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.

Newsom vetoes bill to regulate private equity transactions in healthcare
Assembly Bill 3129 would have given the California Attorney General oversight of all private equity investments or purchases involving a healthcare entity. Gov. Gavin Newsom argued that a similar regulatory framework is already in place.
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.

New legislation would mandate healthcare workplace violence prevention plans

U.S. Representative Ro Khanna, D-California, recently introduced new legislation dubbed the Health Care Workplace Violence Prevention Act, which aims to reduce the risk of workplace violence in healthcare facilities utilizing comprehensive employer-mandated workplace violence plans.

March 19, 2018

UnitedHealth won’t buy Envision’s ambulatory unit after lawsuit

UnitedHealth Group has dropped its bid to acquire the ambulatory services unit of Envision Healthcare and isn’t interested in participating in any deals to scoop up parts or all of the company, according to Bloomberg.

March 17, 2018

CMS’ Kate Goodrich: MACRA changes coming, but not on certified EHR

Easing clinician burden under the payment tracks implemented as part of the Medicare Access and CHIP Reauthorization Act (MACRA) will be a priority for CMS in this year’s rulemaking, according to Kate Goodrich, MD, the agency’s chief medical officer. What won’t be changing, however, is requiring providers to meet the 2015 edition of certified electronic health record technology (CHERT) standards.

March 16, 2018

MIPS can’t be fixed, MedPAC argues in report to Congress

The Medicare Payment Advisory Commission has released its March 2018 report for Congress, which includes its recommendation to eliminate the Merit-based Incentive Payment System (MIPS) after only a one year of clinician reporting to the program.

March 15, 2018

Prices and labor costs, not overutilization, set U.S. healthcare system apart

A new study published in JAMA challenges some of the more common explanations for why the U.S. spends more on healthcare than other high-income countries, finding the U.S. isn’t an outlier on measures like utilization, share of primary care physicians or social services spending.

March 14, 2018

CVS, Aetna shareholders approve $69B acquisition

Shareholders for both CVS Health and Aetna overwhelmingly approved the proposed $69 billion deal for CVS to acquire the health insurer, bringing the merger one step closer to completion.

March 13, 2018

ACA stabilization package would boost coverage, lower premiums on individuals

A pair of bills to fund the Affordable Care Act (ACA)’s cost-sharing reduction (CSR) subsidies and create a new reinsurance program would lower monthly premiums for exchange plans by 20 to 40 percent and boost enrollment by 3.2 million people. Conservative groups, however, call the legislation a “bailout” for insurance companies.

March 13, 2018

CMS didn’t reject ‘our approach’ to ACA, argues Idaho’s governor

When CMS told Idaho it couldn’t move ahead with plans to allow health insurers to offer coverage which doesn’t comply with the Affordable Care Act (ACA), Idaho Gov. Butch Otter didn’t see it as a rejection but rather the start of a negotiation.

March 12, 2018

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.