81_FR_47948 81 FR 47807 - Agency Information Collection Activities: Proposed Collection; Comment Request

81 FR 47807 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 81, Issue 141 (July 22, 2016)

Page Range47807-47809
FR Document2016-17376

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.

Federal Register, Volume 81 Issue 141 (Friday, July 22, 2016)
[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47807-47809]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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



                                                                              Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices                                              47807

                                             Form Number: CMS–10178 (OMB                                Dated: July 18, 2016.                               document(s) that are accepting
                                             control number: 0938–0994); Frequency:                   Martique Jones,                                       comments.
                                             Occasionally; Affected Public: State,                    Director, Regulations Development Group,                2. By regular mail. You may mail
                                             Local, or Tribal Governments; Number                     Office of Strategic Operations and Regulatory         written comments to the following
                                             of Respondents: 34; Total Annual                         Affairs.                                              address: CMS, Office of Strategic
                                             Responses: 28,050; Total Annual Hours:                   [FR Doc. 2016–17251 Filed 7–21–16; 8:45 am]           Operations and Regulatory Affairs,
                                             28,050. (For policy questions regarding                  BILLING CODE 4120–01–P                                Division of Regulations Development,
                                             this collection contact Bridgett Rider at                                                                      Attention: Document Identifier/OMB
                                             410–786–2602.)                                                                                                 Control Number lll, Room C4–26–
                                                                                                      DEPARTMENT OF HEALTH AND                              05, 7500 Security Boulevard, Baltimore,
                                                5. Type of Information Collection                     HUMAN SERVICES                                        Maryland 21244–1850.
                                             Request: Extension of a currently                                                                                To obtain copies of a supporting
                                             approved collection; Title of                            Centers for Medicare & Medicaid                       statement and any related forms for the
                                             Information Collection: Payment Error                    Services                                              proposed collection(s) summarized in
                                             Rate Measurement—State Medicaid and                      [Document Identifiers: CMS–R–70, CMS–R–               this notice, you may make your request
                                             SCHIP Eligibility; Use: The Improper                     72, CMS–R–247, CMS–10151, CMS–10268,                  using one of following:
                                             Payments Information Act (IPIA) of                       CMS–R–5, CMS–10615, and CMS–10062]                      1. Access CMS’ Web site address at
                                             2002 requires CMS to produce national                                                                          http://www.cms.hhs.gov/
                                             error rates for Medicaid and the                         Agency Information Collection                         PaperworkReductionActof1995.
                                             Children’s Health Insurance Program                      Activities: Proposed Collection;                        2. Email your request, including your
                                             (CHIP). To comply with the IPIA, CMS                     Comment Request                                       address, phone number, OMB number,
                                             will use a national contracting strategy                 AGENCY: Centers for Medicare &                        and CMS document identifier, to
                                             to produce error rates for Medicaid and                  Medicaid Services, HHS.                               Paperwork@cms.hhs.gov.
                                             CHIP fee-for-service and managed care                    ACTION: Notice.                                         3. Call the Reports Clearance Office at
                                             improper payments. The Federal                                                                                 (410) 786–1326.
                                             contractor will review States on a                       SUMMARY:   The Centers for Medicare &                 FOR FURTHER INFORMATION CONTACT:
                                             rotational basis so that each State will                 Medicaid Services (CMS) is announcing                 Reports Clearance Office at (410) 786–
                                             be measured for improper payments, in                    an opportunity for the public to                      1326.
                                             each program, once and only once every                   comment on CMS’ intention to collect
                                                                                                      information from the public. Under the                SUPPLEMENTARY INFORMATION:
                                             three years. Subsequent to the first
                                             publication, we determined that we will                  Paperwork Reduction Act of 1995 (the                  Contents
                                             measure Medicaid and CHIP in the same                    PRA), federal agencies are required to
                                                                                                      publish notice in the Federal Register                  This notice sets out a summary of the
                                             State. Therefore, States will measure                                                                          use and burden associated with the
