Agency Information Collection Activities: Submission for OMB Review; Comment Request., 39644-39646 [2016-14405]
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39644
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10377, CMS–
10338, CMS–10465, CMS–10443, and CMS–
10379]
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 a 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
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 18, 2016.
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,
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
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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: Revision of a currently
approved collection; Title of
Information Collection: Student Health
Insurance Coverage; Use: Under the
Student Health Insurance Coverage
Final Rule published March 21, 2012
(77 FR 16453), an issuer that provides
student health insurance coverage that
does not meet the annual dollar limits
requirements under Public Health
Service Act (PHS Act) section 2711
must provide notice in the insurance
policy or certificate and in any other
written materials informing students
that the policy being issued does not
meet the annual limits requirements
under the Affordable Care Act. The
Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment
Parameters for 2017 Final Rule removed
outdated provisions in § 147.145(b)(2)
and (d) allowing student health
insurance issuers to impose restricted
annual dollar limits on policies started
before January 1, 2014, with an
accompanying requirement that student
health issuers must provide notice to
students. Those provisions, by their
own terms, no longer apply and student
health insurance issuers are subject to
the prohibition on annual dollar limits
under PHS Act section 2711 and
§ 147.126 for policy years beginning on
or after January 1, 2014. Therefore, the
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Fmt 4703
Sfmt 4703
annual limit notification requirement is
being discontinued.
The Patient Protection and Affordable
Care Act; HHS Notice of Benefit and
Payment Parameters for 2017 Final Rule
further provides that, for policy years
beginning on or after July 1, 2016,
student health insurance coverage is
exempt from the actuarial value (AV)
requirements under section 1302(d) of
the Affordable Care Act, but must
provide coverage with an AV of at least
60 percent. This provision also requires
issuers of student health insurance
coverage to specify in any plan
materials summarizing the terms of the
coverage the AV of the coverage and the
metal level (or the next lowest metal
level) the coverage would otherwise
satisfy under § 156.140. This disclosure
will provide students with information
that allows them to compare the student
health coverage with other available
coverage options. Form Number: CMS–
10377 (OMB Control Number: 0938–
1157); Frequency: Annually; Affected
Public: Private Sector; Number of
Respondents: 49; Total Annual
Responses: 1,255,000; Total Annual
Hours: 49. (For policy questions
regarding this collection contact Russell
Tipps at 301–492–4371.)
2. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Affordable Care Act Internal
Claims and Appeals and External
Review Procedures for Nongrandfathered Group Health Plans and
Issuers and Individual Market Issuers;
Use: The PHS Act section 2719 and
paragraph (b)(2)(i) of the Appeals
regulations provide that group health
plans and health insurance issuers
offering group health insurance
coverage must comply with the internal
claims and appeals processes set forth
in 29 CFR 2560.503–1, the Department
of Labor (DOL) claims procedure
regulation, and update such processes
in accordance with standards
established by the Secretary of Labor in
paragraph (b)(2)(ii) of the regulations.
Paragraph (b)(3)(i) requires issuers
offering coverage in the individual
health insurance market to also comply
with the DOL claims procedure
regulation as updated by the Secretary
of Health and Human Services (HHS) in
paragraph (b)(3)(ii) of the Appeals
regulation for their internal claims and
appeals processes.
The PHS Act section 2719 and the
Appeals regulation also provide that
health insurance issuers and self-funded
nonfederal governmental health plans
must comply either with a State external
review process or a Federal review
process. The IFR provides a basis for
E:\FR\FM\17JNN1.SGM
17JNN1
sradovich on DSK3TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
determining when health insurance
issuers and self-funded non-federal
governmental health plans must comply
with an applicable State external review
process and when they must comply
with the Federal external review
process.
The PRA coverage and any burdens
contained herein recognize
requirements that the Department
identified in the NAIC Uniform Health
Carrier External Review Model Act that
must be met or exceeded. The claims
procedure regulation imposes
information collection requirements as
part of the reasonable procedures that
an employee benefit plan must establish
regarding the handling of a benefit
claim. Form Number: CMS–10338 (OMB
control number: 0938–1099); Frequency:
Annually; Affected Public: Private
Sector (Business or other for-profits and
not-for-profit institutions); Number of
Respondents: 95,500; Number of
Responses: 399,000,000; Total Annual
Hours: 2,322,500. (For policy questions
regarding this collection contact Leslie
Wagstaffe at (301) 492–4251.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Minimum
Essential Coverage; Use: The final rule
titled ‘‘Patient Protection and Affordable
Care Act; Exchange Functions:
Eligibility for Exemptions;
Miscellaneous Minimum Essential
Coverage Provisions,’’ published July 1,
2013 (78 FR 39494) designates certain
types of health coverage as minimum
essential coverage. Other types of
coverage, not statutorily designated and
not designated as minimum essential
coverage in regulation, may be
recognized by the Secretary of Health
and Human Services (HHS) as minimum
essential coverage if certain substantive
and procedural requirements are met.
