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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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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CHIME announces new appointments to leadership positions

The College of Healthcare Information Management Executives (CHIME) has announced the newest appointments to its board of trustees, board of directors and elected officers for 2018.

Quality Payment Program introduces choices for physicians in 2017

A blog post by Andy Slavitt, Acting Administrator of CMS, highlights the choices eligible physicians will have for the Quality Payment Program starting on Jan. 1, 2017.

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.

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.

FDA recalls the INRatio and INRatio2 PT/INR monitoring systems

The FDA has announced that Alere has recalled their INRatio and INRatio2 PT/INR monitoring systems.

EpiPen's 400 percent price increase has consumers and Congress confused and concerned

U.S. lawmakers are joining concerned parents in demanding to know: What is up with the sudden increase in the price of an EpiPen? 

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Device companies agree to pay $1 billion in user fees to FDA

Medical device companies will pay the FDA nearly $1 billion in user fees for five years beginning in October 2017 under the fourth reauthorization of the Medical Device User Fee & Modernization Act (MDUFA).

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Around the web

Health Exec
These health systems have the biggest digital health portfolios

U.S. health systems are increasingly leveraging digital health to conduct their operations, but how health systems are using digital health in their strategies can vary widely.

Health Exec
Toylike robot pleases counseling clients where humanoid counterpart struggles to connect

When human counselors are unavailable to provide work-based wellness coaching, robots can substitute—as long as the workers are comfortable with emerging technologies and the machines aren’t overly humanlike.

Health Exec
Medsender, Patagonia Health team up to aid public health efforts against COVID-19

A vendor that supplies EHR software to public health agencies is partnering with a health-tech startup in the cloud-communications space to equip state and local governments for managing their response to the COVID-19 crisis.

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