Home dialysis supplies and equipment are covered when they are reasonable and necessary for patients with end stage renal disease (ESRD) who are being dialyzed at home under the supervision of a Medicare approved dialysis facility.

For any item to be covered, 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 statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

When a member has chosen to receive home dialysis supplies and equipment from a dialysis facility, the supplies and equipment are furnished under Method I. When a member has chosen to receive their supplies and equipment from an independent supplier, they are furnished under Method II. This policy only concerns supplies and equipment furnished under Method II.

Home dialysis supplies and equipment will be covered only if all of the following conditions are met:

1. The member has elected to receive home dialysis equipment and supplies from an independent supplier.
   
   
2. The supplier is not a Medicare approved dialysis facility.
   
   
3. The supplier agrees to receive payment only on an assignment-related basis.
   
   
4. The supplier agrees to be the member's sole supplier for all home dialysis equipment and supplies.
   
   
5. Supplier agrees to bill on a monthly basis for the quantity of supplies appropriate for that period. (However, there is one exception to this rule. Members are permitted to have one month's supplies in reserve in case of emergency.)
   
   
6. The supplier reports to the back-up facility within 30 days all items and services that it furnishes to the patient so that the facility can record this information in the patient's medical record.
   
   
7. The supplies and equipment are reasonable and necessary for that patient.

Continuous cycling peritoneal dialysis (CCPD) is covered if in the judgment of the physician, it is medically necessary to achieve optimal dialysis.

Water purification systems are covered for patients on home hemodialysis. Coverage will be provided for either a deionization (E1615) or reverse osmosis (E1610) system, but not both for the same patient at the same time.

Spare deionization tanks are not medically necessary since they are essentially a precautionary supply. Activated carbon filters (A4680) used as a component of water purification systems to remove unsafe concentration of chloride or chloramines are covered when prescribed by a physician.

A water softening system (E1625) is covered for patients on home hemodialysis only if all of the following conditions are met:

1. The patient has a reverse osmosis (RO) purification system and 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); and
   
   
2. The patient's water is demonstrated to be of a lesser quality than required; and
   
   
3. 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.)

An ultrafiltration monitor (E1699) is not medically necessary when the ultrafiltration is independent of conventional hemodialysis.

A peridex filter set (A4913) used with peritoneal dialysis will be denied as not medically necessary.

Back-up equipment supplied in anticipation of the need for substitution or replacement will be denied as not medically necessary.

Rental of equipment while patient owned equipment is being repaired is covered.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

Home dialysis supplies and equipment are covered only if the supplier has a written agreement with a Medicare approved dialysis facility under which the facility will furnish all necessary support, backup, and emergency dialysis services. (For members who are also entitled to military or veterans' benefits, a military or Veterans' Administration hospital satisfies this requirement.)

The dialysis facility must be a reasonable distance from the member's home in order to furnish these services. A reasonable distance is determined by taking into account variables such as terrain, whether the patient's home is located in an urban or rural area, and the usual distances traveled and time in transit by patients in the area in obtaining health care services.

The written agreement must specify that the dialysis facility will provide at least the following services:

1. Surveillance of the patient's home adaptation, including provisions for visits to the home or the facility;
2. Consultation for the patient with a qualified social worker and a qualified dietician;
3. Maintain a record keeping system which assures continuity of care and includes a record of supplies and equipment provided by the Method II supplier;
4. Maintaining and submitting all required documentation to the ESRD network;
5. Assuring that the water supply is of the appropriate quality if hemodialysis is the dialysis method;
6. Assuring that the appropriate supplies are ordered on an ongoing basis;
7. Arranging for the provision of all ESRD related laboratory tests, and billing for the laboratory tests that are included in the composition rate;
8. Furnishing institutional dialysis services and supplies;
9. Furnishing dialysis-related emergency services; and
10. Furnishing all other necessary dialysis services and supplies.

The following parenteral medications/solutions are included in the monthly payment limit and are not separately payable: heparin, heparin antidote (protamine), mannitol, glucose (dextrose), saline, local anesthetics, antiarrhythmics, antihypertensives, pressor drugs, antibiotics (when used to treat an infection of the catheter site or peritonitis associated with peritoneal dialysis).

Repairs and maintenance for rented equipment are included in the rental allowance. Repairs for member owned equipment are covered and separately reimbursed. Repair and maintenance contracts (A4890)(i.e., fees paid in anticipation of the need for service) will be denied as included in the allowances for the equipment. The provider cannot bill the member for the denied service. Only costs incurred for services furnished will be covered.

Claims for tape (A4450, A4452) that are billed without an AX modifier or another modifier indicating coverage under a different policy will be denied as noncovered. A provider can bill the member for the denied service.

Claims for selected supplies and equipment used for home dialysis (A4215, A4244, A4245, A4246, A4247, A4248, A4651, A4652, A4657, A4660, A4663, A4670, A4927, A4928, A4930, A4931, A6250, A6260, E0210, E1632, E1637, E1639 and J1644) that are billed without an AX modifier will be denied as noncovered and not medically necessary.

Emergency reserve supplies are allowed for patients on dialysis to anticipate short-term increased use of supplies or delays in supply delivery. Up to a one month's supply is covered, but this is a once in a lifetime allowance for each dialysis modality (hemodialysis, continuous ambulatory peritoneal dialysis and continuous cycling peritoneal dialysis) that the patient receives. For a single modality, only emergency reserve supplies provided in the same calendar month will be covered. If supplies from the reserve are used, replacement of them must be billed along with the other supplies used during the month, without the EM modifier.

The allowance per month under Method II for home dialysis supplies and equipment is the lesser of (a) the reasonable charge of allowance for all medically necessary equipment and supplies used, or (b) the Medicare Advantage monthly payment limit.

Documentation Requirements

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code. Items submitted with an EY modifier will be denied as not medically necessary.

GY and KX Modifiers
Method II suppliers must add a KX modifier to all dialysis codes only if a written agreement exists between the supplier and a Medicare certified support service facility within a reasonable distance from the member's home.

If no written agreement exists between the supplier and a Medicare certified support service facility within a reasonable distance from the member’s home (see Reasons for Noncoverage section), the GY modifier must be added to each code. Items submitted with a GY modifier will be denied as non-covered. The provider can bill the member for the non-covered service.

Claim lines billed without a GY or KX modifier will be rejected for missing information.

If a miscellaneous supply or equipment code (A4913 or E1699) is billed, the claim must include a narrative description of the item, the manufacturer, and the product name/number.

Items not related to dialysis must not be billed with the miscellaneous codes (A4913 or E1699).

The following codes must be submitted with the AX modifier, when they are used with home dialysis: A4215, A4216, A4217, A4244, A4245, A4246, A4247, A4248, A4450, A4452, A4651, A4652, A4657, A4660, A4663, A4670, A4927, A4928, A4930, A4931, A6216, A6250, A6260, A6402, E0210, E1632, E1637, E1639, and J1644.

If a heating pad (E0210) is not used for home dialysis, it must be billed without an AX modifier.

Miscellaneous medications such as antibiotics covered under this benefit (see ”Indications and Limitations of Coverage”) must be coded A4913.

Code E1594 must be billed for each month that the patient receives CCPD. Use of this code identifies situations in which the higher payment limit for CCPD is being requested.

An EM modifier must only be added to a dialysis supply code when appropriate. An EM modifier is not used with equipment codes.

If billing for repair of patient owned dialysis equipment, use code E1699, which must be accompanied by a narrative description of what is being repaired.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items. https://www.dmepdac.com/

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 230.7, 230.13, 230.14