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Medicare Guidelines

Medical Equipment Criteria Home Health Medicare Criteria
Hospice Medicare Criteria Transportation Criteria (Votran)
Medicare Eligibility Medicaid Eligibility
Nursing Home Diversion Senior Care providers-Volusia
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Resources for Caregivers Medicare Cancer Screenings
Government links Annual Wellness Visit
Return to FAQ's Medicare Preventive Services


Home Medical Equipment Qualifications


Mobility - Medical equipment qualifications for Medicare or Medicaid

Cane or Crutch criteria

Walker criteria
Manual Wheelchair criteria
Cushions and Backs for Wheelchairs criteria
Power Wheelchair & Scooter criteria
Seating Sytems


Respiratory
- Medical equipment qualifications for Medicare or Medicaid


Oxygen criteria

Nebulizer criteria
CPAP criteria
BiPAP criteria
Suction Machine criteria


Beds & Patient Lifts
- Medical equipment qualifications for Medicare or Medicaid


Hospital Beds criteria

Trapeze
Air Mattresses (see Wound Care)
Patient Lift - (Hoyer Lift) criteria
Patient Lift - (Stand Up) criteria


Wound Care
- Medical equipment qualifications for Medicare or Medicaid


Cushions - (Wheelchairs) - prevention criteria
Bed Surfaces - for skin breakdown prevention and treatment
Lymphedema Pumps (compression therapy) criteria


Diabetic - Medical equipment qualifications for Medicare or Medicaid


Diabetic Shoes and Inserts criteria
Diabetic Test strips and lancets criteria
Diabetic Gauntlets criteria
Diabetic Male Pumps criteria
Diabetic Hot/Cold Therapy criteria


Lift Chairs & Mechanisms - Medical equipment qualifications for Medicare or Medicaid


Lift Chair criteria


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Mobility Products

Mobility Products: Canes, Walkers, Wheelchairs, and Scooters

Essentially the new Mobility Assistive Equipment regulations will ensure that Medicare funds are used to pay for:
  • Mobility needs for daily activities within the home
  • Least costly alternative/lowest level of equipment to accomplish these tasks.
  • Most medically appropriate equipment (to meet the needs, not the wants)
Medicare requires that your physician and provider evaluate your needs and expected use of the mobility product you will qualify for. They must determine which is the least level of equipment needed to help you be mobile within your home to accomplish daily activities by asking the following questions:
  • Will a cane or crutches allow you to perform these activities in the home?
  • If not, will a walker allow you to accomplish these activities in the home?
  • If not, is there any type of manual wheelchair that will allow you to accomplish these activities in the home?
  • If not, will a scooter allow you to accomplish these activities in the home?
  • If not, will a power chair allow you to accomplish these activities in the home?
Keep in mind if you have another higher level product in mind that will allow you to do more beyond the confines of the home setting, you can discuss with your provider the option to upgrade to a higher level or more comfortable product by paying an additional out of pocket fee using the Advance Beneficiary Notice (ABN) to select the product you like best. A face-to-face examination with your physician is required prior to the initial setup of a power chair or scooter. Your home must be evaluated to ensure it will accommodate the use of any mobility product.

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Canes and Crutches
Medicare Coverage Criteria


Canes and crutches are covered when prescribed by a physician for a patient with a condition causing impaired ambulation and MRADL's (mobility related activities of daily living) cannot be accomplished without risk of safety, without being performed in a timely manner or complete inability. This must be documented in Physician, nurse or therapy notes.


Required Documentation: Prescription An order for canes and crutches which is reviewed, signed and dated by the ordering physician must be kept on file by the supplier. The medical records must contain information which supports the medical necessity of the item ordered.

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Walkers
Medicare Coverage Criteria


Medicare pays for walkers with our without wheels if a patient has
  • A mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRAD'sL) in the home
  • The patient is able to safely use the walker and
  • The functional mobility deficit can be sufficiently resolved with use of a walker.
A heavy duty walker is covered for patients who meet coverage criteria for a standard walker and who weigh more than 300 pounds.

Medicare pays for Rollators up to $130 (keep in mind that Medicare pays 80% of allowable, 20% must be paid by patient or secondary payer). The difference between the cost of the Rollator and Medicare paid amount is patient's responsibility. Please note that if you have received a regular walker from Medicare and now need a Rollator, Medicare will not pay for it because it will be considered same or similar equipment and change in condition will not justify the new equipment.


