News & Analysis as of

Patient Access Life Sciences

McDermott Will & Emery

Tirzepatide Shortage Resolved

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On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap...

Maynard Nexsen on

This episode, we welcome back one of our favorite guests, Dr. Kashyap Patel, a renowned practicing physician, author, and healthcare thought leader. Dr. Patel has been dedicating much of his attention to analyzing long COVID...more

DLA Piper

FemTech and the use of AI

DLA Piper on

Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more

Manatt, Phelps & Phillips, LLP

CMS and ONC Issue Final Rule on E-Prescribing

On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

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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

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

Burr & Forman on

The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 189: Student Mental Health with Dr. Stephanie Irby...

Maynard Nexsen on

Heather and Lauren welcome Dr. Stephanie Irby Coard, a UNC Professor and researcher, to discuss the ever growing issue of mental health for college students. Dr. Coard shares what she is currently seeing in the mindset of...more

Manatt, Phelps & Phillips, LLP

Expanding Access to Telehealth for Medication Abortion Care in a Constrained Policy Environment

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

Jenner & Block

Client Alert: The Supreme Court Signals That Access to Mifepristone Will Likely Remain Safe for Now

Jenner & Block on

On March 26, 2024, the Supreme Court heard arguments in the two consolidated cases concerning access to mifepristone pending before the Court, FDA v. Alliance for Hippocratic Medicine, Case No. 23-235 and Danco Laboratories,...more

Epstein Becker & Green

Update: Alabama Legislature Moves to Shield IVF from “Personhood” Ruling

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In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...more

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

Whiteford

New CMS Guidance on Use of Algorithms and AI in Prior Authorizations and Utilization Management

Whiteford on

Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more

Dentons

Ep. 4 - Ozempic, Wegovy, and the New Compliance Risks for Providers

Dentons on

Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim...

Maynard Nexsen on

Recorded at SCBIO’s 2024 annual meeting, hosts Heather and Lauren welcome healthcare economist and GlobalData Director Tim Dall, who has studied the economic burden of chronic disease for over 25 years. The group discusses...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

Nelson Hardiman, LLP on

F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Manatt, Phelps & Phillips, LLP

FY 2025 Executive Budget Women’s Health Highlights

Earlier this week, Governor Kathy Hochul released her Executive Budget proposal totaling $233 billion for State Fiscal Year 2025. The budget proposes several initiatives targeted at improving access to, quality of, and...more

Manatt, Phelps & Phillips, LLP

FDA Approves Florida’s Application to Import Drugs from Canada

On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug...more

Manatt, Phelps & Phillips, LLP

Abortion Access and Coverage Survey Results: Key Findings

Editor’s Note: Manatt Health conducted a survey of all 34 states in which abortion is legal as of November 7, 2023, broadly classifying them based on their Medicaid coverage policies, private or exchange-based insurance...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

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Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who are unable to...more

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Knobbe Martens

The FDA Approves Two New Gene Therapies for the Treatment of Sickle Cell Disease

Knobbe Martens on

On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more

Manatt, Phelps & Phillips, LLP

TRIALS AND TRIBULATIONS: How to Remove Barriers Blocking Cancer Patients From Clinical Trials and Advance the Next Generation of...

EXECUTIVE SUMMARY - Clinical trials are a lifesaving option for many cancer patients. But too many patients face barriers preventing access to this critical treatment. Everyone suffers when patients cannot access...more

Epstein Becker & Green

Abortion Rights to Be Codified in Ohio State Constitution

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On November 7, 2023, the citizens of the state of Ohio voted to codify reproductive rights, including the right to abortion, in the state constitution. In 2019, Ohio banned nearly all abortions once fetal cardiac...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

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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

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