Insights

In this episode of The Heart of Healthcare Podcast, our Managing Director Joe Mercer sits down with Steve Kraus to unpack the details of the One Big Beautiful Bill Act. It’s the most significant healthcare legislation since the ACA, with ripple effects across Medicaid, rural hospitals, and the ACA exchange. We cover: - What Medicaid work requirements could mean for coverage and churn - Why safety-net and rural hospitals are bracing for impact - How changes to provider taxes and state-directed payments shift funding dynamics - What happens when ACA subsidies start to expire - Where there may be operational opportunities for coverage tech and patient engagement solutions

Civil Investigative Demands (CIDs) are becoming one of the government’s most aggressive tools to investigate healthcare fraud. With the DOJ issuing a record number of CIDs and leveraging AI to flag outliers, healthcare organizations must be ready to respond with speed, accuracy, and insight. The tight deadlines and high stakes can create significant disruption for healthcare companies. Marwood combines regulatory expertise, proprietary analytics, and proven support to help clients respond to the government while minimizing disruption, and implement any required billing, coding, and compliance program changes.

The NHS 10-Year Health Plan, launched in July 2025, sets out a sweeping reform agenda in response to mounting pressures on the UK’s healthcare system. Triggered by Lord Darzi’s independent review, which warned that the NHS is in "critical condition", the Plan addresses deep-rooted challenges including long waiting times, workforce strain, and poor clinical outcomes. Framed around three core shifts - from hospital to community care, from analogue to digital systems, and from sickness to prevention - the Plan aims to modernise healthcare delivery, expand access, and improve long-term health outcomes. Key initiatives include a greater focus on primary and outpatient care, the rollout of a Single Patient Record, and new public health policies targeting chronic disease, obesity, and tobacco use. These reforms present significant opportunities for private sector providers across digital health, medtech, pharmaceuticals, outpatient services, and preventative care. However, success will require investors to navigate evolving market dynamics, regional implementation variations, and regulatory risks with careful, multi-level analysis.

Marwood Group, a leading healthcare advisory firm, is pleased to announce the appointment of Dr. Ritu Nalubola as Director. Dr. Nalubola brings 25 years of experience at the U.S. Food and Drug Administration (FDA), where she served in various senior leadership roles, most recently as the Associate Commissioner for Policy and the Acting Deputy Commissioner for Policy, Legislation, and International Affairs, where she also served as Deputy Director. She also held a diplomatic posting in the U.S. Mission to the European Union in Brussels as the Director of FDA Regional Office in Europe. Dr. Nalubola’s work at the FDA spanned a wide variety of areas within life sciences and public health. She spearheaded and advised on key policy priorities across biotech, digital healthtech, nanotech, artificial intelligence, and global regulatory cooperation. She led and contributed extensively to numerous FDA regulations and guidances throughout her tenure. “Dr. Nalubola’s deep expertise in FDA regulatory policy and global public health will be an invaluable asset to our clients,” said Joe Mercer, Managing Director, Marwood Group. “Her insight into FDA priorities and policymaking will accelerate Marwood’s growing leadership in life sciences and healthtech.” Dr. Nalubola earned her doctorate from Michigan State University and conducted postdoctoral work at Johns Hopkins University with the U.S. Agency for International Development, prior to joining the FDA. “I’m excited to join Marwood and help clients navigate today’s evolving regulatory landscape,” said Dr. Nalubola. “It’s a great opportunity to apply my public sector experience to support innovation and strategic decision-making across the healthcare industry.” Dr. Nalubola’s addition further enhances Marwood’s growing bench of senior experts advising clients on healthcare policy, regulatory affairs, reimbursement, and commercial strategy.

The specialty care referral process represents a complex intersection of clinical decision-making, operational efficiency, and financial performance. In an era of rising cost, an increasingly complex and value-based healthcare landscape, the seamless transition of patients from primary care to specialty services is paramount. For multi-specialty physician practices, a well-structured referral management system is not merely an administrative function but a strategic asset. Breakdowns in the referral process are common and a significant impediment to revenue growth, with a significant percentage of referrals not resulting in a completed appointment. This "leakage" represents a missed opportunity for both the patient and the specialty practice. In this whitepaper we provide a roadmap for multi-specialty practices to build a robust referral management ecosystem that addresses these challenges head-on.

