Resources
for You and Your Team
What is the CMS ASPIRE Model? A 10-Year Value-Based Care Roadmap for Digital Health
The CMS ASPIRE Model (Accelerating State Pediatric Innovation Readiness and Effectiveness) is a landmark 10-year initiative launched in 2026 to transform pediatric care for Medicaid and CHIP beneficiaries. By moving from Fee-For-Service to a Value-Based Care (VBC) framework, ASPIRE incentivizes "whole-person" health for youth up to age 21. For digital health innovators, the model creates a critical demand for interoperable care management, AI-driven risk stratification, and unified care plans that bridge clinical, school, and home environments.
OIG Work Plan Targets Chronic Care Management: What Care Management Companies and Investors Need to Know
The OIG’s 2026 Work Plan includes a major audit of Medicare Chronic Care Management (CCM) services, focusing on eligibility, documentation, and vendor oversight. With rising Part B payments, regulators are targeting compliance risks tied to “multiple chronic conditions” requirements. This article outlines key audit triggers, common red flags, and how care management companies and investors can proactively strengthen compliance ahead of federal scrutiny.
Is the ACCESS Model the Secret to Tech-Driven Care Management Maintenance?
The Centers for Medicare & Medicaid Services ACCESS Model may seem like a reimbursement downgrade from traditional Virtual Care Management—but it could be the missing link in tech-enabled chronic care maintenance. Instead of rewarding episodic, labor-intensive interventions, ACCESS supports continuous, AI-enhanced oversight that keeps stabilized patients engaged and reduces readmission risk. Here’s why this shift could redefine scalability in value-based care.
Women’s Health & FemTech in 2026: 5 Compliance Pillars for Founders
In 2026, compliance is a competitive advantage in women’s health and FemTech. This article breaks down five critical pillars founders must address—from reproductive data privacy and FDA regulation to AI governance, corporate practice of medicine, and intellectual property strategy—to build trust, attract investment, and scale responsibly.
National Privacy Day: A Data Privacy Check-In for Digital Health and Wellness Companies
Is your digital health privacy strategy keeping pace with your technology? On National Privacy Day, we explore why privacy is a core business driver for telehealth, AI, and RPM innovators. From navigating the intersection of HIPAA and state consumer health laws to managing AI data governance and FDA cybersecurity, discover the five critical questions every healthcare leader must answer to ensure compliance, investor confidence, and long-term scalability.
FDA Relaxes Clinical Decision Support and General Wellness Guidance: What It Means for Generative AI and Consumer Wearables
In January 2026, FDA issued major updates to its Clinical Decision Support and General Wellness guidance, signaling a more innovation-friendly approach to generative AI, clinical copilots, and consumer wearables. This post explains what changed, which AI tools can now remain outside FDA regulation, and how digital health companies can design for compliance while accelerating time to market.
CMS Announces MAHA ELEVATE Model: A New Opportunity to Shape Reimbursement for Lifestyle, Functional, and Whole-Person Care Services
CMS’s new MAHA ELEVATE Model offers $100M in funding to evaluate evidence-based lifestyle, functional, and whole-person care interventions not currently covered by Medicare. Launching in 2026, this initiative creates a pathway for healthcare innovators, digital health companies, and care organizations to influence future Medicare coverage and reimbursement for chronic disease prevention and management.
The 2026 MPFS Final Rule: A Pivot Point for Digital Health in RHCs and FQHCs
The CMS CY 2026 MPFS Final Rule ends simplified G-code billing (G0071, G0512) for safety net providers. FQHCs and RHCs must shift to granular CPT/HCPCS coding for virtual check-ins, Chronic Care Management (CCM), and Behavioral Health Integration (BHI). This structural change is a major product roadmap update for digital health vendors serving the rural and community health market. Learn the 4 key billing changes to maintain revenue for your RHC/FQHC partners.
FDA Launches TEMPO: What Digital Health Innovators Need to Know Now
FDA’s new TEMPO pilot creates a flexible, real-world evidence pathway for digital health, SaMD, DTx, wearables, and AI-enabled devices—aligned with CMS’s ACCESS model. Learn how innovators can use enforcement discretion to deploy faster, collect RWD/RWE, and strengthen future FDA submissions.
CMS Launches ACCESS Model: The Tools Directory Opportunity for Digital Health Vendors
The CMS ACCESS Model is a 10-year Medicare payment demonstration promoting outcomes-based reimbursement for chronic care management. For digital health vendors—from remote monitoring and wearables to interoperability platforms—the accompanying ACCESS Tools Directory creates a critical, new entry point into the Medicare ecosystem. This post breaks down the shift to Outcome-Aligned Payments (OAPs) and provides a compliance-forward strategy for listing your technology in the Directory to gain visibility and establish trust with Access Model Organizations (AMOs) before the July 1, 2026, launch.
Implementing a Privacy Program that Scales: Essential HIPAA Practices for Digital Health Companies
HIPAA compliance is more than encryption and security controls—it requires a scalable privacy program that matures as your digital health company grows. Learn how Privacy Risk Assessments, BAAs, staff training, and patient-rights workflows create a competitive advantage in today’s health tech landscape.
CMS Sharpens Focus on “Upstream Drivers” of Health in the 2026 Medicare Physician Fee Schedule
The final 2026 Medicare Physician Fee Schedule (MPFS) solidifies Medicare’s shift toward paying for the assessment and mitigation of "upstream drivers" (e.g., nutrition, housing, social support). Discover how the revised HCPCS G0136 for physical activity/nutrition assessment and the broadened HCPCS G0019 descriptor for Community Health Integration (CHI) unlock new, aligned reimbursement streams for digital health and comprehensive care models. Also, learn how MFTs and MHCs can now initiate CHI services.
FDA Advisory Committee Signals New Regulatory Expectations for Generative AI in Digital Mental Health: What Innovators Need to Know Now
On November 6, 2025, the FDA’s Digital Health Advisory Committee delivered a clear message to the generative AI DMH sector: expect greater structure and tighter oversight. This article breaks down the 6 key themes—including the need for a new risk taxonomy, model drift management, and clinician-supervised use—and provides 5 immediate actions developers, deployers, and investors must prioritize to navigate the evolving regulatory landscape.
How States Are Enforcing New AI Laws in Healthcare—and Why It Matters
States are rapidly passing new laws to regulate Artificial Intelligence (AI) in healthcare, covering everything from mental health chatbots to AI-generated patient communications. The enforcement landscape is fragmented: some states rely on high administrative fines (up to $\$15,000$ per day), others empower Medical Boards, and some even grant a private right of action for consumers. For national digital health solutions, this patchwork of risk requires immediate mapping and proactive AI governance.
California Cracks Down on MSOs and Private Equity Influence: What Digital Health Companies Must Know
California has escalated its oversight of Management Services Organizations (MSOs) and private investment in healthcare. With the signing of SB-351 and AB-1415, the state reinforces the Corporate Practice of Medicine (CPOM) by banning interference with clinical judgment and introducing mandatory transaction and data reporting to the Office of Health Care Affordability (OHCA). Digital health enterprises using the MSO-PC model must reassess their structures, workflows, and governance to ensure compliance and avoid penalties.