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.

Opinion: Marijuana could curb reliance on opioids for pain relief

Esther K. Choo, MD, MPH, and colleagues urge for a universal standing on cannabis as the solution to the opioid epidemic.

November 7, 2016

New dry-powder asthma inhaler receives FDA clearance

Propeller Health, a producer of digital products for respiratory medication, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the GSK's Ellipta inhaler and platform, a treatment for asthma featuring a patented dry-powder inhaler.

November 7, 2016

Opioid poisonings skyrocket in American youths

America is in the grips of an epidemic, this epidemic isn’t driven by a mysterious virus but rather a drug being prescribed every day. Opioid use has increased at an unprecedented rate, leading to addictions and overdoses among the masses, and those effected aren’t limited to adults.

November 4, 2016

Sutter Health seeks to prevent self-insured companies from suing over prices

Sacramento, California-based Sutter Health is being accused of strong-arming companies into waiving their rights to sue the 24-hospital system, according to KQED.

November 4, 2016

Q&A: Deloitte's Andreaa Balan-Cohen on moving physicians towards value-based care

Some 94 percent of executives at provider organizations say they’re on the path towards value-based care, according to the Deloitte Center for Health Solutions, but only 27 percent say they’ve completed some stage of that transition. What may be holding the transformation back is how physicians are compensated.

November 4, 2016

Mylan settlement ‘irresponsible,’ says West Virginia Attorney General

The $465 million settlement over claims Mylan profited off an improper CMS classification of its EpiPen autoinjector isn’t good enough, according to West Virginia Attorney General Patrick Morrissey.

November 3, 2016

Part D prescriber enrollment requirement delayed to 2019

CMS has announced it will push back a requirement for prescribers be enrolled in Medicare for Part D to cover their prescriptions, marking at least the fourth time the agency has delayed the rule since it was finalized in March 2014.

November 3, 2016

HIMSS eyes 3 main topics to improve homeland security

The U.S. Department of Homeland Security released its Draft National Cyber Incident Response Plan (NCIRP) in September. Now, the Healthcare Information and Management Systems Society (HIMSS) has written a letter focusing on three main topics to improve the plan.

November 2, 2016

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.