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The Trump administration is promising major changes in healthcare policy, with action on the Affordable Care Act leading the way.

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FDA Calls For Switching Studies To Support Biosimilar Interchangeability

FDA will require switching studies as well as consumer testing to determine interchangeability of a biosimilar, according to a highly anticipated draft guidance released Tuesday (Jan. 17).

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The Senate Finance Committee scheduled a confirmation hearing on HHS chief-nominee Tom Price for next Tuesday (Jan. 24), coming as Democratic senators and citizen advocacy groups called for a delay in the confirmation process until all questions regarding the Georgia Republican's investments in health care stocks while a congressman dealing with health care issues have been resolved.

AARP is asking President-elect Donald Trump to protect older Americans' access to care before they are eligible for Medicare, and to also tackle high drug prices and protect Medicare and Medicaid.

Transition team spokesperson Sean Spicer said Tuesday (Jan. 17) Donald Trump was impressed with HHS-nominee Tom Price's work on various health initiatives and legislation, but stopped short of saying the Georgia congressman's ACA repeal and replacement bill would be the starting point for the administration’s plan.

CMS on Tuesday (Jan. 17) finished a rule to prevent increases in pass-through payments and new pass-through payments in states that use private managed care to deliver Medicaid benefits, rejecting calls by hospital and Medicaid managed care groups that the rule be put on hold so the incoming administration could review it.

The Medicaid and CHIP Payment and Access Commission sent a report to Congress Tuesday (Jan. 17) with a package of recommendations built on the core idea that lawmakers should extend federal funding for the Children's Health Insurance Program through fiscal 2022.

Medicaid benefits and beneficiaries covered through optional eligibility categories are most at risk under the new HHS and Medicaid reforms expected from GOP lawmakers, beneficiary advocates say.

FDA rules didn't make the short-list of regulations targeted by a conservative think tank in ongoing meetings with congressional Republicans for repeal under the Congressional Review Act, but Freedom Partners is separately pushing an FDA reform agenda that includes state passage of right-to-try legislation and expediting U.S. approval of drugs cleared by other countries, sources with the group tell Inside Health Policy.

Industry experts say FDA's newly issued rule clarifying when tobacco products should be regulated as drugs, devices or combination products includes new language on “intended uses” that could be perceived by industry as an attempt to push back on recent court decisions that truthful, non-misleading, off-label promotion is legal.