Table of Contents
60 DURABLE MEDICAL
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.
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. A physician's certification of medical necessity for oxygen equipment must
include the results of specific testing before coverage can be determined. Claims for oxygen must also be supported by medical documentation in
the patient's record.
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.
A physician's certification of medical necessity for oxygen equipment must include the results of specific testing before coverage can be determined.
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.
For those patients whose initial oxygen prescription did not originate during a hospital stay, blood gas studies should be done while the patient is in the chronic stable state, i.e., not during a period of an acute illness or an exacerbation of their underlying disease."
Carriers may accept a attending physician's statement of recent hospital test results for a particular patient, when appropriate, in lieu of copies of actual hospital records.
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
1. Conditions for Which Oxygen Therapy May Be Covered.--
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
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
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
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
(1) Dependent edema suggesting
(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;
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
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,
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
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
60-7 SELF-CONTAINED PACEMAKER
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
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
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.
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
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:
|Air cleaners||deny--environmental control equipment; not primarily medical in nature (§l86l (n) of the Act)|
|Air Conditioners||deny--environmental control equipment; not primarily medical in nature (§l861(n) of the Act)|
|Air-Fluidized Bed||(See §60-19.)|
|Alternating Pressure Pads, and Matresses and Lambswool Pads||covered if patient has, or is highly susceptible to, decubitus ulcers and patient's physician has specified that he will be supervising its use in connection with his course of treatment.|
|Audible/Visible Signal||(See Self-Contained Pacemaker Monitor.)|
|Augmentative Communication||(See Communicator.)Device|
|Bathtub Lifts||deny--convenience item; not primarily medical in nature (§l861(n) of the Act)|
|Bathtub Seats||deny--comfort or convenience item; hygienic equipment; not primarily medical in nature (§l861(n) of the Act)|
|Bead Bed||(See §60-19.)|
|Bed Baths (home type)||deny--hygienic equipment; not primarily medical in nature (§l861(n) of the Act)|
|Bed Lifter (bed elevator)||deny--not primarily medical in nature (§1861(n) of the
|Bedboards||deny--not primarily medical in nature (§ 1861(n) n)of the Act)|
|Bed Pans (autoclavable hospital type)||covered if patient is bed confined|
|Bed Side Rails||(See Hospital Beds, §60-l8.)|
|Beds-Lounge (power or manual)||deny--not a hospital bed; comfort or convenience item; not primarily medical in nature (§l86l(n) of the Act)|
|Beds--Oscillating||-deny--institutional equipment; inappropriate for home use|
|Bidet Toilet Seat||(See Toilet Seats.)|
|Blood Glucose Analyzer||deny--unsuitable for home use (See §60-11.)|
|Blood Glucose Monitor||covered if patient meets certain conditions (See |
|Braille Teaching Texts||deny--educational equipment; not primarily medical in nature (§1861(n) of the Act)|
|Canes||covered if patient's condition impairs ambulation (See §60-3.)|
|Carafes||deny--convenience item; not primarily medical in nature (§l861(n) of the Act)|
|Catheters||deny--nonreusable disposable supply (§l861(n) of the Act)|
|Commodes||covered if patient is confined to bed or room NOTE: The term "room confined" means that the patient's condition is such that leaving the room is medically contraindicated. The accessibility of bathroom facilities generally would not be a factor in this determination. However, confinement of a patient to his home in a case where there are no toilet facilities in the home may be equated to room confinement. Moreover, payment may also be made if a patient's medical condition confines him to a floor of his home and there is no bathroom located on that floor (See Hospital Beds in § 60-18 for definition of "bed confinement".)|
|Communicator||deny--convenience item; not primarily medical in nature (§1861(n) of the Act)|
|Continuous Passive Motion||Continuous Passive Motion devices are (CPM) Devices covered for
patients who have received a total knee replacement. To qualify for
coverage, use of the device must commence within two days following
surgery. In addition, coverage is limited to that
portion of the three week period following surgery during which the device is used in the patient's home. There is insufficient evidence to justify coverage of these devices for longer periods of time or for other applications.
