60 DURABLE MEDICAL EQUIPMENT

60-3 WHITE CANE FOR USE BY A BLIND PERSON

60-4 HOME USE OF OXYGEN

60-5 POWER-OPERATED VEHICLES THAT MAY BE USED AS WHEELCHAIRS

60-6 SPECIALLY SIZED WHEELCHAIRS

60-7 SELF-CONTAINED PACEMAKER MONITORS

60-8 SEAT LIFT

60-9 DURABLE MEDICAL EQUIPMENT REFERENCE LIST

60-11 HOME BLOOD GLUCOSE MONITORS

60-14 INFUSION PUMPS

60-15 SAFETY ROLLER

60-16. PNEUMATIC COMPRESSION DEVICES (USED FOR LYMPHEDEMA)

60-17. CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP)

60-18. HOSPITAL BEDS

60-19. AIR-FLUIDIZED BED

60-20 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS (TENS)

60-21 INTRAPULMONARY PERCUSSIVE VENTILATOR (IPV)

60-22 VAGUS NERVE STIMULATION FOR TREATMENT OF SEIZURES

65 PROSTHETIC DEVICES

65-1 HYDROPHILIC CONTACT LENSES

65-2 ELECTRICAL CONTINENCE AID

65-3 SCLERAL SHELL

65-4 CAROTID SINUS NERVE STIMULATOR

65-5 ELECTRONIC SPEECH AIDS

65-6 CARDIAC PACEMAKERS

65-7 INTRAOCULAR LENSES (IOLs)

65-8 ELECTRICAL NERVE STIMULATORS

65-9 INCONTINENCE CONTROL DEVICES

65-10 ENTERAL AND PARENTERAL NUTRITIONAL THERAPY COVERED AS PROSTHETIC DEVICE

65-10.1 Parenteral Nutrition Therapy

65-10.2 Enteral Nutrition Therapy

65-10.3 Nutritional Supplementation

65-11 BLADDER STIMULATORS (PACEMAKERS)--NOT COVERED

65-13 PHRENIC NERVE STIMULATOR

65-14 COCHLEAR IMPLANTATION

65-15 ARTIFICIAL HEARTS AND RELATED DEVICES

65-16 TRACHEOSTOMY SPEAKING VALVE

65-17 URINARY DRAINAGE BAGS

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60        DURABLE MEDICAL EQUIPMENT

60-3    WHITE CANE FOR USE BY A BLIND PERSON--NOT COVERED

A white cane for use by a blind person is more an identifying and self-help device rather than an item which makes a meaningful contribution in the treatment of an illness or injury.

60-4    HOME USE OF OXYGEN

    A.   General.--Medicare coverage of home oxygen and oxygen equipment under the durable medical equipment (DME) benefit (see §1861(s)(6)of the Act) is considered reasonable and necessary only for patients with significant hypoxemia who meet the medical documentation, laboratory evidence, and health conditions specified in subsections B, C, and D. This section also includes special coverage criteria for portable oxygen systems. Finally, a statement on the absence of coverage of the professional services of a respiratory therapist under the DME benefit is included in subsection F.

    B.   Medical documentation.--Initial claims for oxygen services must include a completed Form HCFA-484 (Certificate of Medical Necessity: Oxygen)to establish whether coverage criteria are met and to ensure that the oxygen services provided are consistent with the physician's prescription or other medical documentation. The treating physician's prescription or other medical documentation must indicate that other forms of treatment (e.g., medical and physical therapy directed at secretions, bronchospasm and infection) have been tried, have not been sufficiently successful, and oxygen therapy is still required. While there is no substitute for oxygen therapy, each patient must receive optimum therapy before long-term home oxygen therapy is ordered. Use Form HCFA-484 for recertifications. (See Medicare Carriers Manual §3312 for completion of Form HCFA-484.)

The medical and prescription information in section B of Form HCFA-484 can be completed only by the treating physician, the physician's employee, or another clinician (e.g., nurse, respiratory therapist, etc.) as long as that person is not the DME supplier. Although hospital discharge coordinators and medical social workers may assist in arranging for physician-prescribed home oxygen, they do not have the authority to prescribe the services. Suppliers may not enter this information. While this section may be completed by nonphysician clinician or a physician employee, it must be reviewed and the form HCFA-484 signed by the attending physician.

Claims for oxygen must also be supported by medical documentation in the patient's record. Separate documentation is used with electronic billing. (See Medicare Carriers Manual, Part 3,§4105.5.) This documentation may be in the form of a prescription written by the patient's attending physician who has recently examined the patient (normally within a month of the start of therapy) and must specify:

                 o    A diagnosis of the disease requiring home use of oxygen;

                 o    The oxygen flow rate; and

Rev. 116/ 04-99

                 o    An estimate of the frequency, duration of use (e.g., 2 liters per minute, 10 minutes per hour, 12 hours per day), and duration of need (e.g., 6 months or lifetime).

NOTE: A prescription for "Oxygen PRN" or "Oxygen as needed" does not meet this last requirement. Neither provides any basis for determining if the amount of oxygen is reasonable and necessary for the patient.

A member of the carrier's medical staff should review all claims with oxygen flow rates of more than 4 liters per minute before payment can be made.

The attending physician specifies the type of oxygen delivery system to be used (i.e., gas, liquid, or concentrator) by signing the completed form HCFA-484. In addition the supplier or physician may use the space in section C for written confirmation of additional details of the physician's order. The additional order information contained in section C may include the means of oxygen delivery (mask, nasal, cannula, etc.), the specifics of varying flow rates, and/or the noncontinuous use of oxygen as appropriate. The physician confirms this order information with their signature in section D.

New medical documentation written by the patient's attending physician must be submitted to the carrier in support of revised oxygen requirements when there has been a change in the patient's condition and need for oxygen therapy.

Carriers are required to conduct periodic, continuing medical necessity reviews on patients whose conditions warrant these reviews and on patients with indefinite or extended periods of necessity as described in Medicare Carriers Manual, Part 3, §4105.5. When indicated, carriers may also request documentation of the results of a repeat arterial blood gas or oximetry study.

NOTE: Section 4152 of OBRA 1990 requires earlier recertification and retesting of oxygen patients who begin coverage with an arterial blood gas result at or above a partial pressure of 55 or an arterial oxygen saturation percentage at or above 89. (See Medicare Carriers Manual §4105.5 for certification and retesting schedules.)

   C.    Laboratory Evidence.--Initial claims for oxygen therapy must also include the results of a blood gas study that has been ordered and evaluated by the attending physician. This is usually in the form of a measurement of the partial pressure of oxygen (PO₂) in arterial blood. (See Medicare Carriers Manual, Part 3, §2070.1 for instructions on clinical laboratory tests.) A measurement of arterial oxygen saturation obtained by ear or pulse oximetry, however, is also acceptable when ordered and evaluated by the attending physician and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services. When the arterial blood gas and the oximetry studies are both used to document the need for home oxygen therapy and the results are conflicting, the arterial blood gas study is the preferred source of documenting medical need. A DME supplier is not considered a qualified provider or supplier of laboratory services for purposes of these guidelines. This prohibition does not extend to the results of blood gas test conducted by a hospital certified to do such tests. The conditions under which the laboratory tests are performed must be specified in writing and submitted with the initial claim, i.e., at rest, during exercise, or during sleep.

The preferred sources of laboratory evidence are existing physician and/or hospital records that reflect the patient's medical condition. Since it is expected that virtually all patients who qualify for home oxygen coverage for the first time under these guidelines have recently been discharged from a hospital where they submitted to arterial blood gas tests, the carrier needs to request that such test results be submitted in support of their initial claims for home oxygen. If more than one arterial blood

Rev. 116/ 04-99

gas test is performed during the patient's hospital stay, the test result obtained closest to, but no earlier than 2 days prior to the hospital discharge date is required as evidence of the need for home oxygen therapy.

A repeat arterial blood gas study is appropriate when evidence indicates that an oxygen recipient has undergone a major change in their condition relevant to home use of oxygen. If the carrier has reason to believe that there has been a major change in the patient's physical condition, it may ask for documentation of the results of another blood gas or oximetry study.

    D. Health Conditions.--Coverage is available for patients with significant hypoxemia in the chronic stable state if: (1) the attending physician has determined that the patient has a health condition outlined in subsection D.1, (2) the patient meets the blood gas evidence requirements specified in subsection D.3, and (3) the patient has appropriately tried other alternative treatment measures without complete success. (See subsection B.)

        1.    Conditions for Which Oxygen Therapy May Be Covered.--

            o    A severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, whether of known or unknown etiology; cystic fibrosis bronchiectasis; widespread pulmonary neoplasm; or

            o    Hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy. Examples of these symptoms and findings are pulmonary hypertension, recurring congestive heart failure due to chronic cor pulmonale, erythrocytosis, impairment of the cognitive process, nocturnal restlessness, and morning headache.

        2.   Conditions for Which Oxygen Therapy Is Not Covered.--

            o    Angina pectoris in the absence of hypoxemia. This condition is generally not the result of a low oxygen level in the blood, and there are other preferred treatments;

            o    Breathlessness without cor pulmonale or evidence of hypoxemia. Although intermittent oxygen use is sometimes prescribed to relieve this condition, it is potentially harmful and psychologically addicting;

            o    Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities. There is no evidence that increased PO₂ improves the oxygenation of tissues with impaired circulation; or

        3.   Covered Blood Gas Values.--If the patient has a condition specified in subsection D.1, the carrier must review the medical documentation and laboratory evidence that has been submitted for a particular patient (see subsections B and C) and determine if coverage is available under one of the three group categories outlined below.

            a.    Group I.--Except as modified in subsection d, coverage is provided for patients with significant hypoxemia evidenced by any of the following:

                (1)        An arterial PO₂ at or below 55 mm Hg, or an arterial oxygen saturation at or below 88 percent, taken at rest, breathing room air.

                (2)        An arterial PO₂ at or below 55 mm Hg, or an arterial oxygen saturation at or below 88 percent, taken during sleep for a patient who demonstrates an arterial PO₂ at or above 56 mm Hg, or an arterial oxygen saturation at or above 89 percent, while awake; or a greater than normal fall in oxygen level during sleep (a decrease in arterial PO₂ more than 10 mm Hg, or decrease in arterial oxygen saturation more than 5 percent) associated with symptoms or signs reasonably attributable to hypoxemia (e.g., impairment of cognitive processes and nocturnal restlessness or insomnia). In either of these cases, coverage is provided only for use of oxygen during sleep, and then only one type of unit will be covered. Portable oxygen, therefore, would not be covered in this situation.

               (3)        An arterial PO₂ at or below 55 mm Hg or an arterial oxygen saturation at or below 88 percent, taken during exercise for a patient who demonstrates an arterial PO₂ at or above 56 mm Hg, or an arterial oxygen saturation at or above 89 percent, during the day while at rest. In this case, supplemental oxygen is provided for during exercise if there is evidence the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.

            b.   Group II.--Except as modified in subsection d, coverage is available for patients whose arterial PO₂ is 56-59 mm Hg or whose arterial blood oxygen saturation is 89 percent, if there is evidence of:

                (1)        Dependent edema suggesting congestive heart failure;

                (2)        Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVFL; or

                (3)        Erythrocythemia with a hematocrit greater than 56 percent.

            c. Group III.--Except as modified in subsection d, carriers must apply a rebuttable presumption that a home program of oxygen use is not medically necessary for patients with arterial PO₂ levels at or above 60 mm Hg, or arterial blood oxygen saturation at or above 90 percent. In order for claims in this category to be reimbursed, the carrier's reviewing physician needs to review any documentation submitted in rebuttal of this presumption and grant specific approval of the claims. HCFA expects few claims to be approved for coverage in this category.

            d.   Variable Factors That May Affect Blood Gas Values.--In reviewing the arterial PO₂ levels and the arterial oxygen saturation percentages specified in subsections D. 3. a, b and c, the carrier's medical staff must take into account variations in oxygen measurements that may result from such factors as the patient's age, the altitude level, or the patient's decreased oxygen carrying capacity.

    E.   Portable Oxygen Systems.--A patient meeting the requirements specified below may qualify for coverage of a portable oxygen system either (1) by itself or (2) to use in addition to a stationary oxygen system. A portable oxygen system is covered for a particular patient if:

        o    The claim meets the requirements specified in subsections A-D, as appropriate; and

        o    The medical documentation indicates that the patient is mobile in the home and would benefit from the use of a portable oxygen system in the home. Portable oxygen systems are not covered for patients who qualify for oxygen solely based on blood gas studies obtained during sleep.

    F.   Respiratory Therapists.--Respiratory therapists' services are not covered under the provisions for coverage of oxygen services under the Part B durable medical equipment benefit as outlined above. This benefit provides for coveravge of home use of oxygen and oxygen equipment, but does not include a professional component in the delivery of such services.

(See §60-9; Intermediary Manual, Part 3, §3113ff; and Medicare Carriers Manual, Part 3, §2100ff.)

60-5    POWER-OPERATED VEHICLES THAT MAY BE USED AS WHEELCHAIRS

Power-operated vehicles that may be appropriately used as wheelchairs are covered under the durable medical equipment provision.

These vehicles have been appropriately used in the home setting for vocational rehabilitation and to improve the ability of chronically disabled persons to cope with normal domestic, vocational and social activities. They may be covered if a wheelchair is medically necessary and the patient is unable to operate a wheelchair manually.

A specialist in physical medicine, orthopedic surgery, neurology, or rheumatology must provide an evaluation of the patient's medical and physical condition and a prescription for the vehicle to assure that the patient requires the vehicle and is capable of using it safely. When an intermediary determines that such a specialist is not reasonably accessible, e.g., more than 1 day's round trip from the beneficiary's home, or the patient's condition precludes such travel, a prescription from the beneficiary's physician is acceptable.

The intermediary's medical staff reviews all claims for a power-operated vehicle, including the specialists' or other physicians' prescriptions and evaluations of the patient's medical and physical conditions, to insure that all coverage requirements are met. (See §60-9 and Intermediary Manual, Part 3, §3629.)

60-6    SPECIALLY SIZED WHEELCHAIRS

Payment may be made for a specially sized wheelchair even though it is more expensive than a standard wheelchair. For example, a narrow wheelchair may be required because of the narrow doorways of a patient's home or because of a patient's slender build. Such difference in the size of the wheelchair from the standard model is not considered a deluxe feature.

A physician's certification or prescription that a special size is needed is not required where you can determine from the information in file or other sources that a specially sized wheelchair (rather than a standard one) is needed to accommodate the wheelchair to the place of use or the physical size of the patient.

To determine the reasonable charge in these cases, use the criteria set out in Carriers Manual, §§5022, 5022.1, 5200, and 5205, as necessary.

Cross-refer: Intermediary Manual, §§31l3.2C, 3642.1, 3643 (item 3); Carriers Manual, §§2100.2c, 2105, 4105.2, 5107; Hospital Manual, §§235.2c, 420.1 (item 13).

60-7    SELF-CONTAINED PACEMAKER MONITORS

Self-contained pacemaker monitors are accepted devices for monitoring cardiac pacemakers. Accordingly, program payment may be made for the rental or purchase of either of the following pacemaker monitors when it is prescribed by a physician for a patient with a cardiac pacemaker:

    A.   Digital Electronic Pacemaker Monitor.--This device provides the patient with an instantaneous digital readout of his pacemaker pulse rate. Use of this device does not involve professional services until there has been a change of five pulses (or more) per minute above or below the initial rate of the pacemaker; when such change occurs, the patient contacts his physician.

