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Stoma Appliance Scheme

D) Operational Guidelines for Stoma Associations

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1. Overview

The purpose of this document is to provide a practical reference guide for associations on the practice and procedures that must be followed when providing stoma related products to members under the Australian Government’s subsidised SAS.

These guidelines identify the role and functions that the Department, DHS - Medicare and the ACSA provide in relation to the administration and management of the SAS.

This document also provides Associations with guidance regarding membership requirements, supply requirements of stoma related products, reporting and financial requirements and the location and condition standards of premises which Associations operate from. A detailed reference guide to the range of forms used under the SAS is also listed.



1.1 Meanings




ACSA	Australian Council of Stoma Associations
Association	Stoma Association
Department	Australian Government - Department of Health and Ageing
Member	Eligible person who receives products under the SAS
SAS	Stoma Appliance Scheme
SPAP	Stoma Product Assessment Panel
STN	Stomal Therapy Nurse
GST	Goods and Services Tax

2. Roles of the Department, DHS - Medicare, ASCA & Associations

2.1 Department

The Department has program management responsibility for the SAS in making policy decisions and negotiating the listing price of stoma related products with suppliers. The Department also has responsibility for the SPAP.

2.2 Department of Human Service (DHS) - Medicare

DHS - Medicare has responsibility for the processing and payment of claims lodged for
payment by the Associations.

2.3 ACSA

The ACSA represents, at a national level, the interests of all 22 regional Associations across Australia. ACSA has primary responsibility for the operational management of the distribution to people with a stoma of products listed on the SAS, provides liaison with the Department and suppliers, and coordinates support services for people with a stoma throughout Australia.

2.4 Associations

Associations are non-Government, self-help organisations which distribute stoma related products and provide information, encouragement and emotional support to their members concerning most aspects of living with a stoma.

3. Associations

3.1 Premises and Supply of Products

The premises of an Association may be located within a hospital complex or a private building.

3.1.1 Premises located in a hospital

Where an Association operates within a hospital complex there should not be any other link with the hospital other than that of a professional relationship with the hospital medical staff. Where ever such premises are located, they should conform to the local council requirements.

Associations must provide supplies only to persons with a stoma after discharge from ostomy surgery, and not to in-patients of the hospital.

Under no circumstances should hospital administrative or clerical staff be employed to carry out the day to day operations of the Association. There should not be any financial link between the two organisations in particular the purchasing of stoma related products or pharmaceuticals through the hospital system. All stoma related products and pharmaceuticals should be purchased from the suppliers, or their agents, approved by the Department except in exceptional circumstances (contact the Department for Authority).
A satisfactory working relationship should be arranged with the local hospital. If there is a STN available in the hospital, arrangements for members to have access to this service should be made.

3.1.2 Facility requirements

The premises, where possible, should have adequate space for an office, storage

room for both stoma related products and pharmaceutical benefit items. There should also be adequate space for a work area for the preparation of member's orders and for the dispatch of orders by mail/courier etc to members.

3.2 Approval of new associations

The Department endeavours to have Associations established in geographic areas which complement one another. Associations are generally not approved in areas where an existing association is situated.

Applications for approval should be accompanied by supporting documentation from the other Associations within the region demonstrating the need for an additional Association to be established. All enquiries on the establishment of a new Association should be directed to Department through the ASCA.



3.2.1 Requirements of new Associations

New Associations should:
• Be able to establish that they could develop a reasonable membership base. It is considered in the absence of special circumstances a minimum of 1000 members (actual or projected) in capital cities and 500 in regional areas would be necessary for a new Association to be viable;
• Be able to provide adequate office space, storage space and a shop front for member contact;
• Demonstrate a knowledge of and the ability to administer the SAS:
• Provide similar ostomy support programs as are provided by existing Associations;
• Be prepared to supply any member of the SAS requesting product including members of other Associations;
• Be able to demonstrate financial viability in respect of operating revenue, the provision of premises, acquisition of a computer based claims program, funding of inventory and meeting staffing requirements and/or have volunteer assistance;
• Address the restriction on geographical co-location as set out in Clause 3.2 of the Guidelines;
• Be able to establish eligibility for membership of ACSA;
• Where the new Association is being sponsored by an existing organisation that organisation should be prepared to establish a separate division for ostomy support which would have separate financial accountability and would encompass to the operation of the SAS.

