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<br />') <br /> <br />) <br /> <br />q <br /> <br />\ <br />I <br /> <br />11.12 Durable Medical Equipment (DME) non-covered include (but are not limited to) the following: <br /> <br />11.12.0 I Bed Related Items: bed trays, over the bed tables, bed wedges, pillows, cnstom bedroom <br />equipment, mattresses, including non-power mattresses, custom mattresses and posturepedic <br />mattresses; <br /> <br />11.12.02 Bath Related Items: bath lifts, non-portable whirlpools, bathtub rails, toilet rails, raised toilet <br />seats, bath benches, bath stools, hand held showers, paraffin baths, bath mats, and spas; <br /> <br />11.12.03 Chairs, Lifts and Standing Devices: computerized or gyroscopic mobility systems, roll about <br />chairs, geriatric chairs, hip chairs, seat lifts (mechanical or motorized), patient lifts <br />(mechanical or motorized - mannal hydraulic lifts are covered if patient is two-person <br />transfer), and auto tilt chairs; <br /> <br />11.12.04 Fixtures to Real Property: ceiling lifts and wheelchair ramps; <br /> <br />11.12.05 CarNan Modifications; <br /> <br />11.12.06 Air Quality Items: room humidifiers, vaporizers, air purifiers and electrostatic machines; <br /> <br />11.12.07 BloodlInjection Related items: blood pressure cuffs, centrifuges, nova pens and needle less <br />injectors; and <br /> <br />11.12.08 Other Equipment: heat lamps, heating pads, cryounits, cryotherapy machines, electronic- <br />controlled therapy units, ultraviolet cabinets, sheepskin pads and boots, postural drainage <br />board, AC/DC adaptors, enuresis alanns, magnetic equipment, scales (baby and adult), stair <br />gliders, elevators, saunas, any exercise equipment and diathermy machines. <br /> <br />11.13 Emergency room services for non-emergency purposes. See Sections 2.19 and 2.20. <br /> <br />11.14 Exercise programs, gym memberships, or exercise equipment of any kind, including, but not limited <br />to: exercise bicycles, treadmills, stairmasters, rowing machines, free weights or resistance equipment. <br />Also excluded are massage devices, portable whirlpool pumps, hot tubs, jacuzzis, sauna baths, <br />swimming pools and similar equipment. <br /> <br />11.15 Experimental and/or investigational procedures, except for bone marrow transplants, as approved per <br />Florida Administrative Code, Section 59B-12.001. For the purposes of this Contract, a medication, <br />treatment, device, surgery or procedure may be determined to be experimental and/or investigational if <br />any of the following applies: <br /> <br />11.15.01 The FDA has not granted the approval for general use; <br /> <br />11.15.02 There are insufficient outcomes data available from controlled clinical trials published in <br />peer-reviewed literature to substantiate its safety and effectiveness for the disease or injury <br />involved; <br /> <br />11.15.03 There is no consensus among practicing physicians that the medication, treatment, therapy, <br />procedure or device is safe or effective for the treatment in question or such medication, <br />treatment, therapy, procedure or device is not the standard treatment, therapy, procedure or <br />device utilized by practicing physicians in treating other patients with the same or a similar <br />condition; or <br /> <br />11.15.04 Such medication, treatment, procedure or device is the subject of an ongoing Phase I or <br />Phase II clinical investigation, or experimental or research arm of a Phase III clinical <br />investigation, or under study to determine: maximum tolerated dosages, toxicity, safety, <br />efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the <br />condition in question. <br /> <br />34 <br /> <br />A V-CHOlCE-2009 <br />MP-5320 (10/09) <br />