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.  
  
The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act 
1862(a)(1)(A) provisions.  
  
In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * Refer to the Supplier Manual for additional information on documentation requirements.

  * Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act  1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.  
  
High frequency chest wall oscillation devices (HFCWO) (E0483) are covered for
beneficiaries who meet:

  1. Criterion 1, 2, or 3, and

  2. Criterion 4

    1. There is a diagnosis of cystic fibrosis (refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses).

    2. There is a diagnosis of bronchiectasis (refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses) which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by:

        1. Daily productive cough for at least 6 continuous months; or

        2. Frequent (i.e., more than 2/year) exacerbations requiring antibiotic therapy.

Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the
absence of a confirmed diagnosis of bronchiectasis do not meet this criterion.

    3. The beneficiary has one of the following neuromuscular disease diagnoses (refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses):  
Post-polio  
Acid maltase deficiency  
Anterior horn cell diseases  
Multiple sclerosis  
Quadriplegia  
Hereditary muscular dystrophy  
Myotonic disorders  
Other myopathies  
Paralysis of the diaphragm

    4. There must be well-documented failure of standard treatments to adequately mobilize retained secretions.

  
If all of the criteria are not met, the claim will be denied as not reasonable
and necessary.  
  
It is not reasonable and necessary for a beneficiary to use both a HFCWO
device and a mechanical in-exsufflation device (E0482).  
  
Replacement supplies, A7025 and A7026, used with beneficiary owned equipment,
are covered if the beneficiary meets the criteria listed above for the base
device, E0483. If these criteria are not met claims will be denied as not
reasonable and necessary.  
  
GENERAL  
  
A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.  
  
For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.  
  
For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.  
  
An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.  
  
Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.