Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado interviews partner Chris Schott about takeaways from the conference, including thoughts on the new Medicaid regulation that CMS released just days before the conference.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does...

Recent Supreme Court decisions, such as the opinions in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce that overruled the long-standing Chevron doctrine, will likely impact how federal agencies interpret ambiguous statutes when regulating the pharmaceutical industry. And in Securities & Exchange Commission v. Jarkesy, the Court established a right to a jury trial for defendants facing civil monetary penalties in agency enforcement actions, which may affect...

In this episode of Connected with Latham, we explore the remarkable story of Shabir Kabiri, an Afghan refugee who secured asylum in the United States with the help of a Latham pro bono team. Shabir shares his harrowing journey, his time as a cadet at West Point, and the dangers he faced upon returning home. When Kabul fell to the Taliban in 2021, Shabir experienced the chaos and fear firsthand, as his former West Point roommate and a group of West Point classmates worked to orchestrate...

The US healthcare landscape is undergoing significant changes as the Centers for Medicare & Medicaid Services (CMS) continues to implement the Inflation Reduction Act (IRA). One key stakeholder group affected by the IRA drug price negotiations and Medicare Part D redesign are health insurance companies. In this episode of Connected with Latham, we delve into how these payers are responding to the IRA, including the new ability for Part D beneficiaries to spread their cost-sharing equally...

Current developments grabbed much of the spotlight when key industry stakeholders met in New Orleans for the Pricing and Contracting USA Conference. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and associates Danny Machado and Elisabeth Crusey share their observations from the conference, concluding with four calls to action for pharmaceutical manufacturers.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does...

The Centers for Medicare and Medicaid Services (CMS) recently updated its portal for Average Sales Price (ASP) reporting under Medicare Part B. Data collection portals are also essential for manufacturer compliance with the Inflation Reduction Act and for price reporting under the Medicaid Drug Rebate Program. The 340B program operates yet another online data portal. In addition to these federal programs, states are also implementing data collection interfaces. For example, the Texas Vendor...

As the energy tech sector continues to mature, venture capital offers an increasingly a viable path to growth as emerging energy tech companies seek to disrupt the energy space, often following a fundraising and growth trajectory similar to software and AI. Energy tech provides opportunities for financial institutions and strategic partners to invest early in the company and also at the project level, addressing the capital-intensive needs of emerging companies through innovative funding...

Latham’s recently released 2023 Pro Bono Annual Review highlights our public service initiatives around the world, including our ongoing relationship with Trees for Life. This conservation charity is dedicated to rewilding the Scottish Highlands through the restoration of the Caledonian Forest, which supports wildlife found nowhere else in Britain. In this episode of Connected with Latham, introduced by Lauren Meyer, Latham’s Pro Bono Managing Attorney — EMEA, London partner Huw Thomas sits...

Following an array of ESG-focused regulation and escalating concerns of greenwashing risks in 2023, the year ahead looks to deliver significant industry developments at a rapid pace. In the UK, the FCA's Sustainability Disclosure Requirements (SDR), investment labelling regime, and anti-greenwashing rule will take effect during 2024. The FCA also plans to consult this year on incorporating standards set by the International Sustainability Standards Board into disclosure requirements for...

In 2023, the FCA brought more charges for fraud offences against individuals than any other year in the regulator’s history, and secured several convictions related to fraudulent investment schemes. Yet while the FCA has signaled that economic crime is on its radar, recent years have been defined by relative inactivity, as the higher burden of proof for criminal convictions has resulted in fewer opened enforcement cases and extended investigations. Still, with new leadership appointments to...

The UK’s announcement of the Edinburgh Reforms in 2022 made clear the government’s intention to chart its own course in rulemaking for the UK financial services sector, and no longer prioritise equivalence with EU legislation. The UK is currently in the process of repealing and restating all retained EU legislation, which will result in divergence from the EU in several areas. Priority areas of reform have already seen significant progress, particularly those reflecting areas in which the...

Two new Joint Executive Directors of Enforcement and Market Oversight appointed by the FCA in 2023 will settle into their roles over the year ahead. Following a period of enforcement defined by increased investigations and a willingness to push the envelope of legal interpretation, firms will look toward the coming year to resolve which areas of focus the FCA will prioritise. Recent activity suggests that the FCA aims to align its enforcement with its broader strategy, expedite the resolution...

