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. 

21st Century Cures Act unlikely to move until after election

Legislation aiming to speed up the regulatory approval process for medical devices and drugs and boost research funding will have to wait until after Election Day.

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Q&A: NIH Director Collins, Sen. Durbin on securing medical research funding in an election year

National Institutes of Health Director Francis Collins, MD, PhD, however, sounded optimistic about his agency getting another multi-billion dollar funding boost this year in a forum at Northwestern University’s Feinberg School of Medicine on Aug. 30.

Uninsured rate hits record low, but post-ACA gains are slowing

The number of people without health insurance fell to an all-time low of 8.6 percent in the first quarter of 2016, according to new data from the CDC, but the gains in insurance enrollment caused by the Affordable Care Act appear to be slowing down.

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House members ask HHS to ‘consider flexibilities’ on MACRA start date

Leaders on two powerful House committees encouraged HHS Secretary Sylvia Burwell to “consider flexibilities” in implementing the major changes to physician payment required by the Medicare Access and CHIP Reauthorization Act (MACRA).

AMGA Calls for Enhanced Care Coordination in its Comments on Proposed CY 2017 Physician Fee Schedule and Hospital Outpatient Prospective Payment System Proposed Rules

Alexandria, VA –AMGA today submitted written comments on the Centers for Medicare & Medicaid Services (CMS) CY 2017 Physician Fee Schedule and the CY 2017 Hospital Outpatient Prospective Payment System proposed rules.

Pediatricians told not to use nasal flu vaccine this year

Ahead of flu season, the American Academy of Pediatrics has released its recommendations for using vaccines and antiviral medications for flu prevention, and nasal spray vaccines aren’t part of its plan.

Fresenius sued by Kentucky over marketing of kidney dialysis product

The nation’s largest provider of kidney dialysis and renal care products is being sued by the state of Kentucky, alleging deceptive marketing of its GranuFlo blood screening product.

Interest groups not satisfied with proposed risk adjustment changes

CMS’s proposals to change risk adjustment calculations for exchange plans for 2018 would come too late, according to America’s Health Insurance Plans (AHIP) and Consumers for Health Options, Insurance Coverage in Exchanges in States (CHOICES).

Around the web

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.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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