To be recognized as minimum essential
coverage, the coverage must offer
substantially the same consumer
protections as those enumerated in the
Title I of Affordable Care Act relating to
non-grandfathered, individual health
insurance coverage to ensure consumers
are receiving adequate coverage. The
final rule requires sponsors of other
coverage that seek to have such coverage
recognized as minimum essential
coverage to adhere to certain
procedures. Sponsoring organizations
must submit to HHS certain information
about their coverage and an attestation
that the plan substantially complies
with the provisions of Title I of the
Affordable Care Act applicable to nongrandfathered individual health
insurance coverage. Sponsors must also
provide notice to enrollees informing
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Jkt 238001
them that the plan has been recognized
as minimum essential coverage for the
purposes of the individual coverage
requirement. Form Number: CMS–
10465 (OMB control number 0938–
1189); Frequency: Occasionally;
Affected Public: Public and Private
Sector; Number of Respondents: 10;
Total Annual Responses: 10; Total
Annual Hours: 53. (For policy questions
regarding this collection contact Russell
Tipps at 301–492–4371.)
4. Type of Information Collection
Request: Extension of a previously
approved collection. Title of
Information Collection: Transcatheter
Valve Therapy Registry and KCCQ–10;
Use: The data collection is required by
the Centers for Medicare and Medicaid
Services (CMS) National Coverage
Determination (NCD) entitled,
‘‘Transcatheter Aortic Valve
Replacement (TAVR)’’. The TAVR
device is only covered when specific
conditions are met including that the
heart team and hospital are submitting
data in a prospective, national, audited
registry. The data includes patient,
practitioner and facility level variables
that predict outcomes such as all cause
mortality and quality of life. CMS finds
that the Society of Thoracic Surgery/
American College of Cardiology
Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by
the National Cardiovascular Data
Registry, meets the requirements
specified in the NCD on TAVR. The
TVT Registry will support a national
surveillance system to monitor the
safety and efficacy of the TAVR
technologies for the treatment of aortic
stenosis.
The data will also include the
variables on the eight item Kansas City
Cardiomyopathy Questionnaire (KCCQ–
10) to assess heath status, functioning
and quality of life. In the KCCQ, an
overall summary score can be derived
from the physical function, symptoms
(frequency and severity), social function
and quality of life domains. For each
domain, the validity, reproducibility,
responsiveness and interpretability have
been independently established. Scores
are transformed to a range of 0–100, in
which higher scores reflect better health
status.
The conduct of the STS/ACC TVT
Registry and the KCCQ–10 is in
accordance with Section 1142 of the
Social Security Act (the Act) that
describes the authority of the Agency for
Healthcare Research and Quality
(AHRQ). Under section 1142, research
may be conducted and supported on the
outcomes, effectiveness, and
appropriateness of health care services
and procedures to identify the manner
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Sfmt 4703
39645
in which disease, disorders, and other
health conditions can be prevented,
diagnosed, treated, and managed
clinically. Section 1862(a)(1)(E) of the
Act allows Medicare to cover under
coverage with evidence development
(CED) certain items or services for
which the evidence is not adequate to
support coverage under section
1862(a)(1)(A) and where additional data
gathered in the context of a clinical
setting would further clarify the impact
of these items and services on the health
of beneficiaries.
The data collected and analyzed in
the TVT Registry will be used by CMS
to determine if the TAVR is reasonable
and necessary (e.g., improves health
outcomes) for Medicare beneficiaries
under section 1862(a)(1)(A) of the Act.
Furthermore, data from the Registry will
assist the medical device industry and
the Food and Drug Administration
(FDA) in surveillance of the quality,
safety and efficacy of new medical
devices to treat aortic stenosis. For
purposes of the TAVR NCD, The TVT
Registry has contracted with the Data
Analytic Centers to conduct the
analyses. In addition, data will be made
available for research purposes under
the terms of a data use agreement that
only provides de-identified datasets.
