81 FR 29269 - 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 91 (May 11, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 91 (May 11, 2016)
| Page Range | 29269-29270 | |
| FR Document | 2016-11080 |
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)] [Notices] [Pages 29269-29270] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11080] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-484, CMS-846, 854, 847, 848, 849, 10125, 10126, and CMS-10152] 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 a 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 June 10, 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: Extension of a currently approved collection; Title of Information Collection: Attending Physician's Certification of Medical Necessity and Supporting Documentation Requirements; Use: The certificates of medical necessity (CMNs) collect information required to help determine the medical necessity of certain items. CMS requires CMNs where there may be a vulnerability to the Medicare program. Each initial claim for these items must have an associated CMN for the beneficiary. Suppliers (those who bill for the items) complete the administrative information (e.g., patient's name and address, items ordered, etc.) on each CMN. The 1994 Amendments to the Social Security Act require that the supplier also provide a narrative description of the items ordered and all related accessories, their charge for each of these items, and the Medicare fee schedule allowance (where applicable). The supplier then sends the CMN to the treating physician or other clinicians (e.g., physician assistant, LPN, etc.) who completes questions pertaining to the beneficiary's medical condition and signs the CMN. The physician or other clinician returns the CMN to the supplier who has the option to maintain a copy and then submits the CMN (paper or electronic) to CMS, [[Page 29270]] along with a claim for reimbursement. Form Number: CMS-484 (OMB control number: 0938-0534); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits, Not-for-profits); Number of Respondents: 8,880; Total Annual Responses: 1,632,000; Total Annual Hours: 326,500; (For policy questions regarding this collection contact Paula Smith at 410-786-4709.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Durable Medical Equipment Medicare Administrative Contractors (MAC) Regional Carrier, Certificate of Medical Necessity and Supporting Documentation; Use: The certificates of medical necessity (CMNs) collect information required to help determine the medical necessity of certain items. CMS requires CMNs where there may be a vulnerability to the Medicare program. Each initial claim for these items must have an associated CMN for the beneficiary. Suppliers (those who bill for the items) complete the administrative information (e.g., patient's name and address, items ordered, etc.) on each CMN. The 1994 Amendments to the Social Security Act require that the supplier also provide a narrative description of the items ordered and all related accessories, their charge for each of these items, and the Medicare fee schedule allowance (where applicable). The supplier then sends the CMN to the treating physician or other clinicians (e.g., physician assistant, LPN, etc.) who completes questions pertaining to the beneficiary's medical condition and signs the CMN. The physician or other clinician returns the CMN to the supplier who has the option to maintain a copy and then submits the CMN (paper or electronic) to CMS, along with a claim for reimbursement. Form Number: CMS-846-849, 854, 10125 and 10126 (OMB control number: 0938-0679); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits, Not-for-profits); Number of Respondents: 462,000; Total Annual Responses: 462,000; Total Annual Hours: 418,563; (For policy questions regarding this collection contact Paula Smith at 410-786-4709.) 3. Type of Information Collection Request: Extension of a previously approved collection; Title: Data Collection for Medicare Beneficiaries Receiving NaF-18 Positron Emission Tomography (PET) to Identify Bone Metastasis in Cancer; Use: In Decision Memorandum #CAG- 00065R, issued on February 26, 2010, the Centers for Medicare and Medicaid Services (CMS) determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving NaF-18 PET scan to identify bone metastasis in cancer is reasonable and necessary only when the provider is participating in and patients are enrolled in a clinical study designed to information at the time of the scan to assist in initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in beneficiaries in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and providers accurately report data on all Medicare enrolled patients; and all patient confidentiality, privacy, and other Federal laws must be followed. Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meets specified standards and address the specified research questions. To qualify for payment, providers must prescribe certain NaF-18 PET scans for beneficiaries with a set of clinical criteria specific to each solid tumor. The statuary authority for this policy is section 1862 (a)(1)(E) of the Act. The need to prospectively collect information at the time of the scan is to assist the provider in decision making for patient management. Form Number: CMS-10152 (OCN: 0938-0968); Frequency: Annually; Affected Public: Private Sector (Business or other for- profits); Number of Respondents: 25,000; Total Annual Responses: 25,000; Total Annual Hours: 2,084 hours. (For policy questions regarding this collection contact Stuart Caplan at 410-786-8564.) Dated: May 6, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2016-11080 Filed 5-10-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices 29269
CMS–10295 (OMB control number: DEPARTMENT OF HEALTH AND and CMS document identifier, to
0938–1073). Frequency: Quarterly; HUMAN SERVICES Paperwork@cms.hhs.gov.
