CMS Maintains Hardline Approach In New-Tech Add-On Payment Reviews

The Medicare agency raised significant questions about the qualifications for all five device applicants for FY 2017 new-technology add-on payments in its latest hospital inpatient proposed rule.

The Center for Medicare and Medicaid Services maintained its highly selective approach to considering devices for new-technology add-on payments in its latest hospital inpatient prospective payment system proposed rule. The agency raised significant questions for all five device applicants in the April 18-issued proposal.

The document does not provide up-or-down decisions in response to applications submitted by manufactures to gain temporary extra reimbursement payments in fiscal year 2017. That will come in the final...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Policy & Regulation

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

More from Medtech Insight

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By 

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 

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.

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By 

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.