Form Number: CMS–10443 (OMB
control number: 0938–1202); Frequency:
Annual; Affected Public: Individuals,
Households and Private Sector; Number
of Respondents: 14,871; Total Annual
Responses: 59,484; Total Annual Hours:
19,184. (For policy questions regarding
this collection contact Sarah Fulton at
410–786–2749.)
5. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Rate Increase
Disclosure and Review Reporting
Requirements; Use: Section 1003 of the
Affordable Care Act adds a new section
2794 of the PHS Act which directs the
Secretary of the Department of Health
and Human Services (the Secretary), in
conjunction with the states, to establish
a process for the annual review of
‘‘unreasonable increases in premiums
for health insurance coverage.’’ The
statute provides that health insurance
issuers must submit to the Secretary and
the applicable state justifications for
unreasonable premium increases prior
to the implementation of the increases.
Section 2794 also specifies that
beginning with plan years beginning in
2014, the Secretary, in conjunction with
the states, shall monitor premium
increases of health insurance coverage
offered through an Exchange and
outside of an Exchange.
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39646
Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices
Section 2794 directs the Secretary to
ensure the public disclosure of
information and justification relating to
unreasonable rate increases. Section
2794 requires that health insurance
issuers submit justification for an
unreasonable rate increase to CMS and
the relevant state prior to its
implementation. Additionally, section
2794 requires that rate increases
effective in 2014 (submitted for review
in 2013) be monitored by the Secretary,
in conjunction with the states.
To those ends, section 154 of the CFR
establishes various reporting
requirements for health insurance
issuers, including a Preliminary
Justification for a proposed rate
increase, a Final Justification for any
rate increase determined by a state or
CMS to be unreasonable, and a
notification requirement for
unreasonable rate increases which the
issuer will not implement.
In order to obtain the information
necessary to monitor premium increases
of health insurance coverage offered
through an Exchange and outside of an
Exchange, 45 CFR 154.215 would
require health insurance issuers to
submit the Unified Rate Review
Template for all single risk pool
coverage products in the individual or
small group (or merged) market,
regardless of whether any plan within a
product is subject to a rate increase.
That regulation would also require
health insurance issuers to submit an
Actuarial Memorandum (in addition to
the Unified Rate Review Template)
when a plan within a product is subject
to a rate increase. Although the two
required documents are submitted at the
risk pool level, the requirement to
submit is based on increases at the plan
level. To conduct a review to assess
reasonableness when a plan within a
product has a rate increase that is
subject to review, health insurance
issuers would be required to submit a
written description justifying the
increase (in addition to the Unified Rate
Review Template and Actuarial
Memorandum). Although the required
documents are submitted at the risk
pool level, the requirement to submit is
based on increases at the plan level.
Form Number: CMS–10379 (OMB
control number: 0938–1141); Frequency:
Yearly; Affected Public: Private sector
(Business or other for-profits and Notfor-profit institutions) and State
agencies; Number of Respondents:
1,081; Total Annual Responses: 1,621;
Total Annual Hours: 17,837. (For policy
questions regarding this collection
contact Lisa Cuozzo at 410–786–1746.)
Dated: June 14, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–14405 Filed 6–16–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Information Collection and
Record Keeping for the Timely
Placement and Release of
Unaccompanied Children in ORR Care.
OMB No.:
Description: The ORR
Unaccompanied Children Program
provides placement, care, custody and
mandated services for UC until such
time as they can be successfully
released to a sponsor, repatriated to
their home country, or obtain legal
status.
Through cooperative agreements and
contracts, ORR funds residential care
providers that provide temporary
housing and other services to
unaccompanied children in ORR
custody. These care provider facilities
are State licensed and must meet ORR
requirements to ensure a high level
quality of care. They provide a
continuum of care for children,
including placements in ORR foster
care, group homes, shelter, staff secure,
secure, and residential treatment
centers. The care providers provide
children with classroom education,
health care, socialization/recreation,
vocational training, mental health
services, access to legal services, and
case management.
In order to monitor performance and
ensure compliance with statutory and
regulatory requirements and standards,
ORR:
• Collects information from its
network of care providers to show
evidence that care providers’ standards
of care, family reunification methods,
internal policies and procedures,
personnel, training, and other
components meet minimum standards
and ensure the safety and security of
children in ORR care.
• Requires care providers to track the
timely release process and delivery of
services for individual children and
youth to ensure compliance and allow
ORR to conduct formal monitoring and
performance review.
