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The Missing European Liability

The Missing European Liability

by Meghan Pallardy | Nov 20, 2023 | Energy & Environment (Insights), Featured Article, Insights

By Charlotte Bucchioni, Capstone Energy Analyst November 20, 2023 Capstone’s analysis of the differing operating environments for companies operating in both the US and the European Union often highlights several underappreciated dynamics in their respective policy...

WSJ: 3M, DuPont, Other Makers Expected to Face New Drinking Water Rules on ‘Forever Chemicals’

by Meghan Pallardy | Jan 4, 2023 | Energy & Environment (In the News), In the News

December 21, 2022

NORTH AMERICA

WASHINGTON, DC
1401 New York Ave NW, Ste 600
Washington, DC 20005
202-449-9862

NEW YORK
420 Lexington Ave, Ste 940
New York, NY 10170

HOUSTON
3040 Post Oak Blvd, Ste 1000
Houston, TX 77056

EUROPE

LONDON
7 Howick Place
London, SW1P 1BB

PARIS
15 Rue Feydeau, Room 309
75002 Paris, France

 

ASIA

MUMBAI
One BKC
Plot no. C-66, G Block, Bandra Kurla Complex
Bandra East, Mumbai - 400051

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The investment adviser or investment adviser representative in question may only transact business in this state if first licensed, excluded, or exempted from the state investment adviser or investment adviser representative licensing requirements; and individualized responses to persons in this state by the investment adviser or investment adviser representative that involve either effecting or attempting to effect transactions in securities, or rendering of personalized investment advice for compensation, will not be made without compliance with the state investment adviser or investment adviser representative licensing requirements, or an applicable exemption or exclusion.

Oncology-Focused Specialty Pharmacy

Overview: Capstone evaluated the policy environment surrounding the pharmacy supply chain, including impact analysis of pharmacy reform and Medicare Part D landscape. This included a unit economic evaluation of 15 drugs of the clients’ selection, history of PDUFA legislation, and impact analysis of the Inflation Reduction Act, PBM reform, and reform to Medicare’s six protected classes on the company.

Process: Capstone spoke with 40+ key stakeholders, including:

  • Executives at major payors and PBMs;
  • Top advocates at prominent industry associations; and
  • Key governmental stakeholders.

Capstone analyzed the target’s proprietary claims data to determine the acquisition and reimbursement costs, relevant to benchmarks like WAC, AWP, and NADAC.

Capstone analyzed the target’s reimbursement and market share compared to other key competitors using the 100% Part D Events file, allowing fine-tuned and accurate market comparative analysis.

Deliverable: Capstone provided an in-depth, 150-slide final deck, analyzing both the political outlook that would impact their economics and building drug-level trends in AWP, WAC, NADAC, reimbursement, and drug-level market share compared to pharmacy competitors.

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Home Infusion Pharmacy

Overview: Capstone evaluated the impacts of the Inflation Reduction Act, including implications of the carve-out of IVIG products from IRA negotiation, Medicare Part D redesign, and inflation rebates in Medicare Part D, Part B, and Medicaid. This also included an overview of drug-level trends (2018-2024) in AWP, WAC, ASP, and Medicare Part D reimbursement trends by payor using 100% Part D PDE/claims file.

Process: Capstone spoke with 60 key stakeholders, including:

  • Executives and decision-makers at major pharmaceutical manufacturers;
  • Top leaders at influential payors/PBMs; and
  • Seasoned experts at major providers.

Capstone analyzed the target’s reimbursement and market share compared to other key competitors using the 100% Part D Prescription Drug Events (PDE) file, allowing fine-tuned and accurate market comparative analysis.

Deliverable: Capstone provided an in-depth 100+ slide final deck, including analysis and impact of the unique relationship between IVIG and SCIG manufacturers and PBMs.

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European Generics Manufacturer

Overview: Capstone evaluated the national and international policy environment impacting generic drug markets in seven key European markets. This included an in-depth country-by-country analysis of drug pricing and reimbursement schemes, efforts to expand generic uptake, and outlook for regulations to drive or limit utilization of generic drugs.

Process: Capstone spoke with more than 40 key stakeholders, including:

  • Executives and other decision-makers at major manufacturers; Advocates and lobbyists for industry peers; and
  • Legal experts on pharmaceutical pricing and drug approval processes.

