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Daily News

September 24, 2019

A House Democrat suggested giving the Centers for Disease Control and Prevention power to pull vaping products from the market because FDA is moving slowly.

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House Oversight and Reform consumer policy subcommittee Chair Raja Krishnamoorthi (D-IL) says Congress should investigate so-called fourth-generation vaping products, a term one public health official used to describe newer products that contain higher levels of nicotine that are particularly addictive.

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The use of medical devices in combination with biologic medicines is emerging as a way to ease burdens on patients and reduce health care costs, but the products pose regulatory challenges to FDA, agency drug center director Janet Woodcock told stakeholders Monday (Sept. 23).

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The Center for Medicare and Medicaid Innovation (CMMI) says its current focus is to implement the dozen or so new models unveiled prior to former CMMI Director Adam Boehler’s departure from CMS.

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FDA officials are encouraging developers of drugs to treat amyotrophic lateral sclerosis (ALS) to get the word out about their research and offer access to their investigational products to patients through the agency’s Right to Try and expanded access pathways.

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September 23, 2019

An en-banc panel of 11 judges from the Ninth U.S. Circuit Court of Appeals in San Francisco discussed whether to reverse a ruling by the same appeals court that allowed the Trump administration to proceed with its rule preventing facilities that perform abortions or refer patients for abortions from receiving Title X funds, also known as the Title X “gag rule."

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Former Vice President and Democratic presidential candidate Joe Biden is ramping up his health care message and will spend the week highlighting the Trump administration’s attacks on the Affordable Care Act and alleging a second Trump term would result in millions of people without coverage.

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Advocates for Medicaid beneficiaries on Monday (Sept. 23) filed another lawsuit challenging Medicaid work requirements -- this time by contesting the controversial policy, along with various other coverage restrictions, in an 1115 waiver for Indiana.

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The effective federal matching rate for Puerto Rico’s Medicaid funding in each of the last five years has been well above the statutory cap of 55%, and HHS has released $1.2 billion in supplemental funding to the island based on progress that the Puerto Rican government has made in setting up anti-fraud measures, according to a letter from CMS Administrator Seema Verma to Senate Finance Chair Chuck Grassley (R-IA).

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CMS on Monday (Sept. 23) released a final method for implementing annual Medicaid Disproportionate Share Hospital pay cuts from fiscal 2020 through fiscal 2025.

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A group of Democratic senators is pressing CMS to step up its oversight of Medicare Advantage plans, pointing to problems with MA plan overpayments, provider directory and encounter data accuracy issues and potentially misleading star ratings.

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In a brief two-page report, the Government Accountability Office highlights the potential for opioid vaccines and lays out the challenges and policy questions surrounding their development, including what standards FDA should set for clinical trials and what resources would be needed.

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Compounding company Athenex has withdrawn its appeal of a recent D.C. federal district court ruling that upheld FDA’s ban on bulk compounding of vasopressin.

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FDA wants input from stakeholders on the development of abuse-deterrent formulations (ADFs) of central nervous system stimulants, which are widely prescribed to treat attention deficit hyperactivity disorder and sometimes narcolepsy.

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September 20, 2019

Several high-profile health experts were upset by CMS Administrator Seema Verma’s recent blog in which she denied the increase in uninsured Americans was due to a decline in Medicaid enrollees and instead blamed it on the Affordable Care Act, including Families USA Eliot Fishman who told Inside Health Policy he has been frustrated by the GOP’s narrow focus on the unsubsidized population even as affordability remains a challenge for lower-income people.

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A group of Democratic attorneys general demand the administration immediately comply with federal injunctions that bar the government from implementing rules that loosen the Affordable Care Act’s contraceptive mandate, saying that information posted on, or omitted by, HHS and Department of Labor websites violates the orders.

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The House Energy & Commerce Committee’s surprise billing fix would save $21.9 billion over the course of 10 years, according to the Congressional Budget Office.

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President Donald Trump on Thursday (Sept. 19) issued an executive order to establish a National Influenza Task Force, co-chaired by the heads of HHS and the Department of Defense and comprising senior officials from several federal agencies, including FDA and CMS.

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A Senate Finance Committee task force charged with looking at six expiring health taxes, including the Affordable Care Act’s taxes on medical devices and health insurers, failed to reach a consensus on next steps in a newly issued report.

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Home health providers, Medicare advocates and hospitals again expressed concerns that CMS’ proposed 8% cut within the home health system based on behavioral assumptions is too harsh in its proposed 2020 home health pay rule.

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