Jan 11,2024 TOP STORY

A new prescription app against Type 2 Diabetes

Developed by Perfood GmbH, Glucura type 2 diabetes therapy app has been added provisionally to the DiGA list in Germany, making it available for prescriptions in the country. Approved by the Federal Institute for Drugs and Medical Devices (BfArM) as a Digital Health Application (DiGA), glucura utilizes individual glucose reactions to provide personalized nutrition recommendations for individuals with Type 2 diabetes. Using artificial intelligence, users receive tailored lifestyle recommendations to effectively and sustainably lower their blood sugar levels. A clinical study demonstrated a significant improvement in long-term blood sugar levels (HbA1c) after three months of glucura usage compared to standard treatment. Users can also export their data for sharing with healthcare professionals, contributing to a holistic approach in diabetes care. The app will be available in the DiGA until January 2025.

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Jan 11,2024 TOP STORY

A new prescription app against Type 2 Diabetes

Developed by Perfood GmbH, Glucura type 2 diabetes therapy app has been added provisionally to the DiGA list in Germany, making it available for prescriptions in the country. Approved by the Federal Institute for Drugs and Medical Devices (BfArM) as a Digital Health Application (DiGA), glucura utilizes individual glucose reactions to provide personalized nutrition recommendations for individuals with Type 2 diabetes. Using artificial intelligence, users receive tailored lifestyle recommendations to effectively and sustainably lower their blood sugar levels. A clinical study demonstrated a significant improvement in long-term blood sugar levels (HbA1c) after three months of glucura usage compared to standard treatment. Users can also export their data for sharing with healthcare professionals, contributing to a holistic approach in diabetes care. The app will be available in the DiGA until January 2025.

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#reimbursement

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Dec 20,2023

DiGA Law Updates in Germany

The German Bundestag recently approved the Digital Act (DigiG), a crucial component of the Federal Ministry of Health's digitization strategy. The law introduces significant changes in the digitalization of the healthcare system, particularly in the realm of digital health applications (DiGAs). DiGAs are now treated on par with other medicinal products and aids, ensuring patients' right to use them. Health insurance companies must facilitate DiGA use within two working days, with exceptions being rare. The legislation expands the scope to include DiGAs of higher risk classes, requiring proof of medical benefit for approval. Pricing for DiGAs will be tied more closely to performance criteria. The right to reimbursement no longer depends on patient behavior, and there is an expanded ban on agreements limiting patients' freedom of choice. DiGA manufacturers may need to provide technical equipment on loan, and the law addresses the use of DiGAs during pregnancy. DiGA monitoring, including application-related success measurement, becomes mandatory from January 1, 2026. The law awaits referral to the Federal Council and is expected to come into force after promulgation, earliest by February 2, 2024.

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Dec 22,2023

2024 forecast: Digital therapeutics makers will have to get creative to conquer reimbursement issues

The article discusses the challenges faced by digital therapeutics companies, despite promising study results and FDA approvals. Companies like Better Therapeutics, Akili, and Pear Therapeutics have struggled financially, leading to layoffs, pipeline cuts, and strategy shifts. The lack of payer support for digital therapeutics has been a significant roadblock, as insurers have been reluctant to cover these technologies. Reimbursement issues have been cited as a core challenge to profitability for digital therapeutics makers. The article suggests two potential opportunities for digital therapeutics: fitting into larger digital-enabled ecosystems and becoming part of the broader landscape of remote care.

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Dec 08,2023

Patients wait weeks for treatments: New law could take power away from health insurance companies

The German government is currently in the process of passing two new important laws in the healthcare sector. The consultations are already well advanced and the resolution of the Digital Act (DigiG) and the Health Data Use Act could happen in the coming days. The two laws have many components - but one of them concerns the power and authority of statutory health insurance companies. Specifically, there is likely to be a discussion about the withdrawal of the required permission from the health insurance companies to authorize prescriptions for certain therapies in the future. The background is the complaints from the DiGA manufacturers, who have reported numerous problems with statutory health insurance companies. The health insurance companies are said to have repeatedly tried to make it more difficult for patients to access these new therapies or to deny them completely. There is also the accusation that health insurance companies repeatedly try to interfere with the treatment sovereignty of the doctors by questioning the issuance of a DiGA as therapy. Manufacturers have been complaining for months that, among other things, it can take a very long time until a DiGA is activated for patients.