4. Membership to the SAS

4.1 Eligibility Requirements

4.1.1 General Requirements

To access stoma related products under the Stoma Appliance Scheme (SAS), a person:

• must have a temporary or permanent artificial body opening (created surgically or otherwise) which facilitates the removal of urine and/or products of the gastrointestinal tract where the person does not have normal gastrointestinal tract or bladder functions; and
• be an eligible person within the meaning of the Health Insurance Act 1973. An eligible person means an Australian resident or an eligible overseas representative.
To confirm eligibility, a person must have one of the following recorded on the Stoma Appliance Authority Form (Department Human Services (DHS): Medicare Form 4031), and may be asked to present it as proof of eligibility:

• a valid Medicare card;
• a valid Australian Reciprocal Medicare Card (if the person is a resident of one of the countries that has signed a Reciprocal Health Care Agreement); or
• a valid passport if the person a resident of New Zealand or the Republic of Ireland.
And

the Stoma Appliance Scheme Certificate of Eligibility Form signed by;
• a Stomal Therapy Nurse (STN); or
• a Medical Practitioner.



4.1.2 Access to the SAS under Reciprocal Healthcare Agreements

Visitors who are eligible to receive benefits under a Reciprocal Health Care Agreement (RHCA) can access stoma related products under the SAS for the period of their stay in Australia by virtue of subsection 7(2) of the Health Insurance Act 1973.

In terms of visitors to Australia who are eligible to receive benefits under a RHCA, there is no legislative basis for these persons to be excluded from receiving products through Programs subsidised under Section 9A of the National Health Act (unless the Guidelines for the Program specifically state the exclusion). Therefore, access to benefits under the RHCAs should be honoured by the SAS.
The RHCAs are also intended to be applied beneficently, that is, where there is ambiguity, the patient gets the benefit of the doubt. The RHCAs do not exclude pre-existing conditions from eligibility; the only exclusion is ‘medical tourism’, where someone enters the country for the express purpose of receiving treatment.
It is at the discretion of the Stoma Association as to whether the visitor is required to become a temporary association member.



4.1.3 Migrant Eligibility

A holder of permanent resident status (migrant) must reside in Australia to be eligible for DHS: Medicare benefits- primary place of residence.

A migrant may reside overseas and hold a current DHS: Medicare card, however, if they have been absent from Australia for more than twelve months (return trips to Australia for a holiday is not taken into account) they must provide documentation on their return to Australia to reside which proves they have returned to reside. Documents may be from Australia or documents showing they have severed ties from the country they have left are acceptable.
Further information regarding migrant eligibility can be found on the DHS: Medicare website.



4.1.4 Association Requirements

Each Association will provide to DHS - Medicare a list of persons accepted as members of the SAS, complete with;
• Address;
• Entitlement card number;
• Medicare number;
• Evidence that the person meets the eligibility requirements for membership of the SAS on the approved Certificate of Eligibility; and
• Any other statistical data as requested by the Department or DHS - Medicare.

These details are maintained on the ostomy data base. Changes in membership details are advised monthly to DHS - Medicare when forwarding claims for payment. Evidence of a stoma should consist of a certificate from a registered medical practitioner or STN in an approved form.

Associations are authorised to issue stoma related products to all approved members of the SAS on production of an entitlement card. Eligible people are required to reside in Australia in order to receive stoma related products under the SAS.

4.2 SAS Service Fee

Subject to Clause 4.3 a Service Fee shall be payable by members of the SAS in respect of the costs of operating the SAS that are not met by the 2.75% handling fee (Clause 7.4). The Service Fee shall be a national uniform annual amount as determined from time to time by the Department, in consultation with ACSA, and shall be payable to the Association where the member usually obtains their stoma related products. The fee shall be compulsory but Associations shall make provision for the fee to be paid by instalments in the case of financial hardship.

4.3 Association Membership Fee

Associations may charge an Association Membership Fee in respect of the services they provide to their members. Financial members of Stoma Associations shall not be required to pay the SAS Service Fee provided the Association of which they are a member charges a uniform national membership fee and uses part of its membership fees to meet the costs of operating the SAS that are not met by the 2.75% handling fee (Clause 7.4).

