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Showing posts from November, 2020

CPSC Issues COVID-19 Consumer Products Guidance, Further Muddying the Regulatory Waters and Increasing Scrutiny of COVID-19 Products

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  As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant products has never been more important or widespread among the public.  However, in late October, the Consumer Product Safety Commission (“CPSC”) issued guidance on its website asserting that certain consumer protection rules within its jurisdiction apply to PPE, and reminding consumers of the CPSC laws that apply to cleaning/disinfectant products (the “ COVID Guidance ”).  The CPSC commissioners disagree about the import or official applicability of the COVID Guidance, and questions abound as to how it interplays with FDA regulations issued by the U.S. Food and Drug Administration (“FDA”), including Emergency Use Authorizations (“EUA”), as well as EPA regulations on disinfectant products – not to mention how or whether the COVID Guidance impacts the protections affo

GOVERNMENT-FUNDED SCIENTISTS LAID THE GROUNDWORK FOR BILLION-DOLLAR VACCINES

  When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr.   Barney Graham , then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic. Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial. Basic research conducted by Graham and others at the National Institutes of Health , Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products. The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly

DOCS SAY TELEHEALTH PROVIDES EFFECTIVE ACCESS DURING PANDEMIC

  More than 75% of 1,594 physicians and other clinicians in a   new national survey   say telehealth has allowed them to provide quality care for a variety of specialties, from COVID-19-related care to behavioral health. “The strong support shown for telehealth, as evidenced in these results, reinforces the knowledge that telehealth is critical to how we deliver healthcare today," said study co-author Steve Ommen, MD, medical director, Mayo Clinic Center for Connected Care. "The use of telehealth during the COVID-19 pandemic highlights its importance in care delivery. Its continued use will be instrumental in connecting to patients everywhere, Ommen said. Among the survey findings: 60% said telehealth has improved the health of their patients.   68% said they’re motivated to increase telehealth use in their practices.   11% said they were using remote patient monitoring technologies with patients in their homes, including smartphones, blood pressure cuffs, body weight scales,

WERE YOU NOTIFIED ABOUT MISSING TAX FORMS FOR YOUR ACA SUBSIDY? BLAME COVID.

When they file their annual taxes they complete an IRS form that reconciles how much they received in advance tax credits against their actual income for the year. The letter from the marketplace said they hadn’t filed for 2019, but Schenker knew they had — just as they have every year. “I was more annoyed than anything else,” Schenker, 55, said, remembering an earlier enrollment problem that took months to resolve. “I didn’t want to get stuck in some sort of appeals category.” Schenker’s 25-year-old daughter, Kaily Schenker, who is part owner of the family’s organic farm, got the same letter about her plan. Schenker helps her with her taxes, and she also filed the Form 8962 paperwork, he said. Officials at the Centers for Medicare & Medicaid Services, which oversees the ACA marketplaces, confirmed that some consumers received notices from the agency alerting them that, according to the IRS, they hadn’t filed a tax return or reconciled their advance payments for tax credits. The le

OPINION: FOUR KEY THINGS YOU SHOULD KNOW ABOUT HEALTHCARE

Health care , so far perhaps the biggest issue in the Democratic primary, is also the most complicated issue facing government and the public. Unfortunately the debate is filled with persistent misconceptions, from the role insurance company profits play in health care costs to who is actually paying for workers’ health coverage. Clarifying four fundamental health care fallacies could make it easier for voters to square some of the Democratic proposals — and their critiques — with reality: Fallacy No. 1: Employers pay for employees’ health insurance. Employers write checks that cover most health insurance premiums for employees and their dependents. But as the Princeton health economist Uwe Reinhardt once explained, employer-sponsored insurance is like a pickpocket taking money out of your wallet at a bar and buying you a drink. You appreciate the cocktail until you realize you paid for it yourself. With health coverage, employers write the check to the insurer, but employees bear the

What is “healthcare?”

  Editor's Note:   Welcome to Medical Economics' blog section which features contributions from members of the medical community. These blogs are an opportunity for bloggers to engage with readers about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The opinions expressed here are that of the authors and not UBM / Medical Economics. In the present day, healthcare has come to mean every aspect, service and device for taking care of your health.  It has become conscripted by government, politicians, political ideologues, third parties and media to conveniently and neatly define whatever they want to “give” you. By simply becoming involved, these middlemen are diluting the quality of the actual health service you can achieve, be they government or insurers.  I challenge the notion that healthcare is an entity that can be confined to one simplistic model. Healthcare is not a thing