Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap Patel of Carolina Blood & Cancer Care Associates
Early Returns Podcast with Jan Baran - Josh Gerstein: SCOTUS, the Presidential Immunity Case Fallout, and the Dobbs Case Leak Investigation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 189: Student Mental Health with Dr. Stephanie Irby Coard, UNC Professor
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim Dall, Healthcare Economist
Podcast: Post-Dobbs - One Year Later - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
In the Boardroom With Resnick and Fuller - Episode 2
Let's Talk About the Constitutional Aspects of the Dobbs Decision
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard
Compliance Perspectives: Providing Patient Access to Personal Health Data
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...more
Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General ("OIG") issued Advisory Opinion No. 25-02 ("Opinion") on April 4, 2025, regarding a Health Center proposal to link social support services to...more
The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more
On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more
On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab)....more
President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, Wisconsin’s legislature says no to the Governor’s cannabis proposal. Pennsylvania’s Senate says no to the...more
President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more
On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more
Key points include access to medicines in medicare is reduced as the IRA is implemented; fewer drugs are covered on Medicare Part D formularies in 2025 relative to 2024; medicines for serious conditions with high unmet needs...more
On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more
Stemming from concerns raised during the COVID pandemic, the Ohio General Assembly recently passed House Bill 236, dubbed the “Never Alone Act,” (“Act”) which became effective March 20, 2025. The law requires a wide range of...more
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
On March 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil money penalty (“CMP”) of $200,000 against Oregon Health & Science University (“OHSU”) for failing to...more
CASE AT A GLANCE - In 2018, Planned Parenthood South Atlantic (PPSAT) and one of its patients, Julie Edwards, sued the administrator of South Carolina’s Medicaid program to enforce the “free choice of Medicaid provider”...more
As Medicare physician reimbursement continues in 2025 to suffer from damaging shortfalls due to budget neutrality and lack of an inflation adjuster, steps are being taken in Congress to address the issue. On January 31, the...more
In a move with potentially significant implications for entities subject to the Affordable Care Act, the Department of Health and Human Services (HHS) has reversed course and now contends that Section 1557 of the Affordable...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more
On February 18, 2025, US President Donald Trump signed an executive order directing his administration to develop policy recommendations within 90 days to increase access to in vitro fertilization (IVF) services and to reduce...more
On February 20, 2025, the U.S. Department of Health and Human Services (“HHS”) took action pursuant to President Trump’s Executive Order 14187 (“EO 14187”), which is aimed at ending gender affirming care for minors. EO 14187...more
Following through on a campaign theme focused on transgender issues and access to gender-affirming health care, on Friday, January 28, President Trump signed an Executive Order, titled “Protecting Children from Chemical and...more
On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more