                                             Medicaid and CHIP eligibility in the                     concerning each proposed collection of
                                                                                                      information (including each proposed                  following information collections. More
                                             same year measured for fee-for-service                                                                         detailed information can be found in
                                                                                                      extension or reinstatement of an existing
                                             and managed care. We believe this                                                                              each collection’s supporting statement
                                                                                                      collection of information) and to allow
                                             approach will advantage States through                                                                         and associated materials (see
                                                                                                      60 days for public comment on the
                                             economies of scale (e.g., administrative                                                                       ADDRESSES).
                                                                                                      proposed action. Interested persons are
                                             ease and shared staffing for both                                                                              CMS–R–70 Information Collection
                                                                                                      invited to send comments regarding our
                                             programs reviews). We also determined                    burden estimates or any other aspect of                Requirements in HSQ–110, Acquisition,
                                             that interim case completion timeframes                  this collection of information, including              Protection and Disclosure of Peer review
                                             and reporting are critical to the integrity              any of the following subjects: (1) The                 Organization Information and Supporting
                                             of the reviews and to keep the reviews                                                                          Regulations
                                                                                                      necessity and utility of the proposed                 CMS–R–72 Information Collection
                                             on schedule to produce a timely error                    information collection for the proper                  Requirements in 42 CFR 478.18, 478.34,
                                             rate. Lastly, the sample sizes were                      performance of the agency’s functions;                 478.36, 478.42, QIO Reconsiderations and
                                             increased slightly in order to produce an                (2) the accuracy of the estimated                      Appeals
                                             equal sample size per strata each month.                 burden; (3) ways to enhance the quality,              CMS–R–247 Expanded Coverage for
                                             Periodically, CMS will conduct Federal                   utility, and clarity of the information to             Diabetes Outpatient Self-Management
                                             re-reviews of States’ PERM files to                      be collected; and (4) the use of                       Training Services and Supporting
                                             ensure the accuracy of States’ review                    automated collection techniques or                     Regulations
                                             findings and the validity of the review                                                                        CMS–10151 Data Collection for Medicare
                                                                                                      other forms of information technology to
                                                                                                                                                             Beneficiaries Receiving Implantable
                                             process. CMS will select a random                        minimize the information collection                    Cardioverter-Defibrillators for Primary
                                             subsample of Medicaid and CHIP cases                     burden.                                                Prevention of Sudden Cardiac Death
                                             from the sample selection lists provided                 DATES: Comments must be received by                   CMS–10268 Consolidated Renal Operations
                                             by each State. States will submit all                    September 20, 2016.                                    in a Web Enabled Network (CROWNWeb)
                                             pertinent information related to the                                                                            Third-party Submission Authorization
                                                                                                      ADDRESSES: When commenting, please
                                             review of each sampled case that is                                                                             Form
                                                                                                      reference the document identifier or                  CMS–R–5 Physician Certification/
                                             selected by CMS. Form Number: CMS–                       OMB control number. To be assured                      Recertification in Skilled Nursing Facilities
                                             10184 (OMB control number: 0938–                         consideration, comments and                            (SNFs) Manual Instructions
                                             1012); Frequency: Annually, Quarterly                    recommendations must be submitted in                  CMS–10615 Healthy Indiana Program (HIP)
                                             Affected Public: State, Local, or Tribal
ehiers on DSK5VPTVN1PROD with NOTICES




