19 CERTIFICATE OF NEED REVIEW STANDARDS

 

CERTIFICATE OF NEED (CON) REVIEW STANDARDS SYNOPSIS FOR PUBLICATION IN THE MICHIGAN REGISTER

PURSUANT TO THE ADMINISTRATIVE PROCEDURES ACT, 1969 PA 306, MCL 24.208(1)(k)

 

MAGNETIC RESONANCE IMAGING (MRI) SERVICES

 

Final Approval by the CON Commission 6/14/12 and Effective 9/28/12

 

The language changes include the following:

 

3.      Section 2:  Under subsection (1)(bb), added new definition for "MRI-Guided Electrophysiology intervention" or "MRI-Guided EPI" means equipment specifically designed for the integrated use of MRI technology for the purposes of electrophysiology interventional procedures within a cardiac catheterization lab.

·         “Medicaid” – has been updated.

·         Modified the definition of “MRI unit” to include:  Positron Emission Tomography (PET)/MRI Scanner Hybrids if used for MRI only procedures.

4.      Section 11:  Added new language allowing for an MRI-Guided EPI service to be located at a hospital that has an existing fixed MRI service that has been operational for 36 months and is meeting its minimum volume requirements.  The proposed site has an existing and operational therapeutic cardiac catheterization service and is meeting its minimum volume requirements. Its open heart surgery service must be meeting its minimum volume requirements too. Further, the MRI-guided EPI unit will not be subject to MRI volume requirements, and the applicant shall not utilize the procedures performed on the MRI-guided EPI unit to demonstrate need or to satisfy MRI CON review standards requirements.

3.      Section 12: Added new language allowing for the use of the PET/MRI scanner hybrid to be used for stand-alone MRI procedures.  There must be an approved PET CON, and it must be in compliance with applicable project delivery requirements as set forth in the CON review standards for PET.  In addition, the FDA-approved PET/MRI scanner hybrid unit will not be subject to MRI volume requirements, and the applicant shall not utilize the procedures performed on the FDA- approved PET/MRI scanner hybrid unit to demonstrate need or to satisfy MRI CON review standards requirements.

4.      Section 14:  Under subsection (1)(d)(iii), added project delivery requirements for data reporting for the MRI-Guided EPI UNIT similar to intra-operative MRI (IMRI).  At a minimum, the data reported shall include how often the MRI-guided EPI unit is used and for what type of services, i.e., electrophysiology or diagnostic.

5.      Other technical changes.

 

Complete Standards

 

A complete set of the approved language can be found at www.michigan.gov/con. A hard copy may be obtained, for a fee, by sending a written request to:

 

 

Michigan Department of Community Health Health Policy and Access Division

Health Policy Section Capitol View Building 201 Townsend

Lansing, MI 48913

 

[phone]

 

Email address: [e-mail]