81 FR 11569 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 43 (March 4, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11569-11571 | |
| FR Document | 2016-04841 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Notices] [Pages 11569-11571] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04841] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10110, CMS-10387, CMS-10400 and CMS-10593] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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 (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. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by April 4, 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. [[Page 11570]] 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: Reinstatement of a previously approved collection; Title of Information Collection: Skilled Nursing Facility (SNF) Prospective Payment System and Consolidated Billing; Use: We are requesting approval of a reinstatement of a Change of Therapy OMRA for Skilled Nursing Facilities (SNFs). As described in CMS-1351-F, we finalized the assessment effective October 1, 2011. The SNFs are required to submit this assessment. The COT OMRA is comprised of a subset of resident assessment information developed for use by SNFs to satisfy a Medicare payment requirement. The burden associated with this is the SNF staff time required to complete the COT OMRA, SNF staff time to encode the data, and SNF staff time spent in transmitting the data. The SNFs are required to complete a COT OMRA when a SNF resident was receiving a sufficient level of rehabilitation therapy to qualify for an Ultra High, Very High, High, Medium, or Low Rehabilitation category and when the intensity of therapy (as indicated by the total reimbursable therapy minutes (RTM) delivered, and other therapy qualifiers such as number of therapy days and disciplines providing therapy) changes to such a degree that it would no longer reflect the RUG-IV classification and payment assigned for a given SNF resident based on the most recent assessment used for Medicare payment. The COT OMRA is a type of required PPS assessment which uses the same item set as the End of Therapy (EOT) OMRA. Form Number: CMS-10387 (OMB Control Number: 0938- 1140); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 15,421; Total Annual Responses: 678,524; Total Annual Hours: 701,119. (For policy questions regarding this collection contact Penny Gershman at 410-786-6643). 2. Type of Information Collection Request: Reinstatement of a previously approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Use: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price (ASP) of the drug or biological, beginning in Calendar Year (CY) 2005. The ASP data reporting requirements are specified in Section 1927 of the Act. The reported ASP data are used to establish the Medicare payment amounts. The reporting template was revised in CY 2011 in order to facilitate accurate collection of ASP data. An accompanying user guide with instructions on the template's use was also created and included an explanation of the data elements in the template. Form Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency: Quarterly; Affected Public: Private sector (Business or other For-profits); Number of Respondents: 180; Total Annual Responses: 720; Total Annual Hours: 34,560. (For policy questions regarding this collection contact Amy Gruber at 410-786- 1542). 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Establishment of Exchanges and Qualified Health Plans; Use: The Patient Protection and Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 (collectively, ``Affordable Care Act''), expand access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Insurance Exchanges (Exchanges), including the Small Business Health Options Program (SHOP). As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange will assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and non-discrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR parts 155 and 156, based on the Affordable Care Act, as well as other standards determined by the Exchange. The reporting requirements and data collection in the Exchange rule address Federal requirements that various entities must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a State based or Federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. This proposed information collection was published in the Federal Register on November 23, 2015 (80 FR 72968). No comments were received. Form Number: CMS-10400; Frequency: Monthly, Annual; Affected Public: Private Sector; Number of Respondents: 11,004; Number of Responses: 11,485; Total Annual Hours: 55,775. (For policy questions regarding this collection, contact Leigha Basini at 301-492-4380.) 4. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Establishment of an Exchange by a State and Qualified Health Plans; Use: The Patient Protection and Affordable Care Act, Public Law 111- 148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 (collectively, ``Affordable Care Act''), expand access to health insurance for individuals and employees of small businesses through the establishment of new Affordable Insurance Exchanges (Exchanges), including the Small Business Health Options Program (SHOP). As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange will assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans [[Page 11571]] certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and non-discrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR parts 155 and 156, based on the Affordable Care Act, as well as other standards determined by the Exchange. The reporting requirements and data collection in the Exchange rule address Federal requirements that various entities must meet with respect to the establishment and operation of an Exchange; minimum requirements that health insurance issuers must meet with respect to participation in a State based or Federally-facilitated Exchange; and requirements that employers must meet with respect to participation in the SHOP and compliance with other provisions of the Affordable Care Act. Comments have been received, however; there were no comments that impacted the burden, and therefore no additional changes were made. Form Number: CMS-10593 (OMB Control Number: 0938-NEW); Frequency: Annually, Monthly; Affected Public: Private Sector; Business or other for-profit; Number of Respondents: 20; Total Annual Responses: 400; Total Annual Hours: 36,900. (For policy questions regarding this collection contact Christy Woods at 301-492-5140.) Dated: March 1, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-04841 Filed 3-3-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11569
and guidance for programs addressing However, awardees will also have the Services (HHS), the White House,
IVP have been provided through opportunity to compete to be funded for Congress, and other sources.
cooperative agreement funding and one or both of the Enhanced Information to be collected will also
technical assistance administered by components. It is expected that those strengthen CDC’s ability to monitor
NCIPC. Awardees report progress and funded for Enhanced components will awardee progress, provide data-driven
activity information to NCIPC on an have a greater burden, given the technical assistance, and disseminate
annual schedule using three documents: requirement to report on more domains the most current surveillance data on
Annual Progress Report, Evaluation and of activity. unintentional and intentional injuries.
