[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Pages 70059-70061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28049]



[[Page 70059]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10502, CMS-10503, CMS-10504, CMS-10509, CMS-
10418 and CMS-10157]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by January 21, 2014.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number ----, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at 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:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10502 LTCH Quality Reporting Program: Program Evaluation
CMS-10503 Inpatient Rehabilitation Facilities (IRF) Quality 
Reporting Program (QRP): Program Evaluation
CMS-10504 Hospice Quality Reporting Program: Program Evaluation
CMS-10509 Prospective Evaluation of Evidence-Based Community 
Wellness and Prevention Programs
CMS-10418 Annual MLR and Rebate Calculation Report and MLR Rebate 
Notices
CMS-10157 HIPAA Eligibility Transaction System (HETS) Trading 
Partner Agreement (TPA)

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520), 
federal agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. The term ``collection of information'' is defined in 44 U.S.C. 
3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA requires federal agencies to publish a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice.
Information Collections
    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Long 
Term Care Hospital Quality Reporting Program: Program Evaluation; Use: 
Section 3004(a) of the Affordable Care Act (ACA) mandated that we 
establish a quality reporting program for Long Term Care Hospitals 
(LTCHs). Specifically, section 3004(a) added section 1886(m)(5) to the 
Social Security Act (the Act) to establish a quality reporting program 
for LTCHs. This program requires that quality data be submitted by LTCH 
providers in a time, form and manner specified by the Secretary.
    We are interested in exploring how LTCH providers are responding to 
the new quality reporting program (QRP) and its measures. We believe 
that it is important to understand early trends in outcomes, to make 
adjustments as needed to enhance the effectiveness of the program, and 
to seek opportunities to minimize provider burden, and ensure the QRP 
is useful and meaningful to providers. The methodology employed in the 
evaluation is the utilization of qualitative interviews (as opposed to 
quantitative statistical methods). In consultation with research 
experts, we have decided that at this juncture it would be meaningful 
to use a rich, contextual approach to evaluate the process and success 
of the QRP initiative.
    The decision to pursue this quantitative methodology in 2013, in 
which we learned that providers are anxious to have their voice heard, 
but that they did not feel comfortable expressing themselves fully in 
public open door forums. Providers desired some level of 
confidentiality, which this methodology affords. The intended use of 
the information collected is to help inform us about CMS providers' 
experiences related to the QRPs, such as program impact related to 
quality improvement, burden, process-related issues, and education. 
This will also inform future measurement development for the LTCH QRP, 
future steps related to data validation, as well as future monitoring 
and evaluation. General findings may be used to discuss our future 
efforts in the QRP. Form Number: CMS-10502 (OCN: 0938-NEW); Frequency: 
Occasionally; Affected Public: Private sector--Business or other for-
profits and not-for-profit organizations; Number of Respondents: 30; 
Total Annual Responses: 30; Total Annual Hours: 71. (For policy 
questions regarding this

[[Page 70060]]

