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. 

Exchange premiums still lower than employer-sponsored plans without subsidies

Rising premiums for coverage on the Affordable Care Act’s insurance exchanges have been labeled as a sign of the “death spiral” of the post-ACA market, but a report from the Urban Institute said those plans still offer lower premiums than employer-sponsored insurance.

OIG levies largest fine ever for corporate integrity agreement violation

Kindred Health Care, the largest provider of post-acute care services in the U.S., has paid a $3 million penalty for failing to comply with a corporate integrity agreement (CIA) with HHS’s Office of the Inspector General (OIG).

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FDA will award you $40,000 to develop crowd-sourcing Naloxone app

The FDA is offering a skilled coder $40,000 to make a mobile app that could help people experiencing an opioid overdose find a potentially life-saving dose of Naloxone. 

8 states that have opioid abuse rates above 5.5 percent

As people across the U.S. continue to struggle with opioid addiction and communities face fatal overdoses, the Associated Press and the Center for Public Integrity released a two-part report detailing the many facets of the crisis.

ACOs Using Lightbeam Health Solutions Net $84 Million in Savings for CMS Medicare Shared Savings Program, Doubling Average Savings of Other ACOs

IRVING, Texas – Sept. 19, 2016 – Lightbeam Health Solutions, Inc., a leader in end-to-end population health management solutions, announced today that Accountable Care Organizations (ACOs) using Lightbeam technology delivered $83.8 million in savings to the 2015 Medicare Shared Savings Program (MSSP), fully 20 percent of all MSSP savings in 2015, according to the ACO Financial Report from the Centers for Medicare & Medicaid Services (CMS).

Yale New Haven Hospital will perform HIV-positive organ transplants

Another U.S. hospital (and the first in the New England region), will be allowed to perform organ transplants on HIV-positive patients, according to the Yale Daily News. 

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CMS’s Slavitt defends ACA markets, hints at risk corridor settlement

CMS Acting Administrator Andy Slavitt faced tough questioning from Republican lawmakers about whether increased premiums for 2017 and the failure of ACA co-ops are signs the Affordable Care Act (ACA) exchanges are failing.

Chantix maker defends drug's safety to FDA skeptics

A Sept. 14 statement from drug-maker Pfizer said the company believes the FDA should follow an advisory committee’s recommendation to remove a serious Black Box warning from its anti-smoking drug Chantix, which was released in 2006. But a report released by the FDA the same day outlines concerns about the advisory committee’s data accuracy when it comes to the psychological effects of the medicine. 

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.