    B.   Audible/Visible Signal Pacemaker Monitor.--This device produces an audible and visible signal which indicates the pacemaker rate. Use of this device does not involve professional services until a change occurs in these signals; at such time, the patient contacts his physician.

NOTE:    The design of the self-contained pacemaker monitor makes it possible for the patient to monitor his pacemaker periodically and minimizes the need for regular visits to the outpatient department of the provider.

        Therefore, documentation of the medical necessity for pacemaker evaluation in the outpatient department of the provider should be obtained where such evaluation is employed in addition to the self-contained pacemaker monitor used by the patient in his home.

Cross-refer: §50-1

60-8    SEAT LIFT

Reimbursement may be made for the rental or purchase of a medically necessary seat lift when prescribed by a physician for a patient with severe arthritis of the hip or knee and patients with muscular dystrophy or other neuromuscular diseases when it has been determined the patient can benefit therapeutically from use of the device. In establishing medical necessity for the seat lift, the evidence must show that the item is included in the physician's course of treatment, that it is likely to effect improvement, or arrest or retard deterioration in the patient's condition, and that the severity of the condition is such that the alternative would be chair or bed confinement.

Coverage of seat lifts is limited to those types which operate smoothly, can be controlled by the patient, and effectively assist a patient in standing up and sitting down without other assistance. Excluded from coverage is the type of lift which operates by a spring release mechanism with a sudden, catapult-like motion and jolts the patient from a seated to a standing position. Limit the payment for units which incorporate a recliner feature along with the seat lift to the amount payable for a seat lift without this feature.

Cross Refer: Carriers Manual, § 5107

60-9        DURABLE MEDICAL EQUIPMENT REFERENCE LIST.

The durable medical equipment (DME) list which follows is designed to facilitate your processing of DME claims. This section is designed to be used as a quick reference tool for determining the coverage status of certain pieces of DME and especially for those items which are commonly referred to by both brand and generic names. The information contained herein is applicable (where appropriate) to all DME coverage determinations discussed in the DME portion of this manual. The list is organized into two columns. The first column lists alphabetically various generic categories of equipment on which national coverage decisions have been made by HCFA; and the second column notes the coverage status of each equipment category.

In the case of equipment categories that have been determined by HCFA to be covered under the DME benefit, the list outlines the conditions of coverage that must be met if payment is to be allowed for the rental or purchase of the DME by a particular patient, or cross-refers to another section of the manual where the applicable coverage criteria are described in more detail. With respect to equipment categories that cannot be covered as DME, the list includes a brief explanation of why the equipment is not covered. This DME list will be updated periodically to reflect any additional national coverage decisions that HCFA may make with regard to other categories of equipment.

When you receive a claim for an item of equipment which does not appear to fall logically into any of the generic categories listed, you have the authority and responsibility for deciding whether those items are covered under the DME benefit. These decisions must be made by each contractor based on the advice of its medical consultants, taking into account:
   
    o    The general DME coverage instructions in the Carriers Manual, §2100ff and Intermediary Manual, §3113ff (see below for brief summary);

    o    Whether the item has been approved for marketing by the Food and Drug Administration (FDA) (see Carriers Manual, §2303.1 and Intermediary Manual, §3151.1 ) and is otherwise generally considered to be safe and effective for the purpose intended; and

    o    Whether the item is reasonable and necessary for the individual patient.

As provided in the Carriers Manual, § 2100.1, and Intermediary Manual, §3113.1, the term DME is defined as equipment which

    o    Can withstand repeated use; i.e., could normally be rented, and used by successive patients;

    o    Is primarily and customarily used to serve a medical purpose;

    o    Generally is not useful to a person in the absence of illness or injury; and

    o    Is appropriate for use in a patient's home.

Durable Medical Equipment Reference List:

60-11    HOME BLOOD GLUCOSE MONITORS

There are several different types of blood glucose monitors which use reflectance meters to determine blood glucose levels. Medicare coverage of these devices varies, both with respect to the type of device and the medical condition of the patient for whom the device is prescribed.

Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for use in the home because their need for frequent professional recalibration makes them unsuitable for home use. However, some types of blood glucose monitors which use a reflectance meter specifically designed for home use by diabetic patients may be covered as durable medical equipment, subject to the conditions and limitations described below.

Blood glucose monitors are meter devices which read color changes produced on specially treated reagent strips by glucose concentrations in the patient's blood. The patient, using a disposable sterile lancet, draws a drop of blood, places it on a reagent strip and, following instructions which may vary with the device used, inserts it into the device to obtain a reading. Lancets, reagent strips, and other supplies necessary for the proper functioning of the device are also covered for patients for whom the device is indicated. Home blood glucose monitors enable certain patients to better control their blood glucose levels by frequently checking and appropriately contacting their attending physician for advice and treatment. Studies indicate that the patient's ability to carefully follow proper procedures is critical to obtaining satisfactory results with these devices. In addition, the cost of the devices, with their supplies, limits economical use to patients who must make frequent checks of their blood glucose levels. Accordingly, coverage of home blood glucose monitors is limited to patients meeting the following conditions:

    o    The patient must be an insulin-treated diabetic;

    o    The patient's physician states that the patient is capable of being trained to use the particular device prescribed in an appropriate manner. In some cases, the patient may not be able to perform this function, but a responsible individual can be trained to use the equipment and monitor the patient to assure that the intended effect is achieved. This is permissible if the record is properly documented by the patient's physician; and

    o    The device is designed for home rather than clinical use.

There is also a blood glucose monitoring system designed especially for use by those with visual impairments. The monitors used in such systems are identical in terms of reliability and sensitivity to the standard blood glucose monitors described above. They differ by having such features as voice synthesizers, automatic timers, and specially designed arrangements of supplies and materials to enable the visually impaired to use the equipment without assistance.

These special blood glucose monitoring systems are covered under Medicare if the following conditions are met:

    o    The patient and device meet the four conditions listed above for coverage of standard home blood glucose monitors; and

    o    The patient's physician certifies that he or she has a visual impairment severe enough to require use of this special monitoring system.

The additional features and equipment of these special systems justify a higher reimbursement amount than allowed for standard blood glucose monitors. Separately identify claims for such devices and establish a separate reimbursement amount for them. For those carriers using HCPCS, the procedure code and definition is: EO609--Blood Glucose Monitor--with special features (e.g., voice synthesizers, automatic timer).

1. External Infusion Pumps.--
   
   
   1. Iron Poisoning (Effective for Services Performed On or After 9/26/84).--When used in the administration of deferoxamine for the treatment of acute iron poisoning and iron overload, only external infusion pumps are covered.
      
      
   2. Thromboembolic Disease (Effective for Services Performed On or After 9/26/84).--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.
      
      
   3. Chemotherapy for Liver Cancer (Effective for Services Performed On or After 1/29/85).--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.
      
      
   4. Morphine for Intractable Cancer Pain (Effective for Services Performed On or After 4/22/85).--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).
      
      
   5. Continuous subcutaneous insulin infusion pumps (CSII) (Effective for Services Performed On or After 4/1/2000).--

6. Other uses of external infusion pumps are covered if the contractor's medical staff verifies the appropriateness of the therapy and of the prescribed pump for the individual patient.

2. Implantable Infusion Pumps.--
   
   
   1. Chemotherapy for Liver Cancer (Effective for Services Performed On or After 9/26/84).--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 Duke's Class D colorectal cancer, in whom the metastases are limited to the liver, and where (1) the disease is unresectable or (2) where the patient refuses surgical excision of the tumor.
      
      
   2. 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 noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and
        
        
      • Prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug.
      
      
   3. 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 least 3 months and who have proven unresponsive to less invasive medical therapy as determined by the following criteria:
      
      
      • The patient's history must indicate that he/she would not respond adequately to non-invasive 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.
      
      
   4. Coverage of Other Uses of Implanted Infusion Pumps.--Determinations may be made on coverage of other uses of implanted infusion pumps if the contractor's 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 FDA approved labelling 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.


5. Implantation of Infusion Pump Is Contraindicated.--The implantation of an infusion pump is contraindicated in the following patients:
   
   
   • Patients with a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen, morphine, etc.);
     
     
   • Patients who have an infection;
     
     
   • Patients whose body size is insufficient to support the weight and bulk of the device; and
     
     
   • Patients with other implanted programmable devices since crosstalk between devices may inadvertently change the prescription.

1. External Infusion Pumps.--
   
   
   1. 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.--
   
   
   1. Thromboembolic Disease (Effective for Services Performed On or After 9/26/84).--According to the Public Health Service, 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 covered.
      
      
   2. Diabetes--Implanted infusion pumps for the infusion of insulin to treat diabetes is not covered. The data do not demonstrate that the pump provides effective administration of insulin.

In the case of patients with medical documentation showing severe neurological disorders or restricted use of one hand which makes it impossible for them to use a wheeled walker that does not have a sophisticated braking system, a reasonable charge for the safety roller may be determined without relating it to the reasonable charge for a standard wheeled walker. (Such reasonable charge should be developed in accordance with the instructions in Medicare Carriers Manual §§5010 and 5205.)

Cross Refer: Carriers Manual §§2100ff., §60-9.

60-16.    PNEUMATIC COMPRESSION DEVICES (USED FOR LYMPHEDEMA)

Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from an impairment to the normal clearing function of the lymphatic system and/or from an excessive production of lymph. It is a relatively uncommon, chronic condition which may be due to many causes, e.g., surgical removal of lymph nodes, post radiation fibrosis, scarring of lymphatic channel, onset of puberty (Milroy's Disease), and congenital anomalies. In the home setting, both the segmental and nonsegmental pneumatic compression devices are covered only for the treatment of generalized, refractory lymphedema.

Pneumatic compression devices are only covered as a treatment of last resort, i.e., other less intensive treatments must have been tried first and found inadequate. Such treatments would include leg or arm elevation and custom fabricated gradient pressure stockings or sleeves. Pneumatic compression devices may be covered only when prescribed by a physician and when they are used with appropriate physician oversight, i.e., physician evaluation of the patient's condition to determine medical necessity of the device, suitable instruction in the operation of the machine, a treatment plan defining the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment.

The determination by the physician of the medical necessity of a pneumatic compression device must include (1) the patient's diagnosis and prognosis; (2) symptoms and objective findings, including measurements which establish the severity of the condition; (3) the reason the device is required, including the treatments which have been tried and failed; and (4) the clinical response to an initial treatment with the device. The clinical response includes the change in pre-treatment measurements, ability to tolerate the treatment session and parameters, and ability of the patient (or caregiver) to apply the device for continued use in the home.

In general, the nonsegmented (HCPCS code E0650) or segmented (HCPCS code E0651) compression device without manual control of pressure in each chamber is considered the least costly alternative that meets the clinical needs of the individual. Therefore, when a claim for a segmented pneumatic compression device which allows for manual control in each chamber is received, payment must be made for the least expensive medically appropriate device. If the patient medically needs a segmented device but does not need manual controls, payment must be made for HCPCS code E0651. The segmented device with manual control (HCPCS code E0652) is covered only when there are unique characteristics that prevent the individual from receiving satisfactory pneumatic treatment using a less costly device, e.g., significant sensitive skin scars or the presence of contracture or pain caused by a clinical condition that requires the more costly manual control device.

The use of pneumatic compression devices may be medically appropriate only for those patients with generalized, refractory edema from venous insufficiency

with lymphatic obstruction (i.e., recurrent cellulitis with secondary scarring of the lymphatic system) with significant ulceration of the lower extremity(ies) who have received repeated, standard treatment from a physician using such methods as a compression bandage system or its equivalent, but fail to heal after 6 months of continuous treatment. The exact nature of the medical problem must be clear from the medical evidence submitted. If, after obtaining this information, a question of medical necessity remains, the contractor's medical staff resolves the issue.

Cross Refer: §60-9.

60-17.    CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) (Effective for Claims Adjudicated on and After January 12, 1987.)

CPAP is a non-invasive technique for providing low levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea (OSA). The diagnosis of OSA requires documentation of at least 30 episodes of apnea, each lasting a minimum of 10 seconds, during 6-7 hours of recorded sleep. The use of CPAP is covered under Medicare when used in adult patients with moderate or severe OSA for whom surgery is a likely alternative to CPAP.

Initial claims must be supported by medical documentation (separate documentation where electronic billing is used), such as a prescription written by the patient's attending physician, that specifies:

    o    a diagnosis of moderate or severe obstructive sleep apnea, and
    o    surgery is a likely alternative.

The claim must also certify that the documentation supporting a diagnosis of OSA (described above) is available.

Cross Refer: §60-9.

60-18.    HOSPITAL BEDS

    A.    General Requirements for Coverage of Hospital Beds.--A physician's prescription, and such additional documentation as the contractors' medical staffs may consider necessary, including medical records and physicians' reports, must establish the medical necessity for a hospital bed due to one of the following reasons:

        o    The patient's condition requires positioning of the body; e.g., to alleviate pain, promote good body alignment, prevent contractures, avoid respiratory infections, in ways not feasible in an ordinary bed; or

        o    The patient's condition requires special attachments that cannot be fixed and used on an ordinary bed.

    B.    Physician's Prescription.--The physician's prescription, which must accompany the initial claim, and supplementing documentation when required, must establish that a hospital bed is medically necessary. If the stated reason for the need for a hospital bed is the patient's condition requires positioning, the prescription or other documentation must describe the medical

If the stated reason for requiring a hospital bed is the patient's condition requires special attachments, the prescription must describe the patient's condition and specify the attachments that require a hospital bed.

    C.    Variable Height Feature.--In well documented cases, the contractors' medical staffs may determine that a variable height feature of a hospital bed, approved for coverage under subsection A above, is medically necessary and, therefore, covered, for one of the following conditions:

        o    Severe arthritis and other injuries to lower extremities; e.g., fractured hip. The condition requires the variable height feature to assist the patient to ambulate by enabling the patient to place his or her feet on the floor while sitting on the edge of the bed;

        o    Severe cardiac conditions. For those cardiac patients who are able to leave bed, but who must avoid the strain of "jumping" up or down;

        o    Spinal cord injuries, including quadriplegic and paraplegic patients, multiple limb amputee and stroke patients. For those patients who are able to transfer from bed to a wheelchair, with or without help; or

        o    Other severely debilitating diseases and conditions, if the variable height feature is required to assist the patient to ambulate.

    D.    Electric Powered Hospital Bed Adjustments.--Electric powered adjustments to lower and raise head and foot may be covered when the contractor's medical staff determines that the patient's condition requires frequent change in body position and/or there may be an immediate need for a change in body position (i.e., no delay can be tolerated) and the patient can operate the controls and cause the adjustments. Exceptions may be made to this last requirement in cases of spinal cord injury and brain damaged patients.

    E.    Side Rails.--If the patient's condition requires bed side rails, they can be covered when an integral part of, or an accessory to, a hospital bed.

Cross refer: Carriers Manual, §5015.4

60-19.    AIR-FLUIDIZED BED (Effective for services rendered on or after: 07/30/90)

An air-fluidized bed uses warm air under pressure to set small ceramic beads in motion which simulate the movement of fluid. When the patient is placed in the bed, his body weight is evenly distributed over a large surface area which creates a sensation of "floating." Medicare payment for home use of the air-fluidized bed for treatment of pressure sores can be made if such use is reasonable and necessary for the individual patient.

A decision that use of an air-fluidized bed is reasonable and necessary requires that:

        o    The patient has a stage 3 (full thickness tissue loss) or stage 4 (deep tissue destruction) pressure sore;

        o    The patient is bedridden or chair bound as a result of severely limited mobility;

        o    In the absence of an air-fluidized bed, the patient would require institutionalization;

        o    The air-fluidized bed is ordered in writing by the patient's attending physician based upon a comprehensive assessment and evaluation of the patient after conservative treatment has been tried without success;

        o    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;

        o    A physician directs the home treatment regimen, and reevaluates and recertifies the need for the air-fluidized bed on a monthly basis; and

        o    All other alternative equipment has been considered and ruled out.

Home use of the air-fluidized bed is not covered under any of the following circumstances:

       o    The patient has coexisting pulmonary disease (the lack of firm back support makes coughing ineffective and dry air inhalation thickens pulmonary secretions);

       o    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;

       o    The caregiver is unwilling or unable to provide the type of care required by the patient on an air- fluidized bed;

       o    Structural support is inadequate to support the weight of the air-fluidized bed system (it generally weighs 1600 pounds or more);

       o    Electrical system is insufficient for the anticipated increase in energy consumption; or

       o    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 included for the caregiver or for architectural adjustments such as electrical or structural improvement.

Cross refer: Carriers Manual, §5102.2

60-20    TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS (TENS)

TENS is a type of electrical nerve stimulator that is employed to treat chronic intractable pain. This stimulator is attached to the surface of the patient's skin over the peripheral nerve to be stimulated. It may be applied in a variety of settings (in the patient's home, a physician's office, or in an outpatient clinic). Payment for TENS may be made under the durable medical equipment benefit. (See §45-25 for an explanation of coverage of medically necessary supplies for the effective use of TENS and §45-19 for an explanation of coverage of TENS for acute post-operative pain.)

60-21     INTRAPULMONARY PERCUSSIVE VENTILATOR (IPV) - NOT COVERED

IPV is a mechanized form of chest physical therapy. Instead of a therapist clapping or slapping the patient's chest wall, the IPV delivers mini-bursts (more than 200 per minute) of respiratory gasses to the lungs via a mouthpiece. Its intended purpose is to mobilize endobronchial secretions and diffuse patchy atelectasis. The patient controls variables such as inspiratory time, peak pressure and delivery rates.

Studies do not demonstrate any advantage of IPV over that achieved with good pulmonary care in the hospital environment and there are no studies in the home setting. There are no data to support the effectiveness of the device. Therefore, IPV in the home setting is not covered.

60-22     VAGUS NERVE STIMULATION FOR TREATMENT OF SEIZURES

In the past 10 years, there have been significant advances in surgical treatment for epilepsy and in medical treatment of epilepsy with newly developed and approved medications. Despite these advances, 25-50 percent of patients with epilepsy experience breakthrough seizures or suffer from debilitating adverse effects of antiepileptic drugs.

A partial onset seizure has a focal onset in one area of the brain and may or may not involve a loss of motor control or alteration of consciousness. Partial onset seizures may be simple, complex, or complex partial seizures, secondarily generalized.

65    PROSTHETIC DEVICES

65-1    HYDROPHILIC CONTACT LENSES

Hydrophilic contact lenses are eyeglasses within the meaning of the exclusion in §l862(a)(7) of the law and are not covered when used in the treatment of nondiseased eyes with spherical ametrophia, refractive astigmatism, and/or corneal astigmatism. Payment may be made under the prosthetic device benefit, however, for hydrophilic contact lenses when prescribed for an aphakic patient.

Contractors are authorized to accept an FDA letter of approval or other FDA published material as evidence of FDA approval.

(See §45-7 for coverage of a hydrophilic lens as a corneal bandage.)

Cross-refer:    Intermediary Manual, §§3110.3, 3110.4, 3151, and 3157; Carriers Manual, §§2130, 2320; Hospital Manual, §§228.3, 228.4, 260.1 and 260.7.

65-2    ELECTRICAL CONTINENCE AID--NOT COVERED

An electrical continence aid is a device consisting of a plastic plug, molded into the shape of the patient's anal canal, which contains two implanted electrodes that are connected by a wire to a small portable generator. An electrical current is produced which stimulates the anal musculature to cause a contraction sufficient to hold the plug in while allowing the patient to ambulate without incontinence.

Electrical continence aids are in the experimental stage of development and there is no valid scientific documentation of their effectiveness and safety. Therefore, they are not covered under Medicare since they cannot be considered to be reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member as required by §1862(a)(1) of the law.

65-3    SCLERAL SHELL

Scleral shell (or shield) is a catchall term for different types of hard scleral contact lenses.

A scleral shell fits over the entire exposed surface of the eye as opposed to a corneal contact lens which covers only the central non-white area encompassing the pupil and iris. Where an eye has been rendered sightless and shrunken by inflammatory disease, a scleral shell may, among other things, obviate the need for surgical enucleation and prosthetic implant and act to support the surrounding orbital tissue.

In such a case, the device serves essentially as an artificial eye. In this situation, payment may be made for a scleral shell under §1861(s)(8) of the law.

Scleral shells are occasionally used in combination with artificial tears in the treatment of "dry eye" of diverse etiology. Tears ordinarily dry at a rapid rate, and are continually replaced by the lacrimal gland. When the lacrimal gland fails, the half-life of artificial tears may be greatly prolonged by the use of the scleral contact lens as a protective barrier against the drying action of the atmosphere. Thus, the difficult and sometimes hazardous process of frequent installation of artificial tears may be avoided. The lens acts in this instance to substitute, in part, for the functioning of the diseased lacrimal

gland and would be covered as a prosthetic device in the rare case when it is used in the treatment of "dry eye."

Cross-refer:    HCFA-Pub. 13-3, §§3110.4, 3110.5; HCFA-Pub. 14-3, §§2130, 2133; HCFA- Pub. 10, §§210.4, 211

65-4    CAROTID SINUS NERVE STIMULATOR

Implantation of the carotid sinus nerve stimulator is indicated for relief of angina pectoris in carefully selected patients who are refractory to medical therapy and who after undergoing coronary angiography study either are poor candidates for or refuse to have coronary bypass surgery. In such cases, Medicare reimbursement may be made for this device and for the related services required for its implantation.

However, the use of the carotid sinus nerve stimulator in the treatment of paroxysmal supraventricular tachycardia is considered investigational and is not in common use by the medical community. The device and related services in such cases cannot be considered as reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member as required by §1862(a)(1) of the law.

Cross-refer:     HCFA-Pub. 13-3,§3110.4; HCFA-Pub. 14-3, §2130; HCFA-Pub. 10, §§210.4, 211

65-5    ELECTRONIC SPEECH AIDS

Electronic speech aids are covered under Part B as prosthetic devices when the patient has had a laryngectomy or his larynx is permanently inoperative. There are two types of speech aids. One operates by placing a vibrating head against the throat; the other amplifies sound waves through a tube which is inserted into the user's mouth. A patient who has had radical neck surgery and/or extensive radiation to the anterior part of the neck would generally be able to use only the "oral tube" model or one of the more sensitive and more expensive "throat contact" devices.

Cross-refer:    HCFA-Pub. 13-3, §3110.4; HCFA-Pub. 14-3, §2130; HCFA-Pub. 10, §228.4

65-6    CARDIAC PACEMAKERS

Cardiac pacemakers are covered as prosthetic devices under the Medicare program, subject to the conditions and limitations described in this section. While cardiac pacemakers have been covered under Medicare for many years, until recently there have been no specific guidelines for their implantation other than the general Medicare requirement that covered services be reasonable and necessary for the treatment of the condition. Services rendered for pacemaker implantations on or after the effective dates of this instruction are subject to the guidelines of this section.

