Respiratory Assist Devices New Users (Months 1-3)

For Dates of Service > 10/1/99

	Group 1		Group 2	Group 3	Group 4
	Restrictive Thoracic Disorders
Diagnosis	Progressive Neuromuscular · ALS · Post-polio syndrome	Severe Thoracic Cage Abnormality · Post-thoracoplasty for M. tuberculosis · Severe kyphosis	Severe COPD	Central Sleep Apnea (CSA)	Obstructive Sleep Apnea (OSA)
Awake ABG (breathing FI02)	PaC02 > 45 mm Hg or	PaC02 > 45 mm Hg or	PaC02 > 52 mm Hg and	N/A	N/A
Sleep Oximetry	02 saturation < 88% (for at least 5 continuous minutes while breathing usual FI02) or	02 saturation < 88% (for at least 5 continuous minutes while breathing usual FI02)	02 saturation < 88% (for at least 5 continuous minutes on 2 LPM or usual FI02 (whichever is higher) and	02 saturation < 88% (for at least 5 continuous minutes while breathing usual FI02)	N/A
Pulmonary Function Test (PFT)	Maximal inspiratory pressure < 60 cm H20 or FVC <50% predicted	N/A	N/A	N/A	N/A
Facility Based Polysomnogram	N/A	N/A	N/A	CSA	OSA
Other	COPD does not contribute significantly to pulmonary limitation		Prior to initiating therapy, OSA and treatment with CPAP was considered and ruled out	Exclude OSA and rule out CPAP and significant improvement with RAD	CPAP (E0601) tried and proven ineffective
Device Covered	K0532 or K0533 x 3 months	K0532 or K0533 x 3 months	K0532 x 3 months. K0533 after 2 months with additional criteria.	K0532 or K0533 x 3 months	K0532 x 3 months or downcoded to E0601 K0533 after 2 months not medically necessary
ZX Modifier Prior to 7/1/02 KX Modifier Effective 7/1/02	If < 90 days = MD order with covered diagnosis. If > 90 days = MD statement and beneficiary statement. Suppliers billing claims for beneficiaries who began using the device prior to 10/1/99 should not use KX (formerly ZX) modifier unless their files include completed and signed Beneficiary and Physician statements. This applies to patients in Group I – III. A KX modifier must not be added to claims for K0533 used to treat Group IV patients.				If facility based, attended poly. Established diagnosis of OSA and E0601 is proven ineffective
Patient’s Medical Record	Symptoms characteristic with sleep associated with hypoventilation (e.g. daytime sleepiness, excessive fatigue, morning headache, cognitive dysfunction and/or dyspnea)

Respiratory Assist Devices

New Users ( > 4 months)

For Dates of Service > 10/1/99

	Group 1		Group 2		Group 3	Group 4
	Restrictive Thoracic Disorders
Diagnosis	Progressive Neuromuscular	Severe Thoracic Cage Abnormality	Severe COPD		Central Sleep Apnea (CSA)	Obstructive Sleep Apnea (OSA)
Patient on K0532 or K0533 prior to 10/1/99	Statement from MD · Using 4 hours in 24 hours · Patient benefiting from use Beneficiary Statement					If using < 3 months: Statement from MD · Using 4 hours in 24 hours) · Patient benefiting from use Beneficiary Statement If using > 3 months: N/A
Re-evaluation	Between 61^st and 90^th day of initiating therapy
MD Statement	Signed and dated statement from treating MD · Using 4 hours in 24 hours) · Patient benefiting from use
	N/A	N/A		If change from K0532 to K0533 · No benefit from K0532 · Compliant use of K0532 > 61 days	N/A	N/A
> 60 days Beneficiary Statement	Discontinue billing if applicable
	Yes
Repeat Awake ABG No sooner than day 61 after initiation of compliant use of K0532				PaC02 > 52 breathing FI02 and
Repeat Sleep Oximetry No sooner than day 61 after initiation of compliant use of K0532 while on K0532 device				Saturation < 88% 5 minutes on 2 LPM or FI02 (whichever is higher)
ZX Modifier Prior to 7/1/02 KX Modifier Effective 7/1/02	MD Statement (including detailed documentation in the patient’s medical records) Beneficiary Statement
				Repeat ABG Repeat oximetry