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Category: Regulatory


Regulatory

Congressional doctors lead bipartisan revolt over policy on surprise medical bills

November 17, 2021

Via: The Medical News

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. […]


Regulatory

Texas abortion law harms survivors of rape and incest, activists say

November 17, 2021

Via: The Medical News

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 […]


Regulatory

The FDA Could Authorize COVID-19 Booster Shots For All Adults Later This Week

November 16, 2021

Via: Time Health

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 […]


Regulatory

Pfizer Asks FDA to OK COVID-19 Booster Shots for All Adults

November 10, 2021

Via: Time Health

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 […]


Regulatory

Democrats plan to expand Medicare hearing benefits. What can consumers expect?

November 5, 2021

Via: The Medical News

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 […]


Regulatory

Despite restraints, democrats’ drug pricing plan could still aid consumers

November 5, 2021

Via: The Medical News

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 […]


Regulatory

Biden administration rolls out plan for vaccinating children as FDA weighs clearance

October 20, 2021

Via: Healthcare Dive

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 […]


Regulatory

FDA grants EUA to Acon Laboratories’ Covid-19 antigen home test

October 5, 2021

Via: medicaldevice-network.com

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 […]


Regulatory

Biden pushes forward on Medicare price negotiation

September 13, 2021

Via: Healthcare Dive

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 […]


Regulatory

Biden admin shells out $452M to boost state reinsurance programs

September 8, 2021

Via: Healthcare Dive

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 […]


Regulatory

North Carolina amends certificate of need in bill headed to governor’s desk

August 26, 2021

Via: Healthcare Dive

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, […]


Regulatory

FDA approves COVID-19 mRNA vaccine that uses fundamental Penn technology

August 23, 2021

Via: The Medical News

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 […]


Regulatory

FDA Authorizes Booster Shot of COVID-19 Vaccine for People With Weakened Immune Systems

August 13, 2021

Via: Time Health

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 […]


Regulatory

Biden’s July executive order includes drug pricing provisions. But will they do enough?

July 19, 2021

Via: The Medical News

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 […]


Regulatory

Biden executive order sparks debate on physician noncompete agreements

July 15, 2021

Via: Healthcare Dive

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 […]