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Federal & State Policy

As the largest, single US healthcare payer, the government plays a dominant role in shaping the healthcare marketplace. Our experts track, interpret, and model federal and state policies that affect insurance coverage, access, and consumer choice so you can see around the bend.

New Study Analyzes FDA Advisory Committees’ Trends in First Three Years of Current User Fee Era

The U.S. Food and Drug Administration's (FDA) Advisory Committee (AdComm) process remains a source of significant uncertainty for medical product manufacturers, despite FDA's guidelines in the Code of Federal Regulations (C.F.R.)1 and in guidance.2 While the AdComm process is generally the same across Centers,3 each AdComm is unique and subject to the expertise and opinions of individual panel members, opinions voiced during the public comment period, and challenges exclusive to each new product or indication.

Podcast: Compassionate Use

When life sciences companies consider whether to allow compassionate use—access to unapproved investigational treatments outside of clinical trials—there are no easy answers. Brenda Huneycutt gleans insight from Arthur Caplan, PhD, and Alison Bateman-House, PhD, from the New York University Langone Medical Center Division of Medical Ethics on some of the many questions that life sciences companies should ask themselves before implementing a compassionate use policy.

MACRA and the Promise of Better Patient/Family Engagement in Post-SGR World

The story of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) actually begins in the previous millennium. In 1997, when the Congress passed the Balanced Budget Act, it ushered in the era of the Sustainable Growth Rate (SGR) formula. In theory, the SGR payment adjustment would raise or lower physician reimbursement each year based on spending relative to the target SGR. The caveat, however, was that Congress had the authority to suspend or adjust this benchmark, a "patch" that they regularly deployed through a "doc fix" for nearly two decades.

Webinar: Expanded Access and Right-to-Try Legislation: Can We Find a Balance Between Competing Interests?

Providing patient access to investigational treatments outside of clinical trials is once again in the spotlight of media scrutiny. Earlier this year, social and popular media attention pressured one company to provide an investigational treatment to a young cancer patient. Then, states began debating and passing “Right to Try” bills to set up a new pathway to allow access to investigational drugs.

Podcast: What’s to Come in MolDx?

Meet Kathy Hughes who leads our Molecular Diagnostics team and has successfully advised device, diagnostics and pharmaceutical companies on optimal market access strategies for over a decade. Kathy addresses key evidentiary developments in the diagnostics space, and what she sees as the future of this evolving field.

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