Information to be collected will
Performance Management Plan, and The total estimated annualized
provide crucial data for program
Injury Indicator Spreadsheet. Burden is burden for this collection is 3,120 hours.
performance monitoring and provide
expected to vary based on awardee CDC with the capacity to respond in a OMB approval is requested for three
funding type. For example all awardees timely manner to requests for years. The only cost to respondents will
who successfully compete will be information about the program from the be time spent on responding to the
funded for the BASE component. Department of Health and Human progress reports.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Core SVIPP BASE Awardees ......................... Initial Population—Annual Progress Report .. 20 1 22
Annual Progress Report ................................. 20 1 11
Evaluation and Performance Management 20 1 2
Plan.
Injury Indicator Spreadsheet .......................... 20 1 14
Core SVIPP 1—Enhanced Component Initial Population—Annual Progress Report .. 5 1 73
Awardees.
Annual Progress Report ................................. 5 1 58
Evaluation and Performance Management 5 1 3
Plan.
Injury Indicator Spreadsheet .......................... 5 1 14
Core SVIPP 2—Enhanced Component Initial Population—Annual Progress Report .. 5 1 146
Awardees.
Annual Progress Report ................................. 5 1 116
Evaluation and Performance Management 5 1 4
Plan.
Injury Indicator Spreadsheet .......................... 5 1 14
Leroy A. Richardson, (PRA), federal agencies are required to please reference the document identifier
Chief, Information Collection Review Office, publish notice in the Federal Register or OMB control number. To be assured
Office of Scientific Integrity, Office of the concerning each proposed collection of consideration, comments and
Associate Director for Science, Office of the information, including each proposed recommendations must be received by
Director, Centers for Disease Control and extension or reinstatement of an existing the OMB desk officer via one of the
Prevention.
collection of information, and to allow following transmissions: OMB, Office of
[FR Doc. 2016–04796 Filed 3–3–16; 8:45 am] a second opportunity for public Information and Regulatory Affairs,
BILLING CODE 4163–18–P comment on the notice. Interested Attention: CMS Desk Officer, Fax
persons are invited to send comments Number: (202) 395–5806 or Email:
regarding the burden estimate or any OIRA_submission@omb.eop.gov.
DEPARTMENT OF HEALTH AND other aspect of this collection of
HUMAN SERVICES To obtain copies of a supporting
information, including any of the statement and any related forms for the
Centers for Medicare & Medicaid following subjects: (1) The necessity and proposed collection(s) summarized in
Services utility of the proposed information this notice, you may make your request
collection for the proper performance of using one of following:
[Document Identifiers: CMS–10110, CMS– the agency’s functions; (2) the accuracy
10387, CMS–10400 and CMS–10593] of the estimated burden; (3) ways to 1. Access CMS’ Web site address at
enhance the quality, utility, and clarity http://www.cms.hhs.gov/
Agency Information Collection PaperworkReductionActof1995.
of the information to be collected; and
Activities: Submission for OMB
(4) the use of automated collection 2. Email your request, including your
Review; Comment Request
techniques or other forms of information address, phone number, OMB number,
jstallworth on DSK7TPTVN1PROD with NOTICES
ACTION: Notice. technology to minimize the information and CMS document identifier, to
collection burden. Paperwork@cms.hhs.gov.
SUMMARY: The Centers for Medicare &
DATES:Comments on the collection(s) of 3. Call the Reports Clearance Office at
Medicaid Services (CMS) is announcing
information must be received by the (410) 786–1326.
an opportunity for the public to
comment on CMS’ intention to collect OMB desk officer by April 4, 2016. FOR FURTHER INFORMATION CONTACT:
information from the public. Under the ADDRESSES: When commenting on the Reports Clearance Office at (410) 786–
Paperwork Reduction Act of 1995 proposed information collections, 1326.
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![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Notices 11571
certified as QHPs by the Exchange. A PRA), federal agencies are require; to Contents
QHP must meet certain minimum publish notice in the Federal Register This notice sets out a summary of the
certification standards, such as network concerning each proposed collection of use and burden associated with the
adequacy, inclusion of Essential information (including each proposed following information collections. More
Community Providers (ECPs), and non- extension or reinstatement of an existing detailed information can be found in
discrimination. The Exchange is collection of information) and to allow each collection’s supporting statement
responsible for ensuring that QHPs meet 60 days for public comment on the and associated materials (see
these minimum certification standards proposed action. Interested persons are ADDRESSES).
as described in the Exchange rule under invited to send comments regarding our
45 CFR parts 155 and 156, based on the burden estimates or any other aspect of CMS–10152 Data Collection for
Affordable Care Act, as well as other this collection of information, including Medicare Beneficiaries Receiving NaF–
standards determined by the Exchange. any of the following subjects: (1) The 18 Positron Emission Tomography
The reporting requirements and data necessity and utility of the proposed (PET) To Identify Bone Metastasis in
collection in the Exchange rule address information collection for the proper Cancer
Federal requirements that various performance of the agency’s functions; Under the PRA (44 U.S.C. 3501–
entities must meet with respect to the (2) the accuracy of the estimated 3520), federal agencies must obtain
establishment and operation of an burden; (3) ways to enhance the quality, approval from the Office of Management
Exchange; minimum requirements that utility, and clarity of the information to and Budget (OMB) for each collection of
health insurance issuers must meet with be collected; and (4) the use of information they conduct or sponsor.
respect to participation in a State based automated collection techniques or The term ‘‘collection of information’’ is
or Federally-facilitated Exchange; and other forms of information technology to defined in 44 U.S.C. 3502(3) and 5 CFR
requirements that employers must meet minimize the information collection 1320.3(c) and includes agency requests
with respect to participation in the burden. or requirements that members of the
SHOP and compliance with other
DATES: Comments must be received by public submit reports, keep records, or
provisions of the Affordable Care Act.
May 3, 2016. provide information to a third party.
Comments have been received,
Section 3506(c)(2)(A) of the PRA
however; there were no comments that ADDRESSES: When commenting, please
requires federal agencies to publish a
impacted the burden, and therefore no reference the document identifier or 60-day notice in the Federal Register
additional changes were made. Form OMB control number. To be assured concerning each proposed collection of
Number: CMS–10593 (OMB Control consideration, comments and information, including each proposed
Number: 0938–NEW); Frequency: recommendations must be submitted in extension or reinstatement of an existing
Annually, Monthly; Affected Public: any one of the following ways: collection of information, before
Private Sector; Business or other for- 1. Electronically. You may send your submitting the collection to OMB for
profit; Number of Respondents: 20; comments electronically to http:// approval. To comply with this
Total Annual Responses: 400; Total www.regulations.gov. Follow the requirement, CMS is publishing this
Annual Hours: 36,900. (For policy instructions for ‘‘Comment or notice.
questions regarding this collection Submission’’ or ‘‘More Search Options’’ 1. Type of Information Collection
contact Christy Woods at 301–492– to find the information collection Request: Extension of a previously
5140.) document(s) that are accepting approved collection; Title: Data
Dated: March 1, 2016. comments. Collection for Medicare Beneficiaries
William N. Parham, III, 2. By regular mail. You may mail Receiving NaF–18 Positron Emission
Director, Paperwork Reduction Staff, Office written comments to the following Tomography (PET) to Identify Bone
of Strategic Operations and Regulatory address: CMS, Office of Strategic Metastasis in Cancer; Use: In Decision
Affairs. Operations and Regulatory Affairs, Memorandum #CAG–00065R, issued on
[FR Doc. 2016–04841 Filed 3–3–16; 8:45 am] Division of Regulations Development, February 26, 2010, the Centers for
BILLING CODE 4120–01–P Attention: Document Identifier/OMB Medicare and Medicaid Services (CMS)
Control Number _________, Room C4– determined that the evidence is
26–05, 7500 Security Boulevard, sufficient to conclude that for Medicare
DEPARTMENT OF HEALTH AND Baltimore, Maryland 21244–1850. beneficiaries receiving NaF–18 PET scan
HUMAN SERVICES To obtain copies of a supporting to identify bone metastasis in cancer is
statement and any related forms for the reasonable and necessary only when the
Centers for Medicare & Medicaid proposed collection(s) summarized in provider is participating in and patients
Services this notice, you may make your request are enrolled in a clinical study designed
[Document Identifier: CMS–10152] using one of following: to information at the time of the scan to
1. Access CMS’ Web site address at assist in initial antitumor treatment
Agency Information Collection http://www.cms.hhs.gov/ planning or to guide subsequent
Activities: Proposed Collection; PaperworkReductionActof1995. treatment strategy by the identification,
Comment Request 2. Email your request, including your location and quantification of bone
AGENCY: Centers for Medicare & address, phone number, OMB number, metastases in beneficiaries in whom
Medicaid Services, HHS. and CMS document identifier, to bone metastases are strongly suspected
based on clinical symptoms or the
jstallworth on DSK7TPTVN1PROD with NOTICES
ACTION: Notice. Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at results of other diagnostic studies.
SUMMARY: The Centers for Medicare & (410) 786–1326. Qualifying clinical studies must ensure
Medicaid Services (CMS) is announcing that specific hypotheses are addressed;
FOR FURTHER INFORMATION CONTACT:
an opportunity for the public to appropriate data elements are collected;
Reports Clearance Office at (410) 786–
comment on CMS’ intention to collect hospitals and providers are qualified to
1326.
information from the public. Under the provide the PET scan and interpret the
Paperwork Reduction Act of 1995 (the SUPPLEMENTARY INFORMATION: results; participating hospitals and
VerDate Sep<11>2014 15:22 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1](https://thefederalregister.org/doc/81_FR_11612/page/3.svg)
Document Created: 2018-02-02 15:05:51
Document Modified: 2018-02-02 15:05:51
| 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 on the collection(s) of information must be received by the OMB desk officer by April 4, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 11569 |
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