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.

Lawyers prompt for medical device failure reporting

Technology is prone to breaking from time to time but when the technology within a medical device fails, lives are at risk. Parker Waichman LLP, a law firm protecting patients injured by medical devices, have commented on the safety concerns involving morcellators and duodenoscopes. These comments ask regulators to enforce reporting of medical devices injuries.

February 17, 2017

Republicans policy brief offers few new details on ACA replacement

House Speaker Paul Ryan promised a new plan to repeal and replace the Affordable Care Act is coming after the Presidents Day recess in Congress, but there are still disagreements between House Republicans on several key points of their own legislation.

February 16, 2017

5 things to know from questioning of Trump’s CMS nominee

Seema Verma, MPH, President Donald Trump’s pick to run CMS, faced questions about mandatory payment models, the Affordable Care Act (ACA), and providers’ ability to take on risk-based arrangements in her confirmation hearing before the Senate Finance Committee.

February 16, 2017

SpectraMedix introduces National MACRA Advisory Council

SpectraMedix, a company specializing in transitioning hospitals to to value-based payment models, has developed a national advisory council dealing with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). This council, made up of healthcare policy and IT experts, will assist the industry implement Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) tracks.

February 15, 2017

First Trump-era CMS rule seeks to keep insurers on ACA exchanges

The administration of President Donald Trump has issued its first proposed rule regarding the Affordable Care Act (ACA) insurance exchanges, offering what health policy experts call “insurer-friendly” changes to keep companies from raising premiums or exiting the marketplace.

February 15, 2017

Conservatives want quicker ACA repeal with elimination of Medicaid expansion

With no consensus yet among Republicans on how to repeal and replace the Affordable Care Act (ACA), the conservative House Freedom Caucus voted among itself to oppose any plan it considers to be weaker than a 2015 attempt to eliminate the law. 

February 14, 2017

‘Death panel’ attack revived at ACA town hall

Republican members of Congress are facing angry, pro-Affordable Care Act (ACA) crowds at town halls and constituent meetings across the country. One party official drew a particularly harsh response when he brought up a debunked myth against the law—“death panels.”

February 13, 2017

Idaho's cautionary tale about leaving ACA alternatives up to states

One of the many ideas discussed as Republicans in Congress try to craft a replacement plan for the Affordable Care Act (ACA) is leaving specific policies up to states, whether it be through Medicaid block grants or keeping current ACA regulations.

February 10, 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.