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Five barriers that could keep biosimilar manufacturers from cracking the US market

by James Forsyth, Director, Deloitte MCS Limited, and Cameron McClearn, Principal, Deloitte Consulting LLP

The biosimilars market in the US has lagged well behind the European market for more than a decade.1 While a recent push from the White House could help expand the use of biosimilars in the US, manufacturers could still face some significant challenges there.

In April, the administration released its “blueprint” for lowering drug prices and reducing out-of-pocket costs for US consumers.

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The president’s executive order on health care: Not repeal, but is it a big deal?

by Anne Phelps, Principal, US Health Care Regulatory Leader, Deloitte & Touche LLP

On October 12, the White House issued an executive order directing the Departments of Health and Human Services (HHS), Treasury and Labor to consider promulgating new rules – or reinterpret existing ones – to affect the small group and individual insurance markets with the stated goal of expanding consumer choices. Since its release, quite a bit of information (and some misinformation) has come out about the order’s potential impact on the markets.

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FDA releases plan to fund Innovation Account

by Doug Beaudoin, Principal, Deloitte Consulting LLP

On July 7, the FDA released its Work Plan and Proposed Funding Allocations of the FDA Innovation Account, the agency’s plan to spend the $500 million in new funding provided by the 21st Century Cures Act. The Cures Act, bipartisan legislation that became law in December 2016, allocates $6.3 billion to advance biomedical innovation by funding basic science research and allowing for innovation and flexibility for product regulation at the FDA.

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Fixing health care’s affordability crisis – Let’s win this one for the Gipper!

by Bill Copeland, Vice Chairman, US Life Sciences & Health Care Industry Leader, Deloitte LLP

As of last week, my youngest daughter has her driver’s license, and we are now in the market for a car. Grace knows that, while she will be driving the car, I am the one paying for it. That gives me some special rights to set spending limits, and require certain performance elements – such as safety,

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MACRA: Quietly transforming health care

by Anne Phelps, Principal, US Health Care Regulatory Leader, Deloitte & Touche LLP

It has been a couple weeks since House Republicans passed the American Health Care Act (AHCA). In my last My Take, I outlined the process the Senate will go through in moving the legislation forward, and what it will take to bring a bill to the president’s desk. While repealing and replacing the Affordable Care Act (ACA) is dominating the headlines and would certainly have a significant impact on the health care landscape,

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Chronic care management: New risks, new opportunities

by Ryan Haggerty, Senior Manager, Deloitte Advisory, Deloitte & Touche LLP

Last week, the Senate Finance Committee passed a bipartisan bill aimed at strengthening and improving health care outcomes for chronically ill Medicare beneficiaries. The Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 was introduced April 6, and was unanimously approved by the committee in a 26-0 vote on May 19.

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