• 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
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions.
• The revised draft guidance on CDS further elaborates on how to make CDS...more
10/8/2019
/ 21st Century Cures Act ,
CDS ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Devices ,
Medical Software ,
Patients ,
Popular ,
Public Comment ,
Regulatory Requirements ,
Software Developers
• 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