Clinical Criteria and Insurance Guidelines Quick Reference Guide

1. Patient’s name or Medicare Beneficiary Identifier (MBI)
2. Order date
3. General description of the item
   1. The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/ model number.
   2. For equipment – In addition to the description of the base item, the Rx may include all concurrently ordered options, accessories or additional features that are separately billed or require an upgraded code (List each separately).
   3. For supplies – In addition to the description of the base item, the DMEPOS order/prescription may include all concurrently ordered supplies that are separately billed (List each separately).
4. Quantity to be dispensed, if applicable
5. Treating practitioner name or NPI
6. Treating practitioner’s signature

For a signature to be valid, the following criteria must be met:

1. Services that are provided/ordered must be authenticated by the author.
2. Signatures shall be handwritten or an electronic signature.
3. Signatures are legible.
4. Rubber stamps for signatures are allowed in accordance with the Rehabilitation Act of 1973 in the case of an author with a physical disability that can provide proof to a CMS contractor of his/her inability to sign their signature due to their disability. By affixing the rubber stamp, the provider is certifying that he/she has reviewed the document.
5. Medical record entries completed by a scribe must be authenticated by the treating physician’s/non-physician’s (NPP’s) signature and date.
6. All signatures need to be dated.

All orders must have the following documented in the patient’s file and be provided to Owens:

1. Face-to-face patient evaluation prior to sleep study with:
   1. Document any sleep related signs or symptoms that meet the criteria for obstructive sleep apnea (i.e., fatigue, day time somnolence, snoring, interrupted sleep, or mood disorders)
   2. Documented need for sleep study
   3. Must be signed and dated prior to sleep study
2. Sleep study results (minimum 2-hour sleep time)
   1. Signed and dated by treating physician or other qualified healthcare professional
   2. Physician who interprets sleep study must be credentialed in sleep medicine
   3. AHI > 15, or AHI between 5-14 requires secondary diagnosis*
3. Prescription (Rx) prior to dispensing that contains:
   1. Patient Name or Medicare Beneficiary Identifier (MBI)
   2. Order Date
   3. Description of Item, i.e.:
      1. General description, including corresponding pressure settings
      2. Include corresponding pressure settings
      3. HCPCS code or narrative
      4. Brand name/model number
      5. For equipment: may include all concurrently ordered options/accessories that are separately billed or require upgrade code
      6. For supplies: may include all concurrently ordered supplies that are separately billed
   4. Quantity to be dispensed, if applicable
   5. Treating physician name or NPI
   6. Treating physician signature (e-signature acceptable)
4. Face-to-face with patients between 32 and 90 days after setup date**

Following Required Prior to Dispensing to Medicare Patients:

Reasonable Useful Lifetime

All orders must have the same documentation as a new device

1. Face-to evaluation completed before replacement:
   1. Include documented ongoing patient usage of CPAP
   2. Face-to-face with patients between 32 and 90 days after setup date**
2. Sleep study results must be scored at 4% desaturation (results can be from another timeframe)

Item	Allowance
Chinstrap	1 per 6 months
Combination Oral/Nasal Mask, Each	1 per 3 months
Cushion for Use on Nasal Mask Interface, Replacement Only, Each	2 per 1 month
Exhalation Port With or Without Swivel Used, Replacement Only
Face Mask Interface, Replacement for Full Face Mask, Each	1 per 1 month
Filter, Disposable	2 per 1 month
Filter, Non-Disposable	1 per 6 months
Full Face Mask, Each	1 per 3 months
Headgear	1 per 6 months
Humidifier, Non-heated
Humidifier, Heated
Nasal Interface (Mask or Cannula Type), With or Without Head Strap	1 per 3 months
Nasal Pillow for Combination Oral/Nasal Mask, Replacement Only, Pair	2 per 1 month
Oral Cushion for Combination Oral/Nasal Mask, Replacement Only, Each	2 per 1 month
Oral Interface, Each	1 per 3 months
Pillow for Use on Nasal Cannula Type Interface, Replacement Only, Pair	2 per 1 month
Tubing	1 per 3 months
Tubing with integrated Heating Element	1 per 3 months
Water Chamber for Humidifier, Replacement, Each	1 per 6 months
Owens is required to contact patient prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the patient. Regardless of utilization, Owens must not dispense more than a three (3)-month quantity at a time.

