517.374.2703 info@rwca.com

CON Application Process

MRI

Karmanos Cancer Center had been working for over a decade to become a separately licensed, independent hospital on the campus of the Detroit Medical Center. Certificate of Need hurdles continued to create barriers for the organization until they brought in RWC Advocacy to assist. In less than 1 year RWC were able to devise a strategy which provided Karmanos with a separate license and complete autonomy from the DMC.

The CON application process itself can be quite predictable when you have the guidance of an experienced professional. Our clients benefit a great deal from our years of experience learning what the State is looking for as well as our ability to streamline and simplify a complex system. From a high level perspective, the CON process is as follows:

Letter of Intent
The CON application process begins with the filing of a letter of intent (LOI) with the Michigan Department of Health and Human Services.

The LOI contains basic information about the applicant including the applicant’s name and address, the location where the covered service/ beds will be located, and what the applicant is requesting (number of beds, type of service, etc.). The Department must process the LOI within 15 days from submission and once processed, provides the applicant with a CON application number as well as a list of forms and other information that must be included in the application.

Once a CON number is assigned, a processed LOI is valid up to 1 year. If no application is filed within 1 year the LOI must be resubmitted. If the Department determines during the LOI review that the proposed project does not require a CON application the Department will issue a waiver letter indicating no CON is required.

Waiver letters are beneficial when working with other state agencies when no CON is required, and may even be requested by state licensing/engineering and other state agencies. Waivers require that you submit supporting documentation and a $500.00 LOI waiver fee. Common waivers are for stock transfers, MRI upgrades, lease renewals, construction/renovation projects under the covered capital expenditure amount (currently $3,325,000), and bond issuance for non-CON covered services.

Certificate of Need Application
Once the Department has processed the LOI, the CON application must be drafted and submitted. The application includes more detailed information about the project. Applications for covered clinical equipment must include supporting documentation like vendor quotes and lease proposals. Applicants must provide financial projections as well as documentation to substantiate that funding for the project is available. The application must also include documentation to show that the project meets the requirements of the relevant CON review standards. Upon filing the application, the Department reviews it for completeness. If they determine any items are missing, they will request those items within 15 days of receipt of the application, and allow 15 days to respond with the information. Once the information is received, the application is deemed complete and the Department review commences.

There are Three Types of CON Applications

1. Non-Substantive Review
These applications can be filed at any time following LOI processing and take up to 45 days to review. Projects that qualify for non-substantive review include acquisitions, lease renewals, relocations, and replacements. In addition, mobile CT and mobile PET host site initiations as well as some mobile lithotripsy host site initiations will qualify for non-substantive review.

2.Substantive Review
These applications must be filed on the first business day of any month (if filed any other day, they do not count as filed until the first day of the following month) and take up to 120 days to review. Projects that do not qualify for non-substantive review or comparative review are subject to substantive review. Typically this includes initiations of new services and expansions of existing services.

3. Comparative Review
These applications must be filed on the first business day of February, June, and October and take up to 150 days to review. Applications for beds (hospital, nursing home, and psychiatric)
as well as services that are limited by the number allowed in the state or a planning area (transplantation services) are subject to comparative review.

Decision
Following the review of the application by the Department a proposed decision is issued and shared with the applicant. If the proposed decision is an approval, the Director of the Department must either sign the proposed decision or issue a notice that the decision is being reversed within 5 days.

Typically the letter is signed as proposed and a final approval issued. If the proposed decision is a denial, the applicant has 15 days to file a request for appeal and a final decision is postponed until the appeal is heard.

The Department will accept requests for expedited review of non- substantive and substantive applications. These requests are reviewed by the Department based on a combination of their workload at the time of the request, the justification for the request and the requested decision date. The Department can reduce the review period to as little as 30 days although 60-90 days is more common. If expedited review is granted, the applicant must pay an additional $1,000 fee.

Contact RWC Advocacy for Your Certificate of Need

Melissa D. Cupp
Partner
RWC Advocacy
cuppm@rwca.com
517.374.3877
Twitter: #CONGoddess

Abigail L. Burnell
Government Affairs Consultant
RWC Advocacy
burnella@rwca.com
517.879.5864

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RWC Advocacy
517.374.2703
230 N. Washington Square
Suite 200
Lansing, MI 48933

RWC Advocacy
517.374.2703
230 N. Washington Square
Suite 200
Lansing, MI 48933