Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications (2021)

2021

two sugar-sweetened beverages per day, and one in ten consume three or more sugar-

sweetened beverages per day. Highest intake levels of sugar-sweetened beverages are

observed among adolescents, groups with lower socioeconomic status, and non-Hispanic

Blacks and Hispanics.^{125, 126} Among those who drink one or more sugar-sweetened

beverages, calories from sugar-sweetened beverages alone exceed the recommended

daily limit for added sugars, and often exceed 25% of total daily calories. Sugar-sweetened

beverage consumption is associated with type 2 diabetes, cardiovascular disease, and all-

cause mortality.¹²⁷ Diabetes risk resulting from sugar-sweetened beverage consumption is

a consequence not only of excess caloric intake but of unique effects of added sugars on

metabolism. Consuming one sugar-sweetened beverage per day increases the risk of type

2 diabetes by about 20%. There is an even greater risk among those who consume more

than one sugar-sweetened beverage per day.¹²⁸ In the U.S., sugar-sweetened beverage

consumption alone is projected to account for 1.8 million new cases of type 2 diabetes over

the next 10 years. The percentage of cases attributable to sugar-sweetened beverages is

much higher in low-income populations and communities of color, and sugar-sweetened

beverage consumption is a significant contributor to race/ethnicity-, education-, and

income-related disparities in diabetes.¹²⁹

While numerous public health associations and specialty medical entities have concluded

that consuming sugar-sweetened beverages contributes to type 2 diabetes, the beverage

industry has funded research and campaigns to dispute these conclusions.^130-132 Although

scientific reports have addressed the prevalence and health hazards of sugar-sweetened

beverage consumption,¹³³ the U.S. government has not issued official guidance to the

public about sugar-sweetened beverage consumption and diabetes risk. This has limited

the ability of clinicians to effectively guide their patients in the prevention and treatment

of diabetes and policy makers to address advertising, marketing, and sales of sugar-

sweetened beverages. Recommendations to reduce or eliminate sugar-sweetened

beverages from the daily diet have largely been absent from the CDC’s National DPP

curriculum in the past.¹³⁴It came to the Commission’s attention that by the time this report is

released, CDC is expected to have updated the National DPP program around the language

related to sugar sweetened beverages.

Meanwhile, many non-governmental health organizations have recommended limiting the

intake of sugar-sweetened beverages through communication campaigns, implementing

warning labels (see Background and Rationale for Recommendation 4.5a), restricting access

to sugar-sweetened beverages in schools, and/or raising the price of sugar-sweetened

beverages.¹³⁵ However, less attention has been paid to worksite sales bans. A study of a

workplace sugar-sweetened beverage sales ban by a large employer found that, among

employees who were daily sugar-sweetened beverage consumers (≥12 oz/day), mean daily

intake of sugar-sweetened beverages decreased by approximately 50% 10 months after

the ban; reductions in sugar-sweetened beverage intake correlated with improvements in

Report to Congress

waistline circumference and insulin sensitivity.¹³⁶ The intervention was also found to be cost

saving to the employer.¹³⁷ Based on the evidence, health systems around the country are

beginning to restrict sugar-sweetened beverage sales.

Additionally, increasing the price of sugar-sweetened beverages with excise taxes of as little

as one cent per ounce (about 10% of the price) has been shown to reduce sugar-sweetened

beverage consumption by 10% to 20% and raise significant revenue to fund health

promotion activities.^{138, 139} Modelling studies demonstrate that such reductions will reduce

the incidence of type 2 diabetes, especially among children, low-income individuals, and

people of color.¹²⁹ Furthermore, reductions in sugar-sweetened beverage consumption can

delay or prevent the development of diabetes complications and is cost saving to society.

