On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...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
Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to...more
One fallout of the COVID-19 pandemic is that some, already struggling skilled nursing facilities may now be becoming financially unviable. As a result, owners and operators of such facilities may be actively seeking to...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 Centers for Medicare & Medicaid Services (CMS) published an interim final rule implementing the Most-Favored-Nation (MFN) Model for Medicare Part B drugs and biologics in the November 27, 2020, Federal Register (the...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 and highlights articles from members of AGG outside the Food and Drug practice....more
On September 13, 2020, President Donald Trump issued an Executive Order, “Lowering Drug Prices by Putting America First,” to direct the Secretary of Health and Human Services (HHS) to implement new payment models under...more
As we reported earlier, the Centers for Medicare & Medicaid Services (CMS), as part of its blanket waivers issued on March 30, 2020,2 has waived the location requirement for provider-based status for the duration of the...more
This article examines Medicare billing during the COVID-19 pandemic health emergency (PHE) for telehealth services of provider-based physicians to patients who otherwise would have been seen at hospital outpatient...more
Operators and managers of assisted living facilities (“ALFs”) and skilled nursing facilities (“SNFs”) have been dealt a tremendous responsibility to ensure the safety and welfare of their residents during the COVID-19...more
In July, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its annual publication, Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG's Top Recommendations. ...more
Every year, health lawyers, providers, consultants, and government experts from across the country convene in Baltimore for the American Health Lawyers Association’s Institute on Medicare and Medicaid Payment Issues, the most...more
After an attempt at passing sweeping changes to Georgia Certificate of Need (CON) laws failed to pass the House before Crossover Day, the Georgia Senate has revived another CON bill with less sweeping, albeit significant...more
House Bill 198, proposed this year to amend Georgia’s Certificate of Need (“CON”) laws, has failed to garner the necessary votes in the House, missing the crucial Crossover Day deadline needed to pass the legislation. In...more
On August 17, 2018, the Centers for Medicare and Medicaid Services (CMS) published its final rule for the Hospital Inpatient Prospective Payment System (IPPS) for fiscal year 2019. ...more
On June 14, 2018, the Office of the Inspector General (OIG) issued an advisory opinion regarding a proposed contractual arrangement between offerors of Medicare Supplemental Health Insurance policies, commonly referred to as...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
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On July 18, 2017, the Government Accountability Office (GAO) issued a follow-up report entitled “Update on Agency Efforts to Improve 340B Program Oversight.” In its initial report in 2011, the GAO highlighted the inherent...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
A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more
A recent Senate bill would lift the ban on expansion of physician-owned hospitals imposed by the Patient Protection and Affordable Care Act (PPACA). Senator James Lankford (R-OK) introduced this bill on May 16, 2017. The...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
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
On April 19, 2017 a coalition of hospitals and safety-net providers, known as the 340B Coalition, submitted correspondence urging the government to implement regulations that would subject pharmaceutical manufactures to civil...more
On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more