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CMS Proposes Expanded Coverage for Digital Mental Health Devices—And Seeks Input on Broader Digital Therapeutics Use Cases
CMS proposes expanded reimbursement for digital mental health devices and seeks public input on broader digital therapeutics coverage. Comments due Sept. 12.
Remote Monitoring in the 2026 MPFS: New Codes, Old Concerns, and a Call to Action for Stakeholders
The 2026 Medicare Physician Fee Schedule proposes key changes to remote monitoring reimbursement—including new codes and a shift in data requirements. Learn what’s at stake and why stakeholders should act before the September 12, 2025 comment deadline.
Reshaping Food as Medicine: New Insights from Federal and State Policymakers
Explore how the 2026 Medicare Physician Fee Schedule and the Big Beautiful Bill are shaping the future of Food as Medicine (FaM). Learn about proposed changes to MNT reimbursement, new federal and state laws, and key compliance issues for FaM and virtual food care innovators.
CMS Proposes 2026 Changes to RPM, APCM, DMHT, and More: What Digital Health Companies Need to Know
CMS’ 2026 MPFS rule proposes major changes to RPM, APCM, and DMHT codes. See how digital health innovators can prepare and weigh in on key policies.
Digital Health Stakeholders: Weigh In on CMS 2026 Chronic Disease and Virtual Care RFIs
CMS is exploring major shifts in Medicare reimbursement policy for virtual care and chronic disease management. This article breaks down the 2026 RFIs and what policymakers, providers, and digital health innovators need to know before the September 12, 2025 comment deadline.
FDA’s New Playbook for AI in Medical Devices: What Developers Need to Know
Operating at Scale: Legal Considerations for Growth-Stage Health AI Companies
Scaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.
DEA Delays Implementation of Final Teleprescribing Rules—What’s Next for Telehealth Prescribing?
The DEA has delayed implementation of two major teleprescribing rules until December 31, 2025, citing stakeholder concerns about patient access and pharmacy burden. While current pandemic-era flexibilities remain in place, the future of telehealth prescribing, especially for opioid use disorder treatment, remains uncertain as regulators weigh next steps.
State Health Privacy Laws Expand Beyond HIPAA: What Healthcare Businesses Need to Know About NYHIPA
New York is the latest state to introduce its own health privacy law, the NY Health Information Privacy Act (NYHIPA), signaling a growing trend of state-level regulations extending beyond HIPAA. If enacted, NYHIPA will impose strict requirements on how businesses—both inside and outside the healthcare industry—collect, process, and share consumer health data, making compliance a priority for many organizations.
OIG’s Remote Patient Monitoring Audits Are Here: What You Need to Know
OIG’s increased oversight of Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) has led to a surge in Medicare audits, with a focus on documentation, medical necessity, and compliance with billing requirements. To stay compliant, organizations should ensure clear documentation, conduct proactive compliance assessments, and seek legal guidance when responding to audits.
FDA Resolves Semaglutide Shortage: What This Means for GLP-1 Compounding Pharmacies and Telehealth Weight Loss Companies
The removal of semaglutide from the Drug Shortage List will have a significant impact on the way telehealth practices and compounding pharmacies handle this medication. With the normal FDA restrictions on compounding set to take effect once again, practices and pharmacies need to be aware of the deadlines and regulatory requirements that come with this change.
Navigating Uncertainty: How Healthcare Innovators can Lead in Times of Change
Now is the time for action. Those who embrace uncertainty, focus on enduring industry needs, and leverage technology to enhance the system will lead this next era of healthcare innovation.
Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch
Explore how state laws are shaping the future of AI in healthcare, focusing on transparency, consumer rights, and algorithmic fairness. As regulations evolve, healthcare AI innovators must adapt to ensure compliance and equitable outcomes in a multi-jurisdictional landscape.
AI in Healthcare 2025: Navigating New Frontiers in Innovation and Regulation
The rapid growth in investment and adoption of AI in healthcare in 2024 brings a new wave of legal and regulatory developments. As we kick off 2025, those deploying AI in healthcare must be cognizant of new compliance requirements under federal and state law.
Trends and Opportunities for Digital Health Innovators in 2025
Discover the top trends and opportunities for digital health innovators in 2025, from AI adoption and value-based care to regulatory shifts and cybersecurity challenges. These insights from Nixon Law Group will help you navigate the year ahead.