Capitol Street assists clients with policy landscape analyses regularly.

Due diligence project costs vary depending on the activities required. The end result may be a slide deck, board presentation, white paper and/or business brief that outlines the topic/issue relevant opportunities, potential risks (scenario analysis), and other factors that pertain to the client’s investment, or corporate policy, and decision making.

Our due diligence projects often provide a comprehensive review of reimbursement considerations and pathways at CMS, including recommendations on the best path forward. We also assess legislative policy & odds of enactment with industry winners & losers, FDA precedent approval decisions, competitive factors, and pricing analysis.

Overviews of four recent projects can be found below.

Project 1

Medicare Advantage: Tech-Enabled Platform Investment Opportunity

  • Project Duration: 2 weeks

  • Project Deliverables: Business brief: relevant charts, graphs, statistics

Scope of Work

  • Market Segmentation

    • Disruptors coming to market
    • MA plans in space
    • Value-based care landscape
    • Potential to move into commercial, marketplace, and other insurance lines

  • Technology

    • Assessment of technology (nuances, pros, cons)
    • Market research: interviews with AHIP, AHA, State Exchanges, Software engineers, Quality metrics and Physician satisfaction
    • Market-by-market analysis

  • Founder, Exec Team & Investors

    • Knowledge of key players, policy advisors & individuals in the MA space allowed us to quickly assess management team, cadre of advisors
    • Investor caliber

  • Focused Q&A

    • Would we invest or not? Why?
    • Risks to technology, opportunities?

Project 2

Medical Technology Co Regulatory & Reimbursement Outlook

  • Project Duration: Under 3 weeks
  • Project Deliverables: Slide deck, presentation and Q&A with relevant charts, graphs, statistics

Scope of Work

  • FDA – Class 2 Device

    • Pathway description & timelines, common roadblocks
    • 510(k) approval metrics (and similar device combo stats)
    • Potential hurdles and slowdown reasons: Overall and specific to Product X
    • Predicate devices: clinical & analytical validity
    • Similar devices, lessons learned
  • Combination Device + OTC Clearance Requirements

    • Combination products special features & issues
    • FDA reviewers involved / biases of late as observed by regulatory consultants, trades and companies themselves
  • Testing and Information to be Collected for a 510(k) & Remote Monitoring

    • Biocompatibility, sterility, software validation & verification
    • Performance testing & Medical device EMC Testing
    • Software pre-certification process
    • Telehealth & cloud storage – FDA stance, viewpoints
    • Artificial intelligence (AI) considerations
  • Costs

    • Concept to clearance
    • Costs of development

  • FDA Trends & Politics Impacting Product X

    • Recent FDA slowdowns @ CDRH (And CDER) – Why & whether impactful here
    • Legislation altering FDA/510(k) process & user fee authorization (MDUFA) policies
    • Staffing & other current agency issues
    • FDA Commissioner Rob Califf & CDRH’s Jeff Shuren on 510(k) and equity in clinical trials, smart phones, remote patient monitoring (RPM)
  • CMS Coding, Coverage & Reimbursement Analysis

    • Pricing options in the marketplace, competitor analysis & outlook (rebates, discounts, couponing)
    • Private pay coverage and analysis (United, Elevance, Cigna etc)
  • Other

    • Antitrust concerns form FTC/DOJ
    • Trade association & stakeholder analysis of positions over policy debate
    • Congressional member interest & relevant bills that impact technology i.e., data privacy
    • Health equity & social determinant considerations as technology impacts disproportionately Hispanic, African American and Asian populations

Project 3

CAR-M Market Opportunity & Competitor Analysis

  • Project Duration: 6 weeks
  • Project Deliverables: White paper with Capitol Street projections, relevant charts, graphs, statistics

Scope of Work

  • Market Segmentation

    • Melanoma overview
    • Populations of concern
    • Metastatic solid tumors overview (breast, stomach, prostate)
    • CAR macrophage programming & mechanism
  • Competitive Landscape

    • Current standards of care
    • CAR t & CAR M therapies
    • mRNA oncologic vaccinations in development
    • Late-stage candidate

  • Regulatory Pathway

    • Oncology Center of Excellence
    • Key CDER/CBER thought leaders & approval trends
    • Preclinical
    • Investigational new drugs (IND)
    • Phase 1-3 clinical trials
    • New drug application (NDA)
    • Accelerated approval
    • Fast track designation
    • Breakthrough therapy designation
  • Financing Strategy

    • Funding sources
    • Investment models
    • Revenue models

Project 4

Company A’s Purchase of Company B’s Women’s Health Medical Device Assets

  • Project Duration: 6 weeks

  • Project Deliverables:

    • 25 page assessment with relevant charts, market research analysis, graphs, call out boxes, footnotes
    • Executive summary with 6 pointed questions related to risk of policy impacting investment
    • Board presentation (NYC)

Scope of Work

  • ACA contraceptive mandate
  • Executive order analysis
  • State-specific laws moving through chambers & trends among certain tranches of states
  • Conscience rule
  • Title X
  • Short term limited duration plan analyses
  • Association health plans
  • Medicare for All / single payer considerations
  • Catholic and religious institution coverage policies
  • Election politics