Affected Public: State, Local, or Tribal 3. Call the Reports Clearance Office at
Governments; Number of Respondents: Centers for Medicare & Medicaid (410) 786–1326.
50; Total Annual Responses: 200; Total Services FOR FURTHER INFORMATION CONTACT:
Annual Hours: 400. (For policy [Document Identifier: CMS–484, CMS–846, Reports Clearance Office at (410) 786–
questions regarding this collection 854, 847, 848, 849, 10125, 10126, and CMS– 1326.
contact Martin Burian at 410–786– 10152] SUPPLEMENTARY INFORMATION: Under the
3246.) Paperwork Reduction Act of 1995 (PRA)
Agency Information Collection
3. Type of Information Collection (44 U.S.C. 3501–3520), federal agencies
Activities: Submission for OMB
Request: Revision of a currently must obtain approval from the Office of
Review; Comment Request
approved collection; Title of Management and Budget (OMB) for each
Information Collection: Cooperative ACTION: Notice. collection of information they conduct
Agreement to Support Navigators in or sponsor. The term ‘‘collection of
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
Federally-facilitated and State Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
Partnership Exchanges; Use: Section an opportunity for the public to includes agency requests or
1311(i) of the Affordable Care Act comment on CMS’ intention to collect requirements that members of the public
requires Exchanges to establish a information from the public. Under the submit reports, keep records, or provide
Navigator grant program as part of its Paperwork Reduction Act of 1995 information to a third party. Section
function to provide consumers with (PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
assistance when they need it. Navigators publish a notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
will assist consumers by providing concerning each proposed collection of to publish a 30-day notice in the
education about and facilitating information, including each proposed Federal Register concerning each
selection of qualified health plans extension or reinstatement of an existing proposed collection of information,
(QHPs) within Exchanges, as well as collection of information, and to allow including each proposed extension or
other required duties. Section 1311(i) a second opportunity for public reinstatement of an existing collection
requires that an Exchange operating as comment on the notice. Interested of information, before submitting the
of January 1, 2014, must establish a persons are invited to send comments collection to OMB for approval. To
Navigator Program under which it regarding the burden estimate or any comply with this requirement, CMS is
awards grants to eligible individuals or other aspect of this collection of publishing this notice that summarizes
entities who satisfy the requirements to information, including any of the the following proposed collection(s) of
be Exchange Navigators. In States with following subjects: (1) The necessity and information for public comment:
a Federally-facilitated Marketplace utility of the proposed information 1. Type of Information Collection
(FFM) or State Partnership Marketplace collection for the proper performance of Request: Extension of a currently
the agency’s functions; (2) the accuracy approved collection;
(SPM), CMS will be awarding these
of the estimated burden; (3) ways to Title of Information Collection:
grants. Navigator awardees must
enhance the quality, utility, and clarity Attending Physician’s Certification of
provide weekly, monthly, quarterly, and
of the information to be collected; and Medical Necessity and Supporting
annual progress reports to CMS on the (4) the use of automated collection Documentation Requirements; Use: The
activities performed during the grant techniques or other forms of information certificates of medical necessity (CMNs)
period and any sub-awardees receiving technology to minimize the information collect information required to help
funds. Form Number: CMS–10463 collection burden. determine the medical necessity of
(OMB control number: 0938–1215); DATES: Comments on the collection(s) of certain items. CMS requires CMNs
Frequency: Annually, Quarterly, information must be received by the where there may be a vulnerability to
Monthly, Weekly; Affected Public: OMB desk officer by June 10, 2016. the Medicare program. Each initial
Private sector; Number of Respondents: ADDRESSES: When commenting on the claim for these items must have an
102; Total Annual Responses: 102; Total proposed information collections, associated CMN for the beneficiary.
