[Federal Register Volume 74, Number 226 (Wednesday, November 25, 2009)]
[Notices]
[Pages 62189-62191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26209]



  Federal Register / Vol. 74, No. 226 / Wednesday, November 25, 2009 / 
Notices  

[[Page 62189]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6023-N]


Medicare Program; Solicitation of Independent Accrediting 
Organizations To Participate in the Advanced Diagnostic Imaging 
Supplier Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces to independent accreditation 
organizations an opportunity to submit applications to participate in 
the advanced diagnostic imaging supplier accreditation program as a 
designated accreditation organization. Advanced diagnostic imaging 
accreditation is required for suppliers furnishing the technical 
component (TC) of advanced diagnostic imaging services. This notice 
contains information on accreditation application guidelines for CMS 
approval of suppliers who furnish the TC of advanced diagnostic imaging 
services.

DATES: Applications will be considered for the January 1, 2010 
designation deadline if received at the address, provided in the 
ADDRESSES section of this notice, no later than 5 p.m. eastern standard 
time (e.s.t.) on December 1, 2009.

ADDRESSES: Applications should be sent to the following: Attention: 
Sandra Bastinelli, Office of Financial Management, Mail stop C3-02-16, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244.

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) 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 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 an 
accreditation organization designated by the Secretary beginning 
January 1, 2012.

II. Provisions of the Notice

    This notice solicits applications from accreditation organizations 
with the ability to accredit the TC of at least one of the categories 
of advanced diagnostic imaging services.

A. Eligible Organizations

    An accreditation organization that can show evidence of the ability 
to accredit at least one of the categories of advanced diagnostic 
imaging services as defined in sections 1834(e)(1)(B) and 1848 
(b)(4)(B) of the Act is eligible to apply for approval as a designated 
accreditation organization.

B. Application Requirements

    To be considered for approval as a designated accreditation 
organization for Medicare requirements under 42 CFR 414.68, an 
accreditation organization must furnish to us all of the following 
information:
     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.
     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:

--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.

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--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 includes--
    ++ 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;
    ++ A list of all accreditation surveys scheduled to be performed by 
the organization;
    ++ A plan for reducing the burden and cost of accreditation to 
small and rural suppliers;
    ++ Information to demonstrate the accreditation organization's 
knowledge and experience in the advanced medical imaging arena;
    ++ 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.
     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 deeming 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.

    If, after review of an accreditation organization's submission of 
information we determine that additional information is necessary to 
make a determination for approval or denial of the accreditation 
organization's application, the organization will be notified and 
afforded an opportunity to provide additional information. We may visit 
the organization's office(s) to verify representations made in the 
organization's accreditation application. The site visit may include, 
but is not limited to, review of documents and interviews with the 
organization's staff. The accreditation organization will receive a 
formal notice from us stating whether the request for designation has 
been approved or denied, the rationale for any denial and 
reconsideration, and reapplication procedures.
    We will make every effort to issue a final decision within 30 days 
from the time we receive the completed accreditation reapplication. An 
accreditation organization may withdraw its application for designation 
under section 1834(e) of the Act at any time prior to the formal notice 
of approval or denial is received. An accreditation organization 
notified of a denial of request for designation may request a 
reconsideration in accordance with 42 CFR 488.201 through 488.211. Any 
accreditation organization whose request for approval of designation 
has been denied may resubmit the application if the organization--
     Revises its accreditation program to address the rationale 
for denial of its previous request;
     Provides reasonable assurance that its accredited 
companies meet applicable Medicare requirements; and
     Resubmits the application in its entirety. If an 
accreditation organization is denied reconsideration determination (as 
designated under section 1834(e) of the Act), the organization may not 
submit a new application as a designated accreditation organization for 
the type of modality that is at issue in the reconsideration until the 
reconsideration is final.

C. Application Deadline

    The deadline for the submission of applications is the date 
specified in the DATES section of this notice.

