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A. Water Purification Systems

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Water used for home dialysis should be chemically free of heavy trace metals
and/or organic contaminants which could be hazardous to the patient. It should
also be as free of bacteria as possible but need not be biologically sterile.
Since the characteristics of natural water supplies in most areas of the
country are such that some type of water purification system is needed, such a
system used in conjunction with a home dialysis (either peritoneal or
hemodialysis) unit is covered under Medicare.

There are two types of water purification systems which will satisfy these
requirements:

  *    Deionization - The removal of organic substances, mineral salts of magnesium and calcium (causing hardness), compounds of fluoride and chloride from tap water using the process of filtration and ion exchange; or
  *   Reverse Osmosis (RO) - The process used to remove impurities from tap water utilizing pressure to force water through a porous membrane.

Use of both a deionization unit and RO unit in series, theoretically to
provide the advantages of both systems, has been determined medically
unnecessary since either system can provide water which is both chemically and
bacteriologically pure enough for acceptable use in home dialysis. In
addition, spare deionization tanks are not covered since they are essentially
a precautionary supply rather than a current requirement for treatment of the
patient.

Activated carbon filters used as a component of water purification systems to
remove unsafe concentrations of chlorine and chloramines are covered when
prescribed by a physician.

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B. Water Softening System

**

Except as indicated below, a water softening system used in conjunction with
home dialysis is excluded from coverage under Medicare as not being reasonable
and necessary within the meaning of 1862(a)(1) of the Social Security Act.
Such a system, in conjunction with a home dialysis unit, does not adequately
remove the hazardous heavy metal contaminants (such as arsenic) which may be
present in trace amounts.

A water softening system may be covered when used to pretreat water to be
purified by a RO unit for home dialysis where:

The manufacturer of the RO unit has set standards for the quality of water
entering the RO (e.g., the water to be purified by the RO must be of a certain
quality if the unit is to perform as intended);

The patient's water is demonstrated to be of a lesser quality than required;
and,

The softener is used only to soften water entering the RO unit, and thus, used
only for dialysis. (The softener need not actually be built into the RO unit,
but must be an integral part of the dialysis system.)

**

C. Developing Need When a Water Softening System is Replaced with a Water
Purification Unit in an Existing Home Dialysis System

**

The medical necessity of water purification units must be carefully developed
when they replace water softening systems in existing home dialysis systems. A
purification system may be ordered under these circumstances for a number of
reasons. For example, changes in the medical community's opinions regarding
the quality of water necessary for safe dialysis may lead the physician to
decide the quality of water previously used should be improved, or the water
quality itself may have deteriorated. Patients may have dialyzed using only an
existing water softener previous to Medicare end-state renal disease coverage
because of inability to pay for a purification system. On the other hand, in
some cases, the installation of a purification system is not medically
necessary. Thus, when such a case comes to the Medicare Administrative
Contractor's (MAC's) attention, the MAC asks the physician to furnish the
reason for the changes. Supporting documentation, such as the supplier's
recommendations or water analysis, may be required. All such cases should be
reviewed by the MAC's medical consultants.