Required Documentation:
Prescription
An order for the walker which is signed and dated by the treating physician must be kept on file by the supplier. The medical records must contain information which supports the medical necessity of the item ordered. If a rollator is ordered, the usual out of pocket expense does not exceed $40

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Manual Wheelchairs
Medicare Coverage Criteria


Medicare pays for standard/lightweight manual wheelchairs and transport wheelchairs on a capped rental basis. This means that the equipment is rental 13 months and is the property of Vienna Medical and must be returned to us if the patient is no longer in need of the equipment, has moved into a Skilled Nursing Facility or has passed away. After Medicare pays for the 13 months rental, the equipment will become the beneficiaries. If repairs or maintenance is required on patient owned equipment, Medicare may pay for the repairs. Because the equipment is a rental for the initial 13 months, Vienna Medical can only rent within our service area and cannot bill Medicare for manual wheelchairs or transport wheelchairs purchased online.
If you live within our rental area please read below for manual wheelchair coverage

Required Documentation:
  • Prescription with DX and length of need
  • Progress or Physician notes documenting the mobility deficit
  • Home Evaluation - Your therapist or Vienna Medical perform
Medical Policy A manual wheelchair is covered if:

Criteria A, B, C, D, and E are met,
and Criterion F or G is met.
Additional coverage criteria for specific devices are listed below.
A) The patient has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home.

- A mobility limitation is one that:
Prevents the patient from accomplishing an MRADL entirely, or places the patient at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to perform an MRADL; or Prevents the patient from completing an MRADL within a reasonable time frame.

B) The patient's mobility limitation cannot be sufficiently resolved by the use of an appropriately fitted cane or walker.

C) The patient's home provides adequate access between rooms, maneuvering space, and surfaces for use of the manual wheelchair that is provided.


D) Use of a manual wheelchair will significantly improve the patient's ability to participate in MRADL's and the patient will use it on a regular basis in the home.


E) The patient has not expressed an unwillingness to use the manual wheelchair that is provided in the home.


F) The patient has sufficient upper extremity function and other physical and mental capabilities needed to safely self-propel the manual wheelchair that is provided in the home during a typical day. - Limitations of strength, endurance, range of motion, or coordination, presence of pain, or deformity or absence of one or both upper extremities are relevant to the assessment of upper extremity function.

G) The patient has a caregiver who is available, willing, and able to provide assistance with the wheelchair. If the manual wheelchair will be used inside the home and the coverage criteria are not met, it will be denied as not medically necessary. If the manual wheelchair will only be used outside the home, it will be denied as not medically necessary A standard hemi-wheelchair (K0002) is covered when the patient requires a lower seat height (17" to 18") because of short stature or to enable the patient to place his/her feet on the ground for propulsion. A lightweight wheelchair (K0003) is covered when a patient:
1. The patient self-propels the wheelchair while engaging in frequent activities in the home that cannot be performed in a standard wheelchair.

2. The patient requires a seat width, depth, or height that cannot be accommodated in a standard, and spends at least two hours per day in the wheelchair. A high strength lightweight wheelchair is rarely medically necessary if the expected duration of need is less than three months (e.g., post-operative recovery).
A heavy duty wheelchair (K0006) is covered if the patient weighs more than 250 pounds or the patient has severe spasticity. An extra heavy duty wheelchair (K0007) is covered if the patient weighs more than 300 pounds. Coverage of an ultra-lightweight wheelchair (K0005) and manual tilt in space wheelchair (E1161) are determined on an individual consideration basis. Ultra-lightweight wheelchairs and tilt in space wheelchairs are paid for as a purchase because they must be custom ordered based on patient's specifications and needs - pending Advance Determination of Medical Coverage. Patient's medical records can be submitted to Medicare to determine coverage. This can take up to 30 days after the necessary documentation has been provided by the physician and other clinicians. Sport wheelchairs and bathroom wheelchairs are not covered by Medicare.

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Seat and Back Cushions for Wheelchairs
Medicare Coverage Criteria


A general use seat cushion and a general use wheelchair back cushion are covered for a patient who has a manual wheelchair.

A skin protection seat cushion is covered for a patient who meets both of the following criteria:
1) The patient has a manual wheelchair or a power wheelchair with a sling/solid seat/back and the patient meets Medicare coverage criteria for it; and

2) The patient has either of the following:
    a) Current pressure ulcer or past history of a pressure ulcer  on the area of contact with the seating surface; or
    b) Absent or impaired sensation in the area of contact with the seating surface or inability to carry out a functional weight shift due to one of the following diagnoses: spinal cord injury resulting in quadriplegia or paraplegia (344.00-344.1), other spinal cord disease (336.0-336.3), multiple sclerosis (340), other demyelinating disease (341.0-341.9), cerebral palsy (343.0-343.9), anterior horn cell diseases including amyotrophic lateral sclerosis (335.0-335.21, 335.23-335.9), post polio paralysis (138), traumatic brain injury resulting in quadriplegia (344.09), spina bifida (741.00-741.93), childhood cerebral degeneration (330.0-330.9), Alzheimer’s disease (331.0), Parkinson’s disease (332.0).
A positioning seat cushion and  positioning back cushion  is covered for a patient who meets both of the following criteria:
1) The patient has a manual wheelchair or a power wheelchair with a sling/solid seat/back and the patient meets Medicare coverage criteria for it; and

2) The patient has any significant postural asymmetries that are due to one of the diagnoses listed in criterion 2b above or to one of the following diagnoses: monoplegia of the lower limb (344.30-344.32, 438.40-438.42) or hemiplegia (342.00-342.92, 438.20-438.22) due to stroke, traumatic brain injury, or other etiology, muscular dystrophy (359.0, 359.1), torsion dystonias (333.4, 333.6, 333.71), spinocerebellar disease (334.0-334.9).
Required Documentation: Prescription with DX

A headrest is also covered when the patient has a covered manual tilt-in-space wheelchair, manual semi or fully reclining back on a manual wheelchair, a manual fully reclining back on a power wheelchair, or power tilt and/or recline power seating system.