Annual Hours: 74,188. (For policy please reference the document identifier Suppliers (those who bill for the items)
questions regarding this collection, or OMB control number. To be assured complete the administrative information
contact Gian Johnson at 301–492–4323.) consideration, comments and (e.g., patient’s name and address, items
Dated: May 6, 2016. recommendations must be received by ordered, etc.) on each CMN. The 1994
the OMB desk officer via one of the Amendments to the Social Security Act
William N. Parham, III,
following transmissions: OMB, Office of require that the supplier also provide a
Director, Paperwork Reduction Staff, Office narrative description of the items
of Strategic Operations and Regulatory
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax ordered and all related accessories, their
Affairs. charge for each of these items, and the
Number: (202) 395–5806 OR, Email:
[FR Doc. 2016–11078 Filed 5–10–16; 8:45 am] Medicare fee schedule allowance (where
OIRA_submission@omb.eop.gov.
BILLING CODE 4120–01–P To obtain copies of a supporting applicable). The supplier then sends the
statement and any related forms for the CMN to the treating physician or other
clinicians (e.g., physician assistant,
mstockstill on DSK3G9T082PROD with NOTICES
proposed collection(s) summarized in
this notice, you may make your request LPN, etc.) who completes questions
using one of following: pertaining to the beneficiary’s medical
1. Access CMS’ Web site address at condition and signs the CMN. The
http://www.cms.hhs.gov/ physician or other clinician returns the
PaperworkReductionActof1995. CMN to the supplier who has the option
2. Email your request, including your to maintain a copy and then submits the
address, phone number, OMB number, CMN (paper or electronic) to CMS,
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![29270 Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Notices
along with a claim for reimbursement. sufficient to conclude that for Medicare Disabilities (AIDD), Administration on
Form Number: CMS–484 (OMB control beneficiaries receiving NaF–18 PET scan Disabilities (AoD), Administration for
number: 0938–0534); Frequency: to identify bone metastasis in cancer is Community Living (ACL), Department
Occasionally; Affected Public: Private reasonable and necessary only when the of Health and Human Services (HHS).
Sector (Business or other for-profits, provider is participating in and patients ACTION: Notice.
Not-for-profits); Number of are enrolled in a clinical study designed
Respondents: 8,880; Total Annual to information at the time of the scan to SUMMARY: The Administration on
Responses: 1,632,000; Total Annual assist in initial antitumor treatment Intellectual and Developmental
Hours: 326,500; (For policy questions planning or to guide subsequent Disabilities (AIDD) within the
regarding this collection contact Paula treatment strategy by the identification, Administration on Disabilities (AoD),
Smith at 410–786–4709.) location and quantification of bone located within the Administration for
2. Type of Information Collection metastases in beneficiaries in whom Community Living (ACL) at the United
Request: Revision of a currently bone metastases are strongly suspected States Department of Health and Human
approved collection; Title of based on clinical symptoms or the Services (HHS), has developed a new
Information Collection: Durable Medical results of other diagnostic studies. funding formula for the State Councils
Equipment Medicare Administrative Qualifying clinical studies must ensure on Developmental Disabilities (SCDD)
Contractors (MAC) Regional Carrier, that specific hypotheses are addressed; and Protection and Advocacy Systems
Certificate of Medical Necessity and appropriate data elements are collected; (P&A) located in each State and
Supporting Documentation; Use: The hospitals and providers are qualified to Territory.
certificates of medical necessity (CMNs) provide the PET scan and interpret the
collect information required to help DATES: Effective Date October 1, 2016.
results; participating hospitals and
determine the medical necessity of providers accurately report data on all ADDRESSES: The new formula is printed
certain items. CMS requires CMNs Medicare enrolled patients; and all below and the estimated allotments for
where there may be a vulnerability to patient confidentiality, privacy, and FY 2017 for each SCDD and P&A can be
the Medicare program. Each initial other Federal laws must be followed. found at: http://www.acl.gov/About_
claim for these items must have an Consistent with section 1142 of the ACL/Allocations/DD-Act.aspx.
associated CMN for the beneficiary. Social Security Act (the Act), the FOR FURTHER INFORMATION CONTACT:
Suppliers (those who bill for the items) Agency for Healthcare Research and Andrew Morris, Office of the
complete the administrative information Quality (AHRQ) supports clinical Commissioner, Administration on
(e.g., patient’s name and address, items research studies that CMS determines Disabilities, 330 C St. SW., Washington,
ordered, etc.) on each CMN. The 1994 meets specified standards and address DC 20201. Telephone (202) 795–7408.
