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
Health Law
Analysis, commentary, and the latest developments in health care law and policy
The Health Law blog published by Crowell & Moring LLP focuses on legal developments and regulatory issues affecting the healthcare sector. It covers topics such as federal and state healthcare legislation, Medicaid funding restrictions, the Anti-Kickback Statute, information blocking under the 21st Century Cures Act, and disputes related to healthcare payment and reimbursement. The blog also addresses litigation trends, administrative rulemaking by health agencies, and compliance challenges faced by healthcare providers, insurers, and related entities. It provides analysis of court decisions, regulatory changes, and policy shifts impacting healthcare law and practice.
Latest from Health Law - Page 9
New Proposed MHPAEA Rule Builds on NQTL Comparative Analysis Standards
On July 25, 2023, the U.S. Departments of Labor, Treasury, and Health and Human Services (the “Tri-Agencies”) released long awaited proposed regulations (the “Proposed Rule”) and a Technical Release, which together propose new requirements for comparative analyses of nonquantitative…
CMS Innovation Center Reports Data Challenges in Assessing Health Equity
On July 10, 2023, the Center for Medicare & Medicaid Innovation (CMMI or “Innovation Center”) released a White Paper, Assessing Equity to Drive Health Care Improvements, outlining their analysis and assessment of health equity incorporation in model designs and…
Examining the Use of the Area Deprivation Index in Value-Based Care Models
The Centers for Medicare & Medicaid Services (CMS) has recognized that addressing health care disparities and achieving health equity should drive our nation’s top health priorities.[1] According to the CMS Framework for Health Equity 2022-2023, health equity is…
FDA Decentralized Clinical Trials Draft Guidance
On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).
Background
DCTs include both…
AI in Health Care: AI Bill of Rights, Future Regulations, and What Business Should Consider Now
By Roma Sharma & Allison Kwon
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,…
Food is Medicine: Can Policymakers Come to the Table?
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.…
ONC’s Trusted Exchange Framework and Common Agreement (TEFCA) Announces First Cohort of Participants
On January 19, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published the Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. The Trusted Exchange Framework…
ONC’s Trusted Exchange Framework and Common Agreement (TEFCA) Announces First Cohort of Participants
On January 19, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published the Trusted Exchange Framework and Common Agreement (TEFCA) for health information exchange. The Trusted Exchange Framework…
Clinicians Request Continued Medicare Coverage of Remote Patient Monitoring Services at Contractor Advisory Committee Meeting
On February 28, Medicare Administrative Contractors (MACs) contractors—Novitas Solutions (Jurisdictions H and L), First Coast Service Options (Jurisdiction N), Noridian Healthcare Solutions (Jurisdictions E and F), CGS Administrators (Jurisdiction 15), Palmetto GBA (Jurisdictions J and M), and WPS Government Health…