81 FR 51916 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 151 (August 5, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 151 (August 5, 2016)
| Page Range | 51916-51917 | |
| FR Document | 2016-18662 |
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)] [Notices] [Pages 51916-51917] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18662] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10340 and CMS-10630] 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: 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 must be received by October 4, 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-10340 Collection of Encounter Data From: Medicare Advantage Organizations, Section 1876 Cost HMOS/CMPS, Section 1833 Health Care Prepayment Plans (HCPPS), and PACE Organizations CMS-10630 The PACE Organization (PO) Monitoring and Audit Process in 42 CFR part 460 Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Collection of Encounter Data From: Medicare Advantage Organizations, Section 1876 Cost HMOS/CMPS, Section 1833 Health Care Prepayment Plans (HCPPS), and PACE Organizations; Use: We collect encounter data or data on each item or service delivered to enrollees of Medicare Advantage (MA) plans offered by MA organizations. The MA organizations currently obtain this data from providers. We collect this information using standard transaction forms and code sets. We will use the data for determining risk adjustment factors for payment, updating the risk adjustment model, calculating Medicare DSH percentages, Medicare coverage purposes, and quality review and improvement activities. The data is also used to verify the accuracy and validity of the costs claimed on cost reports. For PACE organizations, encounter data would serve the same purpose it does related to the MA program and would be submitted in a similar manner. Form Number: CMS-10340 (OMB control number: 0938- 1152); Frequency: Weekly, bi-weekly, and monthly; Affected Public: Private sector (Business or other for-profits); Number of Respondents: 691; Total Annual Responses: 18,854,605; Total Annual Hours: 54,054. (For policy questions regarding this collection contact Michael Massimini at 410-786-1566.) [[Page 51917]] 2. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: The PACE Organization (PO) Monitoring and Audit Process in 42 CFR part 460; Use: Historically, the Programs of All-Inclusive Care for the Elderly (PACE) audit protocols have been included in the Medicare Advantage (MA) and Medicare Part D audit protocol's information collection request (CMS-10191, OMB 0938-1000). However, in examining previous submissions, we do not believe that including it with the MA and Part D audit protocols allowed for an accurate representation of the PACE burden. Due to PACE audits being substantially different from our MA and Part D audits, we have separated the PACE audit protocols from the MA and Part D protocols and created this information collection request which seeks OMB approval under a new control number. POs are required to comply with all PACE program requirements. The growth of these PACE organizations forced CMS to develop an audit strategy to ensure we continue to obtain meaningful audit results. As a result, CMS' audit strategy reflected a move to a more targeted, data- driven and outcomes-based audit approach. We focused on high-risk areas that have the greatest potential for participant harm. CMS has developed an audit protocol and will post it to the CMS Web site each year for use by POs to prepare for their audit. The data collected for audit is detailed in this protocol and the exact fields are located in the record layouts, at the end of the protocol. In addition, a questionnaire will be distributed as part of our audit. This questionnaire is also included in this package. Form Number: CMS- 10630 (OMB control number: 0938-New); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits and Not-for- profits institutions); Number of Respondents: 72; Total Annual Responses: 72; Total Annual Hours: 12,960. (For policy questions regarding this collection contact Caroline Zeman at 410-786-0116.) Dated: August 2, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-18662 Filed 8-4-16; 8:45 am] BILLING CODE 4120-01-P
![51916 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices
whether they are applying for a patient any of the following subjects: The Care Prepayment Plans (HCPPS), and
advocate position, for an at-large necessity and utility of the proposed PACE Organizations
standing position, or as an industry information collection for the proper CMS–10630 The PACE Organization
representative. Potential candidates will performance of the agency’s functions; (PO) Monitoring and Audit Process in
be asked to provide detailed information the accuracy of the estimated burden; 42 CFR part 460
concerning such matters as financial ways to enhance the quality, utility, and Under the PRA (44 U.S.C. 3501–
holdings, consultancies, and research clarity of the information to be 3520), federal agencies must obtain
grants or contracts in order to permit collected; and the use of automated approval from the Office of Management
evaluation of possible sources of collection techniques or other forms of and Budget (OMB) for each collection of
financial conflict of interest. Department information technology to minimize the information they conduct or sponsor.
policy prohibits multiple committee information collection burden. The term ‘‘collection of information’’ is
memberships. A federal advisory DATES: Comments must be received by defined in 44 U.S.C. 3502(3) and 5 CFR
committee member may not serve on October 4, 2016. 1320.3(c) and includes agency requests
more than one committee within an or requirements that members of the
ADDRESSES: When commenting, please
agency at the same time. public submit reports, keep records, or
Members are invited to serve for reference the document identifier or
OMB control number. To be assured provide information to a third party.
overlapping 2-year terms. A member Section 3506(c)(2)(A) of the PRA
may continue to serve after the consideration, comments and
recommendations must be submitted in requires federal agencies to publish a
expiration of the member’s term until a 60-day notice in the Federal Register
successor is named. Any interested any one of the following ways:
1. Electronically. You may send your concerning each proposed collection of
person may nominate one or more information, including each proposed
qualified persons. Self-nominations are comments electronically to http://
www.regulations.gov. Follow the extension or reinstatement of an existing
also accepted. Individuals interested in collection of information, before
the representative positions must instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’ submitting the collection to OMB for
include a letter of support from the approval. To comply with this
organization or interest group they to find the information collection
document(s) that are accepting requirement, CMS is publishing this
would represent. notice.
comments.
Dated: July 26, 2016. 2. By regular mail. You may mail
Kate Goodrich,
Information Collection
written comments to the following
Director, Center for Clinical Standards and address: CMS, Office of Strategic 1. Type of Information Collection
Quality, Centers for Medicare & Medicaid Operations and Regulatory Affairs, Request: Revision of a currently
Services. Division of Regulations Development, approved collection; Title of
[FR Doc. 2016–18545 Filed 8–4–16; 8:45 am] Attention: Document Identifier/OMB Information Collection: Collection of
BILLING CODE 4120–01–P Control Number ll, Room C4–26–05, Encounter Data From: Medicare
7500 Security Boulevard, Baltimore, Advantage Organizations, Section 1876
Maryland 21244–1850. Cost HMOS/CMPS, Section 1833 Health
DEPARTMENT OF HEALTH AND To obtain copies of a supporting Care Prepayment Plans (HCPPS), and
HUMAN SERVICES statement and any related forms for the PACE Organizations; Use: We collect
proposed collection(s) summarized in encounter data or data on each item or
Centers for Medicare & Medicaid service delivered to enrollees of
Services this notice, you may make your request
using one of following: Medicare Advantage (MA) plans offered
[Document Identifiers: CMS–10340 and 1. Access CMS’ Web site address at by MA organizations. The MA
CMS–10630] http://www.cms.hhs.gov/Paperwork organizations currently obtain this data
ReductionActof1995. from providers. We collect this
Agency Information Collection information using standard transaction
2. Email your request, including your
Activities: Proposed Collection; forms and code sets. We will use the
address, phone number, OMB number,
Comment Request data for determining risk adjustment
and CMS document identifier, to
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. factors for payment, updating the risk
Medicaid Services, HHS. 3. Call the Reports Clearance Office at adjustment model, calculating Medicare
ACTION: Notice. (410) 786–1326. DSH percentages, Medicare coverage
purposes, and quality review and
FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Centers for Medicare & improvement activities. The data is also
Reports Clearance Office at (410) 786–
Medicaid Services (CMS) is announcing used to verify the accuracy and validity
1326.
an opportunity for the public to of the costs claimed on cost reports. For
comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION: PACE organizations, encounter data
information from the public. Under the Contents would serve the same purpose it does
Paperwork Reduction Act of 1995 (the related to the MA program and would
PRA), federal agencies are required to This notice sets out a summary of the be submitted in a similar manner. Form
publish notice in the Federal Register use and burden associated with the Number: CMS–10340 (OMB control
concerning each proposed collection of following information collections. More number: 0938–1152); Frequency:
information (including each proposed detailed information can be found in Weekly, bi-weekly, and monthly;
mstockstill on DSK3G9T082PROD with NOTICES
extension or reinstatement of an existing each collection’s supporting statement Affected Public: Private sector (Business
collection of information) and to allow and associated materials (see or other for-profits); Number of
60 days for public comment on the ADDRESSES). Respondents: 691; Total Annual
proposed action. Interested persons are CMS–10340 Collection of Encounter Responses: 18,854,605; Total Annual
invited to send comments regarding our Data From: Medicare Advantage Hours: 54,054. (For policy questions
burden estimates or any other aspect of Organizations, Section 1876 Cost regarding this collection contact
this collection of information, including HMOS/CMPS, Section 1833 Health Michael Massimini at 410–786–1566.)
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![Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 51917
2. Type of Information Collection DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
Request: New collection (Request for a HUMAN SERVICES Agenda: On September 7, 2016, the
new OMB control number); Title of committee will meet by teleconference.
Information Collection: The PACE Food and Drug Administration In open session, the committee will hear
Organization (PO) Monitoring and Audit updates of research programs in the
[Docket No. FDA–2016–N–0001]
Process in 42 CFR part 460; Use: Gene Transfer and Immunogenicity
Historically, the Programs of All- Cellular, Tissue, and Gene Therapies Branch, Division of Cellular and Gene
Inclusive Care for the Elderly (PACE) Advisory Committee; Notice of Meeting Therapies, Office of Cellular, Tissue,
and Gene Therapies, Center for
audit protocols have been included in AGENCY: Food and Drug Administration, Biologics Evaluation and Research.
the Medicare Advantage (MA) and HHS. FDA intends to make background
Medicare Part D audit protocol’s ACTION: Notice. material available to the public no later
information collection request (CMS– than 2 business days before the meeting.
