Page 139 - Medicare Benefit Policy Manual

be clearly established until the procedure that makes its use possible is successfully
performed. Therefore, dispensing a prosthetic device in this manner is not considered
reasonable and necessary for the treatment of the patient’s condition.

Colostomy (and other ostomy) bags and necessary accouterments required for attachment
are covered as prosthetic devices. This coverage also includes irrigation and flushing
equipment and other items and supplies directly related to ostomy care, whether the
attachment of a bag is required.

Accessories and/or supplies which are used directly with an enteral or parenteral device
to achieve the therapeutic benefit of the prosthesis or to assure the proper functioning of
the device may also be covered under the prosthetic device benefit subject to the
additional guidelines in the Medicare National Coverage Determinations Manual.

Covered items include catheters, filters, extension tubing, infusion bottles, pumps (either
food or infusion), intravenous (I.V.) pole, needles, syringes, dressings, tape, Heparin
Sodium (parenteral only), volumetric monitors (parenteral only), and parenteral and
enteral nutrient solutions. Baby food and other regular grocery products that can be
blenderized and used with the enteral system are not covered. Note that some of these
items, e.g., a food pump and an I.V. pole, qualify as DME. Although coverage of the
enteral and parenteral nutritional therapy systems is provided on the basis of the
prosthetic device benefit, the payment rules relating to lump sum or monthly payment for
DME apply to such items.

The coverage of prosthetic devices includes replacement of and repairs to such devices as
explained in subsection D.

Finally, the Benefits Improvement and Protection Act of 2000 amended §1834(h)(1) of
the Act by adding a provision (1834 (h)(1)(G)(i)) that requires Medicare payment to be
made for the replacement of prosthetic devices which are artificial limbs, or for the
replacement of any part of such devices, without regard to continuous use or useful
lifetime restrictions if an ordering physician determines that the replacement device, or
replacement part of such a device, is necessary.

Payment may be made for the replacement of a prosthetic device that is an artificial limb,
or replacement part of a device if the ordering physician determines that the replacement
device or part is necessary because of any of the following:

1. A change in the physiological condition of the patient;

2. An irreparable change in the condition of the device, or in a part of the device; or

3. The condition of the device, or the part of the device, requires repairs and the cost
of such repairs would be more than 60 percent of the cost of a replacement device,
or, as the case may be, of the part being replaced.