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Delaware General Assembly· HB 305Signed

Diabetes Study/Sick Care to Well Care, the official text

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SPONSOR: Rep. Hilovsky & Rep. Berry & Rep. Burns &
                                                                                  Sen. Seigfried & Sen. Pettyjohn
                                                                                  Reps. Collins, Dukes, K. Johnson, Michael Smith,
                                                                                  Snyder-Hall, Chukwuocha, Jones Giltner, Postles, Cooke,
                                                                                  Yearick, Lambert; Sens. Buckson, Richardson, Wilson,
                                                                                  Hansen, Brown, Cruce, Hocker, Hoffner, Huxtable,
                                                                                  Lawson, Lockman, Mantzavinos, Paradee, Pinkney,
                                                                                  Poore, Sokola, Sturgeon, Townsend, Walsh

                                   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.

1   WHEREAS, the United States spends $4.3 trillion each year on health care, and last year, nearly 40% of the

2 Delaware budget was spent on healthcare, rising $200 million year over year; and

3   WHEREAS, direct U.S. costs per year for diabetes alone is $413 billion making diabetes the costliest disease in

4 our country, and 24% of Delaware’s healthcare expense annually, and 48% - 64% of lifetime medical costs for a diabetic

5 are for complications related to heart disease and stroke; and

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

7 this cost is unsustainable; and

8   WHEREAS, according to research, the lifetime excess medical spending for people with diabetes can be

9 substantial. For example, if diagnosed at age 40, the additional lifetime medical spending is estimated to be $125,000 -

10 $211,000; and

11  WHEREAS, reversing Type 2 diabetes could lead to significant savings and a recent study suggests if just 47.7%

12 of cases of Type 2 diabetes nationwide were reversed, the savings in subsequent years could total roughly $137 billion

13 annually, and

14  WHEREAS, nearly 40% of Delawareans are obese, and 34% are classified as overweight, and as obesity increases

15 the risk of chronic diseases and other health problems including: diabetes, heart disease, stroke, high blood pressure, high

16 cholesterol, kidney, liver, gall bladder disease, sleep apnea, joint problems, and infertility; and

17  WHEREAS, nearly 28% of all Delawareans have diabetes or prediabetes, and according to the Centers for Disease

18 Control and Prevention (CDC), more than 8 of 10 adults nationally have prediabetes and are not aware of their condition,

19 and those with diabetes often have related co-morbidities, related metabolic syndrome such as: hypertension, abnormal

20 cholesterol or triglyceride levels, heart disease, and stroke; and

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21  WHEREAS, data supports other maladies like atherosclerosis, neuropathy, retinal changes leading to vision

22 changes or blindness, and Alzheimer’s disease are also associated complications caused by diabetes; and

23  WHEREAS, of employees and dependents enrolled in the Delaware Group Health Insurance Plan, nearly 80%

24 with diabetes have multiple secondary diseases (co-morbidities) directly related to their diabetes diagnosis; and

25  WHEREAS, new costly lifelong medicines are now being marketed and prescribed to fight the effects of diabetes

26 in children as well as adults, with costs starting at $800 per month and higher; the minimum cost for these classes of

27 medicines alone is $9,600 per patient per year, and medications, while costly, may also have significant side effects such as

28 muscle wasting that can cause complications such as fracture risks in the elderly, especially females, brain fog,

29 inflammation of the pancreas, and other complications indicating these medications are not a panacea; and

30  WHEREAS, the healthcare expenses for prediabetes and diabetes patients averages 2.3 – 3 times higher than for a

31 person without diabetes/prediabetes; and according to a CDC study last reviewed in 2024, type 2 diabetes diagnosed at the

32 age of 50 shortened life expectancy by an average of 5–6 years; and

33  WHEREAS, according to a University of Eastern Finland study of 1.5 million patients, diabetes diagnosed at the

34 age of 40, reduced potential life years by about 10 years, and diabetes diagnosed in the 30’s meant an average reduction in

35 life expectancy of approximately 13–14 years and the comparison was based on the overall life expectancy by age group

36 calculated for both the European Union and US populations; and

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

38 to 10 years; and

39  WHEREAS, Delaware health care spending continues to grow at an alarming rate, even a modest 5% shift in

40 carefully measured and managed diabetic health metrics in patients has the potential to decrease health care spending on

41 diabetes and metabolic syndrome, significantly, likely millions of dollars per year; and

42  WHEREAS, dietary changes to support healthy eating habits using whole foods or minimally processed foods,

43 sugar reduction, carbohydrate reduction, increasing fatty fish, increased movement throughout the day with mild to

44 moderate exercise, while maintaining good sleep habits, make it possible to fully reverse or reduce the severity of many

45 Type 2 diabetes patients, and therefore the depth and severity of related diseases; and

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

47  WHEREAS, diabetes and metabolic syndrome are more prevalent with age, with nearly 24% of Delawareans aged

48 65 and older having diabetes, followed by ages 55 – 64 with a diabetes percentage of greater than 19%, and all age groups

49 have shown an increase in diabetes; and

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50  WHEREAS, in the Medicare population, the cost of diseases associated with diabetes and heart disease continue to

51 increase at an unsustainable pace: most recently costing $5,876 per year per resident, and chronic kidney disease likely

52 associated with diabetes additionally costs an estimated $38,000 per year, and

53  WHEREAS, recent attempts to improve the health and wellness of Delaware residents with diabetes and related

54 diseases have largely not been effective and medical care costs continue to rise; and

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

56 explored.

57  NOW, THEREFORE:

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

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

60 shown by underline as follows:

61  Chapter 21A. Diabetes Wellness Act Pilot Program.

62  § 2101A. Intent.

63  It is the intent of the General Assembly to improve the health and wellness of the residents of Delaware with

64 diabetes, and related metabolic disease. Accordingly, there is a need to explore and find ways to improve healthcare relating

65 to diabetes, and to control and lower the long-term medical cost relating to this disease.

66  § 2102A. The Delaware Diabetic Wellness Pilot Program is established.

67  The Delaware Diabetic Wellness Pilot Program (Pilot Program) is established and shall be administered by the

68 Secretary of the Department of Health and Social Services (DHSS), who must work with the Delaware healthcare system

69 and physicians in partnership with technology/technologies companies, selected by the Secretary, to deliver focused and

70 targeted healthcare protocols to a measurable volunteer group of patients that are diabetic meeting the specified criteria for

71 admittance to this program and their physicians.

72  § 2103A. Purpose.

73  (a) The purpose of this Pilot Program is to measure the impact of changing healthcare from being reactive “sick

74 care” to being proactive “well care” by studying diabetic healthcare recipients in an observational study employing a

75 measure and manage system. The Pilot Program will establish baseline health data for each participant through physician-

76 led laboratory testing. Comparative laboratory studies will be completed at regular intervals to monitor progress and

77 compare values. Additionally, utilizing a technology that will in real time measure and monitor blood glucose while

78 tracking other diabetes related metrics embedded within the technology will provide the most up to date individually

79 specific health monitoring tailored to each participant, in effect creating personalized medicine.

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80   (b) The Pilot Program will allow physician led healthcare teams of providers to utilize sophisticated technology to

81 suggest food content measurement and portion control recommendations, suggested dietary modifications, and supplement

82 recommendations. Dietary counseling by specially trained dieticians and diabetic care coordinators will enable the patients

83 to be closely monitored and counseled for lifestyle changes such as reducing highly processed foods, and offer real time

84 advice and mitigation strategies as provided by a continuous glucose monitoring system “CGM” to include a functional

85 application that provides real time guidance to the patient on patient food and food combination choices and to include

86 technology that alerts patients when blood sugar levels rise or fall below norms established by the healthcare team. The

87 selected CGM/app system must be compatible to synch with healthcare team medical records for Diabetic Patient Care

88 Coordinators to monitor real time changes. Additionally, other technologies may be included as deemed valuable by the

89 healthcare team after consultation with DHSS and approved by the secretary..

90   (c) When seasonally available, fresh whole foods will be marketed by the Delaware Department of Agriculture’s

91 Delaware Grown brand initiative, assisting patients in selecting farmers markets, farm stands, or retail outlets to source

92 specific whole foods locally grown to integrate into their diet.

93   § 2104A. Request for proposals; process to enlist volunteers for program.

94   (a) The Secretary shall develop a request for proposals (RFP) from technology providers and others as needed and

95 shall list specifications listed within the requirements for the Pilot Program needed to comply with this program.

96 Additionally, the Secretary shall coordinate with the Delaware Health Information Network (DHIN) and the local Delaware

97 medical system selected to develop a process to enlist the voluntary participation of at least 400 but no more than 500

98 participants into this Pilot Program. DHIN will coordinate with the Delaware medical system to compile statistics on 2

99 distinct groups of patients with Type 2 Diabetes: volunteers who participate in the Pillot Program, and a group of no less

100 than 200 deidentified Type 2 diabetic patients exhibiting similar demographic characteristics as those participating in the

101 Pilot Program. These patients will remain deidentified but tracked and reported for comparison of progress and outcomes

102 to the patients in the Pilot Program by DHIN.

