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. 

Government shutdown requires ONC to furlough all but four staff

With legislators failing to reach a last-minute compromise on budget legislation to avoid a shutdown, the Department of Health and Human Services (HHS) and the Office of the National Coordinator for health IT (ONC) in particular, are forced to furlough a significant percentage of staff unless the impasse is broken. In all, this first government shutdown in 17 years is affecting 800,000 federal workers.

Strata Rx 2013: Patients will drive healthcare transformation

BOSTON--“There is no major shift in technology that hasn’t been galvanized by consumers. The same will be true for healthcare,” predicted Claudia Williams, director of the Office of the National Coordinator for Health IT's state health information exchange program, at Strata Rx 2013.

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Muntz also will leave ONC

The exit door of the Office of the National Coordinator of Health IT appears to be in good working order. Principal Deputy David Muntz, MBA, has submitted his resignation.

ACA Preparedness: How to Conduct a Community Health Needs Assessment

House

Non-profit hospitals have to do it every three years to comply with the requirements of the federal Patient Protection and Affordable Care Act (ACA), but probably any hospital or clinic would benefit by conducting a Community Health Needs Assessment (CHNA).

Hospitals lag in HIX enrollment preparation

Few hospitals have developed comprehensive strategies to identify, educate and assist individuals with enrolling in health plans offered through the health insurance exchanges (HIXs). With the Oct. 1 start date for enrollment fast approaching, hospitals and providers should heighten preparations in order to benefit from the financial boost of a new customer base, according to a study from PwC’s Health Research Institute.

Calculation glitches in HIXs two weeks before enrollment begins

The Obama administration is "scrambling" to quickly address a series of "pricing quirks" in the software that will be used for the roughly three dozen federal health insurance exchanges under the Affordable Care Act, according to several insurance executives and sources familiar with the issue, the Wall Street Journal reports.

UDI final rule finally issued

More than a year after the proposed rule was issued, the FDA released the final rule establishing a unique device identification system for tracking medical devices.

Bill would enable behavioral health providers to receive EHR payments

A bill introduced by Sen. Sheldon Whitehouse (D-R.I) would expand eligibility for EHR incentive payments to include mental and behavioral health professionals, including psychologists, community mental health centers and psychiatric hospitals.

Around the web

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.