A combination skin protection and positioning seat cushion is covered for a patient who meets the criteria for both a skin protection seat cushion and a positioning seat cushion.

A seat or back cushion that is provided for use with a transport wheelchair (E1037, E1038) will be denied as not medically necessary.

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Power Wheelchairs and Scooters
Medicare Coverage Criteria


Remember, the rule here is that there must be very good reasons why a other products won't solve the challenged MRADL (mobility related activities of daily living).  For example, if the patient can use a manual wheelchair to solve their affected ADL from the mobility deficit then they do not qualify for a scooter or power chair. Should other products not solve the problem we move to the next step. These are the order of events to qualify a patient for a scooter or pwc.
  • 1st - Prescription  
  • 2nd - Face to Face evaluation and obtain relevant clinical notes 
  • 3rd - Home evaluation 
  • 4th - Detailed Order describing the equipment for physician to  approve.
  • 5th - Dispense product and patient training.
Prescription:

For a power wheelchair (PWC) or mobility scooter (POV – power operated vehicle ) to be covered, we must receive from the treating physician a written order containing all of the following elements:
1) Beneficiary’s name
2) Description of the item that is ordered. This may be general – e.g., “power wheelchair”, “power operated vehicle”, or “power mobility device”– or may be more specific.
3) Date of the face-to-face examination
4) Pertinent diagnoses/conditions that relate to the need for the power wheelchair
5) Length of need
6) Physician’s signature
7) Date of physician signature
This order must be received by Vienna Medical within 45 days before or after completion of the physician’s face-to-face examination and prior to delivery of the device. (Exception: If the examination is performed during a hospital or nursing home stay, we must receive the order within 45 days after discharge.)

Face-to-face examination:

For a power wheelchair or mobility scooter to be covered, the treating physician must conduct a face-to-face examination of the patient; Or the physician may write an order for another clinician to perform such as a PT, OT or RN.  Then the clinician would perform and submit to the physician for final approval in addition to providing clinical notes documenting the evaluation and any history leading up to the need for the product.

The report of the face-to-face examination shall provide information relating to the following questions:
•  What is this patient’s mobility limitation and how does it interfere with the performance of activities of daily living?
•  Why can’t a cane or walker meet this patient’s mobility needs in the home?
•  Why can’t a manual wheelchair meet this patient’s mobility needs in the home?
•  If a powered wheelchair is provided, why can’t a mobility scooter meet this patient’s mobility needs in the home?
•  Does this patient have the physical and mental abilities to operate a power wheelchair or mobility scooter safely in the home?
•  Is the patient willing and motivated to use the power wheelchair or mobility scooter
The report shall provide pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation.
•  Symptoms
•  Related diagnoses
•  History
•  How long the condition has been present
•  Clinical progression
•  Interventions (including medications) that have been tried and the results
•  Past use of walker, manual wheelchair, mobility scooter or power   wheelchair and the results
•  Physical exam
•  Weight
•  Impairment of strength, range of motion, sensation, or coordination of arms and legs
•  Presence of abnormal tone or deformity of arms, legs, or trunk
•  Neck, trunk, and pelvic posture and flexibility
•  Sitting and standing balance
•  Functional assessment – any problems with performing the following activities including the need to use a cane, walker, or the assistance of another person
•  Transferring between a bed, chair, and power wheelchair
•  Walking around their home – to bathroom, kitchen, living room, etc. – provide information on distance the patient is able to walk without stopping, speed, and balance
The elements that are addressed will depend on the diagnoses that are responsible for the mobility deficit.  For example, for patients with COPD, heart failure, or arthritis, the major emphasis will be on symptoms and history of the progression of their condition rather than on the physical examination.  Functional assessment is important for all patients.

Physicians shall also provide reports of pertinent laboratory tests, x-rays, and/or other diagnostic tests (e.g., pulmonary function tests, cardiac stress test, electromyogram, etc.) performed in the course of management of the patient.

Physicians shall document the evaluation in a detailed narrative note in their charts in the format that they use for other entries.  The note must clearly indicate that a major reason for the visit was a mobility evaluation. 

Physician Fee for Face-To-Face evaluation

Due to the MMA requirement that the physician or treating practitioner create a written prescription and a regulatory requirement that the physician or treating practitioner prepare pertinent parts of the medical record for submission to the durable medical equipment supplier, the Centers for Medicare & Medicaid Services (CMS) has established the new
G Code (G0372) to recognize additional physician services and resources required to establish and document the need for a PMD.

