Non-Applicability Requests for Diagnostic Equipment in Non-Hospital Settings
Here is general guidance about standard items required for a Non-Applicability request for diagnostic equipment in a freestanding diagnostic facility or a physician's office. (This information is not to be used for acquisition of diagnostic equipment in a hospital setting.)
However, DHEC staff may need to request additional information following our initial review. And submission of these items does not guarantee approval of the request should we find the total project cost to be in excess of the cost threshold prescribed in Regulation 61-15 (pdf).
Items Required
- Written description or narrative of the proposed acquisition
- Statement of total project cost
- Completed ownership disclosure information.
Your request must also include the following verification documents and exhibits:
- A valid quote for the purchase or lease of the proposed equipment; the quote must not have exceeded its expiration date.
- If freight, installation, rigging, insurance, etc., is not included in equipment, separate quotes for these items
- If the equipment is being leased, documentation of the current purchase price of the proposed equipment. (Please note that the current fair value/purchase price for anyleased items should be assessed in calculating the total project cost.)
- For existing buildings (not new construction), a signed estimate for any renovations or upfit associated with the project, to include all construction costs and related professional fees (All renovation or upfit costs incurred for area dedicated to the proposed modality should be broken out from the overall construction/renovation costs.)
- A schematic or floor plan for the suite and/or building occupied by the diagnostic facility practice that clearly identifies and labels each room or area
- A written gross square footage program of space for each area within the building or suite as well as the total gross square footage for the building (This should correspond with the submitted floor plan/schematic.)
- A current appraisal of the land and building for facilities that are not newly constructed, or verifiable documentation of the cost of the land and building for new construction.(A current appraisal is an appraisal that is less than 1 year old from application submission date.)
- An invoice for the appraisal fees if the appraisal was obtained for the purpose of valuing the land and/or building in the non-applicability request
- A signed estimate for all consultant, attorney, medical physicist, architectural, engineering and other professional fees that have been or may be incurred for the proposed project
- A listing and supporting documentation for the value of all furnishings, computer/fax, telephones and other equipment properly charged under generally accepted accounting principles as a capital cost. (This should include capital costs incurred by the applicant for billing and transcription related to the project — i.e. computers, billing software, T-1 line, etc.)
- Sales tax included in the cost or value of all furnishings, fixtures and equipment
- A signed statement from a bank or lender verifying the estimated costs associated with the financing of the project.
Exemptions & Non-Applicability Determinations
The following are examples of projects and facilities that are either exempt from South Carolina's CON review process or for which CON review is not applicable. (However some do require a written determination.)
- Non-medical projects, such as refinancing existing debt, roof replacement, parking garages, computer systems, etc.
- Healthcare facility upgrades that do not involve additional square footage or additional healthcare services
- Replacement of like healthcare equipment
- Healthcare facilities owned and operated by the federal government
- Federal healthcare facilities sponsored and operated by the State of South Carolina
- Infirmaries maintained by educational and penal institutions for the exclusive use of their respective students and inmates
- Facilities owned and operated by the S.C. Department of Mental Health and the S.C. Department of Disabilities and Special Needs (except in cases involving the addition of one or more beds to the total number of beds existing in the agencies' healthcare facilities as of July 1, 1988).
See pending and recently approved exemptions and projects granted non-applicability status (xls).
Freestanding facilities and physician's offices: Learn how to apply for non-applicability status
For more information, please email Jennifer Dagenhart or call her at 803-545-4200.
For questions regarding the Certificate of Need process and program, please contact us at (803) 545-4200.