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.

Medicaid buy-in proposal would raise payment rates to match Medicare

U.S. Sen. Brian Schatz, D-Hawaii, is preparing to introduce legislation to allow Affordable Care Act (ACA) exchange customers to buy into Medicaid, offering a government-run “public option” similar to ones discussed but ultimately left out of the law.

August 23, 2017

More MIPS exemptions ‘relief’ to some, counterproductive to others

More than 1,100 organizations and individuals offered comments on proposed changes for the second year of the Medicare Access and CHIP Reauthorization Act’s (MACRA) Quality Payment Program (QPP), and some questioned the reasoning behind exempting more clinicians from the new payment tracks.

August 22, 2017

Only 1 rural county still at risk of having no ACA insurer

Less than a month ago, CMS reported 40 counties were in danger of having no insurer offering coverage through the Affordable Care Act (ACA) exchange. As of Aug. 21, that number was shrunk to just one: Paulding County, Ohio.

August 22, 2017

Trump quietly signs FDA user fee reauthorization

With almost zero fanfare, President Donald Trump signed the FDA Reauthorization Act (FDARA) of 2017 into law on Aug. 18, approving the user fee agreements paid by pharmaceutical and medical device companies to the Food and Drug Administration (FDA).

August 21, 2017

Past HHS chiefs urge Congress, Trump to focus on stabilizing ACA markets

The immediate healthcare policy goal for Republicans should be dispelling uncertainty around the Affordable Care Act (ACA) marketplace, according to three former secretaries of HHS.

August 21, 2017

More than 800 ICD-10 code changes introduced for 2017

Two years after the introduction of ICD-10, the ICD-10 Coordination and Maintenance Committee has introduced more than 800 code changes set to take effect in October.

August 18, 2017

Majority of Americans now support universal health coverage

60 percent of Americans believe it’s the government’s responsibility to provide universal health coverage, representing a major shift in opinion since 2013, according to an analysis published in the New England Journal of Medicine.

August 17, 2017

Hospital groups split on CMS canceling mandatory bundles

CMS confirmed Tuesday it will cancel two mandatory bundled payment programs and scale back another—and not all hospitals are happy about it.

August 16, 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.