Deliverable: Capstone provided an in-depth 170+ slide final deck, including opportunities for both risk mitigation and service expansion driven by policy headwinds or tailwinds.

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Clinical Trial Site Management Organization

Overview: Capstone evaluated the national policy environment impacting pharmaceutical research and development policy and the clinical trial pipeline. This included an in-depth analysis of the NIH grant lifecycle, history of PDUFA legislation, and outlook for NIH funding disruptions to the pre-clinical timeline.

Process: Capstone spoke with 35 key stakeholders, including:

  • Experts from leading academic and commercial medical research institutions;
  • Executives and decision-makers at major pharmaceutical manufacturers;
  • Policymakers from key offices and agencies.

Deliverable: Capstone provided an in-depth 75+ slide final deck, including analysis and commentary of recent, relevant headlines and a scenario analysis of the possible impacts of the Trump administration’s proposed changes.

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Opioid Treatment Expansion Opportunity

Overview: Capstone analyzed the outlook for passage of the Modernizing Opioid Treatment Access Act (MOTAA) and assessed the outlook for states to align themselves with new federal policy on the regulation of opioid treatment programs. Specifically, we analyzed the outlook for changes in operations by other operators in the OTP ecosystems, including pharmacies, OTP take-home prescription practices, and pharmaceutical manufacturers participating with the new channel.

Process: Capstone spoke with more than 3 dozen key stakeholders, including:

  • State opioid treatment authorities, providers, and payors, including chief medical officers and members of state medical boards;
  • State lawmakers, federal affairs officials, and state Medicaid agencies; and
  • Various associations and industry groups, such as the American Society of Addiction Medicine (ASAM).
  • Large, national retail pharmacies

Deliverable: Capstone provided an in-depth 47-slide final deck outlining the impact of the potential passage and implications of MOTAA nationally and in 10 states of the client’s choosing.

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Hospital RCM Platform

Overview: Capstone analyzed potential policy options as part of the One Big Beautiful Bill Act and outlined their respective impacts on total Medicaid enrollment and hospitals. As part of our work, we projected changes in both Medicaid enrollment and applications and surveyed hospitals for needs associated with beneficiary enrollment into Medicaid.

Process: Capstone spoke with roughly 2 dozen key stakeholders, including:

  • Relevant policymakers in both the House and Senate;
  • Revenue cycle directors in major hospital systems; and
  • State Medicaid directors.

•Deliverable: Capstone provided an in-depth ~50 slide final deck, including an analysis of the most likely final OBBBA package and associated impacts to Medicaid enrollment over the next decade.

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Home Health & Hospice EHR Solution

Overview: Capstone provided an overview of payment structures across systems, outlining how the core value propositions of the Company aligned with provider incentives. Additionally, Capstone provided an outlook for regulatory changes that could affect the value of the company’s services, including both payment structure reform and reimbursement changes that could impact provider ability to pay.

Process: Capstone spoke with ~20 stakeholders, including providers, payors, competitors, and lead lobbyists behind the home health and hospice industries.

Capstone assessed interoperability-associated disintermediation risk, including analysis of trends toward digital quality reporting, digital HEDIS, bulk FHIR APIs, and national data exchange through TEFCA.

Deliverable: Capstone provided an in-depth 50-slide deck, including an analysis of ROI for the company’s primary offerings and 5-year reimbursement outlooks for respective industries.

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Applied Behavior Analysis Provider

Overview: Capstone evaluated the policy and reimbursement environment impacting the applied behavior analysis space in key states. This included an analysis of healthcare regulatory dynamics such as minimum wage requirements and scrutiny of PE ownership, as well as commercial and Medicaid reimbursement rate trends.

Process: Capstone spoke with more than 3 dozen key stakeholders, including:

  • ABA providers and payors, including medical directors, BCBAs, RBTs, and behavior case managers;
  • State lawmakers, government affairs officials, and state Medicaid agencies; and
  • Various autism advocacy organizations.

Deliverable: Capstone provided an in-depth 65-slide final deck outlining the impact of healthcare policy on an ABA provider, as well as Medicaid and commercial reimbursement rate outlook over the next 3-5 years.

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Personal Care Services Provider

Overview: Capstone provided an overview and outlook of policies impacting personal care services in Arizona, including historical rate volume trends for the target’s top services and a scenario analysis detailing how policy changes would impact those trends. This included assessing perspectives on the value and utilization growth of personal care services and levers available to both the state and payors to potentially limit/encourage growth.

