[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29269-29270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11080]


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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.

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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