With the UK financial services regulators due to publish Policy Statements to their consultations on diversity and inclusion (D&I) this year, conduct and culture remain high on the regulators’ agenda and connect closely to their other regulatory priorities. The regulators have proposed new D&I reporting and disclosure requirements for larger financial services firms, and the FCA is consulting on new guidance on non-financial misconduct. Although final rules are not expected until the...

The coming year looks poised to act as a pivotal junction for the UK financial services regulators in deciding how to approach the regulation of artificial intelligence (AI), as the financial services industry sees the continued expansion of AI-related capabilities and use cases. To avoid stifling innovation, the UK government plans to take an “agile and iterative” approach, focusing on regulating harmful uses of AI rather than regulating AI systems as a whole. Yet this stance stands in...

Since the announcement of the Edinburgh Reforms in 2022, the UK government has made progress on an assortment of measures spanning financial services regulation, with more developments expected in 2024. Though tabled initially as an ambitious suite of reforms, many of the proposals have not been particularly radical in reality. A recent Treasury Committee report found that completed work has had little economic impact, and that many of the workstreams are not true reforms. In this episode...

The pressure and uncertainty of 2023 will likely continue for drug manufacturers in 2024, with the election cycle bringing added scrutiny. At the federal level, continuing implementation of the Inflation Reduction Act, including publication of the so-called negotiated prices, may be disruptive. The states, meanwhile, will likely move forward with their own drug pricing initiatives, including statutes seeking to regulate the federal 340B program. Manufacturers have responded with greater...

The UK’s decision to scrap compulsory research unbundling, following the final recommendations of the Investment Research Review, marked one of the most striking developments for financial services firms in 2023. Permitting rebundling across the board with no market capitalisation threshold comes as part of a wider approach to reinvigorate UK capital markets. With the FCA expected to finalise its rule changes by midyear, firms accustomed to the MiFID II rules will need to adapt to the added...

As part of the FCA’s continued focus on retail markets, updates to several key regimes are due to progress over the next year. In addition to further implementation of the FCA’s Consumer Duty, the government plans to present detailed proposals on modernising the consumer credit regime, develop proposals to address the “advice gap”, and bring in a new UK retail disclosure framework to replace the PRIIPs regime. In this episode of Connected With Latham, the latest in a 10-part series...

The National Institute of Standards and Technology (NIST) recently published a draft guidance framework for considering the exercise of march-in rights. Under the Bayh-Dole Act, government agencies can “march in” on patents resulting from government-funded research if the patent licensee is not sufficiently developing the patented invention, based on the consideration of various factors. The guidance would add price as one such factor. In this episode of Connected with Latham, partners Chris...

Cyberattacks targeting well-resourced businesses, especially those with institutional backing, financial support, and deep insurance coverage, have become increasingly prevalent. PE portfolio companies in particular find themselves in the crosshairs of sophisticated attackers — a heightened risk that underscores the need for boards to devote attention to cyber-incident preparations. In this episode of Connected With Latham, Huw Thomas, Co-Chair of Latham’s London Corporate Department, speaks...

For the last three years, UK regulatory authorities have commissioned an array of reviews and consultations to address friction points in the UK’s primary markets, culminating in reforms to the listing regime scheduled to take place in 2024. In addition to simplifying listing segments, these reforms signal a shift to a more disclosure-based regime, by relaxing eligibility requirements for commercial entities at the point of entry and no longer mandating shareholder votes for a variety of...

Regulatory drivers and stakeholder demands have put environmental, social, and governance (ESG) considerations at the forefront of their agendas, with PE firms adopting ESG strategies across funds, investments, due diligence, and portfolio company management. This strong focus has prompted certain stakeholders to argue that ESG factors are receiving undue attention at the expense of financial considerations, a critique sometimes referred to as “greenbashing” or the “ESG backlash”. In major...

As companies feel heightened pressure from stakeholders to adopt environmental, social, and governance (ESG) measures, greenwashing allegations continue to rise in tandem. Complex regulatory environments in the US and across Europe increase the likelihood of enforcement actions and demands for leadership teams to validate their public statements and disclosures. Lawsuits have become a tool for holding businesses accountable for their environmental practices and claims. Companies implementing...

Regulators in the US, EU, and UK have increasingly scrutinized non-compete and no-poach clauses in employment agreements and M&A deals. The US Federal Trade Commission proposed a rule to ban non-competes in most situations, while several US states seek to implement complete or partial non-compete bans. In Europe, the European Commission and the UK’s Competition and Markets Authority are enhancing enforcement on no-poach agreements, while the UK government plans to limit the length of...