10191, OMB 0938–1000). However, in SUMMARY: The Food and Drug If FDA is unable to post the background
examining previous submissions, we do Administration (FDA) announces a material on its Web site prior to the
not believe that including it with the forthcoming public advisory committee meeting, the background material will
MA and Part D audit protocols allowed meeting of the Cellular, Tissue, and be made publicly available at the
for an accurate representation of the Gene Therapies Advisory Committee. location of the advisory committee
PACE burden. Due to PACE audits being The general function of the committee is meeting, and the background material
substantially different from our MA and to provide advice and recommendations will be posted on FDA’s Web site after
Part D audits, we have separated the to the Agency on FDA’s regulatory the meeting. Background material is
PACE audit protocols from the MA and issues. At least one portion of the available at http://www.fda.gov/
Part D protocols and created this meeting will be closed to the public. AdvisoryCommittees/Calendar/
information collection request which DATES: The meeting will be held on default.htm. Scroll down to the
seeks OMB approval under a new September 7, 2016, from 1 p.m. to 4 appropriate advisory committee meeting
control number. p.m. link.
Procedure: On September 7, 2016,
POs are required to comply with all ADDRESSES: FDA White Oak Campus,
from 1 p.m. to 2:20 p.m., the meeting is
PACE program requirements. The 10903 New Hampshire Ave., Bldg. 31
open to the public. Interested persons
growth of these PACE organizations Conference Center, the Great Room (Rm.
may present data, information, or views,
forced CMS to develop an audit strategy 1503), Silver Spring, MD 20993–0002. orally or in writing, on issues pending
to ensure we continue to obtain Answers to commonly asked questions before the committee. Written
meaningful audit results. As a result, including information regarding special submissions may be made to the contact
accommodations due to a disability, person on or before August 23, 2016.
CMS’ audit strategy reflected a move to
visitor parking, and transportation may Oral presentations from the public will
a more targeted, data-driven and
be accessed at: http://www.fda.gov/ be scheduled between approximately
outcomes-based audit approach. We AdvisoryCommittees/AboutAdvisory
focused on high-risk areas that have the 2:20 p.m. to 3:20 p.m. Those individuals
Committees/ucm408555.htm. interested in making formal oral
greatest potential for participant harm.
FOR FURTHER INFORMATION CONTACT: presentations should notify the contact
CMS has developed an audit protocol Janie Kim or Denise Royster, Center for person and submit a brief statement of
and will post it to the CMS Web site Biologics Evaluation and Research, the general nature of the evidence or
each year for use by POs to prepare for Food and Drug Administration, 10903 arguments they wish to present, the
their audit. The data collected for audit New Hampshire Ave., Bldg. 71, Silver names and addresses of proposed
is detailed in this protocol and the exact Spring, MD 20993–0002, 301–796–9016 participants, and an indication of the
fields are located in the record layouts, or 240–402–8158, Janie.kim@ approximate time requested to make
at the end of the protocol. In addition, fda.hhs.gov or Denise.royster@ their presentation on or before August
a questionnaire will be distributed as fda.hhs.gov; or FDA Advisory 15, 2016. Time allotted for each
part of our audit. This questionnaire is Committee Information Line, 1–800– presentation may be limited. If the
also included in this package. Form 741–8138 (301–443–0572 in the number of registrants requesting to
Number: CMS–10630 (OMB control Washington, DC area). A notice in the speak is greater than can be reasonably
number: 0938–New); Frequency: Yearly; Federal Register about last minute accommodated during the scheduled
Affected Public: Private sector (Business modifications that impact a previously open public hearing session, FDA may
or other for-profits and Not-for-profits announced advisory committee meeting conduct a lottery to determine the
institutions); Number of Respondents: cannot always be published quickly speakers for the scheduled open public
72; Total Annual Responses: 72; Total enough to provide timely notice. hearing session. The contact person will
Annual Hours: 12,960. (For policy Therefore, you should always check the notify interested persons regarding their
Agency’s Web site at http:// request to speak by August 16, 2016.
questions regarding this collection
www.fda.gov/AdvisoryCommittees/ Closed Committee Deliberations: On
contact Caroline Zeman at 410–786–
default.htm and scroll down to the September 7, 2016, from 3:20 p.m. to 4
0116.) appropriate advisory committee meeting p.m., the meeting will be closed to
Dated: August 2, 2016. link, or call the advisory committee permit discussion where disclosure
information line to learn about possible would constitute a clearly unwarranted
mstockstill on DSK3G9T082PROD with NOTICES
William N. Parham, III,
Director, Paperwork Reduction Staff, Office modifications before coming to the invasion of personal privacy (5 U.S.C.
of Strategic Operations and Regulatory meeting. For those unable to attend in 552b(c)(6)). The committee will discuss
Affairs. person, the meeting will also be reports of intramural research programs
[FR Doc. 2016–18662 Filed 8–4–16; 8:45 am] available via Webcast. The Webcast will and make recommendations regarding
be available at the following link: personnel staffing decisions.
BILLING CODE 4120–01–P
https://collaboration.fda.gov/ Persons attending FDA’s advisory
ctgtac0916/. committee meetings are advised that the
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Document Created: 2016-08-05 06:43:34
Document Modified: 2016-08-05 06:43:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by October 4, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 51916 |
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