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 population health, and advance health equity by reducing disparities in health outcomes. Continue reading to learn more about the AHEAD model.
Continue Reading An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) ModelHealthcare Policy Developments to Watch in 2024
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, plans, electronic health record (EHR) vendors and health technology companies.
Stakeholders should use this summary to examine existing regulatory and compliance gaps, prepare their organizations to comply with forthcoming federal regulations, and keep apprised of federal funding opportunities. For more information on these policy developments, please contact the professionals listed below, or your regular Crowell contact.
Continue Reading Healthcare Policy Developments to Watch in 2024CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
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.
Continue Reading CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access ModelCMS Finalizes CY 2024 Medicare Physician Fee Schedule Rule
- In the CY 2024 PFS Final Rule,
FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
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”).
Continue Reading FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding PrinciplesFDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
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 the COVID-19 public health emergency (PHE). Specifically, the FDA will continue to allow most remote monitoring devices to be used in home settings and to allow certain hardware or software changes to allow for increased remote monitoring capabilities under enforcement discretion.
Continue Reading FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient MonitoringFDA Releases Guidance on Digital Health Technologies for Clinical Investigations
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 a growing role in health care and offer important opportunities in clinical research the FDA is providing guidance for ensuring that technologies used are safe, appropriate, and store and transmit data appropriately. Highlights of the guidance are below.
Continue Reading FDA Releases Guidance on Digital Health Technologies for Clinical InvestigationsCrowell Presents “AI and Health Care: Perspectives from Policymakers and Movers in the Industry”
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 came together for a lively and engaging conversation.
Continue Reading Crowell Presents “AI and Health Care: Perspectives from Policymakers and Movers in the Industry”World Bank Issues Digital Health Recommendations in Report
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 the World Bank Report is to provide governments and other stakeholders with practical guidance on how to build digital health infrastructure, regardless of a country’s digital maturity or fiscal challenges.
Continue Reading World Bank Issues Digital Health Recommendations in ReportNIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies
On October 11, the National Institutes of Health (“NIH”) issued a request for information (“RFI”), which proposes sample language regarding the use of digital health technologies in research for inclusion in informed consent documents and requests public feedback on the utility and usability of the proposed language. Comments on the RFI are due by December 12, 2023.
Continue Reading NIH Requests Information on Developing Consent Language for Research Using Digital Health Technologies