80 FR 59781 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 191 (October 2, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 191 (October 2, 2015)
| Page Range | 59781-59782 | |
| FR Document | 2015-25109 |
[Federal Register Volume 80, Number 191 (Friday, October 2, 2015)] [Notices] [Pages 59781-59782] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25109] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10110 and CMS-10387] 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 [[Page 59782]] 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 November 2, 2015. 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_submission@omb.eop.gov. 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 Paperwork@cms.hhs.gov. 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: 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). Dated: September 29, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-25109 Filed 10-1-15; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices 59781
DEPARTMENT OF HEALTH AND To obtain copies of a supporting sound organizations and thereby remain
HUMAN SERVICES statement and any related forms for the a going concern. All contracting
proposed collection(s) summarized in organizations must submit annual
Centers for Medicare & Medicaid this notice, you may make your request independently audited financial
Services using one of following: statements one time per year. The
[Document Identifiers: CMS–906] 1. Access CMS’ Web site address at MAOs with a negative net worth and/or
http://www.cms.hhs.gov/ a net loss and the amount of that loss
Agency Information Collection PaperworkReductionActof1995. is greater than one-half of the
Activities: Proposed Collection; 2. Email your request, including your organization’s total net worth must file
Comment Request address, phone number, OMB number, three quarterly financial statements.
and CMS document identifier, to Currently, there are approximately 71
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. MAOs filing quarterly financial
Medicaid Services. 3. Call the Reports Clearance Office at statements. Part D organizations must
ACTION: Notice. (410) 786–1326. also 3 quarterly financial statements.
FOR FURTHER INFORMATION CONTACT: The PACE organizations are required to
SUMMARY: The Centers for Medicare &
Reports Clearance Office at (410) 786– file 4 quarterly financial statements for
Medicaid Services (CMS) is announcing
1326. the first three years in the program as
an opportunity for the public to
well as PACE organizations with a
comment on CMS’ intention to collect SUPPLEMENTARY INFORMATION: negative net worth and/or a net loss and
information from the public. Under the
Contents the amount of that loss is greater than
Paperwork Reduction Act of 1995 (the
one-half of the organization’s total net
PRA), federal agencies are required to This notice sets out a summary of the worth. Form Number: CMS–906 (OMB
publish notice in the Federal Register use and burden associated with the control number: 0938–0469); Frequency:
concerning each proposed collection of following information collections. More Annually; Affected Public: Business or
information (including each proposed detailed information can be found in other for-profits; Number of
extension or reinstatement of an existing each collection’s supporting statement Respondents: 815; Total Annual
collection of information) and to allow and associated materials (see Responses: 1,518; Total Annual Hours:
60 days for public comment on the ADDRESSES). 506. (For policy questions regarding this
proposed action. Interested persons are
invited to send comments regarding our CMS–906 The Fiscal Soundness collection contact Geralyn Glenn at
burden estimates or any other aspect of Reporting Requirements 410–786–0973.)
this collection of information, including Under the PRA (44 U.S.C. 3501– Dated: September 29, 2015.
any of the following subjects: (1) The 3520), federal agencies must obtain William N. Parham, III,
necessity and utility of the proposed approval from the Office of Management Director, Paperwork Reduction Staff, Office
information collection for the proper and Budget (OMB) for each collection of of Strategic Operations and Regulatory
performance of the agency’s functions; information they conduct or sponsor. Affairs.
(2) the accuracy of the estimated The term ‘‘collection of information’’ is [FR Doc. 2015–25108 Filed 10–1–15; 8:45 am]
burden; (3) ways to enhance the quality, defined in 44 U.S.C. 3502(3) and 5 CFR BILLING CODE 4120–01–P
utility, and clarity of the information to 1320.3(c) and includes agency requests
be collected; and (4) the use of or requirements that members of the
automated collection techniques or public submit reports, keep records, or DEPARTMENT OF HEALTH AND
other forms of information technology to provide information to a third party. HUMAN SERVICES
minimize the information collection Section 3506(c)(2)(A) of the PRA
burden. Centers for Medicare & Medicaid
requires federal agencies to publish a Services
DATES: Comments must be received by 60-day notice in the Federal Register
December 1, 2015. concerning each proposed collection of [Document Identifiers: CMS–10110 and
ADDRESSES: When commenting, please information, including each proposed CMS–10387]
reference the document identifier or extension or reinstatement of an existing
Agency Information Collection
OMB control number. To be assured collection of information, before
Activities: Submission for OMB
consideration, comments and submitting the collection to OMB for
Review; Comment Request
recommendations must be submitted in approval. To comply with this
any one of the following ways: requirement, CMS is publishing this ACTION: Notice.
