On October 9, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, issued a Request for Information (RFI) about the Innovation Center’s proposed Medicare $2 Drug List Model (the M2DL Model), which aims to test whether offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes, and improve satisfaction with the Medicare Part D prescription drug benefit. The RFI includes a sample list of prescription drugs that it intends to include and seeks input from healthcare stakeholders on the sample list of drugs and other features (i.e., outreach efforts and maximizing stakeholder participation) of the model. Comments in response to the RFI may be submitted through the Innovation Center’s online survey portal by December 9, 2024.Continue Reading CMS Innovation Center Seeks Feedback on Medicare $2 Drug List Model

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule (2025 PFS Proposed Rule), which contains proposals to update PFS payment rates, improve payment for and access to behavioral health services, extended telehealth flexibilities, establish ways to enhance access to primary care

The Centers for Medicare & Medicaid Services (CMS) Innovation Center (the Innovation Center) published its data-sharing strategy, which seeks to further enable data sharing while ensuring proper security, risk management, and privacy obligations. The strategy outlines the Innovation Center’s approach to identifying data sharing needs across Innovation Center models and highlights the importance of data in developing and testing innovative healthcare payment and service delivery models.Continue Reading CMS Innovation Center Outlines Data Sharing Principles

On July 25, the Department of Health and Human Services (HHS) announced a number of organizational changes, including renaming the Office of the National Coordinator for Health Information Technology (ONC) to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), among other actions. These organizational changes reflect heightened focus to provide oversight and issue policies governing the use of individuals’ health data and the development of artificial intelligence (AI) technologies. It also demonstrates HHS’ aim to address recent cyberattacks against the healthcare sector entities.Continue Reading HHS Reorganizes ONC and Bolsters AI Leadership

In January 2024, the Centers for Medicare and Medicaid Services (CMS) announced a new innovation care delivery model that seeks to bridge the gap between behavioral and physical health. The Innovation in Behavioral Health (IBH) Model aims to improve the quality of care and behavioral and physical health outcomes for adults with moderate to severe mental health conditions and substance use disorders (SUDs). The IBH Model will service beneficiaries who are enrolled in Medicare and Medicaid, including those who are dual eligible.[1] These populations experience higher than average rates of mental health conditions or SUDs, or both, highlighting the importance of a model that integrates behavioral and physical healthcare as well as addressing health-related social needs (HRSN).[2]Continue Reading CMS Notice of Funding Opportunity for the Innovation in Behavioral Health Model Open Until September 9, 2024

On July 9, 2024, the Office of Science and Technology Policy (OSTP) released new guidance for federal research agencies that require certain research institutions (“covered institutions”) to certify that the institution has established and operates a research security program that includes certain specific standardized requirements.  The certification requirements are in accordance with the National Security Presidential Memorandum-33 (NSPM-33) and the CHIPS and Science Act. The purpose of these guidelines is to address increased foreign risk to research security in the U.S. Research and Development (“R&D”) landscape and to preserve the open and collaborative nature of the R&D environment. The research security requirements are summarized below. Continue Reading New federal guidelines for research security programs at covered institutions

On Monday, June 24, 2024, the U.S. Supreme Court agreed to review last year’s Sixth Circuit decision that allowed Tennessee to keep its ban on gender-affirming care for minors in place. The Supreme Court will determine whether the Tennessee restrictions on gender-affirming care infringe on the Fourteenth Amendment rights of transgender youth for equal protection under the law.[1] The Court did not act on the Biden administration’s petition to review a similar case focused on Kentucky’s gender-affirming care ban for minors; however, the Court’s decision on the Tennessee ban will ultimately determine how the Kentucky case moves forward. The Court will begin their arguments on the Tennessee gender-affirming care ban in the fall. The decision to review the Biden administration’s appeal comes at a time when 39% of transgender youth aged 13-17 are living in states that have bans on gender-affirming care.[2]Continue Reading What to Know about Gender-Affirming Care Following the Supreme Court’s Agreement to Review Sixth Circuit Decision

In March 2024, the Centers for Medicare & Medicaid Services (CMS) released a new voluntary model called the ACO Primary Care Flex Model (ACO PC Flex Model). This model focuses on primary care delivery within the Medicare Shared Savings Program (MSSP), which is Medicare’s longest-running program whereby health care practitioners and other providers and suppliers form an Accountable Care Organization (or ACO) to provide coordinated, high quality care to Medicare beneficiaries. Continue reading to learn more about the ACO PC Flex model.Continue Reading An Overview of the ACO Primary Care Flex (ACO PC Flex) Model

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