|Continuous Positive Airway
|Crutches||covered if patient's condition impairs ambulation|
|Cushion Lift Power Seat||(See Seat Lifts.)|
|Dehumidifiers (room or central heating system type)||deny--environmental control equipment; not primarily medical in nature (§l861(n) of the Act)|
|Diathermy Machines (standard wave types)||deny--inappropriate for home use (See and pulses|
|Digital Electronic Pacemaker Monitor||(See Self-Contained Pacemaker Monitor.)|
|Disposable Sheets and Bags||deny--nonreusable disposable supplies (§l861(n) of the Act)|
|Elastic Stockings||deny--nonreusable supply; not rental- type items (§l861(n) of the Act)|
|Electric Air Cleaners||deny--(See Air Cleaners.) (§l861(n) of the Act)|
|Electric Hospital Beds||(See Hospital Beds §60-18.)|
|Electrostatic Machines||deny--(See Air Cleaners and Air Conditioners.) (§l861(n) of the Act)|
|Elevators||deny--convenience item; not primarily medical in nature (§l861(n) of the Act)|
|Emesis Basins||deny--convenience item; not primarily medical in nature (§l861(n) of the Act)|
|Esophageal Dilator||deny--physician instrument; inappropriate for patient use|
|Exercise Equipment||deny--not primarily medical in nature (§l861(n) n) of the Act)|
|Fabric Supports||deny--nonreusable supplies; not rental- type it (§l861(n) of the Act)|
|Face Masks (oxygen)||covered if oxygen is covered (See § 60-4.)|
|Face Masks (surgical)||deny--nonreusable disposable items (§l861(n) n)of the Act)|
|Flowmeter||(See Medical Oxygen Regulators)|
|Fluidic Breathing Assister||(See IPPB Machines.)|
|Fomentation Device||(See Heating Pads.)|
|Gel Flotation Pads and Mattresses||(See Alternating Pressure Pads and Mattresses.)|
|Grab Bars||deny--self-help device; not primarily medical in nature (§l861(n) of the Act)|
|Heat and Massage Foam Cushion Pad||deny--not primarily medical in nature; personal comfort item (§§ l861(n) and l862(a)(6) of the Act)|
|Heating and Cooling Plants||deny--environmental control equipment; not primarily medical in nature(§l861(n) of the Act)|
|Heating Pads||covered if the contractor's medical staff determines patient's medical condition is one for which the application of heat in the form of a heating pad is therapeutically effective.|
|Heat Lamps||covered if the contractor's medical staff determines patient's medical condition is one for which the application of heat in the form of a heat lamp is therapeutically effective.|
|Hospital Beds||(See § 60-18.)|
|Hot Packs||(See Heating Pads.)|
|Humidifiers (oxygen)||(See Oxygen Humidifiers.)|
|Humidifiers (room or central heating system types)||deny--environmental control equipment; not medical in nature (§l861(n) of the Act)|
|Hydraulic Lift||(See Patient Lifts.)|
|Incontinent Pads||deny--nonreusable supply; hygienic item (§ l861(n) of the Act.)|
|Infusion Pumps||For external and implantable pumps, see §60-14. If the pump is used with an enteral or parenteral ralnutritional therapy system, see §§65-10 - 65.10.2 0.2 for special coverage rules.|
|Injectors (hypodermic jet devices for injection of insulin||deny-- noncovered self-administered drug supply, § 1861(s)(2)(A) of the Act)|
|IPPB Machines||covered if patient's ability to breathe is severely impaired|
|Iron Lungs||(See Ventilators.)|
|Irrigating Kit||deny--nonreusable supply; hygienic equipment (§l861(n) of the Act)|
|Lambs Wool Pads||covered under same conditions as alternating pressure pads and mattresses|
|Leotards||deny--(See Pressure Leotards.) (§l861(n)of the Act)|
|Lymphedema Pumps||covered (See §60-16.)(segmental and non-segmental therapy types)|
|Massage Devices||deny--personal comfort items; not primarily medical in nature (§§l861(n) and l862(a)(6) of the Act)|
|Mattress||covered only where hospital bed is medically necessary (Separate Charge for replacement mattresss should not be allowed where hospital bed with mattress is rented.) (See §60-18.)|
|Medical Oxygen Regulators||covered if patient's ability to breathe is severely impaired (See §60-4.)|
|Mobile Geriatric Chair||(See Rolling Chairs.)|
|Motorized Wheelchairs||(See Wheelchairs (power operated).)|
|Muscle Stimulators||Covered for certain conditions (See §35-77.)|
|Nebulizers||covered if patient's ability to breathe is severely impaired|
|Oscillating Beds||deny--institutional equipment--inappropriate for home use|
|Overbed Tables||deny--convenience item; not primarily medical in nature (§l861(n) of the Act)|
|Oxygen||covered if the oxygen has been prescribed for use in connection with
medically necessary durable|
medical equipment (See §60-4.)