The tasks described in this supporting
statement are mainly conducted through
the ORR online database (The UC
Portal), which provides a central
location for case records and the
documentation of other activities (for
example, when a child or youth is
transferred to another facility). Many of
these records are ‘‘auto-populated’’ on
the UC Portal once the original data
points are completed (such as DOB, ‘‘A’’
number, date of initial placement). The
UC Portal is a secure limited access
database that requires two factor
authentication. The use of electronic
records also allows ORR Project Officers
to more easily monitor grantee
compliance with standards of care and
record keeping compared with hard
copy case files that are only available
onsite. The database also allows ORR to
more easily calculate bed capacity
throughout the network so that
resources are efficiently distributed,
particularly during an influx when large
numbers of unaccompanied children are
crossing the border.
Respondents:
ANNUAL BURDEN ESTIMATES
Number of
respondents
sradovich on DSK3TPTVN1PROD with NOTICES
Instrument
UC Portal Capacity Report ..............................................................................
Further Assessment Swift Track (FAST) Placement Tool ..............................
Placement Authorization Form ........................................................................
Notice of Placement in Secure or Staff Secure Facility ..................................
Initial Intakes Form ..........................................................................................
UC Assessment ...............................................................................................
Individual Service Plan ....................................................................................
UC Case Review Form ...................................................................................
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16:48 Jun 16, 2016
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PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
50
2,320
58,000
2,320
58,000
58,000
58,000
58,000
E:\FR\FM\17JNN1.SGM
1
1
1
1
1
1
1
1
17JNN1
Average
burden hours
per response
.16/hour ..........
.25/hour ..........
.1/hour ............
.1/hour ............
.25/hour ..........
.50/hour ..........
.25 ..................
.50/hour ..........
Total burden
hours
8
580
5,800
232
14,500
29,000
14,500
29,000
]]>Agencies
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39644-39646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14405]
[[Page 39644]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10377, CMS-10338, CMS-10465, CMS-10443, and
CMS-10379]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request.
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 (PRA), federal agencies are required to publish a 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 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 18, 2016.
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.
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: Revision of a currently
approved collection; Title of Information Collection: Student Health
Insurance Coverage; Use: Under the Student Health Insurance Coverage
Final Rule published March 21, 2012 (77 FR 16453), an issuer that
provides student health insurance coverage that does not meet the
annual dollar limits requirements under Public Health Service Act (PHS
Act) section 2711 must provide notice in the insurance policy or
certificate and in any other written materials informing students that
the policy being issued does not meet the annual limits requirements
under the Affordable Care Act. The Patient Protection and Affordable
Care Act; HHS Notice of Benefit and Payment Parameters for 2017 Final
Rule removed outdated provisions in Sec. 147.145(b)(2) and (d)
allowing student health insurance issuers to impose restricted annual
dollar limits on policies started before January 1, 2014, with an
accompanying requirement that student health issuers must provide
notice to students. Those provisions, by their own terms, no longer
apply and student health insurance issuers are subject to the
prohibition on annual dollar limits under PHS Act section 2711 and
Sec. 147.126 for policy years beginning on or after January 1, 2014.
Therefore, the annual limit notification requirement is being
discontinued.
The Patient Protection and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for 2017 Final Rule further provides
that, for policy years beginning on or after July 1, 2016, student
health insurance coverage is exempt from the actuarial value (AV)
requirements under section 1302(d) of the Affordable Care Act, but must
provide coverage with an AV of at least 60 percent. This provision also
requires issuers of student health insurance coverage to specify in any
plan materials summarizing the terms of the coverage the AV of the
coverage and the metal level (or the next lowest metal level) the
coverage would otherwise satisfy under Sec. 156.140. This disclosure
will provide students with information that allows them to compare the
student health coverage with other available coverage options. Form
Number: CMS-10377 (OMB Control Number: 0938-1157); Frequency: Annually;
Affected Public: Private Sector; Number of Respondents: 49; Total
Annual Responses: 1,255,000; Total Annual Hours: 49. (For policy
questions regarding this collection contact Russell Tipps at 301-492-
4371.)
2. Type of Information Collection Request: Revision of currently
approved collection; Title of Information Collection: Affordable Care
Act Internal Claims and Appeals and External Review Procedures for Non-
grandfathered Group Health Plans and Issuers and Individual Market
Issuers; Use: The PHS Act section 2719 and paragraph (b)(2)(i) of the
Appeals regulations provide that group health plans and health
insurance issuers offering group health insurance coverage must comply
with the internal claims and appeals processes set forth in 29 CFR
2560.503-1, the Department of Labor (DOL) claims procedure regulation,
and update such processes in accordance with standards established by
the Secretary of Labor in paragraph (b)(2)(ii) of the regulations.