CMS believes that the typical amount of additional physician services and resources involved is equivalent to the physician fee schedule relative values established for a level 1 office visit for an established patient (Current Procedural Terminology (CPT) code 99211).
The payment amount for such a visit is $21.60

Code G0372 indicates that:
- All of the information necessary to document the PMD prescription is included
in the medical record.
- The prescription, along with the supporting documentation, has been received
by the PMD supplier within 45 days after the face-to-face examination.

Effective October 25, 2005, G0372, will be used to recognize additional physician services and resources required to establish and document the need for the PMD, and are  added to the Medicare physician fee schedule.


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Seating Systems
Medicare Coverage Criteria


A custom-fabricated back module for orthotic seating is covered when:
  1. The recipient has a significant spinal deformity and/or severe weakness of the trunk muscles, and
  2. The recipient's need for prolonged sitting tolerance, postural support to permit functional activities, or pressure reduction cannot be met adequately by a seating system, lap tray, and/or a prefabricated spinal orthotic.
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Respiratory Products


Oxygen
Medicare Coverage Criteria


Medicare coverage of home oxygen therapy is available only for patients with significant hypoxemia in the chronic stable state provided the following conditions are met:
  • The attending or consulting physician has determined that the patient suffers a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy;
  • The patient's blood gas levels indicate the need for oxygen therapy; and
  • Alternative treatment measures have been tried or considered and have been deemed clinically ineffective.
Covered Blood Gas Values

Group 1
- Coverage is provided for patients with significant hypoxemia evidenced by any of the following:
  • An arterial PO2 at or below 55mm. Hg, or an arterial oxygen saturation at or below 88 percent, taken at rest. When a PO2 of greater than 55mm. Hg. is submitted, the service will be denied as not medically necessary unless "Group 2" criteria are met.
  • An arterial PO2 at or below 55mm Hg., or an arterial 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, of a greater than normal fall in oxygen level during sleep (a decrease in arterial PO2 more than 10 mm. Hg., or a decrease in arterial oxygen saturation more than 5 percent) associated with "P" pulmonale n EKG, documented pulmonary hypertension and erythrocytosis. In either of these cases, coverage is provided only for nocturnal use of oxygen.
  • An arterial PO2 at or below 55 mm. Hg. or an arterial oxygen saturation at or below 88 percent taken during activity 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 use during
    exercise if it is documented that the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.
Group 2 - Coverage is available for patients whose arterial PO2 is 56 to 59 mm. Hg. or whose arterial blood oxygen saturation is 89 percent if any of the following are documented:
  • Dependent edema suggesting congestive heart failure;
  • pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scanechocardiogram, or "P" pulmonale of EKG
    (P wave greater than 3 mm in standard leads II, II or AVF); or
  • Erythrocythemia with a hematocrit greater than 56 percent.
Non-Covered Conditions Conditions for which Oxygen therapy is not considered Medically Necessary by Medicare:
  • Angina pectoris in the absence of hypoxemia.
  • Dyspnea without cor pulmonale or evidence of hypoxemia.
  • Severe peripheral vascular disease resulting in clinically evident desaturation in one or more extremities. There is no evidence that increased PO2 will improve the oxygenation of tissues with impaired circulation.
  • Terminal illnesses that do not affect the respiratory system.
  • Medicare will presume that home use of oxygen 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.
Required Documentation:
  • Prescription w/DX - O2 sats Arterial PO2 - liter flow - continuous, nocturnal,  PRN or on exertion.  Can PT use a conserver.
  • Documentation with qualifying O2 saturations or Arterial PO2.

The Certificate of Medical Necessity (CMN) for home oxygen use is HCFA Form 484.2. Federal Law (OBRA 1990) mandates specific sections of this form must be completed by  the physician or their staff.

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Nebulizers
Medicare Coverage Criteria


Nebulizer machines, medications and related accessories are usually covered for patients with obstructive pulmonary disease, but can also be covered to deliver specific medications to patients with HIV, CF, brochiectasis, pneumocystosis, complications of organ transplants, or for persistent thick or tenacious pulmonary secretions.
Patients can obtain up to a three month’s supply of nebulizer medications and accessories at a time.

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CPAP
Medicare Coverage Criteria


Continuous Positive Airway Pressure (CPAP) Devices are covered only for patients with obstructive sleep apnea (OSA).
You must have an overnight sleep study performed in a sleep laboratory to establish a qualifying diagnosis. Home and mobile sleep labs/studies are not accepted for diagnosing this condition. Medicare will also pay for replacement masks, cannulas, tubing and other necessary supplies. After your first three months of use, you will be required to verify if you are benefiting from using the device and how many hours a day you are using the machine.  Most machines and all of Vienna Medical's CPAP and BPAP machines are compliant report ready. 

Q. What are the Medicare requirements before a CPAP device can be prescribed to a patient?
A. Before a CPAP device can be initiated, the patient must meet one of the following criteria:

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

INITIAL COVERAGE:

A single level continuous positive airway pressure (CPAP) device (E0601) is covered if the patient has a diagnosis of obstructive sleep apnea (OSA) documented by an attended, facility-based polysomnogram and meets either of the following criteria (1 or 2):

  • The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour; or,
  • The AHI is from 5 to 14 events per hour with documented symptoms of:
    • Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or,
    • Hypertension, ischemic heart disease, or history of stroke.

If a claim for a CPAP device (E0601) is submitted and the criteria above have not been met, it will be denied as not medically necessary.

For the purpose of this policy, polysomnographic studies must be performed in a facility based sleep study laboratory, and not in the home or in a mobile facility. These labs must be qualified providers of Medicare services and comply with all applicable state regulatory requirements.

For the purpose of this policy, polysomnographic studies must not be performed by a DME supplier. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0601 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

CONTINUED COVERAGE BEYOND THE FIRST THREE MONTHS OF THERAPY:

Continued coverage of an E0601 device beyond the first three months of therapy requires that, no sooner than the 61st day after initiating therapy, the supplier ascertain from either the beneficiary or the treating physician that the beneficiary is continuing to use the CPAP device.

If the above criterion is not met, continued coverage of an E0601 device and related accessories will be denied as not medically necessary.



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BiPAP
Medicare Coverage Criteria

BiPaps/Respiratory Assist Devices

For a respiratory assist device to be covered, the treating physician must fully document in your medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc. A respiratory assist device is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA). Various tests may need to be performed to establish one of the above diagnosis groups. Three months after starting your therapy, both your physician and you will be required to respond in writing to questions regarding your continued use along with how well the machine is treating your condition.

Q. What are the Medicare requirements before a BIPAP device can be prescribed to a patient?
A. Before a BIPAP device can be initiated, the patient must meet one of the following criteria:

GENERAL:

The "treating physician" must be one who is qualified by virtue of experience and training in non-invasive respiratory assistance, to order and monitor the use of respiratory assist devices (RAD). Physicians who treat patients for other medical conditions may or may not be so qualified, and if not, though they may be the treating physician of the beneficiary for other conditions, they are not considered the "treating physician" for the administration of non-invasive positive pressure respiratory assistance (NPPRA) therapy.

For the purpose of this policy, polysomnographic studies must be performed in a sleep study laboratory, and not in the home or in a mobile facility. It must comply with all applicable state regulatory requirements.

For the purpose of this policy, arterial blood gas, sleep oximetry and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy’s coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

If there is discontinuation of usage of an E0470 or E0471 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

INITIAL COVERAGE CRITERIA FOR E0470 And E0471 DEVICES FOR THE FIRST THREE MONTHS OF THERAPY:

For an E0470 or an E0471 RAD to be covered, the treating physician must fully document in the patient’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc.

A RAD (E0470, E0471) used to administer NPPRA therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) (E0470 only) and who also meet the following criteria:

I. Restrictive Thoracic Disorders:

  • There is documentation in the patient’s medical record of a progressive neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB), and
  • B.
    1) An arterial blood gas PaCO2 , done while awake and breathing the patient’s usual FIO2 is greater than or equal to 45 mm Hg, or

    2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing the patient’s usual FIO2, or,

    3) For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity is less than 50% predicted, and
  • C. Chronic obstructive pulmonary disease does not contribute significantly to the patient’s pulmonary limitation.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for patients within this group of conditions for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

II. Severe COPD:

A. 1) An arterial blood gas PaCO2, done while awake and breathing the patient’s usual FIO2, is greater than or equal to 52 mm Hg, and

2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient’s usual FIO2 (whichever is higher), and

B. Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.

If all of the above criteria for patients with COPD are met, an E0470 device will be covered for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, E0470 and related accessories will be denied as not medically necessary.

An E0471 device will not be covered for a patient with COPD during the first two months, because therapy with an E0470 device with proper adjustments of the device’s settings and patient accommodation to its use will usually result in sufficient improvement without the need of a back-up rate. (See below for coverage of an E0471 device for COPD after 2 month’s use of an E0470 device.) If E0471 is billed and the criteria for an E0470 device are met, it will be paid as the least costly medically appropriate alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, it will be denied as not medically necessary.

III. Central Sleep Apnea or Complex Sleep Apnea:

Prior to initiating therapy, a complete facility-based, attended PSG must be performed documenting the following:

  • The diagnosis of central sleep apnea (CSA) or complex sleep apnea (CompSA) (see definitions in Appendices section) and
  • The ruling out of CPAP as effective therapy if either CSA or OSA is a component of the initially observed sleep-associated hypoventilation, and
  • Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the patient’s usual FIO2.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for patients with documented CSA or CompSA for the first three months of NPPRA therapy. (See below for continued coverage after the initial three months.)

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not medically necessary.

IV. Obstructive Sleep Apnea (OSA):

Criteria (A) and (B) are both met:

A. A complete facility-based, attended polysomnogram, has established the diagnosis of obstructive sleep apnea according to the following criteria:
1. The apnea-hypopnea index (AHI) is greater than or equal to 15 events per hour, or
2. The AHI is from 5 to 14 events per hour with documented symptoms of:
a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia, or
b. Hypertension, ischemic heart disease, or history of stroke, and

B. A single level device (E0601, Continuous Positive Airway Pressure (CPAP) Device) has been tried and proven ineffective.

If the above criteria are met, an E0470 device will be covered for the first three months of NPPRA therapy (see below for continued coverage after the initial three months). If E0470 is billed and these criteria are not met but the coverage criteria in the Continuous Positive Airway Pressure System (CPAP) LCD are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

An E0471 device is not medically necessary if the primary diagnosis is OSA. If E0471 is billed and the criteria for an E0470 device are met, it will be paid as the least costly medically appropriate alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, but the coverage criteria in the Continuous Positive Airway Pressure System (CPAP) LCD are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0601.

CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS OF THERAPY:

Patients covered for the first 3 months of an E0470 or an E0471 device must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months. While the patient may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which Medicare will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating physician. Medicare will not continue coverage for the 4th and succeeding months of NPPRA therapy until this re-evaluation has been completed.

There must be documentation in the patient’s medical record about the progress of relevant symptoms and patient usage of the device up to that time. Failure of the patient to be consistently using the E0470 or E0471 device for an average of 4 hours per 24 hour period by the time of the re-evaluation (on or after 61 days after initiation of therapy) would represent non-compliant utilization for the intended purposes and expectations of benefit of this therapy. This would constitute reason for Medicare to deny continued coverage as not medically necessary.

The following items of documentation must be obtained by the supplier of the device for continued coverage beyond three months:

  • A signed and dated statement completed by the treating physician no sooner than 61 days after initiating use of the device, declaring that the patient is compliantly using the device (an average of 4 hours per 24 hour period) and that the patient is benefiting from its use, and
  • A Medicare beneficiary statement completed by the patient no sooner than 61 days after initiating use of the device (see below).

If the above criteria are not met, continued coverage of an E0470 or an E0471 device and related accessories will be denied as not medically necessary.

For Group II patients (COPD) who qualified for an E0470 device, if at a time no sooner than 61 days after initial issue and compliant use of an E0470 device, the treating physician believes the patient requires an E0471 device, the E0471 device will be covered if the following criteria are met:

  • An arterial blood gas PaCO2, repeated no sooner than 61 days after initiation of compliant use of the E0470, done while awake and breathing the patient’s usual FIO2, still remains greater than or equal to 52 mm Hg, and
  • A sleep oximetry, repeated no sooner than 61 days after initiation of compliant use of a E0470 device, and while breathing with the E0470 device, demonstrates oxygen saturation less than or equal to 88% for at least five continuous minutes, done while breathing oxygen at 2 LPM or the patient’s usual FIO2 [whichever is higher], and
  • A signed and dated statement from the treating physician, completed no sooner than 61 days after initiation of the E0470 device, declaring that the patient has been compliantly using the E0470 device (an average of 4 hours per 24 hour period) but that the patient is NOT benefiting from its use, and
  • A Medicare beneficiary statement completed by the patient, no sooner than 61 days after initiation of the E0470 device.

If the above criteria for an E0471 are not met, but the criteria for an E0470 are met, the device will be paid as the least costly medical alternative, E0470. If E0471 is billed and the criteria for an E0470 device are not met, it will be denied as not medically necessary.



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Suction Machines
Medicare Coverage Criteria


Use of a home model suction pump is covered for recipients who have difficulty raising and clearing secretions secondary to:

  • Cancer or surgery of the throat
  • Dysfunction of the swallowing muscles
  • Unconsciousness or obtunded state
  • Tracheostomy
Coverage and Payment Policy Medically necessary disposable supplies that are essential to the effective use of a medically necessary suction pump are covered.

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Beds & Patient Lifts

Hospital Beds
Medicare Coverage Criteria
A hospital bed is covered if one or more of the following criteria (1-4) are met:
  1. The patient has a medical condition which requires positioning of the body in ways not feasible with an ordinary bed. Elevation of the head/upper body less than 30 degrees does not usually require the use of a hospital bed, or
  2. The patient requires positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or
  3. The patient requires the head of the bed to be elevated more than 30 degrees most of the time due to congestive heart failure, chronic pulmonary disease, or problems with aspiration. Pillows or wedges must have been considered and ruled out, or
  4. The patient requires traction equipment which can only be attached to a hospital bed.
Specialty beds that allow the height of the bed to vary are covered for patients that require this feature to permit transfers to a chair, wheelchair or standing position. A semi-electric bed is covered for a patient that requires frequent changes in body position and/or has an immediate need for a change in body position. Heavy-duty/extra-wide beds can be covered for patients that weigh over 350 pounds. The total electric bed is not covered because it is considered a convenience feature. If you prefer to have the total electric feature, your provider usually can apply the cost of the semi-electric bed toward the monthly rental price of the total electric model by using an Advance Beneficiary Notice (ABN). You would be responsible to pay the difference in the retail charges between the two items every month.

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Trapeze & Bed Boards
Medicare Coverage Criteria


A trapeze bar is covered when a recipient needs this device to sit up because of a respiratory condition, to change body position for other medical reasons, or to get in or out of bed. A bed cradle is covered for a recipient with acute gouty arthritis (ICD-9-CM 274.0) or burns (ICD-9-CM 942.00, 943.59, 945.00 or 945.59) for whom it is necessary to prevent contact with the bed coverings. Coverage and Payment Policy An "attachable" trapeze bar is not covered when used on a non- hospital bed. A trapeze bar is covered when it is either an integral part of or used on a hospital bed, and it has been determined that both the hospital bed and the trapeze bar are medically necessary. When "free standing" trapeze equipment is prescribed, it must meet the same criteria as the attached equipment, and the recipient must not be renting or own a hospital bed. Side rails are covered when an integral part of, or an accessory to, a hospital bed if the recipient's condition requires bed side rails. A bed board is not covered, since it is not medical in nature.

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Air Mattresses - GROUP 1 AND 2
Medicare Coverage Criteria


See Wound Care - click here


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Patient Lifts - Hoyer
Medicare Coverage Criteria


A lift is covered if transfer between bed and a chair, wheelchair, or commode requires the assistance of more than one person and, without the use of a lift, the patient would be bed confined. An electric lift mechanism is not covered; because it is considered a convenience feature. If you prefer to have the electric mechanism, your provider Vienna Medical can usually apply the cost of the manual lift toward the purchase price of the electric model by using an Advance Beneficiary Notice (ABN). You would be responsible to pay the difference in the retail charges between the two items. Usually around $40/month.

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Patient Lifts - Stand Up (Sarah Lifts For Rent)
Medicare Coverage Criteria


Stand up lifts covered under Hoyer lifts above but there is a difference in monthly out of pocket expense for patients.  Please call to inquire.


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Wound Care


Cushions and backs - Wheelchairs
Medicare Coverage Criteria


See above in Wheelchairs - click here


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Bed Surfaces - (Group 1 and 2)
Medicare Coverage Criteria


Group 1 products are designed to be placed on top of a standard hospital or home mattress. They can utilize gel, foam, water or air, and are covered for patients that are: Completely immobile OR Have limited mobility with any stage ulcer on the trunk or pelvis (and one of the following):
  • impaired nutritional status
  • fecal or urinary incontinence
  • altered sensory perception
  • compromised circulatory status
Group 2 products take many forms, but are typically powered pressure reducing mattresses or overlays. They are covered for patients with one of three conditions:
  • Multiple stage II ulcers on the pelvis or trunk while on a comprehensive treatment program for at least a month using a Group 1 product, and at the close of that month, the ulcers worsened or remained the same. (Monthly follow-up is required by a clinician to ensure that the treatment program is modified and followed. This product is only covered while ulcers are still present.) OR
  • Large or multiple Stage III or IV ulcers on the trunk or pelvis (Monthly follow-up is required by a clinician to ensure that the treatment program is modified and followed. This product is only covered while ulcers are still present.) OR
  • A recent myocutaneous flap or skin graft for an ulcer on the trunk or pelvis within the last 60 days who were immediately placed on Group 2 or 3 support surface prior to discharge from the hospital and the patient has been discharged within last 30 days.
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Lymphedema Pumps
Medicare Coverage Criteria


Medicare and major insurance carriers recognize these pumps as safe and effective treatment of:
Primary and secondary Lymphedema Post Mastectomy/post lumpectomy/post radiation Lymphedema Venous insufficiency Venous stasis ulcers Prevention of thrombosis Compression pumps are covered for treatment of true Lymphedema as a result of: Primary Lymphedema resulting from a congenital abnormality of lymphatic drainage or Milroy's disease, or Secondary Lymphedema resulting from the destruction of or damage to formerly functioning lymphatic channels such as:
  • radical surgical procedures with removal of regional groups of lymph  nodes (for example, after radical mastectomy),
  • post-radiation fibrosis,
  • spread of malignant tumors to regional lymph nodes with lymphatic obstruction,
  • or other causes
Before you can be prescribed a pump, your physician must monitor you during a four-week trial period where other treatment options are tried such as medication, limb elevation and compression garments. If, at the end of the trial, there is little or no improvement, a Lymphedema pump can be considered. The doctor must then document an initial treatment with a pump and establish that the treatment can be tolerated. - Lymphedema pumps also are covered for the treatment of chronic venus insufficiency (CVI). Before you can be prescribed a pump for this condition, your physician must monitor you during a six month trial period where other treatment options are tried such as medication, limb elevation and compression garments. If at the end of the trial the stasis ulcers are still present, a Lymphedema pump can be considered. The doctor must then document an initial treatment with a pump and establish that the treatment can be tolerated, that there is a caregiver available to assist with the treatment in the home, and then the doctor must prescribe the pressures, frequency, and duration of prescribed use.

