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Thinking of Buying... Image-guided ENT Navigation Systems
Image-guided ENT Navigation Systems
Jay Klarsfeld
Publish Date: October 10, 2007   |  Tags:   ENT

Buying image-guided navigation equipment for ENT procedures is much like purchasing a new digital video system for orthopedics or a new microscope for ophthalmology. They're all big-ticket, complex technologies that require extensive evaluation before you buy. As you'll see, there's much to consider when selecting the most advanced technology available to do endoscopic sinus surgery. Here's how to select the right navigation system for your facility.

Establish an evaluation committee
Form an evaluation committee to standardize the method you'll use to compare systems. The committee must trial the systems in relatively short order so that the members remember the pros and cons to each system and then weigh the costs and benefits of each system's components. The process shouldn't take any longer than six months. Anything longer can result in having to retest previously evaluated systems.

The price range for purchasing an ENT image guidance system is about $100,000 to $175,000 (this is your likely negotiated price range, not the companies' quoted list prices). Additionally, disposable costs per case can run anywhere from $50 up to $400, again depending on what's included in the negotiated base price.

Price alone is not a good starting place, however. Different navigation systems offer a variety of features, capabilities, options, training schedules and service plans. The systems are so different in terms of their technology platform, patient registration modalities and other options and features that it's sometimes tough to compare apples to apples when evaluating these units on the basis of price alone.

The evaluation criteria and the evaluators must be standardized so that whichever navigation system you eventually choose will meet your center's defined needs. If your evaluation criteria are well-formulated, additional costs incurred due to software packages and options costs will be recouped via OR efficiencies and increased utilization. Remember, the cost of this equipment is amortized over five to seven years.

A look at the benefits
Here's how your committee might weigh the clinical, competitive and economic benefits of purchasing a navigation system.

  • Clinical. ENT navigation systems let you do more extensive intranasal surgery with an added degree of assurance. From a clinical standpoint, interest in the technology has grown steadily, especially recently. Over the last year, many journal articles and conference sessions have looked at the benefits of using navigation systems as an adjunctive tool for a variety of sinus procedures. There's also been increasing interest in applying the technology for otologic and temporal bone surgeries (both readily performed in ASCs and hospitals). In particular, an overwhelming perceived benefit of using navigation during appropriate surgical cases is improved patient safety.
  • Competitive. Growth of navigation technology in terms of patient safety and outcomes is creating a dilemma for surgeons who have this technology available when operating at their local hospital but not at the local ASC - especially if they have a financial interest in the facility. However, there's also a legal consideration for ASC physician-owners trying to comply as closely as possible with federal safe harbor facility utilization guidelines.

Just as importantly, as patients become more educated about so-called global positioning surgery (as it's sometimes called in the popular press), they, too, have begun to ask physicians if they're candidates.

The growing demand may put increasing pressure on an ASC to invest in the systems as a competitive strategy, or concede the cases to the HOPD. ASCs that do take the plunge typically market themselves to their customers - docs and patients - as state-of-the-art centers.

  • Economic. As for the economic benefits, an ASC board must make the determination whether the addition case volume, marketing and prestige associated with navigation justifies its purchase. Hospitals can evaluate the equipment primarily for its clinical benefits and volume potential.

Unlike HOPDs, ASCs can't bill Medicare a technical facility fee for the use of CPT Code 61795, which can be used only when the imaging device is used to guide intracranial, extracranial or spinal surgery. Keep in mind that this is an add-on code that is billed in addition to the CPT codes one would normally list for that particular procedure. Medicare should pay a professional (surgeon's) fee when billing 61795 no matter where the procedure is performed.

The Medicare facility fee restriction doesn't necessarily apply to other payers. Negotiated payment for this code with each of your other insurance carriers to more closely parallel the reimbursement hospitals receive.

Lastly, keep in mind that every piece of equipment doesn't directly generate revenue via a separate CPT code. In fact, it's extremely rare that a separate CPT code can be billed for new techniques or equipment. We purchase most new equipment or technology because its use is an integral part of an existing procedure. Along those lines, we attribute its purchase price to the cost of doing business.

Weighing different technology platforms
What you need to know up front is that's crucial to gain a consensus about which system most of your otolaryngologic surgeons prefer. Much of this will come down to accuracy and ease of use.

Time is a critical component to the profitability of your ORs. Therefore, a navigation system's initialization, registration and set-up must be fast, reproducible and generate a very high level of accuracy at the onset of the surgical procedure. Equally important is the system's ability to maintain that accuracy throughout the entirety of the case. Every time your surgeon must re-register the patient, the case time lengthens and affects the center's bottom line.

The system shouldn't require additional personnel for its operation. More importantly, the surgeon should be able to control the majority of the system's functions from the operative field.

As you delve into comparing different systems, you'll find that you have three technology options: active optical LED, passive reflective optical and electromagnetic systems. All three technologies are FDA-approved and each has its own advantages extolled by devotees. Finally, corporate reliability and service plays a significant role when considering the purchase of any large piece of capital equipment.

Consider other applications
If you are a multi-specialty center, the equipment's use outside of ENT surgery should also influence your purchase decision, because many of the top systems are useful in a growing array of specialties. Navigation technology also has orthopedic and neurosurgery applications. For example, over the next couple years, the use of navigation for minimally invasive knee and hip surgery will only increase. Additionally, as these procedures move to the outpatient or 23-hour arena, it's important that the navigation systems you consider be able to accommodate additional specialties via software upgrades.

Your surgical center most likely has contracts with a number of the companies manufacturing navigation equipment. This will give you some history on which you can rely. There have been many companies over the years involved in the image-guidance business. Some of them have gone bankrupt, leaving their customers with an essentially unprotected investment. Just as importantly, those companies with which you have an established relationship can probably offer you advantageous financial arrangements in terms of purchase or leasing options.

As someone passionate about the possibilities for navigational surgery, I'm admittedly a bit biased, but I think we've reached the point at which facilities need to ask themselves if they can afford not to at least seriously consider investing in the technology.