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Can I use This in my Practice?
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Written by Michael T. Schaefer; B.S., D.C., O.M.D., M.D.   
Thursday, 08 November 2007 16:39 Read : 798 times

With recent changes in third party payers (PIP) still not saved in Florida as of this writing as well as fees for procedures declining for all healthcare providers, many doctors are looking for alternatives. Cash practices, which were almost like dinosaurs, have started to make a great resurgence. The cash practice is also changing and that is the focus of this article. The cash practice I am referring to is built around anti-aging medicine.

I am not trying to act as a consultant. I have done that; but what I am attempting is to answer questions I receive seven days a week. (Yes, it even surprises me: calls late at night, Saturdays and even Sundays.) Healthcare providers from the fifty states and even Canada call with uncertainty in their voices. This uncertainty is twofold: one is overt and the other is covert. The one I will focus on is the overt one, but the covert one is very important, also. The covert one is the one I detect in their indirect statements and general demeanors. It is an overall uncertainty about the future of healthcare. The overt one is, "Can I do _____ in my office? Is that in my scope?"

When a doctor calls my company and asks if they can use our intense pulse light equipment (IPL) or laser equipment, red flags go up. Why do red flags go up? Because that doctor is asking a salesperson if they can do a medical treatment and this can only be a recipe for future disaster. Every decision you make can have profound effects on you, your patients, as well as your overall future. For this reason, it is imperative to have command of rules prior; this will help ensure a safe journey.

So, I will focus on the overt one and give my colleagues some helpful advice. The first thing is do not think an equipment company is an expert on the scope of practice in your state. Ok, that might sound negative, but what I am really saying is that you have to educate yourself and do your own homework.

So how do you do this? The internet is a great place to start. It is, for the most part, very user friendly. So, from my point of view, there is really no excuse. Start with a good search engine. There are plenty of them out there. I generally use a meta-search engine, for example Dogpile.com. A meta-search engine is a search engine that sends user requests to several other search engines and/or databases and returns the results from each one. Meta-search enables users to enter search criteria once and access several search engines simultaneously. Once you find good information, save it in your favorites so you can go back to it as you gather more information.

I would like to give you some basis in reference to Light. Light is a very broad term and includes the entire spectrum of electromagnetic radiation of any wavelength. A confusing point, to some, is Class I-IV ANSI (American National Standards Institute). This applies to LASER and the class is the LASER’s power. IPL is not a LASER, thus, ANSI does not apply. Next are FDA Classification I-III devices. When talking about the FDA and medical treatment which includes chiropractic, allopathic and osteopathic treatments, the FDA regulates equipment more so than it does a physician (except, if you do your homework, you will find case law in Pennsylvania where the higher court ruled that the FDA does have a right to regulate physicians). So, again, I would not push it and try to save money on Non-FDA equipment. Companies are required to obtain 510K prior to marketing most Class II medical devices and there are even more regulations on Class III devices. Thus, as I pointed out, if a company breaks a federal law and sells equipment to doctors without 510K, why would you think they’d be honest with you? The overall consensus is that physicians can use Non-FDA registered devices and can use registered devices for off label use. However, legally, it appears that there are much greater liability issues when using a non-registered device compared with using a registered device for off label use.

IPL classification in Florida and most other States have adopted the FDA definition of what a LASER is. Florida requires registration of class 3 and class 4 LASERS; it does not classify IPL units as LASER’s nor does the FDA.

Common Pit falls

Relying on a salesperson for legal advice.

• Training on your device that is sub-par (Sub-par training, in my opinion, is training not provided by a doctor. A jury will probably not look highly on a doctor obtaining training from a non-noctor source).

• Not getting information in writing when it comes to State Boards, FDA, etc.

• Using a Non-FDA registered device. This can get you in trouble in more than one way. There are plenty of companies selling non-registered equipment to physicians. (Buyer beware.) One such company that I was told about was telling the buyers it had a piggyback registration when, in fact, it didn’t. Call the FDA and ask them yourself. FDA information can be found at www.fda.gov.

If you do not obtain consent from your patients prior to treatment, it can be construed as experimentation and your Board might discipline you. .When you make a mistake, your malpractice carrier will be required to pay policy limits and/or they might be able to walk away and leave you to your own defense (good luck to you if this happens). In closing, if you are considering adding these cash generating therapies to you practice, you must do your due diligence first.

Dr. Michael T. Schaefer, President and CEO of Bio-Derm Medical, Inc., graduated from the University of the State of New York with a B.S. degree, graduated from Life University in 1986 with D.C. degree with honors, graduated from USF in 2000 with an M.P.H. degree, and graduated from UHS-USAT in 2004 with O.M.D. and M.D. degrees.

Dr. Schaefer is licensed to practice Chiropractic Medicine in FL and KY. He is licensed to practice Oriental Medicine and Acupuncture in WV, and is registered to practice Medicine in Montserrat in conjunction with USAT. Member of F.C.A., A.M.A., and the A.P.H.A. Email This e-mail address is being protected from spambots. You need JavaScript enabled to view it .


 
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