103  Additionally, the physician-led healthcare team for each accepted volunteer patient also will be enlisted to assist

104 the monitoring and reporting of information needed for the Pilot Program and the development of an individualized

105 healthcare plan for each patient in the Pilot Program. This will include patient care coordinators and dieticians specifically

106 trained in requirements for this Pilot Program.

107  (b) All information made available to the Pilot Program must be in compliance with the Health Insurance

108 Portability and Accountability Act (HIPAA).

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109  (c) If the process under subsection (a) of this section fails to produce at least 400 volunteer patients, the Secretary

110 may open this Pilot Program to healthcare plans to provide qualified Delaware volunteer patients and their physicians.

111  § 2105A. Baseline healthcare data.

112  (a) As this program is designed to change “sick care” to “well care” for diabetic enrollees, and it is critical the RFP

113 list in detail the following: At the beginning of a patient’s enrollment into this Pilot Program, their physician led healthcare

114 team must establish baseline health data through testing protocols and metrics, and utilizing a technology individually

115 tailored to each patient.

116  (b) At the Pilot Program outset, every 3 months the baseline data must be compared to the current real-time data to

117 measure the effectiveness of each patient’s individual healthcare management plan. Laboratory testing will initially be

118 repeated every 6 months. As the results are compared to previous data points, adjustments in patient medications, diet,

119 exercise, and sleep patterns will be considered.

120  § 2106A. Individual healthcare management plan.

121  The physician-led healthcare team for each patient participating in this Pilot Program must establish an

122 individualized healthcare management plan for their patients. Admission to the program will be limited to those patients

123 with a Hemoglobin A1c range including 6.5% to 10.0%. This plan must, at a minimum, assess the following: weight:

124 overweight or obese; diagnosis of diabetes; assess blood pressure control; asses blood lipids; assess cardiovascular health

125 and measuring: waist circumference, fasting glucose, blood pressure, fasting insulin level, Hemoglobin Alc, lipid panel to

126 include: total cholesterol, HDL, LDL, cholesterol to triglyceride/HDL cholesterol ratio level, high sensitivity C reactive

127 protein, vitamin D level, urine albumin to creatinine ratio (UACR), vitamin B levels for patients on Melformin, and

128 magnesium level. Any RFP must specify these tests. Additionally, initial and regular consultation with dieticians who have

129 completed topic appropriate Lifestyle Medicine training related to diet and food consumption will be integrated in an

130 individual basis as directed by the physician-led healthcare team. Also tabulated and tracked, will be the number of primary

131 care, specialty care, and Emergency Department/Urgent care visits, and planned and unplanned hospitalizations.

132  All members of the healthcare team will be required to participate in lifestyle/functional Continuing Medical

133 Education (CME) to familiarize with the protocol requirements of this Pilot Program. The leaders of the Delaware

134 healthcare system will specify course topics necessary to fulfill the education requirement.

135  § 2107A. Control Group.

136  For comparison purposes, the RFP will specify data collection compiled and analyzed by DHIN that will identify a

137 comparable-sized group of patients that are not in the study, whose data would remain deidentified.

138  § 2108A. Delaware Health Information Network (DHIN) Reports.

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139  DHIN will report to the Secretary, the Governor, and the General Assembly the summary results from this study

140 every 6 months after the implementation date until the final report is submitted.

141  Section 2. This Act shall be effective immediately and shall be implemented 90 days after the Secretary gives

142 notice published in the Register of Regulations that the Secretary has selected the technology company under § 2102A of

143 Title 16, and at least 400 but not exceeding 500 volunteer patients have been recruited to participate in the Pilot Program.

144  Section 3. This Act is to be federally funded through the Federal Rural Health Transformation Program and

145 therefore requires no fiscal note.

146  Section 4. The Delaware Diabetic Wellness Pilot Program established by this Act shall sunset 3 years after its

147 implementation date unless otherwise extended by act of the General Assembly. DHIN will prepare and submit a report

148 detailing the progress of the Pilot Program after the first 6 months from the start of the program, and every 6 months

149 thereafter to closely monitor patient health metrics progress as compared to the control group and cost savings to the state.

150 If at any time during the study the results are significantly positive, the Secretary can discontinue the study and expand the

151 program to benefit more Delawareans. The Secretary, with analysis of collected metrics, will determine, with consultation

152 of the Sunset Committee, whether to continue or expand the Pilot Program. All reports will be sent to the Secretary of

153 DHSS, the Governor, the Secretary of the Senate for distribution to all Senators, the Chief Clerk of the House of

154 Representatives for distribution to all Representatives, the Director and Librarian of the Division of Legislative Services,

155 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.

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