Process: Capstone spoke with roughly 2 dozen key stakeholders, including:

  • Experts from managed care organizations;
  • Key providers in the home care space; and
  • Advocates in other states.

Deliverable: Capstone provided an in-depth, 30+ slide final deck, including an analysis of risks to the current structure and offerings of personal care benefits within Arizona Medicaid.

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Global Fertility Clinic

Overview: Capstone evaluated the policy environment impacting the fertility benefits space in the US and Europe. This included an analysis of utilization trends, efforts to expand access to IVF, outlook for coverage expansion, and thesis development on fertility services in a post-Dobbs world.

Process: Capstone spoke with more than 3 dozen key stakeholders, including:

  • Large fertility providers, reproductive tissue banks, and academic centers;
  • State lawmakers, government affairs officials, and lobbyists for industry peers; and
  • Various reproductive rights associations.

Deliverable: Capstone provided an in-depth, 75-slide final deck, along with regular update calls on the developing policy environment and relevant court cases impacting the global fertility space.

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Multi-State Ambulatory Surgical Center Platform

Overview: Capstone analyzed historical and go-forward commercial and Medicare reimbursement for major ASC services, procedures, and top infused products. Additionally, Capstone analyzed state certificate of need policies, Medicaid supplemental payment programs, and site of care trends on a code-by-code basis.

Process: Capstone spoke with ~20 key stakeholders, including:

  • National and regional payors;
  • Competitors; and
  • Policymakers and industry lobbying groups.

Our work outlined how major policy changes in the ASC payment system, including shifts in the covered procedure list and annual rate updates, and implementation of the IRA would affect reimbursement for the company’s top services and products over the next 5-7 years.

Capstone surveyed top payors to identify priorities in shifts of services from the hospital to the ASC setting, including incentives and preferences given to contracted providers.

Overview: Capstone provided an in-depth, 50+ slide final deck with an additional 100-slide appendix and Excel supplement highlighting variance in commercial reimbursement on a payor and provider-specific basis for all key codes and drugs.

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Value-Based Care Enablement Platform

Overview: Capstone evaluated the policy landscape, market opportunity, and competitive landscape for a value-based care enablement tool focused on quality and risk assessment across payor verticals, including Medicare Advantage, Medicaid, and commercial insurers. Capstone’s analysis focused on federal regulation and state regulatory dynamics in 6 key states, as well as key market dynamics.

Process: Capstone performed primary and secondary market research, including:

  • Speaking with 20 key regulators/stakeholders; and
  • Surveying 60 end-user decision makers of VBC enablement tools.

Capstone estimated the market opportunity and forecasted the TAM, SAM, and VM for the company’s core customers using enrollment and VBC data sets.

Capstone defined the competitive landscape for the company’s core services and geographic expansion opportunity.

Capstone gathered market perspectives from current operators and customers.

Capstone assessed interoperability-associated disintermediation risk, including analysis of trends toward digital quality reporting, digital HEDIS, bulk FHIR APIs, and national data exchange through TEFCA.

Deliverable: Capstone provided an in-depth, 170-slide deck for our client’s deal team on key policy and commercial issues, as well as a 15-slide investment committee deck distilling key takeaways for the client.

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Medicare Advantage Risk Bearing Provider

Overview: Capstone evaluated the federal regulatory landscape surrounding a value-based care provider that takes full delegated risk from both Medicare Advantage plans and participates in Medicare FFS programs, such as MSSP and ACO REACH. Capstone’s analysis focused on deriving the per-member-per-month (PMPM) increase or decrease to the Company’s revenue as a result of proposed federal laws and regulations, as well as an analysis of the health of the Medicare Advantage and Medicare FFS end markets based on recent history.

Process: Capstone spoke with key regulators/stakeholders, including:

  • Federal and state lawmakers;
  • Key decision makers for value-based contracting at Medicare Advantage plans; and
  • Key decision makers at value-based care providers.

Capstone estimated the per-member-per-month impact of proposed federal laws and regulations to quantify the impact of passage on value-based care providers.

Capstone created a fan of outcomes for potential changes in contracting dynamics among national, regional, and “blues” payors with VBC partners to understand the potential risks or opportunities for provider partners over the next 5 years.

Deliverable: Capstone provided an in-depth, 80-slide deck for our client’s deal team on key policy and contracting dynamic questions, as well as a 10-slide deck distilling key takeaways for the client to present to their investment committee.

