On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
Recognizing the ongoing impact of the cyberattack experienced by Change Healthcare/Optum on February 21, 2024, the Centers for Medicare & Medicaid Services (CMS) announced over the weekend that it will allow Part A providers...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 September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
10/4/2022
/ 21st Century Cures Act ,
Clinical Trials ,
Consent ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
New Guidance ,
Notice of Proposed Rulemaking (NOPR) ,
Office for Human Research Protections (OHRP) ,
Recordkeeping Requirements ,
The Common Rule ,
Waivers
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
This content was originally published on April 15, 2020. It was last updated as of Friday, May 29, 2020 at 12:40 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
This content was originally published on April 15, 2020. It was last updated as of Saturday, May 2, 2020 at 8:00 a.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
5/4/2020
/ Coronavirus/COVID-19 ,
Emergency Management Plans ,
EU Horizontal Safeguard Regulation (HSR) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health and Safety ,
Medical Research ,
Public Health ,
Scientific Research ,
State of Emergency ,
Travel Rule
This content was originally published on April 15, 2020. It was last updated as of Tuesday, April 21, 2020 at 5:00 p.m. CST.
American universities, hospitals, and other institutions currently have a wide variety of...more
In connection with its efforts to expand COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) announced last week that it will increase payment for high-throughput COVID-19 lab tests to $100. Before this...more
American universities, hospitals, and other institutions currently have a wide variety of healthcare, research, education, and humanitarian projects underway all over the world, with some individual universities conducting...more
The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more
4/10/2020
/ Clinical Trials ,
DATA Act ,
Department of Health and Human Services (HHS) ,
Diversity ,
Drug & Alcohol Abuse ,
Ethics ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Fraud ,
Institutional Review Board (IRB) ,
IRB ,
JCORE ,
Medical Research ,
National Institute of Health (NIH) ,
Office for Human Research Protections (OHRP)
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
4/1/2020
/ Clinical Laboratories ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
EU ,
Food and Drug Administration (FDA) ,
Guidance Update ,
Infectious Diseases ,
Medical Research ,
Public Health ,
South Africa ,
UK ,
Workplace Safety
On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized a rule requiring hospitals to make public a list of standard charges for items and services provided by such hospitals (the Rule). (The...more
11/27/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Disclosure Requirements ,
Final Rules ,
Health Care Providers ,
Health Plan Sponsors ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Physicians ,
Price Transparency ,
Proposed Rules ,
Public Health Service Act
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