81_FR_39761 81 FR 39644 - Agency Information Collection Activities: Submission for OMB Review; Comment Request.

81 FR 39644 - Agency Information Collection Activities: Submission for OMB Review; Comment Request.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 117 (June 17, 2016)

Page Range39644-39646
FR Document2016-14405

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.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016)
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39644-39646]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14405]



[[Page 39644]]

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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_[email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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



                                                39644                           Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices

                                                DEPARTMENT OF HEALTH AND                                and CMS document identifier, to                        annual limit notification requirement is
                                                HUMAN SERVICES                                          Paperwork@cms.hhs.gov.                                 being discontinued.
                                                                                                          3. Call the Reports Clearance Office at                 The Patient Protection and Affordable
                                                Centers for Medicare & Medicaid                         (410) 786–1326.                                        Care Act; HHS Notice of Benefit and
                                                Services                                                FOR FURTHER INFORMATION CONTACT:                       Payment Parameters for 2017 Final Rule
                                                [Document Identifier: CMS–10377, CMS–                   Reports Clearance Office at (410) 786–                 further provides that, for policy years
                                                10338, CMS–10465, CMS–10443, and CMS–                   1326.                                                  beginning on or after July 1, 2016,
                                                10379]                                                                                                         student health insurance coverage is
                                                                                                        SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                               exempt from the actuarial value (AV)
                                                                                                        Paperwork Reduction Act of 1995 (PRA)
                                                Agency Information Collection                                                                                  requirements under section 1302(d) of
                                                                                                        (44 U.S.C. 3501–3520), federal agencies
                                                Activities: Submission for OMB                                                                                 the Affordable Care Act, but must
                                                                                                        must obtain approval from the Office of
                                                Review; Comment Request.                                                                                       provide coverage with an AV of at least
                                                                                                        Management and Budget (OMB) for each
                                                                                                                                                               60 percent. This provision also requires
                                                ACTION:   Notice.                                       collection of information they conduct
                                                                                                                                                               issuers of student health insurance
                                                                                                        or sponsor. The term ‘‘collection of
                                                SUMMARY:    The Centers for Medicare &                                                                         coverage to specify in any plan
                                                                                                        information’’ is defined in 44 U.S.C.
                                                Medicaid Services (CMS) is announcing                                                                          materials summarizing the terms of the
                                                                                                        3502(3) and 5 CFR 1320.3(c) and
                                                an opportunity for the public to                                                                               coverage the AV of the coverage and the
                                                                                                        includes agency requests or
                                                comment on CMS’ intention to collect                                                                           metal level (or the next lowest metal
                                                                                                        requirements that members of the public
                                                                                                                                                               level) the coverage would otherwise
                                                information from the public. Under the                  submit reports, keep records, or provide
                                                                                                                                                               satisfy under § 156.140. This disclosure
                                                Paperwork Reduction Act of 1995                         information to a third party. Section                  will provide students with information
                                                (PRA), federal agencies are required to                 3506(c)(2)(A) of the PRA (44 U.S.C.                    that allows them to compare the student
                                                publish a notice in the Federal Register                3506(c)(2)(A)) requires federal agencies               health coverage with other available
                                                concerning each proposed collection of                  to publish a 30-day notice in the                      coverage options. Form Number: CMS–
