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Evidence-Based Diabetes Management September 2013

The Next Frontier for the Artificial Pancreas: Payer Coverage

Stanton R. Mehr
Ultimately, he believes, “coverage will depend upon evidence demonstrating not only improved health outcomes—both short and long term—but also cost effectiveness and medical cost offsets related to medical resource utilization, such as hospitalization and emergency room  visits for hypoglycemia.” This bionic or artificial pancreas is clearly a powerful evolutionary technological step. Until regenerative bioengineering can synthetically produce an organ with human beta cells that would wholly replace the pancreas of a patient with T1DM, these closed loop systems represent today the closest thing to automatic pancreatic insulin regulation.

The science and engineering moves forward. Perhaps hundreds of thousands of patients—private “sum of their parts?” For example, SelectHealth in Salt Lake City will view the artificial pancreas as completely new technology, according to Medical Director Kenneth Schaecher, MD. “This will require a separate technology assessment and would not be covered simply as another insulin pump,” he said. Ultimately, he believes, “coverage will depend upon evidence demonstrating not only improved health outcomes—both short and long term—but also cost effectiveness and medical cost offsets related to medical resource utilization, such as hospitalization and emergency room visits for hypoglycemia.”

This bionic or artificial pancreas is clearly a powerful evolutionary technological step. Until regenerative bioengineering can synthetically produce an organ with human beta cells that would wholly replace the pancreas of a patient with T1DM, these closed loop systems represent today the closest thing to automatic pancreatic insulin regulation. The science and engineering moves forward. Perhaps hundreds of thousands of patients—private“sum of their parts?”

For example, SelectHealth in Salt Lake City will view the artificial pancreas as completely new technology, according to Medical Director Kenneth Schaecher, MD. “This will require a separate technology assessment and would not be covered simply as another insulin pump,” he said. Ultimately, he believes, “coverage will depend upon evidence demonstrating not only improved health outcomes—both short and long term—but also cost effectiveness and medical cost offsets related to medical resource utilization, such as hospitalization and emergency room visits for hypoglycemia.”

This bionic or artificial pancreas is clearly a powerful evolutionary technological step. Until regenerative bioengineering can synthetically produce an organ with human beta cells that would wholly replace the pancreas of a patient with T1DM, these closed loop systems represent today the closest thing to automatic pancreatic insulin regulation. The science and engineering moves forward. Perhaps hundreds of thousands of patients—private“sum of their parts?”

For example, SelectHealth in Salt Lake City will view the artificial pancreas as completely new technology, according to Medical Director Kenneth Schaecher, MD. “This will require a separate technology assessment and would not be covered simply as another insulin pump,” he said. Ultimately, he believes, “coverage will depend upon evidence demonstrating not only improved health outcomes—both short and long term—but also cost effectiveness and medical cost offsets related to medical resource utilization, such as hospitalization and emergency room visits for hypoglycemia.”

This bionic or artificial pancreas is clearly a powerful evolutionary technological step. Until regenerative bioengineering can synthetically produce an organ with human beta cells that would wholly replace the pancreas of a patient with T1DM, these closed loop systems represent today the closest thing to automatic pancreatic insulin regulation.

The science and engineering moves forward. Perhaps hundreds of thousands of patients—private and public; many with type 1 disease, some with type 2—may want a sip from this holy grail when it is finally revealed. Will coverage of the technology be able to quench the thirst?

NOT JUST 1 DEVICE

The complexity of artificial pancreas systems becomes apparent when considering the 3 types as defined by the US Food and Drug Administration (FDA): (1) threshold suspend devices, (2) control-to-range systems, and (3) control-to-target appliances. Essentially, these divisions relate to how tightly the artificial pancreas tries to maintain appropriate levels.

Threshold Suspend. This type of device is referred to as a “back stop,” the mission being to prevent dangerous episodes of hypoglycemia. Once blood glucose levels reach a certain low level, insulin delivery from the pump is suspended. Therefore, for better glycemic control, patients must still check their own blood glucose levels and provide supplemental insulin as needed.

Control-to-Range (CTR). Use of a CTR device is intended to maintain blood glucose levels within a range, actively changing insulin administration once the preset upper or lower limits are reached. In order to obtain optimal control, patients using a CTR system are still required to occasionally check their own levels and administer supplemental insulin as needed.

Control-to-Target (CTT). The system that attempts to achieve the tightest glucose control, the CTT device continually seeks to achieve target levels, day or night. This is the only artificial pancreas unit that is fully automated—the patient should not need to do any glucose monitoring or inject additional insulin. To help the CTT system achieve target levels, it must do more than add insulin—it may be required to increase sugar levels as well, by injecting glucagon into the body as well. This is referred to as a “bi-hormonal control system.”

Source: Types of artificial pancreas device systems. US Food and Drug Administration, November 9, 2012 (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/ucm259555.htm). Accessed August 7, 2013.

1. Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013;369(3):224-32.

2. Medtronic begins overnight artificial pancreas study (press release). Medtronic, June 24, 2013 (http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irolnewsArticle&
ID=1832288&highlight=). Accessed August 12, 2013.

3. Insulin pump therapy: guidelines for successful outcomes. American Association of Diabetes Educators 2008 Consensus Summit, September 18, 2008 (http://www.diabeteseducator.org/
export/sites/aade/_resources/pdf/Insulin_Pump_White_Paper.pdf). Accessed August 21, 2013.

4. Selam J-L. Advances in insulin pen technologies evolution of diabetes insulin delivery devices. J Diabetes Sci Technol. 2010; 4(3):505–513.

5. Providing diabetes health coverage: state laws & programs. [National Conference of State Legislators website]. (http://www.ncsl.org/issuesresearch/health/diabetes-health-coverage-statelaws-and-programs.aspx). Published May 2011. Accessed August 21, 2013.

6. Artificial pancreas project. [Juvenile Diabetes Research Foundation website.] December 2011 (http://artificialpancreasproject.com/about/insurance.html). Accessed August 15, 2013.

7. Medicaid benefits: medical equipment and supplies. [Kaiser Family Foundation December 2010 website.] (http://kff.org/medicaid/stateindicator/medical-equipment-and-supplies/).
Accessed August 15, 2013.

8. Status of state action on Medicaid expansion [Kaiser Family Foundation website.] July 1, 2013 (http://kff.org/medicaid/state-indicator/state-activity-around-expanding-medicaid-underthe-
affordable-care-act/). Accessed August 23,2013.

9. Garfield RL, Damico A. Medicaid expansion under health reform may increase service use and improve access for low-income adults with diabetes. Health Aff. 2012;31(1):159-167.

10. Centers for Disease Control and Prevention. Diabetes report card, 2012. [CDC website.]2012 (http://www.cdc.gov/diabetes/pubs/pdf/diabetesreportcard. pdf). Accessed August 22, 2013.
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