Medical Device Access in Value-Based Care: New Strategies for Navigating Evolving Payer Requirements

The Changing Coverage Landscape

Coverage decisions for medical devices no longer focus solely on safety and efficacy, creating a more complex environment for manufacturers to navigate. Payer medical review teams evaluate devices and associated procedures through multiple lenses, requiring manufacturers to understand the following market access drivers:

• Total cost of care impacts and economic evidence requirements
• Quality metric requirements and outcomes tracking
• Site-of-service optimization and restrictions
• Risk-sharing arrangements and value-based contracts
• Documentation requirements across different care settings

Traditional coverage monitoring methods struggle to keep pace with these changes—but Policy Reporter helps manufacturers stay ahead by delivering timely, targeted insights into evolving payer requirements and coverage decisions.

Supporting Provider Success

Healthcare providers face their own challenges when using new medical devices. They must understand specific coverage requirements, documentation needs, and payment policies - all while managing patient care. Device manufacturers who help providers navigate these complexities gain a significant competitive advantage. Key ways in which manufacturers can support providers include:

• Providing clear and up-to-date information on coverage requirements by site of service
• Communicating updated payment and coding information for their device
• Enabling access to documentation templates and requirements
• Providing quick access to relevant coverage policies and authorization support materials
• Understanding site-specific requirements and restrictions

Monitoring State-Level Changes

State legislation increasingly affects medical device access and coverage. New laws can impact everything from prior authorization requirements to payment policies – for instance:

Connecticut enacted a law effective July 1, 2024, eliminating prior authorization for wheelchair repairs and mandating a 10-business-day repair deadline. Despite these measures, some users continue to face delays, highlighting challenges in implementation and compliance.

Minnesota passed legislation preventing prior authorization for certain services, including outpatient mental health care and some cancer treatments. The law also mandates that prior authorizations for chronic conditions remain valid as long as the treatment plan doesn't change, reducing administrative burdens for both providers and patients.

Wyoming introduced a "gold carding" program exempting providers with high prior authorization approval rates from PA requirements for specific services. The law also requires insurers to respond to urgent PA requests within 72 hours and to honor existing PAs for a grace period when patients switch insurance plans.

South Carolina expanded prior authorization requirements for physician-administered drugs under Medicaid, effective January 1, 2025. This includes additional medications requiring PA to ensure consistency with clinical guidelines.

New Jersey implemented the "Ensuring Transparency in Prior Authorization Act," requiring insurers to make PA determinations within three days (or 24 hours for urgent requests) and to publicly disclose services requiring PA.

Vermont enacted a law mandating that insurers respond to urgent prior authorization requests within 24 hours and honor existing PAs for up to 90 days when patients change insurance plans.

Leading manufacturers track these legislative changes to protect and enhance market access. Critical areas to monitor include:

• State-specific coverage mandates
• Prior authorization legislation
• Site-of-service requirements
• Payment model regulations
• Network adequacy rules
• Quality reporting requirements

Building an Effective Market Access Strategy Amidst the New Landscape

A winning medical device market access strategy today requires a comprehensive approach to intelligence gathering and analysis. A winning medical device market access strategy today requires a comprehensive approach to intelligence gathering and analysis. This goes beyond tracking FDA approvals or clinical trial outcomes. Manufacturers must actively monitor competitor policy updates, payer coverage decisions, and shifts in health system strategies. For example, a competitor securing positive coverage for a similar device, especially if tied to favorable site-of-service criteria or bundled payment incentives—can quickly shift provider preferences and displace existing products. Likewise, changes in documentation requirements or utilization management protocols can impact workflow efficiency and reimbursement, influencing provider adoption. At the health system level, economic pressures may drive decisions to standardize around devices with demonstrated total cost of care savings, even if clinical performance is similar. Without timely, targeted intelligence, manufacturers risk being reactive rather than strategic—missing opportunities to differentiate, align with payer priorities, or preempt competitive threats. Manufacturers need to understand current coverage landscapes while anticipating future changes. Key strategy elements include:

• Comprehensive policy monitoring across all payer types
• Value proposition alignment with quality metrics
• Payment model impact analysis
• Provider support programs
• State legislation tracking
• Competitive intelligence gathering

Policy Reporter’s suite of market access intelligence tools can help medical device manufacturers be efficient and effective in building their market access strategy.

Our Payer Landscape Dashboard provides a curated view of key coverage details so you can get a full picture view of your product’s coverage and that of competitors in the market.

Our Fee Schedule Lookup tool enables your teams to stay up to date on reimbursement rates, searchable by HCPCS or CPT code and payer.

And our PolicyCore database is your central location for live and historical policies and related documents, with real-time notifications of changes.

Looking Forward

Medical device manufacturers must expand their view of market access to encompass all factors affecting device adoption and use. Integrating a broad understanding of payer coverage expectations, offerings that enhance provider efficiency, and a competitive intelligence platform that supports insights into both manufacturers and legislation is increasingly becoming a necessary approach to device market access optimization. This broader perspective, supported by comprehensive intelligence and analytics, will drive success in an increasingly complex healthcare environment.