The Time is Now – Robotic Surgery & Missouri Certificate of Need
For those providers that are considering purchasing a robotic surgery system (e.g., daVinci, CyberKnife, etc.) in Missouri, you may be well served by deciding to purchase sooner rather than later. The Missouri Health Facilities and Review Committee (“MHFRC” – the entity responsible for administering Missouri’s Certificate of Need Program) is considering adding substantive need requirements prior to issuing approval for the purchase of new or additional robotic surgery units.
In Missouri, Certificate of Need (“CON”) approval is required for purchases of major medical equipment in excess of the applicable expenditure minimum. For the vast majority of major medical equipment projects, the expenditure minimum is One Million Dollars ($1,000,000.00).
Applicants with major medical equipment projects are required to prove (pursuant to a MHFRC regulatory formula) that there is a sufficient need in the proposed service area for such a purchase, including: (1) showing that there is a sufficient patient population to support the addition of another unit; and, (2) showing that all other units of major medical equipment in the service area are sufficiently busy. The requirement to show a need pursuant to this regulatory “need analysis” is necessary in order for the MHFRC to issue approval before providers may purchase any new MRI, CT, PET/CT, linear accelerators, and other specified types of major medical equipment. Depending on the proposed location of the major medical equipment, this “need analysis” can be a very rigorous requirement that may result in denial of a CON project.
For example, the current MHFRC regulatory formula incorporates a ratio of 78,000 population : 1 linear accelerator unit (the numbers vary for different types of equipment). In addition, all other linear accelerator units in the service area must perform at least 3,500 treatments annually before the MHFRC will issue approval for a new unit in the service area (again, these numbers vary based on the equipment being purchased).
The good news is that, currently, there is no specific need formula for robotic surgery systems, and as such, applicants can prove the need for the system in any way they see fit. It is difficult for the MHFRC to deny an application for a new robotic surgery system because there is no regulatory need standard to support the denial. As such, purchasers can generally challenge any denial as arbitrary and capricious.
However, this situation is likely to change in the near future, as the MHFRC is currently considering the establishment of a regulatory formula for the calculation of need for robotic surgery systems, which could potentially be very restrictive. As such, providers that are in the market for a robotic surgery system should strongly consider purchasing the unit and acquiring CON approval before doing so becomes much more difficult.
Please do not hesitate to contact your Lashly & Baer attorney or attorney Richard W. Hill with any questions. Rich has a significant amount of experience with assisting providers in obtaining Certificates of Need from the Missouri Health Facilities Review Committee, and frequently assists in developing new Certificate of Need rules by providing his insight and opinions to the Missouri Health Facilities Review Committee and their staff. Rich can be reached at firstname.lastname@example.org, or at 314-436-8317.