Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
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
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 September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...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) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...more
On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of...more
In response to the large number of public comments received to its recent proposed telemedicine rules, the Drug Enforcement Administration (DEA) is holding public listening sessions to consider a special registration for...more
This report was written in partnership with and funded by the Foundation for Opioid Response Efforts. During the COVID-19 pandemic, the federal government and many states offered regulatory flexibilities intended to make...more
Illinois passed S.B. 1913, which requires Medicaid FFS and Medicaid managed care plans to provide coverage of mental health services, substance use disorder treatment, and ‘behavioral telehealth services’. Requires Medicaid...more
H.R. 4189 / S. 2016: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act ....more
Reversing previously proposed rules, the DEA recently issued new guidance allowing the continued use of telehealth when prescribing controlled substances following the end of the Covid-19 public health emergency (“PHE”)....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
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
As the COVID-19 era comes to an end, health care legislation, and policy continue to evolve. May 2023 has been a busy month for new pharmaceutical legislation and policy. The 118th Congress continues to introduce new health...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On May 9, 2023, the Drug Enforcement Administration (DEA) issued a temporary rule that extends pandemic-era flexibilities allowing prescribing of controlled substances based on a telehealth relationship, after receiving in...more
Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending...more
The Controlled Substances Act, as amended by the Ryan Haight Act, generally prohibits prescribing controlled substances via telehealth without a prior in-person examination, subject to certain very limited exceptions. Those...more
The Drug Enforcement Administration (DEA) is seeking approval from the White House to temporarily extend current COVID-19 Public Health Emergency (PHE) flexibilities for prescribing controlled substances via telemedicine....more
As announced by the White House on January 30, 2023, the public health emergency (PHE) is set to end on May 11, 2023. The end of the PHE also brings an end to several flexibilities that were implemented that impact telehealth...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
Telehealth practitioners must take note of the DEA’s proposed rule making that would impact the way telehealth practitioners can prescribe controlled substances. The Ryan Haight Act and the Proposed Rules-...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more