Trends in Transformation

In September 2023, the Centers for Medicare & Medicaid Services (CMS) released a new state total cost of care (TCOC) model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. This model follows in the footsteps of other successful state total cost of care (TCOC) models to improve health care spending, improve

The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen significant policy activity in recent years and that are relevant to healthcare stakeholders, including providers,

On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers designed to improve Medicaid beneficiaries’ access to cell and gene therapies.

On November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and

On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled medical devices (“MLMD Guiding Principles”).

On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring devices used for patient monitoring at the conclusion of

On December 22, 2023, FDA issued final guidance–Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. This final guidance is aimed at sponsors and others who may be involved in remote data acquisition for clinical trials to evaluate medical products. As digital health technologies (DHTs) used for remote data acquisition are playing

On November 2, Crowell hosted an in-person roundtable discussion, featuring government officials, industry experts and other stakeholders, to discuss the development of artificial intelligence (AI) and machine learning (ML) systems and tools in the healthcare sector as well as the government’s role in regulating such technology. Policy makers, thought leaders, healthcare innovators, and business executives

On August 18, 2023, the World Bank issued a publication entitled, “Digital-in-Health: Unlocking the Value for Everyone (“World Bank Report”),” which recommends to governments a new digital-in-health approach where digital technology and data are infused into every aspect of health systems management and health service delivery to improve individuals’ health outcomes. The stated goal of