80 FR 69228 - 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 216 (November 9, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 216 (November 9, 2015)
| Page Range | 69228-69229 | |
| FR Document | 2015-28448 |
[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)] [Notices] [Pages 69228-69229] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28448] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-906 and CMS-1771] 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 December 9, 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: [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: The Fiscal Soundness Reporting Requirements; Use: The CMS is assigned responsibility for overseeing all Medicare Advantage Organizations (MAOs), Prescription Drug Plan (PDP) sponsors and PACE organizations on-going financial performance. Specifically, CMS needs the requested collection of information to establish that contracting entities within those programs maintain fiscally sound organizations and thereby remain a going concern. All contracting organizations must submit annual independently audited financial statements one time per year. The MAOs with a negative net worth and/or a net loss and the amount of that loss is greater than one-half of the organization's total net worth must file three quarterly financial statements. Currently, there are approximately 71 MAOs filing quarterly financial statements. Part D organizations must also file 3 quarterly financial statements. The PACE organizations are required to file 4 quarterly financial statements for the first three years in the program as well as PACE organizations with a negative net worth and/or a net loss and the amount of that loss is greater than one-half of the organization's total net worth. Form Number: CMS-906 (OMB control number: 0938-0469); Frequency: Annually; Affected Public: Business or other for-profits; Number of Respondents: 815; Total Annual Responses: 1,518; Total Annual Hours: 506. (For policy questions regarding this collection contact Geralyn Glenn at 410-786-0973.) 2. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Emergency and Foreign Hospital Services; Use: Section 1866 of the Social Security Act states that any provider of services shall be qualified to participate in the Medicare program and shall be eligible for payments under Medicare if it files an agreement with the Secretary to meet the conditions outlined in this section of the Act. Section 1814 (d)(1) of [[Page 69229]] the Social Security Act and 42 CFR 424.100, allows payment of Medicare benefits for a Medicare beneficiary to a nonparticipating hospital that does not have an agreement in effect with the Centers for Medicare and Medicaid Services. These payments can be made if such services were emergency services and if CMS would be required to make the payment if the hospital had an agreement in effect and met the conditions of payment. This form is used in connection with claims for emergency hospital services provided by hospitals that do not have an agreement in effect under section 1866 of the Social Security Act. As specified in 42 CFR 424.103(b), before a non-participating hospital may be paid for emergency services rendered to a Medicare beneficiary, a statement must be submitted that is sufficiently comprehensive to support that an emergency existed. Form CMS-1771 contains a series of questions relating to the medical necessity of the emergency. The attending physician must attest that the hospitalization was required under the regulatory emergency definition and give clinical documentation to support the claim. A photocopy of the beneficiary's hospital records may be used in lieu of the CMS-1771 if the records contain all the information required by the form. Form Number: CMS-1771 (OMB control number: 0938-0023); Frequency: Annually; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 100; Total Annual Responses: 200; Total Annual Hours: 50. (For policy questions regarding this collection contact Shauntari Cheely at 410-786-1818.) Dated: November 4, 2015. William N. Parham, III Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015-28448 Filed 11-6-15; 8:45 am] BILLING CODE 4120-01-P
![69228 Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices
physicians, providers (including publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
institutional providers like outpatient concerning each proposed collection of to publish a 30-day notice in the
hospitals), practitioners (such as information, including each proposed Federal Register concerning each
chiropractors), and suppliers, as well as extension or reinstatement of an existing proposed collection of information,
hospice providers and Religious Non- collection of information, and to allow including each proposed extension or
medical Health Care Institutions paid a second opportunity for public reinstatement of an existing collection
under Part A. Home health agencies comment on the notice. Interested of information, before submitting the
providing items and services under Part persons are invited to send comments collection to OMB for approval. To
A or Part B also use the ABN. Other regarding the burden estimate or any comply with this requirement, CMS is
Medicare institutional providers paid other aspect of this collection of publishing this notice that summarizes
under Part A use other approved notices information, including any of the the following proposed collection(s) of
for this purpose. With this PRA following subjects: (1) The necessity and information for public comment:
submission, minimal formatting changes utility of the proposed information 1. Type of Information Collection
have been made to the ABN form, collection for the proper performance of Request: Extension of a currently
including the addition of language the agency’s functions; (2) the accuracy approved collection; Title of
informing beneficiaries of their rights of the estimated burden; (3) ways to Information Collection: The Fiscal
under Section 504 of the Rehabilitation enhance the quality, utility, and clarity Soundness Reporting Requirements;
Act of 1973 (section 504) by alerting the of the information to be collected; and Use: The CMS is assigned responsibility
beneficiary to CMS’s nondiscrimination (4) the use of automated collection for overseeing all Medicare Advantage
practices and the availability of techniques or other forms of information Organizations (MAOs), Prescription
alternate forms of this notice, if needed. technology to minimize the information Drug Plan (PDP) sponsors and PACE
Additionally, minor language and collection burden. organizations on-going financial
grammatical changes have been made to DATES: Comments on the collection(s) of performance. Specifically, CMS needs
the form’s instructions to improve information must be received by the the requested collection of information
provider/supplier comprehension and OMB desk officer by December 9, 2015. to establish that contracting entities
decrease the probability of errors in ADDRESSES: When commenting on the
within those programs maintain fiscally
completing the ABN. There are no proposed information collections, sound organizations and thereby remain
substantive changes to the form or to the please reference the document identifier a going concern. All contracting
instructions. Form Number: CMS–R– or OMB control number. To be assured organizations must submit annual
131 (OMB control number: 0938–0566; consideration, comments and independently audited financial
Frequency: Occasionally; Affected statements one time per year. The
recommendations must be received by
Public: Private sector (Business or other MAOs with a negative net worth and/or
the OMB desk officer via one of the
for-profits and Not-for-profit a net loss and the amount of that loss
following transmissions: OMB, Office of
institutions); Number of Respondents: is greater than one-half of the
Information and Regulatory Affairs,
1,499,910; Total Annual Responses: organization’s total net worth must file
Attention: CMS Desk Officer, Fax
62,910,000; Total Annual Hours: three quarterly financial statements.
Number: (202) 395–5806 OR, Email:
7,339,710. (For policy questions Currently, there are approximately 71
OIRA_submission@omb.eop.gov.
regarding this collection contact Evelyn To obtain copies of a supporting MAOs filing quarterly financial
Blaemire at 410–786–1803). statements. Part D organizations must
statement and any related forms for the
also file 3 quarterly financial statements.
Dated: November 4, 2015. proposed collection(s) summarized in
The PACE organizations are required to
William N. Parham, III, this notice, you may make your request
file 4 quarterly financial statements for
Director, Paperwork Reduction Staff, Office using one of following:
1. Access CMS’ Web site address at the first three years in the program as
of Strategic Operations and Regulatory
http://www.cms.hhs.gov/ well as PACE organizations with a
Affairs.
PaperworkReductionActof1995. negative net worth and/or a net loss and
[FR Doc. 2015–28449 Filed 11–6–15; 8:45 am]
2. Email your request, including your the amount of that loss is greater than
BILLING CODE 4120–01–P
address, phone number, OMB number, one-half of the organization’s total net
and CMS document identifier, to worth. Form Number: CMS–906 (OMB
Paperwork@cms.hhs.gov. control number: 0938–0469); Frequency:
DEPARTMENT OF HEALTH AND
3. Call the Reports Clearance Office at Annually; Affected Public: Business or
HUMAN SERVICES
(410) 786–1326. other for-profits; Number of
Centers for Medicare & Medicaid Respondents: 815; Total Annual
FOR FURTHER INFORMATION CONTACT:
Services Responses: 1,518; Total Annual Hours:
Reports Clearance Office at (410) 786–
506. (For policy questions regarding this
[Document Identifier: CMS–906 and CMS– 1326.
collection contact Geralyn Glenn at
1771] SUPPLEMENTARY INFORMATION: Under the 410–786–0973.)
Paperwork Reduction Act of 1995 (PRA) 2. Type of Information Collection
Agency Information Collection (44 U.S.C. 3501–3520), federal agencies Request: Reinstatement without change
Activities: Submission for OMB must obtain approval from the Office of of a previously approved collection;
Review; Comment Request Management and Budget (OMB) for each Title of Information Collection:
ACTION: Notice. collection of information they conduct Emergency and Foreign Hospital
or sponsor. The term ‘‘collection of Services; Use: Section 1866 of the Social
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. Security Act states that any provider of
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and services shall be qualified to participate
an opportunity for the public to includes agency requests or in the Medicare program and shall be
comment on CMS’ intention to collect requirements that members of the public eligible for payments under Medicare if
information from the public. Under the submit reports, keep records, or provide it files an agreement with the Secretary
Paperwork Reduction Act of 1995 information to a third party. Section to meet the conditions outlined in this
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C. section of the Act. Section 1814 (d)(1) of
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![Federal Register / Vol. 80, No. 216 / Monday, November 9, 2015 / Notices 69229
the Social Security Act and 42 CFR (FDA). The meeting will be open to the submissions may be made to the contact
424.100, allows payment of Medicare public. person on or before November 20, 2015.
benefits for a Medicare beneficiary to a Name of Committee: Food Advisory Oral presentations from the public will
nonparticipating hospital that does not Committee. be scheduled between approximately 11
have an agreement in effect with the General Function of the Committee: a.m. to 12 p.m. on December 8, 2015.
Centers for Medicare and Medicaid To provide advice and Those individuals interested in making
Services. These payments can be made recommendations to the Agency on formal oral presentations should notify
if such services were emergency FDA’s regulatory issues.
