News & Analysis as of

Health Care Providers Pharmaceutical Industry Patient Access

Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

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

Blake, Cassels & Graydon LLP

Des développements législatifs touchent le secteur québécois des soins de santé

Une nouvelle politique fédérale et des modifications législatives au Québec amènent des changements au sein du secteur québécois des soins de santé. Un éventail varié d’entreprises dans ce secteur pourrait devoir s’adapter en...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

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

McDermott Will & Schulte

Trending in Telehealth: February 12 – February 26, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...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

Polsinelli

New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

Polsinelli on

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more

McDermott Will & Schulte

Trending in Telehealth: January 4 – 15, 2024

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

BakerHostetler on

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Sheppard Mullin Richter & Hampton LLP

OIG Advisory Opinion Alert: Medical Flights for Patient Access

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug...more

Polsinelli

DEA Announces Permanent Flexibilities for the Prescribing of Controlled Substances via Telemedicine

Polsinelli on

On February 24, 2024, the Drug Enforcement Administration (“DEA”) released a long-anticipated proposed rule that aims to permanently extend controlled substance prescribing flexibilities beyond the COVID-19 Public Health...more

Quarles & Brady LLP

FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone

Quarles & Brady LLP on

On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 116: Michael Carlin, Manager, Engage HCP by TrialCard

Maynard Nexsen on

On episode 116, Matthew and Amanda chat with Michael Carlin of TrialCard, a life sciences company that provides digital solutions to pharmaceutical companies, connecting them to health care providers and patients while also...more

Downs Rachlin Martin PLLC

Vermont Health Care Update | Week 21

The Senate Health and Welfare Committee took up H. 960 this week, the recently House passed miscellaneous health care bill. The committee will be proposing a series of amendments, including the addition of Act 91 of 2020...more

Robinson+Cole Health Law Diagnosis

Connecticut DCP Issues Guidance for Remotely Refilling Prescriptions

The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an...more

Robinson+Cole Health Law Diagnosis

Massachusetts Issues COVID-19 Orders and Related Guidance for Pharmacies and Pharmacy Professionals

On March 24, 2020, the Massachusetts Commissioner of Public Health issued a Pharmacy Practice Order related to pharmacy practice by retail and institutional pharmacies....more

Robinson+Cole Health Law Diagnosis

DEA Allows Providers to Prescribe Controlled Substances Without an In-Person Medical Examination During COVID-19 Public Health...

The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-17-2020 - An analysis from DRM's Health Law Team

Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more

Hogan Lovells

FDA Simplifies and Clarifies Expanded Access Program

Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

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