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
HHS Reorganizes ONC and Bolsters AI Leadership
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
CMS Releases CY 2025 Hospital OPPS Rule and ASC Proposed Rule
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule (CY 2025 OPPS/ASC Proposed Rule), which contains proposals to update OPPS and ASC payment rates by 2.6 percent in addition to proposals that address health disparities, expand access to behavioral health care, advance maternal health care, and promote safe, effective, and patient-centered care.Continue Reading CMS Releases CY 2025 Hospital OPPS Rule and ASC Proposed Rule
FDA Releases Revised Guidance on Promotional Labeling and Advertising Considerations of Biosimilar Products
On April 25, 2024, the U.S. Food and Drug Administration (FDA) issued and requested public comment on a revised draft guidance (Draft Guidance) providing recommendations related to promotional labeling and advertising that manufacturers, packers, and distributors (collectively “Firms”) should consider when promoting or advertising biosimilar products, including interchangeable biosimilar products, and their reference products. Stakeholders had until June 24, 2024 to submit comments on the Draft Guidance.Continue Reading FDA Releases Revised Guidance on Promotional Labeling and Advertising Considerations of Biosimilar Products
AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
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
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
Senate HELP Committee Ranking Member Issues Health Data Privacy Policy Recommendations
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
CMS Issues Guidance on HIPAA-Compliant Secure Texting Platforms
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
Healthcare 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 2024
CMS 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 Model