These guidelines are based on certain assumptions regarding the clinical goals of pacemaker implantation. While some uses of pacemakers represent relatively certain or unambiguous usage, many others require considerable expertise and judgment

Consequently, the medical necessity for pacemaker implantation must be viewed in the context of the overall management of the particular patient. The appropriateness of such implants may be conditional on other diagnostic or therapeutic modalities having been undertaken. Although significant complications and adverse side effects of pacemakers are relatively rare, they cannot be ignored when considering the use of pacemakers for dubious medical conditions, or marginal clinical benefit.

These guidelines represent current concepts regarding medical circumstances in which pacemaker implantation may be appropriate or necessary. As with other areas of medicine, advances in knowledge and techniques in cardiology are expected. Consequently, judgments about the medical necessity and acceptability of pacemaker implants can be expected to change, and instructions modified as more information becomes available.

It should be noted that this instruction applies only to permanent, implanted pacemakers, and does not address the use of temporary, nonimplanted pacemakers.

The two groups of conditions outlined below deal with the necessity for cardiac pacemaker implants for patients in general. These are intended as guidelines for Medicare contractors to use in assessing the medical necessity of claims for pacemaker implantation. As with other guidelines, final coverage determinations must take account of the circumstances of the particular claim, as well as factors such as the medical history of the individual patient. However, as a general rule, contractors may view the two groups of current medical concepts below as representing:

        Group I: Single-Chamber Cardiac Pacemakers--A) conditions under which single- chamber pacemaker claims may be considered covered without further claims development; and B) conditions under which single-chamber pacemaker claims would be denied unless further claims development shows that they fall into the covered category, or special medical circumstances exist sufficient to convince the contractor that the claim should be paid.

        Group II. Dual-Chamber Cardiac Pacemakers--A) conditions under which dual- chamber pacemaker claims may be considered covered without further claims development, and B) conditions under which dual-chamber pacemaker claims would be denied unless further claims development shows that they fall into the covered categories for single-and dual-chamber pacemakers, or special medical circumstances exist sufficient to convince the contractor that the claim should be paid.

    GROUP I:    SINGLE-CHAMBER CARDIAC PACEMAKERS--Effective for services rendered on or after March 16, 1983.

    A.    COVERED

Conditions under which implantation of a cardiac pacemaker is generally considered acceptable or necessary, provided that the conditions are chronic or recurrent and not due to transient causes such as acute myocardial infarction, drug toxicity, or electrolyte imbalance. (In cases where there is a rhythm disturbance, if the rhythm disturbance is chronic or recurrent, a single episode of a symptom such as syncope or seizure is adequate to establish medical necessity.)

        1.    Acquired complete (also referred to as third degree) AV heart block.

        2.    Congenital complete heart block with severe bradycardia (in relation to age), or significant physiological deficits or significant symptoms due to the bradycardia.

        3.    Second degree AV heart block of Type II (i.e., no progressive prolongation of P- R interval prior to each blocked beat).

        4.    Second degree AV heart block of Type I (i.e., progressive prolongation of P-R interval prior to each blocked beat) with significant symptoms due to hemodynamic instability associated with the heart block.

        5.    Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, congestive heart failure); or substantial sinus bradycardia (heart rate less than 50) associated with dizziness or confusion. The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.

        6.    In selected and few patients, sinus bradycardia of lesser severity (heart rate 50- 59) with dizziness or confusion. The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.

        7.    Sinus bradycardia which is the consequence of long-term necessary drug treatment for which there is no acceptable alternative, when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion). The correlation between symptoms and bradycardia must be documented, or the symptoms must be clearly attributable to the bradycardia rather than to some other cause.

        8.    Sinus node dysfunction with or without tachyarrhythmias or AV conduction block--i.e., the bradycardia-tachycardia syndrome, sino-atrial block, sinus arrest-- when accompanied by significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion).

         9.    Sinus node dysfunction with or without symptoms when there are potentially life- threatening ventricular arrhythmias or tachycardia secondary to the bradycardia (e.g., numerous premature ventricular contractions, couplets, runs of premature ventricular contractions, or ventricular tachycardia).

        10.    Bradycardia associated with supraventricular tachycardia (e.g., atrial fibrillation, atrial flutter, or paroxysmal atrial tachycardia) with high degree AV block which is unresponsive to appropriate pharmacological management and when the bradycardia is associated with significant symptoms (e.g., syncope, seizures, congestive heart failure, dizziness or confusion).

        11.    The occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.

        12.    Bifascicular or trifascicular block accompanied by syncope which is attributed to transient complete heart block after other plausible causes of syncope have been reasonably excluded.

        13.    Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (third degree) and/or Mobitz Type II second degree AV block in association with bundle branch block.

        14.    In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing" (pacing above the basal rate) to prevent ventricular tachycardia.

Effective for services rendered on or after May 9, 1985.

        15.    Second degree AV heart block of Type I with the QRS complexes prolonged.

    B.    NOT COVERED--Additional claims development may be required.

Conditions which, although used by some physicians as bases for permanent pacemaker implantation, are considered unsupported by adequate evidence of benefit and therefore should not generally be considered appropriate uses for single-chamber pacemakers in the absence of indications cited above. Contractors should review claims for pacemakers with these indications to determine the need for further claims development prior to denying the claim. The object of such further development is to establish whether the particular claim actually meets the conditions in A. above. In claims where this is not the case or where such an event appears unlikely, the contractor may deny the claim.

        1.    Syncope of undetermined cause.

        2.    Sinus bradycardia without significant symptoms.

        3.    Sino-atrial block or sinus arrest without significant symptoms.

        4.    Prolonged R-R intervals with atrial fibrillation (without third degree AV block) or with other causes of transient ventricular pause.

        5.    Bradycardia during sleep.

        6.    Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent AV block.

        7.    Asymptomatic second degree AV block of Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle.

    GROUP II:    DUAL-CHAMBER CARDIAC PACEMAKERS--Effective for services rendered on or after May 9, 1985.

    A.    COVERED

Conditions under which implantation of a dual-chamber cardiac pacemaker is considered acceptable or necessary in the general medical community unless conditions #1 and #2, Group II.B., are present):

        1.    Patients in whom single-chamber (ventricular pacing) at the time of pacemaker insertion elicits a definite drop in blood pressure, retrograde conduction, or discomfort.

        2.    Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with significant symptoms, has already been experienced with a pacemaker that is being replaced.

        3.    Patients in whom even a relatively small increase in cardiac efficiency will importantly improve the quality of life, e.g., patients with congestive heart failure despite adequate other medical measures.
        4.    Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and active people, etc.

Dual-chamber pacemakers may also be covered for the conditions, as listed in Group I.A. (Single-Chamber Cardiac Pacemakers), if the medical necessity is sufficiently justified through adequate claims development. Expert physicians differ in their judgments about what constitutes appropriate criteria for dual-chamber pacemaker use. The judgment that such a pacemaker is warranted in the patient meeting accepted criteria must be based upon the individual needs and characteristics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.

    B.    NOT COVERED

Whenever the following conditions (which represent overriding contraindications) are present, dual-chamber pacemakers are not covered:

        1.    Ineffective atrial contractions--e.g., chronic atrial fibrillation or flutter, or giant left atrium.

        2.    Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of the tachycardia.

        3.    A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures.

        4.    Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (third degree) and/or Type II second degree AV block in association with bundle branch block.

Cross refer: HCFA Pub. 13-3, §§3101.4, 3110.4, HCFA Pub. 14-3, §2130; HCFA Pub. 10, §§210.4, 228.4.

