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Picture of ostomy supplies

Since 2003 the Department of Health (DH) have been looking at a way to restructure the fees and services for providing appliances listed in Part IXA, B and C of the Drug Tariff. The first consultation was published in 2003 and it was quickly realised that this was a very sensitive and hugely complicated area of healthcare so was subsequently shelved. It was reopened again in October 2005 when the first of this round of consultations was issued. There were seven further consultations on the subject which is unheard of in the DH. The final Overview of Arrangements was published in April 2009 with a plan to publish the draft Pharmaceutical Terms of Service and Directions in October 2010; however these did not get published until 22nd December 2010.

There are currently 3 types of contractors providing surgical appliances to patients:

Typically most DACs provide products that are delivered directly to the patient's home with little or no direct face to face interaction with the patient, whilst PCs and DDs generally provide products that patients collect with their other prescription items from their local pharmacy or dispensary. It is fair to say that most PCs and DDs do actually provide some level of home deliveries to patients should they require it.

DACs provide a comprehensive support structure for both Ostomy and Urology patients that often include their own qualified stoma and continence nurses, coupled with customisation of products, free disposal bags and wipes and sometimes other extras like a starter kit including a free wash bag, these services are extremely valued by patients. It is also widely acknowledged that many PCs and DDs have little understanding of the vast and wide variety of products that are available within the Ostomy and Incontinence product ranges. As a consequence of this some PCs and DDs have elected not to provide these products and services, others will provide these to normal level of dispensing, while a significant quantity have opted to work in collaboration or partnership with DACs who provide Agency Schemes. Agency Schemes give the patient benefit of a normal DAC, but in the normal course of visiting a pharmacy, as these DACs provide the support in the background for the PCs and DDs. This enhances the patient experience as they have face to face interaction with a healthcare professional as well as the benefits of the additional services.

From April 2010 the DH have changed the way all Dispensing Appliance Contractors and Pharmacy Contractors will get remunerated for the services they provide. No longer will there be the disparity between payments for services provided by these primary care contractors, instead the DH have introduced a set of fees for services provided in both 'Essential' and 'Advanced' categories. These services are designed to give a more level playing field for DACs and PCs, whilst providing a consistent and transparent level of service that these contractors are providing to patients. Dispensing Doctor Practices who operate under a different schedule of the regulations have been excluded from the regulation changes despite the fact they also provide these products to patients.

The new services are due to be implemented to all applicable contractors from 1st April 2010. The services for both Essential and Advanced are set out below.

Essential Services

All DACs and PCs must provide the following Essential Services for dispensing appliances:

For Essential Services both contractors will be paid a set of fees that is based on the different Part IXA, B or C items. For payment information please see the table illustrated at the end of the section explaining the Essential Services.

Advanced Services

Advanced Services are optional and, both DACs and PCs with are able to choose to provide one or both of the Advanced Services as below:

For Advanced Services both contractors will be paid a set of fees based on the criteria requirement for providing the service. For payment information please see the table illustrated at the end of the section explaining the Advanced Services.

In addition to the change in remuneration for services, the DH is cutting reimbursement prices in the drug tariff by 2% from April 2010. This will only apply to certain products listed in Part IXA, B and C. For more information see the Part IX Reimbursement section below.

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Although the Regulations come into force on 1st April 2010, Pharmacy Contractors that are already on the pharmaceutical list before that date will have until 31st December 2010 to comply with providing the essential services. If a Pharmacy Contractor intends on providing either of the new advanced services then the new terms of service must be complied with from or before the time at which the Pharmacy Contractor proposes to provide the new services. A Pharmacy Contractor can choose to give one months notice prior to providing an advanced service at any time in the future, however should a Pharmacy Contractor decide to opt out of providing this advanced service they must give three months notice. Pharmacy Contractors that are included in the pharmaceutical list on or after 1st April 2010 must comply with all the new terms of service from the date the pharmacy opens.

If you are already using an Agency Scheme through NWOS, then you will be contacted shortly by a member of the team who will guide you through the process of moving across to the New Appliance Partnership.

Pharmacies that are not currently using an Agency Scheme and would like to know how NWOS could support you then please see the New Appliance Partnership information and benefits for contractors. Alternatively, you can email enquiries@nwossurgical.co.uk or call our free phone number on 0800 316 7117 and speak to a member of our team.