Paragraph (b)(3)(i) requires issuers offering coverage in the
individual health insurance market to also comply with the DOL claims
procedure regulation as updated by the Secretary of Health and Human
Services (HHS) in paragraph (b)(3)(ii) of the Appeals regulation for
their internal claims and appeals processes.
The PHS Act section 2719 and the Appeals regulation also provide
that health insurance issuers and self-funded nonfederal governmental
health plans must comply either with a State external review process or
a Federal review process. The IFR provides a basis for
[[Page 39645]]
determining when health insurance issuers and self-funded non-federal
governmental health plans must comply with an applicable State external
review process and when they must comply with the Federal external
review process.
The PRA coverage and any burdens contained herein recognize
requirements that the Department identified in the NAIC Uniform Health
Carrier External Review Model Act that must be met or exceeded. The
claims procedure regulation imposes information collection requirements
as part of the reasonable procedures that an employee benefit plan must
establish regarding the handling of a benefit claim. Form Number: CMS-
10338 (OMB control number: 0938-1099); Frequency: Annually; Affected
Public: Private Sector (Business or other for-profits and not-for-
profit institutions); Number of Respondents: 95,500; Number of
Responses: 399,000,000; Total Annual Hours: 2,322,500. (For policy
questions regarding this collection contact Leslie Wagstaffe at (301)
492-4251.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Minimum Essential
Coverage; Use: The final rule titled ``Patient Protection and
Affordable Care Act; Exchange Functions: Eligibility for Exemptions;
Miscellaneous Minimum Essential Coverage Provisions,'' published July
1, 2013 (78 FR 39494) designates certain types of health coverage as
minimum essential coverage. Other types of coverage, not statutorily
designated and not designated as minimum essential coverage in
regulation, may be recognized by the Secretary of Health and Human
Services (HHS) as minimum essential coverage if certain substantive and
procedural requirements are met. To be recognized as minimum essential
coverage, the coverage must offer substantially the same consumer
protections as those enumerated in the Title I of Affordable Care Act
relating to non-grandfathered, individual health insurance coverage to
ensure consumers are receiving adequate coverage. The final rule
requires sponsors of other coverage that seek to have such coverage
recognized as minimum essential coverage to adhere to certain
procedures. Sponsoring organizations must submit to HHS certain
information about their coverage and an attestation that the plan
substantially complies with the provisions of Title I of the Affordable
Care Act applicable to non-grandfathered individual health insurance
coverage. Sponsors must also provide notice to enrollees informing them
that the plan has been recognized as minimum essential coverage for the
purposes of the individual coverage requirement. Form Number: CMS-10465
(OMB control number 0938-1189); Frequency: Occasionally; Affected
Public: Public and Private Sector; Number of Respondents: 10; Total
Annual Responses: 10; Total Annual Hours: 53. (For policy questions
regarding this collection contact Russell Tipps at 301-492-4371.)
4. Type of Information Collection Request: Extension of a
previously approved collection. Title of Information Collection:
Transcatheter Valve Therapy Registry and KCCQ-10; Use: The data
collection is required by the Centers for Medicare and Medicaid
Services (CMS) National Coverage Determination (NCD) entitled,
``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR device is
only covered when specific conditions are met including that the heart
team and hospital are submitting data in a prospective, national,
audited registry. The data includes patient, practitioner and facility
level variables that predict outcomes such as all cause mortality and
quality of life. CMS finds that the Society of Thoracic Surgery/
American College of Cardiology Transcatheter Valve Therapy (STS/ACC
TVT) Registry, one registry overseen by the National Cardiovascular
Data Registry, meets the requirements specified in the NCD on TAVR. The
TVT Registry will support a national surveillance system to monitor the
safety and efficacy of the TAVR technologies for the treatment of
aortic stenosis.
The data will also include the variables on the eight item Kansas
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status,
functioning and quality of life. In the KCCQ, an overall summary score
can be derived from the physical function, symptoms (frequency and
severity), social function and quality of life domains. For each
domain, the validity, reproducibility, responsiveness and
interpretability have been independently established. Scores are
transformed to a range of 0-100, in which higher scores reflect better
health status.