The Labour Party’s victory in the July 2024 general election has ushered in a wave of policy commitments with new implications for Special Educational Needs and Disabilities (SEND) provision. Labour has signalled its intent to address longstanding challenges in the SEND sector, particularly through a “community-wide approach” to enhance inclusivity and support structures in mainstream education. However, the details of this approach remain ambiguous, prompting concerns among SEND stakeholders about practical implementation. Cost pressures from National Living Wage and National Insurance Contribution increases may threaten the viability of smaller independent SEND providers but could present opportunities for consolidation for larger players. For investors in independent special schools, Labour’s agenda presents potential risks and opportunities. The government’s commitment to maintaining special schools for children with the most complex needs offers some stability for high-acuity placements. However, broader moves toward mainstream inclusion, stronger local authority oversight, and evolving funding allocations could shift demand dynamics in the independent SEND sector. In this piece, Marwood examines Labour’s key SEND policies, the implications of new cost pressures for independent SEND providers, and the evolving funding landscape. We assess how these developments may affect the viability of independent special schools and explore strategic considerations for investors navigating this evolving market.

Historically, dermatology has been a key sector in the physician practice management (PPM) space for private equity (PE) firms, largely because the dermatology industry is characterized by diversity in payor and service mix, low concern from a cost management perspective, and favorable reimbursement variability. During COVID-19, investor interest in PPMs diminished due to utilization and revenue pressure, staffing shortages, and regulatory oversight of investment activity under the Biden administration. However, as we progress into the second Trump administration, PPMs are positioned for a reemergence in healthcare. Dermatology is well suited for this reemergence, as the sector is established, meaning it is not risky to be a first mover in, but does not see stagnation in development and demand. In this piece, Marwood explores the outlook for the dermatology PPM market, and why opportunities still exist for investors to add value.

As global demand for pharmaceutical and biotech products continues to rise, the market for CDMOs is expanding rapidly. Reports suggest that the European CDMO market is set to expand at a compound annual growth rate (CAGR) of 7.6% from 2025 to 2034, attracting significant attention from investors. Driving this surge is the rising demand for biologics and personalized medicine, along with cost pressures that are pushing pharmaceutical companies to increasingly outsource to CDMOs. While the market remains fragmented, consolidation is underway, with larger, PE-backed firms acquiring smaller CDMOs. High-growth segments, such as biologics, cell and gene therapies, and niche formulations, offer substantial investment opportunities.

Healthcare M&A is anticipated to surge significantly over the next five years. Several factors are fueling this trend, including an increase in both deal volume and size, a focus on rural healthcare, financial pressures, strategic consolidation, and the integration of new technologies. A critical yet often underestimated enabler of successful healthcare M&A is IT integration. Each deal presents unique challenges, shaped by market dynamics, organizational needs, and the nuances of different healthcare sectors. In this article, Marwood explores the growing trend of mergers and acquisitions (M&A) in healthcare, emphasizing the crucial role of IT integration in these complex transactions. It examines the factors driving M&A activity, the strategic importance of IT, potential challenges, and the key success factors. The aim is to demonstrate how effective IT integration can serve as a powerful tool for success in healthcare M&A.

Compounding Pharmacies play an important role in the US pharmacy ecosystem by fulfilling the need for customized drugs unmet by mass-produced products and by addressing commercial supply shortages. The market is an area of growing interest with favorable drivers driven by awareness and preference for personalized therapies, favorable population demographics, increasing disposable income, and frequent drug shortages in recent years. In this piece, Marwood explores the outlook for the Compounding Pharmacy market, including market sizing, dynamics of the top therapeutic areas, and key trends in the market.

While the 2024 Presidential and Congressional election cycle featured limited discussion of health care, 2025 has featured intense focus on the industry as President Trump staffs his administration and a full Republican lineup looks to pay for extending Tax Cuts and Jobs Act policies. Robert F. Kennedy, Jr. and Dr. Mehmet Oz represent a new type of political appointee for HHS and CMS, respectively. RFK, Jr. takes the helm at HHS as the Trump administration looks to reduce staff across HHS and reduce funding, including for NIH grants. For Dr. Oz, there are questions about how he will handle Inflation Reduction Act (IRA) drug pricing negotiations as well as Medicare Advantage policy. In Congress, Republicans look to extend tax cuts, Medicaid has been at the top of the list of potential cuts. The list of potential policies range from repealing Biden Medicaid rules, to imposing work requirements, to major changes to the program including limiting annual Medicaid growth and reducing the Medicaid expansion federal matching rate to the traditional Medicaid rate, which would eliminate expansion in many states. The search for Medicaid cuts has created tension among House and Senate Republicans, with fiscal hawks arguing for larger cuts while more moderate members and those from battleground states and districts uncomfortable with even more modest cuts. Congressional Republicans are intent on passing an extension of the tax cuts, so this will continue to be an issue until that goal is satisfied. Another key issue is the fate of the enhanced Affordable Care Act (ACA) exchange subsidies, initially passed as part of the American Rescue Plan in 2021 and extended in the IRA in 2022. Since 2021, over 12 million new enrollees have joined the exchanges, but the subsidies are set to expire at the end of 2025. It is not clear how Congressional Republicans could get on board with an extension, but there will be intense lobbying from providers, payors, and patients throughout 2025. Beyond these 2 major issues, there are a host of other issues, including physician fee schedule reform, the impact of the Department of Governmental Efficiency on Medicare and other government systems, and any read through from the IRA on pharma, Part D sponsors, and related entities, such as CROs. We hope you enjoy our latest Washington Health Care Policy Report.

