4088 Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6023–N2] 

Medicare Program; Approval of 

Independent Accrediting Organizations 

To Participate in the Advanced 

Diagnostic Imaging Supplier 

Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces our 

approval of the following three national 

accreditation organizations to accredit 

suppliers seeking to furnish the 

technical component (TC) of advanced 

diagnostic imaging services under the 

Medicare program: the American 

College of Radiology (ACR); the 

Intersocietal Accreditation Commission 

(IAC); and The Joint Commission (TJC). 

FOR FURTHER INFORMATION CONTACT: 

August Nemec, (410) 786–0612. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 135(a) of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA) added 

section 1834(e) of the Social Security 

Act (the Act) that requires the Secretary 

to designate organizations in order to 

accredit suppliers furnishing the 

technical component (TC) of advanced 

diagnostic imaging service and establish 

procedures to ensure that the criteria 

used by an accreditation organization is 

specific to each imaging modality. 

Section 1834(e)(1)(B) of the Act defines 

advanced diagnostic imaging services 

as— 

(i) Diagnostic magnetic resonance imaging, 

computed tomography, and nuclear 

medicine-including positron emission 

tomography; and 

(ii) Such other diagnostic imaging services, 

including services described in section 

1848(b)(4)(B) (excluding x-ray, ultrasound, 

and fluoroscopy), as specified by the 

Secretary in consultation with physician 

specialty organizations and other 

stakeholders. 

Section 1848(b)(4)(B) of the Act 

defines imaging services as ‘‘imaging 

and computer-assisted imaging services, 

including x-ray, ultrasound (including 

echocardiography), nuclear medicine 

(including positron emission 

tomography), magnetic resonance 

imaging, computed tomography, and 

fluoroscopy, but excluding diagnostic 

and screening mammography. 

Suppliers, including physicians, nonphysician practitioners and physician 

and non-physician organizations, of the 

TC of advanced diagnostic imaging 

services for which payment is made 

under the fee schedule established 

under section 1848(b) of the Act, must 

become accredited by a designated 

accreditation organization designated by 

the Secretary beginning January 1, 2012. 

II. Application Requirements, Review, 

and Approval 

The application requirements for 

accrediting organizations were finalized 

in the Physician Fee Schedule final rule 

published on November 25, 2009 (74 FR 

61738) and set forth as application 

criteria in a November 25, 2009 Federal 

Register notice (74 FR 62189), as 

corrected in the November 30, 2009 

correction notice (74 FR 62579). 

We received three applications from 

our solicitation of accrediting 

organizations. An internal professional 

panel reviewed and compared the 

standards contained in the applications 

with our requirements in 42 CFR 

414.68. Accordingly, to be considered 

for approval as a designated 

accreditation organization, each of 

accreditation organization had to 

furnish the following information 

specified in 42 CFR 414.l68: 

• A list of the categories of advanced 

diagnostic imaging services for which 

the organization is requesting approval. 

• A description of the accrediting 

organization’s duration of accreditation 

(annual, biennual, and triennial), to 

include a summary of activities that 

occur at each cycle. 

• A detailed description of how the 

organization’s accreditation criteria 

satisfy the statutory standards at section 

1834(e)(3) of the Act, including the 

following: 

++ Qualifications of medical 

personnel who are not physicians and 

who furnish the TC of advanced 

diagnostic imaging services. 

++ Qualifications and responsibilities 

of medical directors and supervising 

physicians, such as training in advanced 

diagnostic imaging services in a 

residency program, expertise obtained 

through experience or continuing 

medical education courses. 

++ Procedures to ensure the safety of 

persons who furnish the TC of advanced 

diagnostic imaging services and 

individuals to whom such services are 

furnished. 

++ Procedures to ensure the 

reliability, clarity, and accuracy of the 

technical quality of diagnostic images 

produced by the supplier. 

++ Procedures to assist the 

beneficiary in obtaining the 

beneficiary’s imaging records on 

request. 

++ Procedures to notify CMS of any 

changes to the modalities subsequent to 

the organization’s accreditation 

decision. 

• An agreement to conform 

accreditation requirements to any 

changes in Medicare statutory 

requirements authorized by 1834(e) of 

the Act. 

• An agreement to maintain or adopt 

standards that are equal to, or more 

stringent than, those of Medicare. 

• Information that demonstrates the 

accreditation organization’s knowledge 

and experience in the advanced 

diagnostic imaging arena. 

• A plan for reducing the burden and 

cost of accreditation to small and rural 

suppliers— 

++ The organization’s proposed fees 

for accreditation for each modality in 

which the organization intends to offer 

accreditation; and 

++ Any specific documentation 

requirements and attestations requested 

by CMS as a condition of designation. 

• A detailed description of the 

organization’s survey process, to 

include the following: 

++ Type and frequency of the surveys 

performed. 

++ The ability of the organization to 

conduct timely reviews of accreditation 

applications, to include a projection of 

the organization’s national capacity for 

processing new applications before the 

January 1, 2012 accreditation deadline. 

++ Description of the organization’s 

audit procedures, including random site 

visits; site audits or other strategies for 

ensuring suppliers accredited by the 

organization maintain compliance 

throughout the period of accreditation. 

++ Procedures for performing 

unannounced site surveys. 

++ Copies of the organization’s 

survey forms. 

++ A description of the accreditation 

survey review process and the 

accreditation status decision-making 

process, including the process for 

addressing identified deficiencies with 

the accreditation requirements, and the 

procedures used to monitor the 

correction of deficiencies found during 

an accreditation survey. 

