Insights

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.

Pharmacy management systems (PMS) and associated software and data solutions are evolving as patients access a greater diversity of traditional and clinical services from pharmacies. At the intersection of patient, provider, payor, and other pharma industry stakeholders, interoperability is key. Stakeholders in PMS and broader pharmacy interoperability extend beyond health plans and manufacturers to other healthcare providers where bidirectional electronic health record (EHR) communication is vital. Regulation, legislation and resultant standards bodies are now actively engaged in developing recommendations to guide the industry and have moved swiftly, partly due to needs that expanded in magnitude during the pandemic. Correspondingly, more robust information exchange capabilities and pointed data solutions will continue to differentiate pharmacy-focused HIT market players. The analysis herein highlights historical challenges, evolving stakeholder needs, and resulting opportunities this has created for solutions providers in the space.

Over the past decade, the autism therapy sector has solidified itself as one of the fastest growing healthcare sectors. Federal and state mandates have driven broad coverage across payor types as the prevalence of Autism Spectrum Disorder (ASD) continues to increase, now 1 in 36 children (up from the previous rate of 1 in 44). Applied Behavior Analysis (ABA) is still considered one of the only evidence based treatments for children with ASD and continues to be the therapy modality most often covered by payors. Herein we address the history of the sector, some of the major challenges facing providers today, and opportunities providers will have to be successful over the next 5–10 years.

The infusion market has experienced remarkable growth over the past several years, fueled by an increasing number of infused medications across indications in an aging US population. Offsetting hospital and physician office demand has been the growth of alternative sites of care including site-based ambulatory infusion centers, home infusion and hybrid infusion suite models. Herein we compare and contrast provider, pharmacy, and payor roles in these sites of care and their reimbursement structure, delineating key considerations in evaluating opportunities in the space.

Over the past decade, durable medical equipment (DME) has become a growing area of interest for mergers and acquisitions (M&A) and investment activity as the industry experiences increasing levels of demand, product innovation, reimbursement stability, and a degree of market fragmentation across suppliers and manufacturers. In this piece, Marwood explores the outlook for the DME market, including growth drivers, payor contracting dynamics, and reimbursement considerations, while addressing how the space has evolved to meet the risk appetite of investors.

The European Union Artificial Intelligence Regulation, the world’s first comprehensive AI Regulation, will take effect from mid-2025 onwards with most of its provisions taking effect in 2026. In this piece, Marwood analyses the upcoming regulatory changes affecting AI systems in the EU and the potential impact it may have on companies developing or promoting AI applications in healthcare, or investors with existing or potential investments in these companies.

Health insurance claims data are an increasingly widespread and valuable source of information for use in analyzing the healthcare space. This report presents an overview of health insurance claims data, including some of the specific sources integrated into Marwood’s analytics platform, and the possibilities for this data, understanding the complexities of a full patient encounter when undergoing a common esophagus endoscopy procedure.

AI in the life sciences has evolved from its roots in machine learning to applications of generative AI, natural language processing, deep learning and increasingly combinations of the latter 3. These tools are being applied to accelerate target discovery as well as improve design and processing, information aggregation and synthesis, as well as the repurposing of existing drugs. Herein we define and describe leading and emerging applications of AI in preclinical drug development and provide examples of models and companies shaping this burgeoning space.

NHS England has proposed to introduce new tariffs for selected specialist radiotherapy services under the 2023/25 NHS Payment Scheme. This scheme replaced the National Tariff in 2023 and governs reimbursement between providers and commissioners of secondary healthcare. Currently, funding for specialist radiotherapy services varies across England.

Artificial intelligence is being adopted by clinical trial sponsors, clinical research organizations and site management organizations to drive efficiency. As well, AI-enhanced data analysis is a catalyst to the emergence of virtual trials and biosimulation. However, enablement is not without its regulatory and legislative challenges. Herein, we detail leading and emerging applications of AI in the clinical research space, and delineate regulatory and legislative trends shaping the industry.

PFAS are often used in medical devices because of their ‘non-stick’ quality. However, these chemicals are likely to be banned in Europe from 2025 as a result of their toxicity to humans and the environment. An EU-wide ban will force manufacturers to seek out PFAS-alternatives. This presents an upside for manufacturers of PFAS-free materials but may also introduce supply-chain disruptions and regulatory hurdles in the medium-term.

As we begin 2024, Marwood Group is pleased to share CATALYSTS: Health Policy Catalysts for the US, EU And UK. In the US, 2024 is likely to open with a flurry of activity before Congress slows pre-election, and the Biden administration looks to finalizing any outstanding policies. EU and the UK will see many changes introduced in health care regulation, reimbursement, and funding in sectors such as acute care hospitals, pharmaceuticals, social care and medical equipment.

Demand for urgent care services has increased over the last few years due to increased awareness of urgent care centers following the COVID-19 pandemic, as well as shifting consumer preferences and payor steerage toward urgent care over alternative care settings. Although increased demand has led to some saturated markets, expansion of service offerings, such as primary care add-ons and joint ventures with hospitals, positions the urgent care market for continued growth.

Through emerging artificial intelligence (AI) tools, pharmacies will enhance their operational capabilities across limited labor and better allocate pharmacist time toward potential improvements in not only productivity, but patient outcomes. Target analysis in this environment requires an understanding of not only the emerging AI market and its applications, but federal and state regulatory and legislative trends shaping this emerging technology.

Payor investment into AI is a consideration not only to those with a direct stake in payors and the vendors which serve them, but to those invested in provider organizations which payor impacts may touch. Target analysis in this environment requires not only an understanding of payor applications, market and both federal and state regulatory and legislative trends, but a clear grasp on billing and coding. Herein we address key areas of AI innovation by payors and the potential impacts on providers.

Marwood takes a deeper look at the key health policy proposals in the PSOE-Sumar Pact that could be pursued in Spain's next legislature. Even if the ultimate jurisdiction and decision-making power remains with Autonomous Communities, a PSOE-Sumar coalition could push elements within the Pact, marking the direction of travel for Spanish health policy over the next 4 years.

The drive towards cost-containment, improved quality and safety, and equity of access in healthcare - all while trying to keep pace with innovation in digital health, medical devices, and pharmaceuticals - has resulted in regulations, policies, and revamped funding structures that will have broad and lasting impact across European markets. Our Compass publication aims to act as an important reference document to chart a path through the complex healthcare waters of the EU and UK.