|Oxygen Humidifiers||covered if a medical humidifier has been prescribed for use in connection with medically necessary durable medical equipment for purposes of moisturizing oxygen (See §60-4.)|
|Oxygen Regulators (Medical)||(See Medical Oxygen Regulators.)|
|Oxygen Tents||(See § 60-4.)|
|Paraffin Bath Units (Portable)||(See Portable Paraffin Bath Units.)|
|Paraffin Bath Units (Standard)||deny--institutional equipment; inappropriate for home use|
|Parallel Bars||deny--support exercise equipment; primarily for institutional use; in the home setting other devices (e.g., a walker) satisfy the patient's need|
|Patient Lifts||covered if contractor's medical staff determines patient's condition is such that periodic movement is necessary to effect improvement or to arrest or retard deterioration in his condition.|
|Percussors||covered for mobilizing respiratory tract secretions in patients with chronic obstructive lung disease, chronic bronchitis, or emphysema, when patient or operator of powered percussor has received appropriate training by a physician or therapist, and no one competent to administer manual therapy is available.|
|Portable Oxygen Systems:|| 1. Regulated (adjustable
--covered under conditions specified in flow rate)§60-4. Refer all claims
to medical staff for this determination.|
2. Preset (flow rate --deny--emergency, first-aid, or not adjustable) precautionary equipment; essentially not therapeutic in nature
|Portable Paraffin Bath Units||covered when the patient has undergone a successful trial period of paraffin therapy ordered by a physician and the patient's condition is expected to be relieved by long term use of this modality.|
|Portable Room Heaters||deny--environmental control equipment; not primarily medical in nature (§l861(n) of the Act)|
|Portable Whirlpool Pumps||deny--not primarily medical in nature; personal comfort items (§§l861(n) and l862(a)(6) of the Act)|
|Postural Drainage Boards||covered if patient has a chronic pulmonary condition|
|Preset Portable Oxygen Units||deny--emergency, first-aid, or precautionary equipment; essentially not therapeutic in nature|
|Pressure Leotards||deny--nonreusable supply, not rental-type item (§l861(n) of the Act)|
|Pulse Tachometer||deny--not reasonable or necessary for monitoring pulse of homebound patient with or without a cardiac pacemaker|
|Raised Toilet Seats||deny--convenience item; hygienic equipment; not primarily medical in nature (§l861(n) of the Act)|
|Reflectance Colorimeters||(See Blood Glucose Analyzers.)|
|Rolling Chairs||covered if the contractor's medical staff determines that the
patient's condition is such that there is a medical need for this item and
it has been prescribed by the patient's physician in lieu of a wheelchair.
