Charlie Speno

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.