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[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43178-43180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18139]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-5047-N]

Medicare Program; Solicitation for Proposals for the Medicare 
Imaging Demonstration

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

ACTION: Notice.

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SUMMARY: This notice informs interested parties (here in there after 
referred to as conveners) of an opportunity to apply to participate in 
the Medicare Imaging Demonstration (MID) that was authorized by section 
135(b) of the Medicare Improvements for Patients and Providers Act of 
2008 (MIPPA). The goal of the MID is to collect data regarding 
physician compliance with appropriateness criteria selected by the 
Secretary under the terms of the statute in order to determine the 
appropriateness of advanced diagnostic imaging services furnished to 
Medicare beneficiaries.

DATES: Proposals will be considered timely if they are received on or 
before 5 p.m., Eastern Standard Time (E.S.T.) on September 21, 2010.

[[Page 43179]]

ADDRESSES: Proposals should be mailed to the following address: Centers 
for Medicare & Medicaid Services, Attention: Linda R. Lebovic, 7500 
Security Boulevard, Mail Stop: C4-17-27, Baltimore, Maryland 21244-
1850.

FOR FURTHER INFORMATION CONTACT: Linda R. Lebovic at (410) 786-3402 or 
by e-mail at ImagingDemo135b@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:
    General Information: Please refer to file code [CMS-5047-N] on the 
application. Proposals (an unbound original and 3 copies plus an 
electronic copy on CD-ROM) must be typed for clarity and should not 
exceed 40 double-spaced pages, exclusive of cover letter, the executive 
summary, resumes, forms, and supporting documentation. Because of 
staffing and resource limitations, we cannot accept proposals by 
facsimile (FAX) transmission. Applicants may, but are not required to, 
submit a total of 10 copies to assure that each reviewer receives a 
proposal in the manner intended by the applicant (for example, 
collated, tabulated color copies). Hard copies and electronic copies 
must be identical.
    Eligible Organizations: CMS anticipates that a wide variety of 
interested parties may be eligible to apply as conveners or in 
collaboration with other organizations to perform the responsibilities 
specified. Examples of conveners include, but are not limited to, 
medical specialty societies, physician groups, integrated health care 
delivery systems, independent practice associations, radiology benefit 
managers, health plans, information technology vendors, and 
collaborations among the above parties.

