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
CMS Announces Hospice Capitation Rates for Medicare Advantage -
The U.S. Centers for Medicare and Medicaid Services (CMS) recently released the capitation rates for hospice care through the value-based insurance design...more
Investor Interest in Health IT Expected to Remain Strong in 2020 -
After three years of strong growth in healthcare technology funding, investor interest in the space has not abated....more
During 2018, five nursing facilities sought to create a more livable space for their residents by reducing their licensed bed capacities. These changes eliminated 3-bed wards in favor of semi-private rooms and improved living...more
Digital Health Companies Look Toward IPOs as M&A Stabilizes -
Digital health funding in 2019 suggests more companies will be looking to go public or be acquired in the coming years, according to a report from seed fund and...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
The decisions of appellate courts often establish precedent that will have ramifications that extend far beyond the immediate parties to an appeal. ...more