65-7    INTRAOCULAR LENSES (IOLs)

An intraocular lens, or pseudophakos, is an artificial lens which may be implanted to replace the natural lens after cataract surgery. Intraocular lens implantation services, as well as the lens itself, may be covered if reasonable and necessary for the individual. Implantation services may include hospital, surgical, and other medical services, including pre-implantation ultrasound (A-scan) eye measurement of one or both eyes.

Cross-refer: HCFA Pub. 13-3, §§3110.4, 3151, and 3157; HCFA Pub.14-3, §2130; HCFA Pub. 10, §228.4

65-8    ELECTRICAL NERVE STIMULATORS

Two general classifications of electrical nerve stimulators are employed to treat chronic intractable pain: peripheral nerve stimulators and central nervous system stimulators.

    A.    Implanted Peripheral Nerve Stimulators.--Payment may be made under the prosthetic device benefit for implanted peripheral nerve stimulators. Use of this stimulator involves implantation of electrodes around a selected peripheral nerve. The stimulating electrode is connected by an insulated lead to a receiver unit which is implanted under the skin at a depth not greater than 1/2 inch. Stimulation is induced by a generator connected to an antenna unit which is attached to the skin surface over the receiver unit. Implantation of electrodes requires surgery and usually necessitates an operating room.

NOTE:    Peripheral nerve stimulators may also be employed to assess a patient's suitability for continued treatment with an electric nerve stimulator. As explained in §35-46, such use of the stimulator is covered as part of the total diagnostic service furnished to the beneficiary rather than as a prosthesis.

    B.    Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators).--The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions:

        1.    Types of Implantations.--There are two types of implantations covered by this instruction:

            a.    Dorsal Column (Spinal Cord) Neurostimulation.--The surgical implantation of neurostimulator electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the epidural space is covered.

            b.    Depth Brain Neurostimulation.--The stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter) is covered.

        2.    Conditions for Coverage.--No payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met:

            a.    The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;

            b.    With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;

            c.    Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation);

            d.    All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and followup of the patient (including that required to satisfy item c) must be available; and

            e.    Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.

Contractors may find it helpful to work with PROs to obtain the information needed to apply these conditions to claims.

See Intermediary Manual, §3110.4 and §§35-20 and 35-27.

    A.    Mechanical/Hydraulic Incontinence Control Devices.--Mechanical/hydraulic incontinence control devices are accepted as safe and effective in the management of urinary incontinence in patients with permanent anatomic and neurologic dysfunctions of the bladder. This class of devices achieves control of urination by compression of the urethra. The materials used and the success rate may vary somewhat from device to device. Such a device is covered when its use is reasonable and necessary for the individual patient.

    B.    Collagen Implant.--A collagen implant, which is injected into the submucosal tissues of the urethra and/or the bladder neck and into tissues adjacent to the urethra, is a prosthetic device used in the treatment of stress urinary incontinence resulting from intrinsic sphincter deficiency (ISD). ISD is a cause of stress urinary incontinence in which the urethral sphincter is unable to contract and generate sufficient resistance in the bladder, especially during stress maneuvers.

Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4 week period.

In male patients, the evaluation must include a complete history and physical examination and a simple cystometrogram to determine that the bladder fills and stores properly. The patient then is asked to stand upright with a full bladder and to cough or otherwise exert abdominal pressure on his bladder. If the patient leaks, the diagnosis of ISD is established.

In female patients, the evaluation must include a complete history and physical examination (including a pelvic exam) and a simple cystometrogram to rule out abnormalities of bladder compliance and abnormalities of urethral support. Following that determination, an abdominal leak point pressure (ALLP) test is performed. Leak point pressure, stated in cm H2O, is defined as the intra-abdominal pressure at which leakage occurs from the bladder (around a catheter) when the bladder has been filled with a minimum of 150 cc fluid. If the patient has an ALLP of less than 100 cm H2O, the diagnosis of ISD is established.

To use a collagen implant, physicians must have urology training in the use of a cystoscope and must complete a collagen implant training program.

Coverage of a collagen implant, and the procedure to inject it, is limited to the following types of patients with stress urinary incontinence due to ISD:

        o    Male or female patients with congenital sphincter weakness secondary to conditions such as myelomeningocele or epispadias;

        o    Male or female patients with acquired sphincter weakness secondary to spinal cord lesions;

        o    Male patients following trauma, including prostatectomy and/or radiation; and

        o    Female patients without urethral hypermobility and with abdominal leak point pressures of 100 cm H2O or less.

Patients whose incontinence does not improve with 5 injection procedures (5 separate treatment sessions) are considered treatment failures, and no further

treatment of urinary incontinence by collagen implant is covered. Patients who have a reoccurrence of incontinence following successful treatment with collagen implants in the past (e.g., 6-12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be allowed but must be supported by medical justification.

    C.    Electronic Stimulators.--Pelvic floor electrical stimulators, whether inserted into the vaginal canal or rectum or implanted in the pelvic area, used as a treatment for urinary incontinence, e.g., as a bladder pacer or a retraining mechanism, are not covered. The effectiveness of these devices is unproven. (See §65-11.)

See Intermediary Manual, §3110.4.

65-10    ENTERAL AND PARENTERAL NUTRITIONAL THERAPY COVERED AS PROSTHETIC DEVICE (Effective for items and services furnished on or after 07-11-84.)

There are patients who, because of chronic illness or trauma, cannot be sustained through oral feeding. These people must rely on either enteral or parenteral nutritional therapy, depending upon the particular nature of their medical condition.

Coverage of nutritional therapy as a Part B benefit is provided under the prosthetic device benefit provision, which requires that the patient must have a permanently inoperative internal body organ or function thereof. (See Intermediary Manual, §3110.4.) Therefore, enteral and parenteral nutritional therapy are not covered under Part B in situations involving temporary impairments. Coverage of such therapy, however, does not require a medical judgment that the impairment giving rise to the therapy will persist throughout the patient's remaining years. If the medical record, including the judgment of the attending physician, indicates that the impairment will be of long and indefinite duration, the test of permanence is considered met.

If the coverage requirements for enteral or parenteral nutritional therapy are met under the prosthetic device benefit provision, related supplies, equipment and nutrients are also covered under the conditions in the following paragraphs and Intermediary Manual, §3110.4.

65-10.1    Parenteral Nutrition Therapy.--Daily parenteral nutrition is considered reasonable and necessary for a patient with severe pathology of the alimentary tract which does not allow absorption of sufficient nutrients to maintain weight and strength commensurate with the patient's general condition.

Since the alimentary tract of such a patient does not function adequately, an indwelling catheter is placed percutaneously in the subclavian vein and then advanced into the superior vena cava where intravenous infusion of nutrients is given for part of the day. The catheter is then plugged by the patient until the next infusion. Following a period of hospitalization, which is required to initiate parenteral nutrition and to train the patient in catheter care, solution preparation, and infusion technique, the parenteral nutrition can be provided safely and effectively in the patient's home by nonprofessional persons who have undergone special training. However, such persons cannot be paid for their services, nor is payment available for any services furnished by nonphysician professionals except as services furnished incident to a physician's service.

For parenteral nutrition therapy to be covered under Part B, the claim must contain a physician's written order or prescription and sufficient medical documentation to permit an independent conclusion that the requirements of the

prosthetic device benefit are met and that parenteral nutrition therapy is medically necessary. An example of a condition that typically qualifies for coverage is a massive small bowel resection resulting in severe nutritional deficiency in spite of adequate oral intake. However, coverage of parenteral nutrition therapy for this and any other condition must be approved on an individual, case- by-case basis initially and at periodic intervals of no more than 3 months by the carrier's medical consultant or specially trained staff, relying on such medical and other documentation as the carrier may require. If the claim involves an infusion pump, sufficient evidence must be provided to support a determination of medical necessity for the pump. Program payment for the pump is based on the reasonable charge for the simplest model that meets the medical needs of the patient as established by medical documentation.