I. Provisions of This Notice

    This notice informs interested parties (here in there after 
referred to as conveners) of an opportunity to apply to participate in 
the Medicare Imaging Demonstration (MID) that was authorized by section 
135(b) of the Medicare Improvements for Patients and Providers Act of 
2008 (MIPPA). The goal of the MID is to collect data regarding 
physician compliance with appropriateness criteria selected by the 
Secretary under the terms of the statute in order to determine the 
appropriateness of advanced diagnostic imaging services furnished to 
Medicare beneficiaries. The authorizing legislation allows the 
Secretary to include in the demonstration advanced diagnostic imaging 
services such as those defined in Sec.  1834(e)(1)(B) of the Social 
Security Act (the Act): Diagnostic magnetic resonance imaging (MRI), 
computed tomography (CT), nuclear medicine (including positron emission 
tomography) and such other diagnostic imaging services, including 
services described in Sec.  1848(b)(4)(B) of the Act (excluding X-ray, 
ultrasound, and fluoroscopy), as specified by the Secretary in 
consultation with physician specialty organizations and other 
stakeholders. The law requires that the appropriateness criteria used 
in the demonstration be based on those developed or endorsed by medical 
specialty societies. The Centers for Medicare & Medicaid Services (CMS) 
worked with medical specialty societies and other stakeholders, 
including the AQA Alliance, to get their input and information on 
available appropriateness criteria. For purposes of this demonstration, 
the ``appropriateness criteria'' referenced in the statute will be 
published medical specialty society guidelines relevant to the 11 
procedures studied in the demonstration that are developed or endorsed 
by relevant medical specialty societies, are consistent with the spirit 
of section 135(b)(2)(B)(ii)(II), and which have been selected by the 
Secretary under the terms of the statute. (We believe the 
appropriateness criteria are the product of consensus and meet the 
spirit of section 135(b)(2)(B)(ii)(II) of MIPPA. Consequently, 
published medical specialty society guidelines relevant for the 11 
procedures are included in the demonstration.
    The law prohibits the use of prior authorization in the 
demonstration. The design of the demonstration will permit evaluation 
of the appropriateness of imaging services across a range of advanced 
diagnostic imaging studies, geographic areas, demographic 
characteristics and practice settings (such as private and academic 
practices) in the Medicare fee-for-service program. CMS is seeking 
participation by 2,500 to 3,500 physicians from 500 to 650 physician 
practices that vary in size, specialty mix, type (academic and private 
practice), and location (urban, rural, and suburban) to obtain 
substantial sample size for the evaluation.
    The demonstration will test whether the use of decision support 
systems (DSSs) can improve quality of care and reduce unnecessary 
radiation exposure and utilization by promoting appropriate ordering of 
advanced diagnostic imaging services. Physician practices will receive 
feedback on the degree of appropriateness relative to the specified 
medical specialty society guidelines used under the demonstration.
    CMS is seeking conveners that can provide a panel of participating 
physician practices that agree to use an advanced diagnostic imaging 
DSS for purposes of this demonstration. The Secretary has chosen to use 
conveners as a vehicle to recruit physician practices for participation 
in the demonstration because it is expected that the likely applicants 
for the convener have well developed relationships (or the ability to 
establish) with a significant network of physicians that could be 
potential applicants for participation in the demonstration. Therefore, 
conveners would be highly effective at providing a robust panel of 
physicians that could satisfy the selection requirements outlined in 
the statute. The convener will secure a DSS for advanced diagnostic 
imaging services that will remain current with the medical specialty 
society guidelines used under the demonstration, recruit physician 
practices, and make the DSS available to physician practices 
participating in the demonstration. Through the DSS, a convener will 
collect data on physician ordering of the specified services and test 
results, and provide feedback to physicians on ordering 
appropriateness. The convener will also distribute payments (as 
determined by CMS) to the participating practices for reporting data. 
In this capacity, the convener will be responding to the solicitation 
on its behalf as applicant. For the demonstration, interested parties 
may need to collaborate as a convener in order to have a panel of 
participating physician practices, the availability of the DSS for use 
by the physician practices, and must comply with demonstration 
requirements.
    A competitive process will be used to select conveners. CMS 
anticipates selecting up to six conveners to participate in the 2-year 
demonstration. CMS is aware that certain arrangements under this 
demonstration could raise possible fraud, waste, and abuse concerns, 
including concerns under the anti-kickback statute and the physician 
self-referral law. While CMS has the authority to waive the application 
of certain fraud, waste, and abuse laws, it is anticipated that doing 
so, if at all, will only occur after evaluating the provisions of the 
proposals on a case-by-case basis and considering whether a waiver is 
necessary to carry out the demonstration project.
    Physician practices must apply through a convener and the 
convener's application must include the criteria and rationale for 
recruiting physician practices and obtaining their buy-in for the use 
of the DSS. The Secretary has

[[Page 43180]]

chosen to use conveners as a vehicle to recruit physician practices for 
participation in the demonstration because it is expected that the 
likely applicants for the convener have well developed relationships 
(or the ability to establish) with a significant network of physicians 
that could be potential applicants for participation in the 
demonstration. Therefore, conveners would be highly effective at 
providing a robust panel of physicians that could satisfy the selection 
requirements outlined in the statute. Conveners must also disclose in 
the application whether the DSS may be retained by the participating 
practice after the demonstration is concluded and whether the DSS may 
be used to order items and services other than the subject imaging 
services.
    Applicants must submit their applications in the standard format 
outlined in CMS' Medicare Waiver Demonstration Application and MID 
solicitation in order to be considered for review by the technical 
review panel. Applications not received in this format will not be 
considered for review.
    The Medicare Waiver Demonstration Application can be found 
electronically at: http://www.cms.hhs.gov/cmsforms/downloads/cms10069.pdf.
    For specific details regarding the MID, please refer to the 
solicitation on the CMS Web site at: http://www.cms.hhs.gov/DemoProjectsEvalRpts/downloads/Medicare_Imaging_Demonstration.pdf.

II. Collection of Information Requirements

    Section 135(b)(4)(A) of the MIPPA (Pub. L. 110-275) exempts this 
demonstration from the Chapter 35 of Title 44 of the United States 
Code; however, the collection form entitled ``Medicare Demonstration 
Waiver Application'' is currently approved under OMB control number 
0938-0880.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: April 1, 2010.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-18139 Filed 7-22-10; 8:45 am]
BILLING CODE 4120-01-P
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