FDA

CA Bill Protects Reproductive Health, TX Judge Denies Preventive Care Law

by Hayden Schmidt

State laws and court rulings are diverging as some state governments work to protect citizens’ health and others seek to eliminate safeguards.   Last month, the California State Legislature...

FTC Investigating Amazon’s One Medical Purchase and Data Broker Lawsuit

by Hayden Schmidt

Amazon’s foray into primary care may be under threat after the FTC declared it was investigating the company’s acquisition of One Medical. Officials at the agency also decided to sue data...

Medicare Advantage Plans Face Scrutiny, Biden Secures COVID-19 Boosters

by Hayden Schmidt

Chair of the Senate Finance Committee Senator Ron Wyden is digging into Medicare Advantage marketing practices that may target consumers with misleading and harmful tactics. The Senator sent letters to...

DOJ Busts $1.2B Telemedicine Fraud Ring, CDC Recommends Novavax

by Hayden Schmidt

DOJ officials are prosecuting 36 individuals linked to a telemedicine fraud ring that generated over a billion dollars in faulty Medicare claims. The defendants working throughout the United States now...

Hospitals Fined for Price Transparency, CDC Drops Coronavirus Testing

by Hayden Schmidt

In Georgia, CMS has issued two fines totaling over $1 million to the Northside Hospital network after failing to comply with price transparency guidelines. And CDC Director Rochelle Walensky has...

FDA Issues Medical Device Cybersecurity Warning, FTC Blocks Hospital Merger

by Hayden Schmidt

FDA and FBI officials are sharing their cybersecurity knowledge as the pace of healthcare cyberattacks picks up. From the FDA, an urgent message issued a warning to organizations that may be...

US Surgeon General Addresses Burnout, Telemental Health Bill Proposed

by Hayden Schmidt

Two pieces of proposed legislation are seeking to modernize healthcare IT infrastructure in the US. One such bill introduced by four senators would expand telehealth access and reduce regulations that...

Montana Governor Funds HIE, CO Supreme Court Rules on Surprise Billing

by Hayden Schmidt

Montana’s governor plans to utilize federal and private funds to increase access to a statewide HIE system. The effort is considered a critical investment for the largely rural state. Also, in...

Cerner VA EHR Fails Uptime Obligation, Nurse Avoids Jail After Fatal Error

by Hayden Schmidt

Cerner’s endeavor to modernize the VA EHR system has experienced several speed bumps since its first site implementation in 2020. The most recent issues with the EHR program forced Cerner to...

FDA to Ban Flavored Tobacco, OIG Audit Criticizes HHS Cybersecurity

by Hayden Schmidt

Last week, FDA officials continued their campaign against flavored nicotine products with a proposed ban on cigarettes and cigars containing added flavors. And on the cybersecurity front, the FBI has...

Coronavirus Vaccination Disparities Widen, FDA Warns Against Baby Formula

by Hayden Schmidt

In a promising move for consumers, the Food and Drug Administration (FDA) has accepted an application for Abrilada, a biosimilar that will compete with Humira. Elsewhere within the administration,...

FDA Approval for Eli Lilly Antibodies, HHS Issues $55M for Virtual Care

by Hayden Schmidt

The Department of Health and Human Services (HHS) is doling out $55 million to boost virtual care access at 29 community health centers. HHS secretary Xavier Beccara also announced that the agency had...

Congress Addresses Nurse Staffing Pricing, Florida Expands Telehealth

by Hayden Schmidt

Last week, a bipartisan group of Congress members issued a letter to the White House urging an investigation into price gouging occurring among nurse staffing agencies. Congress also sent another...

VA Adopts Google’s API, FDA Revises Coronavirus Antibody Drug Approvals

by Hayden Schmidt

Organizations are urging Congress to reinstate pre-deductible coverage for telehealth services in an effort to help patients. Also in the nation’s capital, the VA will implement a Google...

FDA’s New Emergency Authorizations, CMS Reinstates Vaccine Mandate

by Hayden Schmidt

CMS has issued a revised COVID-19 vaccine mandate for healthcare workers. The new mandate requires that healthcare workers in 25 states be vaccinated by the end of February 2022. In a series of...

CURES 2.0 set to Expand Telehealth, CMS Zeros in on Drug Prices

by Hayden Schmidt

Senators have introduced an act that would dole out the rest of the Provider Relief Fund to front-line hospitals and care centers. Another bill, CURES 2.0, would expand the actions of the initial CURES...

Push for Inclusive EHR Data, HHS Funding for Title X Programs

by Hayden Schmidt

Healthcare workers need to be more cognizant of gender and sex identifiers in EHR documentation, according to a recent blog post from Steven Posnack of the ONC. After encouraging clinical trial data...

CMS Codifies Value-Based Care Strategy, $800M for Abuse Victims

by Hayden Schmidt

In a white paper released last week, CMS Administrator Chiquita Brooks-LaSure reiterated the agency’s plan to support health equity and expand value-based care for Medicare and Medicaid...

CMS Increases Call Center Wages, ONC Shifts SVAP Timeline

by Hayden Schmidt

The Biden-Harris Administration greenlit transgender care to be included as a part of Colorado’s Essential Health Benefits. Days later, CMS has boosted their hourly wages for call center workers...

Kaiser Workers Approve Strike, Medicare Advantage Plans Rank Well

by Hayden Schmidt

In Southern California, Kaiser Permanente healthcare workers have overwhelmingly approved a strike during a recent vote. If negotiations fail, staffing shortages could ensue. A Class I FDA recall was...

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