++ Procedures for coordinating 

surveys with another accrediting 

organization (when the organization 

does not accredit all modalities) 

provided by an applicant for 

accreditation which the supplier 

provided. 

++ Comprehensive information about 

the individuals who perform 

evaluations for the accreditation 

organization, including all of the 

following information: 

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Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / Notices 4089 

—Detailed information about the size 

and composition of accreditation 

teams for each category of advanced 

medical imaging service supplier 

accredited. 

—The number of professional and 

technical staff that are available for 

survey. 

—The education, current employment 

and experience requirements 

surveyors must meet. 

—The content and length of any 

orientation program. 

—The frequency and types of in-service 

training provided to survey personnel. 

—The evaluation systems used to 

monitor the performance of 

individual surveyors and survey 

teams. 

—Policies and procedures regarding an 

individual’s participation in the 

survey or accreditation decision 

process of any organization with 

which the individual is professionally 

or financially affiliated. 

++ Policies and procedures used 

when an organization has a dispute 

regarding survey findings or an adverse 

decision. 

• A description of the organization’s 

data management and analysis 

capabilities in support of its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• The organization’s procedures for 

investigating and responding to 

complaints against accredited facilities, 

including policies and procedures 

regarding coordination of these 

activities with relevant licensing bodies 

and CMS. 

• A description of the organization’s 

policies and procedures for withholding 

or removal of accreditation status for 

facilities that fail to meet the 

organization’s accreditation standards 

and other actions taken by the 

organization in response to 

noncompliance with its accreditation 

criteria. These policies and procedures 

must include notifying CMS of facilities 

that fail to meet the requirements of the 

accrediting organization as required by 

CMS. 

• The information submitted for 

notification of these organizations 

include— 

++ A list of all accredited suppliers 

that the accrediting organization has 

accredited to include the type and 

category of accreditation currently held 

by each supplier, and the expiration 

date of each supplier’s current 

accreditation; and 

++ A list of all accreditation surveys 

scheduled to be performed by the 

organization. 

• The accreditation organization must 

also submit the following supporting 

documentation: 

++ A written presentation that 

demonstrates the organization’s ability 

to furnish us with electronic data in 

ASCII comparable code. 

++ A resource analysis that 

demonstrates that the organization’s 

staffing, funding, and other resources 

are adequate to perform the required 

surveys and related activities. 

+ A statement acknowledging that, as 

a condition for approval the 

organization will agree to the following: 

—Provide a statement agreeing to notify 

us, in writing, of any supplier that 

had its accreditation revoked, 

withdrawn, revised, or any other 

remedial or adverse action taken 

against it by the accreditation 

organization within 30 calendar days 

of any such action taken. 

—Notify all accredited suppliers within 

10 calendar days of our withdrawal of 

the organization’s approval of 

designation authority. 

—Notify us, in writing, at least 30 

calendar days in advance of the 

effective date of any proposed 

changes in accreditation 

requirements. 

—Permit its surveyors to serve as 

witnesses if we take an adverse action 

based on accreditation findings. 

—Notify us, in writing, within 2 

calendar days of a deficiency 

identified in any accreditation entity 

where the deficiency poses an 

immediate jeopardy to the supplier’s 

beneficiaries or a hazard to the 

general public. 

—Provide, on an annual basis, summary 

data specified by us that relates to the 

past years’ accreditations and trends. 

—Attest that the organization will not 

perform any accreditation surveys of 

Medicare participating suppliers with 

which it has a financial relationship 

with or interest. For further 

information regarding the application 

requirements see the November 25, 

2009 (74 FR 62189) and November 30, 

2009 (74 FR 62579) notices. 

The three national accreditation 

organizations that have applied for 

approval provided us with 

demonstrated evidence of their ability to 

accredit the categories of advanced 

diagnostic imaging services as defined 

in sections 1834(e)(1)(B) and 1848 

(b)(4)(B) of the Act. Therefore, we are 

initially approving the following 

designated accreditation organizations 

to accredit suppliers furnishing the TC 

of all advanced imaging modalities (that 

is, computerized tomography, nuclear 

medicine, positron emission 

tomography, and magnetic resonance 

imaging) on or after January 1, 2010: (1) 

American College of Radiology (ACR); 

(2) the Intersocietal Accreditation 

Commission (IAC); and (3) The Joint 

Commission (TJC). 

Authority: Section 1834(e) of the Act. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, MedicareSupplementary Medical Insurance Program) 

Dated: January 20, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–1457 Filed 1–22–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Respiratory 

Integrative Biology and Translational 

Research Study Section, February 4, 

2010, 8:30 a.m. to February 5, 2010, 12 

p.m., Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD, 20814 which 

was published in the Federal Register 

on January 8, 2010, 75 FR 1066–1067. 

The meeting will be held February 3, 

2010, to February 4, 2010. The meeting 

time and location remain the same. The 

meeting is closed to the public. 

Dated: January 15, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–1404 Filed 1–25–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Neurobiology of 

Motivated Behavior Study Section, 

February 4, 2010, 8 a.m. to February 5, 

2010, 5 p.m., Bahia Resort Hotel, 998 

West Mission Bay Drive, San Diego, CA, 

92109 which was published in the 

FEDERAL REGISTER on January 8, 2010, 75 

FR 1066–1067. 

The meeting will be held at the 

Catamaran Resort Hotel and Spa, 3999 

Mission Boulevard, San Diego, CA 

92109. The meeting dates and time 

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