Medicare Program; Solicitation for Proposals for the Medicare Imaging Demonstration

AGENCY:

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

ACTION:

Notice.

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.

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 § 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 § 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 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)