                                                                                                      any one of the following ways:                         2.0 Beneficiaries Survey, Focus Groups,
                                             Governments; Number of Respondents:                        1. Electronically. You may send your                 and Informational Interviews
                                             34; Total Annual Responses: 1,583;                       comments electronically to http://                    CMS–10062 Collection of Diagnostic Data
                                             Total Annual Hours: 946,164. (For                        www.regulations.gov. Follow the                        from Medicare Advantage Organizations
                                             policy questions regarding this                          instructions for ‘‘Comment or                          for Risk Adjusted Payments
                                             collection contact Bridgett Rider at 410–                Submission’’ or ‘‘More Search Options’’                 Under the PRA (44 U.S.C. 3501–
                                             786–2602.)                                               to find the information collection                    3520), federal agencies must obtain


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                                             47808                            Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices

                                             approval from the Office of Management                   physician, or other practitioner does not             furnished to a beneficiary with diabetes
                                             and Budget (OMB) for each collection of                  agree with the initial determination of a             by an entity approved to furnish the
                                             information they conduct or sponsor.                     Quality Improvement Organization                      services. The physician or qualified
                                             The term ‘‘collection of information’’ is                (QIO) or a QIO subcontractor, it is                   non-physician practitioner treating the
                                             defined in 44 U.S.C. 3502(3) and 5 CFR                   within that party’s rights to request                 beneficiary’s diabetes would certify that
                                             1320.3(c) and includes agency requests                   reconsideration. The information                      these services are needed as part of a
                                             or requirements that members of the                      collection requirements 42 CFR 478.18,                comprehensive plan of care. This rule
                                             public submit reports, keep records, or                  478.34, 478.36, and 478.42, contain                   established the quality standards that an
                                             provide information to a third party.                    procedures for QIOs to use in                         entity would be required to meet in
                                             Section 3506(c)(2)(A) of the PRA                         reconsideration of initial                            order to participate in furnishing
                                             requires federal agencies to publish a                   determinations. The information                       diabetes outpatient self-management
                                             60-day notice in the Federal Register                    requirements contained in these                       training services. It set forth payment
                                             concerning each proposed collection of                   regulations are on QIOs to provide                    amounts that have been established in
                                             information, including each proposed                     information to parties requesting the                 consultation with appropriate diabetes
                                             extension or reinstatement of an existing                reconsideration. These parties will use               organizations. It implements section
                                             collection of information, before                        the information as guidelines for appeal              4105 of the Balanced Budget Act of
                                             submitting the collection to OMB for                     rights in instances where issues are                  1997. Form Number: CMS–R–247 (OMB
                                             approval. To comply with this                            actively being disputed. Form Number:                 control number: 0938–0818); Frequency:
                                             requirement, CMS is publishing this                      CMS–R–72 (OMB control number:                         Recordkeeping and Reporting—
                                             notice.                                                  0938–0443); Frequency: Reporting—On                   Occasionally; Affected Public: Business
                                                                                                      occasion; Affected Public: Individuals or             or other for-profit institutions; Number
                                             Information Collection
                                                                                                      Households and Business or other for-                 of Respondents: 5327; Total Annual
                                                1. Type of Information Collection                     profit institutions; Number of                        Responses: 63,924; Total Annual Hours:
                                             Request: Extension of a currently                        Respondents: 2,590; Total Annual                      197,542. (For policy questions regarding
                                             approved collection; Title of                            Responses: 5,228; Total Annual Hours:                 this collection contact Kristin Shifflett
                                             Information Collection: Information                      2,822. (For policy questions regarding                at 410–786–4133.)
                                             Collection Requirements in HSQ–110,                      this collection contact Winsome Higgins                  4. Type of Information Collection
                                             Acquisition, Protection and Disclosure                   at 410–786–1835.)                                     Request: Extension of a currently
                                             of Peer review Organization Information                                                                        approved collection; Title of
                                             and Supporting Regulations; Use: The                        3. Type of Information Collection                  Information Collection: Data Collection
