News Briefs - Hospitals Report Major Drug Shortages, Many Rationing Care - As drug shortages near record levels in the United States, a new survey shows how widespread -- and serious -- the effects are. About 99 percent of...more
8/23/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Hospitals ,
Nurses ,
Physicians ,
Popular ,
Prescription Drugs ,
Private Equity ,
Section 340B
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 - FTC-Proposed Merger Guidelines Could Slow Healthcare Deals - Newly proposed merger guidelines from the Federal Trade Commission could chill dealmaking in the healthcare sector, as well as increase the costs and...more
8/2/2023
/ Data Breach ,
Data Privacy ,
Federal Trade Commission (FTC) ,
Hospice ,
Hospitals ,
Medicare ,
Mergers ,
Nursing Homes ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Telehealth
News Briefs - States Investigate Nonprofit Hospitals' Lack of Charity Care - More than a dozen states have considered or passed legislation to better define charity care, to increase transparency about the benefits hospitals...more
7/20/2023
/ Acquisitions ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
Drug Pricing ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Mergers ,
Nursing Homes ,
Physicians
News Briefs - SCOTUS Affirmative Action Ruling May Impact Healthcare Sector - Doctors are concerned that a Supreme Court ruling issued June 29 will have far-reaching effects not only on the diversity of doctors and other care...more
7/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospice ,
Hospitals ,
Long-Term Care ,
Nurses ,
Physicians ,
Section 340B ,
Telehealth
News Briefs - High Court Rules Residents Can Sue Publicly Owned Nursing Homes - The U.S. Supreme Court preserved the ability of people to sue for civil rights violations under an 1871 law as it rejected a bid to prevent an...more
News Briefs - Debt Limit Deal Will Claw Back $27.1B in Unspent COVID Funding - President Joe Biden signed a debt limit deal that includes some minimal cuts for healthcare programs just days before the federal government was...more
In a unanimous opinion issued on June 1, 2023, the Supreme Court of the United States clarified the relevant standard for scienter — or knowledge — in False Claims Act (“FCA”) actions by ruling that an objectively reasonable...more
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 - WHO Warns Rapid Adoption of AI in Healthcare Could Be Dangerous - The World Health Organization is warning that the "meteoric" rise of artificial intelligence tools in healthcare threatens the safety of patients...more
5/26/2023
/ American Hospital Association ,
Artificial Intelligence ,
Breach Notification Rule ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Hospitals ,
Long Term Care Facilities ,
Nursing Homes ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs
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
News Briefs - DEA Seeks to Extend Virtual Prescribing Flexibility as PHE Ends - After receiving thousands of comments asking for an extension of pandemic-era virtual prescribing flexibilities, the Drug Enforcement...more
News Briefs - CMS Enforces Hospital Price Transparency Rule with Fines CMS is cracking down on hospital price transparency compliance -- or lack thereof. The federal agency announced updated enforcement procedures, including...more
The United States Court of Appeals for the Sixth Circuit recently affirmed an order dismissing a qui tam False Claims Act (“FCA”) suit based on alleged violations of the Anti-Kickback Statute (“AKS”). The appeals court agreed...more
The United States District Court for the Southern District of New York recently rejected Pfizer’s request for a declaration that its co-pay program would not violate the Anti-Kickback Statute (“AKS”). The case is Pfizer Inc....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
Since 1925, Congress and the United States Supreme Court have recognized arbitration as a favored means of dispute resolution, offering a faster, more private, and less expensive alternative to the court systems....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
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently updated its 2021 Work Plan in January to include audits of Medicare Part B and home health telehealth services by OIG’s Office...more
On November 24, 2020, the Eleventh Circuit issued an opinion in U.S. v Shah (Case No. 19-12319), in which it disposed of the Anti-Kickback Statute’s (AKS or the “statute”) “one purpose” rule in certain circumstances. In this...more
The financial stakes are often very high for providers when statistical sampling and extrapolation is used to calculate an alleged Medicare overpayment. In post-payment audits involving extrapolation, an actual claims denial...more
Drawing to a close a protracted battle over Georgia’s hospital lien statute, the Georgia Supreme Court issued an opinion on June 29, 2020, siding with Georgia’s hospital community. The class action case involved allegations...more
Between 2006 and 2014, affiliated long-term care hospitals and a skilled nursing facility (“the Providers”) provided covered services to patients who were eligible for both Medicare and Medicaid (“dual-eligible...more