• 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
• 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• The revised draft guidance on CDS further elaborates on how to make CDS...more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Draft Guidance ,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 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
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
5/14/2019
/ Clinical Laboratories ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Care Providers ,
Labeling ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny.
• Conducting effective legal and regulatory due diligence can mean uncovering risks...more
5/2/2019
/ Acquisitions ,
Anti-Kickback Statute ,
Due Diligence ,
False Claims Act (FCA) ,
Health Care Providers ,
Investors ,
Life Sciences ,
Medicaid ,
Mergers ,
OIG ,
Patient Referrals ,
Private Equity ,
Provider Payments ,
Safe Harbors ,
Sunshine Act ,
TRICARE ,
Venture Capital
• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML).
• The white paper distinguishes three...more
• Review the AdvaMed Code revisions with an eye towards other key fraud and abuse, transparency and compliance issues on the horizon: the expansion of the Sunshine Act and anticipated regulatory changes to address value-based...more
3/6/2019
/ AdvaMed ,
Ethics ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Policies and Procedures ,
Regulatory Oversight ,
Sunshine Act ,
Technology Sector ,
Transparency ,
Value-Based Care
• 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