[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12848-12851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5013]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6043-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.

-----------------------------------------------------------------------

SUMMARY: This notice invites independent accreditation organizations 
who have not previously submitted applications to participate in the 
advanced diagnostic imaging supplier accreditation program as a 
designated accreditation organization, for the purpose of accrediting 
suppliers furnishing the technical component (TC) of advanced 
diagnostic imaging services. It also sets forth the application 
guidelines for approval of organizations wishing to accredit suppliers 
furnishing the TC of advanced diagnostic imaging services.

DATES: Applications will be considered if received at the address 
provided in the ADDRESSES section of this notice, no later than 5 p.m. 
daylight savings time (d.s.t.) on May 1, 2012.

ADDRESSES: Applications should be sent to the following: Attention: 
Sandra Bastinelli, Mail stop AR-18-50, 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) to the Social 
Security Act (Act). Section 1834(e) of the Act requires the Secretary 
to designate organizations to accredit suppliers furnishing the 
technical component (TC) of advanced diagnostic imaging services 
(section 1834(e)(2)(B) of the Act), and to establish procedures to 
ensure that the criteria used by such accrediting organizations to 
accredit TC suppliers are specific to each imaging modality and meet 
the requirements of the statute (section 1834(e)(3)). Section 1834 
(e)(1)(B) of the Act defines advanced diagnostic imaging services as--


[[Page 12849]]


    (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 (that is, the Physician Fee Schedule 
(FFS)), must become accredited by an accreditation organization 
designated by the Secretary (for the TC of the defined advanced 
diagnostic imaging services) on or after January 1, 2012 in order to 
receive payment from Medicare.
    We implemented these statutory provisions via the CY 2010 PFS final 
rule which appeared in the November 25, 2009 Federal Register 
(``Medicare Program; Payment Policies Under the Physician Fee Schedule 
and Other Revisions to Part B for CY 2010'' (74 FR 61738). This final 
rule set out criteria for designating organizations to accredit 
suppliers furnishing the TC of advanced diagnostic imaging services, as 
specified in section 1834(e) of the Act. In addition, 45 CFR 414.68(h) 
specifies our procedures for ensuring that accreditation organizations 
correctly apply the criteria to ensure that suppliers are meeting 
minimum standards for each imaging modality.
    In the same issue of the Federal Register, we published a notice 
soliciting applicants for participation in the advanced diagnostic 
imaging supplier accreditation program as designated accreditation 
organizations (``Medicare Program; Solicitation of Independent 
Accrediting Organizations To Participate in the Advanced Diagnostic 
Imaging Supplier Accreditation Program'', (74 FR 62189), November 25, 
2009). As a result of this solicitation, we published a second Federal 
Register notice (Medicare Program; Approval of Independent Accrediting 
Organizations To Participate in the Advanced Diagnostic Imaging 
Supplier Accreditation Program'' (January 26, 2010 (75 FR 4088)) 
announcing approval of three national accreditation organizations to 
accredit suppliers seeking to furnish the 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).

II. Provisions of the Notice

    This notice solicits additional applications from accreditation 
organizations with the ability to accredit the TC of at least one of 
the categories of advanced diagnostic imaging services as defined at 42 
CFR 414.68(b).

A. Eligible Organizations

    Any 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 imaging services accreditation organization. As previously 
noted, this notice solicits applications from accrediting organizations 
that have not previously applied; the three existing designated 
accreditation organizations and current applicants are not required to 
reapply.

