On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in artificial intelligence (AI), including in the healthcare sector. The Report is intended to serve as a blueprint for Members of Congress as they conduct oversight and introduce legislation to address advances in AI technologies, including the regulation of health-specific AI applications.Continue Reading House Task Force on AI Issues Report and Proposes Healthcare Recommendations
Delta MLR Contracting: Integrating Risk, Quality and Affordability
Executive Summary
The healthcare industry is undergoing a significant transformation, moving away from volume-based care towards value-based models that prioritize patient outcomes and cost efficiency. This issue brief delves into delta MLR contracting, a type of value-based contracting that measures and rewards improved performance based upon incremental improvements in medical loss ratio.
Delta MLR contracting is the next chapter on the way to full risk delegation, aiming to improve medical loss ratios by reducing unnecessary utilization through innovative tech-enabled care delivery transformations and offering the potential for future revenue increases for providers who achieve improved quality and appropriately document and code clinical conditions for accurate risk adjustment.
Medical Loss Ratio (MLR) refers to the percentage of premiums payers spend on medical claims and healthcare quality improvement, as opposed to administrative costs and profits. Delta MLR contracting presents an innovative framework for population health providers and virtual care organizations to align to the clinical and operational value created for risk bearing entities. Below we discuss the necessary emphasis in delta MLR contracting on the integration of documentation and coding practices, data, actuarial analytics, quality initiatives, and medical management. We also focus on the need for full financial alignment of virtual care solutions and risk bearing entities in achieving the Quintuple Aim.
By focusing on these elements, innovative providers can enhance patient outcomes, optimize financial performance, and navigate the complexities of value-based care more effectively. Continue Reading Delta MLR Contracting: Integrating Risk, Quality and Affordability
Taking a Closer Look at ONC’s AI Transparency Regulations
In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.
The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations
ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.Continue Reading ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
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 Principles
FDA 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 Monitoring
Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
On November 8, 2023, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security discussed the impact of artificial intelligence (AI) on the healthcare sector in the Committee’s second AI hearing in nine days. The hearing comes as the White House and Congressional leaders seek to quickly respond to AI threats, mitigate its dangers, and harness its potential for American industry. Senators discussed the recent Executive Order issued by the White House to guide AI regulation and innovation across all sectors, including in the health and human services sectors.Continue Reading Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
NIH 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
Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
Last week, Ranking Member Bill Cassidy (R-LA) of the Senate Committee on Health, Education, Labor and Pensions (“HELP”) issued two separate requests for information (“RFIs”) asking for stakeholder feedback on artificial intelligence (“AI”) and health data privacy policy issues to identify current challenges and receive recommendations to inform potential legislation. With deadlines set for the end of September, each RFI provides a short window for organizations to submit comments.Continue Reading Senate HELP Committee Ranking Member Requests Stakeholder Feedback on AI and Health Data Privacy and Security Policies
HHS-OIG Releases Final Rule Implementing Information Blocking Penalties
On June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking Penalties