                                                information, including each proposed                    Federal Register concerning each                       10377 (OMB Control Number: 0938–
                                                extension or reinstatement of an existing               proposed collection of information,                    1157); Frequency: Annually; Affected
                                                collection of information, and to allow                 including each proposed extension or                   Public: Private Sector; Number of
                                                a second opportunity for public                         reinstatement of an existing collection                Respondents: 49; Total Annual
                                                comment on the notice. Interested                       of information, before submitting the                  Responses: 1,255,000; Total Annual
                                                persons are invited to send comments                    collection to OMB for approval. To                     Hours: 49. (For policy questions
                                                regarding the burden estimate or any                    comply with this requirement, CMS is                   regarding this collection contact Russell
                                                other aspect of this collection of                      publishing this notice that summarizes                 Tipps at 301–492–4371.)
                                                information, including any of the                       the following proposed collection(s) of                   2. Type of Information Collection
                                                following subjects: (1) The necessity and               information for public comment:                        Request: Revision of currently approved
                                                utility of the proposed information                       1. Type of Information Collection                    collection; Title of Information
                                                collection for the proper performance of                Request: Revision of a currently                       Collection: Affordable Care Act Internal
                                                the agency’s functions; (2) the accuracy                approved collection; Title of                          Claims and Appeals and External
                                                of the estimated burden; (3) ways to                    Information Collection: Student Health                 Review Procedures for Non-
                                                enhance the quality, utility, and clarity               Insurance Coverage; Use: Under the                     grandfathered Group Health Plans and
                                                of the information to be collected; and                 Student Health Insurance Coverage                      Issuers and Individual Market Issuers;
                                                (4) the use of automated collection                     Final Rule published March 21, 2012                    Use: The PHS Act section 2719 and
                                                techniques or other forms of information                (77 FR 16453), an issuer that provides                 paragraph (b)(2)(i) of the Appeals
                                                technology to minimize the information                  student health insurance coverage that                 regulations provide that group health
                                                collection burden.                                      does not meet the annual dollar limits                 plans and health insurance issuers
                                                DATES: Comments on the collection(s) of                 requirements under Public Health                       offering group health insurance
                                                information must be received by the                     Service Act (PHS Act) section 2711                     coverage must comply with the internal
                                                OMB desk officer by July 18, 2016.                      must provide notice in the insurance                   claims and appeals processes set forth
                                                ADDRESSES: When commenting on the                       policy or certificate and in any other                 in 29 CFR 2560.503–1, the Department
                                                proposed information collections,                       written materials informing students                   of Labor (DOL) claims procedure
                                                please reference the document identifier                that the policy being issued does not                  regulation, and update such processes
                                                or OMB control number. To be assured                    meet the annual limits requirements                    in accordance with standards
                                                consideration, comments and                             under the Affordable Care Act. The                     established by the Secretary of Labor in
                                                recommendations must be received by                     Patient Protection and Affordable Care                 paragraph (b)(2)(ii) of the regulations.
                                                the OMB desk officer via one of the                     Act; HHS Notice of Benefit and Payment                 Paragraph (b)(3)(i) requires issuers
                                                following transmissions: OMB, Office of                 Parameters for 2017 Final Rule removed                 offering coverage in the individual
                                                Information and Regulatory Affairs,                     outdated provisions in § 147.145(b)(2)                 health insurance market to also comply
                                                Attention: CMS Desk Officer, Fax                        and (d) allowing student health                        with the DOL claims procedure
                                                Number: (202) 395–5806 or Email:                        insurance issuers to impose restricted                 regulation as updated by the Secretary
                                                OIRA_submission@omb.eop.gov.                            annual dollar limits on policies started               of Health and Human Services (HHS) in
                                                   To obtain copies of a supporting                     before January 1, 2014, with an                        paragraph (b)(3)(ii) of the Appeals
                                                statement and any related forms for the                 accompanying requirement that student                  regulation for their internal claims and
                                                                                                        health issuers must provide notice to                  appeals processes.
sradovich on DSK3TPTVN1PROD with NOTICES




                                                proposed collection(s) summarized in
                                                this notice, you may make your request                  students. Those provisions, by their                      The PHS Act section 2719 and the
                                                using one of following:                                 own terms, no longer apply and student                 Appeals regulation also provide that
                                                   1. Access CMS’ Web site address at                   health insurance issuers are subject to                health insurance issuers and self-funded
                                                http://www.cms.hhs.gov/                                 the prohibition on annual dollar limits                nonfederal governmental health plans
                                                PaperworkReductionActof1995.                            under PHS Act section 2711 and                         must comply either with a State external
                                                   2. Email your request, including your                § 147.126 for policy years beginning on                review process or a Federal review
                                                address, phone number, OMB number,                      or after January 1, 2014. Therefore, the               process. The IFR provides a basis for


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                                                                                Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices                                           39645

                                                determining when health insurance                       them that the plan has been recognized                 in which disease, disorders, and other
                                                issuers and self-funded non-federal                     as minimum essential coverage for the                  health conditions can be prevented,
                                                governmental health plans must comply                   purposes of the individual coverage                    diagnosed, treated, and managed
                                                with an applicable State external review                requirement. Form Number: CMS–                         clinically. Section 1862(a)(1)(E) of the
                                                process and when they must comply                       10465 (OMB control number 0938–                        Act allows Medicare to cover under
                                                with the Federal external review                        1189); Frequency: Occasionally;                        coverage with evidence development
                                                process.                                                Affected Public: Public and Private                    (CED) certain items or services for
                                                   The PRA coverage and any burdens                     Sector; Number of Respondents: 10;                     which the evidence is not adequate to
                                                contained herein recognize                              Total Annual Responses: 10; Total                      support coverage under section
                                                requirements that the Department                        Annual Hours: 53. (For policy questions                1862(a)(1)(A) and where additional data
                                                identified in the NAIC Uniform Health                   regarding this collection contact Russell              gathered in the context of a clinical
                                                Carrier External Review Model Act that                  Tipps at 301–492–4371.)                                setting would further clarify the impact
                                                must be met or exceeded. The claims                        4. Type of Information Collection                   of these items and services on the health
                                                procedure regulation imposes                            Request: Extension of a previously                     of beneficiaries.
                                                information collection requirements as                  approved collection. Title of                             The data collected and analyzed in
                                                part of the reasonable procedures that                  Information Collection: Transcatheter                  the TVT Registry will be used by CMS
                                                an employee benefit plan must establish                 Valve Therapy Registry and KCCQ–10;                    to determine if the TAVR is reasonable
                                                regarding the handling of a benefit                     Use: The data collection is required by                and necessary (e.g., improves health
                                                claim. Form Number: CMS–10338 (OMB                      the Centers for Medicare and Medicaid                  outcomes) for Medicare beneficiaries
                                                control number: 0938–1099); Frequency:                  Services (CMS) National Coverage                       under section 1862(a)(1)(A) of the Act.
                                                Annually; Affected Public: Private                      Determination (NCD) entitled,                          Furthermore, data from the Registry will
                                                Sector (Business or other for-profits and               ‘‘Transcatheter Aortic Valve                           assist the medical device industry and
                                                not-for-profit institutions); Number of                 Replacement (TAVR)’’. The TAVR                         the Food and Drug Administration
                                                Respondents: 95,500; Number of                          device is only covered when specific                   (FDA) in surveillance of the quality,
                                                Responses: 399,000,000; Total Annual                    conditions are met including that the                  safety and efficacy of new medical
                                                Hours: 2,322,500. (For policy questions                 heart team and hospital are submitting                 devices to treat aortic stenosis. For
                                                regarding this collection contact Leslie                data in a prospective, national, audited               purposes of the TAVR NCD, The TVT
                                                Wagstaffe at (301) 492–4251.)                           registry. The data includes patient,                   Registry has contracted with the Data
                                                   3. Type of Information Collection                    practitioner and facility level variables              Analytic Centers to conduct the
                                                Request: Revision of a currently                        that predict outcomes such as all cause
                                                                                                                                                               analyses. In addition, data will be made
                                                approved collection; Title of                           mortality and quality of life. CMS finds
                                                                                                                                                               available for research purposes under
                                                Information Collection: Minimum                         that the Society of Thoracic Surgery/
                                                Essential Coverage; Use: The final rule                                                                        the terms of a data use agreement that
                                                                                                        American College of Cardiology
                                                titled ‘‘Patient Protection and Affordable                                                                     only provides de-identified datasets.
                                                                                                        Transcatheter Valve Therapy (STS/ACC
                                                Care Act; Exchange Functions:                                                                                  Form Number: CMS–10443 (OMB
                                                                                                        TVT) Registry, one registry overseen by
                                                Eligibility for Exemptions;                                                                                    control number: 0938–1202); Frequency:
                                                                                                        the National Cardiovascular Data
                                                Miscellaneous Minimum Essential                                                                                Annual; Affected Public: Individuals,
                                                                                                        Registry, meets the requirements
                                                Coverage Provisions,’’ published July 1,                                                                       Households and Private Sector; Number
                                                                                                        specified in the NCD on TAVR. The
                                                2013 (78 FR 39494) designates certain                                                                          of Respondents: 14,871; Total Annual
                                                                                                        TVT Registry will support a national
                                                types of health coverage as minimum                     surveillance system to monitor the                     Responses: 59,484; Total Annual Hours:
                                                essential coverage. Other types of                      safety and efficacy of the TAVR                        19,184. (For policy questions regarding
