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Next Year’s Congress Likely To Reinforce ACA Preexisting Conditions, Attorneys Say

Supreme Court action on ACA constitutional case not expected until June, so Democrats plan to shore up the act’s provisions through lawmaking in interim

 
• By Sue Darcey

Industry attorneys predict that in the absence of the Supreme Court’s immediate response to arguments made in a key Affordable Care Act constitutionality case, that Congress will reaffirm the law.

Supreme Court long shot
US Supreme Court Building

Industry attorneys are predicting that the new US Congress will work quickly to reestablish key provisions of the Affordable Care Act to assure the continuity of the ACA’s preexisting conditions, sufficient Medicaid funding, and Medicare innovation provisions.

When the Biden administration takes charge of the government on 20 January, “there does seem to be some interest in...

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FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Trump Taps Food And Drug Law Outsider For FDA Chief Counsel

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

More from Policy & Regulation

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.