Associations may also charge an additional Membership Fee in respect of the services they provide other than to the supply of stoma related products under the SAS. A member who is not able to pay the additional Membership Fee because of financial hardship may apply to the Association in writing to have the additional Fee waived. If the additional Membership Fee is waived, the Association shall also make provision for remainder of the Membership Fee to be paid by instalments.

4.4 Membership to ACSA

All Associations must be a member of the ACSA. Associations that have operational problems in relation to the SAS must first refer the matter to ACSA for advice or assistance. If ACSA cannot resolve the matter they will seek assistance from either the Department or DHS - Medicare. However, problems relating to the processing and payment of claims should be referred directly to DHS - Medicare unless they are of a general nature in which case they should first be discussed with ACSA.

5. Reporting requirements for associations

5.1 ACSA

Associations are required to provide ACSA with:

• Monthly new membership numbers and statistical details;
• Annual membership numbers and statistical details;
• Details of members accessing the SAS; and
• Yearly financial statements.

5.2 DHS - Medicare

It is important that any change that may effect the day to day operation of the payment and processing procedures in particular any changes to banking details, mailing address and location of premises be reported as soon as possible to DHS - Medicare to prevent any unnecessary delays to payments being forwarded to associations.

Associations should provide to DHS - Medicare details relating to changes in membership i.e. new members joining, transfer of existing members to other associations, change of address for members and details of those members have had a reversal, and no longer require aids and appliances, or are deceased.

5.3 Department

Any information or data the Department requests from Associations will need to be provided in a timely manner.

6. Supply of products

6.1 The SAS schedule

The schedule is a list of stoma related products that are able to be accessed under the SAS. The schedule contains information on each product such as a description, SAS and Company Product codes, pack size, maximum issue, manufacturer code and lists the maximum price that suppliers can charge for a product on the SAS. If an Association pays less than the maximum price for an item, DHS - Medicare should be informed of this when claiming.

6.2 Updates to the SAS schedule

Associations and key stakeholder groups receive quarterly from the Department the SAS Schedule updates which contains the latest version of the schedule and information relating to those stoma related products that have been deleted, added, have changes to the maximum issue or an advance notice for the deletion from the schedule.

6.3 Dual or multiple stomas

The following procedures have been implemented for people who have more than one stoma and require additional stoma related products and pharmaceutical benefits:

• Issue the first number from the membership numbers allocated to the Association by DHS - Medicare for members with a single stoma.
• A second group of entitlement cards available to each Association for use by members who have dual or multiple stomas (numeration to be as provided by DHS - Medicare). These cards are to be issued by the Association to members for their second and subsequent stomas in a similar manner to the initial card issue.
• Send a copy of the dual stoma application form to DHS - Medicare endorsed "dual stoma" and indicate the membership number allocated by the Association.
• The member, when obtaining supplies, uses one number for normal requirements and the second for additional supplies.
• Where the second stoma occurs some time after the first, send a second application form to DHS - Medicare showing details of the original application and the number allocated and marked "dual stoma".

6.4 Two month ordering cycle

Associations wishing to adopt a two month ordering cycle will be required to abide by the following restriction and process:

6.4.1 Restriction

The two-month ordering cycle will be available to members who have had their stoma for six months or greater. The two-month ordering cycle may be suspended for members during any period when the stoma related products they order are subject to change or review.

6.4.2 Process

For claiming purposes an Association will need to place a “T” in the “medical certificate obtained and send to DHS - Medicare” box found at the top of the ‘Supply of Stoma Appliance’ form which is sent to DHS - Medicare with every claim. This will enable DHS - Medicare to recognise that the claim is a two-month order.

6.5 Procedures for the supply of products to members

6.5.1 Maximum quantity

It is the responsibility of each Association to ensure that no more than the maximum quantity of any of the stoma related products is provided to members on a monthly or annual basis unless there has been a certificate of authorisation issued for an increase in quantities forwarded to DHS - Medicare requesting additional supplies. This certificate must be signed by either the members' medical practitioner or an STN.

