Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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HHS proposals for 340B drug pricing program prompt industry objections

Proposed changes to the 340B drug pricing program, in addition to other cuts in payments, are being called out by industry associations and providers.

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'Breakthrough' drug designations result in less certainty

Speeding up the regulatory process has led to uncertainty about the effectiveness of some new drugs.

Hospital utilization slows as healthcare moves to cheaper care settings

Hospital utilization is slowing down in its growth, according to a recent survey of hospital administrators. The trend underscores the shift across the healthcare system away from high-cost settings toward lower-cost outpatient utilization.

Healthcare venture capital funding to hit new high in 2018

Venture capital funding continues to pour into healthcare startups, and the pace this year is already expected to top 2017's total figure of $15 billion.

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Major insurers won’t be impacted negatively by halted ACA risk adjustment payments

The largest U.S. health insurers aren’t likely to be at risk of negative credit ratings after the Trump administration halted about $10 billion in risk adjustment payments, according to Fitch Ratings.

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Medicaid work requirements aren’t working in Arkansas

After work requirements for eligible Medicaid beneficiaries too effect in Arkansas, more than 7,000 people failed to report they worked at least 80 hours in June.

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CVS acquisition of Aetna may not face antitrust challenges

U.S. antitrust enforcers might not move to block CVS Health’s acquisition of health insurance company Aetna, Bloomberg reported.

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FDA issues recall of valsartan

The FDA has issued a voluntary recall of valsartan, due to concerns of an impurity N-nitrosodimethylamine (NDMA), a known carcinogen, which was found in a batch of the drug manufactured in China. Valsartan is commonly used to control hypertension and heart failure.

Around the web

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

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