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Emergency supply

In the case of urgency, the supplier of appliances may supply an appliance if asked to do so by a prescriber as long as the prescriber undertakes to issue a prescription to the dispenser within 72 hours (or transmit an electronic prescription). In practice, this change is likely to have little impact.

Repeat dispensing

The new terms of service require DACs to provide this service in line with Pharmacy Contractors.

Repeat dispensing is an alternative model for prescribing and dispensing regular medicines and appliances to patients on stable long-term treatment. Repeat supplies of appliances may be managed by the patient's chosen supplier of appliances. The prescriber produces a repeatable prescription and a set of identical 'batch' forms - the number required, is equal to the number of times the prescription is to be repeated and this is to be indicated on the form, for example, 1 of X, 2 of X.

Each repeatable prescription can be dispensed at regular intervals, for example, monthly for a period of up to twelve months. However, an NHS repeatable prescription needs to be dispensed for the first time within six months of being written and can then only be dispensed subsequently for up to a year from being written or until any expiry date specified by the prescriber, whichever is less.

A dispensing interval does not have to be set by the prescriber, so that the supplier has maximum flexibility to make a professional decision when to dispense the next supply for the patient. This is of particular benefit for patients with certain appliances or for patients that may be travelling and require an additional supply of their items ahead of time.

The aims and intended service outcomes for repeat dispensing is:

A detailed service specification was developed for the implementation of this service element into the Community Pharmacy Contractual Framework in 2005. This can be found on NHS Primary Care Commissioning website.

Record keeping

The supplier of appliances must keep accurate records of all supplies made to patients. The purpose of the records is to ensure there is an accurate audit trail for items supplied, and also to assist suppliers of appliances to provide advice and support to patients with regard to their appliance(s), provide continuing care for patients, and document any interventions or referrals made during the dispensing process.

Home Delivery of Stoma and Incontinence Appliances

The regulations state that from April 2010 there will be a requirement to make available home delivery, which is only applicable to Incontinence and Stoma Appliances. This will include all items listed in part IX B & C of the drug tariff and certain qualifying items* listed in part IX A (mainly catheters). This service has to be offered, but is not compulsory and it will be the patient's choice whether they collect their appliances from the pharmacy or have it home delivered.

Provision of wipes and disposal bags

A reasonable supply of wipes and disposal bags for qualifying items will also need to be supplied against all items that are indicated in the drug tariff part IXA (qualifying items*), B & C. It is indicated that a reasonable supply would be a one for one ratio for actual number of stoma or continence bags verses the free bags and wipes. i.e. 1 box of 30 stoma bags would provide 30 disposal bags and wipes. Unfortunately, little thought has been made of the relationship between how appliances and how wipes and disposal bags are actually available.

Provision of appropriate advice

There will be a requirement to ensure that both Pharmacy Contractors (PCs) and Dispensing Appliance Contractors (DACs) provide appropriate advice to patients about any stoma or incontinence appliance provided to them in order to enable them to utilise, store and dispose of the appliance appropriately. Advice may already be available by some pharmacies, however arrangements must be in place for giving appropriate advice, both written and verbal, when patients order their appliance and when the items are dispensed. This can be provided through a telephone care line. PCs and DACs must also ensure that a patient may consult, if the patient so wishes, someone to obtain expert advice regarding the appliance being dispensed.

Referrals and signposting

If the supplier of appliances cannot dispense an item prescribed, for example it is out of stock, or cannot provide the required stoma appliance customisation, then he or she must - with the patient's consent - refer the prescription form or repeatable prescription to another supplier of appliances (i.e. another pharmacy or DAC). If the patient does not consent to this, then the supplier of appliances must provide contact details for at least two other suppliers (if he or she has the details) that may be able to dispense the required item or service. If the supplier of appliances is unable to provide the AUR service then he/she must give the patient the contact details of at least two people who are suppliers of appliances who are able to arrange for the service to be provided, if these details are known to the supplier.

PCTs are advised to provide this information to suppliers of appliances prior to the implementation of these contractual arrangements. They should ensure this information remains up to date.

Inducements

The terms of service for Pharmacy Contractors with regards to inducements were extended by amending regulations in September 2009; The terms of service for DACs have been brought into line with Pharmacy Contractors under the new contractual arrangements.

DACs may not give, promise or offer to any person, including Pharmacy Contractors, any gift or reward as an inducement to or in consideration of them presenting a prescription for an appliance, or for nominating the DAC as their dispensing contractor, or one of them, in an NHS Care Record (Schedule 3 paragraph 15). Therefore, Pharmacy Contractors that signpost patients to a DAC either because they do not provide appliances, or because they do not provide that appliance in their normal course of business, are complying with their terms of service and therefore should receive no gift or reward for doing so.

However, there are circumstances where Pharmacy Contractors may provide an element of Essential Services to a patient when signposting them to a DAC, where a payment may be appropriate. These circumstances could include:

In these circumstances the pharmacy contractor would be acting outside of their NHS terms of service and this would be a commercial arrangement.

NWOS have introduced their New Appliance Partnership to support Pharmacy Contractors in providing the required services that fall within the guidelines issued by DH, but without the hassle to the pharmacy.

Clinical Governance

In 2005, the DH introduced a new 'Community Pharmacy Contractual Framework' and as part of this framework Pharmacy Contractors had to operate their business in a clinical governance framework. From April 2010 this clinical governance framework will extend to Dispensing Appliance Contractors. It is designed to ensure that all paperwork and procedures are in place to enable a relevant monitoring and audit to be carried out by the regulating body and also ensure both patient and contractor accountability.

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Essential Services Fee Structure Table

Service Requirement Fee Level
Normal Dispensing As current For all items in Part IXA, B and C - a fee of 90p will be paid.
Additional Dispensing Service Home delivery (NB: the fee is paid per qualifying item dispensed, regardless of whether the patient has requested collection from the pharmacy or home delivery). A fee of £3.40 will be paid for each item listed in Part IXA (qualifying items¹), Part IX B and C dispensed, with the exception of all intermittent self-catheters (ISC) listed in Part IX A where a fee of £9.30 will be paid for each ISC dispensed.
Dispensing of appliances measured and fitted The measure and fitting of applicable appliances - this has been extended to include belts and girdles £2.60 per item (based on the contractor's endorsement of measured and fitted).
Expensive Prescription Fee Additional fee paid on all prescription items over £100 2% of the net ingredient cost (pharmacies already receive this fee)

1. Qualifying items for home delivery are items in Part IXB and IC of the Drug Tariff and the following products in Part IXA of the Tariff: catheter, laryngectomy and tracheostomy, catheter accessories, catheter maintenance solutions, anal irrigation system, vacuum pumps and constrictor rings for erectile dysfunction, and wound drainage pouches.

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Stoma Customisation

The aim of a stoma customisation is to ensure the proper use and comfortable fitting of the stoma appliance by a patient throughout the duration of usage of the appliance, thereby reducing wastage.

Stoma appliance customisation is the customisation of a quantity of more than one stoma appliance, where:

Requirements for the service

The PCT and NHS Business Services Authority (NHS BSA) must be notified of the intention to provide the stoma appliance customisation service by the last working day prior to the month in which the service is to be provided.

The supplier of appliances must be satisfactorily complying with the obligations for Essential Services for the supply of appliances and must have an acceptable system of clinical governance in place within the premises. They must have procedures in place to ensure referral to the prescriber, where a customised stoma appliance is not suitable for further customisation. Or where a stoma appliance has been customised and is not a proper fit for the patient.

Stoma appliance customisation must be provided at an 'acceptable location' as specified below:

The standards for the location where stoma appliance customisation is undertaken is to ensure patient dignity and privacy. For some DAC premises, patients may only attend for this service and in this instance, the DAC should ensure they have an area where the appliance can be customised in comfort for the patient. For many Pharmacy Contractors they will already have a room where they undertake Medicines Use Reviews and this may well be deemed to be acceptable.

Where the service is to be provided elsewhere other than at the supplier's premises, procedures are in place to ensure co-operation with any reasonable inspection or review of the area by the PCT. It may not be possible for the DAC or Pharmacy Contractor to provide this service from their premises e.g. a lack of an acceptable location. In this instance it is permissible for the service to be provided at an alternative address. However, the PCT must be able to inspect these premises and it must still comply with all the standards for an area within the contractor's premises.