6.5.2 Ordering supplies within one sub-group listed on the schedule

When supplies are requested from within one sub-group listed on the schedule, and the products are intended for the same purpose, then the supplied amount is restricted to the maximum limit for that type of product.

6.5.3 Ordering supplies from more than one group listed on the schedule

When supplies are requested from two or more different groups listed on the schedule, but for which the products serve the same purpose, then the maximum amount supplied from each group must be reduced accordingly (e.g. If the products are supplied equally from two groups then the maximum quantity for each group should be reduced by 50 %.).

6.5.4 Monthly Supplies

If a member has not ordered or has not been supplied under a one or two month ordering cycle they are not entitled to add that supply of stoma related products to any subsequent claim.

6.5.5 Holiday Issue

Members are entitled to have up to six months supply if travelling overseas. Members requiring more than two months supply of products will need to supply Associations with proof of travel, such as documents.

6.5.6 Stock Control

Individual associations should have a system in place so that they are fully aware of the stock they need to replace and methods to predict when stock is required. It is important that all associations are aware of the different supplier's ordering system and how long it will take to get new stock after ordering.

6.5.7 Unavailability of Products

In the event of unavailability of a product, an alternative product should not be supplied unless an order has been placed by the member for the alternative product. Members should be advised to seek advice from an STN or their Medical Practitioner.

7. Finance

7.1 Requirements of an association manager

A manager of an association should have the ability to:

• operate a small business organisation with particular reference to financial skills in the area of accounting; and
• operate an accounting system including receipt of membership fees, preparation of claims submitted to DHS - Medicare for processing and payment. Managers are required to set procedures to ensure that accounts are processed quickly to obtain any financial advantage that may be offered by the suppliers e.g. discounts for accounts paid within a specified time.

7.3 Payment of accounts

Associations should endeavour to make the full payments of their accounts by the due date. Payment of invoices in a prompt and timely manner to the manufacturers is recommended upon receipt of invoice.

7.4 Pricing arrangements

Prices for the supply of approved stoma related products are negotiated directly by the Department with the relevant supplier. GST is not payable on any item listed on the SAS schedule. GST is only payable on the 2.75% handling fee.

Associations are responsible for the purchase of stoma related products to distribute to their members. They are reimbursed on the listing price in the SAS schedule plus a 2.75% handling fee.

8. DHS - Medicare claims processing and payments

8.1 Preparation of an ostomy claim

Due care should be exercised by each Association when preparing a claim for submission for processing and payment. If a claim does not meet the appropriate standard the processing of the claim may be delayed or returned to the Association to be corrected. If a claim contains items that are not listed these items will be rejected and payment will be refused. For stoma related products that have been supplied to a member who does not have a certificate authorising a supply in excess of the allowable maximum quantity, only the maximum quantity will be allowed and paid for.

All medical certificates provided for additional supplies should include the members name and address and the members entitlement number. These certificates are only valid if they are issued by a medical practitioner or an STN. Each certificate is valid for a period of up to six months from date of nominated and the quantity of additional stoma related appliances and benefits must be specified including the reason for additional supplies, by the medical practitioner or the STN requesting the increased quantity.

8.2 Submission of an ostomy claim

Claims for reimbursement by DHS - Medicare should be lodged by each Association on a regular basis.

Associations should also ensure that each form that is lodged in a claim is completed correctly. Details on this form include the name of the organisation, approval number, member's name, member's entitlement card number, member's address, indication if a medical certificate has been obtained for excess quantities, item supplied, quantity ordered and supplied, code and brand supplied, serial number of the item in the claim.

The original is then forwarded to DHS - Medicare with the claim for payment form and the duplicate is retained by the Association. Each form must be signed by the member or agent receiving the items. If the order has been forwarded by other means this should be indicated on the form e.g. "certified despatched" and carry an original signature from a responsible officer, this would then indicate that the items have been forwarded by mail/courier etc.

The claim for payment form should be completed and attached to the claim when lodged for payment. The original of this form is forwarded to DHS - Medicare together with the relevant supply forms to constitute a claim. The certification on the Claim for Payment Form must be signed by the approved or authorised person of the Association confirming that the supplies have been made. Other details that must be completed on the Claim for Payment Form are the name of the Association, address, claimant's approval number and serial numbers of the items submitted in the claim. The duplicate of this form is retained by the Association.

