Medical Device
Cleared does not mean covered.
Know the difference before launch.
FDA clearance and payer coverage are two separate decisions. Polify maps every payer's coverage position for your device category, identifies the evidence gaps standing between you and coverage, and monitors the landscape as it evolves.
Note: Polify focuses on the medical benefit side of coverage. This includes devices and procedures covered under the medical benefit, as well as some drugs covered under the medical benefit. Polify does not monitor pharmaceutical drug coverage, step therapy edits, or formulary policy under the pharmacy benefit.
The coverage problem
FDA clearance and payer coverage are two separate decisions.
A 510(k) clearance or PMA approval establishes that a device is safe and effective. It does not establish that any payer will cover it. Coverage is determined independently by each payer, under their own evidentiary standards, on their own timeline. Many cleared devices reach the market with no coverage policy in place.
Coverage gaps are discovered after the sales infrastructure is built.
By the time a field team is trained and a territory is assigned, the coverage landscape should already be mapped. When it is not, the first calls surface objections that could have been anticipated. Coverage gaps found in the field are expensive to close.
Payer policies for a device category are not in one place.
Commercial payer policies, Medicare Local Coverage Determinations, and Medicaid managed care policies each live in separate systems, use different terminology, and update on different schedules. Assembling a complete picture manually takes weeks and goes stale immediately.
How it works
From device category to coverage strategy.
Map the current coverage landscape
Enter your device category or FDA clearance number. Polify maps current coverage positions across commercial payers, Medicare, and Medicaid, with the criteria each payer applies.
Identify evidence gaps by payer
Polify compares your evidence package against each payer's published evidentiary standards. Gaps are specific, cited, and actionable.
Build the market access strategy
With a complete coverage map and gap analysis in hand, your market access team can prioritize payer outreach, target evidence generation, and sequence the launch.
Monitor as the landscape evolves
Coverage policies change after launch. Polify monitors continuously and surfaces changes before they affect the field team or the revenue cycle.
What Polify provides for medical device teams
Coverage intelligence built for market access.
Coverage position mapping
Current coverage positions across commercial payers, Medicare LCDs, and Medicaid managed care for your device category. Which payers cover, which classify as investigational, and what criteria each applies.
Evidence gap analysis
Map the gap between your current evidence package and what each payer requires for coverage. Specific gaps by payer, with citations to the policy language that creates each gap.
Prior authorization requirements
PA requirements by payer and line of business, updated as payers revise their criteria. Know what documentation is required before the first claim is submitted.
Policy version history
Access the full version history of payer policies for your device category. Understand how coverage has evolved, when key changes occurred, and what the trajectory suggests about future policy movement.
Competitive coverage benchmarking
Compare coverage positions for your device against predicate devices and competitive alternatives. Identify where competitors have coverage advantages and what evidence drove those decisions.
Policy change monitoring
Continuous monitoring across all relevant payer policies. Alerts when coverage criteria, PA requirements, or coverage status changes for your device category.
Who uses Polify for device coverage
Built for every team that touches coverage.
Coverage intelligence is not a single team's problem. Market access, regulatory, revenue cycle, and clinical affairs all need current, accurate coverage data. Polify provides a shared source of truth across the organization.
What a coverage map includes
Know where your device stands before the first call.
Polify was built by people who understand how payer coverage decisions are made. The intelligence in the product reflects more than 20 years of payer policy experience.