Despite the health benefits of reductions in sugar-sweetened beverage consumption, the

beverage industry has consistently opposed taxation and has lobbied for state laws to make

sugar-sweetened beverage taxation unlawful at county and municipality levels.¹⁴⁰ It has

been estimated that a federal sugar-sweetened beverage tax of only one penny per ounce

would generate ~$7 billion per year.¹⁴¹ Over time, such a tax would generate at least $80

billion and save $55 billion in direct health care costs.¹⁴²

Recommendation 4.4: The National Clinical Care Commission recommends

that all relevant federal agencies promote the consumption of water and reduce

the consumption of sugar-sweetened beverages in the U.S. population, and that

they employ all the necessary tools to achieve these goals, including education,

communication, accessibility, water infrastructure, and sugar-sweetened beverage

taxation.

•

4.4a. USDA should add a symbol for drinking water to the MyPlate graphic

and increase water promotion messaging in all consumer-facing materials

issued by its Center for Nutrition Policy Promotion. Water is not currently

depicted on the USDA MyPlate.

•

4.4b. Child nutrition programs should be a conduit for education to promote

consumption of water and reduce consumption of sugar-sweetened

beverages. USDA should encourage hydrating with water instead of sugar-

sweetened beverages and provide safe water education in WIC nutrition

education and in childcare settings. Congress should harness the Child

Nutrition Reauthorization Act to strengthen existing water provisions for

school nutrition programs.

•

4.4c. HHS should commission a scientific report under the joint auspices of

the U.S. Surgeon General and include other relevant federal health agencies

to summarize and present a synthesis of the evidence regarding the causal

relationship between sugar-sweetened beverage consumption and obesity

and type 2 diabetes. The report should be authored by experts in diabetes

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2021

and clinical medicine, nutrition and metabolism, epidemiology and public

health, and health disparities; authors should be free of any conflicts of

interest related to the food and beverage industry.

•

4.4d. With additional funding, CDC, NIH, and USDA should develop and

implement a national campaign and associated materials to both promote

consumption of water and reduce consumption of sugar-sweetened

beverages as a strategy to promote overall health, including the prevention of

obesity, type 2 diabetes, and cardiovascular disease. CDC should also include

such messages across all its relevant programs.

•

4.4e. Similar to the federal tobacco tax, the U.S. Department of the Treasury

should impose an excise (not sales) tax on sugar-sweetened beverages

to cause at least a 10% to 20% increase in their shelf price. The revenues

generated should be reinvested to promote the health of those communities

that bear a disproportionate burden of type 2 diabetes (for example, promote

child nutrition and improve access to clean water in low-income communities

and communities of color). This federal sugar-sweetened beverage tax should

not pre-empt state or local authorities from levying their own additional

excise tax on sugar-sweetened beverages.

•

4.4f. All federal agencies should promote drinking water and reduce sugar-

sweetened beverage consumption within their own organizations and

through the grants and programs they fund or administer. All agencies should

increase access to free, clean, and appealing sources of drinking water for

their employees and visitors and develop procurement and other policies

that curb the availability and sale of sugar-sweetened beverages to their

employees and visitors.

•

4.4g. HHS should serve as a federal model by (a) ensuring onsite access to

safe, clean, and appealing drinking water; (b) restricting the sale of sugar-

sweetened beverages in HHS-owned or HHS-leased offices, workplaces, and

health care facilities; and (c) measuring the impact of these interventions

on employee behavior and diabetes-related outcomes through voluntary

participation in an evaluation of the model.

•

4.4h. The Office of the U.S. Trade Representative should ensure that all

international trade agreements allow for the taxation of sugar-sweetened

beverages and front-of-package health advisory labels and icons (see also

Recommendation 4.5).

Report to Congress

Patient Testimonial

--Carmen George MS, Community Outreach and Patient

Empowerment, Navajo Nation

“Working in Navajo communities in the public health

field with COPE (Community Outreach and Patient

Empowerment), our vision and hope is to enable people to

live healthier lives. This often begins with increasing access

and availability of healthy foods and healthy beverages. As

we know, diabetes rates in many indigenous communities

are sky high. Several Navajo Nation communities have

shared with us that the water quality and water access on

the reservation is a major concern and barrier to leading a

healthier lifestyle. There is a history of uranium mining here

that has contaminated many water sources. We are

working hard to turn this around and promote the

consumption of water instead of sugary drinks. By

addressing this underlying issue, Navajo people

will have access to choose healthy food and clean,

safe water to reduce the burden of diabetes.”