Date and Time: The meeting will be the contact person and submit a brief
services and if CMS would be required statement of the general nature of the
to make the payment if the hospital had held on December 7 and 8, 2015, from
8 a.m. to 5 p.m. evidence or arguments they wish to
an agreement in effect and met the
Location: FDA White Oak Campus, present, the names and addresses of
conditions of payment. This form is
used in connection with claims for 10903 New Hampshire Ave., Bldg. 31 proposed participants, and an
emergency hospital services provided Conference Center, the Great Room (rm. indication of the approximate time
by hospitals that do not have an 1503A), Silver Spring, MD 20993–0002. requested to make their presentation on
agreement in effect under section 1866 Answers to commonly asked questions or before November 30, 2015. Time
of the Social Security Act. As specified including information regarding special allotted for each presentation may be
in 42 CFR 424.103(b), before a non- accommodations due to a disability, limited. If the number of registrants
participating hospital may be paid for visitor parking, and transportation may requesting to speak is greater than can
emergency services rendered to a be accessed at: http://www.fda.gov/ be reasonably accommodated during the
Medicare beneficiary, a statement must AdvisoryCommittees/ scheduled open public hearing session,
be submitted that is sufficiently AboutAdvisoryCommittees/ FDA may conduct a lottery to determine
comprehensive to support that an ucm408555.htm. the speakers for the scheduled open
emergency existed. Form CMS–1771 Contact Person: Karen Strambler, public hearing session. The contact
contains a series of questions relating to Center for Food Safety and Applied
person will notify interested persons
the medical necessity of the emergency. Nutrition, HFS–024, Food and Drug
regarding their request to speak by
The attending physician must attest that Administration, 5100 Paint Branch
Parkway, College Park, MD 20740, 240– November 23, 2015.
the hospitalization was required under
the regulatory emergency definition and 402–2589, or FDA Advisory Committee Persons attending FDA’s advisory
give clinical documentation to support Information Line, 1–800–741–8138 committee meetings are advised that the
the claim. A photocopy of the (301–443–0572 in the Washington, DC Agency is not responsible for providing
beneficiary’s hospital records may be area). A notice in the Federal Register access to electrical outlets.
used in lieu of the CMS–1771 if the about last minute modifications that FDA welcomes the attendance of the
records contain all the information impact a previously announced public at its advisory committee
required by the form. Form Number: advisory committee meeting cannot meetings and will make every effort to
CMS–1771 (OMB control number: always be published quickly enough to accommodate persons with disabilities.
0938–0023); Frequency: Annually; provide timely notice. Therefore, you
If you require accommodations due to a
Affected Public: Private sector (Business should always check the Agency’s Web
disability, please contact Karen
or other for-profits and Not-for-profit site at http://www.fda.gov/
AdvisoryCommittees/default.htm and Strambler at least 7 days in advance of
institutions); Number of Respondents: the meeting.
100; Total Annual Responses: 200; Total scroll down to the appropriate advisory
Annual Hours: 50. (For policy questions committee meeting link, or call the FDA is committed to the orderly
regarding this collection contact advisory committee information line to conduct of its advisory committee
Shauntari Cheely at 410–786–1818.) learn about possible modifications meetings. Please visit our Web site at
before coming to the meeting. http://www.fda.gov/
Dated: November 4, 2015. Agenda: The Food Advisory AdvisoryCommittees/
William N. Parham, III Committee will meet to discuss FDA’s AboutAdvisoryCommittees/
Director, Paperwork Reduction Staff, Office policies related to the presence of
of Strategic Operations and Regulatory
ucm111462.htm for procedures on
Listeria monocytogenes in foods. public conduct during advisory
Affairs. FDA intends to make background
[FR Doc. 2015–28448 Filed 11–6–15; 8:45 am] committee meetings.
material available to the public no later
BILLING CODE 4120–01–P than 2 business days before the meeting. Notice of this meeting is given under
If FDA is unable to post the background the Federal Advisory Committee Act (5
material on its Web site prior to the U.S.C. app. 2).
DEPARTMENT OF HEALTH AND meeting, the background material will Dated: November 3, 2015.
HUMAN SERVICES be made publicly available at the Leslie Kux,
Food and Drug Administration location of the advisory committee
Associate Commissioner for Policy.
meeting, and the background material
[Docket No. FDA–2015–N–0001] [FR Doc. 2015–28387 Filed 11–6–15; 8:45 am]
will be posted on FDA’s Web site after
the meeting. Background material is BILLING CODE 4164–01–P
Food Advisory Committee; Notice of available at http://www.fda.gov/
Meeting AdvisoryCommittees/Calendar/
srobinson on DSK5SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, default.htm. Scroll down to the
HHS. appropriate advisory committee meeting
ACTION: Notice. link.
Procedure: Interested persons may
This notice announces a forthcoming present data, information, or views,
meeting of a public advisory committee orally or in writing, on issues pending
of the Food and Drug Administration before the committee. Written
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Document Created: 2015-12-14 15:04:58
Document Modified: 2015-12-14 15:04:58
| 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 December 9, 2015. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 69228 |
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