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Category: Regulatory


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 […]


Regulatory

First nonprescription birth control pill approved by FDA

July 13, 2023

Via: Healthcare Dive

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, […]


Regulatory

CDC to Reduce Funding for States’ Child Vaccination Programs

July 5, 2023

Via: Kaiser Health News

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 […]


Regulatory

DOJ charges dozens in multiple states for $2.5 billion healthcare fraud

June 29, 2023

Via: Healthcare Dive

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 […]


Regulatory

Merck sues to stop Medicare negotiation of drug prices

June 6, 2023

Via: Healthcare Dive

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. […]


Regulatory

Will a ‘National Patient Safety Board,’ Modeled After the NTSB, Actually Fly?

June 5, 2023

Via: Kaiser Health News

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 […]


Regulatory

Biden administration aims to increase Medicaid drug transparency

May 24, 2023

Via: Healthcare Dive

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 […]


Regulatory

The Abortion Pill Goes Back to Court

May 18, 2023

Via: Kaiser Health News

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 […]


Regulatory

As Federal Emergency Declaration Expires, the Picture of the Pandemic Grows Fuzzier

April 26, 2023

Via: Kaiser Health News

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. […]


Regulatory

DOJ charges 18 in COVID healthcare frauds totaling $490M

April 24, 2023

Via: Healthcare Dive

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 […]


Regulatory

CDC approves second updated COVID-19 booster for some high-risk groups

April 19, 2023

Via: Fox News

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 […]


Regulatory

COVID booster dose for certain people approved by FDA

April 18, 2023

Via: Fox News

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 […]


Regulatory

New ONC rule aims to raise trust in clinical decision support algorithms

April 12, 2023

Via: Healthcare Dive

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 […]


Regulatory

HIPAA Security Policies

April 3, 2023

Via: Health IT Answers

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, […]