Respiratory Care: Regulating RADs

What do you get when you mix an abundance of claims for one type of the Health Care Financing Administration's (HCFA) Common Procedure Coding System (HCPCS) code and a relatively high Medicare allowable? Answer: A new restrictive medical policy.

Such is the case for noninvasive positive pressure respiratory assist devices (noninvasive positive pressure ventilators (NPPVs)) now known by HCFA as Respiratory Assist Devices or RADs. Due to be implemented Oct. 1, the new policy regarding RADs is burdensome and restrictive in some respects but more lenient than expected given the original draft policy. This article will review the policy below and discuss its impact on the home medical equipment (HME) industry.

Coverage Restrictions By Diagnosis

RADs will be divided into two HCPCS codes. K0532 is for those with bi-level pressure capabilities without a backup rate feature, and K0533 is for those with bi-level pressure with a backup rate feature. Both are administered through a noninvasive interface such as nasal cannula or facial mask.

Effective Oct. 1, HCFA will determine coverage based on diagnosis with each condition having unique requirements. RADs will be covered for patients with restrictive thoracic disorders such as: progressive neuromuscular diseases or severe thoracic cage abnormalities; severe chronic obstructive pulmonary disease (COPD); central sleep apnea (CSA); and obstructive sleep apnea (OSA). Patients also must meet the following criteria:

Restrictive Thoracic Disorders:

  • there must be documentation in the patient's medical record showing a progressive neuromuscular disease or a severe thoracic cage abnormality; and
  • an arterial blood gas PaCO2 while the patient is awake and breathing his or her usual FI02 is greater than 45mm Hg, or a sleep oximetry shows an oxygen saturation level of less than 88 percent for at least five continuous minutes, while breathing the patient's usual FI02; and
  • COPD cannot contribute significantly to the patient's pulmonary limitation
  • If all of the criteria are met, one of the two RAD devices will be covered for the first three months.

    Severe COPD:

    The patient's arterial blood gas PaCO2, which is tested while the patient is awake and breathing the usual FI02, must be greater than 55mm Hg; and a sleep oximetry shows the patient's oxygen saturation level is less than 88 percent for at least five continuous minutes while breathing oxygen at 2 liters per minute (lpm) or the patient's usual FI02, whichever is higher. Additionally, prior to initiating therapy, OSA and treatment with continuos positive airway pressure (CPAP) device has been considered and ruled out.
    If all of the criteria are met, a K0532 will be covered for the first three months of therapy. A K0533 will not be covered for a patient with COPD during the first two months.

    Central Sleep Apnea:

    A complete facility-based attended polysomnogram must be performed to show the following:

    • the patient's diagnosis is CSA
    • OSA is not a primary cause of sleep-associated hypoventilation
    • a CPAP is ruled out as effective therapy if OSA is a component of the sleep-associated hypoventilation
    • the oxygen saturation level is less than 88 percent for at least five continuous minutes done while the patient is breathing oxygen at 2 lpm or the patient's usual FI02, whichever is higher
    • the patient has significant improvement of the sleep-associated hypoventilation with the use of a K0532 or K0533 on the settings prescribed at home, while breathing his or her usual FI02

    If all of the criteria are met, a K0532 or K0533 will be covered for the first three months of therapy.

    Obstructive Sleep Apnea:

    The patient must have an attended polysomnogram done at a facility-based sleep lab to establish that OSA is the diagnosis. Additionally, a CPAP has been tried and proven ineffective.
    If all the criteria are met, the patient will be covered for a K0532 device for the first three months of therapy. Medicare does not consider a K0533 medically necessary for a primary diagnosis of OSA.

    Continued Coverage Beyond First Three Months of Therapy

    For a patient to continue use of a K0532 or K0533 device beyond the first three months, he or she must be re-evaluated to establish the continued medical need for the device. Specifically, the treating physician must re-evaluate the patient between the 61st and 90th days of initial therapy. The doctor must document progress in the patient's medical record with regard to symptoms and patient usage of the device up through that time. If the patient does not use the device for an average of for hours per 24-hour period by the time of the re-evaluation, Medicare will deny coverage and consider the device as not medically necessary.

    Further, the HME provider must obtain the following to have continued coverage beyond the first three months:

    If the above listed criteria are met, except for COPD patients, continued coverage of a K0532 or K0533 device and related accessories will be covered.
    Additionally, if after severe COPD patients who qualified for a K0532 complete the 60th day of compliant use of the device, the treating physician believes the patient requires a K0533, new tests must be performed while using the device and while breathing the patient's usual FI02 with the same results depicted in the COPD section above. Further, the treating physician must write a statement declaring that although the patient has been in compliance using the K0532 device, the patient is not benefiting from its use. The patient must also complete a beneficiary statement as shown in the Sidebar.

