Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 59701 

Kimberly S. Lane, 

Deputy Director, Office of Scientific Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2013–23534 Filed 9–26–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6023–N3] 

Medicare Program; Approval of 

Accrediting Organization for Suppliers 

of Advanced Diagnostic Imaging 

Supplier Accreditation Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces our 

approval of RadSiteTM, a national 

accreditation organization to accredit 

suppliers seeking to furnish the 

technical component (TC) of advanced 

diagnostic imaging services under the 

Medicare program. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Bastinelli (410) 786–3630. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 135(a) of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA) added 

section 1834(e) to the Social Security 

Act (the Act) requiring the Secretary to 

designate organizations that accredit 

suppliers furnishing the technical 

component (TC) of advanced diagnostic 

imaging (ADI) service and establish 

procedures to ensure that the criteria 

used by an accreditation organization 

are specific to each imaging modality. 

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

advanced diagnostic imaging services 

as— 

(i) [D]iagnostic magnetic resonance 

imaging, computed tomography, and nuclear 

medicine (including positron emission 

tomography); and 

(ii) [S]uch 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, which include physicians, 

non-physician 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, were required to be accredited by 

an accreditation organization designated 

by the Secretary beginning January 1, 

2012. 

The application requirements for 

accrediting organizations were finalized 

in the Calendar Year 2010 Physician Fee 

Schedule final rule published on 

November 25, 2009 (74 FR 61738), as 

corrected in the November 30, 2009 

correcting document (74 FR 62579) 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). 

In the January 26, 2010, Federal 

Register (75 FR 4088), we announced 

the approval of the American College of 

Radiology (ACR), the Intersocietal 

Accreditation Commission (IAC), and 

The Joint Commission (TJC) as 

designated accreditation organizations 

to accredit suppliers furnishing the 

technical component of the following 

advanced diagnostic imaging 

modalities: Computerized tomography, 

nuclear medicine, positron emission 

tomography, and magnetic resonance 

imaging. 

II. Application Requirements, Review, 

and Approval 

We received the completed 

application from RadSiteTM to be 

considered as a designated accreditation 

organization for advanced diagnostic 

imaging services on January 18, 2011. 

An internal professional panel reviewed 

and compared the standards contained 

in the application with our 

requirements in 42 CFR 414.68. 

Accordingly, to be considered for 

approval as a designated accreditation 

organization, the accreditation 

organization had to furnish the 

following information specified in 42 

CFR 414.68(c): 

• 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, biannual, 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 that include— 

++ 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. 

++ 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. 


pmangrum on DSK3VPTVN1PROD with NOTICES
59702 Federal Register / Vol. 78, No. 188 / Friday, September 27, 2013 / Notices 

++ 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: 

—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.) 

We have complete our review and 

believe that RadSiteTM has provided us 

with demonstrated evidence of their 

qualifications and ability to accredit the 

categories of advanced diagnostic 

imaging services to include 

computerized tomography, nuclear 

medicine, positron emission 

tomography, and magnetic resonance 

imaging as defined in sections 

1834(e)(1)(B) and 1848(b)(4)(B) of the 

Act. Therefore this notice announces 

our approval of RadSiteTM 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 September 27, 2013. 

Authority: Section 1834(e) of the Act. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, MedicareSupplementary Medical Insurance Program) 

Dated: September 19, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–23664 Filed 9–26–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–4167–N] 

Medicare Program; Medicare Appeals: 

Adjustment to the Amount in 

Controversy Threshold Amounts for 

Calendar Year 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

annual adjustment in the amount in 

controversy (AIC) threshold amounts for 

Administrative Law Judge (ALJ) 

hearings and judicial review under the 

Medicare appeals process. The 

adjustment to the AIC threshold 

amounts will be effective for requests 

for ALJ hearings and judicial review 

filed on or after January 1, 2014. The 

calendar year 2014 AIC threshold 


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