All orders must have the following documented in the patient’s file:

1. Documented failure to meet therapeutic goals with CPAP device (E0601) based on:
   1. Titration portion of a facility-based study, or
   2. During home use 3-month trial period despite optimal therapy
2. Face-to-face evaluation for bi-level device is only required if patient has used CPAP device for more than 3 months before switch request
3. New PSG not required if switching from CPAP
4. Chart notes required if patient fails CPAP upon titration as well within 6 months

All orders must have the following documented in the patient’s file:

1. With use of a positive airway pressure device without a backup rate (E0601 or E0470), the polysomnogram (PSG) shows a pattern of apneas and hypoapneas that demonstrates the persistence or emergence of central apneas or central hypoapneas upon exposure to CPAP (E0601) or a bi-level device without backup rate (E0470) device when titrated to the point where obstructive events have been effectively treated (obstructive AHI < 5 per hour). Diagnosis of either central (CSA) or complex sleep apnea (CompSA); and
2. Significant improvement of the sleep-associated hypoventilation with use of an E0470 or E0471 on the settings the physician prescribed for initial use at home while breathing the prescribed FIO2. After resolution of the obstructive events, the sum total of central apneas plus central hypoapneas >50% of the total apneas and hypoapneas; and
   1. Significant improvement of the sleep-associated hypoventilation with use of an E0470 or E0471 on the settings the physician prescribed for initial use at home while breathing the prescribed FIO2.
3. After resolution of the obstructive events, a central apneas-central hypoapnea index (CAHI) > 5 per hour

All orders must have the following documented in the patient’s file:

1. Arterial blood gas PaCO2 > 52 mmHg, and
2. Sleep oximetery < 88% for> 5 minutes (minimum 2-hour recording time) while breathing O2 at 2 LPM or patient’s prescribed FIO2 (whichever is higher)**
3. OSA and CPAP treatment have been considered and ruled out

* Commercial and Medi-Cal guidelines may vary

** Applies to oxygen bleed in needs

All orders must have the following documented in the patient’s file:

1. Documentation of neuromuscular disease or a severe thoracic cage abnormality, and:
   1. Arterial blood gas PaCO2 > 45 mmHg while awake, or
   2. Sleep oximetry < 88% for> 5 minutes (minimum 2-hour recording time), or
   3. Max inspiratory pressure < 60 cm H2O or FVC < 50% predicted (NMD only)
2. Documentation that COPD does not contribute significantly to patient’s pulmonary limitation

All orders must have the following documented in the patient’s file:

1. Initial arterial blood gas PaCO2 while awake > 45 mm Hg, and
2. FEV1/FVC > 70% and
   1. Arterial blood gas PaCO2 while asleep or immediately on wakening worsened > 7 mmHg compared to initial PaCO2, or
   2. Facility-based PSG demonstrates sleep oximetry < 88% for> 5 minutes (minimum 2-hour recording time) not caused by obstructive upper airway events (i.e., AHI <5)< /li>

* Bi-level with backup rate (E0471) is covered if patient demonstrates same results as above while on existing bi-level device (E0470)

All orders must have the following in the patient’s file:

1. Primary DX of Chronic Respiratory Failure consequent to COPD, or Neuromuscular Diseases (NMDs), or Thoracic Restrictive Diseases with PFT indicating severe restrictive lung disease
2. Detailed item description, i.e., “ventilator non-invasive” (Orders that only state “PRN” or “as needed” are not acceptable)
3. Bi-level considered or insufficient/failed with explanation or proof
4. Face-to-face within 6 months prior to Prescription (Rx)
5. Labs that meet one of the following criteria (a, b, or c):
   1. ABG
      If CRF w/COPD/TRD: PCO2 > 52 mmHg or …
   2. PFT/Spirometry
      FEV1/FVC < 70%, FEV1 < 50
      If TRD/NMD: FVC < 50%
6. Chart notes supporting progression of disease or history of hospitalizations or increased frequency of physician visits secondary to progression of respiratory disease despite typical interventions (Oxygen, neb tx)
   1. Details of the patient’s history or progression of breathing issues

Owens is committed to optimizing patient care and offers the following platforms for you to access compliance data for your patients:

1. Philips Care Orchestrator:
   https://www.careorchestrator.com/#/login
2. ResMed AirView:
   https://login.airview.resmed.com/

Owens can help set up accounts for your office and train your team to get patient reports, putting information easily within your reach!

All orders must have the following in the patient’s file:

1. Notes stating the patient is ventilated via tracheostomy and the patient must meet the requirements of non-invasive ventilation
2. Chart notes in the patient’s file stating the patient is ventilator dependent
3. Secondary vent requires documentation of the following:
   1. Patient is confined to wheelchair during day and needs second vent for portability, or
   2. Patient requires one type of vent for part of the day and a different type of vent during the rest of the day, or
   3. Patient may be prone to certain medical complications or may not be able to achieve appropriate outcomes without two vents
   4. Prescription (Rx)
   5. Face-to-face required to justify second vent request

Provides coverage for:

• Patient in state of chronic respiratory failure resulting in inability to maintain proper gas exchange.
• Lifetime rental
• Secondary ventilator may be obtained with proper documentation demonstrating:
  • How activities of daily living cannot be accomplished without a wheelchair, and wheelchair serial number
  • Patient requires one type of ventilator for part of day and different type of ventilator during rest of day
  • Patient may be prone to certain medical complications or may not be able to achieve appropriate outcomes without two pieces of equipment

Provides coverage for:

• Patient in state of chronic respiratory failure resulting in inability to maintain proper gas exchange.
• Lifetime rental
• Secondary ventilator may be obtained with proper documentation demonstrating:
  • How activities of daily living cannot be accomplished without a wheelchair, and wheelchair serial number
  • Patient requires one type of ventilator for part of day and different type of ventilator during rest of day
  • Secondary ventilator may be obtained for back-up with proper documented medical necessity (e.g., nearest hospital is 2+ hours away)

Must have Medi-Cal authorization prior to delivery

All Patients Require the Following Documentation to be Covered for Home Oxygen:

1. Provider has determined that patient has acute or chronic disease process with associated Hypoxia related symptoms that might improve with O2 therapy, and well-documented in chart notes. For acute conditions, reevaluation within 61- 90 days to determine whether acute condition is resolved or a co-existing chronic condition is creating ongoing need
2. Qualified testing (see tables)
3. Provider has signed test results to indicate evaluation
4. If portability is being ordered, the provider must document that the patient is mobile within home, therefore requiring portability
5. Provider has documented that oxygen will improve patient’s condition in the home setting
6. An annual prescription is required for oxygen. Please consider adding it to your in-office chart note template.

* If patient requires greater than 4lpm to maintain SpO2 greater than 88% at rest, an ABG or SpO2 is required on 4lpm at rest with documented results.

Group II Requires:

Respiratory or Cardiac Secondary Diagnosis

1. Dependent edema suggesting congestive heart failure, or
2. Pulmonary hypertension or cor pulmonale, or
3. Erythrocythemia

Test results are valid 3 months and retesting is required within 61-90 days to establish ongoing need

Is your patient having troubles clearing their airway?

Medicare requirements for AffloVest:

(Please contact your rep for other payor guidelines)

Covered Diagnoses:

Bronchiectasis:

1. Diagnosis confirmed via CT scan
2. One of the following:
   • – Daily productive cough for at least 6 months
   OR
   • – Frequent (more than 2/year) exacerbations/chest infections requiring antibiotic therapy.
3. Well-documented failure of other treatments and why they did not effectively mobilize secrections. (CPT, Flutter/Acapella device, Huff Cough)

• Example: “Patient used flutter device but it did not effectively mobilize secretions.”

Disorders of diaphragm, cystic fibrosis, other neuromuscular diseases:

1. Diagnosis
2. Chart notes to support the DX
   Example: “Patient is deconditioned due to drug induced myopathy subsequent to COPD therapies.”
3. Well-documented failure of other treatment
   Example: “Patient tried CPT but was unable to tolerate treatment or has no caregiver available to perform treatment.”

Owens offers semi-electric hospital beds (E0260)

1. Owens requires a standard prescription (Rx)
2. All orders must have the following in the patient’s file:
   • Patient meets criteria for a fixed height hospital bed; and
     • 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
     • Patient requires positioning of the body in ways not feasible with an ordinary bed to alleviate pain; or
     • 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; or
     • Patient requires traction equipment, which can only be attached to a hospital bed.
   • Patient requires frequent changes in body position and/or has an immediate need for a change in position.

Owens offers manual wheelchairs

1. Owens requires a standard prescription (Rx)
2. All orders must have the following in the patient’s file:

General Coverage Criteria: Criteria A, B, C, D, and E are met; AND

1. The beneficiary has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. A mobility limitation is one that:
   • Prevents the beneficiary from accomplishing an MRADL entirely, or
   • Places the beneficiary at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to perform an MRADL; or
   • Prevents the beneficiary from completing an MRADL within a reasonable time frame.
2. The beneficiary’s mobility limitation cannot be sufficiently resolved using an appropriately fitted cane or walker.
3. The beneficiary’s home provides adequate access between rooms, maneuvering space, and surfaces for use of the manual wheelchair that is provided.
4. Use of a manual wheelchair will significantly improve the beneficiary’s ability to participate in MRADLs and the beneficiary will use it on a regular basis in the home.
5. The beneficiary has not expressed an unwillingness to use the manual wheelchair that is provided in the home.

Criterion F or G is met:

• F: The beneficiary 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; or
• G: The beneficiary has a caregiver who is available, willing, and able to provide assistance with the wheelchair.

Heavy Duty Wheelchairs (K0006) require all the above AND

• Medical records support the beneficiary:
  • Weighs more than 250 pounds; or
  • Has severe spasticity.

Extra Heavy Duty Wheelchairs (K0007) require all the above AND

• Weighs more than 300 lbs

Owens offers FWW (E0143). If a seat is required the Rx must specify, “with seat”.

1. Owens requires a standard prescription (Rx)
2. All orders must have the following in the patient’s file:
   • The beneficiary has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADL) in the home. A mobility limitation is one that:
     • Prevents the beneficiary from accomplishing the MRADL entirely; or
     • Places the beneficiary at a reasonably determined heightened risk or morbidity or mortality secondary to the attempts to perform the MRADL; or
     • Prevents the beneficiary from completing the MRADL within a reasonable timeframe; and
   • The beneficiary can safely use the walker; and
   • The functional mobility deficit can be sufficiently resolved by use of a walker.