Coverage is limited to those rollabout chairs having casters of at least 5
inches in diameter and specifically designed to meet the needs of ill,
injured, or otherwise impaired individuals.|
Coverage is denied for the wide range of chairs
with smaller casters as are found in general use in homes, offices, and institutions for many purposes
not related to the care or treatment of ill or injured
persons. This type is not primarily medical in
nature. (§l861(n) of the Act)
|Safety Roller||(See §60-15.)|
|Sauna Baths||deny--not primarily medical in nature; personal|
comfort items (§§l861(n) and (l862(a)(6) of the Act)
|Seat Lift||covered under the conditions specified in §60-8.|
Refer all to medical staff for this determination.
|Self-Contained Pacemaker Monitor||covered when prescribed by a physician for a patient with a cardiac pacemaker (See §§50-1C and 60-7.)|
|Sitz Bath||covered if the contractor's medical staff determines patient has an infection or injury of the perineal area and the item has been prescribed by the patient's physician as a part of his planned regimen of treatment in the patient's home.|
|Spare Tanks of Oxygen||deny--convenience or precautionary supply|
|Speech Teaching Machine||deny--education equipment; not primarily medical in nature (§l861(n) of the Act)|
|Stairway Elevators||deny--(See Elevators.) (§l861(n) of the Act)|
|Standing Table||deny--convenience item; not primarily medical in nature (§1861(n) of the Act)|
|Steam Packs||these packs are covered under the same condition as a heating pad (See Heating Pads.)|
|Suction Machine||covered if the contractor's medical staff determines that the machine specified in the claim is medically required and appropriate for home use without technical or professional supervision.|
|Support Hose||deny (See Fabric Supports.) (§l861(n) of the Act)|
|Surgical Leggings||deny--nonreusable supply; not rental-type item (§l861(n) of the Act)|
|Telephone Alert Systems||deny--these are emergency communications systems and do not serve a diagnostic or therapeutic purpose|
|Telephone Arms||deny--convenience item; not medical in|
nature (§l861(n) of the Act)
|Toilet Seats||deny--not medical equipment (§l861(n)of the Act)|
|Traction Equipment||covered if patient has orthopedic impairment requiring traction equipment which prevents ambulation during the period of use (Consider covering devices usable during ambulation; e.g., cervical traction collar, under the brace provision)|
|Trapeze Bars||covered if patient is bed confined and the patient needs a trapeze bar to sit up because of respiratory condition, to change body position for other medical reasons, or to get in and out of bed.|
|Treadmill Exerciser||deny--exercise equipment;not primarily medical in nature(§l861(n) of the Act)|
|Ultraviolet Cabinet||covered for selected patients with generalized intractable psoriasis.
Using appropriate consultation, the contractor should determine whether
medical and other factors justify|
treatment at home rather than at alternative sites, e.g., outpatient department of a hospital.
|Urinals (autoclavable hospital type)||covered if patient is bed confined|
|Vaporizers||covered if patient has a respiratory illness|
|Ventilators||covered for treatment of neuromuscular diseases,|
thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease. Includes both positive and negative pressure types.
|Walkers||covered if patient's condition impairs ambulation (See also §60-15.)|
|Water and Pressure Pads and Mattresses||(See Alternating Pressure Pads and Mattresses.)|
|Wheelchairs||covered if patient's condition is such that without the use of a wheelchair he would otherwise be bed or chair confined. An individual may qualify for a wheelchair and still be considered bed confined.|
|Wheelchairs (power operated) and wheelchairs with other special features||covered if patient's condition is such and that a wheelchair is
medically necessary and the patient is unable to operate the wheelchair
manually. Any claim involving a power wheelchair or a wheelchair with
other special features should be referred for medical consultation since
payment for the special features is limited to those which are
medically required because of the patient's condition. (See §60-5 for
power operated and §60-6 for specially sized wheelchairs.)
NOTE: A power-operated vehicle that may appropriately be used as a wheelchair can be covered. (See §60-5 for coverage details.)
|Whirlpool Bath Equipment||covered if patient is homebound and has a|
(standard) condition for which the whirlpool bath can be expected to provide substantial therapeutic benefit justifying its cost. Where patient is not homebound but has such a condition, payment is restricted to the cost of providing the services elsewhere; e.g., an outpatient department of a participating hospital, if that alternative is less costly. In all cases, refer claim to medical staff for a determination.
|Whirlpool Pumps||deny--(See Portable Whirlpool Pumps.)|
(§l861(n) of the Act)
|White Cane||deny--(See §60-3.)|
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
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
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).
