[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Notices]
[Pages 62741-62742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-588, CMS-10146, CMS-10185, CMS-10261, and 
CMS-10631]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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: The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; the accuracy of the 
estimated burden; ways to enhance the quality, utility, and clarity of 
the information to be collected; and the use of automated collection 
techniques or other forms of information technology to minimize the 
information collection burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by October 12, 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: 
[email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Electronic Funds 
Transfer Authorization Agreement; Use: The information is needed to 
allow providers to receive funds electronically in their bank accounts. 
Form Number: CMS-588 (OMB control number: 0938-0626); Frequency: On 
occasion; Affected Public: Business or other for-profit, Not-for-profit 
institutions; Number of Respondents: 45,807; Total Annual Responses: 
45,807; Total Annual Hours: 22,906. (For policy questions regarding 
this collection contact Kimberly McPhillips at 410-786-4645.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare Part D 
Reporting Requirements and Supporting Regulations; Use: Data collected 
via Medicare Part D Reporting Requirements will be an integral resource 
for oversight, monitoring, compliance and auditing activities necessary 
to ensure quality provision of the Medicare Prescription Drug Benefit 
to beneficiaries. For all reporting sections, data are reported 
electronically to CMS. Each reporting section is reported at one of the 
following levels: Contract (data should be entered at the H#, S#, R#, 
or E# level) or Plan (data

[[Page 62742]]

should be entered at the Plan Benefit Package (PBP level, e.g. Plan 001 
for contract H#, R#, S#, or E). Sponsors should retain documentation 
and data records related to their data submissions. Data will be 
validated, analyzed, and utilized for trend reporting by the Division 
of Clinical and Operational Performance (DCOP) within the Medicare Drug 
Benefit and C&D Data Group. If outliers or other data anomalies are 
detected, DCOP will work in collaboration with other Divisions within 
CMS for follow-up and resolution. For CY2017 Reporting Requirements, 
the following 7 reporting sections will be reported and collected at 
the Contract-level or Plan-level: Enrollment and Disenrollment, Retail, 
Home Infusion, and Long-Term Care Pharmacy Access, Medication Therapy 
Management (MTM) Programs, Grievances, Improving Drug Utilization 
Review Controls, Coverage Determinations and Redeterminations, and 
Employer/Union Sponsored Sponsors. Form Number: CMS-10185 (OMB control 
number: 0938-0992); Frequency: Annually and semi-annually; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 561; Total Annual Responses: 11,438; Total Annual Hours: 
14,750. (For policy questions regarding this collection contact 
Chanelle Jones at 410-786-8008.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage Reporting Requirements and Supporting Regulations in 42 CFR 
422.516(a); Use: Medicare Advantage Organizations (MAOs) must have an 
effective procedure to develop, compile, evaluate, and report to CMS, 
to its enrollees, and to the general public, at the times and in the 
manner that CMS requires, and while safeguarding the confidentiality of 
the doctor-patient relationship, statistics and other information with 
respect to: The cost of its operations; the patterns of service 
utilization; the availability, accessibility, and acceptability of its 
services; to the extent practical, developments in the health status of 
its enrollees; information demonstrating that the MAO has a fiscally 
sound operation; and other matters that CMS may require. CMS also has 
oversight authority over cost plans which includes establishment of 
reporting requirements. This revision would add five new data elements 
to the reporting section: Organization Determinations and 
Reconsiderations. These new data elements are needed to obtain more 
information about case reopenings. The revision would also suspend the 
Sponsor Oversight of Agents reporting section beginning 2017 so that 
the reporting section can be reassessed based on burden and usage. Form 
Number: CMS-10261 (OMB control number: 0938-1054); Frequency: Yearly 
and Semi-annually; Affected Public: Private sector (Business or other 
For-profits); Number of Respondents: 544; Total Annual Responses: 
3,508; Total Annual Hours: 160,215. (For policy questions regarding 
this collection contact Terry Lied at 410-786-8973.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Notice of Denial 
of Medicare Prescription Drug Coverage; Use: The notice provides 
information to enrollees when prescription drug coverage has been 
denied, in whole or in part, by their Part D plans. The notice must be 
readable, understandable, and state the specific reasons for the 
denial. The notice must also remind enrollees about their rights and 
protections related to requests for prescription drug coverage and 
include an explanation of both the standard and expedited 
redetermination processes and the rest of the appeal process. Form 
Number: CMS-10146 (OMB control number: 0938-0976); Frequency: 
Occasionally; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 580; Total Annual Responses: 
1,902,055; Total Annual Hours: 475,514. (For policy questions regarding 
this collection contact Amber Casserly at 410-786-0976.)
    5. Type of Information Collection Request: New collection (request 
for a new OMB control number); Title of Information Collection: The 
PACE Organization Application Process in 42 CFR part 460; Use: In 
general, Programs of All-Inclusive Care for the Elderly (PACE) services 
are provided through a PACE Organization (PO). An entity wishing to 
become a PO must submit an application to CMS that describes how the 
entity meets all the requirements in the PACE program. An entity's 
application must be accompanied by an assurance from the State 
Administering Agency (SAA) of the State in which the PO is going to be 
located.
    Initial application requirements for the PACE program are currently 
set forth in 42 CFR 460.12 and in the PACE Manual, Ch. 17. Until 
recently, the submission of initial and service area expansion (SAE) 
PACE applications and supporting information was in paper format. These 
applications are often hundreds of pages long, expensive to reproduce 
and transmit, and administratively inefficient, as staff reviewing 
different parts of the application are located in different physical 
locations and must receive hard copies of the material. However, 
beginning in 2016, initial PACE applications are being submitted via a 
new automated, electronic submission process. As with initial 
applications, an application also must be submitted for a PO that seeks 
to expand its service area and/or add a new service site, and with OMB 
approval, an automated application process will now also be required of 
PACE organizations submitting service area expansion applications.
    While this collection is being submitted to OMB as a ``New'' 
package, the collection is not new. The collection is currently 
approved by OMB under control number 0938-0790 (CMS-R-244). Based on 
internal review we intend to remove the application from that package 
but, before doing so, we need approval of the application under a new 
OMB control number. This will avoid lapses in OMB's approval along with 
any violations of the PRA.
    As is, the currently approved CMS-R-244 package is lengthy and 
somewhat time consuming to review. We believe the change will help 
streamline the public and OMB's review of the application as well as 
the remaining requirements and burden under CMS-R-244. The 60-day 
notice published in the Federal Register on December 8, 2015 (80 FR 
76193). The 30-day notice published on May 2, 2016 (81 FR 26234). Both 
published under CMS-R-244. We are republishing the 30-day notice under 
the new CMS ID number (CMS-10631) and the tentative OMB control number 
(0938-New). Otherwise, all changes are nonsubstantive.
    Form Number: CMS-10631 (OMB control number: 0938-New); Frequency: 
Once and occasionally; Affected Public: Private sector (Business or 
other for-profits and Not-for-profit institutions) and State, Local, or 
Tribal Governments; Number of Respondents: 730; Total Annual Responses: 
84; Total Annual Hours: 4,576. (For policy questions regarding this 
collection contact Debbie Vanhoven at 410-786-6625.)

    Dated: September 7, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-21873 Filed 9-9-16; 8:45 am]
BILLING CODE 4120-01-P