The NHS priorities and operational planning guidance for 2025/26 presents an evolving landscape for investors and service providers, characterised by greater flexibility in funding, digital enhancements, and workforce optimisation. With increased financial flexibility granted to local systems, streamlined procurement processes, and an emphasis on best-value frameworks, this changing landscape presents investors with new opportunities. Investors and operators who are able to strategically align with these priorities may stand to capitalise on the UK healthcare sector’s shift towards sustainability, efficiency and modernisation.

NHS dentistry has been significantly impacted in recent years, with the COVID-19 pandemic exacerbating systemic weaknesses. Pre-existing issues including chronic underfunding, workforce issues, and unattractive NHS contracts have collided with pandemic-related disruptions to leave millions of patients waiting for care. With the recent uplift in NHS dental contract falling short of the recommendations from the Review Body on Doctors’ and Dentists’ Remuneration (DDRB), the Labour government has failed to alleviate the funding challenges associated with NHS dentistry, and intensified financial pressures on NHS dental providers. As investors look towards the rest of 2025 and beyond, one key question is this: how are these challenges accelerating uptake of private dentistry within the UK dental landscape, and what new investment opportunities may they present in the future? In this paper, Marwood examines the implications of the NHS contract uplift and broader funding constraints, assessing their impact on the competitive landscape of UK dentistry. We explore key market trends, identify potential areas of growth for private providers, and outline strategic considerations for investors seeking to capitalise on emerging trends in dental care.

Penetration of VBC initiatives in Medicaid, particularly those that are risk-based, has historically lagged the more significant growth in VBC within the Medicare Advantage population. However, as Medicaid Managed Care plans and states face cost pressures while aiming to improve outcomes and increase access, there has been an increasing shift away from fee-for-service reimbursement models tied to volume and towards alternative payment models (APMs) that more closely tie reimbursement to outcomes and align incentives by gradually encouraging providers to take on more risk. As a result, there is growing interest among a diverse group of stakeholders including investors, providers, MCOs, and healthcare technology companies in pursuing new revenue opportunities within Medicaid VBC. Programs that effectively realign incentives to prioritize outcomes and value can generate savings for states and MCOs and lead to improvement in the overall quality of care for patients. Herein we address opportunities for VBC for the Medicaid population, identify major challenges facing stakeholders, and examine differences between states that may facilitate greater adoption and success.

Italy is expanding the scope of its Innovative Medicines Fund which will undergo a restructure to now include specific spending ceilings for conditionally innovative medicines and specific antibiotic drugs in 2025, as indicated by the 2025 Budget Law. Alongside this, the Italian Medicines Agency (AIFA) is expected to review the current evaluation criteria for the attribution of innovative status by 31 March 2025, and is likely to include new criteria which are expected to focus on a wider combination of technological and clinical factors that spans the entire pharmaceutical life cycle such as production technology and impact on patients’ lives. This reform presents an important shift for the innovative medicine landscape in Italy by offering ring-fenced funding for specific drug categories and allowing more drugs to be eligible for funding. In this piece, Marwood analyses the changing landscape for innovative pharmaceuticals in Italy and how this may impact investors as well as manufacturers.

Over the last few years, the biotech market has grappled with a global pandemic, numerous drug shortages, burdensome supply chain disruptions, escalating trade tensions, and a difficult funding environment. Underlying these broader issues is the threat to each nation’s biosecurity. Historically, the term has mostly referred to practices that prevent the spread of harmful pathogens, such as disinfection or quarantine. Today, nations have broadened the term to encompass practices that improve the health of their biotech industries. After all, fostering domestic biotech innovation with self-sustaining, high-quality supply chains inarguably does bolster a nation’s biosecurity. On the other hand, enabling a country’s biotech startups to access foreign, low-cost supplies and services also fosters domestic innovation. Providing citizens with expedited access to breakthrough treatments approved in foreign countries also bolsters a nation’s biosecurity. China, as the world’s fastest-growing hub for biotech development, manufacturing, and research services, is now causing western nations to grapple with this delicate balance; some through domestic stimulus and others through punitive restrictions. As the current market leader in biotech innovation, the US seems to favor the latter approach.

The Autumn Budget 2024 is the first budget by a Labour Government in more than a decade. On 30 October 2024, Rachel Reeves, Chancellor of the Exchequer delivered a one-year budget (Phase 1) setting out both an updated 2024/25 spend and planned funding for next year. A longer-term Spending Review will follow in Spring of 2025 (Phase 2). A public audit in July 2024 showed that the new Labour Government inherited a budget deficit with a projected overspend of £22 billion in 2024/25. Therefore, this Budget’s objectives are to keep public spending on a sustainable path, grow day-to-day departmental spending to support public services, and to boost capital investments with a greater focus on value for money and long-term growth. This is a significant event for investors in healthcare and provider entities as it highlights the Labour Party’s priorities and ambitions. In this publication, Marwood provides an overview of key budgetary announcements that affect the health and social care sectors in the UK.

In recent years, the European Union (EU) has commenced several reforms in the life sciences sector. However, to drive the EU towards a more competitive environment in the health and life sciences sectors, more needs to be done. This is the assessment of Mario Draghi’s new competitiveness strategy, published in September 2024. In the second of a two-part series, Marwood examines how the recommendations from the European Commission’s (EC) new competitiveness strategy will steer the EC’s work to improve attractiveness in the fields of Artificial Intelligence (AI) and digital health. In this piece Marwood provides insights on the impact that the new recommendations may have on the EU’s AI and digital health sector over the next few years.

The European Union (EU) has undertaken several reforms in the life sciences sector, such as in pharmaceuticals, clinical trials, Artificial Intelligence (AI), and digital health. To guide the EU on a path towards a more competitive environment in the healthcare and life sciences sectors, the European Commission (EC) published a new competitive strategy in September 2024, and its findings will steer the EC’s work to improve its attractiveness to this industry. In the first of a two-part series, Marwood analyses how these recommendations may develop over the medium-term and assesses the impact they may have on the EU’s pharmaceutical and clinical trials sectors.

Following the two-year anniversary of the signing of the Inflation Reduction Act (IRA), Marwood takes a closer look at the state of clinical trials. In this piece, Marwood analyzes the IRA’s potential impact on clinical trial starts for industry-sponsored mid-(Phase II) and late-stage (Phase III) trials. Additionally, Marwood examines Phase I trial starts, which is likely more closely linked to early-stage biopharma companies. Marwood notes that for early stage companies the current challenging capital market environment may also be an influence on clinical trial activity.

Skilled home healthcare is a growing area of interest as the industry experiences strong tailwinds driven by an aging US demographic. Home health has always appealed to patients and providers as it allows patients to remain in their preferred setting and reduces costs for providers. The increase in the US population that typically receives home healthcare creates an opportunity and challenges, such as staff shortages, that must be addressed to serve this growing market. In this piece, Marwood explores the outlook for the skilled home healthcare market, including growth drivers and ways in which providers are navigating through potential challenges to prepare for the increasing market demand.

Following The Labour Party’s election win on 04 July 2024, Marwood takes a closer look at how the change in Government may impact the volume of National Health Service (NHS) outsourcing to the Independent Sector (IS). In this piece, Marwood examines Labour’s 2024 manifesto pledges around reducing wait times for elective care in the context of the current economic and social climate, as well as historic precedence. On the one hand, Labour campaigned hard on saving our NHS, implying a negative impact on the IS, and on the other they promised reductions in waiting times and lists for elective care. In this piece Marwood weighs these seemingly conflicting policies and examines the net potential impact of this change on NHS outsourcing of elective activity to the IS.

On May 6, 2024, the Food and Drug Administration (FDA) issued a landmark Final Rule clarifying that in vitro diagnostics (IVDs) marketed as laboratory developed tests (LDTs) under the Clinical Laboratory Improvements Amendment (CLIA) are now explicitly designated medical devices with the accompanying regulatory requirements. Although the FDA did carve out certain exceptions subject to their enforcement discretion including, most notably, grandfathering exceptions for certain quality system and FDA submission requirements, this decision will still be costly and burdensome for the IVD space as a whole. However, for those LDT diamonds in the rough with superior clinical validation, this Final Rule could instead present a significant market access opportunity if developers are quick to adapt.

Physician practices and other provider groups have always been at a disadvantage when it comes to negotiating with managed care companies and payors for initial fees or fee increases. Managed care organizations and payors have access to proprietary provider claims data, patient demographics and benefit utilization data that is not generally available to providers. In addition to access to proprietary data, payors have internal teams of professionals who are trained to specialize in provider reimbursement. Physician practices and other providers must be prepared to have detailed discussions with payors regarding reimbursement and other contractual obligations. Reimbursement, while important, should not be the only area of focus of a contractual relationship negotiation with a payor. This paper provides an overview of some of the key considerations for physician practices and other provider groups as they look to navigate the complexities of contracting with payors.