Nutrient solutions for parenteral therapy are routinely covered. However, Medicare pays for no more than one month's supply of nutrients at any one time. Payment for the nutrients is based on the reasonable charge for the solution components unless the medical record, including a signed statement from the attending physician, establishes that the beneficiary, due to his/her physical or mental state, is unable to safely or effectively mix the solution and there is no family member or other person who can do so. Payment will be on the basis of the reasonable charge for more expensive pre-mixed solutions only under the latter circumstances.

65-10.2    Enteral Nutrition Therapy.--Enteral nutrition is considered reasonable and necessary for a patient with a functioning gastrointestinal tract who, due to pathology to or nonfunction of the structures that normally permit food to reach the digestive tract, cannot maintain weight and strength commensurate with his or her general condition. Enteral therapy may be given by nasogastric, jejunostomy, or gastrostomy tubes and can be provided safely and effectively in the home by nonprofessional persons who have undergone special training. However, such persons cannot be paid for their services, nor is payment available for any services furnished by nonphysician professionals except as services furnished incident to a physician's service.

Typical examples of conditions that qualify for coverage are head and neck cancer with reconstructive surgery and central nervous system disease leading to interference with the neuromuscular mechanisms of ingestion of such severity that the beneficiary cannot be maintained with oral feeding. However, claims for Part B coverage of enteral nutrition therapy for these and any other conditions must be approved on an individual, case-by-case basis. Each claim must contain a physician's written order or prescription and sufficient medical documentation (e.g., hospital records, clinical findings from the attending physician) to permit an independent conclusion that the patient's condition meets the requirements of the prosthetic device benefit and that enteral nutrition therapy is medically necessary. Allowed claims are to be reviewed at periodic intervals of no more than 3 months by the contractor's medical consultant or specially trained staff, and additional medical documentation considered necessary is to be obtained as part of this review.

Medicare pays for no more than one month's supply of enteral nutrients at any one time.

If the claim involves a pump, it must be supported by sufficient medical documentation to establish that the pump is medically necessary, i.e., gravity feeding is not satisfactory due to aspiration, diarrhea, dumping syndrome, etc. Program payment for the pump is based on the reasonable charge for the simplest model that meets the medical needs of the patient as established by medical documentation.

65-10.3    Nutritional Supplementation.--Some patients require supplementation of their daily protein and caloric intake. Nutritional supplements are often given as a medicine between meals to boost protein-caloric intake or the mainstay of a daily nutritional plan. Nutritional supplementation is not covered under Medicare Part B.

65-11    BLADDER STIMULATORS (PACEMAKERS)--NOT COVERED

There are a number of devices available to induce emptying of the urinary bladder by using electrical current which forces the muscles of the bladder to contract. These devices (commonly known as bladder stimulators or pacemakers) are characterized by the implantation of electrodes in the wall of the bladder, the rectal cones, or the spinal cord. While these treatments may effectively empty the bladder, the issue of safety involving the initiation of infection, erosion, placement, and material selection has not been resolved. Further, some facilities previously using electronic emptying have stopped using this method due to the pain experienced by the patient.

The use of spinal cord electrical stimulators, rectal electrical stimulators, and bladder wall stimulators is not considered reasonable and necessary. Therefore, no program payment may be made for these devices or for their implantation.

65-13    PHRENIC NERVE STIMULATOR

The implantation of a phrenic nerve stimulator is covered for selected patients with partial or complete respiratory insufficiency.

The phrenic nerve stimulator provides electrical stimulation of the patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs). The device has been used successfully to treat hypoventilation caused by a variety of conditions, including respiratory paralysis resulting from lesions of the brain stem and cervical spinal cord and chronic pulmonary disease with ventilatory insufficiency. The phrenic nerve stimulator is intended to be an alternative to management of patients with respiratory insufficiency who are dependent upon the usual therapy of intermittent or permanent use of a mechanical ventilator as well as maintenance of a permanent tracheotomy stoma.

However, an implanted phrenic nerve stimulator can be effective only if the patient has an intact phrenic nerve and diaphragm. Moreover, nerve injury may occur during the surgical procedure and if sufficient injury is incurred, the device will not prove useful to the patient. Consequently, it is possible for such a device to be indicated for a patient but, due to injury sustained during implant, fail to assist the patient, resulting in a return to the use of mechanical ventilation.

65-14    COCHLEAR IMPLANTATION

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze and code sound. Cochlear implant devices are available in single channel and multi-channel models. The purpose of implanting the device is to provide an awareness and identification of sounds and to facilitate communication for persons who are profoundly hearing impaired.

Medicare coverage is provided only for those patients who meet all of the following selection guidelines.

    A.    General.--

        o    Diagnosis of bilateral severe-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;

        o    Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;

        o    Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;

        o    No contraindications to surgery; and

        o    The device must be used in accordance withe the FDA-approved labeling.

    B.    Adults.--Cochlear implants may be covered for adults (over age 18) for prelinguistically, perilinguistically, and postlinguistically deafened adults. Postlinguistically deafened adults must demonstrate test scores of 30 percent or less on sentence recognition scores from tape recorded tests in the patient's best listening condition.

    C.    Children.--Cochlear implants may be covered for prelinguistically and postlinguistically
deafened children aged 2 through 17. Bilateral profound sensorineural deafness must be demonstrated by the inability to improve on age appropriate closed-set word identification tasks with amplification.

65-15     ARTIFICIAL HEARTS AND RELATED DEVICES

A ventricular assist device (VAD) is used to assist a damaged or weakened heart in pumping blood. VADs are used as either a bridge to a heart transplant or for support of blood circulation postcardiotomy, which is the period following open heart surgery. VADs used for support of blood circulation postcardiotomy are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA approved labeling instructions. Since there is no authoritative evidence substantiating the safety and effectiveness of a VAD used as a replacement for the human heart, Medicare does not cover this device when used as an artificial heart.

All of the following criteria must be fulfilled in order for Medicare coverage to be provided for a VAD used as a bridge to transplant:
        1.    The VAD must be used in accordance with the FDA approved labeling instructions. This means that the VAD is used as a temporary mechanical circulatory support for approved transplant candidates as a bridge to cardiac transplantation;

        2.    The patient is approved and listed as a candidate for heart transplantion by a Medicare approved heart transplant center; and,

        3.    The VAD is implanted in a Medicare approved heart transplant center on a patient who is listed by that center. If the patient is listed by another Medicare approved transplant center, the implanting center must receive written permission from the center under which the patient is listed.

Centers implanting VADs should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the centers should determine patient-specific timetables for transplantation and should not maintain such patients on VADs if suitable hearts become available.

65-16    TRACHEOSTOMY SPEAKING VALVE

A trachea tube has been determined to satisfy the definition of a prosthetic device, and the tracheostomy speaking valve is an add on to the trachea tube which may be considered a medically necessary accessory that enhances the function of the tube. In other words, it makes the system a better prosthesis. As such, a tracheostomy speaking valve is covered as an element of the trachea tube which makes the tube more effective.

65-17    URINARY DRAINAGE BAGS

Uninary collection and retention system are covered as prosthetic devices that replace bladder function in the case of permanent urinary incontinence. Urinary drainage bags that can be used either as bedside or leg drainage bags may be either multi-use or single use systems. Both the multi-use and the single use bags have a system that prevents urine backflow. However, the single use system is non-drainable. There is insufficient evidence to support the medical necessity of a single use system bag rather than the multi-use bag. Therefore, a single use drainage system is subject to the same coverage parameters as the multi-use drainage bags.