Calmare Therapeutics Inc (fka CTTC)

[powderbum]

NO SIR, YOU ARE IGNORING THE FACTS.

CMS changed their reimbursement requirements in 2016. Read about it! It is now VALUE BASED MEDICINE. NOT STUDY BASED MEDICINE. The judge certainly gets it.It's all about patient results, not studies.

"If the Secretary determines that there exists valid scientific evidence .... (i) which is sufficient to determine the effectiveness of a device, and (ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for purposes of this section......the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence."

Additionally, the FDA, pursuant to 21 USCA § 355d, also requires the individual or entity seeking approval of a device to provide adequate, well-controlled investigations which include clinical investigations by qualified experts who, by possessing the necessary training and expertise, can conclude that the device in question will have the effect it purports to have when used as directed.The Court finds unavailing, the fact that no specific evidence that Calmare Scrambler Pain Therapy is widely accepted in the medical field for the treatment of neurological pain has been presented. The Court notes that no real evidence of non-acceptance has been presented. What is significant and noteworthy is that evidence of independent testing was presented which demonstrated that Ms. Fertitta's pain level decreased following the administration of Calmare Scrambler Pain Therapy treatments.

The Court certainly recognizes that anything new, whether it be a mechanical device or a scientific theory, will inevitably have "kinks" which need to be worked out over time. However, this fact should not fuel any unreasonable fear or disapproval of a device which has the potential to literally revolutionize how the medical field addresses and combats chronic pain.Therefore, in consideration of this, the Court finds no reason to deny the instant claim for reimbursement. The Court finds that Calmare Scrambler Therapy, in the instant action, was a medical necessity for Ms. Fertitta's pain management.

Accordingly, it is hereby

ORDERED that judgment in the amount of $3,490.00, in addition to attorney's fees and statutory interest, is awarded to plaintiff FOREST REHABILITATION MEDICINE PC A/A/O TRACY FERTITTA.

This constitutes the decision and order of the Court.

http://law.justia.com/cases/new-york/other-courts/2014/2014-ny-slip-op-24160.html