Tag: FDA

RAPID Pathway: Transforming Medicare Coverage for Breakthrough Devices

Discover how the RAPID pathway streamlines Medicare coverage for breakthrough devices, improving access and accelerating reimbursement processes.

Expedited Medicare Coverage for Breakthrough Devices via RAPID Pathway

Learn about the RAPID pathway that expedites Medicare coverage for breakthrough devices, streamlining the approval process between FDA authorization and Medicare coverage.

Streamlined Medicare Access to Breakthrough Devices through RAPID Pathway

Discover how the RAPID coverage pathway improves Medicare access to Breakthrough Devices, enhancing collaboration between CMS and the FDA for effective treatment.

2025 Year-End U.S. Healthcare and Insurance Regulatory Update

Key regulatory and legislative developments shaping U.S. healthcare and insurance in late 2025, including APTC expirations, CMS innovations, FDA initiatives, and congressional healthcare policy efforts.

Federal Rescheduling of Cannabis and Medicare Pilot Coverage Poised to Transform U.S. Healthcare and Investment

Federal rescheduling of cannabis to Schedule III and a Medicare pilot program are set to advance U.S. healthcare integration, research, and institutional investment in cannabis-derived products.

CMS and FDA Launch ACCESS and TEMPO to Expand Tech-Enabled Medicare Care

CMS and FDA announce ACCESS and TEMPO initiatives to expand technology-enabled care for Medicare beneficiaries with chronic conditions, focusing on outcomes-based payments and regulatory enforcement discretion.

CMS and FDA Launch ACCESS and TEMPO Pilots to Enhance Tech-Enabled Chronic Care for Medicare

CMS and FDA have initiated the ACCESS Model and TEMPO pilot to expand technology-driven care for Medicare chronic condition patients, focusing on outcomes-based payments and regulatory flexibility.

CMS and FDA Launch Digital Health Models to Transform Medicare Care Delivery

CMS Innovation Center and FDA introduce ACCESS and TEMPO models to integrate digital health devices into Medicare, boosting care and payment innovation for chronic conditions.

FDA and CMS Pilot Programs Aim to Expand Digital Health Access for Medicare

FDA and CMS launch pilots to expand Medicare access to digital health technologies through outcome-aligned payments and regulatory flexibility, targeting chronic disease management.

CMS and FDA Launch Models to Integrate Digital Health in Traditional Medicare

CMS and FDA introduce ACCESS and TEMPO models to enable digital health device integration in traditional Medicare, focusing on outcome-aligned payments, regulatory easing, and expanded patient access.