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. 

Ebola remained in semen for 565 days—far longer than previously thought possible

A study of Liberian men found previous estimates of how long the Ebola virus could remain in semen were significantly too low, as one man was found to still carry the virus 565 days after he recovered from the illness.

Congressmen want investigation of Purdue Pharma and other opioid makers

Two members of Congress from California, Democrat Reps. Ted Lieu and Mark DeSaulnier, are calling for a congressional investigation into manufacturers of opioid painkillers.

Mylan offers EpiPen generic in attempt to quell price controversy

Mylan, manufacturer of the allergic reaction treatment EpiPen, has announced it will sell a generic version of the autoinjector at half the price of the branded device after federal lawmakers and consumer groups questioned why its price has gone up 400 percent since Mylan acquired it.

Risk adjustment gets overhauled for 2018 under CMS proposal

CMS proposed a series of adjustments it intends to strengthen the Affordable Care Act’s insurance exchanges for 2018, including some initiatives insurers have been pushing for, such as pooling high-cost enrollees and adjusting for special enrollment customers. 

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Pediatricians want non-medical vaccination exemptions eliminated

The American Academy of Pediatrics (AAP) says states should get rid of laws which allow children to go unvaccinated for diseases like measles for non-medical reasons and advises individual physicians to consider excluding families who continually refuse immunizations from their practice.

Mental healthcare breakdown in Massachusetts

Government cuts to state- and federally funded mental healthcare are causing troubles for patients, families and their communities, according to a report by the Boston Globe’s famous investigative Spotlight Team. 

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Nearly a third of U.S. counties likely limited to a single exchange insurer in 2017

A preliminary analysis of insurer participation on the Affordable Care Act’s insurance exchanges said that 31 percent of counties in the U.S. are likely to have a single insurer marketplace in 2017.

PuraPly products now available for Medicare reimbursement in 10 states

Following the decision by the National Government Services to end its local coverage determination for both cellular and tissue-based products, Organogenesis’s PuraPly and PuraPly Antimicrobial products for wound management will be eligible for Medicare coverage and reimbursement in 10 states.

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.