Department of Health and Human Services

2021

Focus Area 5. Enhance FDA’s Role in Preventing and Controlling

Diabetes Through New Labeling and Claim Requirements

Background and Rationale

The general public, especially those of lower educational and income status who are at

greater risk for type 2 diabetes and diabetes complications, is frequently misinformed

about the nutritional value and health risk of foods and beverages,¹⁴³ especially processed

and packaged foods. Current labeling regulations are inadequate to identify risk and allow

individuals to reduce their consumption of foods and beverages that can lead to a higher

burden of diabetes and other cardiometabolic diseases. Inaccurate marketing claims about

the health benefits of products, combined with a federal nutrition label that requires high

levels of scientific numeracy and health literacy to be understood, poses challenges for

many consumers when it comes to protecting their own and their families’ health.¹⁴⁴ The fact

that many Americans are uncertain as to which foods increase diabetes risk has contributed

to the disease burden, making the work of other federal health agencies (for example,

CDC, CMS, and Health Resources and Services Administration [HRSA]) more challenging

and more costly.

Evidence from around the globe suggests that food and beverage labeling that is

clearer, more direct, and more compelling than that required by FDA can improve dietary

quality at individual and population levels.^145-147 This is due to both changes in consumer

purchase patterns and product reformulations by industry. In addition, to fulfill FDA’s goal

of supporting informed consumer decision making, the agency should ensure that food

labels are truthful, not misleading, and provide clarity for consumers seeking a healthy diet.

For example, FDA should enhance regulations to ensure that objective, science-based

standards are used when products use the term “whole grain.”¹⁴⁸ New standards of identity,

nutrition labeling, and claim allowances for so-called toddler drinks (“toddler milks” and

“transition formulas”) are needed to prohibit the use of misleading terms such as “milk” and

“formula” and “recommended” or “necessary” for these products. FDA should also mandate

scientific evidence for all health claims and require disclaimers that such products are not

intended for children younger than 12 months or as a substitute for breastmilk or infant

formula.^{149, 150} Additionally, a new requirement around the inclusion of “added sugars” is

needed; specifically, “added sugars” should be added to the existing regulation that

disqualifies the use of health claims or qualified health claims if a product contains excess

levels of total fat, saturated fat, cholesterol, or sodium. This rule should also apply to

nutrient content claims.¹⁴⁴

Recommendation 4.5: The National Clinical Care Commission recommends that the

U.S. Food and Drug Administration (FDA) improve its food and beverage labeling

regulations that influence both food and beverage industry practices and consumer

behavior to better prevent and control diabetes.

Report to Congress

•

4.5a. Congress should authorize FDA to implement a new national,

compulsory, uniform, simple, easily recognizable and understandable front-of-

package icon system that alerts consumers to the health attributes and health

risks of food and beverage products based on their ingredients. The front-of-

package icon/warning system should be informed by evidence accrued from

existing epidemiological, clinical, and nutritional sciences, and its design

should be informed by health communication science.

•

4.5b. In communicating added sugar content contained in products in the

revised Nutrition Facts Label (and in the Recommended Daily Allowance),

FDA should use teaspoon units in addition to grams to enable consumers to

estimate their added sugar intake relative to daily limits.

•

4.5c. FDA should implement a robust, multilingual communication campaign

to improve awareness of the new labeling on added sugar and the rationale

for the labeling (highlighting the potential harms of consuming excess added

sugars).

•

4.5d. FDA should update its policies and regulations to prevent industry

claims on food and beverage products that mislead U.S. consumers to believe

that unhealthy foods are healthy.

