[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47807-47809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-R-70, CMS-R-72, CMS-R-247, CMS-10151, CMS-
10268, CMS-R-5, CMS-10615, and CMS-10062]


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 September 20, 2016.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. 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-R-70 Information Collection Requirements in HSQ-110, 
Acquisition, Protection and Disclosure of Peer review Organization 
Information and Supporting Regulations
CMS-R-72 Information Collection Requirements in 42 CFR 478.18, 
478.34, 478.36, 478.42, QIO Reconsiderations and Appeals
CMS-R-247 Expanded Coverage for Diabetes Outpatient Self-Management 
Training Services and Supporting Regulations
CMS-10151 Data Collection for Medicare Beneficiaries Receiving 
Implantable Cardioverter-Defibrillators for Primary Prevention of 
Sudden Cardiac Death
CMS-10268 Consolidated Renal Operations in a Web Enabled Network 
(CROWNWeb) Third-party Submission Authorization Form
CMS-R-5 Physician Certification/Recertification in Skilled Nursing 
Facilities (SNFs) Manual Instructions
CMS-10615 Healthy Indiana Program (HIP) 2.0 Beneficiaries Survey, 
Focus Groups, and Informational Interviews
CMS-10062 Collection of Diagnostic Data from Medicare Advantage 
Organizations for Risk Adjusted Payments

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain

[[Page 47808]]

approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements in HSQ-110, Acquisition, Protection and 
Disclosure of Peer review Organization Information and Supporting 
Regulations; Use: The Peer Review Improvement Act of 1982 authorizes 
quality improvement organizations (QIOs), formally known as peer review 
organizations (PROs), to acquire information necessary to fulfill their 
duties and functions and places limits on disclosure of the 
information. The QIOs are required to provide notices to the affected 
parties when disclosing information about them. These requirements 
serve to protect the rights of the affected parties. The information 
provided in these notices is used by the patients, practitioners and 
providers to: Obtain access to the data maintained and collected on 
them by the QIOs; add additional data or make changes to existing QIO 
data; and reflect in the QIO's record the reasons for the QIO's 
disagreeing with an individual's or provider's request for amendment. 
Form Number: CMS-R-70 (OMB control number: 0938-0426); Frequency: 
Reporting--On occasion; Affected Public: Business or other for-profits; 
Number of Respondents: 400; Total Annual Responses: 21,200; Total 
Annual Hours: 42,400. (For policy questions regarding this collection 
contact Winsome Higgins at 410-786-1835.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Information 
Collection Requirements in 42 CFR 478.18, 478.34, 478.36, 478.42, QIO 
Reconsiderations and Appeals; Use: In the event that a beneficiary, 
provider, physician, or other practitioner does not agree with the 
initial determination of a Quality Improvement Organization (QIO) or a 
QIO subcontractor, it is within that party's rights to request 
reconsideration. The information collection requirements 42 CFR 478.18, 
478.34, 478.36, and 478.42, contain procedures for QIOs to use in 
reconsideration of initial determinations. The information requirements 
contained in these regulations are on QIOs to provide information to 
parties requesting the reconsideration. These parties will use the 
information as guidelines for appeal rights in instances where issues 
are actively being disputed. Form Number: CMS-R-72 (OMB control number: 
0938-0443); Frequency: Reporting--On occasion; Affected Public: 
Individuals or Households and Business or other for-profit 
institutions; Number of Respondents: 2,590; Total Annual Responses: 
5,228; Total Annual Hours: 2,822. (For policy questions regarding this 
collection contact Winsome Higgins at 410-786-1835.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Expanded Coverage 
for Diabetes Outpatient Self-Management Training Services and 
Supporting Regulations; Use: According to the National Health and 
Nutrition Examination Survey (NHANES), as many as 18.7 percent of 
Americans over age 65 are at risk for developing diabetes. The goals in 
the management of diabetes are to achieve normal metabolic control and 
reduce the risk of micro- and macro-vascular complications. Numerous 
epidemiologic and interventional studies point to the necessity of 
maintaining good glycemic control to reduce the risk of the 
complications of diabetes. Despite this knowledge, diabetes remains the 
leading cause of blindness, lower extremity amputations and kidney 
disease requiring dialysis. Diabetes and its complications are primary 
or secondary factors in an estimated 9 percent of hospitalizations 
(Aubert, RE, et al., Diabetes-related hospitalizations and hospital 
utilization. In: Diabetes in America. 2nd ed. National Institutes of 
Health, National Institute of Diabetes and Digestive and Kidney 
Disease, NIH, Pub. No 95-1468-1995: 553-570). Overall, beneficiaries 
with diabetes are hospitalized 1.5 times more often than beneficiaries 
without diabetes. HCFA-3002-F provided for uniform coverage of diabetes 
outpatient self-management training services. These services include 
educational and training services furnished to a beneficiary with 
diabetes by an entity approved to furnish the services. The physician 
or qualified non-physician practitioner treating the beneficiary's 
diabetes would certify that these services are needed as part of a 
comprehensive plan of care. This rule established the quality standards 
that an entity would be required to meet in order to participate in 
furnishing diabetes outpatient self-management training services. It 
set forth payment amounts that have been established in consultation 
with appropriate diabetes organizations. It implements section 4105 of 
the Balanced Budget Act of 1997. Form Number: CMS-R-247 (OMB control 
number: 0938-0818); Frequency: Recordkeeping and Reporting--
Occasionally; Affected Public: Business or other for-profit 
institutions; Number of Respondents: 5327; Total Annual Responses: 
63,924; Total Annual Hours: 197,542. (For policy questions regarding 
this collection contact Kristin Shifflett at 410-786-4133.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data Collection 
for Medicare Beneficiaries Receiving Implantable Cardioverter-
Defibrillators for Primary Prevention of Sudden Cardiac Death; Use: We 
provide coverage for implantable cardioverter-defibrillators (ICDs) for 
secondary prevention of sudden cardiac death based on extensive 
evidence showing that use of ICDs among patients with a certain set of 
physiologic conditions are effective. Accordingly, we consider coverage 
for ICDs reasonable and necessary under Section 1862(a)(1)(A) of the 
Social Security Act. However, evidence for use of ICDs for primary 
prevention of sudden cardiac death is less compelling for certain 
patients.
    To encourage responsible and appropriate use of ICDs, we issued a 
``Decision Memo for Implantable Defibrillators'' on January 27, 2005, 
indicating that ICDs will be covered for primary prevention of sudden 
cardiac death if the beneficiary is enrolled in either an FDA-approved 
category B IDE clinical trial (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1) or a qualifying 
prospective data collection system (either a practical clinical trial 
or prospective systematic data collection, which is sometimes referred 
to as a registry). Form Number: CMS-10151 (OMB control number: 0938-
0967); Frequency: Occasionally; Affected Public: Business or other for-
profits, Not-for-profit institutions; Number of Respondents: 1,702; 
Total Annual Responses: 82; Total Annual Hours:

[[Page 47809]]

139,356. (For policy questions regarding this collection contact JoAnna 
Baldwin at 410-786-7205.)
    5. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Consolidated 
Renal Operations in a Web Enabled Network (CROWNWeb) Third-party 
Submission Authorization Form; Use: The Consolidated Renal Operations 
in a Web Enabled Network (CROWNWeb) Third-Party Submission 
Authorization form (CWTPSA) is to be completed by ``Facility 
Administrators'' (administrators of CMS-certified dialysis facilities) 
if they intend to authorize a third party (a business with which the 
facility is associated, or an independent vendor) to submit data to us 
to comply with the recently-revised Conditions for Coverage of dialysis 
facilities. The CROWNWeb system is the system used as the collection 
point of data necessary for entitlement of ESRD patients to Medicare 
benefits and for federal government monitoring and assessing of the 
quality and types of care provided to renal patients. The information 
collected through the CWTPSA form will allow us along with our 
contractors to receive data from authorized parties acting on behalf of 
CMS-certified dialysis facilities. Since February 2009, we have 
received 4,160 CWTPSA forms and anticipates that they will continue to 
receive no more than 400 new CWTPSA forms annually to address the 
creation of new facilities under the current participating ``third 
party submitters.'' Form Number: CMS-10268 (OMB control number: 0938-
1052); Frequency: Occasionally; Affected Public: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 400; 
Total Annual Responses: 400; Total Annual Hours: 34. (For policy 
questions regarding this collection contact Victoria Schlining at 410-
786-6878.)
    6. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Physician 
Certification/Recertification in Skilled Nursing Facilities (SNFs) 
Manual Instructions; Use: Section 1814(a) of the Social Security Act 
(the Act) requires specific certifications in order for Medicare 
payments to be made for certain services. Before the enactment of the 
Omnibus Budget Reconciliation Act of 1989 (OBRA1989, Pub. L. 101-239), 
section 1814(a)(2) of the Act required that, in the case of post 
hospital extended care services, a physician certify that the services 
are or were required to be given because the individual needs or 
needed, on a daily basis, skilled nursing care (provided directly by or 
requiring the supervision of skilled nursing personnel) or other 
skilled rehabilitation services that, as a practical matter, can only 
be provided in a SNF on an inpatient basis. The physician certification 
requirements were included in the law to ensure that patients require a 
level of care that is covered by the Medicare program and because the 
physician is a key figure in determining the utilization of health 
services. Form Number: CMS-R-5 (OMB control number: 0938-0454); 
Frequency: Occasionally; Affected Public: Business or other for-profits 
and Not-for-profit institutions; Number of Respondents: 2,711,136; 
Total Annual Responses: 2,711,136; Total Annual Hours: 624,515. (For 
policy questions regarding this collection contact Kia Sidbury at 410-
786-7816.)
    7. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Healthy Indiana 
Program (HIP) 2.0 Beneficiaries Survey, Focus Groups, and Informational 
Interviews; Use: The collected information will be used to make 
decisions about the renewal of precedent-setting waivers of Medicaid 
policy that assure important beneficiary protections regarding coverage 
and access to care; e.g., the State of Indiana's non-emergency medical 
transportation waiver which will end or will be extended by no later 
than December 1, 2016. To support CMS decision making, the collection's 
survey effort would provide more detailed information on the Healthy 
Indiana Program (HIP) 2.0 demonstration's beneficiary understanding and 
experiences (current and new enrollees as well as disenrollees/
lockouts). Additional information on other key policies under the 
demonstration, such as the 60-day beneficiary lock-out period, is also 
included in this information collection request.
    This request does not propose any new or revised information 
collection requirements or burden estimates outside of what is 
currently approved by OMB. Rather, it seeks to extend the collection's 
current expiration date of September 30, 2016 (approved under the 
emergency PRA process on March 21, 2016; see 81 FR 17460 dated March 
29, 2106, and 81 FR 26798 dated May 4, 2016). Since the collection has 
already been subject to the public comment process for collection 
activities taking place through September 30, 2016, this ``Extension of 
a currently approved collection'' will only consider comments for 
activities taking place from October 1, 2016, through the end of the 
revised expiration date. The revised expiration date will be made 
available upon OMB approval at reginfo.gov. Form Number: CMS-10615 (OMB 
control number: 0938-1300); Frequency: Once; Affected Public: 
Individuals and households, Private sector (Business or other for-
profits and Not-for-profits institutions), and State, Local, or Tribal 
Governments; Number of Respondents: 5,240; Total Annual Responses: 
5,240; Total Annual Hours: 1,442. (For policy questions regarding this 
collection contact Teresa DeCaro at 202-384-6309.)
    8. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Collection of 
Diagnostic Data from Medicare Advantage Organizations for Risk Adjusted 
Payments; Use: CMS requires hospital inpatient, hospital outpatient and 
physician diagnostic data from Medicare Advantage (MA) organizations to 
continue making payment under the risk adjustment methodology. CMS will 
use the data to make risk adjusted payment under Parts C and D. MA and 
MA-PD plans will use the data to develop their Part C and D bids. As 
required by law, CMS also annually publishes the risk adjustment 
factors for plans and other interested entities in the Advance Notice 
of Methodological Changes for MA Payment Rates (every February) and the 
Announcement of Medicare Advantage Payment Rates (every April). Lastly, 
CMS issues monthly reports to each individual plan that contains the 
CMS Hierarchical Condition Category (HCC) and RxHCC models' output and 
the risk scores and reimbursements for each beneficiary that is 
enrolled in their plan. Form Number: CMS-10062 (OMB control number: 
0938-0878); Frequency: Quarterly; Affected Public: Private sector 
(Business or other for profit and Not-for-profit institutions); Number 
of Respondents: 691; Total Annual Responses: 83,000,000; Total Annual 
Hours: 40,650. (For policy questions regarding this collection contact 
Michael P. Massimini at 410-786-1566.)

    Dated: July 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-17376 Filed 7-21-16; 8:45 am]
 BILLING CODE 4120-01-P