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Scrutiny on health care professional transparency and inducement in the Netherlands

On 8 April 2024, the Dutch Minister of Medical Care sent a letter to Dutch Parliament (in Dutch: “Tweede Kamer”) regarding interactions between life sciences companies and...

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FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate...

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CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

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CMS finalizes new standards and reporting obligations affecting Medicaid and CHIP managed care plans

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality...

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HHS final rule requires HIPAA compliance changes for reproductive health care information

The HIPAA Privacy Rule has been modified by the US Department of Health and Human Services (“HHS”) to increase privacy protections for reproductive health care information....

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HRSA issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...

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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

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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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Podcast: Talking the cure

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...

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