Aug 19,2024

Digital Therapeutics Sector Sees Billing Codes as Key to Breaking Free of Reimbursement Rut

On August 19, 2024, it was announced that Medicare's physician fee schedule will now include billing codes for digital therapeutics for the first time, a significant development for the sector. The Centers for Medicare and Medicaid Services (CMS) has proposed three codes specifically for FDA-cleared digital mental health treatment devices, marking a shift in federal recognition of these technologies. This change is expected to address some of the reimbursement challenges that have plagued digital therapeutics, as seen with companies like Pear Therapeutics and Better Therapeutics, which faced difficulties securing payer coverage.

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Jul 22,2024 TOP STORY

What CMS’s proposed reimbursement codes could mean for the digital therapeutics industry

The Centers for Medicare and Medicaid Services (CMS) has proposed new CPT payment codes for digital therapeutics, marking a significant step towards widespread reimbursement for the DTx products. Previously, CMS introduced Level II HCPCs codes for behavioral health digital therapeutics, which mainly applied to Medicare and Medicaid. The new CPT codes, applicable to all payers, could significantly expand coverage. These codes were included in the 2025 Medicare Physician Fee Schedule proposed rule and are specific to digital therapeutics for mental health conditions. The proposed codes (GMBT1, GMBT2, and GMBT3) allow physicians to bill for digital therapeutics similarly to how they bill for vaccines, covering initial provision, patient education, and ongoing management services. This proposal is expected to lead to broader payer coverage and increase demand from employers, potentially boosting the industry’s sustainability and attracting more investment.

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Jun 11,2024 TOP STORY

Mahana Secures Permanent Reimbursement in Germany for its Cara Care for Irritable Bowel Syndrome (IBS) Digital Therapeutic

Mahana Therapeutics has secured permanent reimbursement in Germany for its digital therapeutic, Cara Care for Irritable Bowel Syndrome (IBS). Following price negotiations with Germany’s National Association of Statutory Health Insurance Funds (GKV-SV), Cara Care for IBS is now widely accessible to IBS patients insured by statutory health insurers. The reimbursement is based on the therapeutic's proven clinical efficacy, cost-effectiveness, and quality of life improvements. Cara Care, which can be prescribed for 90 days for patients aged 18 to 70, uses a personalized treatment plan including cognitive behavioral therapy (CBT), dietary therapy, and gut-directed hypnosis. Clinical trials have demonstrated significant improvements in symptom severity and quality of life for users, solidifying its value in the German healthcare system.

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Jun 04,2024 TOP STORY

Jasper Health Expands its Reimbursable Cancer Supportive Services to 27 States, Advancing Biden Cancer Moonshot Vision

Jasper Health, a leading provider of human and AI-enabled supportive cancer care, has expanded its 1:1 virtual care services to 27 states across the U.S. This growth aligns with the company's shift towards a new reimbursable business model, prompted by the acceptance of Principal Illness Navigation (PIN) codes by Medicare, Medicaid, and major commercial payers. The expansion enables Jasper to serve patients covered by these payers, including Aetna, Elevance, and UnitedHealthcare.

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May 02,2024

Intuity Medical’s POGO Automatic®, the First and Only FDA-Cleared Automatic Blood Glucose Monitor, Now Covered by Medicare Part B

Intuity Medical's POGO Automatic Blood Glucose Monitoring system, designed to simplify diabetes management, is now covered by Medicare Part B. This expansion of coverage benefits the 16.5 million seniors aged 65 and up living with diabetes. POGO Automatic aims to improve testing compliance, particularly among seniors facing challenges with traditional meters. The system addresses the need for simpler blood glucose testing methods, with new coverage codes allowing Medicare beneficiaries to access this technology. Intuity Medical is collaborating with retail pharmacies to ensure timely access for patients.

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Apr 19,2024

Korea approves 2 more DTx for vision improvement, respiratory rehabilitation

The Ministry of Food and Drug Safety in South Korea has granted approval to two new digital therapeutic (DTx) devices, developed by Nunaps and Share&Service. Nunaps VIVID Brain is a mobile application tailored for patients with vision impairments due to brain disorders, offering a 12-week visuoperceptual training program to expand the visual field. Share & Service's EasyBreath, on the other hand, is an eight-week customized respiratory rehabilitation program for individuals with COPD, asthma, and lung cancer, focusing on enhancing aerobic capacity and reducing breathlessness. These approvals mark the third and fourth authorized DTx devices in South Korea, signifying a growing recognition of software-based interventions to prevent, manage, or treat medical impairments or diseases.

REGULATORY

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Apr 10,2024

Newfoundland and Labrador expands access to continuous glucose monitoring program

Newfoundland & Labrador (Canada)'s Government expands its continuous glucose monitoring program in Budget 2024, now including patients up to age 25 with type 1 diabetes (T1D) enrolled in the NL Insulin Pump Program and pregnant individuals with gestational diabetes. Previously limited to those under 18, a one-year pilot project paved the way for this expansion. With an investment of nearly $1.8 million, the program becomes permanent, benefiting from JDRF Canada's support.

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Mar 05,2024 TOP STORY

The DTx Solution for Borderline Personality Disorder, priovi Secures Permanent Reimbursement in Germany with the Phase 3 Trial Results

priovi, the world’s first and only fully automated digital therapy for borderline personality disorder (BPD) developed by GAIA Group, has been available for clinical use in Germany since March 2023, and now its effectiveness has been confirmed in a large clinical trial (RCT) with 580 patients. Thanks to the positive results, the Federal Institute for Drugs and Medical Devices (BfArM) in Germany granted permanent reimbursement for priovi's digital therapy intervention. The study, which included 580 patients, showed a significant and clinically relevant reduction in borderline symptoms as well as a decrease in both depression and anxiety symptoms in the intervention group, compared to the control group. In addition, the number of suicide attempts was significantly lower in the priovi group. Patients also reported a high level of satisfaction while using the program and their satisfaction scores increased with time.

CLINICAL STUDY

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Feb 28,2024

Nova Scotia announces expanded coverage for insulin pumps and advanced glucose monitoring

The Government of Nova Scotia announced a historic investment to provide better access to diabetes devices such as insulin pumps and glucose monitors for Nova Scotians with diabetes. The province will be investing $5.9 million to fund sensor-based glucose monitoring supplies, and $1.3 million to expand the Nova Scotia Insulin Pump Program by removing the current age cap. Glucose monitoring supplies will be obtained through a new income-based program and through existing pharmacare programs. While Nova Scotians living with either type 1 diabetes (T1D) or type 2 diabetes can access this new program, eligibility requirements will include the need for multiple daily injections of insulin or insulin pumps to manage their diabetes.

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Feb 13,2024

Medicare Coverage Significantly Expanded for the Eversense E3 CGM System

Ascensia Diabetes Car, and Senseonics Holdings announced that Medicare has significantly expanded access to the Eversense E3 CGM System, with the implementation of Local Coverage Determinations providing access to implantable CGM for basal only patients, by the first three Medicare Administrative Contractors (MACs). Medicare coverage has been expanded for implantable CGMs to include all people with diabetes using insulin, removing the previous requirement for multiple insulin administrations per day. The new policy has also been updated to cover non-insulin-users who have a history of problematic hypoglycemia. Noridian, Palmetto and National Government Services (NGS) are the first three MACs to publish final local coverage determinations (LCD). The earliest MAC expansion becomes effective on February 25, 2024 and the companies expect the remaining MACs to finalize their expansion in the near future.

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