8.3 Payment of an ostomy claim

There is a provision, for those items that may delay payment or where an incorrect price has been paid, to be adjusted by using a bulk adjustment note. This allows the variation of a payment either positive or negative to be amended in subsequent claims. If the adjustment is positive the payment can be released immediately. If the adjustment is negative the amount owing will be deducted from future claims.

Payments for all claims processed by DHS - Medicare are now made by means of electronic funds transfer to the financial institution nominated by an Association. A statement of account is forwarded to each Association and should arrive at about the same time that the funds are deposited into the appropriate bank account.

The statement of account is supplied in one of two formats, i.e. summary or detailed. The summary report lists all items of the same code together with a total number and cost for the item. A detailed statement lists each item in serial number order individually costed. To choose the type of report that is required you should advise the processing centre of your needs. The statement contains all details of items rejected for payment, any adjustments that may be made to a claim including the payment of the 2.5% administration fee. The statement may contain details of more than one claim.

8.4 Receipt of products

It is a requirement that members upon receiving their appliances from their Association should ensure they sign upon receipt. Associations should ensure those members who receive their appliances via the post should ensure that the appliances form forwarded to DHS - Medicare are clearly marked “certified dispatched”. The officer from the Association must countersign each claim marked in such manner.

8.5 Audit

DHS - Medicare may choose to undertake an audit of an Associations claims on site. A follow-up check may be made later if considered necessary, and orders and invoices checked as to the items supplied to members over that period of time.

Associations are required to retain any orders or copies thereof, submitted by members, or their agents, requesting supplies of stoma related products, for a minimum of two years. Associations should also retain copies of the invoices provided by the suppliers of the stoma related products for at least the same period of time. Audit checks may be undertaken by DHS - Medicare during this period.

After each annual general meeting where required by state laws each incorporated Association may need to be required to complete the periodical return to the Office of Consumer and Business Affairs in the State they are registered.

9. Forms

A list of the current DHS - Medicare forms used under the SAS are detailed below:

9.1 Authorisation forms for irrigation kits, tieman tip catheters, ace stoppers, and silicone adhesive spray

9.1.1 Irrigation kits, tieman tip catheters and ace stoppers

The use of irrigation kits, tieman tip catheters and ace stoppers by persons with a stoma requires special authorisation by a registered medical practitioner or STN. These products should not be dispensed to a member prior to the sighting of the duly completed and signed authorisation form.

9.1.2 Silicon adhesive spray

This product requires a registered medical practitioner or STN authorisation prior to ordering. A separate clinical justification is to be provided giving details of the investigation of the condition and the basis on which the product is required.

It is the responsibility of each Association to ensure that no more than the maximum quantity of any of the stoma related products is provided to members on a monthly or annual basis unless there has been a certificate of authorisation issued for an increase in quantities forwarded to DHS - Medicare requesting additional supplies. This certificate must be signed by either a registered medical practitioner or an STN. Products should not be ordered prior to the sighting of the signed authorisation form.

9.2 Claim for payment pharmaceutical benefits/ appliances – form DHS - Medicare 4027

This form is used by the Association as a claim for payment for items supplied. The original of this form is forwarded to DHS - Medicare together with the relevant supply forms to constitute a claim. The certification on the claim for payment form must be signed by the approved or authorised person of the Association confirming that supplies have been made. Other details which must be completed on the Claim for Payment form are the name of the Association, address, claimant's approval number, claimant's reference, serial numbers of items submitted in the claim. The duplicate of this form is retained by the Association.

9.3 Supply of pharmaceutical benefits/ stoma appliances – form DHS - Medicare 4095 & 4028

(Computer form). This form is used by Associations as a supply form stoma related products where claims are submitted in electronic format (on computer disk). Details on this form include the name of the Association, approval number, members name, members entitlement card number, members address, indication if a medical certificate has been obtained for excess quantities, item supplied, quantity ordered and supplied, code number, brand supplied and the serial number of the item in the claim. The original of this form is forwarded to DHS - Medicare with a Claim for Payment Form; the duplicate is retained by the Association. This form must be signed by the member or their agent when collecting the appliances and benefits. If the items have been dispatched by other means this should be indicated on the form.

9.4 Stoma appliance authority – form DHS - Medicare 4031

This form is to be completed prior to the issuing of a membership entitlement card. It is to be completed by each member giving details of their name, address, Medicare number, appliance entitlement number to be issued (see Membership Entitlement Card), Association's name and address. An authorisation on this form must be signed by the member giving DHS - Medicare authority to examine or make enquiries on aids and appliances used by the member. The original of this form is to be forwarded to DHS - Medicare and the duplicate is to be retained by the member.

A stoma appliance authority form to be completed and submitted to DHS - Medicare endorsed "Dual Stoma" for each additional stoma that requires stoma related products.

9.5 Membership entitlement card – form DHS - Medicare 4032

This card is issued to members of Associations to indicate entitlement to receive supplies through an Association. Each card is serially numbered by DHS - Medicare before being issued to an Association. This enables DHS - Medicare or the Association to identify a member by the number. Details which are included on the card are the member's name, address and signature.

9.6 Dual stoma membership entitlement card – form DHS - Medicare 4059

For those members who have more than one stoma and require additional stoma related product, this card must be completed as per the Membership Entitlement Card (form-DHS - Medicare 4032). These cards are to be issued by the Association to members for their second and subsequent stomas in the same manner to the initial card issue. Each card is serially numbered by DHS - Medicare before being issued to an Association.

9.7 Application for additional stoma supplies – form DHS - Medicare 4050

To be eligible for approval for additional stoma supplies, the member must be under the continuing care of a medical professional (either a registered medical practitioner or a STN), with regular and ongoing reviews. A DHS: Medicare form 4050 will be considered incomplete if not signed and dated by a recognised medical professional.

This form is to be used to obtain additional supplies above the maximum allowance and must include the members name, address and entitlement number. These certificates are valid for a period of up to six months from the date nominated on the form must be signed by either a registered medical practitioner or STN. A full description of the product and the amount of additional quantity authorised must be specified by the registered medical practitioner or STN as well as the reason for the additional supplies.

Certificates authorising additional supplies which result in a total supply to the member of more than twice the normal allocation of any one product must be accompanied by a clinical justification of the additional supply quantity. More than twice but less than four times the normal allocation of any one product must have clinical justification submitted with the authority certificate signed by an STN or Medical Practitioner. More than four times the normal allocation of any one product must also have clinical justification and authority certificate and must receive approval from the Department.

The particular requirements below must be addressed when completing an Application for Additional Stoma Supplies form (DHS: Medicare Form 4050):

9.7.1 Review Dates

A DHS: Medicare form 4050 is valid for a period of up to six months only. A review date must be supplied which is up to but not exceeding six months from the date which the form was issued to the member. Forms which do not include a valid review date will be returned to the medical professional for correction. This may delay the member from receiving the benefits due to them under this Scheme.

9.7.2 Replacing Authorities

Replacement authorities can only be issued following a review by a medical professional and subsequent completion of a new DHS: Medicare form 4050. The review needs to take place prior to the review date nominated on the original form (up to but not exceeding six months – see 9.8.1 Review Dates). Requests for replacement authorities cannot be submitted over the phone, even if the authority has expired.

9.7.3 Clinical Justification

In certain circumstances a member’s requirements may exceed the 2 month standard supply. If this occurs, the reviewing medical professional is required to provide separate clinical justification which substantiates this requirement. Separate clinical justification should provide details of the basis for which additional products are required, including detailed medical reasoning as to why additional supplies are necessary and the implications for the member if those supplies are not approved. Inadequate clinical justification may result in a delay in processing the request and may delay the member receiving products necessary for their medical welfare.

9.7.4 Reason for Increased Supply – Use of ‘other’ as a Reason Code

A medical professional should only tick ‘other’ in the category of Reason for Increased Supply where the reason is not already listed on the form. This should be only in exceptional circumstances where the member’s situation is highly unusual and additional information which clarifies the circumstances must be provided on the form. It should also be noted that the use of the category ‘other’ will assist DHS: Medicare and the Department of Health and Ageing in ensuring that members who fall into these unusual circumstances are appropriately monitored and that information regarding stomas is kept complete and up-to-date.