The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in
accordance with Section 1142 of the Social Security Act (the Act) that
describes the authority of the Agency for Healthcare Research and
Quality (AHRQ). Under section 1142, research may be conducted and
supported on the outcomes, effectiveness, and appropriateness of health
care services and procedures to identify the manner in which disease,
disorders, and other health conditions can be prevented, diagnosed,
treated, and managed clinically. Section 1862(a)(1)(E) of the Act
allows Medicare to cover under coverage with evidence development (CED)
certain items or services for which the evidence is not adequate to
support coverage under section 1862(a)(1)(A) and where additional data
gathered in the context of a clinical setting would further clarify the
impact of these items and services on the health of beneficiaries.
The data collected and analyzed in the TVT Registry will be used by
CMS to determine if the TAVR is reasonable and necessary (e.g.,
improves health outcomes) for Medicare beneficiaries under section
1862(a)(1)(A) of the Act. Furthermore, data from the Registry will
assist the medical device industry and the Food and Drug Administration
(FDA) in surveillance of the quality, safety and efficacy of new
medical devices to treat aortic stenosis. For purposes of the TAVR NCD,
The TVT Registry has contracted with the Data Analytic Centers to
conduct the analyses. In addition, data will be made available for
research purposes under the terms of a data use agreement that only
provides de-identified datasets. Form Number: CMS-10443 (OMB control
number: 0938-1202); Frequency: Annual; Affected Public: Individuals,
Households and Private Sector; Number of Respondents: 14,871; Total
Annual Responses: 59,484; Total Annual Hours: 19,184. (For policy
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)
5. Type of Information Collection Request: Revision of a currently
approved information collection; Title of Information Collection: Rate
Increase Disclosure and Review Reporting Requirements; Use: Section
1003 of the Affordable Care Act adds a new section 2794 of the PHS Act
which directs the Secretary of the Department of Health and Human
Services (the Secretary), in conjunction with the states, to establish
a process for the annual review of ``unreasonable increases in premiums
for health insurance coverage.'' The statute provides that health
insurance issuers must submit to the Secretary and the applicable state
justifications for unreasonable premium increases prior to the
implementation of the increases. Section 2794 also specifies that
beginning with plan years beginning in 2014, the Secretary, in
conjunction with the states, shall monitor premium increases of health
insurance coverage offered through an Exchange and outside of an
Exchange.
[[Page 39646]]
Section 2794 directs the Secretary to ensure the public disclosure
of information and justification relating to unreasonable rate
increases. Section 2794 requires that health insurance issuers submit
justification for an unreasonable rate increase to CMS and the relevant
state prior to its implementation. Additionally, section 2794 requires
that rate increases effective in 2014 (submitted for review in 2013) be
monitored by the Secretary, in conjunction with the states.
To those ends, section 154 of the CFR establishes various reporting
requirements for health insurance issuers, including a Preliminary
Justification for a proposed rate increase, a Final Justification for
any rate increase determined by a state or CMS to be unreasonable, and
a notification requirement for unreasonable rate increases which the
issuer will not implement.
In order to obtain the information necessary to monitor premium
increases of health insurance coverage offered through an Exchange and
outside of an Exchange, 45 CFR 154.215 would require health insurance
issuers to submit the Unified Rate Review Template for all single risk
pool coverage products in the individual or small group (or merged)
market, regardless of whether any plan within a product is subject to a
rate increase. That regulation would also require health insurance
issuers to submit an Actuarial Memorandum (in addition to the Unified
Rate Review Template) when a plan within a product is subject to a rate
increase. Although the two required documents are submitted at the risk
pool level, the requirement to submit is based on increases at the plan
level. To conduct a review to assess reasonableness when a plan within
a product has a rate increase that is subject to review, health
insurance issuers would be required to submit a written description
justifying the increase (in addition to the Unified Rate Review
Template and Actuarial Memorandum). Although the required documents are
submitted at the risk pool level, the requirement to submit is based on
increases at the plan level. Form Number: CMS-10379 (OMB control
number: 0938-1141); Frequency: Yearly; Affected Public: Private sector
(Business or other for-profits and Not-for-profit institutions) and
State agencies; Number of Respondents: 1,081; Total Annual Responses:
1,621; Total Annual Hours: 17,837. (For policy questions regarding this
collection contact Lisa Cuozzo at 410-786-1746.)
Dated: June 14, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2016-14405 Filed 6-16-16; 8:45 am]
BILLING CODE 4120-01-P