Amendments to the Social Security Act the specified research questions. To Email andrew.morris@acl.hhs.gov.
require that the supplier also provide a qualify for payment, providers must Please note the telephone number is not
narrative description of the items prescribe certain NaF–18 PET scans for toll free. This document will be made
ordered and all related accessories, their beneficiaries with a set of clinical available in alternative formats upon
charge for each of these items, and the criteria specific to each solid tumor. The request. Written correspondence can be
Medicare fee schedule allowance (where statuary authority for this policy is sent to Administration for Community
applicable). The supplier then sends the section 1862 (a)(1)(E) of the Act. The Living, U.S. Department of Health and
CMN to the treating physician or other need to prospectively collect Human Services, 330 C St. SW.,
clinicians (e.g., physician assistant, information at the time of the scan is to Washington, DC 20201.
LPN, etc.) who completes questions assist the provider in decision making SUPPLEMENTARY INFORMATION:
pertaining to the beneficiary’s medical for patient management. Form Number:
condition and signs the CMN. The Background
CMS–10152 (OCN: 0938–0968);
physician or other clinician returns the Frequency: Annually; Affected Public: The Developmental Disabilities
CMN to the supplier who has the option Private Sector (Business or other for- Assistance and Bill of Rights Act of
to maintain a copy and then submits the profits); Number of Respondents: 2000 (Pub. L. 106–402) provides, among
CMN (paper or electronic) to CMS, 25,000; Total Annual Responses: other things, formula grants to States for
along with a claim for reimbursement. 25,000; Total Annual Hours: 2,084 the purpose of operating State Councils
Form Number: CMS–846–849, 854, hours. (For policy questions regarding on Developmental Disabilities and
10125 and 10126 (OMB control number: this collection contact Stuart Caplan at Protection & Advocacy Systems for
0938–0679); Frequency: Occasionally; people with developmental disabilities.
410–786–8564.)
Affected Public: Private Sector (Business The Developmental Disabilities
or other for-profits, Not-for-profits); Dated: May 6, 2016.
Assistance and Bill of Rights Act of
Number of Respondents: 462,000; Total William N. Parham, III,
2000 (DD Act) provides authority and
Annual Responses: 462,000; Total Director, Paperwork Reduction Staff, Office
flexibility in Section 122 to determine
Annual Hours: 418,563; (For policy of Strategic Operations and Regulatory
Affairs. the formula for distributing the annual
questions regarding this collection grant awards as long as the three
contact Paula Smith at 410–786–4709.) [FR Doc. 2016–11080 Filed 5–10–16; 8:45 am]
statutory factors are met. These factors
3. Type of Information Collection BILLING CODE 4120–01–P
are:
Request: Extension of a previously
approved collection; Title: Data 1. Total population of the State/
Collection for Medicare Beneficiaries DEPARTMENT OF HEALTH AND Territory
mstockstill on DSK3G9T082PROD with NOTICES
Receiving NaF–18 Positron Emission HUMAN SERVICES 2. Need for services for people with
Tomography (PET) to Identify Bone developmental disabilities in the State/
Metastasis in Cancer; Use: In Decision Administration for Community Living Territory
Memorandum #CAG–00065R, issued on 3. Financial need of the State/
New Funding Formula Territory
February 26, 2010, the Centers for
Medicare and Medicaid Services (CMS) AGENCIES: Administration on Responding to years of requests for a
determined that the evidence is Intellectual and Developmental modernized funding formula and after a
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Document Created: 2016-05-11 01:11:31
Document Modified: 2016-05-11 01:11:31
| 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 June 10, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 81 FR 29269 |
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