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Daily News

December 18, 2019

The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

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The Trump administration on Wednesday moved forward on its plan to let states and drug makers import lower-cost prescription drugs from other countries.

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December 17, 2019

Stephen Hahn, shortly after being sworn in as FDA commissioner on Tuesday (Dec. 17), emailed FDA staff that he’s optimistic about continuing to advance FDA’s talent, expertise and infrastructure, and said he will adhere to sound data and uphold the law.

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FDA recently detailed how it will execute its new authorities to require sponsors of molecularly targeted adult cancer drugs to submit data on how those drugs can also be used in pediatric populations.

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FDA unveiled a draft proposal for a new qualification process for drug development tools, including biomarkers, clinical outcome assessments, and other methods or materials used to aid in drug development and regulatory review.

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FDA is proposing to no longer publish a list of premarket approval applications and humanitarian device exemption approvals and denials in the Federal Register each quarter, according to a proposed rule published Monday (Dec. 16).

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A new study released Tuesday (Dec. 17) by the Pharmaceutical Research and Manufacturers of America says that 340B hospitals are, on average, reimbursed by commercial insurers at about three times what they pay for drugs under the discount program.

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December 16, 2019

Health stakeholders are praising Senate and House appropriators for permanently repealing the so-called “Cadillac” health insurance and medical device taxes in the end-of-year spending package released Monday (Dec. 16), following years of lobbying to get rid of the industry taxes Congress had passed to offset the coverage expansion in the Affordable Care Act.

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Congress included the pro-generic CREATES Act to help pay for five months of so-called Medicare and Medicaid “extenders” in the one-year government funding bill, plus a few minor biologics policies.

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The year-end spending deal released Monday (Dec. 16) includes industry-sought exemptions from Medicare competitive bidding for manual complex rehab technology wheelchairs and the accessories, but other durable medical equipment stakeholder priorities, like exempting non-invasive ventilators from competitive bidding, were not included in the package.

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The end-of-year spending deal released Monday (Dec. 16) includes funding for five months for several Medicare and Medicaid extenders, as well as two years of Medicaid funding for the territories and an even longer extension for the Patient-Centered Outcomes Research Trust Fund, as previously anticipated.

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FDA scored a $91 million increase in the year-long fiscal 2020 funding deal hammered out by congressional appropriators Monday (Dec. 16).

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Kentucky’s new Democratic governor revoked the state’s controversial Medicaid waiver on Monday (Dec. 16), ending the state’s two-year effort to impose work requirements, premiums and new coverage restrictions on hundreds of thousands of beneficiaries.

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The spending package being nailed down by congressional leadership includes a provision that blocks the Trump administration from sabotaging the Affordable Care Act by ending silver loading or auto-enrollment, two moves the administration considered but did not proceed with last year, a congressional source and lobbyists confirm.

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CMS will extend open enrollment on healthcare.gov through Dec. 18 following widespread reports that consumers were unable to enroll by the Sunday (Dec. 15) deadline for technical reasons and after dozens of advocates and lawmakers urged the agency to grant those seeking to purchase coverage more time.

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Congress is slated to fully repeal three controversial health care taxes after congressional leaders agreed to include the repeals in an end-of-year spending package, sources familiar with the talks say.

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Congress is creating a new opening to vote on surprise billing and drug pricing legislation next May by limiting Medicare and Medicaid extenders to five months in a year-long government funding bill. 

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Key senators had aimed to get their bill that would ban non-tobacco-flavored e-cigarettes from the market into a year-end spending deal.

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Key senators are aiming to get their bill that would ban non-tobacco-flavored e-cigarettes from the market into a year-end spending deal expected to be released soon.

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A federal district court judge on Monday (Dec. 16) turned down hospitals’ request to keep CMS from putting the second year of so-called site-neutral cuts for clinics at certain off-campus hospitals in place next year, as she said the court doesn’t have jurisdiction over the 2020 rule at this time.

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