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.

Joint Commission, CMS release clarifying recommendations regarding text ordering

The Joint Commission, working with CMS, has released a list of clarifying recommendations in response to the use of text messaging for patient care orders.

January 11, 2017

Trump: ACA replacement details coming once his HHS Secretary confirmed

In his first press conference since July 2016, President-elect Donald Trump confirmed he favored an “essentially simultaneous” repeal-and-replace of the Affordable Care Act (ACA) and said his nominee to take over HHS, U.S. Rep. Tom Price, MD, R-Georgia, will be introducing details of the plan after he’s confirmed. 

January 11, 2017

New Data Shows MedTech Industry Poised for Greater Investment & Growth with Full Device Tax Repeal

Another Suspension of Disruptive Tax Won’t Have Same Economic Impact

January 11, 2017

Burwell’s final speech as HHS Secretary: ‘In healthcare, there is no free lunch’

In what was billed as HHS Secretary Sylvia Burwell’s farewell speech, she criticized several proposals to replace the Affordable Care Act (ACA), while challenging the Republican majorities to introduce a replacement plan if they plan to quick repeal the law.

January 10, 2017

Health Care Leaders Convene in Colorado to Discuss Recommended Actions to Solve Nation’s Primary Care Crisis

“Critical Conversation” on Transforming Primary Care System via Enhanced Role for RNs to be Held at University of Colorado Anschutz Medical Campus on January 12

January 10, 2017

Obama calls ACA repeal plan ‘reckless’ in NEJM article

President Barack Obama warned against repealing the Affordable Care Act (ACA) in a New England Journal of Medicine article, saying without a replacement ready to take its place, the result “could slowly bleed the healthcare system that all of us depend on.”

January 9, 2017

How insurance markets could survive an ACA repeal

Supporters of the Affordable Care Act (ACA) have warned repealing the law could “unravel” the individual and small group insurance markets within months, but subsidies may be able to stabilize health plans in the short-term.

January 9, 2017

Specialty drugs tripled Part D catastrophic coverage spending in 5 years

Between 2010 and 2015, payments for Medicare Part D catastrophic coverage tripled to $33 billion, thanks to increased prices for drugs, according to a report from HHS’s Office of the Inspector General (OIG).

January 6, 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.