News Briefs - Congressional Extension of Telehealth Waivers Left in Limbo - Pandemic-era telehealth waivers that allowed providers to expand their virtual care footprint will end this year unless Congress takes action. The...more
11/18/2024
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospice ,
Medical Devices ,
Medicare ,
Prescription Drugs ,
Skilled Nursing Facility ,
Telehealth ,
Telemedicine
News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more
9/11/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Medical Devices ,
Medicare ,
Physicians ,
Popular ,
Ransomware ,
Rural Health Care Providers ,
Telehealth ,
Web Tracking
News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more
9/4/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Data Breach ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospice ,
Hospitals ,
HRSA ,
Medical Devices ,
Prescription Drugs ,
Surprise Medical Bills
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
8/21/2024
/ Artificial Intelligence ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medical Devices ,
Medicare ,
Prescription Drugs ,
Private Equity ,
Rural Health Care Providers ,
Surprise Medical Bills
News Briefs - Texas Federal Court Ruling Puts Noncompete Ban on Hold - A Texas federal court issued a preliminary injunction against the Federal Trade Commission's noncompete ban, which if implemented would allow existing...more
7/12/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Hospice ,
Hospitals ,
Medical Devices ,
Medicare ,
Nursing Homes ,
Prescription Drugs ,
Shared Savings Program
News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more
11/21/2023
/ Artificial Intelligence ,
Cyber Threats ,
Cybersecurity ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Medical Devices ,
Mental Health ,
Nurses ,
Nursing Homes ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Ransomware
News Briefs - Insurers Ignoring Rulings to Pay Surprise Bills, Doctors Say -Insurers are sometimes ignoring rulings to pay providers, or failing to pay them in full, under the arbitration system established by the new federal...more
8/18/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Data Breach ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Long-Term Care ,
Medical Devices ,
Nursing Homes ,
Price Transparency ,
Surprise Medical Bills
News Briefs - More States Introducing 'Conscience' Healthcare Bills - A new Montana law will provide sweeping legal protections to healthcare practitioners who refuse to prescribe marijuana or participate in procedures and...more
8/9/2023
/ Cybersecurity ,
Data Breach ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospice ,
Manufacturers ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians
News Briefs - Inflation Causes Many Patients to Skip Doctors' Appointments - As prices go up generally, patients stay away from their physicians, according to federal analysts. In 2022, 28 percent of adults went without some...more
5/31/2023
/ Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospice ,
Life Sciences ,
Long Term Care Facilities ,
Medical Devices ,
Nursing Homes ,
Pharmaceutical Industry ,
Physicians ,
Telehealth
News Briefs - PHE End Brings Challenges for Nursing Home Operators - As the public health emergency (PHE) came to an end on May 11, industry leaders point out that nursing home operators are still in pandemic recovery mode...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The United States Court of Appeals for the Ninth Circuit recently considered an Order of the Central District of California dismissing a qui tam False Claims Act (FCA) suit against a medical device manufacturer based on...more
News Briefs -
FDA Exempts Some Medical Devices from Premarket Review -
FDA closed out the year with the publication of a final order that exempts dozens of Class I and Class II medical devices from 510(k) premarket...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar