Medical Insurance, Licensing, Quality Assurance
What you should know about private medical insurers
Private medical insurers may sometimes give the impression that they will not reimburse OSTENIL® or OSTENIL® PLUS injections, and, as a result, you may be led to offer OSTENIL® injections only for self-funding patients.
However, depending on the patient's insurance policy, the affected joint, and other potential factors, Bupa, Aviva, AXA-PPP and VitalityHealth will fund viscosupplementation if you use the correct specific code that the insurers require, . Please have a look at this website: www.ccsd.org.uk. The "Clinical Coding & Schedule Development Group" provides the specific codes used by the four major insurers (BUPA, Aviva, AXA-PPP, and VitalityHealth) for injecting a viscosupplement into a joint with or without guidance.
AXA-PPP, Aviva, and VitalityHealth:
The relevant codes for AXA-PPP, Aviva and VitalityHealth can be found by clicking the ‘procedural’ (green) tab and entering ‘Viscosupplement’ in the search box. The codes that come up are:
W9032 – Injection of viscosupplement into joint WITH image guidance
W9033 – Injections of viscosupplement into joints WITH image guidance (bilateral)
W9042 – Injection of viscosupplement into joint
W9043 - Injections of viscosupplement into joints (bilateral)
The code for BUPA is AA663, which has to be used in conjunction with W9030 (joint injection under guidance), or W9040 (joint injection without guidance). If you go to the individual insurers websites then you can also see how much they pay for using each of the codes and what restrictions there are.
Do insurers only fund knee injections?
Sometimes an insurer may say that they will only cover the cost of a viscosupplement injected into the knee and not any other joint. However, on the codes schedule it does not specify that the related codes are only for the knee. This means injections into other joints, i.e. hip, shoulder, ankle, etc, should also be covered by the insurers.
However, the insurers will have their own specific policy regarding applicable clinical circumstances and products to be used.
Product Licensing, MDR Certification, UKCA Mark, MSDS, NHS Reimbursement, Prescribing License:
- OSTENIL® injections are classed as a Class III medical device, not a Drug.
- All genuine OSTENIL® intra-articular products as of March 2022 are compliant with the new MDR certification which applies to all TRB Chemedica intra-articular injections.
- From July 2023 [UPDATE: delayed until 2024], only genuine OSTENIL® range products delivered via closed logistic supply chain from our manufacturing plant to TRBUK will carry the UKCA mark, and this will render any Ostenil range products purchased from any other source illegitimate.
- VISMED® and REMOGEN® OMEGA eye drops are also classed as Class III Medical Devices, not drugs.
- MSDS (Material Safety Data Sheets) are not required. The issues provided in a MSDS are checked within the conformity assessment procedure.
- All our products are currently CE-marked medical devices manufactured in the EU and in Switzerland, and are licensed for sale within the EU.
- Most of our products are listed in the Drug Tariff, MIMS, C&D, and the BNF.
Extended Scope Physiotherapists and other clinicians who have had training in intra-articular injections don’t necessarily also need to have a prescribing license in order to administer viscosupplementation.
For OSTENIL® TENDON peritendinous injections, however, we recommend the use of ultrasound equipment to ensure correct placement of the hyaluronan close to the affected tendon and thus the best possible treatment outcome.
Quality Assurance, Pack Identifiability, Unauthorised Suppliers
At TRB Chemedica UK we continuously review our stringent safety procedures, as well as our transportation and storage standards. We must therefore advise customers purchasing any of the OSTENIL® products from internet-based sales companies offering TRB Chemedica proprietary products (primarily OSTENIL® and OSTENIL® PLUS) at heavily discounted prices, that TRB Chemedica UK cannot offer any provenance or quality assurance in relation to the authenticity, quality, safety, or efficacy of these products. Neither can we attest to the accuracy regarding the batch numbers, use by date, manufacturing integrity, storage, or transportation conditions of any TRB Chemedica products purchased from a non-accredited third-party re-seller, nor can we accept any liability arising from their use within the UK.
As of June 2019, new measures have come into effect to safeguard against counterfeit OSTENIL® range products being sold in the UK. New packaging livery on all genuine OSTENIL® and OSTENIL® PLUS injections, featuring the UK flag for easy pack identifiability, will ensure our customers purchase only verified and quality assured products. In addition, the English-only pack insert with “Instructions for Use” or SPC, reduces the possibility of counterfeit suppliers “passing off” their wares – which usually include multi-language instruction sheets - as genuine.
You can read our full statement here.
For any products not stocked by our authorised wholesalers, or for any problems or questions, please find our contact details below:
TRB CHEMEDICA (UK) Ltd
Lymedale Business Park
Hooters Hall Road