On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more
11/17/2022
/ ADLT ,
Bureau of Labor Statistics ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Data Collection ,
Fees ,
Final Rules ,
Home Health Agencies ,
Medicare ,
PAMA ,
Physician Fee Schedule
This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
5/6/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Enforcement Actions ,
Fair Market Value ,
Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Pay-Per-Click ,
Payment Services Directive ,
Remuneration ,
Risk Factors
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more
9/3/2020
/ CARES Act ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Public Health Emergency ,
Uninsured Patients ,
Virus Testing
Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more
9/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Long Term Care Facilities ,
Medicare ,
Physicians ,
Reporting Requirements ,
Urgent Care Facilities ,
Virus Testing
On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more
Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more
4/18/2019
/ Clinical Laboratories ,
Direct to Consumer Sales ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Human Genes ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Public Health