|(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 dose 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:
|(1)||Glycosylated hemoglobin level(HbAlc) > 7.0%|
|(2)||History of recurring hypoglycemia|
|(3)||Wide fluctuations in blood glucose before mealtime|
|(4)||Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl|
|(5)||History of severe glycemic
|(B)||The patient with Type I 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
|NOTE:||Payment may also be made for drugs necessary for the effective use of an external infusion pump as long as the drug being used with the pump is itself reasonable and necessary for the patient's treatment.|
|NOTE:||Payment may also be made for drugs necessary for the effective use of an implantable infusion pump as long as the drug being used with the pump is itself reasonable and necessary for the patient's treatment.|
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,
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
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
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
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
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
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
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
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.
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. The vagus nerve is a mixed nerve carrying both somatic and visceral afferent
and efferent signals. The majority of vagal nerve fibers are visceral afferents
with wide distribution. The basic premise of vagus nerve stimulation in the
treatment of epilepsy is that vagal visceral afferents have a diffuse central
nervous system projection and the activation of these pathways has a widespread
effect upon neuronal excitability. Besides activation of well-defined reflexes,
vagal stimulation produces evoked potentials recorded from the cerebral cortex,
the hippocampus, the thalamus, and the cerebellum. The vagus nerve stimulation system is comprised of an implantable pulse
generator and lead and an external programming system used to change stimulation
settings. Clinical evidence has shown that vagus nerve stimulation is safe and
effective treatment for patients with medically refractory partial onset
seizures, for whom surgery is not recommended or for whom surgery has failed.
Vagus nerve stimulation is not covered for patients with other types of seizure
disorders which are medically refractory and for whom surgery is not recommended
or for whom surgery has failed. 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
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.
The vagus nerve is a mixed nerve carrying both somatic and visceral afferent and efferent signals. The majority of vagal nerve fibers are visceral afferents with wide distribution. The basic premise of vagus nerve stimulation in the treatment of epilepsy is that vagal visceral afferents have a diffuse central nervous system projection and the activation of these pathways has a widespread effect upon neuronal excitability. Besides activation of well-defined reflexes, vagal stimulation produces evoked potentials recorded from the cerebral cortex, the hippocampus, the thalamus, and the cerebellum.
The vagus nerve stimulation system is comprised of an implantable pulse generator and lead and an external programming system used to change stimulation settings. Clinical evidence has shown that vagus nerve stimulation is safe and effective treatment for patients with medically refractory partial onset seizures, for whom surgery is not recommended or for whom surgery has failed. Vagus nerve stimulation is not covered for patients with other types of seizure disorders which are medically refractory and for whom surgery is not recommended or for whom surgery has failed.
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
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
65-2 ELECTRICAL CONTINENCE AID--NOT
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
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
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
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
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.
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
complete (also referred to as third degree) AV heart block.
complete heart block with severe bradycardia (in relation to age), or
significant physiological deficits or significant symptoms due to the
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.
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.
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).
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).
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).
occasional patient with hypersensitive carotid sinus syndrome with syncope due
to bradycardia and unresponsive to prophylactic medical measures.
or trifascicular block accompanied by syncope which is attributed to transient
complete heart block after other plausible causes of syncope have been
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
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
bradycardia without significant symptoms.
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.
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
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
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
2. Patients in
whom the pacemaker syndrome (atrial ventricular asynchrony), with significant
symptoms, has already been experienced with a pacemaker that is being
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
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
B. NOT COVERED
Whenever the following conditions (which represent overriding
contraindications) are present, dual-chamber pacemakers are not covered:
atrial contractions--e.g., chronic atrial fibrillation or flutter, or giant left
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
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
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
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
b. Depth Brain Neurostimulation.--The stereotactic
implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal
gray matter) is covered.
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
a. The implantation of the stimulator is used only as a late
resort (if not a last resort) for patients with chronic intractable
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;
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
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.
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
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
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
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
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
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
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.
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.
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.
Children.--Cochlear implants may be covered for prelinguistically and
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
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
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.
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.