AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE DELAWARE DIABETES WELLNESS PILOT PROGRAM WITHIN THE DEPARTMENT OF HEALTH AND SOCIAL SERVICES TO STUDY DIABETIC WELL CARE.

Legislation Document

SPONSOR:

Rep. Hilovsky & Rep. Berry & Rep. Burns & Sen. Seigfried & Sen. Pettyjohn

Reps. Collins, Dukes, K. Johnson, Michael Smith, Snyder-Hall, Chukwuocha, Jones Giltner, Postles; Sens. Buckson, Richardson, Wilson

HOUSE OF REPRESENTATIVES

153rd GENERAL ASSEMBLY

HOUSE BILL NO. 305

AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE DELAWARE DIABETES WELLNESS PILOT PROGRAM WITHIN THE DEPARTMENT OF HEALTH AND SOCIAL SERVICES TO STUDY DIABETIC WELL CARE.

WHEREAS,

the United States spends $4.3 trillion each year on health care, and last year, nearly 40% of the Delaware budget was spent on healthcare, rising $200 million year over year; and

WHEREAS, direct U.S. costs per year for diabetes alone is $413 billion making diabetes the costliest disease in our country, and 24% of Delaware’s healthcare expense annually, and 48% - 64% of lifetime medical costs for a diabetic are for complications related to heart disease and stroke; and

WHEREAS, in Delaware, the cost of diabetes care has exceeded $1.1 billion each year for the past 3 years, and this cost is unsustainable; and

WHEREAS, according to research, the lifetime excess medical spending for people with diabetes can be substantial. For example, if diagnosed at age 40, the additional lifetime medical spending is estimated to be $125,000 - $211,000; and

WHEREAS, reversing Type 2 diabetes could lead to significant savings and a recent study suggests if just 47.7% of cases of Type 2 diabetes nationwide were reversed, the savings in subsequent years could total roughly $137 billion annually, and

WHEREAS, nearly 40% of Delawareans are obese, and 34% are classified as overweight, and as obesity increases the risk of chronic diseases and other health problems including: diabetes, heart disease, stroke, high blood pressure, high cholesterol, kidney, liver, gall bladder disease, sleep apnea, joint problems, and infertility; and

WHEREAS, nearly 28% of all Delawareans have diabetes or prediabetes, and according to the Centers for Disease Control and Prevention (CDC), more than 8 of 10 adults nationally have prediabetes and are not aware of their condition, and those with diabetes often have related co-morbidities, related metabolic syndrome such as: hypertension, abnormal cholesterol or triglyceride levels, heart disease, and stroke; and

WHEREAS, data supports other maladies like atherosclerosis, neuropathy, retinal changes leading to vision changes or blindness, and Alzheimer’s disease are also associated complications caused by diabetes; and

WHEREAS, of employees and dependents enrolled in the Delaware Group Health Insurance Plan, nearly 80% with diabetes have multiple secondary diseases (co-morbidities) directly related to their diabetes diagnosis; and

WHEREAS, new costly lifelong medicines are now being marketed and prescribed to fight the effects of diabetes in children as well as adults, with costs starting at $800 per month and higher; the minimum cost for these classes of medicines alone is $9,600 per patient per year, and medications, while costly, may also have significant side effects such as muscle wasting that can cause complications such as fracture risks in the elderly, especially females, brain fog, inflammation of the pancreas, and other complications indicating these medications are not a panacea; and

WHEREAS, the healthcare expenses for prediabetes and diabetes patients averages 2.3 – 3 times higher than for a person without diabetes/prediabetes; and according to a CDC study last reviewed in 2024, type 2 diabetes diagnosed at the age of 50 shortened life expectancy by an average of 5–6 years; and

WHEREAS, according to a University of Eastern Finland study of 1.5 million patients, diabetes diagnosed at the age of 40, reduced potential life years by about 10 years, and diabetes diagnosed in the 30’s meant an average reduction in life expectancy of approximately 13–14 years and the comparison was based on the overall life expectancy by age group calculated for both the European Union and US populations; and

WHEREAS, the CDC also confirms lifestyle changes can extend the life of a diabetic by 3 years, and in some, up to 10 years; and

