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Transparency Pharmaceutical Industry

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 4, August 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more

Cozen O'Connor

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

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A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more

White & Case LLP

AI implementation & data protection regulation: German authorities publish guidelines for implementing AI in compliance with the...

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The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Wiley Rein LLP

Proposed State and Federal PBM Legislation: Is There Reason for Action Now?

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Legislation aiming to reform the regulation of pharmacy benefit managers (PBMs) remains on the horizon on both the federal and state levels. In particular, 2023 was a fertile year for PBM legislative initiatives....more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

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Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Foley Hoag LLP

Healthcare Issues to Watch Following the FY2024 Spending Deal

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Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

Morgan Lewis - As Prescribed

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more

Sheppard Mullin Richter & Hampton LLP

Oregon Prescription Drug Price Transparency Act in Limbo

On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more

Wiley Rein LLP

Health Care AI and Drug Prices: Highlights From Two Senate Hearings

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Health Care was a hot topic in the U.S. Senate on February 8, as two important Senate Committees – the Committee on Finance and the Committee on Health, Education, Labor, and Pensions (HELP) – held hearings, respectively, on...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

Goodwin

2023 State Drug Transparency Law Development Update

Goodwin on

In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws...more

Cooley LLP

EMA Adopts Revised CTIS Transparency Rules

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On 5 October 2023, the European Medicines Agency (EMA) adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The CTIS plays a...more

Manatt, Phelps & Phillips, LLP

[Webinar] Understanding PBM Reform: A Guide to Congress’s Proposals to Enact Federal PBM Reform Legislation - October 26th, 1:00...

After the enactment of the Inflation Reduction Act, which enables Medicare to negotiate the price of certain prescription drugs, Congress is again attempting to lower the cost of prescription drugs. This time—in a rare...more

McDermott+

McDermottPlus Check-Up: September 8, 2023

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CONGRESS - House Republicans Release Healthcare Package. On September 6, House Republicans unveiled the Lower Costs, More Transparency Act, a draft package of healthcare transparency provisions, pharmacy benefit manager...more

McDermott+

Drug Payment Reform and Transparency: It’s What’s on the Menu for Policymakers

McDermott+ on

August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

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While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more

Morgan Lewis

New Jersey Latest to Join States Signing Drug Price Transparency Reporting Measures into Law

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Following in the footsteps of other states, New Jersey’s state legislature has recently signed into law three bills for containing prescription drug costs. One bill—Senate Bill 1615—is likely to have a particularly sweeping...more

Maynard Nexsen

Pharmacy Benefit Managers: The Market Demands Transparency and Perhaps a Whole Lot More

Maynard Nexsen on

Pharmacy Benefit Managers (PBMs) have recently been facing increased scrutiny and negative attention. PBMs first formed in the late 1960’s and were originally designed to negotiate drug prices with drug manufacturers on...more

McDermott+

Healthcare Preview for the Week of: May 1, 2023

McDermott+ on

Lots of Healthcare Activity in Congress - Activity in Congress focusing on healthcare issues has increased over the last few weeks and is not slowing down anytime soon. This week, the Senate Health, Education, Labor, and...more

McDermott+

Healthcare Preview for the Week of: April 24, 2023

McDermott+ on

A Busy Week in Congress - This week will be very busy on Capitol Hill. Six hearings will focus specifically on healthcare. The House Energy and Commerce Committee will hold a legislative hearing to review 17 pieces of...more

Blank Rome LLP

Nevada Publishes 2023 Drug Price Transparency Lists

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On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more

Holland & Knight LLP

Holland & Knight Health Dose: July 12, 2022

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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

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

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As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

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On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

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