Reimbursement

Researchers from the Brigham and Women’s Hospital and Harvard Medical School argue that the Ensuring Patient Access to Critical Breakthrough Products Act is “a step in the wrong direction.”

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.

The Boston, MA-based company says the pivot away from Rx will enable it to pursue a significantly larger market and remove “key friction points” that have prevented patients from accessing its game-based digital ADHD treatment. The company is targeting year-over-year cost savings of $8m-$18m after investments to juice up its direct digital marketing program.

China’s growing market for medtech, estimated at $70bn in 2021, could more than double this decade if the government’s Healthy China 2030 plan stays on track.  

CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

Comments submitted by industry members about CMS’s TCET notice highlight the need for greater device eligibility and transparency for the pathway.

The ActiGraft PRO treatment for diabetic ulcers recently procured Medicare coverage nationwide, despite anti-abuse policies that have made reimbursement for new wound care products rare. Company general manager Robert Mueller talked about the process.

The American Telemedicine Association has published a new set of data principles to ensure telehealth visits meet standards for patient safety as well privacy of data and information.

Technical teams have laid the cornerstone for the platform that will be developed to link up multiple public and private data sources and make it easier to access, integrate and analyze the vast and diverse range of data they contain.

Successful IVD reimbursement requires communication of analytical validity, clinical validity and clinical utility.

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

AdvaMed, MITA and MDMA say cuts to Medicare reimbursement rates for office visits would disproportionately harm specialists.