47852 Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10381, CMS–484, 

CMS–10152 and CMS–R–290] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this 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. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title: ICD–10 

Industry Readiness Assessment; Use: 

The Congress addressed the need for a 

consistent framework for electronic 

transactions and other administrative 

simplification issues in the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA), 

Public Law 104–191, enacted on August 

21, 1996. Through subtitle F of title II 

of HIPAA, the Congress added to title XI 

of the Social Security Act (the Act) a 

new Part C, entitled ‘‘Administrative 

Simplification.’’ Part C of title XI of the 

Act now consists of sections 1171 

through 1180, which define various 

terms and impose several requirements 

on HHS, health plans, health care 

clearinghouses, and certain health care 

providers concerning the transmission 

of health information. Specifically, 

HIPAA requires the Secretary of HHS to 

adopt standards that covered entities are 

required to use in conducting certain 

health care administrative transactions, 

such as claims, remittance, eligibility, 

and claims status requests and 

responses. Findings from the ICD–10 

industry readiness assessment will be 

used by CMS to understand each 

sector’s progress toward compliance and 

to determine what communication and 

educational efforts can best help 

affected entities obtain the tools and 

resources they need to achieve timely 

compliance with ICD–10. Insights 

gleaned from the proposed research will 

be valid for education and outreach 

purposes only, and will not be used for 

policy purposes. Form Number: CMS– 

10381 (OCN: 0938–1149); Frequency: 

Annual; Affected Public: Private 

Sector—Business or other for-profits, 

Not-for-profits; Number of Respondents: 

1,200; Total Annual Responses: 1,200; 

Total Annual Hours: 204. (For policy 

questions regarding this collection 

contact Rosali Topper at 410–786–7260. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Reinstatement of a previously 

approved collection; Title: Attending 

Physician’s Certification of Medical 

Necessity for Home Oxygen Therapy 

and Supporting Documentation 

Requirements; Use: Under Section 

1862(a)(1)(A) of the Social Security Act 

(the Act), 42 U.S.C. 1395y(a), the 

Secretary may only pay for items and 

services that are ‘‘reasonable and 

necessary for the diagnosis or treatment 

of illness or injury or to improve the 

functioning of a malformed body 

member.’’ In order to assure this, CMS 

and its contractors develop Medical 

policies that specify the circumstances 

under which an item or service can be 

covered. The certificate of medical 

necessity (CMN) provides a mechanism 

for suppliers of Durable Medical 

Equipment, defined in 42 U.S.C. 1395x 

(n), and Medical Equipment and 

Supplies defined in 42 U.S.C. 1395j(5), 

to demonstrate that the item being 

provided meets the criteria for Medicare 

coverage. Section 1833(e), 42 U.S.C. 

1395l(e), provides that no payment can 

be made to any provider of services, or 

other person, unless that person has 

furnished the information necessary for 

Medicare or its contractor to determine 

the amounts due to be paid. Certain 

individuals can use a CMN to furnish 

this information, rather than having to 

produce large quantities of medical 

records for every claim they submit for 

payment. Under Section 1834(j)(2) of 

the Act, 42 U.S.C. 1395m(j)(2), suppliers 

of DME items are prohibited from 

providing medical information to 

physicians when a CMN is being 

completed to document medical 

necessity. The physician who orders the 

item is responsible for providing the 

information necessary to demonstrate 

that the item provided is reasonable and 

necessary and the supplier shall also list 

on the CMN the fee schedule amount 

and the suppliers charge for the medical 

equipment or supplies being furnished 

prior to distribution of such certificate 

to the physician. Any supplier of 

medical equipment who knowingly and 

willfully distributes a CMN in violation 

of this restriction is subject to penalties, 

including civil money penalties (42 

U.S.C. 1395m(j)(2)(A)(iii)). Under 

Section 42 Code of Federal Regulations 

§ 410.38 and § 424.5, Medicare has the 

legal authority to collect sufficient 

information to determine payment for 

oxygen, and oxygen equipment. Oxygen 

and oxygen equipment is by far the 

largest single total charge of all items 

paid under durable medical equipment 

coverage authority. Detailed criteria 

concerning coverage of home oxygen 

therapy are found in Medicare Carriers 

Manual Chapter II–Coverage Issues 

Appendix, Section 60–4. For Medicare 

to consider any item for coverage and 

payment, the information submitted by 

the supplier (e.g., claims and CMNs), 

including documentation in the 

patient’s medical records must 

corroborate that the patient meets 

Medicare coverage criteria. The patient’s 

medical records may include: 

