
For the first time, US healthcare providers can claim reimbursement for pain monitoring through CMS, using PainChek®.
Following its recent FDA De Novo clearance, PainChek® now qualifies as an RTM-eligible medical device under the reimbursement framework of the Centers for Medicare & Medicaid Services (CMS). This creates a new pathway for healthcare professionals to monitor and manage musculoskeletal pain in people with moderate to severe dementia who cannot reliably self-report their pain.
It is estimated that up to 800,000 residents in US long-term care facilities suffer from musculoskeletal conditions, with a significant proportion also living with moderate to severe dementia.
Pain is often under-recognised in this cohort due to communication barriers, and until now, healthcare professionals lacked an FDA-cleared medical device capable of supporting reimbursable monitoring of pain.
PainChek® addresses this gap by enabling clinicians to objectively detect and monitor pain, while generating the clinical data needed to support therapeutic decision-making and RTM reimbursement claims.
Philip Daffas, CEO and Managing Director of PainChek, said the milestone represents an important advancement for dementia care and pain management:
“Until PainChek® was cleared as an FDA-approved medical device, there was no medical device available for healthcare professionals to diagnose or treat pain in individuals with moderate to severe dementia. Consequently, musculoskeletal conditions in this cohort were underdiagnosed.
PainChek® objectively detects pain and links pain scores to musculoskeletal diagnoses such as osteoarthritis, fractures, joint pain and post-operative musculoskeletal pain, and provides the essential pain assessment and therapeutic response data sets to make RTM reimbursement claims.”
The RTM reimbursement pathway extends on global momentum, with 2,000+ organizations worldwide using PainChek® and 17 million+ pain assessments completed to date, supporting our mission to give a voice to those who cannot verbalise their pain.
Interested in learning how RTM reimbursement with PainChek® could work for your organization? Fill in the form below or call 1 800 720 7504.