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Nov 15,2023

Tempus Announces Medicare Coverage for Tempus|xT Across Solid Tumor and Hematologic Malignancies

Tempus, a leader in artificial intelligence and precision medicine, today announced that Palmetto GBA, a Medicare Administrative Contractor, and the Molecular Diagnostics Services Program (MolDx) has approved coverage for Tempus|xT, Tempus’ 648-gene DNA sequencing panel, for use in solid tumor and hematologic malignancies. xT is now covered for Medicare patients under the MolDx program for tumor-only as well as normal match sequencing in all solid tumors, and tumor sequencing for patients with myeloid and suspected myeloid malignancies. xT is a DNA sequencing panel that provides a comprehensive view of patients’ genomic profiles, equipping physicians to make informed treatment decisions.

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Oct 16,2023 TOP STORY

Better Therapeutics Announces Launch of AspyreRxTM to Treat Adults with Type 2 Diabetes

Better Therapeutics announced the commercial launch of AspyreRx, the first cognitive behavioral therapy (CBT) app to receive U.S Food and Drug Administration (FDA) authorization as a Class II device to treat adults with type 2 diabetes (T2D). Licensed healthcare providers are now able to prescribe AspyreRx via EMR and PhilRx will determine the insurance coverage. The app is available for download on the Apple App and Google Play Stores.

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Oct 16,2023 TOP STORY

Better Therapeutics Announces Launch of AspyreRxTM to Treat Adults with Type 2 Diabetes

Better Therapeutics announced the commercial launch of AspyreRx, the first cognitive behavioral therapy (CBT) app to receive U.S Food and Drug Administration (FDA) authorization as a Class II device to treat adults with type 2 diabetes (T2D). Licensed healthcare providers are now able to prescribe AspyreRx via EMR and PhilRx will determine the insurance coverage. The app is available for download on the Apple App and Google Play Stores.

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Sep 22,2023

Q&A: The status of the Access to Prescription Digital Therapeutics Act

Jennifer Mathieu, senior vice president of professional and government affairs at AMCP, provides an update on the Access to Prescription Digital Therapeutics Act 2023 moving through Congress. The Access to Prescription Digital Therapeutics Act, introduced in the U.S. Senate in 2022 and reintroduced in March of this year, seeks to amend the Social Security Act to provide Medicare and Medicaid coverage and reimbursement for prescription digital therapeutics. Despite changes in the digital health landscape, the bill has remained largely unchanged and has bipartisan support. Efforts have been made to educate lawmakers about digital therapeutics, with a noticeable shift in understanding. Concerns among lawmakers include data security, privacy, and clinical evidence. The next steps include hosting a demo day on the Senate side, working on data for the Congressional Budget Office, and aiming to include the bill in a year-end omnibus package.

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Sep 12,2023 TOP STORY

Dexcom Unlocks Access to Real-Time CGM for a Further Half a Million People With Diabetes in France

DexCom, Inc. today announced the availability of its Dexcom ONE real-time CGM sensor via reimbursement, in France. Specifically, access is now secured to the Dexcom ONE sensor for all patients with type 1 and type 2 diabetes, two years and older, who are undergoing intensive insulin therapy (by external pump or >3 injections per day). “We believe this is truly exciting news for people living with diabetes in France,” said Gérald Zammit, Country Director of Dexcom France. "Access to Dexcom real-time CGM sensors is now available to those who live with diabetes, who aren’t necessarily seen as ‘high risk’, but who can still greatly benefit from it. The launch of Dexcom ONE in France will help to make real-time CGM accessible to as many patients as possible.”

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