(Medicare Benefit Policy Manual)

10-1-22 Low Frequency Ultrasonic Diathermy Treatment Device for Home Use  No DMEPOS Benefit Category --Minimum lifetime requirement of at least three years not met. These items are not the standard pulses wave types of diathermy machines referenced in section 280.1 of chapter 1, part 4 of the National Coverage Determinations Manu al. However, the equipment must be able to be rented and used by multiple patients for a minimum of three years in order to be classified as DME.   10-1-22 Mechanical Allergen Particle Barrier/Inhalation Filter, Cream, Nasal, Topical  No DMEPOS Benefit Category --Minimum lifetime requirement of at least three years not met.   10-1-22 Molecular diagnostic test reader, nonprescription self -No DMEPOS Benefit Category -- In vitro diagnostic medical device for analyzing 4-1-23  administered and self -collected use, fda approved, authorized or cleared  specimens in the home collected with the single -use cartridges.  Neuromuscular electrical stimulator (nmes), disposable, replacement only  No DMEPOS Benefit Category  These single -patient items cannot withstand repeated use and therefore are not DME.    4-1-23  Non-Invasive Vagus Nerve Stimulator  DME --These devices stimulate the cervical branch of the vagus nerve when applied to the side of the neck through two stainless steel stimulation surfaces.  10-1-22 Non-Pneumatic Compression Controller  DME --These devices use non-pneumatic compression to treat and manage lymphedema.  10-1-22 Oral Device/Appliance for Neuromuscular Electrical Stimulation of the Tongue Muscle for the Reduction of Snoring and Obstructive Sleep Apnea, Controlled by Phone Application  No DMEPOS Benefit Category --The component that performs the medically necessary function of the device is a smartphone which is useful to an individual in the absence of an illness or injury. 10-1-22 Prescription Digital Therapy  No DMEPOS Benefit Category --Digital therapies or computer software are housed on non-medical devices like smartphones or computers and the equipment and software as a whole are not DME.  10-1-22 Speech Volume Modulation System  DME --These devices are worn behind the ear and play background noise (multi -talker babble) in the patients ear only when the patient speaks. The noise elicits the Lombard Effect, automatically increasing the patients vocal intensity, slowing their speech rate, and/or increasing the clarity of their speech.   10-1-22 Suction Pump, Home Model, Portable or Stationary, Electric, for Use with External Urine Management System   DME --Home suction pumps have been classified as DME under the HCPCS since 1984 or earlier. This type of home suction pump is used for urine collection or drainage.  10-1-22 Transcutaneous Electrical Nerve Stimulator for Electrical Stimulation of the Trigeminal Nerve  DME --These devices are used during sleep for the treatment for pediatric attention deficit hyperactivity disorder (ADHD).  10-1-22 Upper extremity medical tubing/lines enclosure or covering device, restricts elbow range of motion  No DMEPOS Benefit Category The device is safety equipment to prevent patient entanglement when stationary or mobile with  vital tubes, lines and catheters. There is not a benefit category under Medicare Part B for safety equipment used in the home.  4-1-23 Virtual reality cognitive behavioral therapy device (cbt), including pre -programmed therapy software  DME -- The device delivers a clinically based multimodal pain self -management program incorporating evidence -based principles of Cognitive Behavioral Therapy (CBT).  4-1-23 Wheelchair Accessory: Dynamic Positioning Hardware for Back  DME --These items are hardware added to the wheelchair to absorb the force of a patients uncontrollable backward jerking motions is classified as DME if necessary for the effective use of a wheelchair classified as DME.  10-1-22 Whirlpool Tub, Walk -In, Portable  No DMEPOS Benefit Category --A portable hydrotherapy unit or whirlpool is useful to individuals in the absence of an illness or injury for relaxation and soothing sore muscles. Per section 280.1 of chapter 1, part 4 of the Medicare National Coverage Determinations Manual, portable whir lpool pumps are not DME because they are not primarily medical in nature and are personal comfort items excluded from Medicare coverage (186 2(a)(6) of the Act).  10-1-22       120 - Prosthetic Devices  (Rev. 1, 10-01-03) B3-2130, A3-3110.4, HO-228.4, A3-3111, HO-229  A.  General   Prosthetic devices (other than dental) which replace all or part of an internal body organ (including contiguous tissue), or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ are covered when furnished on a physicians order.  This does not require a determination that there is no possibility that the patients condition may improve sometime in the future.  If the medical record, including the judgment of the attending physician, indicates the condition is of long and indefinite duration, the test of permanence is considered met.  (Such a device may also be covered under 60.l as a supply when furnished incident to a physicians service.)  Examples of prosthetic devices include artificial limbs, parenteral and enteral (PEN) nutrition, cardiac pacemakers, prosthetic lenses (see subsection B), breast prostheses (including a surgical brassiere) for postmastectomy patients, maxillofacial devices , and devices which replace all or part of the ear or nose.  A urinary collection and retention system with or without a tube is a prosthetic device replacing bladder function in case of permanent urinary incontinence.  The foley catheter is also considere d a prosthetic device when ordered for a patient with permanent urinary incontinence.  However, chucks, diapers, rubber sheets, etc., are supplies that are not covered under this provision.  Although hemodialysis equipment is a prosthetic device, payment for the rental or purchase of such equipment in the home is made only for use under the provisions for payment applicable to durable medical equipment.  An exception is that if payment cannot be made on an inpatients behalf under Part A, hemodialysis equipment, supplies, and services required by such patient could be covered under Part B as a prosthetic device, which replaces the function of a kidney.  