CDC Makes Monkeypox Treatment Available Via Telehealth

The Centers for Disease Control and Prevention and FDA have unveiled a streamlined process for health care providers to offer a smallpox antiviral treatment to patients who have monkeypox, which includes the option to prescribe the drug via telehealth. CDC is using an Investigational New Drug expanded access flexibility that “allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages,” according to a new update...
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U.S. Govt Eyes Decentralized Clinical Trials For Monkeypox Research

The U.S. government’s monkeypox research team plans to prioritize the use of decentralized clinical trials and remote monitoring to gain more information about the current monkeypox outbreak, the White House announced as part of its broader $140 million monkeypox research plan released late last week. Remote clinical trials played a key part in the COVID-19 pandemic response, allowing vaccine makers to enroll patients from diverse communities and make use of digital tools that allowed researchers to connect with patients via...
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Lawmakers, Stakeholders Cheer Prior Auth Reform As Bill Clears W&M

Medicare Advantage prior authorization reform legislation sailed through the House Ways & Means Committee on Wednesday (July 27) with unanimous support as lawmakers touted provisions aimed at modernizing the process, including real-time authorization for routine services and time limits for prior authorization decisions -- even as some Republicans said prior authorization can be a useful tool for MA plans in certain circumstances and pointed to MA plans’ popularity. Rep. Suzan DelBene (D-WA), who spearheaded both the legislation Ways & Means...
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CMS Issue: 
Inside CMS - 08/04/2022
CMS Volume: 
Vol. 25, No. 31
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U.S. Govt Eyes Decentralized Clinical Trials For Monkeypox Research

The U.S. government’s monkeypox research team plans to prioritize the use of decentralized clinical trials and remote monitoring to gain more information about the current monkeypox outbreak, the White House announced as part of its broader $140 million monkeypox research plan released late last week. Remote clinical trials played a key part in the COVID-19 pandemic response, allowing vaccine makers to enroll patients from diverse communities and make use of digital tools that allowed researchers to connect with patients via...
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FDA Issue: 
FDA Week - 07/29/2022
FDA Volume: 
Vol. 28, No. 30
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Inside CMS - 08/04/2022
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Vol. 25, No. 31
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