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CMS Issues Guidance on Usage of AI in Making Coverage Determinations

On February 6, 2024, the US Centers for Medicare & Medicaid Services (CMS) issued a letter to all Medicare Advantage (MA) organizations and Medicare-Medicaid plans. The letter covered frequently asked questions and answers related to the coverage criteria and utilization management requirements in the CMS Final Rule issued on April 5, 2023.

Among the FAQs was guidance related to the use of artificial intelligence (AI) and other technologies to assess coverage decisions. CMS wrote, “An algorithm or software tool can be used to assist MA plans in making coverage determinations, but it is the responsibility of the MA organization to ensure that the algorithm or artificial intelligence complies with all applicable rules for how coverage determinations by MA organizations are made.” For example, in a decision to terminate post-acute care services, an algorithm or software tool can be used to predict the potential length of stay, but that prediction alone cannot be used as the basis to terminate services.

CMS also expressed concern that algorithms and AI technologies can exacerbate discrimination and biases, emphasizing that MA organizations must comply with nondiscrimination requirements of Section 1557 of the Affordable Care Act.




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Global Labor and Employment Legal Update

Following a dynamic 2023 coupled with a continually evolving legal landscape, employers may feel that they are left with more questions than answers. During a recent webinar, McDermott’s employment team took a dive into the most pertinent legal updates of 2023 and shed light on uncertainties to prepare employers for the year ahead. The discussion covered new laws taking effect in 2024, explored key developments impacting the workforce and advised on what employers can expect heading into the new year.

Access webinar recording and key takeaways.




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Healthcare Payors and Providers and AI Companies Voluntarily Commit to AI Principles

The Biden administration recently announced that 28 healthcare payors and providers intend to implement and adhere to voluntary commitments for the safe, secure and trustworthy development and deployment of artificial intelligence (AI) in healthcare. The signatory companies aligned around the FAVES principle—namely, that AI should lead to healthcare outcomes that are fair, appropriate, valid, effective and safe.

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What Does Landmark AI Executive Order Mean for Healthcare?

On October 30, 2023, the Biden administration released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI while highlighting many known risks of AI tools and systems. It directs a broad range of actions around new standards for AI that will impact many sectors, and it articulates eight guiding principles and priorities to govern the development and use of AI.

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Digital Health and the Direction of AI in Healthcare

What is the current state of digital health? Where will artificial intelligence (AI) see the most growth and adoption in healthcare? And what are the key AI issues most relevant to healthcare providers?

In this TripleTree article, Alya Sulaiman offers her perspective on some of the essential AI questions facing the digital health space.

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Artificial Intelligence Myth Versus Reality: Where Do Healthcare Experts Think We Stand?

As the healthcare industry evaluates how to pay for artificial intelligence (AI) solutions, industry experts say data and real-world evidence are essential for reaching any payment decisions. In this Forbes article, McDermott Partners Dale C. Van Demark and Jiayan Chen provide insight into some of the regulatory challenges AI presents.

“For AI to be paid for, you need data that shows your product is making a difference,” Chen notes. “To do that, you need massive quantities of data to develop the tool or algorithm, but you also have to show that it works in a real-world setting.”

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Employers and Artificial Intelligence: Six Pitfalls to Watch Out For

As governments lift COVID-19 pandemic restrictions, employers are turning to artificial intelligence tools to accelerate their hiring processes.

However, these AI-based tools can open businesses up to discrimination claims if they are not careful, according to McDermott partner Brian Mead.

“[The technology] could decide that certain words [are] unlikely to [yield] successful candidates, and then it’s prescreening out members of protected classes and categories of applicants in a discriminatory way,” Mead said in a recent Law360 article.

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Transformative Healthcare Collaboration Opportunities Emerge from COVID-19 Pandemic

The seismic, virtually overnight transformation of healthcare delivery as a result of the pandemic has flung open doors to innovation, as a diverse cross-section of digital health and life sciences stakeholders mobilize crisis resources; adjust operations for enhanced screening, sanitization and social distancing measures; harness telehealth capabilities to deliver healthcare remotely; and identify opportunities for smarter, better healthcare going forward.

Writing for The US-Israel Legal Review, partners from McDermott’s Health practice highlight the challenges and opportunities that digital health and life sciences operators and investors should consider as the industry charts a course through the post-pandemic changed healthcare landscape.

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