                                             Peer Review Improvement Act of 1982                      Request: Extension of a currently                     for Medicare Beneficiaries Receiving
                                             authorizes quality improvement                           approved collection; Title of                         Implantable Cardioverter-Defibrillators
                                             organizations (QIOs), formally known as                  Information Collection: Expanded                      for Primary Prevention of Sudden
                                             peer review organizations (PROs), to                     Coverage for Diabetes Outpatient Self-                Cardiac Death; Use: We provide
                                             acquire information necessary to fulfill                 Management Training Services and                      coverage for implantable cardioverter-
                                             their duties and functions and places                    Supporting Regulations; Use: According                defibrillators (ICDs) for secondary
                                             limits on disclosure of the information.                 to the National Health and Nutrition                  prevention of sudden cardiac death
                                             The QIOs are required to provide                         Examination Survey (NHANES), as                       based on extensive evidence showing
                                             notices to the affected parties when                     many as 18.7 percent of Americans over                that use of ICDs among patients with a
                                             disclosing information about them.                       age 65 are at risk for developing                     certain set of physiologic conditions are
                                             These requirements serve to protect the                  diabetes. The goals in the management                 effective. Accordingly, we consider
                                             rights of the affected parties. The                      of diabetes are to achieve normal                     coverage for ICDs reasonable and
                                             information provided in these notices is                 metabolic control and reduce the risk of              necessary under Section 1862(a)(1)(A) of
                                             used by the patients, practitioners and                  micro- and macro-vascular                             the Social Security Act. However,
                                             providers to: Obtain access to the data                  complications. Numerous epidemiologic                 evidence for use of ICDs for primary
                                             maintained and collected on them by                      and interventional studies point to the               prevention of sudden cardiac death is
                                             the QIOs; add additional data or make                    necessity of maintaining good glycemic                less compelling for certain patients.
                                             changes to existing QIO data; and reflect                control to reduce the risk of the                        To encourage responsible and
                                             in the QIO’s record the reasons for the                  complications of diabetes. Despite this               appropriate use of ICDs, we issued a
                                             QIO’s disagreeing with an individual’s                   knowledge, diabetes remains the leading               ‘‘Decision Memo for Implantable
                                             or provider’s request for amendment.                     cause of blindness, lower extremity                   Defibrillators’’ on January 27, 2005,
                                             Form Number: CMS–R–70 (OMB control                       amputations and kidney disease                        indicating that ICDs will be covered for
                                             number: 0938–0426); Frequency:                           requiring dialysis. Diabetes and its                  primary prevention of sudden cardiac
                                             Reporting—On occasion; Affected                          complications are primary or secondary                death if the beneficiary is enrolled in
                                             Public: Business or other for-profits;                   factors in an estimated 9 percent of                  either an FDA-approved category B IDE
                                             Number of Respondents: 400; Total                        hospitalizations (Aubert, RE, et al.,                 clinical trial (42 CFR 405.201), a trial
                                             Annual Responses: 21,200; Total                          Diabetes-related hospitalizations and                 under the CMS Clinical Trial Policy
                                             Annual Hours: 42,400. (For policy                        hospital utilization. In: Diabetes in                 (NCD Manual § 310.1) or a qualifying
                                             questions regarding this collection                      America. 2nd ed. National Institutes of               prospective data collection system
                                             contact Winsome Higgins at 410–786–                      Health, National Institute of Diabetes                (either a practical clinical trial or
                                             1835.)                                                   and Digestive and Kidney Disease, NIH,                prospective systematic data collection,
                                                2. Type of Information Collection                     Pub. No 95–1468–1995: 553–570).                       which is sometimes referred to as a
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                                             Request: Extension of a currently                        Overall, beneficiaries with diabetes are              registry). Form Number: CMS–10151
                                             approved collection; Title of                            hospitalized 1.5 times more often than                (OMB control number: 0938–0967);
                                             Information Collection: Information                      beneficiaries without diabetes. HCFA–                 Frequency: Occasionally; Affected
                                             Collection Requirements in 42 CFR                        3002–F provided for uniform coverage                  Public: Business or other for-profits,
                                             478.18, 478.34, 478.36, 478.42, QIO                      of diabetes outpatient self-management                Not-for-profit institutions; Number of
                                             Reconsiderations and Appeals; Use: In                    training services. These services include             Respondents: 1,702; Total Annual
                                             the event that a beneficiary, provider,                  educational and training services                     Responses: 82; Total Annual Hours:


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                                                                              Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices                                                 47809

                                             139,356. (For policy questions regarding                 basis, skilled nursing care (provided                 through the end of the revised
                                             this collection contact JoAnna Baldwin                   directly by or requiring the supervision              expiration date. The revised expiration
                                             at 410–786–7205.)                                        of skilled nursing personnel) or other                date will be made available upon OMB
                                                5. Type of Information Collection                     skilled rehabilitation services that, as a            approval at reginfo.gov. Form Number:
                                             Request: Extension of a currently                        practical matter, can only be provided                CMS–10615 (OMB control number:
                                             approved collection; Title of                            in a SNF on an inpatient basis. The                   0938–1300); Frequency: Once; Affected
                                             Information Collection: Consolidated                     physician certification requirements                  Public: Individuals and households,
                                             Renal Operations in a Web Enabled                        were included in the law to ensure that               Private sector (Business or other for-
                                             Network (CROWNWeb) Third-party                           patients require a level of care that is              profits and Not-for-profits institutions),
                                             Submission Authorization Form; Use:                      covered by the Medicare program and
                                                                                                                                                            and State, Local, or Tribal Governments;
                                             The Consolidated Renal Operations in a                   because the physician is a key figure in
                                             Web Enabled Network (CROWNWeb)                                                                                 Number of Respondents: 5,240; Total
                                                                                                      determining the utilization of health
                                             Third-Party Submission Authorization                     services. Form Number: CMS–R–5                        Annual Responses: 5,240; Total Annual
                                             form (CWTPSA) is to be completed by                      (OMB control number: 0938–0454);                      Hours: 1,442. (For policy questions
                                             ‘‘Facility Administrators’’                              Frequency: Occasionally; Affected                     regarding this collection contact Teresa
                                             (administrators of CMS-certified dialysis                Public: Business or other for-profits and             DeCaro at 202–384–6309.)
                                             facilities) if they intend to authorize a                Not-for-profit institutions; Number of                   8. Type of Information Collection
                                             third party (a business with which the                   Respondents: 2,711,136; Total Annual                  Request: Extension of a currently
                                             facility is associated, or an independent                Responses: 2,711,136; Total Annual                    approved collection; Title of
                                             vendor) to submit data to us to comply                   Hours: 624,515. (For policy questions                 Information Collection: Collection of
                                             with the recently-revised Conditions for                 regarding this collection contact Kia                 Diagnostic Data from Medicare
                                             Coverage of dialysis facilities. The                     Sidbury at 410–786–7816.)                             Advantage Organizations for Risk
                                             CROWNWeb system is the system used                          7. Type of Information Collection                  Adjusted Payments; Use: CMS requires
                                             as the collection point of data necessary                Request: Extension of a currently
                                                                                                                                                            hospital inpatient, hospital outpatient
                                             for entitlement of ESRD patients to                      approved collection; Title of
                                                                                                                                                            and physician diagnostic data from
                                             Medicare benefits and for federal                        Information Collection: Healthy Indiana
                                             government monitoring and assessing of                   Program (HIP) 2.0 Beneficiaries Survey,               Medicare Advantage (MA) organizations
                                             the quality and types of care provided                   Focus Groups, and Informational                       to continue making payment under the
                                             to renal patients. The information                       Interviews; Use: The collected                        risk adjustment methodology. CMS will
                                             collected through the CWTPSA form                        information will be used to make                      use the data to make risk adjusted
                                             will allow us along with our contractors                 decisions about the renewal of                        payment under Parts C and D. MA and
                                             to receive data from authorized parties                  precedent-setting waivers of Medicaid                 MA–PD plans will use the data to
                                             acting on behalf of CMS-certified                        policy that assure important beneficiary              develop their Part C and D bids. As
                                             dialysis facilities. Since February 2009,                protections regarding coverage and                    required by law, CMS also annually
                                             we have received 4,160 CWTPSA forms                      access to care; e.g., the State of Indiana’s          publishes the risk adjustment factors for
                                             and anticipates that they will continue                  non-emergency medical transportation                  plans and other interested entities in the
                                             to receive no more than 400 new                          waiver which will end or will be                      Advance Notice of Methodological
                                             CWTPSA forms annually to address the                     extended by no later than December 1,                 Changes for MA Payment Rates (every
                                             creation of new facilities under the                     2016. To support CMS decision making,                 February) and the Announcement of
                                             current participating ‘‘third party                      the collection’s survey effort would                  Medicare Advantage Payment Rates
                                             submitters.’’ Form Number: CMS–10268                     provide more detailed information on                  (every April). Lastly, CMS issues
                                             (OMB control number: 0938–1052);                         the Healthy Indiana Program (HIP) 2.0                 monthly reports to each individual plan
                                             Frequency: Occasionally; Affected                        demonstration’s beneficiary                           that contains the CMS Hierarchical
                                             Public: Business or other for-profits and                understanding and experiences (current                Condition Category (HCC) and RxHCC
                                             Not-for-profit institutions; Number of                   and new enrollees as well as
                                                                                                                                                            models’ output and the risk scores and
                                             Respondents: 400; Total Annual                           disenrollees/lockouts). Additional
                                                                                                                                                            reimbursements for each beneficiary
                                             Responses: 400; Total Annual Hours:                      information on other key policies under
                                             34. (For policy questions regarding this                 the demonstration, such as the 60-day                 that is enrolled in their plan. Form
                                             collection contact Victoria Schlining at                 beneficiary lock-out period, is also                  Number: CMS–10062 (OMB control
                                             410–786–6878.)                                           included in this information collection               number: 0938–0878); Frequency:
                                                6. Type of Information Collection                     request.                                              Quarterly; Affected Public: Private
                                             Request: Extension of a currently                           This request does not propose any                  sector (Business or other for profit and
                                             approved collection; Title of                            new or revised information collection                 Not-for-profit institutions); Number of
                                             Information Collection: Physician                        requirements or burden estimates                      Respondents: 691; Total Annual
                                             Certification/Recertification in Skilled                 outside of what is currently approved by              Responses: 83,000,000; Total Annual
                                             Nursing Facilities (SNFs) Manual                         OMB. Rather, it seeks to extend the                   Hours: 40,650. (For policy questions
                                             Instructions; Use: Section 1814(a) of the                collection’s current expiration date of               regarding this collection contact
                                             Social Security Act (the Act) requires                   September 30, 2016 (approved under                    Michael P. Massimini at 410–786–1566.)
                                             specific certifications in order for                     the emergency PRA process on March
                                                                                                                                                               Dated: July 19, 2016.
                                             Medicare payments to be made for                         21, 2016; see 81 FR 17460 dated March
                                             certain services. Before the enactment of                29, 2106, and 81 FR 26798 dated May                   William N. Parham, III,
                                             the Omnibus Budget Reconciliation Act                    4, 2016). Since the collection has                    Director, Paperwork Reduction Staff, Office
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                                             of 1989 (OBRA1989, Pub. L. 101–239),                     already been subject to the public                    of Strategic Operations and Regulatory
                                             section 1814(a)(2) of the Act required                   comment process for collection                        Affairs.
                                             that, in the case of post hospital                       activities taking place through                       [FR Doc. 2016–17376 Filed 7–21–16; 8:45 am]
                                             extended care services, a physician                      September 30, 2016, this ‘‘Extension of               BILLING CODE 4120–01–P
                                             certify that the services are or were                    a currently approved collection’’ will
                                             required to be given because the                         only consider comments for activities
                                             individual needs or needed, on a daily                   taking place from October 1, 2016,


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Document Created: 2016-07-22 02:38:29
Document Modified: 2016-07-22 02:38:29
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 must be received by September 20, 2016.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation81 FR 47807 

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