1. Medtech Insight
  2. >>Policy & Regulation

US HHS Inspector General Asks For Data On Anti-Kickback Law Barriers To Value-Based Care

 
• By Sue Darcey

The US HHS Office of Inspector General on Aug. 27 issued a request for information on ways the department may loosen provisions of the anti-kickback statute – such as restrictions on Accountable Care Organization arrangements – that may be acting as barriers in the pursuit of value-based care.

HHS Building_1200

The medtech industry is praising an Aug. 27 “request for information” from the US Health and Human Services' (HHS) Office of Inspector General (OIG) asking the general public and stakeholders in the Medicare program for ways to address barriers posed by the anti-kickback statute to carrying out value-based care models.

Portions of the statute can also collide with gainsharing arrangements, although some hospitals have been granted exceptions to the law to set up gainsharing programs that reward physicians for selecting...

More from Policy & Regulation

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.

Medtech Experts Debate EU Recertification Gridlock

 
• By Amanda Maxwell

Modifying or doing away with the EU medtech recertification requirement is far from straightforward. Four experts from an EU national authority, an EU notified body trade association and industry, plus a well-known medtech consultant, reflect on how to move forward.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

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.

More from Medtech Insight

GE HealthCare Announces US Launch Of Longer Half-Life PET MPI Agent For Ischemia Detection

 
• By Shubham Singh

GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.

DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

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

 
• By Natasha Barrow

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.