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A Recruiting Platform for Motor Carriers

magnifying glass

We added value by…

Predicting the policy around federal autonomous vehicle rules and their likely adoption timeline

Quantifying the impact of the deployment of automated driver systems and changes in worker classification laws on driver supply

Creating a strategy for the company to navigate the regulatory landscape and position products with motor carriers

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A Semiconductor Equipment Manufacturer

semiconductor chip

We added value by…

Predicting the policy for semiconductor incentives in the US and abroad

Quantifying the impact of CHIPS Act funding on the manufacturer’s R&D initiatives and other operations

Creating a strategy to qualify for subsidies as a non-traditional contractor and upstream supplier

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A Global Media Analytics Firm

connected people

We added value by…

Predicting the policy landscape by assessing sanction and payment risks

Quantifying the impact of sanctions and export controls that would prevent the company from operating in specific regions

Creating a strategy for company leadership to evaluate third-party resources, develop a licensing plan, and network with US Embassies

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Post Hurricane Economic Outlook in Puerto Rico

house in storm

We added value by…

Predicting the policy surrounding continued federal support of essential services and disaster recovery efforts in Puerto Rico

Quantifying the impact that federal funding and the restructuring of Puerto Rico’s debt obligations would have on Gross Domestic Product and read throughs to the local economy

Creating a strategy for investors to take advantage of this improvement in the economic outlook by investing in a consumer lending company based in Puerto Rico

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A Payment Processor in Alcohol Distribution

beer bottles

We added value by…

Predicting the policy surrounding the three-tier model for alcohol distribution

Quantifying the impact of state-level changes to alcohol distribution policies and the risk posed to alcohol distributors from retailers engaging in self distribution and consumers purchasing from out-of-state vendors

Creating a strategy for the company to grow its revenue base in an increasingly competitive alcohol distribution market

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An Airport Services P3 Operator

airport terminal

We added value by…

Predicting the policy and regulatory environment surrounding airport security with respect to inbound logistics to airport terminals

Quantifying the impact of future changes in airport security and investments in airport expansions funded through the bipartisan infrastructure law

Creating a strategy for the company to best position itself for future contracting opportunities in the security screening and logistics space

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A Supplemental Benefits Vendor

heartbeat

We added value by…

Predicting the policy landscape in US healthcare to anticipate major changes impacting its markets

Quantifying the impact of these likely changes on the company’s revenue drivers, such as federal health programs and employer insurance markets

Creating a strategy for C-suite leadership to inform new market entry, revenue optimization, and effectively execute stakeholder building, communications, and advocacy

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A Retirement Custody Solutions Provider

We added value by…

Predicting the policy surrounding specialized retirement custody solutions, such as automatic IRAs

Quantifying the impact of evolving federal policy on missing participants

Creating a strategy for investors to take advantage of efforts to expand access to retirement savings

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A Leading EdTech Company

online learning

We added value by…

Predicting the policy landscape around K-12 funding, assessment policy, and credentialing

Quantifying the impact of shifting economic scenarios on school budgets

Creating a strategy to approach state and local education agencies based on their needs

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A Leading Reverse Mortgage Lender

house

We added value by…

Predicting the policy around reverse mortgages

Quantifying the impact of shifting FHA policy changes that historically held back reverse mortgage volumes

Creating a strategy to avoid enforcement risk and benefit from a stabilizing policy environment around reverse mortgages

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An Integrated Shipping and Logistics Company

container ship

We added value by…

Predicting the policy outlook for the US shipping and logistics sector in the context of the Inflation Reduction Act (IRA)

Quantifying the impact of decarbonization incentives and requirements of specific IRA provisions to build a clean fuels and electrification strategy

Creating a strategy to engage the White House on its decarbonization plans and provide industry perspectives on IRA implementation

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An American Private Equity Firm

electric car

We added value by…

Predicting the policy and regulatory outlook for hydrogen, carbon capture and vehicle electrification in the Western United States

Quantifying the impact of nascent policy opportunities to create new revenue streams for the target

Creating a strategy to identify the most favorable policy-driven pathways for decarbonizing the target’s natural gas assets

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An American Private Equity Firm

airplane

We added value by…

Predicting the policy landscape around sustainable aviation fuel and renewable diesel in North America and Europe

