(Medicare National Coverage Determinations Manual)

The patients history must indicate that he/she would not respond adequately to noninvasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain); and a preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief  and degree of side effects (including effects on the activities of daily living) and patient acceptance.   d. Coverage of Other Uses of Implanted Infusion Pumps   Determinations may be made on coverage of other uses of implanted infusion pumps if the MAC medical staff verifies that:    The drug is reasonable and necessary for the treatment of the individual patient;    It is medically necessary that the drug be administered by an implanted infusion pump; and,   The Food and Drug Administration- approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump.  e. Implantation of Infusion Pump Is Contraindicated  The implantation of an infusion pump is contraindicated in the following patients:   With a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.); or,   Who have an active infection; or,  Whose body size is insufficient to support the weight and bulk of the device; or,  With other implanted programmable devices since crosstalk between devices may inadvertently change the prescription.  NOTE:   Payment may also be made for drugs necessary for the effective use of an implantable infusion pump as long as the drug being used with the pump is itself reasonable and necessary for the patients treatment.   C. Nationally Non -Covered Indications   The following indications for treatment using infusion pumps are not covered under Medicare:   1. External Infusion Pumps   Vancomycin (Effective for Services Beginning On or After September 1, 1996)   Medicare coverage of vancomycin as a durable medical equipment infusion pump benefit is not covered.  There is insufficient evidence to support the necessity of using an external infusion pump, instead of a disposable elastomeric pump or the gravity drip method, to administer vancomycin in a safe and appropriate manner.   2. Implantable Infusion Pump   a. Thromboembolic Disease (Effective for Services Performed On or After September 26, 1984)   There is insufficient published clinical data to support the safety and effectiveness of the heparin implantable pump.  Therefore, the use of an implantable infusion pump for infusion of heparin in the treatment of recurrent thromboembolic disease is not c overed.   b. Diabetes   An implanted infusion pump for the infusion of insulin to treat diabetes is not covered.  The data does not demonstrate that the pump provides effective administration of insulin.  D. Other  Not applicable.   280.15 - INDEPENDENCE iBOT  4000 Mobility System (Effective July 27, 2006)  (Rev. 65; Issued:  02- 23-07; Effective:  07 -27-06; Implementation:  04 -02-07)  A.  General   The INDEPENDENCE iBOT  4000 Mobility System is a battery- powered mobility device that relies on a computerized system of sensors, gyroscopes, and electric motors to allow indoor and outdoor use on stairs as well as on level and uneven surfaces.  The mobility system incorporates  a number of different functions, including:  a) Standard Function that provides mobility on smooth surfaces and inclines at home, work, and in other environments; b) 4- Wheel Function that provides movement across obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces; c) Balance Function that provides mobility in a seated position at an elevated height; d) Stair Function that allows for ascent and descent of stairs, with or without assistance; and e) Remote Function that assists in the tr ansportation of the product while unoccupied.  In Standard Function, the INDEPENDENCE iBOT 4000 Mobility System functions like a traditional power wheelchair.  The mobility device can be programmed for Standard Function only to meet the assessed needs of t he user.  B.  Nationally Covered Indications   Effective for services performed on and after July 27, 2006, the Centers for Medicare & Medicaid Services (CMS) finds that the evidence is sufficient to determine that the Standard Function of the INDEPENDENCE iBOT 4000 Mobility System meets the definition of Durable Medical Equipment (DME) under section 1861(n) of the Social Security Act (the Act) as a wheelchair used in the patients home that is reasonable and necessary for beneficiaries who have a personal mobility deficit sufficient to impair their participation in mobility -related activities of daily living (MRADL), such as toileting, feeding, dress ing, grooming, and bathing in customary locations in the home.  Determination of the presence of a mobility deficit will use an algorithmic process, as outlined in Chapter 1, Part 4, Section 280.3 of this manual.  C.  Nationally Non -covered Indications   Effective for services performed on and after July 27, 2006, CMS has reviewed the evidence and concludes that the 4- Wheel, Balance, Stair and Remote Functions of the INDEPENDENCE iBOT 4000 Mobility System do not meet the definition of DME under section 1861(n) of the Act.  D.  Other   N/A  (This NCD last reviewed July 2006)   280.16 Seat Elevation Equipment (Power Operated) on Power Wheelchairs  (Rev. 12183, Issued:08- 03-23, Effective:05 -16-23, Implementation:09- 04-23) A. General  Power seat elevation equipment used with a power wheelchair raises and lowers users while they remain in the seated position. This equipment uses an electromechanical lift system to provide varying amounts of vertical seat to floor height. It does not change the seated angles or the seats angle relative to the ground. Complex rehabilitative power -driven wheelchairs are defined in 42 CFR 414.202. B. Nationally Covered Indications  Effective for services performed on or after May 16, 2023, power seat elevation equipment is reasonable and necessary for individuals using complex rehabilitative power -driven wheelchairs, when the following conditions are met:  1. The individual has undergone a specialty evaluation that confirms the individuals ability to safely operate the seat elevation equipment in the home. This evaluation must be performed by a licensed/certified medical professional such as a physical ther apist (PT), occupational therapist (OT), or other practitioner, who has specific training and experience in rehabilitation wheelchair evaluations; and,  2. At least one of the following apply:  a. The individual performs weight bearing transfers to/from the power wheelchair while in the home, using either their upper extremities during a non- level (uneven) sitting transfer and/or their lower extremities during a sit to stand transfer. Transfers m ay be accomplished with or without caregiver assistance and/or the use of assistive equipment (e.g. sliding board, cane, crutch, walker, etc.); or,  b. The individual requires a non- weight bearing transfer (e.g. a dependent transfer) to/from the power wheelchair while in the home. Transfers may be accomplished with or without a floor or mounted lift; or, c. The individual performs reaching from the power wheelchair to complete one or more mobility related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming and bathing in customary locations within the home. MRADLs may be accomplished with or without caregiver assistance and/or the use of assistive equipment.  