1. Electronically. You may send your notice.
comments electronically to http:// SUMMARY: The Centers for Medicare &
Information Collection Medicaid Services (CMS) is announcing
www.regulations.gov. Follow the
instructions for ‘‘Comment or 1. Type of Information Collection an opportunity for the public to
Submission’’ or ‘‘More Search Options’’ Request: Extension of a currently comment on CMS’ intention to collect
to find the information collection approved collection; Title of information from the public. Under the
document(s) that are accepting Information Collection: The Fiscal Paperwork Reduction Act of 1995
comments. Soundness Reporting Requirements; (PRA), federal agencies are required to
2. By regular mail. You may mail Use: The CMS is assigned responsibility publish notice in the Federal Register
mstockstill on DSK4VPTVN1PROD with NOTICES
written comments to the following for overseeing all Medicare Advantage concerning each proposed collection of
address: CMS, Office of Strategic Organizations (MAOs), Prescription information, including each proposed
Operations and Regulatory Affairs, Drug Plan (PDP) sponsors and PACE extension or reinstatement of an existing
Division of Regulations Development, organizations on-going financial collection of information, and to allow
Attention: Document Identifier/OMB performance. Specifically, CMS needs a second opportunity for public
Control Number lll, Room C4–26– the requested collection of information comment on the notice. Interested
05, 7500 Security Boulevard, Baltimore, to establish that contracting entities persons are invited to send comments
Maryland 21244–1850. within those programs maintain fiscally regarding the burden estimate or any
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![59782 Federal Register / Vol. 80, No. 191 / Friday, October 2, 2015 / Notices
other aspect of this collection of comply with this requirement, CMS is Calendar Year (CY) 2005. The ASP data
information, including any of the publishing this notice that summarizes reporting requirements are specified in
following subjects: The necessity and the following proposed collection(s) of Section 1927 of the Act. The reported
utility of the proposed information information for public comment: ASP data are used to establish the
collection for the proper performance of 1. Type of Information Collection Medicare payment amounts. The
the agency’s functions; the accuracy of Request: Reinstatement of a previously reporting template was revised in CY
the estimated burden; ways to enhance approved collection; Title of 2011 in order to facilitate accurate
the quality, utility, and clarity of the Information Collection: Skilled Nursing collection of ASP data. An
information to be collected; and the use Facility (SNF) Prospective Payment accompanying user guide with
of automated collection techniques or System and Consolidated Billing; Use: instructions on the template’s use was
other forms of information technology to We are requesting approval of a also created and included an
minimize the information collection reinstatement of a Change of Therapy explanation of the data elements in the
burden. OMRA for Skilled Nursing Facilities template. Form Number: CMS–10110
(SNFs). As described in CMS–1351–F, (OMB Control Number: 0938–0921);
DATES: Comments on the collection(s) of we finalized the assessment effective
information must be received by the Frequency: Quarterly; Affected Public:
October 1, 2011. The SNFs are required Private sector (Business or other For-
OMB desk officer by November 2, 2015. to submit this assessment. The COT profits); Number of Respondents: 180;
ADDRESSES: When commenting on the OMRA is comprised of a subset of Total Annual Responses: 720; Total
proposed information collections, resident assessment information Annual Hours: 34,560. (For policy
please reference the document identifier developed for use by SNFs to satisfy a questions regarding this collection
or OMB control number. To be assured Medicare payment requirement. The contact Amy Gruber at 410–786–1542).
consideration, comments and burden associated with this is the SNF
recommendations must be received by Dated: September 29, 2015.
staff time required to complete the COT
the OMB desk officer via one of the OMRA, SNF staff time to encode the William N. Parham, III,
following transmissions: data, and SNF staff time spent in Director, Paperwork Reduction Staff, Office
OMB, Office of Information and transmitting the data. The SNFs are of Strategic Operations and Regulatory
Regulatory Affairs, Attention: CMS Desk required to complete a COT OMRA Affairs.