WHEREAS, Delaware health care spending continues to grow at an alarming rate, even a modest 5% shift in carefully measured and managed diabetic health metrics in patients has the potential to decrease health care spending on diabetes and metabolic syndrome, significantly, likely millions of dollars per year; and

WHEREAS, dietary changes to support healthy eating habits using whole foods or minimally processed foods, sugar reduction, carbohydrate reduction, increasing fatty fish, increased movement throughout the day with mild to moderate exercise, while maintaining good sleep habits, make it possible to fully reverse or reduce the severity of many Type 2 diabetes patients, and therefore the depth and severity of related diseases; and

WHEREAS, it is now possible with technology to help patients measure and manage food consumption; and,

WHEREAS, diabetes and metabolic syndrome are more prevalent with age, with nearly 24% of Delawareans aged 65 and older having diabetes, followed by ages 55 – 64 with a diabetes percentage of greater than 19%, and all age groups have shown an increase in diabetes; and

WHEREAS, in the Medicare population, the cost of diseases associated with diabetes and heart disease continue to increase at an unsustainable pace: most recently costing $5,876 per year per resident, and chronic kidney disease likely associated with diabetes additionally costs an estimated $38,000 per year, and

WHEREAS, recent attempts to improve the health and wellness of Delaware residents with diabetes and related diseases have largely not been effective and medical care costs continue to rise; and

WHEREAS, therefore, new innovative solutions to the diabetes and related metabolic health crises must be explored.

NOW, THEREFORE:

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Title 16 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

Chapter 21A. Diabetes Wellness Act Pilot Program.

§ 2101A. Intent.

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.

§ 2102A. The Delaware Diabetic Wellness Pilot Program is established.

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.

§ 2103A. Purpose.

(a) The purpose of this 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 DHSS 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.

§ 2104A. Request for proposals; process to enlist volunteers for program.

(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 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. 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).

(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.

§ 2105A. Baseline healthcare data.

(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 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.

§ 2106A. Individual healthcare management plan.

The physician-led healthcare team for each patient participating in this 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.

§ 2107A. Control Group.

For comparison purposes, the RFP will specify data collection compiled and analyzed by DHIN that will identify a comparable-sized group of patients that are not in the study, whose data would remain deidentified.

§ 2108A. Delaware Health Information Network (DHIN) Reports.

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.

Section 2. This Act shall be effective immediately and shall be implemented 90 days after the Secretary gives notice published in the Register of Regulations that the Secretary has selected the technology company under § 2102A of Title 16, and at least 400 but not exceeding 500 volunteer patients have been recruited to participate in the Pilot Program.

Section 3. This Act is to be federally funded through the Federal Rural Health Transformation Program and therefore requires no fiscal note.

Section 4. The Delaware Diabetic Wellness Pilot Program established by this Act shall sunset 3 years after its implementation date unless otherwise extended by act of the General Assembly. DHIN will prepare and submit a report detailing the progress of the Pilot Program after the first 6 months from the start of the program, and every 6 months thereafter to closely monitor patient health metrics progress as compared to the control group and cost savings to the state. If at any time during the study the results are significantly positive, the Secretary can discontinue the study and expand the program to benefit more Delawareans. The Secretary, with analysis of collected metrics, will determine, with consultation of the Sunset Committee, whether to continue or expand the Pilot Program. All reports will be sent to the Secretary of DHSS, the Governor, the Secretary of the Senate for distribution to all Senators, the Chief Clerk of the House of Representatives for distribution to all Representatives, the Director and Librarian of the Division of Legislative Services, and the Director of the Delaware Public Archives.

SYNOPSIS

This Act provides a roadmap via an observational study on a small but representative group of diabetic patients to change standard healthcare from current reactive “sick care” to proactive “well care”. This will be accomplished by using a Delaware health system combined with a technology partner to regularly test, measure and manage, and incentivize diabetic patients and their providers to improve the health outcomes for Delawareans and drive down healthcare costs. The length of the observational study will be 3 years. During that time, data analysis will track results to determine if this Pilot Program shall be renewed and expanded.

This Act requires no fiscal note in that this Pilot Program is to be federally funded through the Federal Rural Health Transformation Program.