physician’s office records; hospital 

records; nursing home records; home 

health agency records; records from 

other healthcare professionals or test 

reports. This documentation must be 

available to the DME MACs upon 

request. Form Number: CMS–484 (OCN: 

0938–0534); Frequency: Occasionally; 

Affected Public: Private Sector: Business 

or other for-profits, Not-for-profits; 

Number of Respondents: 8,880; Total 

Annual Responses: 1,541,359; Total 

Annual Hours: 308,271. (For policy 

questions regarding this collection 

contact Doris Jackson at 410–786–4459. 

For all other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Reinstatement 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 

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Federal Register / Vol. 77, No. 155 / Friday, August 10, 2012 / Notices 47853 

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 Agency for 

Healthcare Research and Quality 

(AHRQ) supports clinical research 

studies that the CMS determines meet 

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 Social 

Security 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: Annual; Affected 

Public: Private Sector—Business or 

other for-profits; Number of 

Respondents: 25,000; Total Annual 

Responses: 25,000; Total Annual Hours: 

2,084. (For policy questions regarding 

this collection contact Stuart Caplan at 

410–786–8564. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Reinstatement of a currently 

approved collection; Title: Medicare 

Program: Procedures for Making 

National Coverage Decisions; Use: The 

Centers for Medicare & Medicaid 

Services (CMS) revised the April 27, 

1999 (64 FR 22619) notice and 

published a new notice on September 

26, 2003 (68 FR 55634) that described 

the process we use to make Medicare 

coverage decisions including decisions 

regarding whether new technology and 

services can be covered. We have made 

changes to our internal procedures in 

response to the comments we received 

following publication of the 1999 notice 

and experience under our new process. 

Over the past several years, we received 

numerous suggestions to further revise 

our process to continue to make it more 

open, responsive, and understandable to 

the public. We share the goal of 

increasing public participation in the 

development of Medicare coverage 

issues. This will assist us in obtaining 

the information we require to make a 

national coverage determination in a 

timely manner and ensuring that the 

Medicare program continues to meet the 

needs of its beneficiaries. Form Number: 

CMS–R–290 (OCN: 0938–0776); 

Frequency: Annual; Affected Public: 

Private Sector: Business or other forprofits; Number of Respondents: 200; 

Total Annual Responses: 200; Total 

Annual Hours: 8,000. (For policy 

questions regarding this collection 

contact Katherine Tillman at 410–786– 

9252. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by October 9, 2012: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: August 7, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–19694 Filed 8–9–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0781] 

Request for Notification From Industry 

Organizations Interested in 

Participating in Selection Process for 

Nonvoting Industry Representative on 

the Pediatric Advisory Committee and 

Request for Nominations for 

Nonvoting Industry Representatives on 

the Pediatric Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of a 

nonvoting industry representative to 

serve on the Pediatric Advisory 

Committee for the Office of the 

Commissioner (OC) notify FDA in 

writing. FDA is also requesting 

nominations for a nonvoting industry 

representative(s) to serve on the 

Pediatric Advisory Committee. A 

nominee may either be self-nominated 

or nominated by an organization to 

serve as a nonvoting industry 

representative. Nominations will be 

accepted for current vacancies effective 

with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by September 10, 2012, for the 

vacancy listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA by September 10, 2012. 

ADDRESSES: All letters of interest and 

nominations should be submitted in 

writing to Walter Ellenberg (see FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Walter Ellenberg, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5154, Silver Spring, 

MD 20993, 301–796–0885, FAX: 301– 

847–8640, walter.ellenberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 

I. OC Advisory Committee 

Pediatric Advisory Committee 

The Committee reviews and evaluates 

and makes recommendations to the 

Commissioner of Food and Drugs 

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