Officer, Fax Number: (202) 395–5806 or when a SNF resident was receiving a [FR Doc. 2015–25109 Filed 10–1–15; 8:45 am]
Email: OIRA_submission@omb.eop.gov. sufficient level of rehabilitation therapy BILLING CODE 4120–01–P
To obtain copies of a supporting to qualify for an Ultra High, Very High,
statement and any related forms for the High, Medium, or Low Rehabilitation
proposed collection(s) summarized in category and when the intensity of DEPARTMENT OF HEALTH AND
this notice, you may make your request therapy (as indicated by the total HUMAN SERVICES
using one of following: reimbursable therapy minutes (RTM)
Centers for Medicare & Medicaid
1. Access CMS’ Web site address at delivered, and other therapy qualifiers
such as number of therapy days and Services
http://www.cms.hhs.gov/
PaperworkReductionActof1995. disciplines providing therapy) changes [CMS–1657–N]
2. Email your request, including your to such a degree that it would no longer
address, phone number, OMB number, reflect the RUG–IV classification and Medicare, Medicaid, and Children’s
and CMS document identifier, to payment assigned for a given SNF Health Insurance Programs;
Paperwork@cms.hhs.gov. resident based on the most recent Announcement of the Advisory Panel
3. Call the Reports Clearance Office at assessment used for Medicare payment. on Clinical Diagnostic Laboratory
(410) 786–1326. The COT OMRA is a type of required Tests Meeting on October 19, 2015
FOR FURTHER INFORMATION CONTACT: PPS assessment which uses the same
item set as the End of Therapy (EOT) AGENCY: Centers for Medicare &
Reports Clearance Office at (410) 786– Medicaid Services (CMS), HHS.
1326. OMRA. Form Number: CMS–10387
(OMB Control Number: 0938–1140); ACTION: Notice.
SUPPLEMENTARY INFORMATION: Under the Frequency: Yearly; Affected Public:
Paperwork Reduction Act of 1995 (PRA) Private sector (Business or other For- SUMMARY: This notice announces the
(44 U.S.C. 3501–3520), federal agencies profits and Not-for-profit institutions); next meeting date of the Advisory Panel
must obtain approval from the Office of Number of Respondents: 15,421; Total on Clinical Diagnostic Laboratory Tests
Management and Budget (OMB) for each Annual Responses: 678,524; Total (the Panel) on Monday, October 19,
collection of information they conduct Annual Hours: 701,119. (For policy 2015. The purpose of the Panel is to
or sponsor. The term ‘‘collection of questions regarding this collection advise the Secretary of the Department
information’’ is defined in 44 U.S.C. contact Penny Gershman at 410–786– of Health and Human Services (DHHS)
3502(3) and 5 CFR 1320.3(c) and 6643). (the Secretary) and the Administrator of
includes agency requests or 2. Type of Information Collection the Centers for Medicare & Medicaid
requirements that members of the public Request: Reinstatement of a previously Services (CMS) (the Administrator) on
submit reports, keep records, or provide approved collection; Title of issues related to clinical diagnostic
information to a third party. Section Information Collection: Manufacturer laboratory tests.
3506(c)(2)(A) of the PRA (44 U.S.C. Submission of Average Sales Price DATES: Meeting Date: The meeting of the
mstockstill on DSK4VPTVN1PROD with NOTICES
3506(c)(2)(A)) requires federal agencies (ASP) Data for Medicare Part B Drugs Panel is scheduled to take place at
to publish a 30-day notice in the and Biologicals; Use: In accordance with CMS’s headquarters in Baltimore, MD
Federal Register concerning each Section 1847A of the Social Security on Monday, October 19, 2015. beginning
proposed collection of information, Act (the Act), Medicare Part B covered at 9:00 a.m., Eastern Daylight Time
including each proposed extension or drugs and biologicals not paid on a cost (EDT). The Panel will address issues
reinstatement of an existing collection or prospective payment basis are paid relating to the CY 2016 clinical
of information, before submitting the based on the average sales price (ASP) laboratory fee schedule (CLFS)
collection to OMB for approval. To of the drug or biological, beginning in preliminary determinations of new and
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Document Created: 2015-12-15 08:45:02
Document Modified: 2015-12-15 08:45:02
| 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 November 2, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 59781 |
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