Focus Area 6. Restrict Commercial Advertising and Marketing of

Unhealthy Foods and Beverages to Children Younger Than 13

Years of Age

Background and Rationale

Over the last decade, rates of type 2 diabetes have been exploding among U.S. youth

of color, with rates tripling among certain Native American tribal youth, doubling among

Black youth, and increasing up to 50% among Latinx and Asian/Pacific Islander youth.¹⁰²

The expansion of the type 2 diabetes epidemic into children and adolescents in large part

is a result of a food environment that increasingly promotes unhealthy dietary patterns. The

unfettered advertising and marketing of what is commonly described as “junk food” (high-

calorie, high-sugar, high-sodium, nutrient-poor foods) and beverages to children through

television, film, social media, and other internet platforms, including marketing campaigns

targeting children of color, have been shown to be significant drivers of the consumption

of unhealthy foods and beverages among children.¹⁵¹ Children under the age of 13 are

especially vulnerable to marketing and advertising and lack the critical skills to detect if and

when they are being deceived.¹⁵²

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2021

A number of countries have instituted regulations and/or bans related to the marketing of

unhealthy food to children in their efforts to prevent type 2 diabetes in younger people.

These strategies have been shown to significantly reduce children’s exposure to unhealthy

food advertisements and consumption of sugar-sweetened beverages.¹⁴⁶

Extensive work by FTC over a decade ago, in collaboration with other agencies, examined

the industry practices that were contributing to the obesity and type 2 diabetes epidemics

in children and adolescents. FTC was subsequently not empowered to regulate the

practices of advertisers or their communication platforms to protect children.¹⁵² Specifically,

FTC was not allowed to create guidelines or promulgate regulations through notice-

and-comment rulemaking regarding food and beverage advertising to children; restrict

commercial advertising and marketing to children by advertisers, communication networks,

and online platforms of those foods and beverages that contribute to unhealthy dietary

patterns (calorie-dense and nutrient-poor foods and beverages, as defined by U.S. Dietary

Guidelines); or monitor the practices of food and beverage advertisers, and any associated

communication networks and online platforms, by routinely accessing marketing and

advertising information. The food and beverage industry’s commitment to self-regulate what

and how it markets to children is widely acknowledged to have failed to reverse or change

these marketing practices or children’s diets.¹⁵³

Recommendation 4.6: The National Clinical Care Commission recommends that

the Federal Trade Commission—in order to prevent children’s exposure to, and

consumption of, calorie-dense and nutrient-poor foods and beverages that can lead

to obesity and type 2 diabetes—be provided the authority, mandate, and requisite

resources to (a) create guidelines and rules regarding the marketing and advertising

practices of the food and beverage industry and associated communication networks

and platforms targeted to children younger than 13 years old, (b) restrict industry

practices based on these rules, (c) fully monitor these practices, and (d) enforce such

rules.

Report to Congress

Patient Testimonial

-- Monteil Lee, aka Telly Mac, a 39-year-old rap artist with

diabetes and a history of an amputation

“When I was younger, the beverage companies and their

ads made me want to chase sugar. That big glass jug with

a big smile made from the sugary drink mix -- it kind of

inspired me as a kid. They tricked me into thinking that if

I drank it, I’d be happy too. I just had to have it. But that’s

not right. They shouldn’t be tricking kids to drink stuff that

can make them sick later on. I suffered an amputation from

diabetes when I was 37 years old, so I know how this goes

down.

Anything that can make these sugary drinks less accessible to people is a good thing in my

book. Right now, they’re cheap, they market them like crazy, and they’re everywhere in my

neighborhood. No doubt a tax would make folks less likely to buy them. That would not only

keep people healthy but would leave them more money in their pockets to spend on the

good things in life, instead of having to spend it on diabetes medications or syringes.”

Department of Health and Human Services

2021

Focus Area 7. Further Promote and Support Breastfeeding to

Reduce the Risk of Diabetes Among Mothers and Their Children

Background and Rationale

Breastfeeding has long been recognized as providing short-term health benefits for babies

and mothers. Growing evidence supports breastfeeding as having long-term benefits.