                                                coverage, not statutorily designated and                technologies for the treatment of aortic               this collection contact Sarah Fulton at
                                                not designated as minimum essential                     stenosis.                                              410–786–2749.)
                                                coverage in regulation, may be                             The data will also include the                         5. Type of Information Collection
                                                recognized by the Secretary of Health                   variables on the eight item Kansas City                Request: Revision of a currently
                                                and Human Services (HHS) as minimum                     Cardiomyopathy Questionnaire (KCCQ–                    approved information collection; Title
                                                essential coverage if certain substantive               10) to assess heath status, functioning                of Information Collection: Rate Increase
                                                and procedural requirements are met.                    and quality of life. In the KCCQ, an                   Disclosure and Review Reporting
                                                To be recognized as minimum essential                   overall summary score can be derived                   Requirements; Use: Section 1003 of the
                                                coverage, the coverage must offer                       from the physical function, symptoms                   Affordable Care Act adds a new section
                                                substantially the same consumer                         (frequency and severity), social function              2794 of the PHS Act which directs the
                                                protections as those enumerated in the                  and quality of life domains. For each                  Secretary of the Department of Health
                                                Title I of Affordable Care Act relating to              domain, the validity, reproducibility,                 and Human Services (the Secretary), in
                                                non-grandfathered, individual health                    responsiveness and interpretability have               conjunction with the states, to establish
                                                insurance coverage to ensure consumers                  been independently established. Scores                 a process for the annual review of
                                                are receiving adequate coverage. The                    are transformed to a range of 0–100, in                ‘‘unreasonable increases in premiums
                                                final rule requires sponsors of other                   which higher scores reflect better health              for health insurance coverage.’’ The
                                                coverage that seek to have such coverage                status.                                                statute provides that health insurance
                                                recognized as minimum essential                            The conduct of the STS/ACC TVT                      issuers must submit to the Secretary and
                                                coverage to adhere to certain                           Registry and the KCCQ–10 is in                         the applicable state justifications for
                                                procedures. Sponsoring organizations                    accordance with Section 1142 of the                    unreasonable premium increases prior
                                                must submit to HHS certain information                  Social Security Act (the Act) that                     to the implementation of the increases.
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                                                about their coverage and an attestation                 describes the authority of the Agency for              Section 2794 also specifies that
                                                that the plan substantially complies                    Healthcare Research and Quality                        beginning with plan years beginning in
                                                with the provisions of Title I of the                   (AHRQ). Under section 1142, research                   2014, the Secretary, in conjunction with
                                                Affordable Care Act applicable to non-                  may be conducted and supported on the                  the states, shall monitor premium
                                                grandfathered individual health                         outcomes, effectiveness, and                           increases of health insurance coverage
                                                insurance coverage. Sponsors must also                  appropriateness of health care services                offered through an Exchange and
                                                provide notice to enrollees informing                   and procedures to identify the manner                  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                                pool level, the requirement to submit is                      secure, and residential treatment
                                                ensure the public disclosure of                                         based on increases at the plan level.                         centers. The care providers provide
                                                information and justification relating to                               Form Number: CMS–10379 (OMB                                   children with classroom education,
                                                unreasonable rate increases. Section                                    control number: 0938–1141); Frequency:                        health care, socialization/recreation,
                                                2794 requires that health insurance                                     Yearly; Affected Public: Private sector                       vocational training, mental health
                                                issuers submit justification for an                                     (Business or other for-profits and Not-                       services, access to legal services, and
                                                unreasonable rate increase to CMS and                                   for-profit institutions) and State                            case management.
                                                the relevant state prior to its                                         agencies; Number of Respondents:                                 In order to monitor performance and
                                                implementation. Additionally, section                                   1,081; Total Annual Responses: 1,621;                         ensure compliance with statutory and
                                                2794 requires that rate increases                                       Total Annual Hours: 17,837. (For policy                       regulatory requirements and standards,
                                                effective in 2014 (submitted for review                                 questions regarding this collection                           ORR:
                                                in 2013) be monitored by the Secretary,                                 contact Lisa Cuozzo at 410–786–1746.)                            • Collects information from its
                                                in conjunction with the states.                                           Dated: June 14, 2016.                                       network of care providers to show
                                                   To those ends, section 154 of the CFR                                                                                              evidence that care providers’ standards
                                                establishes various reporting                                          William N. Parham, III,
                                                                                                                       Director, Paperwork Reduction Staff, Office                    of care, family reunification methods,
                                                requirements for health insurance                                                                                                     internal policies and procedures,
                                                issuers, including a Preliminary                                       of Strategic Operations and Regulatory
                                                                                                                       Affairs.                                                       personnel, training, and other
                                                Justification for a proposed rate                                                                                                     components meet minimum standards
                                                increase, a Final Justification for any                                [FR Doc. 2016–14405 Filed 6–16–16; 8:45 am]
                                                                                                                                                                                      and ensure the safety and security of
                                                rate increase determined by a state or                                 BILLING CODE 4120–01–P
                                                                                                                                                                                      children in ORR care.
                                                CMS to be unreasonable, and a
                                                                                                                                                                                         • Requires care providers to track the
                                                notification requirement for
                                                                                                                       DEPARTMENT OF HEALTH AND                                       timely release process and delivery of