D. Evaluation of Applications

    A panel will evaluate all applications from accreditation 
organizations seeking designation under section 1834(e) of the Act 
using the existing survey and certification process as established in 
42 CFR part 488.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.

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     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs):
    We detailed the burden associated with the submission of advanced 
diagnostic imaging provider accreditation applications from independent 
accrediting bodies in the CY 2010 Physician Fee Schedule final rule 
that published elsewhere in this Federal Register. We are reprinting 
the discussion of the information collection requirements in this 
notice.
    Section 414.68(b) contains the application and reapplication 
procedures for accreditation organizations. Specifically, an 
independent accreditation organization applying for approval or 
reapproval of authority to survey suppliers for purposes of accrediting 
suppliers furnishing the technical component (TC) of advanced 
diagnostic imaging services must furnish CMS with all of the 
information listed in proposed Sec.  414.68(b)(1) through (14). The 
requirements include but are not limited to reporting, notification, 
documentation, and survey requirements.
    The burden associated with the collection requirements in Sec.  
414.68(b) is the time and effort necessary to develop, compile and 
submit the information listed in Sec.  414.68(b)(1) through (14). We 
believe all 3 entities will choose to comply with these requirements. 
We estimate that it will take each of the 3 entities, 80 hours to 
submit a complete application for approval or reapproval authority to 
become an accrediting organization approved by CMS.
    Section 414.68(c) contains the information collection requirements 
pertaining to CMS approved accrediting organizations. An accrediting 
organization approved by CMS must undertake all of the activities 
listed in Sec.  414.68(c)(1) through (6). The burden associated with 
the collection requirements in Sec.  414.68(c) is the time and effort 
necessary to develop, compile and submit the information listed in 
Sec.  414.68(c)(1) through (6). We believe that 3 entities will choose 
to comply with these requirements. We estimate that it will take each 
of the 3 entities, 80 hours to submit the required information on an 
ongoing basis.
    Section 414.68(d)(1) states that CMS or its contractor may conduct 
an audit of an accredited supplier, examine the results of a CMS 
approved accreditation organization's survey of a supplier, or observe 
a CMS approved accreditation organization's onsite survey of a 
supplier, in order to validate the CMS approved accreditation 
organizations accreditation process. The burden associated with this 
requirement is the time and effort necessary for an accrediting 
organization to comply with the components of the validation audit. 
While this requirement is subject to the PRA, we believe the associated 
burden is exempt as stated in 5 CFR 1320.3(h)(6). The burden associated 
with a request for facts addressed to a single person, as defined in 5 
CFR 1320.3(j), is not subject to the PRA.
    As stated in Sec.  414.68(e)(1), an accreditation organization 
dissatisfied with a determination that its accreditation requirements 
do not provide or do not continue to provide reasonable assurance that 
the suppliers accredited by the organization meet the applicable 
quality standards is entitled to a reconsideration. CMS reconsiders any 
determination to deny, remove, or not to renew the approval of deeming 
authority to an accreditation organization if the accrediting 
organization files a written request for reconsideration by its 
authorized officials or through its legal representative. The written 
request must be filed within 30 calendar days of the receipt of CMS' 
notice of an adverse determination or nonrenewal. In addition, the 
request must also specify the findings or issues with which the 
accreditation organization disagrees and the reasons for the 
disagreement.
    The burden associated with this requirement is the time and effort 
necessary for an accrediting organization to develop and file a written 
request for reconsideration. While this requirement is subject to the 
PRA, the associated burden is exempt under 5 CFR 1320.4. The 
information in question is being collected as a result of an 
administrative action; accrediting organizations are submitting 
requests for reconsideration after receiving a notice of an adverse 
decision.

    Authority:  Section 1834(e) of the Act.


    Dated: October 13, 2009.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare-Supplementary Medical Insurance Program)
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-26209 Filed 10-29-09; 8:45 am]
BILLING CODE 4120-01-P