News & Analysis as of

Reimbursements Life Sciences

Hogan Lovells

The increasing legalisation of French market access positions is confirmed

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The new amendments to the French framework agreement. The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical...more

Smart & Biggar

CDA–AMC (formerly CADTH) announces several pilot projects, including Target Zero initiative

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CADTH is now known as Canada’s Drug Agency (CDA-AMC or CDA). Its mandate extends beyond CADTH’s mandate to include: improving the appropriate prescribing and use of medications; increasing pan-Canadian data collection and...more

McDermott Will & Emery

Trending in Telehealth: May 14 – May 20, 2024

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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

McDermott Will & Emery

Trending in Telehealth: May 7 – May 13, 2024

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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

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

A&O Shearman

UK CMA issues 'prioritisation statement' to allay competition law fears that prevent combination therapies reaching NHS

A&O Shearman on

The UK Competition and Markets Authority (CMA) has taken the unusual step of issuing a prioritisation statement on cooperation between competitors to make combination therapies available to the NHS. The CMA worked closely...more

Smart & Biggar

CADTH time-limited recommendation category to enhance earlier access to promising new drugs

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On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target...more

Smart & Biggar

pCPA announces new three-year pricing initiative agreement for generic drugs with CGPA, appointment of Douglas Clark as its first...

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The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs, effective October 1, 2023. This agreement, which...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] Understanding the 340B Program: A Guide to the Newest Developments - November 9th, 3:00 pm - 4:00 pm ET

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - The 340B discount program—which requires manufacturers to provide outpatient drugs to...more

Manatt, Phelps & Phillips, LLP

Supreme Court Strikes Down Medicare Part B Reimbursement Reduction for 340B Drugs

The Supreme Court yesterday issued a unanimous opinion striking down the federal government’s reduction in Medicare Part B reimbursement for 340B drugs for calendar years 2018 and 2019. As background, the Centers for Medicare...more

Quarles & Brady LLP

U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

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On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2021

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Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more

Hogan Lovells

Nouvelle doctrine de la Commission de la Transparence de la Haute Autorité de santé

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Dans la continuité de son Plan d’action pour les médicaments innovants exposé début 2020, la Haute Autorité de santé a mis à jour sa doctrine d’évaluation des médicaments. ...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter: Life Sciences - What's new in France? Decree of 25 August 2020 on the harmonization of...

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In the context of the pandemic, Decree No. 2020-1090 of 25 August 2020 on various measures relating to the reimbursement of health products (the “Decree”) could have been overseen as merely being a technical document.  ...more

Smart & Biggar

CADTH harmonizes Drug Reimbursement Review Process

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On September 30, 2020, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced the launch of new Procedures for CADTH Drug Reimbursement Reviews (updated October 29, 2020), which harmonize procedures under...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

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The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Hogan Lovells

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

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Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...more

McDermott Will & Emery

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

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McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Morgan Lewis

FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders

Morgan Lewis on

The US Food and Drug Administration has updated its Information Sheet on payments to clinical trial subjects, including travel reimbursements, and announced a public meeting on enrollment criteria, signaling the agency’s...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Arnall Golden Gregory LLP

Compensation to Human Clinical Study Participants: A (Very) Informal Survey

At least once a month, life science clients reach out to us to ask us about best practices on a particular topic or to benchmark a proposed activity against what others in the industry might be doing. One such request,...more

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