Top

Category: Regulatory


Regulatory

UnitedHealth under antitrust investigation by DOJ: reports

February 28, 2024

Via: Healthcare Dive

UnitedHealth is under investigation by the Department of Justice over antitrust concerns, according to reporting by the Examiner News and the Wall Street Journal. Over the past few weeks, investigators have been inquiring about UnitedHealth’s effect on competition in sectors […]


Regulatory

Washington state bill seeks to regulate hospital mergers, care access

February 14, 2024

Via: Healthcare Dive

Software engineer Alexander Surkov recently proposed a new addition to the Chromium source code, the layout engine on which many modern browsers are based. The programmer aims to implement the Web Monetization specifications, providing Chrome and many other free browsers […]


Regulatory

FDA approves Edwards’ EVOQUE for tricuspid regurgitation

February 5, 2024

Via: Medical Device Network

Edwards Lifesciences has received approval from the US Food and Drug Administration (FDA) for its EVOQUE tricuspid valve replacement system, a transcatheter therapy, for treating TR. The system has been designed for patients with symptomatic severe TR who have not […]


Regulatory

Senators reintroduce bill to boost telemental healthcare

January 25, 2024

Via: Healthcare Dive

The Telemental Health Care Access Act comes as a number of Medicare telehealth flexibilities that first went into effect during the COVID-19 pandemic are set to expire at the end of the year without congressional action. Lawmakers have previously shown […]


Regulatory

Providers push back on info blocking penalties

January 8, 2024

Via: Healthcare Dive

The HHS released the proposed information blocking penalties for providers in the fall, years after rules went into effect that banned preventing the exchange of health data. Regulators also finalized penalties for health IT developers over the summer, allowing the […]


Regulatory

Mask mandates return to health facilities amid soaring COVID, flu cases

January 4, 2024

Via: Healthcare Dive

The New York City health commissioner reinstated an indoor mask mandate Jan. 3 for public hospitals, health centers and long-term care facilities amid a rise in COVID-19, flu and respiratory virus cases, according to ABC 7 NY. Health Commissioner Dr. […]


Regulatory

Biden administration urges 9 states to curb high child Medicaid, CHIP disenrollments

December 19, 2023

Via: Healthcare Dive

State Medicaid programs began reassessing eligibility for the safety-net insurance program this spring after a long period of continuous enrollment during the COVID-19 pandemic. Continuous enrollment provisions caused rolls to swell to nearly 94 million people before unwinding began in […]


Regulatory

Senate subcommittee signals support for permanent telehealth flexibilities

November 15, 2023

Via: Healthcare Dive

Lawmakers showed bipartisan support for making pandemic-era telehealth flexibilities permanent in Medicare during a Senate subcommittee hearing on Tuesday. But witnesses noted Congress shouldn’t wait to address the temporary accommodations — some of which expire at the end of next […]


Regulatory

New California Law Offers Fresh Protection From Steep Ambulance Bills

November 7, 2023

Via: Kaiser Health News

Last year, Jennifer Reisz’s college-age daughter, Megan, was kicked in the chest multiple times by the family’s horse. Megan fell to the ground, unable to move or speak. Though she was alone, her Apple Watch detected her distress and called […]


Regulatory

White House orders HHS to collect reports on healthcare AI safety

November 1, 2023

Via: Healthcare Dive

Regulatory scrutiny of AI has increased over the past year. The European Union is developing the AI Act, legislation that it claims will be the first comprehensive AI law, and the FDA is drafting guidance on AI-enabled device software functions. […]


Regulatory

US issues executive order for AI regulation in healthcare

October 31, 2023

Via: Medical Device Network

Apresidential executive order aimed at establishing a new set of guidelines and intended regulations for Artificial Intelligence (AI) has been issued by the United States government. The Joe Biden administration on 30 October released what it describes as a new […]


Regulatory

FDA rule change sees Laboratory Developed Tests regulated as medical devices

October 3, 2023

Via: Medical Device Network

Laboratory Developed Tests (LDT) are set to be regulated as medical devices under new rules proposed by the US Food and Drug Administration. The proposed rule seeks to amend the FDA’s regulations to make explicit that In Vitro Diagnostic Products […]


Regulatory

Ohio lawmakers propose minimum nurse-to-patient ratios

September 27, 2023

Via: Healthcare Dive

The COVID-19 pandemic highlighted the struggles of front-line healthcare workers including long-standing issues like staffing shortages and burnout. Hospitals still struggle with staffing, with over 80% of healthcare executives labeling recruitment a significant business risk in a survey conducted by […]


Regulatory

Biden Administration to Ban Medical Debt From Americans’ Credit Scores

September 21, 2023

Via: Kaiser Health News

The Biden administration announced a major initiative to protect Americans from medical debt on Thursday, outlining plans to develop federal rules barring unpaid medical bills from affecting patients’ credit scores. The regulations, if enacted, would potentially help tens of millions […]


Regulatory

Privacy concerns around diabetics’ patient data prompt Medtronic lawsuit

September 11, 2023

Via: Medical Device Network

As a result of the global spread of Covid-19, healthcare firms started to increasingly depend on emerging technologies and ramp up their data collection efforts. While the incorporation of new technologies undeniably offers substantial benefits to the healthcare sector, such […]


Regulatory

CDC Faces Dilemma Over Recommending New Covid Booster for All

September 11, 2023

Via: Kaiser Health News

A small percentage of Americans got the most recent covid-19 booster shot, and even fewer probably realize the federal government is preparing to recommend yet another shot as early as Tuesday. Until a week or two ago, William Schaffner read […]


Regulatory

Humana sues HHS over Medicare Advantage audits

September 5, 2023

Via: Healthcare Dive

The HHS first proposed the rule to conduct audits of MA payers in 2018 and finalized it in January. The government expects to claw back roughly $4.7 billion over the next decade by recouping payments from cases where payers inflated […]


Regulatory

FDA cracks down on companies that sell unauthorized vapes to kids: ‘We will hold anyone accountable’

August 23, 2023

Via: Fox News

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 […]


Regulatory

Seeking Medicare Coverage for Weight Loss Drugs, Pharma Giant Courts Black Influencers

August 8, 2023

Via: Kaiser Health News

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 […]


Regulatory

Biden administration cracks down on payers over mental health coverage

July 25, 2023

Via: Healthcare Dive

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 […]