Healthcare’s Premier Industry Advisor

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.