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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)
POSITRON EMISSION TOMOGRAPHY (PET) SERVICES
Final Approval by the CON Commission 9/22/11 and Effective 11/21/11
The language changes include the following:
1. Section 1: Modified the language consistent with recent changes in other CON review standards.
2. Section 2: Definitions related to equivalency methodology removed based on a proposed simpler methodology for replacement and expansion.
• A definition that is used only in a certain section has been moved to the applicable section to make it easier for the reader to identify the defined terms.
3. Section 3: Sections 3 and 4 were combined as these sections related to the initiation of a PET service, as well as requirements for mobile services and host site conversions.
• Added language in Section 3(2) to allow applicants to not only contract for special services from hospitals within the same planning area but also from hospitals that may be near the proposed site but not within the planning area (25-mile radius of the proposed site).
• Modified the conversion methodology for host sites to convert to a fixed PET scanner service.
• Simplified Section 3(6) to make it easier to read.
• Section 3(7)(c) applies both to new fixed PET scanner services as well to host sites that have converted from mobile to fixed services.
• Section 3(8)(c) continues to allow existing host sites to change from one existing mobile provider to another provider; however, a minimum volume requirement was added at 50 PET equivalents at the applicant host site.
4. Section 4: The replacement section covers both the replacement of the scanner as well as replacing the existing service to a new geographical site.
• Replacement of a scanner(s) no longer requires the applicant to meet a set volume requirement. Upgrades to existing PET scanners, without the replacement of the scanner(s), do not require CON review/approval.
5. Section 5: Modified expansion methodology and updated PET equivalents.
• Section 5(3) added to allow a fixed PET scanner service that has re-initiated a host site at the fixed site to expand to another fixed PET scanner if both the fixed scanner(s) and host site average enough volume to justify expansion (similar volumes as fixed site expansion).
6. Section 6: Added language to allow for the first acquisition of a PET scanner service without meeting the maintenance volume requirement. This provision is similar to other standards.
• Section 6(2) adds a volume requirement threshold for acquisition of a fixed or mobile PET scanner service.
• Section 6(3) adds a volume requirement threshold to acquire an existing host site.
• Section 6(4) adds language for renewal of lease.
7. Section 7: The number of dedicated research PET scanners is limited to three at any one site, and the site must already offer PET services.
• Language added allowing for dedicated research PET scanners to be used primarily for research purposes with the intent being that at least 70% will be dedicated research with no more than 30% being clinical scans.
8. Section 8: The number of dedicated pediatric research PET scanners is limited to two at any one site.
• Language added allowing for dedicated pediatric research PET scanners to be used primarily for research purposes with the intent being that at least 70% will be dedicated research with no more than 30% being clinical scans.
9. Section 9: New section for positron emission mammography (PEM).
• Section 9(1) identifies requirements for adding a fixed PEM scanner to an existing fixed PET scanner site.
• Section 9(2) identifies requirements for adding a mobile PEM scanner to an existing mobile PET scanner service.
• Section 9(3) identifies requirements for initiating mobile PEM scanner services as a host site.
• Section 9(4) identifies requirements for adding an existing PEM scanner host site to an existing mobile PEM scanner service.
10. Section 11: Divided requirements into distinct groups: quality assurance, access to care, monitoring and reporting, and specialized services for consistency with other CON review standards.
• Added language under subection (2)(d) to assure all services set forth in Section 3, subsections
(1) through (4), are maintained for the life of the PET scanner service.
• Added a minimum maintenance volume requirement (500 equivalents), except when an applicant is proposing to replace a PET scanner.
• Added requirements for PEM scanners.
11. Section 17: The methodology has been simplified and the table has been updated.
12. 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
(517) 335-6708
Email address: MDCH-ConWebTeam@michigan.gov