B. Application Requirements

    To be considered for approval as a designated accreditation 
organization for Medicare requirements under 42 CFR 414.68 and as 
defined by sections 1834(e)(1)(B) and 1848 (b)(4)(B) of the Act an 
accreditation organization must furnish us with the following, as 
specified in 42 CFR 414.68(c):
    <bullet> A detailed description of how the organization's 
accreditation criteria satisfy the statutory standards at section 
1834(e)(3)of the Act, including--
    ++ 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 (who may be the same person), such as their 
training in advanced diagnostic imaging services in a residency 
program, expertise obtained through experience, or continuing medical 
education courses.
    ++ Procedures to ensure the reliability, clarity, and accuracy of 
the technical quality of diagnostic images produced by the supplier, 
including a thorough evaluation of equipment performance and safety;
    ++ 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 assist the beneficiary in obtaining the 
beneficiary's imaging record on request; and
    ++ Procedure to notify the accreditation organization of any 
changes to the modalities subsequent to the organizations' 
accreditation decision.
    <bullet> An agreement to conform accreditation requirements to any 
changes in Medicare statutory requirements authorized by section 
1834(e) of the Act. The accreditation organization must maintain or 
adopt standards that are equal to, or more stringent than, those of 
Medicare.
    <bullet> Information that demonstrates the accreditation 
organization's knowledge and experience in the advanced diagnostic 
imaging arena.
    <bullet> The organization's proposed fees for accreditation for 
each modality in which the organization intends to offer accreditation, 
including any plans for reducing the burden and cost of accreditation 
to small and rural suppliers.
    <bullet> Any specific documentation requirements and attestations 
requested by CMS as a condition of designation under this part.
    <bullet> A detailed description of the organization's survey 
process, including the following:
    ++ Type and frequency of the surveys performed.
    ++ The ability of the organization to conduct timely reviews of 
accreditation applications, to include the organizations national 
capacity.
    ++ Description of the organization's audit procedures, including 
random site visits, site audits, or other strategies for ensuring 
suppliers maintain compliance for the duration of accreditation.
    ++ Procedures for performing unannounced site surveys.
    ++ Copies of the organizations survey forms.
    ++ A description of the accreditation survey review process and the 
accreditation status decision-making process, including the process for 
addressing deficiencies identified what 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 if the organization does not accredit all products the 
supplier provides.
    ++ Detailed information about the individuals who perform 
evaluations for the accreditation organization,

[[Page 12850]]

including all of the following information:
--The number of professional and technical staff that are available for 
surveys.
--The education, employment, and experience requirements surveyors must 
meet.
--The content and length of the 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.
    ++ The 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.
    ++ The policies and procedures used when an organization has a 
dispute regarding survey findings or an adverse decision.
    <bullet> Detailed information about the size and composition of 
survey teams for each category of advanced medical imaging service 
supplier accredited.
    <bullet> A description of the organization's data management and 
analysis system for its surveys and accreditation decisions, including 
the kinds of reports, tables, and other displays generated by that 
system.
    <bullet> The organization's procedures for responding to and for 
the investigation of complaints against accredited facilities, 
including policies and procedures regarding coordination of these 
activities with appropriate licensing bodies and CMS.
    <bullet> The organization's policies and procedures for the 
withholding or removal accreditation status for facilities that fail to 
meet the accreditation organization's standards or requirement, and 
other actions taken by the organization in response to noncompliance 
with its standards and requirements. These policies and procedures must 
include notifying CMS of Medicare facilities that fail to meet the 
requirements of the accrediting organization.
    <bullet> A list of all currently accredited suppliers, the type and 
category of accreditation currently held by each supplier, and the 
expiration date of each supplier's current accreditation.
    <bullet> A written presentation that demonstrates the 
organization's ability to furnish CMS with electronic data in ASCII 
comparable code.
    <bullet> A resource analysis that demonstrates that the 
organization's staffing, funding, and other resources are adequate to 
perform the required surveys and related activities.
    <bullet> A statement acknowledging that, as a condition for 
approval of designation, the organization agrees to:
    ++ Notify CMS, in writing, of any Medicare 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 supplier within 10 calendar days of the 
organizations' removal for the list of designated accreditation 
organizations.
    ++ Notify CMS, in writing, at least 30 calendar days in advance of 
the effective date of any significant proposed changes in its 
accreditation requirements.
    ++ Permit its surveyors to serve as witnesses if CMS takes an 
adverse action based on accreditation findings.
    ++ Notify CMS, in writing (electronically or hard copy), within 2 
business days of a deficiency identified in any accreditation supplier 
from any source 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 CMS that 
relates to the past year's accreditations and trends.
    ++ Attest that the organization will not perform any accreditation 
surveys of Medicare-participating suppliers with which it has a 
financial relationship in which it has an interest.
    ++ Conform accreditation requirements to changes in Medicare 
requirements.
    ++ If CMS withdraws an accreditation organization's approved 
status, work collaboratively with CMS to direct suppliers to the 
remaining accreditation organizations within a reasonable period of 
time.

C. Application Deadline and Notification of Receipt

    The deadline for the submission of applications is the date 
specified in the DATES section of this notice. We will acknowledge 
receipt of applications via email.