                                                unreasonable rate increases which the
                                                                                                                       HUMAN SERVICES                                                 services for individual children and
                                                issuer will not implement.
                                                   In order to obtain the information                                                                                                 youth to ensure compliance and allow
                                                                                                                       Administration for Children and                                ORR to conduct formal monitoring and
                                                necessary to monitor premium increases
                                                                                                                       Families                                                       performance review.
                                                of health insurance coverage offered
                                                through an Exchange and outside of an                                                                                                    The tasks described in this supporting
                                                                                                                       Submission for OMB Review;                                     statement are mainly conducted through
                                                Exchange, 45 CFR 154.215 would                                         Comment Request
                                                require health insurance issuers to                                                                                                   the ORR online database (The UC
                                                submit the Unified Rate Review                                           Title: Information Collection and                            Portal), which provides a central
                                                Template for all single risk pool                                      Record Keeping for the Timely                                  location for case records and the
                                                coverage products in the individual or                                 Placement and Release of                                       documentation of other activities (for
                                                small group (or merged) market,                                        Unaccompanied Children in ORR Care.                            example, when a child or youth is
                                                regardless of whether any plan within a                                  OMB No.:                                                     transferred to another facility). Many of
                                                product is subject to a rate increase.                                   Description: The ORR                                         these records are ‘‘auto-populated’’ on
                                                That regulation would also require                                     Unaccompanied Children Program                                 the UC Portal once the original data
                                                health insurance issuers to submit an                                  provides placement, care, custody and                          points are completed (such as DOB, ‘‘A’’
                                                Actuarial Memorandum (in addition to                                   mandated services for UC until such                            number, date of initial placement). The
                                                the Unified Rate Review Template)                                      time as they can be successfully                               UC Portal is a secure limited access
                                                when a plan within a product is subject                                released to a sponsor, repatriated to                          database that requires two factor
                                                to a rate increase. Although the two                                   their home country, or obtain legal                            authentication. The use of electronic
                                                required documents are submitted at the                                status.                                                        records also allows ORR Project Officers
                                                risk pool level, the requirement to                                      Through cooperative agreements and                           to more easily monitor grantee
                                                submit is based on increases at the plan                               contracts, ORR funds residential care                          compliance with standards of care and
                                                level. To conduct a review to assess                                   providers that provide temporary                               record keeping compared with hard
                                                reasonableness when a plan within a                                    housing and other services to                                  copy case files that are only available
                                                product has a rate increase that is                                    unaccompanied children in ORR                                  onsite. The database also allows ORR to
                                                subject to review, health insurance                                    custody. These care provider facilities                        more easily calculate bed capacity
                                                issuers would be required to submit a                                  are State licensed and must meet ORR                           throughout the network so that
                                                written description justifying the                                     requirements to ensure a high level                            resources are efficiently distributed,
                                                increase (in addition to the Unified Rate                              quality of care. They provide a                                particularly during an influx when large
                                                Review Template and Actuarial                                          continuum of care for children,                                numbers of unaccompanied children are
                                                Memorandum). Although the required                                     including placements in ORR foster                             crossing the border.
                                                documents are submitted at the risk                                    care, group homes, shelter, staff secure,                         Respondents:

                                                                                                                                 ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                     Number of            Average
                                                                                                                                                                   Number of                                                    Total burden
                                                                                               Instrument                                                                          responses per        burden hours
                                                                                                                                                                  respondents                                                      hours
                                                                                                                                                                                     respondent         per response
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                                                UC Portal Capacity Report ..............................................................................                      50                 1     .16/hour ..........                 8
                                                Further Assessment Swift Track (FAST) Placement Tool ..............................                                        2,320                 1     .25/hour ..........               580
                                                Placement Authorization Form ........................................................................                     58,000                 1     .1/hour ............            5,800
                                                Notice of Placement in Secure or Staff Secure Facility ..................................                                  2,320                 1     .1/hour ............              232
                                                Initial Intakes Form ..........................................................................................           58,000                 1     .25/hour ..........            14,500
                                                UC Assessment ...............................................................................................             58,000                 1     .50/hour ..........            29,000
                                                Individual Service Plan ....................................................................................              58,000                 1     .25 ..................         14,500
                                                UC Case Review Form ...................................................................................                   58,000                 1     .50/hour ..........            29,000



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Document Created: 2016-06-17 01:04:52
Document Modified: 2016-06-17 01:04:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the collection(s) of information must be received by the OMB desk officer by July 18, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 39644 

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