16270 Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Laboratorians .................... National Laboratory Training Network Registration Form (Attachment 3).6,500 1 5/60 

Dated: March 7, 2013. 

Ron A. Otten, 

Director, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2013–05821 Filed 3–13–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–484, CMS–10152, 

CMS–10449] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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: 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 title 

42 of the 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.) 

2. 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 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 50 / Thursday, March 14, 2013 / Notices 16271 

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: Annual; Affected Public: 

Private Sector—Business or other forprofits; Number of Respondents: 25000; 

Total Annual Responses: 25000; Total 

Annual Hours: 2,084 hours. (For policy 

questions regarding this collection 

contact Stuart Caplan at 410–786–8564. 

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

3. Type of Information Collection 

Request: Revision; Title of Information 

Collection: Recognized Accrediting 

Entities Data Collection; Use: The final 

rule that was released on July 20, 2012 

(77 FR 42658) establishes a process for 

recognizing accrediting entities for the 

purposes of implementing section 

1311(c)(1)(D)(i) of the Affordable Care 

Act. In order for a health plan to be 

certified as a QHP and operate in an 

Exchange, it must be accredited by an 

accrediting entity that has been 

recognized by the Secretary of Health 

and Human Services. The final rule 

establishes the first phase of a twophased process for recognition of 

accrediting entities. In phase one, the 

National Committee for Quality 

Assurance (NCQA) and URAC were 

recognized as accrediting entities for the 

purposes of fulfilling the accreditation 

requirement as part of qualified health 

plan certification. In a subsequent final 

rule, released February 22, 2013, we 

amended the first phase of this process 

to allow additional accrediting entities 

to apply to be recognized. The 

assessment used to assess these 

additional accrediting entities will be 

the same as the assessment underlying 

the recognition of NCQA and URAC. 

This information collection is necessary 

to ensure that the recognized accrediting 

entities meet the proposed conditions. 

45 CFR 156.275(c) requires that the 

accrediting entities provide 

accreditation survey data elements, 

including accreditation status, 

accreditation score, accreditation 

expiration date, clinical quality measure 

results and adult and child CAHPS 

measure survey results to the Exchanges 

once these data are released by the 

issuers. Further, accrediting entities 

applying to be recognized must provide 

to HHS the accreditation standards and 

requirements, processes, and measure 

specifications for performance measures 

and, once recognized, any proposed 

changes or updates to these standards, 

and requirements, processes and 

measure specifications with 60-day 

notice prior to public notification. This 

collection, which is approved under 

OCN: 0938–1176), is necessary in order 

for Exchanges to verify that the QHPs 

being offered in their Exchange meet the 

accreditation requirement and are high 

quality plans. 

The 60-day Federal Register notice 

published on November 23, 2012 (77 FR 

70163). We received two comments. The 

comments concerned issuer burden 

associated with the data collection and 

the content of the data submission. 

These comments were addressed in full 

in the Patient Protection and Affordable 

Care Act; Standards Related to Essential 

Health Benefits, Actuarial Value, and 

Accreditation Final Rule. Generally, we 

noted that this data collection pertained 

to the submission of data from 

accrediting entities seeking to be 

recognized and accrediting entities 

already recognized, rather than issuers. 

Comments related to the content of the 

data submission were deemed out of 

scope. Form Number: CMS–10449; 

Frequency: Monthly, Occasionally; 

Affected Public: Private sector, Not-forprofit institutions; Number of 

Respondents: 4; Number of Responses: 

60; Total Annual Hours: 3,544. (For 

policy questions regarding this 

collection contact Rebecca 

Zimmermann at (301) 492–4396. 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on April 15, 2013: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: March 8, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–05802 Filed 3–13–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0001] 

Joint Meeting of the Advisory 

Committee for Reproductive Health 

Drugs and the Drug Safety and Risk 

Management Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committees: Advisory 

Committee for Reproductive Health 

Drugs and the Drug Safety and Risk 

Management Advisory Committee. 

General Function of the Committees: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 18, 2013, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

ACRHD@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 


tkelley on DSK3SPTVN1PROD with NOTICES