Welcome to the November-December edition of Akin Intelligence. As the end of 2024 approached, the European Union (EU) sustained progress on guidance and supporting materials for its AI Act and international AI Safety...more
2/3/2025
/ Artificial Intelligence ,
Bureau of Industry and Security (BIS) ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
Clinical Trials ,
Compliance ,
Department of Homeland Security (DHS) ,
Enforcement Actions ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
GAO ,
New Rules ,
NIST ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Key Points -
The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more
• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more
10/18/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
EHR ,
Fair Market Value ,
Health Care Providers ,
OIG ,
Physicians ,
Popular ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
• On Oct. 9, 2019, the U.S. Department of Health and Human (HHS) Services Office of Inspector General (OIG) has issued its proposed rule to reform the Anti-Kickback Statute’s (AKS) regulatory safe harbors to address...more
10/18/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Care Providers ,
OIG ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
• On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (CMMI) published a proposal to implement a new mandatory Medicare payment model in select geographic...more
8/12/2019
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Fee-for-Service ,
Health Care Providers ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
PAMA ,
Physician Fee Schedule ,
Quality Payment Program (QPP) ,
Secretary of HHS ,
Social Security Act
• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more
8/5/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Disclosure Requirements ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Nurse Practitioners ,
Nurses ,
Open Payments ,
Pharmaceutical Industry ,
Physicians ,
Proposed Rules ,
Public Comment ,
Reporting Requirements ,
Sunshine Act
• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more
4/3/2018
/ American Medical Association ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coding ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Laboratories ,
Marketing Authorization Application ,
Medicare ,
Medicare Part B ,
PAMA ,
Payment Rates ,
Personalized Medicine ,
Physician Medicare Reimbursements