C. Nationally Non -Covered Indications  N/A D. Other  The Durable Medical Equipment Medicare Administrative Contractor (DME MAC) has discretion to determine reasonable and necessary coverage of power seat elevation equipment for individuals who use Medicare covered power wheelchairs other than complex rehabil itative power -driven wheelchairs.  (This NCD last reviewed May 16, 2023.)  Cross -references: Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services. Medicare Claims Processing Manual, Chapters 20, Durable Medical Equipment, Prosthetics and Orthotics, and Supplies (DMEPOS), 23, Fee Schedule Admi nistration and Coding Requirements.   290 - Nursing Services  (Rev. 1, 10- 03-03)  290.1 - Home Health Visits to a Blind Diabetic  (Rev. 55, Issued: 05- 05-06, Effective: 10 -01-06, Implementation: 10- 02-06)  Many individuals who are blind and require daily insulin for the control of a diabetic condition are able to administer their injections without assistance (other than possibly that which may be furnished by family members or friends).  There are organizat ions which encourage and train blind diabetics, both to fill their own syringes and to inject themselves.  There are also a number of devices available for blind individuals to fill their syringes accurately.  However, the individuals who may need assistance with prefilling their syringes may also require periodic observation and evaluation, even though their diabetes is fairly stabilized.  In such cases, probably few in number, home health services may be required for this purpose.  To qualify for home health benefits, a blind diabetic must be confined to his home, under the care of a physician, and in need of either skilled nursing services on an intermittent basis or physical therapy or speech- language pathology services.  Effective  July 1, 1981, a person may qualify for home health benefits based on his or her need for skilled nursing services on an intermittent basis, physical therapy, speech- language pathology, or occupational therapy.  Effective December 1, 1981, occupational therapy is eliminated as a basis for entitlement to home health services.  However, if a person has otherwise qualified for home health services because of the need for skilled nursing care, physical therapy or speechlanguage pathology, the patients eligibility for home health services may be extended solely on the basis of the continuing need for occupational therapy.  (See the Medicare Benefit Policy Manual, Chapter 7, Home Health Services, 20.) There must be a plan of treatment, established and periodically reviewed by a physician, which indicates that there is a recurring need for home health services to supplement the physicians contacts with the patient; e.g., skilled nursing visits for observing and determining the need for changes in the level and type of care which has been prescribed. (See the Medicare Benefit Policy Manual, Chapter 7, Home Health Services, 30 .) Once an initial regimen has been established, the frequency of need for further home health services can vary greatly from patient to patient, depending on their condition and the likelihood of its changing.  Some may need visits only every 90 days, for  example, while others may require them much more frequently.  If a nurse makes a visit to provide skilled services, and also prefills syringes, the purpose of the visit which was to provide skilled services, does not change.  However, if the sole purpose of the nurses visit is to prefill insulin syringes for a blind diabetic, it is not a skilled nursing visit although it may be reimbursed as such as indicated below.   Filling a syringe can be safely and effectively performed by the average nonmedical person without the direct supervision of a licensed nurse.  Consequently, it would not constitute a skilled nursing service even if it is performed by a nurse.  (See the Medicare Benefit Policy Manual, Chapte r 7, Home Health Services, 30.2.2.) The personal care duties normally performed by home health aides include assisting the patient with medications ordered by a physician which are ordinarily self -administered. (See the Medicare Benefit Policy Manual, C hapter 7, Home Health Services, 50.2.)   Performance of such a service by an aide is consistent with the Medicare conditions of participation for home health agencies.  Therefore, home health aide services would be appropriate for those blind diabetics who are qualified for home health benefits and who cannot fill their syringes.  An adequately trained home health aide could make intermittent visits, usually on a weekly basis, to the home for the purpose of filling that supply of insulin ordere d by the physician.  If State law, however, precludes a home health aide from prefilling insulin syringes, payment may be made for this service as part of the cost of skilled nursing services when performed by a nurse for a blind diabetic who is otherwise unable to prefill his  or her syringes.  There are no adverse consequences with respect to reimbursement to the home health agency for providing the service in this manner.   If State law does not preclude a home health aide from prefilling insulin syringes, but the home health agency chooses to send a nurse to perform only this task, the visit is reimbursed as if made by a home health aide.   NOTE:  As indicated, to qualify for home health benefits, a patient must require skilled nursing services on an intermittent basis or physical therapy or speech -language pathology.  If a beneficiary does not qualify for home health benefits but only needs someone to prefill syringes with the correct dosage of insulin, then no program payment can be made.   Cross -reference: