Your trusted partner in navigating health regulation complexity
Translating Regulation
The regulatory process has always been fairly difficult to translate and formalize into one general best practice. Over the past decade, federal agencies (such as CMS, FDA, ONC, and others) have moved from their independent silos
to a more coordinated regulatory process. This has
created a more complex terrain to navigate for
businesses.
As former authors and directors of federal
regulations and programs, our experts at Elevation
support regulatory coordination. However, we have
quickly realized the barriers companies face in
conducting regulatory due diligence. Elevation was
uniquely created with a strategic combination of
regulatory expertise and real-world operators.
We provide health technology companies with regulatory due diligence for the most important and highly impactful national policy verticals
Companies must steer through these verticals to thrive in today's heavily regulated healthcare market.
Reimbursement Analysis
Translating available payment codes into sustainable health tech business models that align with real world health delivery workflows.
Revenue Strategies
Understanding the intent behind federal, state, and private payer policies to create product strategies that accounts for current and emerging reimbursement options.
Complex Payment Models
Design your product and services to optimize the data collection necessary to support required documentation for various payment models.
Billing Algorithms
Tailor the application and implementation of available payment codes to match provider workflows and ensure a return of investment in your health tech products.
FDA Navigation
Align to the right approval pathway in the midst of evolving FDA policies and programs to maximize R&D budgets and accelerate go-to-market timelines and compete at the highest of levels.
Approval Processing
Evaluate the capabilities and intended use of your products against FDA regulatory requirements and capitalize on FDA programs intended to streamline the device approval process.
Revenue Analysis and Forecasting
Complete product business model due diligence to ensure that designs meet client end goals, such as payer requirements, to prevent go-to-market delays.
Compliance and Growth
Set your company up to properly collect required data to ensure product safety and support the evolution of your product for future FDA approval mandates.
Interoperability and Data Guidance
Bridging data exchange policies with product design to optimize the end-user experience reimbursement capabilities.
Regulatory Compliance
Ensure that your product is collecting, storing, and exchanging health data in a manner that aligns with federal and state data sharing policies.
Product and Integration Strategy
Enable your clients to collect and exchange the data necessary to meet the regulatory requirements for reimbursement and reporting.
Government & Regulatory Partnering
Showcase your products capabilities to national audiences by partnering with policy makers wanting to test real-world applications of data sharing goals.
Advocacy
Move from reacting to new regulations to shaping policy conversations and leading your market.
Influencing regulatory language
Drive the next generation of regulatory requirements to match the business environments where your company can thrive.
Educating policy makers
Inform policy makers on the regulatory support you will need to remain sustainable while improving health outcomes.
Ensuring Sector Leadership
Capture greater market share through recognition as a industry influencer and steer your product in a direction where policy and patients are optimally intertwined.
Regulatory alignment for the next generation of health tech companies
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