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.

‘A huge win’: CMS significantly increases Medicare payments for cardiac CT
CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.
Kentucky AG launches criminal probe after conscious man nearly has organs harvested
The incident happened three years ago when Anthony Hoover was declared brain-dead on his medical record, only to wake up on the operating room table moments before his organs were harvested. The incident has spurred a criminal investigation by Kentucky's attorney general.
FDA announces Class I recall of ventilators after 3 patient injuries
An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately.
FDA clears AI tool that flags signs of heart disease in chest CT scans
The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer.
Stewardship Health sale to private equity finalized for $245M
The physician group, once part of Steward Health Care, has been rebranded as Revere Medical.

Durbin: Some Republicans waiting on ACA repeal to fail to start bipartisan talks

U.S. Sen. Dick Durbin, D-Illinois, believes opponents of the Senate’s Better Care Reconciliation Act (BCRA) can use a delay in considering the bill to convince undecided Republicans to block it, particularly now that health insurers have come out strongly against the legislation.

July 17, 2017

Hospitals remain opposed to Senate healthcare bill; AMA sees slight improvement

Whenever Republicans in the House or Senate have released a new version of an Affordable Care Act (ACA) replacement plan in 2017, healthcare industry reaction has been almost uniformly negative. The same can largely be said for the newest version of the Better Care Reconciliation Act (BCRA), with the notable exception of the American Medical Association (AMA) when it comes to two provisions. 

July 14, 2017

New Senate healthcare bill allows insurance plans with fewer benefits, keeps Medicaid cuts

Senate Republicans have released a new version of their Affordable Care Act (ACA) replacement plan, adding new funding for stabilizing the individual market and keeping more of the ACA’s taxes, while also including a controversial proposal to allow insurance plans which don’t comply with ACA regulations on benefits and community rating.

July 13, 2017

House passes FDA user fee reauthorization, Senate schedule unclear

The House has passed legislation to reauthorize user fee programs through the Food and Drug Administration (FDA) affecting medical devices, prescription and generic drugs.

July 12, 2017

AHIP: Market instability, higher premiums for sicker enrollees under Cruz amendment

America’s Health Insurance Plans (AHIP), health insurers’ largest lobbying group, has been largely silent on Senate Republicans’ version on an Affordable Care Act (ACA) replacement plan, but now is warning against a conservative amendment to allow insurers to now offer plans which don’t comply with ACA regulations.

July 12, 2017

HHS approves Alaska reinsurance program to shore up ACA market

Alaska will receive $323 million from HHS from 2018 to 2022 for a reinsurance program to offset claims from high-cost patients for the lone insurer offering coverage on its Affordable Care Act exchange.

July 12, 2017

Senate delaying August recess to work on healthcare bill

Senate Majority Leader Mitch McConnell, R-Kentucky, has taken the unusual step of delaying the Senate’s August recess, announcing the chamber will stay in session during the first two weeks of the month to address legislative priorities like the replacement of the Affordable Care Act.

July 11, 2017

CMS: Fewer insurer sign-ups on exchange show ACA is ‘failing’

The number of applications for insurers planning to participate in the Affordable Care Act’s exchanges for 2018 has fallen by 38 percent, according to CMS.

July 10, 2017

Around the web

Cardiovascular Business

Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more.

Cardiovascular Business

Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

Cardiovascular Business

FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country.

Policy & Regulations

‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

Kentucky AG launches criminal probe after conscious man nearly has organs harvested

FDA announces Class I recall of ventilators after 3 patient injuries

FDA clears AI tool that flags signs of heart disease in chest CT scans

Stewardship Health sale to private equity finalized for $245M

Around the web