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Labs Get Extra Year To Adjust To Diagnostics Reimbursement Revamp

 
• By David Filmore

CMS issued a long-awaited final rule that will establish a new market-based approach to setting lab-test payment rates. The Medicare agency was convinced to delay implementation by one year, to 2018, and to make other tweaks to its policy that industry stakeholders say will make the system more accurate.

CMS delayed implementation and expanded the number of laboratories that will need to report pricing data in a final regulation that will remake Medicare lab-test reimbursement into a more market-based system.

The Medicare agency posted the rule on June 17, moving ahead with significant diagnostic provisions passed by Congress as part of the 2014 Protecting Access to Medicare Act. CMS's rulemaking...

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• By Marion Webb

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SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

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Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
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• By Natasha Barrow

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