Maternal breastfeeding is independently associated with lower odds of type 1 diabetes

and lower odds of obesity in the offspring, an important risk factor for type 2 diabetes.

Breastfeeding also generates health benefits for the mother that may persist for decades.

Women who breastfeed enjoy a 30% reduction in the risk of developing diabetes and a

lower risk of cardiovascular disease, hypertension, and breast and ovarian cancer.¹⁵⁴ These

benefits are associated with greater breastfeeding intensity (proportion of infant feedings

from breast milk) and duration of breastfeeding with an apparent threshold at six months’

duration.

Over the past 10 years, effective breastfeeding promotion policies and programs at federal,

state, and community levels have been guided by strategies outlined in the 2011 Surgeon

General’s Call to Action to support breastfeeding. These policies and programs have helped

improve overall breastfeeding rates. One example is the federal Special Supplemental

Nutrition Program for WIC, which serves more than half of the infants born in the U.S. WIC

works to ensure that mothers and families who utilize its services understand the benefits

of breastfeeding and receive the support they need to achieve their breastfeeding goals.

WIC provides several different types of breastfeeding support, including access to trained

breastfeeding staff, the WIC Peer Counseling Program, free classes on newborn behavior

and breastfeeding, and the provision of breast pumps for mothers returning to school or

work.

Currently, four of five U.S. mothers begin breastfeeding at the birth of their infant; however,

the proportion who breastfeed quickly declines such that fewer than half of infants are

exclusively breastfed at three months of age.^{155, 156} Moreover, there are marked racial and

ethnic, socioeconomic, geographic, and occupation-related disparities in breastfeeding

initiation and duration.¹⁵⁷ These factors must be addressed to ensure that all mothers

and families have the opportunity to reach their breastfeeding goals and experience the

potential long-term health benefits, including reduced risk of diabetes.

A leading reason for mothers, and particularly low-income mothers, to stop breastfeeding

is the need to return to work. While the work environment has improved for lactating

mothers, a recent CDC study found that only about half of worksites offer lactation support

for breastfeeding mothers.^{155, 158} Research has demonstrated that paid maternity leave for

Report to Congress

at least three months is positively associated with breastfeeding duration, with women who

return to work at or after 13 weeks have two to three times higher odds of breastfeeding

beyond three months¹⁵⁹ and nearly two-fold greater odds of breastfeeding for at least six

months.

Recommendation 4.7: The National Clinical Care Commission recommends that

federal agencies promote and support breastfeeding to (a) increase breastfeeding

rates, (b) enhance the intensity and duration of breastfeeding among mothers who

breastfeed, and (c) reduce disparities in breastfeeding rates, duration, and intensity.

Additional funding should be provided for federal programs that promote and

support breastfeeding to overcome persistent societal and employment-based

obstacles to breastfeeding.

•

4.7a: Provide additional funding for successful programs that promote and

support breastfeeding, including USDA’s Food Nutrition Service (FNS) WIC

Peer Counselor programs; HRSA Maternal and Child Health Bureau’s Healthy

Start program and the Maternal, Infant, and Early Childhood Home Visiting

Program; and CDC’s Maternity Practices in Infant Nutrition and Care and

Breastfeeding Report Card.

•

4.7b: The Department of Labor should

◊ Expand existing federal protections for mothers in the workplace

including mothers covered under the Fair Labor Standards Act (non-

salaried employees) as well as those who are not covered under the

Fair Labor Standards Act (salaried employees).

◊ Develop and disseminate resources to help employers comply with

federal law requiring them to provide the time and a place for nursing

mothers to express breast milk.

◊ Implement a monitoring system to ensure that employers are

complying with federal law requiring that they implement lactation

support programs.

