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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

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) Model

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 2024

On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Physician Fee Schedule (PFS) Final Rule (“CY 2024 PFS Final Rule”). The final rule reflects CMS’ broader strategy to promote a more equitable health care system.

Key Takeaways

  • In the CY 2024 PFS Final Rule,
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On October 17, 2023, CMS held their quarterly National Stakeholder Call to provide updates on recent accomplishments and how their initiatives advance CMS’ Strategic Plan. Administrator Chiquita Brooks-LaSure, kicked off the call by announcing the start of Medicare open-enrollment and how the entire agency is focused on educating beneficiaries on all 2024 benefits and encouraging people to renew their vaccinations which are available at no additional cost. Brooks-LaSure also revealed how for the first-time, high-cost prescription drugs will have a “catastrophic limit” in 2024. Dr. Meena Seshamani, the Director for the Center for Medicare explained that in 2024, Part D enrollees who reach what CMS calls “catastrophic fees” (the maximum threshold for paying out of pocket) will no longer have to pay a co-pay or out of pocket costs at the pharmacy. Dr. Seshamani also shared that beneficiaries taking insulin will not have to pay more than $35 for each supply of insulin products covered under part D and that people will not have to pay nothing out of pocket for recommended vaccines like shingles. CMS also spoke about the drugs selected for the Medicare Drug Price Negotiation program. CMS will have a patient-focused listening session on 11/15 for each selected drug to provide an opportunity for patients, beneficiaries, caregivers, and patient organizations can share relevant input for these selected drugs. Lastly, Dr. Seshamani shared that ACOs participating in the Medicare Shared Savings Program (MSSP) saved Medicare $1.8 billion in 2022. This is the 6th consecutive year that the program has generated overall savings, and the 2nd highest annual savings accrued for Medicare since the program’s inception.Continue Reading Current CMS Policy Priorities and Initiatives in Quarter 4

On October 30, President Joe Biden signed an Executive Order (“EO”) 14110 entitled the, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence,” which establishes a policy framework to manage the risks of artificial intelligence (“AI”); to direct agency action to regulate the use of health AI systems and tools; and to guide AI…

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

The Federal Trade Commission (“FTC”) has taken a number of actions this year against healthcare apps based on data practices that FTC alleges are a violation of federal law. The latest enforcement action, on May 17, 2023, is against Easy Healthcare Corporation (“Easy Healthcare”), which operates the Premom ovulation tracker application (“Premom”), for allegedly violating…

In 2021, 1 in 10 American households experienced food insecurity, an issue exacerbated by the COVID-19 pandemic.[1] Diet-related diseases such as diabetes, heart disease, and cancer are some of the leading causes of death and disability in the U.S. Each year in the U.S. there is an estimated $52.8 billion in excess health care costs as a result of adults experiencing food insecurity.[2] Since recognizing the influence of nonmedical factors such as socioeconomic status, education, and physical education on health, there have been a growing number of initiatives to address social determinants of health (SDOH) within the health care system. Food is medicine interventions are tailored to respond to the connection between food and health in order to help prevent, manage, or reverse diet-related disease.[3] Food is medicine interventions may include medically tailored meals, produce prescriptions, and medically tailored food packages. These interventions have been associated with decreased inpatient hospital admissions, decreased overall healthcare costs, increased medication adherence, and increased diet quality.[4] The concept of using healthy foods to reduce diet-related disease in the U.S. is increasing in popularity. There is bipartisan support for food is medicine initiatives to target food insecure and medically vulnerable populations.Continue Reading Food is Medicine: Can Policymakers Come to the Table?

Rapid developments and competition in artificial intelligence (AI) will drive proliferation of new AI technologies in health care in the coming years, along with a number of legal and ethical issues.

ChatGPT 3.5 created a huge splash, rife with controversy, when it was released in November 2022. Launched by the San Francisco-based startup OpenAI, ChatGPT is a natural language processing (NLP) model (a type of machine learning (ML)), that automatically learns and recognizes patterns. ChatGPT uses a neural network architecture to generate human-sounding responses to questions, providing users with large amounts of potentially useful information in seconds. According to a recent review, ChatGPT demonstrated that it was capable of passing all three parts of the U.S. Medical Licensing Exam (USMLE), which tests medical students on topics including the basic sciences, clinical knowledge and patient treatment and diagnosis, without any specialized training. ChatGPT also showed proficiency in medical charting, diagnosing, and performing nonclinical tasks. OpenAI recently launched ChatGPT 4.0, which offers expanded capabilities and improved performance on various professional and academic assessments.Continue Reading AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now