & Medicaid Services (CMS)
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 requires federal agencies to publish a 60-day notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension or reinstatement of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Cost
Sharing Reduction Reconciliation; Use: Under established Department of
Health and Human Services (HHS) regulations, qualified health plan
(QHP) issuers will receive estimated advance payments of cost-sharing
reductions throughout the year. Each issuer will then be subject to a
reconciliation process at the end of the benefit year to ensure that
HHS reimburses each issuer only for actual cost sharing. This
information collection establishes the data elements that a QHP issuer
would be required to report to HHS in order to establish the cost-
sharing reductions provided on behalf of enrollees for the benefit
year.
Form Number: CMS-10526 (OMB control number: 0938-NEW); Frequency:
Annually; Affected Public: Private Sector--Business or other for-
profits; Number of Respondents: 295; Total Annual Responses: 4,000,000;
Total Annual Hours: 2,469. (For policy questions regarding this
collection contact Patricia Meisol at 410-786-1917.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Skilled Nursing
Facility and Skilled Nursing Facility Health Care Complex Cost Report;
Use: Providers of services participating in the Medicare program are
required under sections 1815(a), 1833(e) and 1861(v)(1)(A) of the
Social Security Act (42 U.S.C. 1395g) to submit annual information to
achieve settlement of costs for health care services rendered to
Medicare beneficiaries. In addition, regulations at 42 CFR 413.20 and
413.24 require adequate cost data and cost reports from providers on an
annual basis. Form CMS-2540-10 is used by Skilled Nursing Facilities
(SNFs) and Skilled Nursing Facility Complexes participating in the
Medicare program to report health care costs to determine the amount of
reimbursable costs for services rendered to Medicare beneficiaries.
Form Number: CMS-2540-10 (OMB control number: 0938-0463);
Frequency: Yearly; Affected Public: Private Sector--Business or other
for-profits and Not-for-profit institutions; Number of Respondents:
14,185; Total Annual Responses: 14,185; Total Annual Hours: 2,865,370.
(For policy questions regarding this collection contact Amelia Citerone
at 410-786-3901.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Independent Renal
Dialysis Facility Cost Report and Supporting Regulations; Use:
Providers of services participating in the Medicare program are
required under sections 1815(a) and 1861(v)(1)(A) of the Social
Security Act (42 U.S.C. 1395g) to submit annual information to achieve
settlement of costs for health care services rendered to Medicare
beneficiaries. In addition, regulations at 42 CFR 413.20 and 413.24
require adequate cost data and cost reports from providers on an annual
basis. The Form CMS-265-11 cost report is needed to determine a
provider's reasonable costs incurred in furnishing medical services to
Medicare beneficiaries.
Form Number: CMS-265-11 (OMB control number: 0938-0263); Frequency:
Yearly; Affected Public: Private Sector--Business or other for-profits
and Not-for-profit institutions; Number of Respondents: 5,677; Total
Annual Responses: 5,677; Total Annual Hours: 369,005. (For policy
questions regarding this collection contact Gail Duncan at 410-786-
7278.)
4. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Medicare Authorization to Disclose Personal Health
Information; Use: Unless permitted or required by law, the
[[Page 36518]]
Health Insurance Portability and Accountability Act (HIPAA) prohibits
Medicare (a HIPAA covered entity) from disclosing an individual's
protected health information without a valid authorization. In order to
be valid, an authorization must include specified core elements and
statements. Medicare will make available to Medicare beneficiaries a
standard, valid authorization to enable beneficiaries to request the
disclosure of their protected health information. This standard
authorization will simplify the process of requesting information
disclosure for beneficiaries and minimize the response time for
Medicare. Form CMS-10106, the Medicare Authorization to Disclose
Personal Health Information, will be used by Medicare beneficiaries to
authorize Medicare to disclose their protected health information to a
third party. Form Number: CMS-10106 (OMB control number: 0938-0930);
Frequency: Occasionally; Affected Public: Individuals or Households;
Number of Respondents: 1,298,329; Total Annual Responses: 1,298,329;
Total Annual Hours: 324,582. (For policy questions regarding this
collection contact Sam Jenkins at 410-786-3261.)
5. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Data Use
Agreement (DUA) for Data Acquired from the Centers for Medicare &
Medicaid Services (CMS); Use: The Privacy Act of 1974 allows for
discretionary releases of data maintained in Privacy Act protected
systems of records under Sec. 552a(b) (Conditions of Disclosure). The
mandate to account for disclosures of data under the Privacy Act is
found at Sec. 552a(c)(Accounting of Certain Disclosures). This section
states that certain information must be maintained regarding
disclosures made by each agency. This information is: Date, Nature,
Purpose, and Name/Address of Recipient. Section 552a(e) sets the
overall requirements that each agency must meet in order to maintain
records under the Privacy Act. The Data Use Agreement (DUA) form is
needed as part of the review of each CMS data request to ensure
compliance with the requirements of the Privacy Act for disclosures
that contain personally identifiable information (PII). The DUA form
also provides data requestors and custodians with a formal means to
agree to the data protection and destruction statutory and regulatory
requirements of CMS' PII data. The Health Insurance Portability and
Accountability Act (HIPAA) of 1996, Sec. 1173(d) (Security Standards
for Health Information) requires us to protect PII. Additionally, the
Federal Information Security Management Act (FISMA) of 2002, Sec. 3544
(b) (Federal Agency Responsibilities--Agency Program) also requires us
to develop policies and procedures for the protection and destruction
of sensitive data to include PII. We use the information collected by
the DUA to track disclosures, conditions for disclosure, accounting of
disclosures and agency requirements dictated by the Privacy Act, HIPAA
and FISMA.
Form Number: CMS-R-235 (OMB control number: 0938-0734); Frequency:
Annually; Affected Public: Private sector--business or other for-
profits and not-for-profit institutions; Number of Respondents: 9,220;
Total Annual Responses: 9,220; Total Annual Hours: 2,740. (For policy
questions regarding this collection contact Sharon Kavanagh at 410-786-
5441.)
Dated: June 24, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-15075 Filed 6-26-14; 8:45 am]
BILLING CODE 4120-01-P
