TITLE 16

Health and Safety

Regulatory Provisions Concerning Public Health

CHAPTER 21A. Diabetes Wellness Act Pilot Program [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4]

§ 3001T. Intent [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

It is the intent of the General Assembly to improve the health and wellness of the residents of Delaware with diabetes, and related metabolic disease. Accordingly, there is a need to explore and find ways to improve healthcare relating to diabetes, and to control and lower the long-term medical cost relating to this disease.

85 Del. Laws, c. 453, § 1

§ 3002T. The Delaware Diabetic Wellness Pilot Program is established [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

The Delaware Diabetic Wellness Pilot Program (Pilot Program) is established and shall be administered by the Secretary of the Department of Health and Social Services (DHSS), who must work with the Delaware healthcare system and physicians in partnership with technology/technologies companies, selected by the Secretary, to deliver focused and targeted healthcare protocols to a measurable volunteer group of patients that are diabetic meeting the specified criteria for admittance to this program and their physicians.

85 Del. Laws, c. 453, § 1

§ 3003T. Purpose [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

(a) The purpose of this Delaware Diabetic Wellness Pilot Program (Pilot Program) is to measure the impact of changing healthcare from being reactive “sick care” to being proactive “well care” by studying diabetic healthcare recipients in an observational study employing a measure and manage system. The Pilot Program will establish baseline health data for each participant through physician-led laboratory testing. Comparative laboratory studies will be completed at regular intervals to monitor progress and compare values. Additionally, utilizing a technology that will in real time measure and monitor blood glucose while tracking other diabetes related metrics embedded within the technology will provide the most up to date individually specific health monitoring tailored to each participant, in effect creating personalized medicine.

(b) The Pilot Program will allow physician led healthcare teams of providers to utilize sophisticated technology to suggest food content measurement and portion control recommendations, suggested dietary modifications, and supplement recommendations. Dietary counseling by specially trained dieticians and diabetic care coordinators will enable the patients to be closely monitored and counseled for lifestyle changes such as reducing highly processed foods, and offer real time advice and mitigation strategies as provided by a continuous glucose monitoring system “CGM” to include a functional application that provides real time guidance to the patient on patient food and food combination choices and to include technology that alerts patients when blood sugar levels rise or fall below norms established by the healthcare team. The selected CGM/app system must be compatible to synch with healthcare team medical records for diabetic patient care coordinators to monitor real time changes. Additionally, other technologies may be included as deemed valuable by the healthcare team after consultation with the Department of Health and Social Services and approved by the secretary.

(c) When seasonally available, fresh whole foods will be marketed by the Delaware Department of Agriculture’s Delaware Grown brand initiative, assisting patients in selecting farmers markets, farm stands, or retail outlets to source specific whole foods locally grown to integrate into their diet.

85 Del. Laws, c. 453, § 1

§ § 3004T. Request for proposals; process to enlist volunteers for program [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

(a) The Secretary shall develop a request for proposals (RFP) from technology providers and others as needed and shall list specifications listed within the requirements for the Delaware Diabetic Wellness Pilot Program (Pilot Program) needed to comply with this program. Additionally, the Secretary shall coordinate with the Delaware Health Information Network (DHIN) and the local Delaware medical system selected to develop a process to enlist the voluntary participation of at least 400 but no more than 500 participants into this Pilot Program. In recruiting volunteer participants, the Secretary shall make a reasonable effort to work to guarantee that the enrolled patient population reflects the racial, ethnic, socioeconomic, geographic, age, and gender diversity of Delawareans living with type 2 diabetes, consistent with available epidemiological data on diabetes prevalence across demographic groups in the State. DHIN will coordinate with the Delaware medical system to compile statistics on 2 distinct groups of patients with type 2 diabetes: volunteers who participate in the Pillot Program, and a group of no less than 200 deidentified type 2 diabetic patients exhibiting similar demographic characteristics as those participating in the Pilot Program. These patients will remain deidentified but tracked and reported for comparison of progress and outcomes to the patients in the Pilot Program by DHIN.

Additionally, the physician-led healthcare team for each accepted volunteer patient also will be enlisted to assist the monitoring and reporting of information needed for the Pilot Program and the development of an individualized healthcare plan for each patient in the Pilot Program. This will include patient care coordinators and dieticians specifically trained in requirements for this Pilot Program.

(b) All information made available to the Pilot Program must be in compliance with the Health Insurance Portability and Accountability Act (HIPAA) [P.L. 104-191].

(c) If the process under subsection (a) of this section fails to produce at least 400 volunteer patients, the Secretary may open this Pilot Program to healthcare plans to provide qualified Delaware volunteer patients and their physicians.

85 Del. Laws, c. 453, § 1

§ 3005T. Baseline healthcare data [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

(a) As this program is designed to change “sick care” to “well care” for diabetic enrollees, and it is critical the RFP list in detail the following: At the beginning of a patient’s enrollment into this Delaware Diabetic Wellness Pilot Program (Pilot Program), their physician led healthcare team must establish baseline health data through testing protocols and metrics, and utilizing a technology individually tailored to each patient.

(b) At the Pilot Program outset, every 3 months the baseline data must be compared to the current real-time data to measure the effectiveness of each patient’s individual healthcare management plan. Laboratory testing will initially be repeated every 6 months. As the results are compared to previous data points, adjustments in patient medications, diet, exercise, and sleep patterns will be considered.

85 Del. Laws, c. 453, § 1

§ 3006T. Individual healthcare management plan [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

The physician-led healthcare team for each patient participating in this Delaware Diabetic Wellness Pilot Program (Pilot Program) must establish an individualized healthcare management plan for their patients. Admission to the program will be limited to those patients with a hemoglobin A1c range including 6.5% to 10.0%. This plan must, at a minimum, assess the following: weight: overweight or obese; diagnosis of diabetes; assess blood pressure control; asses blood lipids; assess cardiovascular health and measuring: waist circumference, fasting glucose, blood pressure, fasting insulin level, hemoglobin Alc, lipid panel to include: total cholesterol, HDL, LDL, cholesterol to triglyceride/HDL cholesterol ratio level, high sensitivity C reactive protein, vitamin D level, urine albumin to creatinine ratio (UACR), vitamin B levels for patients on Melformin, and magnesium level. Any RFP must specify these tests. Additionally, initial and regular consultation with dieticians who have completed topic appropriate lifestyle medicine training related to diet and food consumption will be integrated in an individual basis as directed by the physician-led healthcare team. Also tabulated and tracked, will be the number of primary care, specialty care, and emergency department/urgent care visits, and planned and unplanned hospitalizations.

All members of the healthcare team will be required to participate in lifestyle/functional continuing medical education (CME) to familiarize with the protocol requirements of this Pilot Program. The leaders of the Delaware healthcare system will specify course topics necessary to fulfill the education requirement.

85 Del. Laws, c. 453, § 1

§ § 3007T. Control group [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

For comparison purposes, the request for proposals will specify data collection compiled and analyzed by the Delaware Health Information Network that will identify a comparable-sized group of patients that are not in the study, whose data would remain deidentified.

85 Del. Laws, c. 453, § 1

§ 3008T. Delaware Health Information Network (DHIN) reports [For application and expiration of this chapter upon fulfillment of contingency, see 85 Del. Laws, c. 453, §§ 2, 4].

DHIN will report to the Secretary, the Governor, and the General Assembly the summary results from this study every 6 months after the implementation date until the final report is submitted.

85 Del. Laws, c. 453, § 1

85 Del. Laws, c. 453, § 1