Quantifying the impact of policy incentives for biofuel production in the United States and demand-side incentives from Canada and Europe

Creating a strategy to highlight the company’s expansion opportunities in the most favorable biofuel markets

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A Global Private Equity Firm

offshore wind turbines

We added value by…

Predicting the policy surrounding offshore wind interconnection and transmission infrastructure in the northeast and western United States

Quantifying the impact of federal grant opportunities and IRA tax incentives, in addition to state-level offshore wind solicitations

Creating a strategy to underscore the company’s funding opportunities and expansion potential in favorable states

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An At-Risk Primary Care Provider

stethoscope

We added value by…

Predicting the policy and rate changes for Medicare Advantage

Quantifying the impact on 10-year per-member-per-month revenue projections

Creating a strategy to optimize payments under various regulatory scenarios

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A 340B Company

pills

We added value by…

Predicting the policy and regulation for the 340B drug pricing program

Quantifying the impact of likely regulation and legislation on script revenue in on-site vs. contract pharmacies

Creating a strategy to gain an investment advantage in a volatile policy space

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A Risk Adjustment Vendor

medical records

We added value by…

Predicting the policy changes to Medicare Advantage and risk adjustment

Quantifying the impact of changes to the risk scoring system

Creating a strategy for investing into the risk adjustment ecosystem

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A UK Motor Vehicle Insurance Provider

electric car

We added value by…

Predicting the policy landscape outlook for tax incentives for electric vehicle purchases through salary sacrifice schemes

Quantifying the impact of higher Benefit-in-Kind tax rates on employee take-up rates of company car schemes

Creating a strategy around the broader UK transport decarbonization agenda and opportunities for car leasing

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A Global Private Equity Firm

revenue

We added value by…

Predicting the policy landscape for commission payments in the EU and Swedish insurance brokerage sector

Quantifying the impact of a ban on fund kickbacks on the company’s future revenue

Creating a strategy to offset the revenue loss by moving to a fee-based model

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A Hydrogen-Focused Energy Company

hydrogen molecule

We added value by…

Predicting the policy landscape around hydrogen in European countries the company was considering entering

Quantifying the impact of policy support on its market entry strategy in the next five years

Creating a strategy for our client to expand in the countries with the most favorable future markets

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An American Defense Company

wildfire

We helped our client…

Predict the policy and regulatory environment enabling US governments and utilities to adopt technology that supports wildfire prediction and mitigation

Quantify the impact of future spending on technology investment for wildfire fighting to inform the strategy development of a new service offering

Create a strategy for the company to design its products with an informed view of customer needs and procurement requirements, as well as build a complementary strategic engagement strategy to soften the ground for its public sector-focused products and services

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A Global Energy Corporation

pipeline

We added value by…

Predicting the policy and regulatory outlook for Carbon Capture and Storage and CO2 pipelines in the Midwestern United States

Quantifying the impact of Midwestern regulatory developments and stakeholder perspectives on the company’s project

Creating a strategy to mitigate risk while maximizing the likelihood that the company’s project succeeds

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A US-Based Global Airline

airplane

We added value by…

Predicting the policy landscape around sustainable aviation fuel (SAF)

Quantifying the impact of policy support on the company’s investment plans over the next five years

Creating a strategy for building a SAF ecosystem among the industry and its suppliers to help the company achieve its sustainability goals

Connect

A Major Korean Conglomerate

skyscrapers

We added value by…

Predicting the policy landscape around the introduction of voluntary environmental protection credits

Quantifying the impact of the voluntary credits as a new revenue stream for decarbonization projects

Creating a strategy for the Chair’s office to become a leader in this space and incentivize the private sector to decarbonize without direct government support

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A Global Transit Infrastructure Company

elevator

We added value by…

Predicting the policy landscape around the Biden administration’s infrastructure bill before its passage to anticipate areas of opportunity

Quantifying the impact of new funding on the company’s existing and potential customer base, as well as how their customers will likely invest the funds

Creating a strategy to utilize billions of dollars in pre-RFP projects that helped the client prioritize regions and projects for their broker-dealer teams and get ahead of the competition

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A Global Mining Company

sledgehammer

We added value by…

Predicting the policy landscape around US mining reform efforts in response to global critical mineral supply chain shortages

Quantifying the impact of geopolitical instability and supply chain shortages on the company

Creating a strategy to domesticate the company’s critical mineral supply chain, minimizing geopolitical risk

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