(Medicare National Coverage Determinations Manual)

 A trained adult caregiver is available to assist the patient with activities of daily living, fluid balance, dry skin care, repositioning, recognition and management of altered mental status, dietary needs, prescribed treatments, and management and support  of the air -fluidized bed system and its problems such as leakage;    A physician directs the home treatment regimen, and reevaluates and recertifies the need for the air -fluidized bed on a monthly basis; and   All other alternative equipment has been considered and ruled out.   Conservative treatment must include:   Frequent repositioning of the patient with particular attention to relief of pressure over bony prominences (usually every 2 hours);    Use of a specialized support surface (Group II) designed to reduce pressure and shear forces on healing ulcers and to prevent new ulcer formation;    Necessary treatment to resolve any wound infection;    Optimization of nutrition status to promote wound healing;    Debridement by any means (including wet to dry dressings -which does not require an occlusive covering) to remove devitalized tissue from the wound bed;    Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings protected by an occlusive covering, while the wound heals.  Home use of the air -fluidized bed is not covered under any of the following circumstances:    The patient has coexisting pulmonary disease (the lack of firm back support makes coughing ineffective and dry air inhalation thickens pulmonary secretions);    The patient requires treatment with wet soaks or moist wound dressings that are not protected with an impervious covering such as plastic wrap or other occlusive material;    The caregiver is unwilling or unable to provide the type of care required by the patient on an air -fluidized bed;    Structural support is inadequate to support the weight of the air -fluidized bed system (it generally weighs 1600 pounds or more);    Electrical system is insufficient for the anticipated increase in energy consumption; or    Other known contraindications exist.  Coverage of an air -fluidized bed is limited to the equipment itself.  Payment for this covered item may only be made if the written order from the attending physician is furnished to the supplier prior to the delivery of the equipment.  Payment is not incl uded for the caregiver or for architectural adjustments such as electrical or structural improvement.   Cross reference:   The Medicare Claims Processing Manual, Chapter 23, Fee Schedule Administration and Coding Requirements, 60.   280.10 - Prosthetic Shoe  (Rev. 1, 10- 03-03) CIM 70 -3  A prosthetic shoe (a device used when all or a substantial portion of the front part of the foot is missing) can be covered as a terminal device; i.e., a structural supplement replacing a totally or substantially absent hand or foot.  The coverage of artif icial arms and legs includes payment for terminal devices such as hands or hooks even though the patient may not require an artificial limb.  The function of the prosthetic shoe is quite distinct from that of excluded orthopedic shoe and supportive foot de vices which are used by individuals whose feet, although impaired, are essentially intact.  (Section 1862(a)(8)  of the Act excludes payment for orthopedic shoes or other supportive devices for the feet.)  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Services, 130.   280.11 - Corset Used as Hernia Support  (Rev. 1, 10- 03-03) CIM 70 -1  A hernia support (whether in the form of a corset or truss) which meets the definition of a brace is covered under Part B under 1861(s)(9)  of the Act.  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Services, 130.  280.12 - Sykes Hernia Control  (Rev. 1, 10- 03-03) CIM 70 -2  Based on professional advice, it has been determined that the sykes hernia control (a spring- type, U-shaped, strapless truss) is not functionally more beneficial than a conventional truss.  Make program reimbursement for this device only when an ordinary t russ would be covered.  (Like all trusses, it is only of benefit when dealing with a reducible hernia).  Thus, when a charge for this item is substantially in excess of that which would be reasonable for a conventional truss used for the same condition, ba se reimbursement on the reasonable charges for the conventional truss. See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Services, 130.  280.13 - Transcutaneous Electrical Nerve Stimulators (TENS) (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 280.13 has been removed from the NCD Manual and incorporated into NCD 160.27 effective June 8, 2012.   280.14  Infusion Pumps  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.  General   Infusion pumps are medical devices used to deliver solutions containing parenteral drugs under pressure at a regulated flow rate.   B.  Nationally Covered Indications   The following indications for treatment using infusion pumps are covered under Medicare:   1.  External Infusion Pumps   a. Iron Poisoning (Effective for Services Performed On or After September 26, 1984)   When used in the administration of deferoxamine for the treatment of acute iron poisoning and iron overload, only external infusion pumps are covered.   b. Thromboembolic Disease (Effective for Services Performed On or After September 26, 1984)   When used in the administration of heparin for the treatment of thromboembolic disease and/or pulmonary embolism, only external infusion pumps used in an institutional setting are covered.   