Home Oxygen Therapy
- The treating physician has determined that the patient has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy, and
- The patient's blood gas study meets the criteria stated below, and
- The qualifying blood gas study was performed by a physician or by a qualified provider or supplier of laboratory services, and
- The qualifying blood gas study was obtained under the following conditions:
- If the qualifying blood gas study is performed during an inpatient hospital stay, the reported test must be the one obtained closest to, but no earlier than 2 days prior to the hospital discharge date, or
- If the qualifying blood gas study is not performed during an inpatient hospital stay, the reported test must be performed while the patient is in a chronic stable state i.e., not during a period of acute illness or an exacerbation of their underlying disease, and
- Alternative treatment measures have been tried or considered and deemed clinically ineffective.
- An arterial PO 2 at or below 55 mm Hg or an arterialoxygen saturation at or below 88 percent taken at rest (awake), or
- An arterial PO 2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88 percent, for at least 5 minutes taken during sleep for a patient who demonstrates an arterial PO 2 at or above 56 mm Hg or an arterial oxygen saturation at or above 89% while awake, or
- A decrease in arterial PO 2 more than 10 mm Hg, or a decrease in arterial oxygen saturation more than 5 percent, for at least 5 minutes taken during sleep associated with symptoms or signs reasonably attributable to hypoxemia (e.g., cor pulmonale, "P" pulmonale on EKG, documented pulmonary hypertension and erythrocytosis), or
- An arterial PO 2 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 PO 2 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, oxygen is provided for 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.
- At rest without oxygen
- After exercise to show the decrease in oxygen saturation
- After exercise with oxygen to document improvement
- Dependent edema suggesting congestive heart failure, or
- 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 AVF), or
- Erythrocythemia with a hematocrit greater than 56 percent.
- Permanent nonfuctioning or disease of the structures that normally permit food to reach small bowel
- Disease of the small bowel which impairs digestion and absorption of an oral diet, either of which requires tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with the patient's overall health status.
- Patient has diarrhea, vomiting, dumping syndrome, aspiration or reflux which would be aggravated by putting patient on bolus or gravity.
- Patient has been tried on bolus or gravity and has experienced one of the complications listed above.
- Pt has a Jejunostomy tube
- Pt requires an administration rate of less than 100/ml per hour due to:
- Blood glucose fluctuations
- Circulatory overload due to CHF
- 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
- The patient requires positioning of the body in ways not feasible with an ordinary bed in order to alleviate pain, or
- 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
- The patient requires traction equipment, which can only be attached to a hospital bed.
PAP Device Coverage (Cpap and Bilevel) for OSA
Continued coverage of a PAP device (CPAP or Bi-level) beyond the first three months of therapy requires that, no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating physician* must conduct a clinical re-evaluation and document that the beneficiary is benefiting from PAP therapy.
For PAP devices with initial dates of service on or after November 1, 2008, documentation of clinical benefit is demonstrated by:
- Face-to-face clinical re-evaluation by the treating physician* with documentation that symptoms of obstructive sleep apnea are improved; and,
- Objective evidence of adherence to use of the PAP device, reviewed by the treating physician*.
Adherence to therapy is defined as use of PAP > 4 hours per night on 70% of nights during a consecutive thirty (30) day period anytime during the first three (3) months of initial usage.
If the above criteria are not met, continued coverage of a PAP device and related accessories will be denied as notmedically necessary.
Beneficiaries who fail the initial 12 week trial are eligible to requalify for a PAP device but must have both:
- Face-to-face clinical re-evaluation by the treating physician*to determine the etiology of the failure to respondto PAP therapy; and,
- Repeat sleep test in a facility-based setting (Type 1 study).
If the physician re-evaluation does not occur until after the 91st day but the evaluation demonstrates that the patient is benefiting from PAP therapy as defined in criteria 1 and 2 above, continued coverage of the PAP device will commence with the date of that re-evaluation.
If a CPAP device is tried and found ineffective during the initial 3 month home trial, substitution of a Bi-level does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of CPAP.
If a CPAP device was used for more that 3 months and the patient was switched to a Bi-level, then the clinical re-evaluation would occur between the 31st and 91st day following the initiation of the Bi-level. There would also need to be documentation of adherence to therapy during the 3 month trial with the Bi-level.
For a PAP device dispensed priortoNovember 1, 2008, if the initial coverage criteria in effect at the time were met and the criteria for coverage after the first 3 months that were in effect at the time were met, the device will continue to be covered for PAP devices with initialdates of service on or after November 1,2008 as long as the patient continues to compliantly use the device.
Bi-level with back up rate
· Severe COPD
· Central Sleep Apnea or Complex Sleep Apnea
· Obstructive SleepApnea
· Restrictive Thoracic Disorders
· Central Sleep Apnea or Complex Sleep Apnea
· Restrictive Thoracic Disorders
· Severe COPD patients must be initially tried on a standard Bi-level
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
Central Sleep Apnea or Complex Sleep Apnea:
If the above criteria are met the pt will qualify for either a standard Bi-level or a Bi-level with back up rate.