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Diabetics


Diabetic Shoes & Inserts
Medicare Coverage Criteria

In an effort to prevent foot ulcers in people with diabetes who are at risk, Medicare will help pay for therapeutic shoes. For those who qualify, Medicare will pay 80 percent of the allowed amount for one pair of shoes and up to three pairs of molded innersoles per year. (The allowed amount varies depending on the kind of footwear you need.) Most secondary insurers will help pay the other 20 percent.

Who Qualifies Medicare Diabetic Shoes and Inserts?
To qualify, you must be under a comprehensive diabetes treatment plan and have one or more of the following:
  • history of partial or complete amputation of the foot
  • history of previous foot ulceration
  • history of pre-ulcerative callus
  • peripheral neuropathy with evidence of callus formation
  • foot deformity
  • poor circulation
Your fitting starts one of two ways.  You can print out the physician statement of certification and have your physician sign it or a prescription for diabetic shoes and we can complete the paperwork with your primary care physician.

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Diabetic Test Strips & Lancets
Medicare Coverage Criteria


Diabetic Supplies
  • For diabetics, Medicare covers the glucose monitor, lancets, spring- powered devices, test strips, control solution and replacement batteries for the meter.
  • Medicare does not cover insulin injections or diabetic pills unless covered through a Medicare Part D benefit plan.
  • Diabetics can obtain up to a three month supply at a time.
  • Medicare will approve up to one test per day for non-insulin dependent diabetics and three tests per day for insulin-dependent diabetics without additional verification.
    • Patients who test above these guidelines are required to be seen and evaluated by their physician within six months of ordering these supplies.
    • In addition, patients must send their provider evidence of compliant testing (e.g. a testing log) every six months to continue getting refills at the higher levels.
  • If at any time your testing frequency changes, your physician will need to give your provider a new prescription.
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Diabetic Gauntlets
Medicare Coverage Criteria


The ankle/foot gauntlet was designed to provide stability and elevate the subcutaneous skin temperature to help stimulate circulation and provide protection and comfort.  This therapeutic device can increase blood flow and help provide temporary pain relief. One of the following conditions will qualify you for coverage:
  • Ankle pain and support
  • Defective circulation (lower extremity)
  • Joint stiffness
  • Joint swelling
  • Circulation (peripheral disorder)                                                         
  • Arthritis
  • Disuse atrophy
  • contractive of ankle joint
  • or other conditions (which must be specified)
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Diabetic Impotence Device
Medicare Coverage Criteria


Impotence Device - The vacuum erection pump offers a drug-free, safe and effective solution to diabetic impotence.  It is non-invasive and has no side effects.  Vacuum therapy restores adequate blood flow to the penis by creating negative vacuum pressure to create the erection in less than 60 seconds.  It is rapidly becoming one of the most popular solutions to erectile dysfunction.  If you have one of the following conditions, it may be covered by Medicare:
  • Diabetes
  • Hypertension
  • Vascular Disease
  • Drug interaction
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Diabetic Hot/Cold Therapy
Medicare Coverage Criteria


Moist heating pads provide treatment that retains moisture from the air.  Great for arthritis, it dilates the blood vessels, increasing circulation and creating blood flow.  This takes away waste and toxins that may have settled in injured areas and brings new blood cells to the tissue. Must have severe Arthritis pain and meet one of the following criteria:
  • Rheumatoid arthritis
  • Unspecified Inflammatory Polyarthopathies
  • Osteoarthrosis
  • Arthropathy unspecified
  • Lumbosacral Spondylosis without Myelopathy
  • Spondylosis of unspecified site
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Lift Chairs & Mechanisms


Lift Chairs
Medicare Coverage Criteria


For lift chairs, Medicare will only cover the seat lift mechanism, but not the actual chair itself. The reimbursement amount is roughly $300 depending on the state in which the patient is located. A lift chair would be considered medically necessary if all of the following coverage criteria are met:
  • The patient must have severe arthritis of the hip or knee, or have a severe neuromuscular disease.
  • The seat lift mechanism must be a part of the physician's course of treatment and be prescribed to effect improvement, or arrest or retard deterioration in the patient's condition.
  • The patient must be completely incapable of standing up from a regular armchair or any chair in their home.
  • Once standing, the patient must have the ability to walk.
  • By Medicare standards, the fact that a patient has difficulty or is even incapable of getting up from a chair, particularly a low chair, is not sufficient justification for a seat lift mechanism. Almost all patients who are capable of ambulating can get out of an ordinary chair, if the seat height is appropriate and the chair has arms. Medicare requires that the physician ordering the seat lift mechanism must be the attending physician or a consulting physician for the disease or condition resulting in the need for a seat lift.
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