collection contact Caroline Gallaher at 410-786-8705.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Inpatient Rehabilitation Facilities Quality Reporting Program: Program 
Evaluation; Use: Section 3004 of the Affordable Care Act (ACA) mandated 
that we establish a quality reporting program for Inpatient 
Rehabilitation Facilities (IRFs). Specifically, section 3004(a) added 
section 1886(j)(7) to the Social Security Act (``the Act'') to 
establish a quality reporting program (QRP) for IRFs. This program 
requires IRFs to submit quality data in a time, form and manner 
specified by the Secretary.
    We are interested in exploring how IRF providers are responding to 
the new QRP and its measures. We believe that it is important to 
understand early trends in outcomes, to make adjustments as needed to 
enhance the effectiveness of the program, and to seek opportunities to 
minimize provider burden, and ensure the quality reporting program is 
useful and meaningful to the providers. The methodology employed in the 
evaluation is the utilization of qualitative interviews (as opposed to 
quantitative statistical methods). In consultation with research 
experts, we have decided that at this juncture it would be meaningful 
to use a rich, contextual approach to evaluation the process and 
success of the QRP initiative. The decision to pursue this quantitative 
methodology in 2013, in which we learned that providers are anxious to 
have their voice heard, but that they did not feel comfortable 
expressing themselves fully in public open door forums. Providers 
desired some level of confidentiality, which this methodology affords.
    The intended use of the information collected is to help inform CMS 
providers' experiences related to the QRPs, such as program impact 
related to quality improvement, burden, process-related issues, and 
education. This will also inform future measurement development for the 
IRF QRP, future steps related to data validation, as well as future 
monitoring and evaluation. General findings may be used to discuss our 
future efforts in the QRP. Form Number: CMS-10503 (OCN: 0938-NEW); 
Frequency: Occasionally; Affected Public: Private sector--Business or 
other for-profits and not-for-profit organizations; Number of 
Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 71. 
(For policy questions regarding this collection contact Caroline 
Gallaher at 410-786-8705.)
    3. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Hospice 
Quality Reporting Program: Program Evaluation; Use: Section 3004(c) of 
the Affordable Care Act (ACA) mandated that we establish a quality 
reporting program (QRP) for hospices. Specifically, section 3004(c) 
added section 1814(i)(5) to the Social Security Act (the Act) to 
establish a quality reporting program for hospices. This program 
requires that quality data be submitted by hospice providers in a time, 
form and manner specified by the Secretary.
    We are interested in exploring how hospice providers are responding 
to the new QRP and its measures. We believe that it is important to 
understand early trends in outcomes, to make adjustments as needed to 
enhance the effectiveness of the program, and to seek opportunities to 
minimize provider burden, and ensure the quality reporting program is 
useful and meaningful to the providers. The methodology employed in the 
evaluation is the utilization of qualitative interviews (as opposed to 
quantitative statistical methods). In consultation with research 
experts, we have decided that at this juncture it would be meaningful 
to use a rich, contextual approach to evaluation the process and 
success of the QRP initiative. The decision to pursue this quantitative 
methodology in 2013, in which we learned that providers are anxious to 
have their voice heard, but that they did not feel comfortable 
expressing themselves fully in public open door forums. Providers 
desired some level of confidentiality, which this methodology affords.
    The intended use of the information collected is to help inform CMS 
providers' experiences related to the QRPs, such as program impact 
related to quality improvement, burden, process-related issues, and 
education. This will also inform future measurement development for the 
hospice QRP, future steps related to data validation, as well as future 
monitoring and evaluation. General findings may be used to discuss our 
future efforts in the QRP. Form Number: CMS-10504 (OCN: 0938-NEW); 
Frequency: Occasionally; Affected Public: Private sector--Business or 
other for-profits and not-for-profit organizations; Number of 
Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 71. 
(For policy questions regarding this collection contact Caroline 
Gallaher at 410-786-8705.)
    4. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Prospective Evaluation of Evidence-Based Community Wellness and 
Prevention Programs; Use: Section 4202(b) of the Affordable Care Act 
(ACA) mandated that we conduct an evidence review and independent 
evaluation of wellness programs focusing on the following six 
intervention areas: Chronic disease self-management, increasing 
physical activity, reducing obesity, improving diet and nutrition, 
reducing falls, and mental health management. In response to the ACA 
mandate, we adopted a three-phase approach to evaluate the impact of 
wellness programs on Medicare beneficiary health, utilization, and 
costs to determine whether broader Medicare beneficiary participation 
in wellness programs could lower future growth in Medicare spending. 
Phase I consisted of a comprehensive literature review and 
environmental scan to identify a list of wellness programs for further 
evaluation. Phase II involved a retrospective evaluation of 10 wellness 
programs in the targeted intervention areas mentioned above. The 
purpose of the Phase II evaluation was to use Medicare claims data to 
assess the 10 wellness programs' impact on Medicare beneficiary 
outcomes including health service utilization and medical costs. The 
findings in Phase II were promising in that several wellness programs 
demonstrated the potential to save medical costs among participating 
beneficiaries.
    Phase III of our evaluation, of which this work is the key 
component, aims to round out our understanding of how wellness programs 
affect Medicare beneficiaries and what cost saving opportunities exist 
for the Medicare program. This evaluation effort will (1) describe the 
overall distribution of readiness to engage with wellness programs in 
the Medicare population, (2) better adjust for selection biases of 
individual programs and interventions using beneficiary level survey 
data, (3) evaluate program impacts on health behaviors, self-reported 
health outcomes, and claims-based measures of utilization and costs, 
and (4) better describe program implementation, operations and cost in 
relation to the expected benefits. The results of these analyses will 
be used to inform wellness and prevention activities in the future.
    To achieve the goals of this project, we will be conducting a 
nationally representative survey of Medicare beneficiaries to assess 
their readiness to participate in community-based wellness programs. 
National estimates of Medicare beneficiary demand for wellness services 
and benefits will be generated from this population-based

