Health data exchange and interoperability have entered a new chapter in the U.S. In 2016, the 21st Century Cures Act (Cures Act) included a requirement that the Office of the National Coordinator for Health Information Technology (ONC) create a Trusted Exchange Framework and Common Agreement (TEFCA) for nationwide health information exchange.  Seven years later, on December 12, 2023, ONC announced that the nationwide health data exchange governed by TEFCA is operational. At the signing event, many Department of Health and Human Services (HHS) officials celebrated the announcement including Secretary Xavier Becerra, Deputy Secretary Andrea Palm, and National Coordinator for Health Information Technology, Micky Tripathi.

Continue Reading The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024

In late March 2023, Dr. Paul Koch, the former owner of a chain of Rhode Island ophthalmology practices, agreed to pay $1.1 million to the U.S. Attorney’s Office to settle false claims act allegations.  This case arose from a qui tam complaint brought by two whistleblowers alleging that over a five-year period, Koch paid kickbacks to optometrists to induce referrals for patients for cataract surgeries.  Notably, the settlement included a non-admission clause by Dr. Koch, denying liability and disputing the relators’ entitlement to attorneys’ fees, and the court entered a Stipulation of Partial Dismissal and Consent to Dismissal on Behalf of the United States shortly thereafter.

Continue Reading Settling False Claims Act Cases Involves More than Just Cutting a Check to DOJ

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

On April 18, 2024, the Department of Health and Human Services’ (HHS’) Agency for Healthcare Research and Quality (AHRQ) issued the Digital Healthcare Equity Framework (the Framework) to guide users and stakeholders to consider equity throughout the entire lifecycle when implementing digital healthcare solutions. AHRQ also released a separate implementation guide (the Guide) to outline best practices and examples to implement the Framework. The Framework’s guiding principles provide a clear purpose for the Framework and development of its domains while the separate Guide provides actionable steps on how to implement the Framework.

Digital healthcare developers and vendors, health systems, health plans, and clinical providers should review the Framework and Guide to assess equity during each phase of the digital healthcare lifecycle for digital health technologies. Specifically, the Framework recommends that these stakeholders should consider the Framework’s principles and recommendations to address the accessibility, purpose, security, privacy features, usability, and safety concerns applying to digital solutions.

Continue Reading AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity

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

On February 21, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report to propose policy recommendations to revise the Health Insurance Portability and Accountability Act of 1996 (HIPAA) framework and ensure privacy protections for health data and information. In the report, Senator Cassidy highlights recent reports of breaches and violations of patients’ health data privacy and outlines several proposals to modernize the HIPAA framework and other privacy regulations.

Continue Reading Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations

The Office of the National Coordinator for Health Information Technology (ONC) released a draft of their 2024–2030 Federal Health IT Strategic Plan (Draft Strategic Plan) on March 27, 2024, updating the 2020-2025 Federal Health IT Strategic Plan. In collaboration with 25 other federal organizations, the purpose of this strategic Plan is to create overall improvements in health care by aligning its health IT policies, programs, and investments and to signal priorities to the industry. This Draft Strategic Plan builds on the previous Plan, and includes objectives to address challenges in our healthcare landscape post-COVID as well as recognizing current disparities in health care access and outcomes.

Continue Reading ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan

On February 8, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a quality standard memorandum (Memorandum) clarifying that hospitals and critical access hospitals (CAHs) may transmit patient information and orders via text message under certain conditions. Although Computerized Provider Order Entry (CPOE) continues to be the preferred method of order entry, healthcare team members are permitted to share patient information and orders among themselves through a Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant secure texting platform (STP) in accordance with Medicare and Medicaid Conditions of Participation (CoPs). The Memorandum reverses CMS’s position in a January 2018 memorandum and is effective immediately.

Continue Reading CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms

For several years now, the United States Department of Justice (“DOJ”) has indicated an increased desire to exercise its dismissal authority over qui tam actions, even over the objections of relators who initially brought the claims.  However, the slight uptick in such dismissals was seemingly stunted while United States ex rel. Polansky v. Exec. Health Res., Inc., 599 U.S. 419 (2023) (which involved the scope of the government’s authority to dismiss False Claims Act (“FCA”) qui tam actions) made its way to the United States Supreme Court (“SCOTUS”). 

Continue Reading Encouraging Signs that DOJ May Finally Be Using Its Dismissal Authority

In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).

Continue Reading Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision