[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59701-59702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23664]


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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.

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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.

[[Page 59702]]

    ++ 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, 
Medicare-Supplementary 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