Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
[Podcast] Food for Thought and Thoughts on Food: What to Expect in 2023
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
PODCAST: Williams Mullen's Benefits Companion - New Prescription Drug and Health Coverage Reporting Requirements
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
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
The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more
News Briefs - New Foreign Nurse Visas Frozen by State Department - The State Department has essentially frozen foreign nurse visas for the rest of the fiscal year amid high demand, and health groups are warning it threatens...more
Healthcare enforcement is never quiet. There’s always something, or many things, going on, and compliance teams need to stay on top of the trends to ensure that their programs are staying ahead of the risks. To find out...more
May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more
Abstract Issue: As states continue to enact new restrictions on abortion since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, access to critical reproductive health and abortion care...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
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more
In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA) published, on January 31, its Final Rule allowing telehealth access to...more
Background Three years following the onset of the COVID-19 public health emergency (PHE), states across the United States continue to enact permanent changes to telehealth laws that impact how physicians and other health care...more
The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...more
The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more
On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of...more
On October 10, 2023, the federal Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) published a new temporary rule which extends, through December 31, 2024, the ability of ...more
Earlier this month, the United States Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a temporary rule extending certain flexibilities for the prescription of controlled...more
The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the...more
This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more
On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) announced they would further extend the COVID-19 flexibilities allowing for telemedicine prescription of controlled...more
The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services...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
News Briefs - Google Cloud Unveils AI to Help Doctors with Search Capabilities - Google Cloud announced new artificial intelligence-powered search capabilities that it said will help healthcare workers quickly pull accurate...more