c. Chemotherapy for Liver Cancer (Effective for Services Performed On or After January 29, 1985)   The external chemotherapy infusion pump is covered when used in the treatment of primary hepatocellular carcinoma or colorectal cancer where this disease is unresectable; OR, where the patient refuses surgical excision of the tumor.  d. Morphine for Intractable Cancer Pain (Effective for Services Performed On or After April 22, 1985)   Morphine infusion via an external infusion pump is covered when used in the treatment of intractable pain caused by cancer (in either an inpatient or outpatient setting, including a hospice).   e. Continuous Subcutaneous Insulin Infusion (CSII) Pumps (Effective for Services Performed On or after December 17, 2004)   Continuous subcutaneous insulin infusion (CSII) and related drugs/supplies are covered as medically reasonable and necessary in the home setting for the treatment of diabetic patients who: (1) either meet the updated fasting C -Peptide testing requirement, or, are beta cell autoantibody positive; and, (2) satisfy the remaining criteria for insulin pump therapy as described below.  Patients must meet either Criterion A or B as follows:  Criterion  A: The patient has completed a comprehensive diabetes education program, and has been on a program of multiple daily injections of insulin (i.e., at least 3 injections per day), with frequent self -adjustments of insulin doses for at least 6 months prior to initiation of the insulin pump, and has documented frequency of glucose self -testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump, and meets one or more of the following criteria while on the multiple daily injection regimen:   Glycosylated hemoglobin level (HbAlc) >7.0%;    History of recurring hypoglycemia;    Wide fluctuations in blood glucose before mealtime;    Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl; or,    History of severe glycemic excursions.   Criterion  B:  The patient with diabetes has been on a pump prior to enrollment in Medicare and has documented frequency of glucose self -testing an average of at least 4 times per day during the month prior to Medicare enrollment.  General CSII Criteria   In addition to meeting Criterion A or B above, the following general requirements must be met:   The patient with diabetes must be insulinopenic per the updated fasting C -peptide testing requirement, or, as an alternative, must be beta cell autoantibody positive.  Updated fasting C -peptide testing requirement:    Insulinopenia is defined as a fasting C -peptide level that is less than or equal to 110% of the lower limit of normal of the laboratorys measurement method.   For patients with renal insufficiency and creatinine clearance (actual or calculated from age, gender, weight, and serum creatinine) 50 ml/minute, insulinopenia is defined as a fasting C -peptide level that is less than or equal to 200% of the lower limit of normal of the laboratorys measurement method.  Fasting C -peptide levels will only be considered valid with a concurrently obtained fasting glucose 225 mg/dL.  Levels only need to be documented once in the medical records.  Continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating physician at least every 3 months.  The pump must be ordered by and follow -up care of the patient must be managed by a physician who manages multiple patients with CSII and who works closely with a team including nurses, diabetes educators, and dietitians who are knowledgeable in the use of CSII.   Other Uses of CSII   The Centers for Medicare & Medicaid Services will continue to allow coverage of all other uses of CSII in accordance with the Category B investigational device exemption clinical trials regulation (42 CFR 405.201) or as a routine cost under the clinical tr ials policy (Medicare National Coverage Determinations Manual 310.1).  f. Other Uses   Other uses of external infusion pumps are covered if the DME MAC medical staff verifies the appropriateness of the therapy and the prescribed pump for the individual patient.  NOTE:   Payment may also be made for drugs necessary for the effective use of a covered external infusion pump as long as the drug being used with the pump is itself reasonable and necessary for the patients treatment.   2. Implantable Infusion Pumps   a. Chemotherapy for Liver Cancer (Effective for Services Performed On or After September 26, 1984)   The implantable infusion pump is covered for intra -arterial infusion of 5- FUdR for the treatment of liver cancer for patients with primary hepatocellular carcinoma or Dukes Class D colorectal cancer, in whom the metastases are limited to the liver, and wh ere: (1) the disease is unresectable, or, (2) the patient refuses surgical excision of the tumor.  b. Anti -Spasmodic Drugs for Severe Spasticity   An implantable infusion pump is covered when used to administer anti -spasmodic drugs intrathecally (e.g., baclofen) to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy as determined by the following criteria:   As indicated by at least a 6 -week trial, the patient cannot be maintained on non- invasive methods of spasm control, such as oral anti -spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effect s.  And prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti -spasmodic drug.   c. Opioid Drugs for Treatment of Chronic Intractable Pain   An implantable infusion pump is covered when used to administer opioid drugs (e.g., morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at leas t 3 months, and who have proven unresponsive to less invasive medical therapy as determined by the following criteria:   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