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.

Possible repeal of required health benefits draws ire of public hospitals, ER docs

In last-minute negotiations on the American Health Care Act (AHCA), eliminating the 10 “essential health benefits” requirements put in place by the Affordable Care Act (ACA) was floated as an option to win over conservative lawmakers, a development which was quickly opposed by groups representing public hospitals and emergency physicians.

March 23, 2017

Trump HHS budget proposal raises FDA user fees

President Donald Trump's 2018 budget proposal for the U.S. Department of Health and Human Services (HHS) includes a doubling of U.S. Food and Drug Administration (FDA) user fees, putting added strain on small digital health businesses.

March 22, 2017

Major players remain opposed to ACA replacement ahead of House vote

The American Medical Association (AMA), the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) have all come out against passage of the American Health Care Act (AHCA), the Republican-sponsored plan to replace the Affordable Care Act (ACA), which is scheduled for a vote before the full House of Representatives on March 23.

March 22, 2017

GOA to investigate FDA’s orphan drug program

The Government Accountability Office (GAO) has confirmed it will investigate the U.S. Food and Drug Administrations (FDA) Orphan Drug program following a letter from senators citing possible exploitation.

March 22, 2017

Both Dems, Repubs misinform constituents on healthcare policy

Members of both parties have received and answered plenty of letters from their constituents about the Affordable Care Act (ACA) and other aspects of healthcare policy. According to a fact check from ProPublica, neither side can claim it has always been truthful to the people it represents. 

March 22, 2017

5 changes made in revised ACA replacement plan

Ahead of a planned March 23 vote on the American Health Care Act (AHCA), House Republican leaders released a new version of the replacement plan for the Affordable Care Act (ACA) with several big changes aimed at bolstering support for the legislation within their own party.

March 21, 2017

ACA replacement set for vote in House on March 23

The Republican-sponsored replacement for the Affordable Care Act (ACA), the American Health Care Act (AHCA), will get a vote in the full U.S. House on March 23, despite doubts that it has enough votes to pass.

March 20, 2017

MGMA to CMS: Where are the MIPS eligibility notifications?

The Medical Group Management Association (MGMA) has asked newly confirmed CMS Administrator Seema Verma to quickly release overdue eligibility information for the Merit-based Incentive Payment System (MIPS), one of two new payment tracks implemented as part of the Medicare Access and CHIP Reauthorization Act (MACRA). 

March 17, 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.