On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more
5/5/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Manufacturers ,
Medicaid ,
Medicare ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration
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
Over the past several years, the Centers for Medicare and Medicaid Services (CMS) has expanded payment for care management and remote monitoring services in an effort to recognize and pay for non-face-to-face services that...more
7/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicare ,
Medicare Beneficiaries ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Telehealth
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more
A recent multijurisdictional contractor advisory committee (CAC) meeting held by six of the seven Medicare Administrative Contractors (MACs) gave stakeholders an initial opportunity to provide feedback on the strength of...more
3/6/2023
/ Comment Period ,
Deadlines ,
Health Care Providers ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Physicians ,
Stakeholder Engagement ,
Subject Matter Experts (SMEs) ,
Technology Sector ,
Telehealth ,
Telemedicine
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more
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 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
On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...more
9/28/2020
/ Comment Period ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
Labeling ,
Motion for Reconsideration ,
Motion To Stay ,
Off-Label Use ,
Proposed Rules ,
Public Health Service Act ,
Repeal
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
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
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The updated guidance documents...more
10/17/2019
/ 21st Century Cures Act ,
Comment Period ,
Digital Health ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
Public Comment ,
Regulatory Oversight ,
Software
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
1/21/2017
/ 21st Century Cures Act ,
Ambulatory Surgery Centers ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Long Term Care Facilities ,
Manufacturers ,
Medical Devices ,
Medicare ,
Medicare Advantage ,
MedPAC ,
Mental Health ,
Mental Health Parity Rule ,
National Institute of Health (NIH) ,
Off-Campus Departments ,
Opioid ,
Patients ,
Pharmaceutical Industry ,
Research and Development ,
Small Business ,
Substance Abuse ,
Telehealth ,
Transparency
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more