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)

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, 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.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish 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.

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    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