Se e the Medicare Benefit Policy Manual, Chapter 11, End Stage Renal Disease, for payment for hemodialysis equipment used in the home. See the Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 10, for additional instructions on hospitalization for renal dialysis.   NOTE:   Medicare does not cover a prosthetic device dispensed to a patient prior to the time at which the patient undergoes the procedure that makes necessary the use of the device.  For example, the A/B MAC (B) does not make a separate Part B payment for an intraocular lens (IOL) or pacemaker that a physician, during an office visit prior to the actual surgery, dispenses to the patient for his or her use.  Dispensing a prosthetic device in this manner raises health and safety issues.  Moreover, the need for the device cannot be clearly established until the procedure that makes its use possible is successfully performed.  Therefore, dispensing a prosthetic device in this manner is not considered reasonable and necessary for the treatment of the patients con dition.  Colostomy (and other ostomy) bags and necessary accouterments required for attachment are covered as prosthetic devices.  This coverage also includes irrigation and flushing equipment and other items and supplies directly related to ostomy care, whether the attachment of a bag is required.   Accessories and/or supplies which are used directly with an enteral or parenteral device to achieve the therapeutic benefit of the prosthesis or to assure the proper functioning of the device may also be covered under the prosthetic device benefit subject to the additional guidelines in the Medicare National Coverage Determinations Manual.  Covered items include catheters, filters, extension tubing, infusion bottles, pumps (either food or infusion), intravenous (I.V.) pole, needles, syringes, dressings, tape, Heparin Sodium (parenteral only), volumetric monitors (parenteral only), and parente ral and enteral nutrient solutions.  Baby food and other regular grocery products that can be blenderized and used with the enteral system are not covered.  Note that some of these items, e.g., a food pump and an I.V. pole, qualify as DME.  Although covera ge of the enteral and parenteral nutritional therapy systems is provided on the basis of the prosthetic device benefit, the payment rules relating to lump sum or monthly payment for DME apply to such items.  The coverage of prosthetic devices includes replacement of and repairs to such devices as explained in subsection D.  Finally, the Benefits Improvement and Protection Act of 2000 amended 1834(h)(1) of the Act by adding a provision (1834 (h)(1)(G)(i)) that requires Medicare payment to be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or us eful lifetime restrictions if an ordering physician determines that the replacement device, or replacement part of such a device, is necessary.   Payment may be made for the replacement of a prosthetic device that is an artificial limb, or replacement part of a device if the ordering physician determines that the replacement device or part is necessary because of any of the following:  1. A change in the physiological condition of the patient;  2. An irreparable change in the condition of the device, or in a part of the device; or  3. The condition of the device, or the part of the device, requires repairs and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.  This provision is effective for items replaced on or after April 1, 2001.  It supersedes any rule that that provided a 5- year or other replacement rule with regard to prosthetic devices.   B.  Prosthetic Lenses   The term internal body organ includes the lens of an eye.  Prostheses replacing the lens of an eye include post-surgical lenses customarily used during convalescence from eye surgery in which the lens of the eye was removed.  In addition, permanent lense s are also covered when required by an individual lacking the organic lens of the eye because of surgical removal or congenital absence.  Prosthetic lenses obtained on or after the beneficiarys date of entitlement to supplementary medical insurance benefits may be covered even though the surgical removal of the crystalline lens occurred before entitlement.   1.  Prosthetic Cataract Lenses   One of the following prosthetic lenses or combinations of prosthetic lenses furnished by a physician (see 30.4 for coverage of prosthetic lenses prescribed by a doctor of optometry) may be covered when determined to be reasonable and necessary to restore essentially the vision provided by the crystalline lens of the eye:   Prosthetic bifocal lenses in frames;    Prosthetic lenses in frames for far vision, and prosthetic lenses in frames for near vision; or   When a prosthetic contact lens(es) for far vision is prescribed (including cases of binocular and monocular aphakia), make payment for the contact lens(es) and prosthetic lenses in frames for near vision to be worn at the same time as the contact lens(es), and prosthetic lenses in frames to be worn when the contacts have been removed.   Lenses which have ultraviolet absorbing or reflecting properties may be covered, in lieu of payment for regular (untinted) lenses, if it has been determined that such lenses are medically reasonable and necessary for the individual patient.   Medicare does not cover cataract sunglasses obtained in addition to the regular (untinted) prosthetic lenses since the sunglasses duplicate the restoration of vision function performed by the regular prosthetic lenses.  2.  Payment for Intraocular Lenses (IOLs) Furnished in Ambulatory Surgical Centers (ASCs)   Effective for services furnished on or after March 12, 1990, payment for intraocular lenses (IOLs) inserted during or subsequent to cataract surgery in a Medicare certified ASC is included with the payment for facility services that are furnished in connection with the covered surgery.  Refer to the Medicare Claims Processing Manual, Chapter 14, Ambulatory Surgical Centers, for more information.  3.  Limitation on Coverage of Conventional Lenses   One pair of conventional eyeglasses or conventional contact lenses furnished after each cataract surgery with insertion of an IOL is covered.  C.  Dentures   Dentures are excluded from coverage.  However, when a denture or a portion of the denture is an integral part (built -in) of a covered prosthesis (e.g., an obturator to fill an opening in the palate), it is covered as part of that prosthesis.  D.  Supplies, Repairs, Adjustments, and Replacement