Category: Regulatory

August 23, 2023

The Food and Drug Administration (FDA) has sent warning letters to 15 companies for selling “unauthorized e-cigarette products” — otherwise known as vapes — disguised as school supplies, food and drinks, toys and other kid-enticing designs, according to a Wednesday […]

August 8, 2023

Pharmaceutical giant Novo Nordisk has turned to influential Black Americans in pursuit of what would be a lucrative victory: having Medicare cover a new class of weight loss drugs, including the company’s highly sought Wegovy, which can cost patients more […]

July 25, 2023

Insurers often make it more difficult to access mental healthcare than physical services. Plans might not have enough therapists in-network, forcing patients to turn to out-of-network providers and leaving them on the hook for high bills. In other cases, insurers […]

July 13, 2023

The Food and Drug Administration on Thursday approved the first birth control pill to be used without a prescription, potentially expanding access to contraception in the U.S. Called Opill, the once-daily pill will be available over the country in drug, […]

July 5, 2023

The Centers for Disease Control and Prevention is reducing funding to states for child vaccination programs, according to an agency email obtained by KFF Health News. The funding cut “is a significant change to your budget,” said the email to […]

June 29, 2023

Last year was the fourteenth consecutive year the DOJ recovered over $2 billion in False Claim Act settlements and judgments from fraud related to Medicare, Medicaid and TRICARE, according to law firm Rivkin Radler. Still, rampant fraud has proven difficult […]

June 6, 2023

Merck & Co. has sued the U.S. government over Medicare’s newly granted authority to negotiate the prices of certain top-selling medicines, intensifying the pharmaceutical industry’s attack on a law that drugmakers claim will hurt their ability to develop innovative therapies. […]

June 5, 2023

People concerned about the safety of patients often compare health care to aviation. Why, they ask, can’t hospitals learn from medical errors the way airlines learn from plane crashes? That’s the rationale behind calls to create a “National Patient Safety […]

May 24, 2023

The new proposal on drug transparency follows an October 2022 executive order President Joe Biden issued on lowering prescription drug costs, which directed the HHS to look into steps it could take to lower prescription drug costs for working and […]

May 18, 2023

The fate of the abortion pill mifepristone remains in jeopardy, as an appellate court panel during a hearing this week sounded sympathetic to a lower court’s ruling that the FDA should not have approved the drug more than two decades […]

April 26, 2023

Joel Wakefield isn’t just an armchair epidemiologist. His interest in tracking the spread of covid is personal. The 58-year-old lawyer who lives in Phoenix has an immunodeficiency disease that increases his risk of severe outcomes from covid-19 and other infections. […]

April 24, 2023

The Department of Justice announced Thursday that the agency charged 18 criminal defendants, including doctors and testing suppliers, in the largest-yet enforcement action against COVID-19 healthcare fraud schemes that resulted in over $490 million in false federal billing. The enforcement […]

April 19, 2023

The CDC signed off on an additional updated COVID-19 vaccine dose for Americans who are older than 65 or have compromised immune systems, while doing away with the original monovalent vaccines. About 23 million elderly Americans are now eligible for […]

April 18, 2023

The Food and Drug Administration announced on Tuesday that older individuals and those with weakened immune systems are eligible for another dose of the updated COVID-19 booster. According to the FDA’s announcement, most people who received a single dose of […]

April 12, 2023

The Biden administration has released a sweeping new rule touching on multiple aspects of health information technology in the U.S., including proposals meant to create more transparency and trust in clinical decision support software. The rule proposed Tuesday would give […]

April 3, 2023

In healthcare, it is crucial to ensure the security and privacy of electronic health records and all patient data with security policies. HIPAA provides guidelines for healthcare organizations and covered entities to follow in order to maintain the confidentiality, integrity, […]

April 3, 2023

Thursday’s ruling drew immediate backlash from provider groups who argued that the decision could hamper access to some preventive services that health plans have been required to fully cover since the ACA’s inception. “Denying access to proven preventive care flies […]

March 31, 2023

Victoria Ferrell Ortiz learned she was pregnant during summer 2017. The Dallas resident was finishing up an AmeriCorps job with a local nonprofit, which offered her a small stipend to live on but no health coverage. She applied for Medicaid […]

March 30, 2023

The COVID-19 pandemic highlighted the struggles of front-line healthcare workers including long-standing issues like staffing shortages and burnout. Some workers have taken action through union organizing, picketing and strikes to secure new contracts with terms to quell challenges — especially […]

March 30, 2023

A federal judge on Thursday overturned a portion of the Affordable Care Act that makes preventive services, such as some cancer screenings, free to enrollees, a decision that could affect health insurance policyholders nationwide. The decision from the U.S. District […]