•

4.7c: NIH, the Agency for Healthcare Research and Quality, the Center for

Medicare and Medicaid Innovation, USDA, and other federal agencies should

support community-based and community-informed demonstration projects

and research to (1) identify and evaluate the impact of effective, evidence-

based breastfeeding support interventions among minority women and

women with lower socioeconomic status; and (2) inform implementation and

scaling efforts.

Department of Health and Human Services

2021

•

4.7d: HHS should update the 2011 Surgeon General’s Call to Action to

Support Breastfeeding to reflect the current landscape of breastfeeding

research and provide updated breastfeeding policy and program guidance for

the new generation of health care providers, public health officials, women,

and families.

•

4.7e: CMS should enact and adequately fund a Medicaid incentive payment

mechanism to incentivize hospitals and facilities providing maternal and

newborn services to implement and demonstrate adherence to evidence-

based policies, practices, and procedures proven effective in both initiating

and increasing the duration of breastfeeding (for example, the Ten Steps

to Successful Breastfeeding framework developed by the World Health

Organization and the United Nations Children’s Emergency Fund [UNICEF]).

•

4.7f: Enact national maternity leave legislation to provide mothers with up to

three months of paid leave, which has been shown to both increase rates of

breastfeeding initiation and enhance the duration of breastfeeding. The paid

leave provided under this legislation would be distinct from unpaid leave

available to employees through the Family and Medical Leave Act.

Report to Congress

Patient Testimonial

--Darian Torrez, school teacher

“[I did not have a good breastfeeding experience with my

first child], solely because I had lack of knowledge. I didn’t

know that I could reach out to a lactation consultant. My

doctors at the time didn’t inform me or help me in any way,

like say you can reach out to a lactation consultant to help

you, to get you help. So I kind of felt like that was the main

reason why.

When I had my daughter five years later, it was completely

different. I mean, I knew that those resources were available.

And so, at the hospital, I made sure to have the lactation

consultant in my room whenever I needed her. And I got the help I needed if something

was wrong. I asked questions. And so I think it’s really important for those resources to be

available for women.

[About my pumping experience at work], my only option that was given was, ‘Well, I guess

you could use your lunchtime and there’s a room in the lounge that you can use to do that.’

[The room] was pretty small. It fit a chair and a little table and that was it. I told my husband

over and over, ‘It feels so weird because all of the teachers are sitting in the lounge and …

they know that I’m going to hide in this closet to pump and it just makes for a very awkward

encounter.’

That 30 minutes was just so stressful, and I think I started producing less and less milk

because I was so stressed.”

Department of Health and Human Services

2021

Focus Area 8. Improve the Ambient and Built Environments to

Prevent Type 2 Diabetes and Diabetes Complications

Background and Rationale

Attributes of the ambient and built environments are influenced by federal policies and

have substantial population-level impacts on the risk of developing type 2 diabetes and

diabetes complications. To date, however, the federal agencies and departments whose

work affects the ambient and built environments have not evaluated how their work may

influence diabetes in the U.S. and have not coordinated their efforts with other agencies

working on diabetes prevention and control.

Accumulating evidence links diabetes to ambient environmental factors such as air

pollution, water contamination, and chemicals associated with metabolic and endocrine

(hormonal) dysfunction.¹⁶⁰ Relevant pollutants and contaminants present in the air, land,

water, and/or manufactured and household products include (a) particulate matter and

nitrogen oxides in the air; (b) heavy metals (arsenic, lead, uranium) in water; (c) and

endocrine-disrupting chemicals including polychlorinated biphenyls; organochlorine

pesticides; bisphenol A, phthalates, and possibly per- and polyfluoroalkyl substances

present in plastics.^39-41 Disproportionate exposure to such environmental toxins is an

underappreciated contributor to racial, ethnic, and geographic disparities in diabetes.^42-44

With respect to the built environment, area-level attributes such as walkability, green space,

urban sprawl, physical activity resources, and active transport opportunities have also been

shown to be determinants of type 2 diabetes and diabetes complications.^31-34 In addition,

the built environments of areas and neighborhoods with higher concentrations of Latinos,

African Americans, American Indians, and low-income individuals have been shown to be

less health promoting than those with lower concentrations, a phenomenon that contributes

to disparities in diabetes and its complications. Enhancing the built environment will also

improve the ambient environment by reducing air pollution.

