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| Advisories |
As a means of continuing to provide our users with quick and easy access to recent changes in policy or procedures, the CON Section offers advisory notifications detailed below. Please continue to refer to the Frequently Asked Questions page for information that deals with clarification of existing policies or procedures.
Application Fee/Checks: According to Department accounting practice, checks submitted with a CON application must be dated within 60 days of the CON application to be considered received. If an outdated check is received with an application, the application will not be processed by the Department until a valid check for the required application fee is received. Upon receipt of the valid check, the application will be processed pursuant to the applicable Administrative Rules.
Cancer Data Advisory
:
Cancer Data for Megavoltage Radiation Therapy (MRT) or Positron Emission Tomography (PET) Services - Beginning September 3, 2008, the Department will begin accepting requests for the verification of cancer patient data from Calendar Year 2007 for MRT applications, excluding the Tri-county region of Macomb, Oakland, and Wayne. The Tri-county area will use 2005 data due to reporting predominantly through the Detroit Metropolitan Cancer Surveillance System. All PET applications will also use 2005 data.
Applicants wishing to obtain CON approval to initiate MRT services should ensure that the committing entities' Cancer Registry data is submitted timely. Otherwise data an applicant may wish to use will not be in the most recent data set and, moreover, the applicant will not be permitted to use a previous year's Cancer registry data. As noted above, the most recent Cancer Registry data for the Tri-County region is 2005 for MRT and PET applications until the next annual update.
Please note that annual updates for the next calendar year will be September 2009 or when a complete cancer registry is available for release, whichever occurs first. Any change will be posted on this web site prior to the effective date of the change.
All MRT and PET applications received after September 2, 2008 will be reviewed under the terms and data sets above. For questions regarding the submission of new cancer case data for CON applications involving the initiation of MRT or PET services, please contact Glenn Copeland at (517) 335-8677 or
copelandg@michigan.gov
.
Change of Ownership of Real Property: A change in the ownership of a building (real property), without a change in the licensee that provides health care services from that building and without a change in the lease terms to the licensee, such as no change in licensed use and no change in the terms of the lease greater than that granted in the most current CON approving the lease terms for the health facility, as well as no change in bed capacity or physical plant structure, does not require a certificate of need.
Section 22209 of the Public Health Code, 1978 PA 368, as amended, MCL 333.1101 et seq; MSA 14.15(1101) et seq, requires the issuance of a certificate of need prior to the acquisition of a health facility. While a building is a significant part of most types of health facilities, such as a nursing home, it is not itself the licensed health facility. A licensee, which of course must obtain a certificate of need, is the business entity that operates a health facility. That licensee may own or lease its building. If it leases the building, and only the landlord changes, no certificate of need is needed for that change in landlord.
Please note that any change in licensee does require certificate of need review/approval. The Department will request as part of an application identification of the current landlord, if applicable, and a draft lease agreement.
CON e-Serve Roles for External Uses:
External users registering with Single Sign-on system for using DCH CON
e-Serve must select either "Applicant" or "Guest" role only.
Covered Imaging Equipment: Effective July 7, 2008, the following new technology/scanners are covered by the CON Review Standards for Computed Tomography (CT) Services and, therefore, is a covered clinical service for the purposes of Part 222 of the Public Health Code. In accordance with MCL 333.22209(1), a CON must first be obtained prior to offering services on the following scanners: Imaging Sciences i-CAT, Xoran Technologies MiniCAT, Aperio NewTom, Hitachi Mercuray, Morita 3D Accuitomo, ILUMA Ultra Cone Beam CT Scanner, Kodak 9000 3D, Planmeca Promax 3D unit/upgrades, and other similar devices.
CT Scanners approved for dental purposes only are restricted for use as defined in Section 2(1)(k) and (l) of the CON Review Standards for CT Scanner Services.
Doctor Commitment Forms: The Department will only accept doctor commitment forms (i.e., surgical, CT, MRI) that are submitted with the respective CON application. Doctor commitment forms sent directly to the Department, separate from the formal application, will not be accepted. It is the applicant's responsibility to submit all doctor commitment forms as part of the submission of the application or during the review phase, when applicable.
Lithotripsy Shielding: A lithotripsy unit is to be operated in a room that complies with Radiation Safety Standards. Operating or procedure rooms in which a lithotripsy unit is used must have a steel or leaded door, as well as shielding for windows in these rooms. If a unit is to be used in an area that does not meet these criteria, approval of the radiation shielding must be obtained from the Radiation Safety Section prior to clinical use in that location. For detailed information, click on the following link to the
Radiation Safety Web site
.
As of April 2, 2007, Notices for MRI/PET Services require proof of Medicaid participation.
Medicaid Participation: Verification of Medicaid participation is required for all applicants at the time of application submission, excluding applications for nursing homes and HLTCU beds. Proof of participation may include any official correspondence from the Medicaid program that demonstrates participation, including enrollment agreement, recent Medicaid cost report, Turnaround Form (PE-200), cost report acceptance letter, and remittance advice.
For non-licensed health facilities (i.e., imaging centers) or freestanding surgical outpatient facilities (until these health facilities are allowed to enroll in Medicaid), proof of Medicaid participation may include documentation from individual physicians affiliated with the proposed project.
For Central Service Coordinators (CSC), who may not be a direct provider of the covered clinical service as an applicant, they must provide proof of Medicaid participation from at least two (2) host sites at the time of application submission and for all host sites on the proposed route prior to a proposed decision.
As of April 2, 2007, Notices for MRI/PET Services require proof of Medicaid participation.
Medicare Participation: This advisory is being posted on the Certificate of Need Web site in cooperation with the Nursing Home Monitoring Division, within the Bureau of Health Systems, MDCH, and the Centers for Medicare and Medicaid Services (CMS). Please note that CMS requires an initial certification survey for new Medicare providers. In order for the state to conduct the initial Medicare certification survey an approved priority exception request must be obtained from CMS. Some providers have the option of attaining accreditation that conveys Medicare deemed status by a CMS-approved accreditation organization in lieu of a Medicare survey.
For more information on accreditation alternatives or how a provider may obtain a priority exception see CMS S & C 08-03, November 5, 2007 available at http://www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp or contact the CMS Regional Office in Chicago, Illinois.
New provider nursing homes (only) may contact the Division of Nursing Home Monitoring at (517) 334-8408 for information.
Mobile Route Host Site Applications: (Revised 07/20/07)
Effective July 2, 2007, all MRI notices must be submitted with an application fee of $1,500. Notice applications not accompanied by the required fee shall not be considered timely and shall be deemed submitted and processed after receipt of the required fee. Further, existing host sites for all mobile services (i.e., CT, PET, Litho) to be added to existing mobile routes without data commitments will now be categorized as NONSUB [Notice] and reviewed on an expedited basis. Pursuant to MCL 333.22233, Project Costs, such as operating leases, renovations, etc., are not required to be listed for a NONSUB [Notice]. The letters of intent for such projects should not include Project Costs or Sources of Funds.
MRI Service Provider Reporting Requirements:
The July 1, 2007 data reporting requirements for MRI Service Providers are as follows:
Memo to Providers
Data Collection Format
Data Collection Code Definitions
Referring Doctor Format
Data Reporting Schedule
New Design Model Pilot Program: The linked spreadsheet lists nursing homes related to subsection 3(4)(b)(i) under the Addendum in the Review Standards for Nursing Homes.
Radial Distance Verification:
The Department will accept maps generated by commercially available software (e.g., MapPoint, Streets & Trips, etc.) as part of an application required to demonstrate distance between locations. It is the applicant's responsibility to submit all required maps to demonstrate compliance with standards requirements, along with identifying the software used. If the commercial software used to demonstrate distance is within one (1) mile of the required distance to demonstrate compliance, the Department will verify the distance(s) in question with Michigan State University (MSU) Department of Geography. Please note the Department will render its final decision based on the methodology/software used by MSU.
Regional Review Agency:
Certificate of Need documents for proposed projects in West Central Michigan will not be accepted until the Michigan Department of Community Health (MDCH) and the
Alliance for Health
each has received them pursuant to M.C.L. 333.22226(6) and Administrative Rule 325.9201.
Some applications are subject to a limited number of "window dates" for receipt by MDCH and Alliance for Health. Receipt after the designated application date will result in placement of the application in the next "window period." Failure to submit at the proper time could therefore add 30 to 120 days to the start of the formal review period. This obviously would impact the date on which a final decision can be expected. Some of the data used to support the need for projects must be dated, and a delay in the start of a review could require an applicant to secure new supporting data. Applicants must adhere to this advisory. In particular, applications will not be considered submitted to the department unless the application is received at the department's Lansing office and, if applicable, the appropriate regional review agency, before 5:00 p.m., on or before a designated application date.
Renewal of Leases for Licensed Health Facilities:
A renewal of a lease beyond the time frame granted in the most current CON approving the lease terms for the health facility, with or without a change in the landlord, also does not require a certificate of need as long as the total lease costs for the renewal is below the covered capital expenditure threshold and there is no change in the licensed use, bed capacity, or physical plant structure (unless otherwise specified in the applicable CON Review Standards). If a licensee determines CON review/approval is not required for a renewal of a lease based on the guidance above, the licensee must maintain documentation to demonstrate that the renewed lease did not exceed the covered capital expenditure threshold and provide to the Department if requested.
Please note that any change in licensee does require certificate of need review/approval. The Department will request as part of an application identification of the current landlord, if applicable, and a draft lease agreement.
Seminar - 2008 CON Program:
The Certificate of Need Program Section will hold a one day seminar onThursday, November 13, 2008. The goal of the Seminar is to provide a greater understanding of the CON application process, follow up procedures, and new Web-based systems (application, survey, etc.) as well as other regulatory requirements after CON approval.
The Seminar will be held at Lansing Community College - West Campus, located at 5708 Cornerstone Drive, Lansing, Michigan 48917.
The following links will take you to seminar brochure/registration form, directions/maps, and over night accommodations.
If you have any questions, please contact the CON Program Section at 517-241-3344.
State Holidays: Following are the State of Michigan holidays for the remainder of 2008. The CON office will be closed on these days, as well.
Election Day - Tuesday, November 4, 2008
Veterans' Day - Tuesday, November 11, 2008
Thanksgiving - Thursday, November 27, 2008 and Friday, November 28, 2008
Christmas - Wednesday, December 24, 2008 and Thursday, December 25, 2008
New Year's Eve - Wednesday, December 31, 2008
Utilization Forms: When completing a utilization form as part of an application, please verify the data to assure there are no discrepancies with past annual surveys reported to the Department. If discrepancies exist, please provide clarification/justification along with the utilization form.
Vendor Quotations:
All proposed projects involving initiation, expansion or replacement/upgrade of covered clinical equipment (CT, PET, MRI, etc.) must submit a valid vendor quote signed by a vendor representative and dated within six (6) months of the application submission date.
State of Michigan
Department of Community Health - Certificate of Need Program
Lewis Cass Building, 320 S. Walnut Street, Lansing, MI 48913
Your questions and comments regarding our website are welcome.
Send them to us via
CON WebTeam
Updated October 13, 2008
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