Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program, 12848-12851 [2012-5013]
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12848
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices
Section 1311 for planning and
establishment of an Exchange within
one year of the enactment of the
Affordable Care Act, by Statute, it will
not be eligible for Section 1311
Exchange planning and establishment
money in the future. Section 1311 of the
Affordable Care Act provides for grants
to States for the planning and
establishment of these Exchanges. Given
the innovative nature of Exchanges and
the statutorily prescribed relationship
between the Secretary and States in
their development and operation, it is
critical that the Secretary work closely
with States to provide necessary
guidance and technical assistance to
ensure that States can meet the
prescribed timelines, federal
requirements, and goals of the statute.
In order to provide appropriate and
timely guidance and technical
assistance, the Secretary must have
access to timely, periodic information
regarding State progress. Consequently,
the information collection associated
with these grants is essential to
facilitating reasonable and appropriate
federal monitoring of funds, providing
statutorily mandated assistance to States
to implement Exchanges in accordance
with Federal requirements, and to
ensure that States have all necessary
information required to proceed, such
that retrospective corrective action can
be minimized.
There are two levels of awards for
States to apply for the Establishment
grants. Grants are open to States that
received federal funding for Exchange
Planning activities, awardees of the
Cooperative Agreements to Support
Innovative Exchange Information
Technology Systems, and awardees
under the Cooperative Agreement to
Support Establishment of StateOperated Health Insurance Exchanges.
Level One Establishment cooperative
agreements provide one year of funding
to States that are ready to initiate
establishment activities having made
progress under their Exchange Planning
grant. Level Two Establishment
cooperative agreements are designed to
provide funding to applicants for the
establishment of a State-based Exchange
and that can demonstrate specific
eligibility criteria. Level One
Establishment grantees may apply for
additional funding under Level Two
Establishment grants once they have
achieved the benchmarks identified in
the Level Two Establishment review
criteria.
HHS anticipates releasing this
funding opportunity on June 15, 2012.
There will be four opportunities for
applicants to apply for funding. HHS
anticipates Level One Establishment
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and Level Two Establishment
applications will be due: August 1,
2012; November 1, 2012; February 1,
2013; May 1, 2013; August 1, 2013;
November 1, 2013; February 3, 2014;
May 1, 2014; August 1, 2014; and
November 3, 2014. The Period of
Performance for Level One
Establishment grants is up to one year
after date of award. The Period of
Performance for Level Two
Establishment grants is up to three years
after date of award. Form Number:
CMS–10424 (OCN: 0938–NEW);
Frequency: Annually; Affected Public:
State, Local, or Tribal Governments.
Number of Respondents: 50. Number of
Responses: 325. Total Annual Hours:
49,175. (For policy questions regarding
this collection contact Katherine
Harkins at 301–492–4445. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by May 1, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: February 27, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–5011 Filed 2–27–12; 4:15 pm]
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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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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:
SUMMARY:
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—
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(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
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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):
• 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
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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.
• 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.
• Information that demonstrates the
accreditation organization’s knowledge
and experience in the advanced
diagnostic imaging arena.
• 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.
• Any specific documentation
requirements and attestations requested
by CMS as a condition of designation
under this part.
• 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,
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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 inservice 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.
• Detailed information about the size
and composition of survey teams for
each category of advanced medical
imaging service supplier accredited.
• 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.
• 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.
• 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.
• 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.
• A written presentation that
demonstrates the organization’s ability
to furnish CMS with electronic data in
ASCII comparable code.
• A resource analysis that
demonstrates that the organization’s
staffing, funding, and other resources
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are adequate to perform the required
surveys and related activities.
• 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
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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—
• 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.
An organization may not submit a
new application for the same type of
modality as that initially applied for,
until any reconsideration proceedings
under § 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 § 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.
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III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day 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.
• 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 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
§ 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 § 414.68(b) is
the time and effort necessary to develop,
compile and submit the information
listed in § 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
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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
§ 414.68(c)(1) through (6). The burden
associated with the collection
requirements in § 414.68(c) is the time
and effort necessary to develop, compile
and submit the information listed in
§ 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 caseby-case basis. If we determine that the
number of submissions may exceed the
threshold of 10 or more persons in a 12month 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
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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 § 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]
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Agencies
[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12848-12851]
From the Federal Register Online via the Government Printing 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):
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.
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.
Information that demonstrates the accreditation
organization's knowledge and experience in the advanced diagnostic
imaging arena.
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.
Any specific documentation requirements and attestations
requested by CMS as a condition of designation under this part.
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.
Detailed information about the size and composition of
survey teams for each category of advanced medical imaging service
supplier accredited.
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.
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.
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.
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.
A written presentation that demonstrates the
organization's ability to furnish CMS 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 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--
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.
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:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
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 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