1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?
The search for non-opioid pain relief focuses on pharmaceuticals, in part because CMS does not cover "comfort items". The structure of United States healthcare prohibits innovation in physical medicine, and without high prices supporting medical device rep education or coverage, FDA 510K devices for pain can't reach patients. Mechanical stimulation in the frequency to elicit gate control pain relief more effectively than electricity won't be covered without external evidence support from within a government agency. Over 100M US patients with chronic pain, and the 80,000 who died from opioid overdoses could be helped with an inexpensive reusable device if policies were changed.
2. Why are you struggling with this issue?
Bureaucracy cannot keep up with science. Our system constrains both the FDA and CMS, while the NIH vets, funds, and develops interventions. Without coverage, the orthopedists who are accustomed to receiving 3/4 of the covered cost of braces will not change behavior. Without a benefit category, hospitals and workers compensation don't have time to use miscellaneous codes.
3. What do you want to see changed? How will you know that your issue is improving or has been addressed?
When the FDA creates new guidance for both benefit and risk of mechanical stimulation, and when CMS has a mechanism to cover physical devices using the same criteria as pharmaceuticals, the problem will be improving. When a universal standard allocates payment based on benefit, toleration, patient acceptance, and outcomes, regardless of a pharmaceutical or physiologic mechanism, the problem will be addressed.
4. When do you need the evidence report?
Friday, September 29, 2023
5. What will you do with the evidence report?
We are again submitting a HCPCS request for benefit category given new FDA 510K indications for surgery and PT pain relief. Movement prior to that decision in September will be helpful if the information can be transmitted.
Supporting Documentation
Stimulation Therapy for AHRQ's Evidence-based Practice Center (EPC) Program (PDF, 4 MB)
Optional Information About You
What is your role or perspective? Physician, NIH scientist, Inventor of and owner of Buzzy and VibraCool, Clinical Associate professor Augusta University
If you are you making a suggestion on behalf of an organization, please state the name of the organization - Pain Care Labs a dba of MMJ Labs LLC
May we contact you if we have questions about your nomination? Yes
