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Pre-Recess Legislative & Regulatory Update | July 2024
Our experts Mark Galay, Stephen Williams, Kim Vukhac, and Joe Mercer discuss recent legislative & regulatory catalysts, including Congressional priorities entering August recess and setting up for the lame-duck session as well as the recently proposed Calendar Year 2025 rules

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All Change Please, All Change: Will Labour Move The Needle On NHS Outsourcing?
All Change Please, All Change: Will Labour Move The Needle On NHS Outsourcing?
July 08, 2024
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.
LDT Diamonds in the Rough; Apparent Risks and Hidden Opportunities in the Fallout of the FDA’s Final Rule
LDT Diamonds in the Rough; Apparent Risks and Hidden Opportunities in the Fallout of the FDA’s Final Rule
July 01, 2024
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.
Data Analytics Is Shifting Payor/Provider Dynamics – Are You On The Right Side?
Data Analytics Is Shifting Payor/Provider Dynamics – Are You On The Right Side?
June 27, 2024
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.
The Growing Demand For Interoperability In Pharmacy Management Solutions
The Growing Demand For Interoperability In Pharmacy Management Solutions
June 20, 2024
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.
ABCs of Autism: Opportunities In The ABA Space As Continued Demand Revives Investor Interest
ABCs of Autism: Opportunities In The ABA Space As Continued Demand Revives Investor Interest
June 03, 2024
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.
Infusion Confusion? Marwood Breaks Down The Attractive But Complex Sector
Infusion Confusion? Marwood Breaks Down The Attractive But Complex Sector
May 22, 2024
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.
Medicaid Access Rule Review—HCBS Payment Adequacy; Next Steps for Stakeholders, Implementation; Outlook for Litigation
On April 22, HHS released the anticipated Ensuring Access to Medicaid Services final rule. In addition to Marwood’s forthcoming published analysis, Joe Mercer will host a call to offer takeaways from the rule and read-through for states and providers—especially around the HCBS payment adequacy standard, a provision that was highly contested by stakeholders throughout the rulemaking process.
April 23, 2024
1 p.m. ET
Key Takeaways
Medicare Advantage 2025 Final Rate Announcement Review
On April 1, HHS released the awaited Medicare Advantage and Part D Final Announcement. Our managed care and health care services senior analyst, Joe Mercer, hosted a call to offer takeaways from the rule, including the impacts of fourth quarter data, IME/DGME phase-out, and changes to the FFS normalization factor calculation, among other key provisions.
Tuesday, April 2, 2024
2 p.m. ET
Key Takeaways
DME: A Developing And Durable Market
DME: A Developing And Durable Market
March 21, 2024
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.
Inpatient Psych Outlook—PPS Reform, Mental Health Parity, Telehealth, EHR Compliance
This year, CMS will be working on reforms to the inpatient psych prospective payment system. Looking ahead to the forthcoming FY 2025 proposed rule, Marwood hosted a call with Shawn Coughlin, President and CEO of the National Association for Behavioral Healthcare, to discuss broader industry priorities for the sector.
Tuesday, March 19, 2024
11 ET
Key Takeaways
A New European Regulatory Landscape For Artificial Intelligence
A New European Regulatory Landscape For Artificial Intelligence
March 08, 2024
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 and Practical Uses
Health Insurance Claims Data and Practical Uses
March 07, 2024
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.
Emerging Artificial Intelligence Applications In Preclinical Drug Development
Emerging Artificial Intelligence Applications In Preclinical Drug Development
February 20, 2024
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.
Inpatient Rehab Outlook with AMRPA: Review Choice Demo Roll-Out, Landscape for MA Utilization, Case Mix Calculations, Early Discharge Penalty
Marwood hosted a call with Kate Beller, EVP of Policy Development and Government Relations at the American Medical Rehabilitation Providers Association, to discuss the forthcoming 2025 proposed rule and broader industry priorities.
February 22, 2024
11 ET
Key Takeaways
Specialist Cancer Procedures in English NHS to Get New National Tariffs in 2024/25 – A Boon For Private Providers
Specialist Cancer Procedures in English NHS to Get New National Tariffs in 2024/25 – A Boon For Private Providers
February 14, 2024
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.
HCBS Update with NAHC—Outlook for Payment Adequacy Standard Rule
Marwood’s Joe Mercer and Sherill Mason hosted a call with Damon Terzaghi, Director of Medicaid Advocacy at the National Association for Homecare and Hospice, to discuss provider priorities and different scenarios ahead of the anticipated Medicaid Home- and Community-Based Services (HCBS) payment adequacy final rule.
Thursday, February 15, 2024
11 a.m. ET
Key Takeaways
Emerging AI Applications In Clinical Trials—CRO/SMO Considerations
Emerging AI Applications In Clinical Trials—CRO/SMO Considerations
February 05, 2024
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.
The End Of Forever Chemicals In Europe, The Beginning Of New Investment Opportunities In The Medical Device Sector
The End Of Forever Chemicals In Europe, The Beginning Of New Investment Opportunities In The Medical Device Sector
January 31, 2024
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.
Medicare Advantage 2025 Advance Notice and Implications for Health Plans
We discussed the 2025 Medicare Advantage Advance Notice, reactions from the industry and policymakers and what it all means for health plans.
Tuesday, February 13, 2024
11 a.m. ET
Key Takeaways
CATALYSTS: Health Policy Catalysts For The US, EU And UK
CATALYSTS: Health Policy Catalysts For The US, EU And UK
January 03, 2024
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.
How Urgent Care Centers Can Position For Continued Growth After COVID-19
How Urgent Care Centers Can Position For Continued Growth After COVID-19
January 03, 2024
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.
Emerging Artificial Intelligence Applications In Pharmacy
Emerging Artificial Intelligence Applications In Pharmacy
December 20, 2023
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.
Marwood at 42nd Annual JP Morgan Healthcare Conference
Select members of our senior executive team were joined by Marwood's subject matter experts across various subsectors for meetings in San Francisco.
January 8-10, 2024
Key Takeaways
Payor Adoption of Artificial Intelligence And Its Impact On Provider Organizations
Payor Adoption of Artificial Intelligence And Its Impact On Provider Organizations
November 29, 2023
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.
Healthcare Policies in the Wake of Spain’s 2023 General Election
Healthcare Policies in the Wake of Spain’s 2023 General Election
November 10, 2023
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.
Legislative Outlook: November 17 CR and Year-End Congressional Priorities, Opportunities for Provider Relief; Landscape for 2024
Our senior analysts discussed the outlook for the November Continuing Resolution, as well as Congressional priorities expected to pass year-end vs. 2024.
Tuesday, November 14, 2023
11 a.m. ET
Key Takeaways
The Compass: Healthcare Insights for Europe
The Compass: Healthcare Insights for Europe
November 01, 2023
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.
Marwood at HLTH 2023
Marwood sponsored HLTH 2023, discussing opportunities and solutions across the healthcare marketplace.
October 8–10, 2023 | Las Vegas
Key Takeaways
Navigating Medicare Advantage Risk Adjustment
Marwood and the Alliance of Community Health Plans hosted a webinar focused on CMS modernization, and the past, present, and future of MA risk adjustment
September 12, 2023
11 a.m. ET
Key Takeaways