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2024 outlook: Advancing AI innovations in patient care

Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety....

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Public comment period reopened for Proposed Rule on No Surprises Act’s IDR Operations

The Office of Personnel Management (OPM) along with the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) announced on January 17, 2024, that ...

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JPM2024: Investing in preemptive medicine programs

An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity....

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MedTech 2023: Key takeaways from conversations on women’s health, antitrust, and AI

AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists,...

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CMS Issues Final Guidance on the Inflation Reduction Act (IRA) Drug Price Negotiation Program

On July 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. CMS showed some willingness...

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A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies...

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CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...

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CMS issues Medicare Part B and Part D inflation rebate guidance

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “initial” guidance documents implementing the Medicare Part B and Part D inflation...

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JPM2023 Trendspotting: portfolio valuation in the aftermath of the IRA

Caution remains a strong theme in the current market downturn. Now more than ever, companies must think strategically and be more nimble about attracting investments and/or strategic...

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