[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66031-66033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23157]


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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-10062, CMS-
10268, CMS-10615 and CMS-10623]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

ACTION: Notice.

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

[[Page 66032]]


DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by October 26, 2016.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR Email: OIRA_ 
[email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: 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: 5,327; 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: Collection of 
Diagnostic Data from Medicare Advantage Organizations for Risk

[[Page 66033]]

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.)
    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: 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.)
    7. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Testing 
Experience and Functional Tools Demonstration: Personal Health Record 
(PHR) User Survey; Use: The PHR user survey is important to the TEFT 
Program Evaluation and understanding the impact of the TEFT PHR on 
Medicaid CB-LTSS beneficiaries. The TEFT evaluation team's approach 
includes monitoring state PHR implementation efforts and fielding a 
follow-up questionnaire to CB-LTSS program participants that asks about 
their experiences using the PHR. The evaluation seeks to measure the 
degree to which the PHR is implemented in an accessible manner for 
Medicaid beneficiaries of CB-LTSS. The survey also is designed to 
assess the user experience of the PHR, including access and usability, 
as well as some measures of user satisfaction and perceived impacts of 
PHR use.
    The information collection request has been revised subsequent to 
the publication of the 60-day Federal Register notice on June 13, 2016 
(81 FR 38187). Details can be found in the package's Supporting 
Statement. While the June 13 Supporting Statement had set out the 
correct number of burden hours, the 60-day Federal Register notice had 
inadvertently set out 192,113 hours. This should have been 206 hours. 
Form Number: CMS-10623 (OMB control number: 0938-New); Frequency: Once; 
Affected Public: Individuals and households; Number of Respondents: 
576; Total Annual Responses: 576; Total Annual Hours: 190. (For policy 
questions regarding this collection contact Kerry Lida at 410-786-
4826.)

     Dated: September 21, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-23157 Filed 9-23-16; 8:45 am]
 BILLING CODE 4120-01-P