    Patients On A K0532 or K0533 Prior to Effective Date

    If an OSA patient started on a K0532 device more than three months prior to the effective date of the policy, coverage will continue. K0533 devices; however, were not covered for OSA patients prior to this policy and will continue to be denied as not medically necessary.

    For all other patients who used K0532 or K0533 devices prior to the effective date of this policy, providers will be required to get a signed and dated statement from the treating physician explaining that the patient is compliant in using the device an average of four hours per 24-hour period, and the patient is benefiting from its use. Additionally, the patient must complete a beneficiary statement as shown in the side bar.

    An order for all equipment and accessories must show the patient's diagnosis and be signed and dated by the treating physician. It should be kept on file by the provider.

    A ZX modifier should be used to show that all required documentation has been obtained and is in the patient's file. Policy coverage and payment rules must be met to apply this modifier. Please note that the modifier should not be added to accessory codes.

    While this policy sets forth many specific requirements, it does not address one of HCFA's main goals: to move ventilators from the frequent and substantial category, where they have belonged for more than seven years, to the capped rental category. According to the American Association for Respiratory Care (AARC) and many other clinicians, reclassifying these devices to the capped rental category poses "unambiguous health risks to the patient."

    Operationally, changing the reimbursement category on RADs would make the patient vulnerable to inadequate follow-up care and less than acceptable service. If these devices become capped because a patient elects to purchase the ventilator, after 13 months, when the patient owns the ventilator, he or she will ultimately be responsible for servicing, monitoring and adjusting the device. Such responsibilities are beyond most patients.

    On the other hand, if the patient decides to rent the equipment beyond the 15th month, few suppliers will be able to afford to treat the patient at the current level of care.

    COPD Coverage Restrictions

    More restrictive than expected are the coverage requirements for the COPD patient. Before patients are allowed to receive treatment with K0533 devices, they must first use a K0532 device for a 60- to 90-day trial period. Traditionally, the K0532 devices are used by clinicians for the treatment of sleep disorders, not respiratory insufficiency or other causes, according to Roger Richardson, RRT, RPFT, vice president of RT/HME for Messick/Housecall.

    Furthermore, patients must now have both an arterial blood gas test and sleep oximetry. PaCO2 levels of 55 and oxygen saturation levels of 88 percent must be present to qualify COPD patients for coverage, a restriction not even required for oxygen therapy.

    Finally, the prerequisite trials requiring the physician to write off-label prescriptions for two to three months does not meet with the Food and Drug Administration's original approval for classification and labeling.

    As with any new medical policy, this iteration could change in the 11th hour. Stay informed of any changes by closely monitoring DMERC manual updates and newsletters and industry trade publications. Know that when the policy becomes effective, Medicare will be looking more closely than ever at your claims for any item related to noninvasive positive pressure ventilation.

    With any new policy comes heightened scrutiny to keep you compliant - for more than an average of four hours in a 24-hour period.

    Accessories and Their Quantity Limitations

    Accessories and Their Quantity Limitations

    Item Description

    HCPCS Code

    Number allowed/period

    Nasal application device


    One per three months

    Nasal pillows/seals


    Two per month



    One per six months

    Chin strap


    One per six months



    One per month

    Disposable filters


    Two per month

    Non-disposable filter


    One per six months



    Beneficiary Name:____________________ Beneficiary Birth Date:___/___/___

    Beneficiary Telephone Number: ( ) ___ - ____

    The Supplier May Not Answer Any Of The Following Questions:

    1. Are you (the Medicare beneficiary) now using a machine that helps you take breaths while you are asleep (separate from a machine that may be giving you oxygen or medicine)?  Yes  No

    2. How many hours a day do you usually use this machine? _____ Hours

    3. How many months have you been using this machine? _____ Months

    4. When did you last see the doctor who ordered this machine for you? ___/___/___

    5. Will you keep using this treatment in the future?  Yes  No

    6. Did you (the Medicare beneficiary) complete answers #1 - 6?  Yes  No
    If you did not answer these questions, who did and what is their relationship to you (for example, wife, husband, supplier of machine, etc.)?

    Name:____________________ Relationship:___________________
    ________________________ ________________
    Beneficiary signature Date of signature

    Return to main story

    This article originally appeared in the September 1999 issue of HME Business.


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