Physiologic Insulin Resensitization (PIR)

POLICY NUMBER

L.2.01.438

DESCRIPTION

Physiological Insulin Resensitization (PIR) is an approach where insulin is “administered as a hormone rather than a drug” by way of infusion through a programmable, portable pump and is proposed to address the primary cause of diabetes, metabolic failure. Insulin doses are client specific, and insulin is released in a pulsatile manor (versus continuous administration). The objective of the precise PIR dosing is to achieve biomimicry of insulin as a hormone communicator to stimulate the metabolism. During treatment, small, specific amounts of glucose (ingested as a dextrose liquid) are given to the patient in addition to the insulin in order to stimulate the digestive system.

The research available regarding PIR is limited at this time. The hypothesized clinical outcomes of PIR include a decrease in hemoglobin A1c, reversals of diabetic neuropathy, improvements in wound healing, decrease in insulin requirements, improvements in estimated glomerular filtration rate (eGFR), weight loss, reduced symptoms of Alzheimer’s and dementia, and decreases in systolic blood pressure.

POLICY

Physiologic Insulin Resensitization is considered investigational for all indications as there is insufficient evidence of clinical benefit, and the use of Physiological Insulin Resensitization has not yet been addressed in treatment guidelines.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

03/16/2023: New policy added. Approved by Medical Policy Advisory Committee.

04/30/2024: Policy reviewed; no changes.

08/01/2025: Policy reviewed; no changes.

SOURCE(S)

1. Greenway F, Loveridge B, Grimes RM, Tucker TR, Alexander M, Hepford SA, Fontenot J, Nobles-James C, Wilson C, Starr AM, Abdelsaid M, Lewis ST, Lakey JRT. Physiologic Insulin Resensitization as a Treatment Modality for Insulin Resistance Pathophysiology. Int J Mol Sci. 2022 Feb 8;23(3):1884. doi: 10.3390/ijms23031884. PMID: 35163806; PMCID: PMC8836751.

2. https://professional.diabetes.org/content-page/practice-guidelines-resources

   .

   Accessed February 2023.

3. https://restormetabolix.com

   .

   Accessed February 2023.

4. Loveridge B, Tucker T, Laurent M, Hpeford S, Alexancer M, Lakey J. Dynamic diabetes solution: physiologic insulin resensitization. Aug 2021.

5. Tucker T, Hadley J, Alexander M, Lakey J, Loveridge B Case Series: Reversal of Diabetic Neuropathy Utilizing Physiologic Insulin Resensitization. Int J Diabetes Metab Disord 6(2): 160-163. (2021) Accessed February 2023.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.