Obstructive Sleep Apnea (OSA):
Restrictive Thoracic Disorders:
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 60cm H20 or forced vital capacity is less than 50% predicted, and
CONTINUED COVERAGE FOR BILEVEL AND BILEVEL WITH BACKUP RATE DEVICES BEYOND FIRST THREE MONTHS OF THERAPY:
For continued coverage under a diagnosis of OSA please refer to PAP Device Coverage listed above. Patients covered for the first 3 months of a BILEVEL or BILEVEL WITH BACKUP RATE 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 succeedingmonths 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 BILEVEL or BILEVEL WITH BACKUP RATE 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 thistherapy. This would constitute reason for Medicareto deny continued coverage as not medically necessary.
The following items of documentation must be obtained by the supplier of the device for continuation of coverage beyond threemonths:
1) 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
2) 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 BILEVEL or BILEVEL WITH BACKUP RATE device and related accessories will be denied as not medically necessary.
For Group II patients (COPD) who qualified for a BILEVEL device, if at a time no sooner than 61 days after initial issue and compliant use of a BILEVEL device, the treating physician believes the patient requires a BILEVEL WITH BACKUP RATE device, the BILEVEL WITH BACKUP RATE device will be covered if the following criteria are met:
1) An arterial blood gas PaCO2, repeated no sooner than 61 days after initiation of compliant use of the BILEVEL, done while awake and breathing the patient’s usual FIO2, stillremains greater than or equal to 52 mm Hg, and
2) A sleep oximetry, repeated no sooner than 61 days after initiation of compliant use of a BILEVEL device, and while breathing with the BILEVEL 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
3) A signed and dated statement from the treating physician, completed no sooner than 61 days after initiation of the BILEVEL device, declaringthat the patient has been compliantly using theBILEVEL device (an average of 4 hours per 24 hour period) but that the patient is NOT benefiting from its use, and
4) A Medicare beneficiary statement completed by the patient, no sooner than 61 days after initiation of the BILEVEL device.
If the above criteria for an BILEVEL WITH BACKUP RATE are not met, but the criteria for an BILEVEL are met, the device will be paid as the least costly medical alternative, BILEVEL. If BILEVEL WITH BACKUP RATE is billed and the criteria for an BILEVEL device are not met , it will be denied as not medically necessary.
Wheelchair Cushion Coverage
- The patient has a wheelchair and the patient meets Medicare coverage criteria for it; and
- The patient has either of the following:
- Current pressure ulcer (707.03, 707.04, 707.05) or past history of a pressure ulcer (707.03, 707.04, 707.05) on the area of contact with the seating surface; or
- 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), muscular dystrophy (359.0, 359.1), hemiplegia (342.00 - 342.92, 438.20-438.22), Huntignton's chorea (333.4), idiopathic torsion dystonia (333.6), athetoid cerebral palsy (333.71).
Group I Support Surfaces: APP, Overlay
- The patient is completely immobile - i.e., patient cannot make changes in body position without assistance, or
- The patient has limited mobility - i.e., patient cannot independently make changes in body position significant enough to alleviate pressure and at least one of conditions A-D below, or
- The patient has any stage pressure ulcer on the trunk or pelvis and at least one of conditions A-D below.
- Impaired nutritional status
- Fecal or urinary incontinence
- Altered sensory perception
- Compromised circulatory status
Group II Support Surfaces: LowAir Loss Mattress
- Criterion a and b and c, or
- Criterion d, or
- Criterion e and f.
- Multiple stage II pressure ulcers located on the trunk or pelvis (ICD-9 707.02 -707.05).
- Patient has been on a comprehensive ulcer treatment program for at leastthe past month which has included the use of an appropriate group 1 support surface.
- The ulcers have worsened or remained the same over the past month.
- Large or multiple stage III or IV pressure ulcer(s) on the trunk or pelvis (ICD-9 707.02 -707.05).
- Recent myocutaneous flap or skin graft for a pressure ulcer on the trunk or pelvis (surgery within the past 60 days) (ICD-9 707.02 -707.05).
- The patient has been on a group 2 or 3 support surface immediately prior to a recent discharge from a hospital or nursing facility (discharge within the past 30 days).
- Education of the patient and caregiver on the prevention and/oressure ulcers.
- Regular assessment by a nurse, physician, or other licensed healthcare practitioner (usually at least weekly for a patient with a stage III or IV ulcer).
- Appropriate turning and positioning.
- Appropriate wound care (for a stage II, III, or IV ulcer).
- Appropriate management of moisture/incontinence.
- Nutritional assessment and intervention consistent with the overall plan of care.