Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

July 2022: What’s new in the world of diagnostics? – (Digital) Diagnostics access / policy news around the globe

In July 2022, we have identified the following access and policy-relevant news that caught our attention from the (digital) diagnostics perspective. Check them out:

1.       European Commission finalizes rules on high-risk IVD tests, resisting industry calls for change

The European Commission has finalized its class D in vitro diagnostic implementing regulation to create common specifications for high-risk devices.

2.       ESMO Releases Guidelines for Liquid Biopsy Testing in Cancer Patients

The European Society for Medical Oncology released new recommendations Thursday on the use of circulating tumor DNA assays in cancer patients.

3.       CMS Retains Unspecified Cancer Dx Codes After Industry Stakeholder Feedback (USA)

One year after postponing a decision that would impact reimbursement for certain cancer diagnostic tests, the Centers for Medicare and Medicaid Services has rescinded the original proposal – a move industry stakeholders have pushed for.

4.       DMP diabetes mellitus type 2 is updated (Germany)

The disease management program for type 2 diabetes mellitus has been revised. In particular, the recommendations for drug therapy have been adapted to current guideline recommendations. In addition, the documentation is streamlined.

5.       Bremen becomes a model region for cancer prevention (Germany)

Bremen becomes a model region as part of the National Decade Against Cancer. In the smallest federal state, scientists from the Leibniz Institute for Prevention Research and Epidemiology - BIPS want to investigate how cancer can be effectively prevented.

6.       Additional contribution rate is to increase by 0.3 percentage points (Germany)

Essential components of the key points presented by Lauterbach for the stabilization of the GKV financing are the increase in the federal subsidy by two billion euros in connection with a federal loan of one billion euros by 2026, the increase in the average additional contribution rate by 0.3 points to 1.6 Percent and the renewed shutdown of the financial reserves at the health insurance companies.

7.       An INCA guide specifies the molecular testing strategy for colorectal cancers (France)

The National Cancer Institute (Inca) provides health professionals with a new guide containing recommendations for patients with colorectal adenocarcinoma. These relate in particular to the test strategy to be implemented in these patients for optimal management at all stages of the disease.

8.       NHS England to be ‘between 30 and 40 per cent smaller than current size’ (UK)

The chief executive of NHS England has revealed that the organisation is expected to be between 30-40% “smaller than the current combined size of NHS England, Health Education England and NHS Digital” by the end of 2023/24.

9.       Evidence Based Guide launched focused on digital transformation (UK)

The University of Plymouth, the AHSN Network and Boehringer Ingelheim, has launched evidence-based recommendations to drive inclusive digital health tech innovation. How to involve and engage patients in digital health tech innovation, An Evidence Based Guide sets standards to ensure patients are at the centre of digital transformation.

10.   Sussex ICS adopts new data tool to support bowel cancer screening (UK)

Sussex Integrated Care System (ICS) has work with South, Central and West (SCW) to adopt a new tool to support its bowel screening programme.

11.   Patients to automatically access GP record in NHS app from November (UK)

NHS England will switch on automatic access to patient’s prospective GP record via the NHS App in November, following a delay due to ‘safeguarding’ concerns.

12.   Euroespes launches Mylogy, the digital platform to personalize drug treatments according to the genetic profile (Spain)

One of the greatest experts in this discipline and in cutting-edge personalized medicine is the EuroEspes Health International Center for Neuroscience and Genomic Medicine, which has developed Mylogy, a digital platform for genomic medicine for individuals and professionals developed by more than 50 people from the field medical, scientific and bioinformatician.

13.   GluCare.Health launches value-based weight management pilot
A Dubai-based healthtech startup has partnered with Novo Nordisk to launch what is considered one of the first value-based reimbursement model trials in the Middle East and North Africa (MENA).