D. Evaluation of Application

    A professional and medical panel will evaluate all applications 
from accreditation organizations seeking designation under section 
1834(e) of the Act.
    If we determine that additional information is necessary to make a 
determination for approval or denial of the accreditation 
organization's application for designation, we will notify the 
organization and afford it an opportunity to provide the additional 
information. We may also visit the organization's offices to verify 
representations made by the organization in its application, including, 
but not limited to, reviewing documents and interviewing the 
organization's staff.

E. Approval of Application

    The accreditation organization will receive a formal notice via 
mail from CMS approving or denying the request for consideration. If 
denied, the notice will state the basis for denial, and include 
information about seeking reconsideration and reapplication procedures. 
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 reconsideration in accordance with 42 CFR 414.68(i). Any 
accreditation organization whose request for approval of designation 
has been denied may also resubmit the application to us if the 
organization--
    <bullet> Revises its accreditation program to address the rationale 
for denial of its previous request;
    <bullet> Provides reasonable assurance that its accredited 
companies meet applicable Medicare requirements; and
    <bullet> Resubmits the application in its entirety.
    An organization may not submit a new application for the same type 
of modality as that initially applied for, until any reconsideration 
proceedings under Sec.  414.68(i) with respect to the previous 
application are completed.
    We will publish a Federal Register document notifying the public of 
the approved applicants.

F. Term of Approval of Designation of Accreditation Organizations

    Under section 1834(e)(2)(C)(i) of the Act, the Secretary shall 
review the list of accreditation organizations designated, taking into 
account the performance of such organizations, and may, by regulation, 
modify the list of accreditation organizations designated. Our 
regulations at Sec.  414.68(h) set out the specific criteria and 
procedures for continuing CMS oversight of approved accreditation 
organizations, and for withdrawing approval of a CMS approved 
accreditation organization. There is no stated period of performance 
related to this accreditation designation.

[[Page 12851]]

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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We detailed the burden associated with the submission of advanced 
diagnostic imaging provider accreditation applications from independent 
accrediting bodies in the CY 2010 PFS final rule that published 
November 25, 2009 (74 FR 61738). We are summarizing 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 
estimate that it will take an entity 80 hours to submit a complete 
application for approval or reapproval authority to become an 
accrediting organization approved by CMS. Three entities complied with 
these requirements during the initial round of submissions. Currently, 
we are only aware of one other entity that is eligible to submit an 
application. In addition, the three currently approved accrediting 
organizations are not required to resubmit applications. Furthermore, 
we are not able to accurately quantify the total number of entities 
that are eligible to comply with these requirements beyond those 
previously identified. While these requirements are subject to the PRA, 
we believe the associated burden is exempt under 5 CFR 1320.3(c)(4). 
This collection will impact less than 10 entities in a 12-month period. 
We cannot estimate the number of expected submissions from entities 
seeking to become accrediting organizations. We will review each 
submission on a case-by-case basis. If we determine that the number of 
submissions may exceed the threshold of 10 or more persons in a 12-
month period, as defined in 5 CFR 1320.3(c)(4), we will develop an 
information collection request as part of the formal OMB approval 
process.
    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 estimate that it will take the 
applicant entity 80 hours to submit the required information on an 
ongoing basis. As stated earlier, there are 3 currently approved 
accrediting organizations that have already complied with this 
requirement. In addition, we are only aware of one other entity that is 
eligible to submit an application; we are not able to accurately 
quantify the total number of entities that are eligible to comply with 
these requirements beyond those previously identified. While these 
requirements are subject to the PRA, we believe the associated burden 
is exempt under 5 CFR 1320.3(c)(4). This collection will impact less 
than 10 entities in a 12-month period. Because we cannot estimate the 
number of expected submissions from new CMS approved accrediting 
organizations, we will review each submission on a case-by-case basis. 
If we determine that the number of submissions may exceed the threshold 
of 10 or more persons in a 12-month period, as defined in 5 CFR 
1320.3(c)(4), we will develop an information collection request as part 
of the formal OMB approval process.
    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. We reconsider 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 our 
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 file, develop and file 
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 
determination.

    Authority: Section 1834(e) of the Act.

(Catalog of Federal Domestic Assistance Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)


    Dated: February 24, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-5013 Filed 3-1-12; 8:45 am]
BILLING CODE 4120-01-P