FDA biologics center chief Peter Marks said the testing of gene editing therapy, specifically CRISPR-Cas9-associated protein 9 (CRISPR-Cas9) in animal models, which some companies have relied on, is “less than ideal” because testing requires guides specific to human DNA.
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Coronavirus Response
Verma: Providers Will See $30 Billion In CARES Act Grants Soon
CMS Administrator Seema Verma on Tuesday (April 7) said providers will see $30 billion from the CARES Act distributed this week, and the money will be divvied up based on providers' Medicare revenue.
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In Duke Report, Gottlieb, McClellan Detail Plans For COVID-19 Surveillance
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CMS Says It Can’t Change 10.25% Interest On Accelerated Medicare Pay
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CMS Tells Ambulatory Surgical Centers How To Enroll As Hospitals
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Giroir: If Validated, Millions Of Serology Tests Could Be Available By May
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Connecticut Executive Order Prevents Surprise Billing For COVID-19
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Gottlieb Joins Maryland Gov. Hogan’s Coronavirus-Response Team
Latest News
Former FDA chiefs Scott Gottlieb and Mark McClellan are pushing for the government to implement a national surveillance system for COVID-19.
The Trump administration slammed an HHS Office of Inspector General report released Monday (April 6) that found hospitals are facing significant challenges with medical supplies, protective gear and COVID-19 testing.
The country’s second COVID-19 stimulus law, the Families First Coronavirus Response Act, will increase the federal deficit by $192 billion through 2030, mostly over the next two years, and the largest health-related expenditure is due to the increased federal match rate for Medicaid that doesn’t account for increased enrollment during the downturn, according to an initial estimate from the Congressional Budget Office and the Joint Committee on Taxation.
FDA’s latest guidance on sterilization and disinfecting devices can be applied to a broad swath of decontaminating equipment, including those used in homes and businesses, and manufacturers are scrambling to meet the guidance’s requirements so equipment can be deployed quickly, according to Paul Krupin, the creator of search tool Presari.
CMS on Monday (April 6) announced that Medicare Advantage plans would see slightly higher expected pay in 2021 under the final rate notice -- about 1.7% -- than projected under the advanced notice -- slightly under 1%.
The health insurance industry is generally resisting the hospital industry’s request that insurers voluntarily offer accelerated payments and additional administrative relief to providers during the COVID-19 pandemic, saying insurers already are offering billions in resources, face their own financial risk and need help from Congress and providers to stabilize the insurance market.
CMS on Thursday (April 2) issued additional guidance for nursing homes as they tackle COVID-19, but the nursing home lobby says it’s not possible to fully comply with CMS’ and Centers for Disease Control and Prevention’s recommendations without an adequate supply of personal protective equipment.
The Medicaid and CHIP Payment and Access Commission Thursday (April 2) approved two chapters outlining ways such as value-based purchasing that Medicaid could be used to improve maternal health, including for beneficiaries with substance use disorders, although the chapters to be included in the commission’s June report to Congress don’t make recommendations.
Following HHS Secretary Alex Azar’s announcement that a part of the $100 billion hospital fund in the CARES Act will be used to reimburse treatment for uninsured COVID-19 patients, Democratic leaders called for legislation that would ensure all patients can get cost-free care, and from any provider, not just from hospitals.
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