Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Notices 44255 

VII. Files Available to the Public via the 

Internet 

This section lists the Addenda 

referred to in the preamble of this 

notice. Beginning in CY 2012, the 

Addenda for the annual hospice wage 

index proposed and final rulemakings 

or notices will no longer appear in the 

Federal Register. Instead, the Addenda 

will be available only through the 

Internet. We will continue to post the 

Addenda through the Internet. 

The following addenda are posted to 

the CMS Web site at http:// 

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/Hospice/ 

index.html: 

Addendum A: The FY 2013 Hospice 

Wage Index for Urban Areas 

Addendum B: The FY 2013 Hospice 

Wage Index for Rural Areas 

Readers who experience any problems 

accessing the Addenda that are posted 

on the CMS Web site at http:// 

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/Hospice/ 

index.html should contact Anjana Patel 

at (410) 786–2120. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, No. 93.773 Medicare— 

Hospital Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: June 5, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: July 16, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–18336 Filed 7–24–12; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3259–FN] 

Medicare Program; Application by the 

American Association of Diabetes 

Educators (AADE) for Continued 

Recognition as a National 

Accreditation Organization for 

Accrediting Entities To Furnish 

Outpatient Diabetes Self-Management 

Training 

AGENCY: Centers for Medicare & 

Medicare Services (CMS), HHS. 

ACTION: Final Notice. 

SUMMARY: This final notice announces 

the approval of an application from the 

American Association of Diabetes 

Educators for continued recognition as a 

national accreditation program for 

accrediting entities that wish to furnish 

outpatient diabetes self-management 

training to Medicare beneficiaries. 

DATES: Effective Date: This notice is 

effective on August 27, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Leach, (410) 786–4282. 

Kristin Shifflett, (410) 786–4133. 

Maria Hammel, (410) 786–1775. 

SUPPLEMENTARY INFORMATION

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive outpatient 

diabetes self-management training 

(DSMT) when ordered by the physician 

(or qualified non-physician practitioner) 

treating the beneficiary’s diabetes, 

provided certain requirements are met 

by the provider. Pursuant to our 

regulations at 42 CFR 410.141(e)(3), we 

use national accrediting organizations 

(NAOs) to assess whether provider 

entities meet Medicare requirements 

when providing DSMT services for 

which Medicare payment is made. If a 

provider entity is accredited by an 

approved accrediting organization, it is 

‘‘deemed’’ to meet applicable Medicare 

requirements. 

Under section 1865(a)(1)(B) of the 

Social Security Act (the Act), a NAO 

must have an agreement in effect with 

the Secretary, and meet the standards 

and requirements specified by the 

Secretary in part 410, subpart H, to 

qualify for deeming authority. The 

regulations pertaining to application 

procedures for NAOs for DSMT are 

specified at § 410.142 (CMS process for 

approving national accreditation 

organizations). 

A NAO applying for deeming 

authority must provide us with 

reasonable assurance that the 

accrediting organization requires 

accredited entities to meet requirements 

that are at least as stringent as our 

requirements. 

We may approve and recognize a 

nonprofit organization with 

demonstrated experience in 

representing the interests of individuals 

with diabetes to accredit entities to 

furnish DSMT. The accreditation 

organization, after being approved and 

recognized by CMS, may accredit an 

entity to meet one of the sets of quality 

standards in § 410.144 (Quality 

standards for deemed entities). 

Section 1865(a)(2) of the Act further 

requires that we review the applying 

accreditation organization’s 

requirements for accreditation, as 

follows: 

• Survey procedures. 

• Ability to provide adequate 

resources for conducting required 

surveys. 

• Ability to supply information for 

use in enforcement activities. 

• Monitoring procedures for 

providers found out of compliance with 

the conditions or requirements. 

• Ability to provide CMS with 

necessary data for validation. 

We then examine the NAO’s 

accreditation requirements to determine 

if they meet or exceed the Medicare 

conditions as we would have applied 

them. Section 1865(a)(3)(A) of the Act 

requires that we publish a notice 

identifying the national accreditation 

body making the request within 30 days 

of receipt of a completed application. 

The notice must describe the nature of 

the request and provide at least a 30-day 

public comment period. We have 210 

days from receipt of the request to 

publish a finding of approval or denial 

of the application. If we recognize an 

accreditation organization in this 

manner, any entity accredited by the 

national accreditation body’s CMSapproved program for that service will 

be ‘‘deemed’’ to meet the Medicare 

conditions for coverage. 

