News & Analysis as of

Patients Prescription Drugs Pharmaceutical Industry

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

Napoli Shkolnik on

Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....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

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

McDermott Will & Emery

This Week in 340B: November 2023

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Quarles & Brady LLP

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

Quarles & Brady LLP on

In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

McDermott Will & Emery

This Week in 340B: September 2023 #3

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more

McDermott Will & Emery

This Week in 340B: February 2023

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Bass, Berry & Sims PLC

Federal District Court Vacates Copay Accumulator Adjustment Rule: Programs Remain the Same for Now

Bass, Berry & Sims PLC on

On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more

Bass, Berry & Sims PLC

Kentucky Federal Court Temporarily Bars CVS from Imposing Block on Interventional Pain Doctor’s Prescriptions

Bass, Berry & Sims PLC on

In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more

Baker Donelson

OIG Allows Pharmaceutical Manufacturer to Provide Financial Assistance for Travel, Lodging and Other Expenses to Certain Patients...

Baker Donelson on

A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's...more

Sheppard Mullin Richter & Hampton LLP

Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts...more

Sheppard Mullin Richter & Hampton LLP

The Next in the Series of Executive Orders Affecting the Pharmaceutical Industry

On Sunday, September 13, 2020, President Trump signed an Executive Order, the next in a series of Executive Orders targeting the pharmaceutical industry, which aims to lower prescription drug prices in the United States (the...more

Steptoe & Johnson PLLC

FDA Recommends Naloxone Prescription for Patients Receiving Opioids or Medications Used to Treat Substance Use Disorder

Steptoe & Johnson PLLC on

In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Robinson+Cole Health Law Diagnosis

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more

Robinson+Cole Health Law Diagnosis

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Faegre Drinker Biddle & Reath LLP

FDA Final Guidance Document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry”

On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more

Sheppard Mullin Richter & Hampton LLP

The Eliminating Kickbacks in Recovery Act: A Critical Analysis of an Altered Landscape for Financial Relationships with Clinical...

I. Introduction - The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the “SUPPORT Act”), passed at the end of October 2018, seeks to prohibit...more

Butler Snow LLP

Pro Te: Solutio – Vol. 11, No. 2

Butler Snow LLP on

In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

Holland & Knight LLP on

On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

Holland & Knight LLP

FDA Announces Modernization of Drug Review Process and Operations

Holland & Knight LLP on

On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Drug Pricing Blueprint: Overview and Analysis

• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more

36 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide