Tag: FDA

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.

Challenges and Contradictions in U.S. Health Insurance, FDA Oversight, and Public Health

An overview of key issues in U.S. health insurance, FDA regulatory inconsistencies, health care costs, anti-vaccine impacts, and emerging digital health policies affecting public health.

Safe Food Coalition Calls for Urgent Infant Formula Safety Oversight After Botulism Outbreak

The Safe Food Coalition urges urgent regulatory action after a Clostridium botulinum outbreak linked to ByHeart infant formula reveals inspection gaps, stressing need for enhanced safety protocols in infant nutrition products.

Medicare Coverage of Botox: Medical Uses, Requirements, and Costs

Explore Medicare coverage guidelines for Botox focusing on FDA-approved medical uses, prior authorization, medical necessity, and cost factors under Medicare Part B and Advantage plans.