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.

Medical device industry may see up to 5% growth

Moody’s Investors Service has upgraded the financial outlook for the medical products and device industry from stable to positive, predicting that “continued product innovation” and synergies from acquisitions will drive growth of earnings before interest, depreciation and amortization (EBITDA) of between 4 and 5 percent over the next 12 to 18 months.

March 9, 2018

HIMSS18: What providers have learned, what comes next for the Quality Payment Program

Clinicians have until March 31 to submit 2017 performance data for the Quality Payment Program established after passage of Medicare Access and CHIP Reauthorization Act (MACRA). HealthExec spoke with Beth Houck, MBA, the vice president of client services at value-based program compliance and analytics software company SA Ignite, at the HIMSS18 conference in Las Vegas.

March 9, 2018

CMS rejects Idaho’s plans to expand non-ACA-compliant insurance

Idaho’s plan to allow health insurers to offer coverage which doesn’t comply with the Affordable Care Act (ACA) would result in CMS fining insurance companies and taking over the state’s role in enforcing the law, essentially denying the state’s proposal to violate the ACA—but also offering the state some guidance on how it could approve the plans in the future.

March 9, 2018

Cigna to buy Express Scripts for $67B

Cigna announced this morning it will buy Express Scripts in a deal worth a total of $67 billion. The health insurer will assume $15 billion in debt from the pharmacy benefits manager (PBM) in addition to the $52 billion stock-and-cash transaction.

March 8, 2018

Massachusetts officials give thumbs-up to Beth-Israel-Lahey merger

A potential merger of 13 hospitals in Massachusetts, led by Beth-Israel Deaconess Medical Center and Lahey Health, has been endorsed by state health officials, claiming it will improve services for patients.

March 7, 2018

HIMSS18: 6 key data points from US leadership, workforce survey

As the healthcare professionals touch down in Las Vegas for the 2018 Healthcare Information and Management Systems Society (HIMSS), the organization released its annual survey of the marketplace. HIMSS published the 2018 U.S. HIMSS Leadership and Workforce Survey on March 6, which examines trends in employment, technology and expectations.

March 6, 2018

HIMSS18: CMS's Verma warns information blocking will no longer be tolerated

CMS Administrator Seema Verma, MPH, announced at HIMSS18 in Las Vegas new agency initiatives aimed at promoting interoperability and giving patients easier access to health records, drawing applause for talk about reforming regulations while the audience of health IT professionals sat silent when she warned of a crackdown on information blocking.

March 6, 2018

HIMSS18: Out-of-pocket costs increased 11% in 2017

The trend of costs increasingly being shifted onto patients continued in 2017 with average out-of-pocket costs hitting $1,813 in 2017, an 11 percent jump from the year before, according to an analysis released by TransUnion Healthcare at the HIMSS18 conference in Las Vegas.

March 5, 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.