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.

FDA announces recall of Pfizer's fast-tracked sickle cell drug
The drugmaker is voluntarily withdrawing Oxbryta from the market due to a higher-than-acceptable risk of death.
Public health coalition wins lawsuit against EPA for lack of fluoride oversight
A federal judge in California ruled existing evidence of the negative effects of fluoride in drinking water warrants an investigation and potential action from the Environmental Protection Agency.
Cardiology groups cheer new bill that would improve access to Medicare claims data
If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation.
Walmart workers sue over tobacco fees levied for health plan trust
The class action lawsuit argues employees cannot escape the fees even after they stop using tobacco, a violation of labor regulations.
HHS awards $75M for addiction and maternal health services in rural areas
The funds will be used to expand services and improve the financial stability of existing healthcare organizations located in underserved regions of the South.

Q&A: Why repeal-and-replace of the ACA isn’t dead

Years of efforts by Republicans to repeal and/or repeal the Affordable Care (ACA) culminated in a dramatic early-morning defeat as three GOP senators voted against the rest of their party. Which leaves the healthcare industry wondering: What now?

July 31, 2017

FDA introduces 'action plan' to improve digital innovation in healthcare

The U.S. Food and Drug Administration (FDA) has released its “Digital Health Innovation Action Plan” to provide guidance on medical devices and software in the 21st Century Cures Act. The Center for Devices and Radiological Health (CDRH) was launched as a pilot precertification program for the development of digital health technology.

July 28, 2017

ACA repeal bill fails in dramatic vote; healthcare groups now seek ‘bipartisan effort’

The decisive vote to repeal and/or replace the Affordable Care Act (ACA) ended in an early-morning defeat for Republican opponents of the law, as three GOP senators—Sens. Susan Collins of Maine, Lisa Murkowski of Alaska and John McCain of Arizona—voted no on the so-called “skinny repeal” plan.

July 28, 2017

CBO: ‘Skinny’ repeal of ACA would increase uninsured by 16M

The Senate’s ongoing debate of plans to repeal and/or replace the Affordable Care Act (ACA) has resulted in two separate Republicans plans being voted down. One hope for the party is to pass a so-called “skinny repeal” which eliminates the individual and employer mandates along with a medical device tax, but that approach would have an immediate impact on insurance coverage and premiums.

July 27, 2017

ACA ‘repeal-and-delay’ bill fails in Senate as industry worries about ‘skinny repeal’

As part of the Senate’s flurry of action on proposals to repeal and/or replace the Affordable Care Act, Republicans brought up the same bill to get rid much of the law, without a replacement ready, which had passed through Congress in 2015. This time, it failed, with seven Republicans and all Democrats voting against it.

July 26, 2017

Senate opens debate on ACA repeal; BCRA fails to pass

Republicans in the U.S. Senate voted to open debate on repealing and replacing the Affordable Care Act (ACA), with 50 senators voting in favor of what’s called a motion to proceed, or MTP, opening the door to the chamber offering numerous amendments to craft some sort of repeal bill. The first option put forward—the Better Care Reconciliation Act (BCRA)—failed to pass as expected.

July 25, 2017

Hospitals, doctors delaying price transparency law in Ohio

Ohio passed a law requiring “good faith” estimates from providers to patients on the cost of elective procedures two years ago, but opposition from the state’s hospital and physician groups has keep the law from being implemented.

July 25, 2017

Senate plans Tuesday healthcare vote—but doesn’t know what bill will be considered

Senate Republican leaders are pushing for a July 25 vote on some form of legislation to repeal the Affordable Care Act, but haven’t decided on what will be in the bill.

July 21, 2017

Around the web

Cardiovascular Business

Cardiology groups cheer new bill that would improve access to Medicare claims data

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation.

Cardiovascular Business

Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Cardiovascular Business

Most recalled cardiovascular devices gained FDA approval with little to no clinical evidence

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing.