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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State news: N.Y. may change malpractice limits, Calif. considers coverage for undocumented

Here’s a roundup of healthcare news from New York, California, North Carolina, Massachusetts, New Jersey and Texas.

OIG triples healthcare fraud, abuse recoveries in the last three years

The Office of Inspector General's Semiannual Report to Congress has found that the total amount of expected recoveries reported between October 1, 2015 and March 31, 2016, is $2.77 billion, including $555 million in recoveries found through audits and $2.2 billion through investigations.

FDA promises new compassionate use form will save physicians time

Physicians will have to fill out a new form to request access to investigational drugs for patients with terminal illnesses, which the Food and Drug Administration said will take 45 minutes to complete.

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Medicaid dollars can be used on Zika prevention like mosquito repellent

States can use Medicaid funding for items like condoms and mosquito repellent to prevent the spread of the Zika virus, according to a new letter from CMS.

AMIA asks for new approach on ONC interoperability standards

Measuring interoperability as required by the Medicare Access and CHIP Reauthorization Act (MACRA) calls for a “patient-centric” and flexible strategy, wrote the American Medical Informatics Association (AMIA).

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UnitedHealthcare leaving California ACA exchange

California insurance officials have confirmed UnitedHealthcare won’t be offering health coverage of the state’s Covered California marketplace in 2017

FDA approves first monthly self-administered MS injection despite side effects

The Food and Drug Administration (FDA) has approved Zinbryta (daclizumab), a once-monthly injection for treating relapsing multiple sclerosis that patients can administer themselves.

CMS changes course on allowing ACOs into CPC+

Accountable care organizations (ACOs) will be allowed to participate in the Comprehensive Primary Care Plus (CPC+) pilot program.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

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. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

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.