Category: Regulatory

November 17, 2021

The detente that allowed Congress to pass a law curbing surprise medical bills has disintegrated, with a bipartisan group of 152 lawmakers assailing the administration’s plan to regulate the law and medical providers warning of grim consequences for underserved patients. […]

November 17, 2021

The Safe Alliance in Austin, Texas, helps survivors of child abuse, sexual assault and domestic violence. Before Texas’ new abortion law took effect, the organization counseled a 12-year-old who had been repeatedly raped by her father. Piper Stege Nelson, chief […]

November 16, 2021

An influential U.S. advisory panel will discuss expanding eligibility for COVID-19 vaccine booster shots to all adults Friday, a move that could make the shots available nationwide as early as this weekend. Some cities and states already allow all adults […]

November 10, 2021

Pfizer asked U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings. Older Americans and other groups particularly […]

November 5, 2021

President Joe Biden’s mammoth domestic spending bill would add hearing benefits to the traditional Medicare program — one of three major new benefits Democrats had sought. The Biden administration appears to have fallen short of its ambition to expand dental […]

November 5, 2021

The Medicare prescription drug pricing plan Democrats unveiled this week is not nearly as ambitious as many lawmakers sought, but they and drug policy experts say the provisions crack open the door to reforms that could have dramatic effects. Tamping […]

October 20, 2021

The decision to release this plan before any official decisions from the FDA or CDC carries some communication risk for the administration, similar to how it announced plans in August to offer booster shots to all adults by mid-September, only […]

October 5, 2021

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Acon Laboratories’ Flowflex COVID-19 Antigen Home Test. Flowflex is an over the counter (OTC) antigen test, which uses nasal swab specimens from individuals suspected of active […]

September 13, 2021

As Congress prepares to debate limits on prescription drug costs as part of a massive spending bill, President Joe Biden reiterated his support for proposals that would allow the federal government to directly negotiate Medicare’s prices with pharmaceutical companies. The […]

September 8, 2021

The funds, known as “pass-through funding,” are determined by HHS and the Treasury Department on an annual basis, and go to states that have implemented their reinsurance programs to lower premiums through a section 1332 waiver. The waivers allow states […]

August 26, 2021

The measure in North Carolina allows healthcare facilities to move forward with projects and purchases without having to go through a regulatory review process. CON laws require healthcare operators to gain approval from state health regulators when building new facilities, […]

August 23, 2021

The U.S. Food and Drug Administration has given the first full approval to a COVID-19 mRNA vaccine, which uses modified mRNA technology invented and developed by scientists in the Perelman School of Medicine at the University of Pennsylvania, whose years […]

August 13, 2021

U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge. The late-night announcement Thursday by […]

July 19, 2021

President Joe Biden’s executive order of July 9 included various steps toward making good on campaign promises to take on pharmaceutical companies by allowing the importation of prescription drugs and curbing the high cost of medicines.These issues were key to […]

July 15, 2021

The executive order President Joe Biden released last week asks federal agencies to harness their power in regulating competition, nudging the Federal Trade Commission to ban or limit noncompete agreements — including in healthcare. Roughly half of private-sector businesses require […]