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readiness national survey. In addition, we will partner with evidence-
based wellness programs for the purposes of enrolling an estimated 
2,000 participants per program. Surveys of program participants will be 
conducted to assess program impacts on health and behavior. Form 
Number: CMS-10509 (OCN: 0938-NEW); Frequency: Semi-annually; Affected 
Public: Individuals and households; Number of Respondents: 20,833; 
Total Annual Responses: 45,420; Total Annual Hours: 18,531. (For policy 
questions regarding this collection contact Benjamin Howell at 410-786-
4942.)
    5. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Annual MLR and 
Rebate Calculation Report and MLR Rebate Notices; Use: Under Section 
2718 of the Affordable Care Act and implementing regulation at 45 CFR 
Part 158, a health insurance issuer (issuer) offering group or 
individual health insurance coverage must submit a report to the 
Secretary concerning the amount the issuer spends each year on claims, 
quality improvement expenses, non-claims costs, Federal and State taxes 
and licensing and regulatory fees, and the amount of earned premium. An 
issuer must provide an annual rebate if the amount it spends on certain 
costs compared to its premium revenue (excluding Federal and States 
taxes and licensing and regulatory fees) does not meet a certain ratio, 
referred to as the medical loss ratio (MLR). An interim final rule 
(IFR) implementing the MLR was published on December 1, 2010 (75 FR 
74865) and modified by technical corrections on December 30, 2010 (75 
FR 82277), which added Part 158 to Title 45 of the Code of Federal 
Regulations. The IFR was effective January 1, 2011. A final rule 
regarding selected provisions of the IFR was published on December 7, 
2011 (76 FR 76574) and an interim final rule regarding an issue not 
included in issuers' reporting obligations (disbursement of rebates by 
non-federal governmental plans) was also published December 7, 2011 (76 
FR 76596) Both rules published on December 7, 2011 and were effective 
January 1, 2012. Each issuer is required to submit annually MLR data, 
including information about any rebates it must provide, on a form we 
prescribed, for each State in which the issuer conducts business. Each 
issuer is also required to provide a rebate notice to each policyholder 
that is owed a rebate and each subscriber of policyholders that are 
owed a rebate for any given MLR reporting year. Additionally, each 
issuer is required to maintain for a period of seven years all 
documents, records and other evidence that support the data included in 
each issuer's annual report to the Secretary.
    Based upon HHS' experience in the MLR data collection and 
evaluation process, HHS is updating its annual burden hour estimates to 
reflect the actual numbers of submissions, rebates and rebate notices. 
The 2013 MLR Reporting Form and instructions also reflect changes for 
the 2013 reporting year and beyond that are set forth in the March 2012 
update to 45 CFR 158.120(d)(5) regarding aggregation of student health 
plans on a nationwide basis, similar to expatriate plans. The 
instructions also addresses recent applicability guidance issued by the 
Departments of Labor, Treasury and HHS concerning expatriate plan 
reporting prior to plan years ending before or on December 31, 2015. In 
2014, it is expected that issuers will send fewer notices and rebate 
checks to policyholders and subscribers which will reduce burden on 
issuers. On the other hand, the requirement to report data on student 
health plans will increase burden for some issuers. It is estimated 
that there will be a net reduction in total information collection 
burden. Form Number: CMS-10418 (OCN: 0938-1164); Frequency: Annually; 
Affected Public: Private sector--Business or other for-profits and not-
for-profit institutions; Number of Respondents: 522; Number of 
Responses: 3,394; Total Annual Hours: 294,911. (For policy questions 
regarding this collection, contact Julie McCune at (301) 492-4196.)
    6. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: HIPAA 
Eligibility Transaction System (HETS) Trading Partner Agreement (TPA); 
Use: The HIPAA Eligibility Transaction System (HETS) is intended to 
allow the release of eligibility data to Medicare providers, suppliers 
or their authorized billing agents for the purposes of preparing 
accurate Medicare claims, determining beneficiary liability or 
determining eligibility for specific services. Such information may not 
be disclosed to anyone other than providers, suppliers or a beneficiary 
for whom a claim has been filed. Form Number: CMS-10157 (OCN: 0938-
0960); Frequency: Yearly; Affected Public: Private sector--Business or 
other for-profit and not-for-profit institutions; Number of 
Respondents: 1,000; Total Annual Responses: 1,000; Total Annual Hours: 
125. (For policy questions regarding this collection contact Ada 
Sanchez at 410-786-9466.)

    Dated: November 19, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-28049 Filed 11-21-13; 8:45 am]
BILLING CODE 4120-01-P