False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional...more
On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more
A couple of recent large-scale enforcement actions suggest that the U.S. Department of Justice (DOJ) may be placing increased emphasis on targeting black market prescription drug diversion. This is when pharmaceutical...more
Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration’s (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA’s...more
Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more
Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more
On October 18, 2023, AGG Healthcare of counsel Jennifer Hilliard ably reported on Georgia’s new regulation that would allow pharmacies to dispense medical marijuana to registered users. Thus, Georgia became the first state in...more
Despite the federal ban on the sale, use, and possession of cannabis in the U.S., in October, Georgia became the first U.S. state to allow pharmacies to sell low-dose tetrahydrocannabinol (THC) products. Pursuant to statutes...more
On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...more
Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more
Historically, a retail pharmacy unable to fill an initial electronic prescription for Schedule II-V controlled substances could not transfer it to another pharmacy – even if the two pharmacies were affiliated and part of a...more
On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V controlled...more
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008...more
On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth...more
In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
The United States Department of Justice (DOJ) recently announced the nation’s largest settlement involving allegations of drug diversion at a health care system. The settlement, totaling $7,750,000, came after a years-long...more
The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more
In 2019, the Drug Enforcement Administration (“DEA”) amended its regulations to implement a single sheet format to its Form 222 replacing the triplicate form currently used. Form 222 is used by DEA registrants to order...more
Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more
The Drug Enforcement Administration (“DEA”) has waived the in-person examination requirement for prescribing controlled substances via telemedicine in the wake of COVID-19, relaxing the prescribing requirements under the...more
A waiver granted by the Drug Enforcement Administration (DEA) may provide a solution for long term care providers with opioid-addicted residents who are unable to access medication-assisted treatment (MAT) due to...more
The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical...more
With the rapid spread of the novel coronavirus (COVID-19) pandemic and the looming possibility of large scale isolations and quarantines, lawmakers continue to demonstrate willingness to expand access to telehealth to combat...more