1. Medtech Insight
  2. >>Policy & Regulation

HHS Plan To Exempt Employers From Birth-Control Mandate Threatens IUD Sales

 
• By Sue Darcey

An HHS draft proposal to broaden the "religious and moral objections" exemption from an Affordable Care Act rule mandating that employers cover employees' contraceptive use in health care plans, threatens US sales of intrauterine devices (IUDs), which total more than $1bn annually.

Young doctor holding an IUD birth control copper coil device in hand, used for contraception
Copper-based IUD • Source: Shutterstock

Under a draft rule sent by US HHS to the Office of Management and Budget for review May 23, any employers could exempt themselves from the Affordable Care Act (ACA) contraceptive coverage mandate by stating they have moral objections to offering birth control options in health plans. Without the mandated coverage, many employers could drop birth control devices from health-care plans, and employees who can't afford the $500 to $1,000 cost per IUD won't buy them, or will turn to less-effective, cheaper options, according to Planned Parenthood, leading to a drop in use of intrauterine devices.

Before the ACA's birth control provision took effect, more than 20% of American women had to pay out-of-pocket for their prescription birth control, and many went without, according to Planned...

More from Policy & Regulation

Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

More from Medtech Insight

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.