March 2024 Update

Welcome to our March update and to the 33 new subscribers who joined us on LinkedIn last week. If you haven’t done so already, please subscribe to join the 1,180 supporters of our efforts in the European Union this month.

If you have only just joined us, Odelle Technology empowers biotech, MedTech, and healthcare AI companies to obtain HTA approvals and clinical? reimbursement and drive innovation successfully. We achieve this by transforming their approach or methods for developing impactful evidence and optimising market access. ?

Using stakeholder insights, patient-reported outcomes, innovative HTA submissions, data-agnostic expertise in the submissions, and a revolutionary engagement model we can provide agile, scientifically rigorous solutions, real-world evidence, patient-facing market access, and HEOR (Health Economics and Outcomes Research. ?

We were pleased to read that now that the new AI act was passed on 12 March 2024 to represent Healthcare, Marco Marsella, Director for Digital, EU4Health, Health Systems modernisation of DG SANTE will join the AI (Artificial Intelligence) committee.?

Also on 12 March a ￡10m government investment was?unveiled that will provide new robotic AI (Artificial Intelligence) laboratories at Liverpool MedTech organisation, iiCON. This award is part of the Liverpool City Region Life Sciences Investment Zone that plans to supercharge the sector. ?

Niklas Hedberg Chief Pharmacist at TLV, The Dental and Pharmaceutical Benefits Agency have made some small but significant changes to the reimbursement applications asking for Patient Reported Outcomes.?

We were also pleased to hear that the EU passed its AI Act this month, and France follows very closely, with the Artificial Intelligence Commissions publication of Our AI: Our Ambition for France – a very interesting read.?

Here's the latest news on the NICE interim methods and processes for Late-Stage Assessment (LSA) in HealthTech continues to unfold in the UK (United Kingdom).

Best wishes and thank you for your time.?#digital?#roboticsurgery? ?

Steven Haken - Managing Director of Odelle Technology?

[email protected]?

DRG (Diagnosis Related Groups) Updates in Europe:?

• The Netherlands introduced 23 new DRG codes for diverse medical treatments and 9 new supplementary codes. You can read more about this here.?

• France have updated their DRG system - National Institute for Health and Disability Insurance (INAMI-RIZIV) - to reflect a 5% increase in reimbursement?tariffs.?
• In France, the new Nomenclature of Medical Biology Acts (NABM089) was released. Various changes were implemented, including the introduction of new codes and modifications of the existing codes and titles. The newly introduced codes concern microbiological and biochemical tests and include the following:?- 1003 “Biological diagnosis of GLUT1 transporter deficiency syndrome” with a tariff of €290.42;?-1684 “Faecal calprotectin” with a tariff of €33.80;?- 5306 “Resistance to macrolides in mycoplasma genitalium” with a tariff of €22.10?

See the details in French?here.?

Cell Therapy??

In January cell therapy had a big moment within and outside of Oncology.?

Autoimmune-focused Kyverna Therapeutics went public in a $319 million IPO and epilepsy biotech Neurona Therapeutics raised $120 million to move into Phase II next year and setting the nine-year-old company up for its own public listing.?

Spain introduces Genetic Tests Nationwide

On 23 January 2024, the Ministry of Health in Spain introduced a new national catalogue, which guarantees the Spanish populations genetic tests nationwide. Currently, the catalogue includes 672 tests in eight disease areas, including adult and paediatric onomatology, pharmacogenomics, hereditary metabolic and mitochondrial diseases to name a few. Twelve more disease areas are expected to be added in 2024.?

Podcasts are a firm favourite for us. Below are the great guests we've spoken to over the past month, covering a range of interesting and informative topics.

For our latest podcasts visit our website or our YouTube channel.

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Mismatch Mindset! Why does digital health fail repeatedly??

What are the key challenges organisations are faced with when appreciating Digital Health. How can you address these challenges surrounding the creation of Digital Health? Click here to read how this has been approached.?

AI Gets Reimbursed in the USA ?

Medicare, the Centres for Medicare &?Medicaid Health Plans of America (MHPA)?Services (CMS), The?American Medical Association?and nine USA based and three EU based AI providers have helped generate?#reimbursement?in the USA for the use of artificial intelligence (#ai) in specific cases involving the diagnosis of Diabetic?#Retinopathy.?

Under the Medicare Physician Fee Schedule (MPFS), AI can be used for diagnosing Diabetic retinopathy as well as Diagnosis and Treatment of Large-Vessel Occlusion Strokes - AI is reimbursed under the Inpatient Prospective Payment System (IPPS) for large-vessel occlusion strokes.?

The?FDA (Food & Drug Administration)?has cleared over 700 AI medical algorithms in the US, with the majority related to medical imaging. The number of new radiology algorithms continues to grow by more than 100 per year. Now after 2 years of commercial availability, the Centres for Medicare & Medicaid Services in the US have finally approved the first reimbursement opportunity for AI. Specifically, this approval is for computer-assisted triage and notification in patients with suspicion of stroke. The focus is on demonstrating measurable value within a clinical setting, benefiting hospitals, radiologists, and patients. The approved code applies not only to the applicant’s technology but also to other technologies that are “substantially similar” in functionality. ?

This recognition of value by CMS is a significant step forward for AI-based triage in radiology of which I was happy to have played a part.?

Value-Based Care and Patient Outcomes: Reimbursement for AI in radiology currently operates on a per-user basis with Current Procedural Terminology (CPT) codes and New Technology Add-On Payments (NTAPs).?

Please follow our endeavours in the EU (European Union) and USA. We have also been privileged to have done similar work in France and Spain, for further information click here. ?

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