With regards to how large the acceptable location is, this will be for the PCT to determine. Not only must it be large enough to hold all necessary equipment, it must also allow the patient and the person providing the service sufficient room to sit and move around in. Suppliers of appliances who provide a considerable number of stoma appliance customisations would be expected to have a larger area than one who only does a few each month. Suppliers of appliances are encouraged to discuss this with their PCT before commencing the provision of this service.

Additional requirements for the service

Only appropriately trained and qualified persons are permitted to customise an appliance. Neither the Directions nor the Drug Tariff specify what training and/qualifications are deemed appropriate for the provision of this service. PCTs and suppliers of appliances should therefore discuss what would be appropriate in advance of this service being provided.

A record of each customisation must be completed. The record must contain the minimum requirements as stated within the Directions (see below). This may be in the form of a paper record or electronic record. The record must be retained for a minimum of 12 months unless the PCT has specified longer.

A copy of the record must be supplied to the patient or, if requested by the patient, to the prescriber or other healthcare professional.

Record keeping for stoma appliance customisation

The records made and retained can be in either paper or electronic form and should be retained for a period of no less than 12 months or a longer period as specified by the PCT. Each record must include:

Withdrawal from the service

If a supplier of appliances wishes to withdraw stoma appliance customisation, three months' notice must be given to both the NHS BSA and the PCT of their intention to do so.

Claims procedure

Suppliers of appliances will not be required to make monthly claims for stoma appliance customisations carried out. Payment will be automatic once the NHS BSA has received notification from the supplier for the premises

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Appliance Use Reviews

The aim of the AUR service is to improve patient knowledge, concordance and use of specified appliances by:

An AUR can be provided when a pharmacist or specialist nurse visits a patient at home or when a patient visits the premises of the supplier of appliances.

Suppliers of appliances may choose to provide AURs in relation to Part IXA (qualifying items*), Part IXB or Part IXC prescription items. Such reviews must be conducted by a specialist nurse - working on behalf of the supplier of appliances that dispensed the appliance - or by a pharmacist.

AURs are intended to complement the care provided by healthcare professionals working in the NHS, therefore the specialist nurse - working on behalf of the supplier of appliances - or pharmacist must maintain close contact with the NHS healthcare professional looking after the user, where possible.

AURs may take place at the user's home or at the supplier of appliances' premises. However, if the AUR takes place at the supplier of appliances' premises, there are certain minimum standards that the area must meet - see box below. These standards are similar to those that pharmacy contractors are required to meet when providing Medicines Use Reviews.

Requirements for the consultation area where an AUR may be provided

The area must be:

Requirements for the service

Before any arrangements are entered into, the PCT and NHS BSA should each be supplied with the correct notice that the supplier of appliances wishes to provide AUR service and a statement of where the service will be provided from.

Before any arrangements are entered into, the PCT has also been supplied with the required details of each of the pharmacists and/or specialist nurses who will be providing the AUR service. The details that are required are:

Again, neither the Directions nor the Drug Tariff set out any particular qualifications that are required by the healthcare professional providing this service, unlike for the provision of Medicines Use Reviews. PCTs and suppliers of appliances should therefore look at the experience and continuous professional development of the specialist nurse or community pharmacist providing the service. However, it is not for the PCT to assess the competency of the individual.

The supplier of appliances must:

If an AUR is to be provided at the supplier of appliances' premises there is a consultation area which meets the requirements as previously detailed above. Pharmacy Contractors will note that these standards are very similar to those for the provision of Medicines Use Reviews. However, due to the nature of specified appliances it is likely that hand-washing facilities will need to be available in the consultation area. PCTs may therefore wish to discuss with their suppliers of appliances what standards would be required to meet infection control standards.

Additional requirements for the service

Only appropriately trained and qualified persons (pharmacists and specialist nurses) are permitted to provide the AUR service. This is similar to the advanced service provided by Pharmacy Contractors, where Medicines Use Reviews must be provided by a pharmacist. This requirement ensures that the healthcare profession providing the service works within their competencies, and if they work outside their competence then they may be subject to investigation by their professional regulatory body.

Where reasonably possible an AUR must be provided within 2 working days of the day on which the patient requests a review or agrees to one at the suggestion of the supplier of appliances.

The pharmacist or specialist nurse providing the service must obtain the patient's prior written consent to receiving the service.

The patient must be informed in writing that a record will be kept of the AUR and that certain information resulting from the service will be forwarded to the supplier of appliances and an appropriate healthcare professional involved in the care of the patient e.g. their registered GP.

A record of each AUR must be completed. This can be paper or electronic, and must be forwarded to the supplier of appliances.

Each record must include the information listed below:

The record must be kept for a minimum of 12 months, or longer if specified by the PCT.

The information contained within the record and any other useful relevant information must be forwarded to the patient's GP and any other healthcare professional, including any PCT nurse, providing care for that patient.

Payments for AURs

The maximum number of AURs for which a supplier of appliances is eligible for payment in any financial year is not more than 1/35th of the aggregate number of specified appliances dispensed during that financial year. Suppliers of appliances must self-declare in the monthly return form (FP34) the number of AURs conducted.

When claiming for AURs the FP34 form will have different boxes for the two different AUR rates (£28 and £54). Suppliers of appliances will need to specify how many of each rate they are claiming for.

With regard to more than one AUR being carried out at the same location in a 24-hour period, the first AUR needs to be claimed as if it had been carried out at a user's home and subsequent reviews at the same location need to be claimed as if they had been carried out at the supplier of appliances' premises.

Advanced Services Fee Structure Table

Service Requirement Fee Level
Stoma Customisation The process of modifying multiple identical parts for use with a stoma appliance to the same specification, where the modification is based on the patient's measurements or record of those measurements and, if applicable, a template. £4.32 for every qualifying Part IXC prescription item dispensed, the fee is paid per qualifying Part IXC item dispensed, regardless of whether customisation is required.
Appliance Use Reviews AURs are intended to improve the patient's knowledge and use of the appliance they are using. They can only be conducted with consent by the user. Must be conducted by a specialist nurse - working on behalf of the appliance contractor or pharmacy contractor - or by a pharmacist. £28 per AUR conducted at the premises of the contractor. £54 per AUR conducted at user's home. If more than one AUR conducted in the same location within a 24-hour period, £54 for the first AUR and £28 for each subsequent AUR.

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In addition DACs will receive an infrastructure payment in the same way Pharmacy Contractors receive a practice payment. The table below shows how this will be paid to DACs and will be based on fee per item dispensed. DACs will receive the infrastructure payment which does not have to be claimed but which will be paid automatically.

For items dispensed within the first band, all DACs will receive a fixed monthly payment of £150.00 and in the remaining bands; DACs will be paid a fee per each Part IX prescription item dispensed each month.

Band identifier No. of Part IX prescription items dispensed in one month Infrastructure payment
A 1 - 10 £ 150.00 fixed
B 11 - 1,000 £ 13.60 per item
C 1,001 - 35,000 £ 2.40 per item
D 35,000 + £ 2.30 per item

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Part IX Reimbursement

A uniform reduction of 2% will be made on the reimbursement prices of all items listed as of 31st March 2010 in the following sections of Part IX of the Drug Tariff:

Manufacturers whose products have a combined Net Ingredient Cost of less than £5.6 million a year were able to apply to submit an application to the NHS Business Services Authority - Prescription Services (NHS BSA) for an exemption from this reduction.

The new reimbursement prices come into effect on 1st April 2010 and be published in the April 2010 Drug Tariff. An annual reimbursement price increase mechanism will be introduced six months after the price reduction has been implemented. The price increase mechanism will be the similar to the reimbursement price increase mechanism used previously: it will be related to the GDP deflator minus Factor X. Factor X will be subject to review.

It had been decided that the reimbursement price increase mechanism should be introduced six months after the reimbursement price reduction had been implemented. This recognises that the previous price increase mechanism has been suspended since April 2006. Consequently, the reimbursement price increase mechanism should be introduced in October 2010.

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Information and Useful Links

For further information and detailed copies of the consultation documents there are some links below.

PSNC Website

Department of Health Consultations

The Drug Tariff

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