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FDA OKs Vericiguat for Unique HF Population


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FDA approved vericiguat (Verquvo) on Wednesday to lower cardiovascular events in patients with heart failure with reduced ejection fraction (HFrEF) who had recently been hospitalized or had received IV diuretic therapy, Merck announced.
The soluble guanylate cyclase (sGC) stimulator was cleared as a therapy that reduces the risk of cardiovascular death and heart failure hospitalization in these patients. This makes it the first chronic heart failure treatment approved specifically for the recently decompensated population.
Regulatory approval was based on the VICTORIA trial, first presented at the 2020 virtual American College of Cardiology annual meeting, which had 5,050 recently decompensated HFrEF patients randomized to vericiguat (up to 10 mg once daily) or placebo. ....

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Telehealth Waivers Extended; Virtual Visit Triage; Post-MI Remote Care


Claims Lines Steady as Waivers Extended
The Department of Health and Human Services (HHS) extended the COVID-19 public health emergency including key waivers for telehealth until April 2021,
Under the emergency, HHS has allowed more types of providers to bill Medicare for telehealth services and has granted waivers for audio-only telemedicine to be reimbursed.
The extension comes as new FAIR Health data show that telehealth claim lines the individual services or procedures listed on an insurance claim continued to be relatively steady through October, though wildly outpacing 2019 levels.
Telehealth accounted for 5.61% of medical claims lines in October 2020, a giant leap from 0.18% in October 2019, the nonprofit s Monthly Telehealth Regional Tracker showed. ....

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ACC Updates Heart Failure Guidance, Highlights New Drugs


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Streamlined interim heart failure guidance, including newer therapies and acknowledging the changes in care wrought by the COVID-19 pandemic, was released by the American College of Cardiology (ACC).
Angiotensin receptor-neprilysin inhibitors (ARNIs) and SGLT2 inhibitors were added to the treatment algorithms for new-onset and chronic heart failure in this update to the ACC s 2017 expert consensus decision pathway (ECDP) for treatment of heart failure with reduced ejection fraction (HFrEF).
The document was meant to serve as interim guidance while the ACC drafts more comprehensive heart failure guidelines, according to the writing group chaired by Thomas Maddox, MD, MSc, of Washington University School of Medicine in St. Louis. ....

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