II. Provisions of the Proposed Notice 

On February 24, 2012, we published 

a proposed notice in the Federal 

Register (77 FR 11130) entitled, 

‘‘Application by the American 

Association of Diabetes Educators 

(AADE) for Continued Recognition as a 

National Accreditation Organization for 

Accrediting Entities to Furnish 

Outpatient Diabetes Self-Management 

Training,’’ to notify the public of the 

AADE’s request for continued approval 

of its accreditation to deem entities 

furnishing DSMT services. 

III. Analysis of and Responses to Public 

Comments on the Proposed Notice 

We received 1 public comment in 

response to the February 24, 2012 

proposed notice. A summary of the 

comment and our response is set forth 

below. 

Comment: A commenter supported 

the approval of the AADE to deem 

DSMT programs. The commenter stated 

that the AADE provides guidance for its 

members and represents the values of 

the profession. The commenter further 

stated that qualified diabetes educators 

can lead the way toward a healthier 

population by guiding those with 

chronic conditions toward healthier 

lifestyles and stronger self-advocacy. 

Response: We thank the commenter 

for his or her comment. The goal of the 

DSMT program is to provide 


erowe on DSK2VPTVN1PROD with NOTICES
44256 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Notices 

beneficiaries with tools to better manage 

their diabetes and to achieve good 

clinical and behavioral outcomes. Based 

on the information submitted by the 

AADE, we believe that the AADE is 

striving to meet the same goals we 

developed for quality DSMT. 

IV. Provisions of the Final Notice 

AADE’s application to continue as an 

accredited NAO to deem entities for the 

purposes of DSMT is approved for a 

period of 3 years. The accreditation is 

effective on August 27, 2012. This 

approval is subject to renewal 

subsequent to the receipt of an 

application from the AADE and subject 

to review, evaluation, and approval of 

its program. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare-Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: July 3, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–17293 Filed 7–26–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0630] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Safety 

Considerations for 510(k) Submissions 

To Mitigate the Risks of 

Misconnections With Small-Bore 

Connectors Intended for Enteral 

Applications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Safety Considerations for 

510(k) Submissions to Mitigate the Risks 

of Misconnections with Small-bore 

Connectors Intended for Enteral 

Applications.’’ The use of common 

connector designs, such as luer 

connectors, has led to unintended 

connections between devices that have 

different intended uses and has resulted 

in serious and sometimes fatal 

consequences to patients. This guidance 

provides recommendations to 510(k) 

submitters regarding the submission 

expectations regarding design and 

testing to reduce the risk of unintended 

connections between enteral and 

nonenteral devices. This draft guidance 

is not final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 25, 

2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Safety 

Considerations for 510(k) Submissions 

To Mitigate the Risks of Misconnections 

With Small-Bore Connectors Intended 

for Enteral Applications’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Priya Venkataraman-Rao, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. G222, 

Silver Spring, MD 20993–0002, 301– 

796–6243. 

I. Background 

Multiple publications regarding 

patient injury and death from tubing 

and catheter misconnections indicate 

that reports of misconnections have 

gradually increased in frequency. On 

July 9, 2010, FDA issued a letter to 

health care professionals, hospital 

purchasing departments, and 

manufacturers of enteral feeding tubes 

regarding luer lock misconnections. 

FDA advised manufacturers to assess 

the risks of misconnections for their 

devices and provide proposed solutions 

with validation for premarket review. At 

that time, some manufacturers were 

using color coding and labeling to 

reduce the risk of misconnections; 

others were creating proprietary 

connectors designed to be incompatible 

with nonenteral devices. However, 

recent reports of adverse events have 

demonstrated that reliance on colorcoding of enteral devices alone cannot 

adequately mitigate the risk of 

misconnections, especially with 

similarly color-coded PICC 

(percutaneously inserted central 

catheter) lines on the market. 

This guidance provides updated 

recommendations to manufacturers on 

the submission requirements for 510(k)s 

for small-bore connectors used in 

enteral applications. The guidance 

recommends that 510(k) submitters (1) 

Design and test enteral connectors based 

on the Association for the Advancement 

of Medical Instrumentation (AAMI)/ 

American National Standards Institute 

(ANSI)/International Organization for 

Standardization (ISO) 80369–1, ‘‘SmallBore Connectors for Liquids and Gases 

in Healthcare Applications—Part 1: 

General Requirements’’ standard; (2) no 

longer rely strictly on color coding and 

tagging to prevent misconnections; and 

(3) perform risk assessments to 

demonstrate that the proposed design 

and testing has effectively mitigated the 

risk of the proposed enteral connector 

misconnecting to nonenteral devices. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on mitigating the risks of 

misconnections with small-bore 

connectors intended for enteral 

applications. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 


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