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WASHINGTON, DC USA -- HEALTHCARE UPDATE NEWS SERVICE -- APRIL 6, 2017: Sign up for a free trial to Inside Health Policy, the online news service on health care policy from the regulatory reporting experts at Inside Washington Publishers.
President Trump is battling for support for his Obamacare replacement but uncertainty abounds regarding how the new plan will play out. Inside Health Policy is the essential health policy news source that can help you sort through the noise of the potentially tumultuous changes ahead.
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Califf: Trump Proposals Dangerous, New FDA Chief Must Work Within 'Violently Deregulatory' Administration
Former FDA Commissioner Robert Califf says the Trump administration's proposed cuts to FDA would pose a danger to public health. Califf, who stepped down after the election, believes that the next FDA commissioner's biggest task will be dealing with an administration, which he called "violently deregulatory."
Administration Confirms It Will Fund CSRs As Long As Lawsuit In Play
An administration official on Monday (April 3) told Inside Health Policy that the Trump administration will follow precedent and will fund the ACA's cost-sharing reductions subsidies as long the House suit over the payments is in litigation, providing one of the first indications of where the White House stands on the issue.
Split Emerges On Biosimilar Interchangeability Switching Requirements
Industry stakeholders are concerned that FDA's requirement for biosimilar sponsors to use only American samples of reference products when conducting switching studies to demonstrate interchangeability could slow biosimilar market entry, according to recently posted comments on the agency's January draft guidance. However, one physician group argues that the requirement is prudent, given that there may be differences between United States and international products.
CMS Seeks Input On Further MA, Part D Changes To Hike Plan Flexibility, Affordability
CMS is seeking advice from stakeholders on ways to further tweak Medicare Advantage and Part D to increase benefit flexibility, innovation and affordable plan choices as part of a broad Request for Information included in the 2018 MA and Part D Call Letter released Monday (April 3). With the new administration coming in, there is an interest in collecting ideas from the public on the programs, senior Medicare officials said.
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