In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
11/15/2023
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Data Collection ,
Durable Medical Equipment ,
Final Rules ,
Food and Drug Administration (FDA) ,
FQHC ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Medical Billing Codes ,
Medical Devices ,
Medical Monitoring ,
Medicare ,
Mental Health ,
Payment Systems ,
Physician Fee Schedule ,
Public Health Emergency ,
Reimbursements
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
2/6/2023
/ Biologics ,
Clinical Laboratory Testing ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Legislative Agendas ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Safety Inspections ,
Supply Chain
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community.
Gain insight into how the industry addresses regulatory and business...more
3/18/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Enforcement Actions ,
Evidence ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Legislative Agendas ,
Life Sciences ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Regulatory Oversight ,
Scientific Research ,
Stark Law ,
Vaccinations ,
Webinars
In light of the COVID-19 pandemic, our 9th McDermott International Seminar Series will be held as a virtual series, with eight sessions taking place between January 21 – February 4, 2021. Though we cannot see you in person,...more
1/7/2021
/ Acquisitions ,
Biden Administration ,
Compliance ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Cybersecurity ,
Data Privacy ,
Enforcement Actions ,
FRAND ,
Global Market ,
Intellectual Property Protection ,
International Data Transfers ,
Investors ,
Japan ,
Mergers ,
Patent Portfolios ,
US Trade Policies ,
Webinars ,
White Collar Crimes
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/15/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/14/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
In a year marked by unexpected challenges and rapid change, staying connected with industry peers and keeping a watchful eye on market trends, policy developments and collaborations in the life sciences space is crucial to...more
10/13/2020
/ Acquisitions ,
Collaboration ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Due Diligence ,
Early Stage Companies ,
Health and Safety ,
Health Care Providers ,
Healthcare Facilities ,
Infectious Diseases ,
Innovation ,
Investment Banks ,
Investors ,
Life Sciences ,
Mergers ,
Physicians ,
Presidential Elections ,
Startups ,
Telehealth ,
Telemedicine ,
Vaccinations ,
Webinars
The Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
5/5/2020
/ Acquisitions ,
Contact Tracing ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Divestiture ,
Due Diligence ,
Foreign Investment ,
Health Care Providers ,
Intellectual Property Protection ,
Joint Venture ,
Life Sciences ,
Medical Testing ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Vaccinations ,
Virus Testing ,
Webinars
The Food and Drug Administration issued an enforcement policy on the use of digital health devices that are considered therapeutic for psychiatric disorders during the Coronavirus (COVID-19) public health emergency. The...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more
4/10/2020
/ Best Practices ,
Biologics ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Face-Filtering ,
Health and Safety ,
Healthcare ,
Hospitals ,
Infectious Diseases ,
Medical Devices ,
OSHA ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more
As part of its initiatives to expedite access to investigational drugs or biologics for the treatment of Coronavirus (COVID-19), on March 24, 2020, the US Food and Drug Administration announced that healthcare providers may...more
In a series of notices and enforcement-policy statements, the FDA has announced additional efforts to address the critical shortage of face masks, filtering facepiece respirators (FFRs) and ventilators in response to the...more
The US Food and Drug Administration (FDA) announced several initiatives to increase access to ventilators and other respiratory devices during the Coronavirus (COVID-19) pandemic, as well as relaxed enforcement of certain...more
The Coronavirus (COVID-19) pandemic presents significant challenges for clinical trial sponsors. The US Food and Drug Administration issued guidance on March 19, 2020, that provides greater flexibility to adjust clinical...more
On March 20, 2020, the US Food and Drug Administration announced updates to its enforcement policy on the use of non-invasive remote monitoring devices, specifically for uses designed to support patient monitoring during the...more
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
3/13/2020
/ Appropriations Bill ,
Biologics ,
China ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Response ,
Expedited Approval Process ,
Food and Drug Administration (FDA) ,
Medical Devices ,
National Institute of Allergy and Infectious Diseases (NIAID) ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Risk Management ,
Risk Mitigation ,
Supply Chain ,
Vaccinations