Recommendation 4.8: The National Clinical Care Commission recommends that all

federal agencies whose work influences the ambient (air, water, land, and chemical)

and built environments modify their policies, practices, regulations, and funding

decisions so as to lead to environmental changes to prevent and control diabetes.

•

4.8a. All federal agencies should limit the extent to which their work

contributes to individual-level and population-level exposure to

environmental pollutants and contaminants associated with diabetes and/or

diabetes complications. The Environmental Protection Agency should ensure

that environmental protections are in place to limit individual-level and

population-level exposure and implement abatement measures, prioritizing

those exposures that contribute to diabetes-related disparities.

Report to Congress

•

4.8b. All federal agencies (in particular, the U.S. Department of Transportation

and the U.S. Department of Housing and Urban Development [HUD]) should

modify their policies, practices, regulations, and funding decisions related

to the built environment to prevent diabetes and diabetes complications by

enhancing walkability, green space, physical activity resources, and active

transport opportunities. Priority should be given to those regions and projects

that could mitigate the effects of unhealthy built environments on diabetes-

related disparities.

Focus Area 9. Improve Housing Policy and Expand Smoke-Free

Policies to HUD’s Subsidized Housing

Background and Rationale

Homelessness, housing instability, and poor-quality housing pose a risk for diabetes,³⁵ and

significantly impair diabetes management among those with diabetes.^{36, 37} The federal

government currently influences housing through two of its agencies: HUD and the Internal

Revenue Service (IRS). HUD subsidizes housing through public authority-owned housing

(more than two million people), and the housing voucher program (approximately five

million people) for privately owned subsidized housing (commonly known as “Section 8

Housing”). However, fewer than one in five families (17%) eligible for public or subsidized

housing ever receive these services.¹⁶¹

IRS manages the Low-Income Housing Tax Credit Program, which gives tax credits to

developers who build low-income, subsidized, or mixed housing. States use a process

called a Qualified Allocation Plan (QAP)¹⁶² to choose which projects receive the low-income

tax credits. This process scores a project based on a set of mandatory criteria set up by IRS,

and any supplemental criteria that individual states choose to add. Currently, the mandatory

IRS criteria address the location of the property, characteristics of the population that will

move into the housing, types of properties existing on the site, and energy efficiency.

However, there are no health-related attributes in the IRS criteria.

Data suggest that housing plays an important role in clinical outcomes, and families that

need to spend more than 30% of their incomes on housing have difficulty affording food,

medications, and medical care (see Recommendation 4.1). A large, randomized trial

sponsored by HUD (Moving to Opportunity) demonstrated that moving families from public

housing in a high poverty zone to subsidized housing in a low poverty zone is associated

with lower diabetes incidence.¹⁶³

Exposure to tobacco smoke elevates the risk of type 2 diabetes and amplifies the risk of

diabetes complications (especially macrovascular complications) and death among people

with diabetes.¹⁶⁴ Diabetes prevalence is nearly twice as high among people living in public

housing (17.6%) compared to the general population (9.4%).¹⁶⁵ Smoking rates and rates of

exposure to secondhand smoke are higher among people with diabetes and prediabetes,

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2021

especially among those who are poor, have limited education, and are Black, which more

than double the odds of smoke exposure.^166-168Socioeconomic and racial/ethnic disparities

in diabetes incidence, complications, and death, arise in part due to inequitable access to

tobacco control interventions. In July 2018 HUD implemented a mandatory smoke-free

policy¹⁶⁹ that required all public housing authority-owned housing to prohibit combustible

tobacco use in indoor dwelling, indoor shared areas, and outdoor areas within 25 feet

of exits and windows. The policy includes the provision of smoking cessation services to

residents who smoke. However, this policy does not apply to multi-unit housing including

Section 8 federally subsidized housing, leaving these sites unprotected from secondhand

smoke unless residents voluntarily make their apartments smoke-free. Expanding HUD’s

smoke-free policy to federally subsidized housing units could have population-level benefits

by reducing diabetes incidence, diabetes-related complications, and diabetes-related

deaths.

Recommendation 4.9: The National Clinical Care Commission recommends that, to

reduce type 2 diabetes incidence and diabetes complications, housing opportunities

for low-income individuals and families be expanded, and that such individuals and

families be housed in health-promoting environments.

•

4.9a. The U.S. Department of Housing and Urban Development (HUD) should

expand its federal housing assistance programs to allow access for more

qualifying families, such that over a 20-year period, all that qualify can access

subsidized or public housing.

•

4.9b. The Internal Revenue Service (IRS) should further incentivize developers

to place new housing units in areas of low poverty, as data show that moving

people from areas of high poverty to low poverty favorably affects the

incidence of obesity and diabetes.

•

4.9c. The IRS should mandate that states include neighborhood health

parameters (such as availability of health care services, transportation,

employment opportunities, education opportunities, food availability, and

physical activity resources) in the required IRS Qualified Allocation Plan

criteria.

•

4.9d. IRS should establish a means to fund or subsidize the cost of embedding

health services (if needed) in housing developments to incentivize committing

space or employing unused space for such services in their plans.

•

4.9e. HUD should broaden implementation of indoor smoke-free policies to

include subsidized multi-unit housing, require multi-unit housing adopting

smoke-free policies to provide access to cessation resources (that is,

referrals to cessation resources), and in collaboration with the CDC Office

on Smoking and Health, work to align these policies with its related policies

in public housing so as to ensure that loss of housing is not an unintended

consequence.

Report to Congress

Patient Testimonial

--Ricardo Guillory, a veteran and former residential

construction worker

“I’ve had diabetes for 11 years, and for four of them I was

homeless. When I was homeless, my diabetes got so out of

control that I had to be hospitalized. My blood sugar was

over 600 and the doctor said I was one step away from a

coma.

There were so many challenges to taking care of my

diabetes when I was homeless and living in a shelter. For

one, I had no place to store my medications and no place

to keep my insulin cold. So I missed a ton of doses. I had a really bad diet because I had no

place to cook. For breakfast and dinner, I relied on the unhealthy food in the shelter and

spent all day on street trying to find lunch. It was hard to have regular meals, which made it

tricky knowing when to take my insulin. I had to be on my feet all day, which was really hard

with my neuropathy. I couldn’t even keep a regular doctor. Not having a home base made

it hard to stay organized and I couldn’t keep appointments, plus I had so many more urgent

demands. So I just got my care in the ER.

I was on the list for low income housing for 3-4 years and finally got a place. The place is

not much to write home about, but it is right near Lake Merritt [Oakland] and there are

great walking paths there. Having my own place means that I can rest, sleep well, exercise,

and cook my own food—healthy food. I have a place to safely store my medications. I can

get mail, I can schedule and make my doctor appointments, and I now have a regular

doctor. My mental health is better; I’m not so worried anymore and I am more motivated

to care [for] myself. Now I can really focus on my diabetes care. During this time my HbA1c

went from 13% [very poor diabetes control] to 7% now [excellent diabetes control].

I think my story tells it all in terms of how important it is to have your own roof over your

head, your own bed to sleep in, and your own kitchen to cook in when you have diabetes.”

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Focus Area 10. Align Federal Research Priorities to Enable

Population-Wide Discoveries Related to Diabetes Prevention

and Control

Background and Rationale

It has been nearly 50 years since Congress passed the National Diabetes Research

and Education Act,¹⁷⁰ the first legislation directed at coordinating and expanding the

government’s research and prevention efforts related to diabetes. This law mandated that

the National Institutes of Health establish a National Commission on Diabetes to develop

a long-range plan to combat diabetes,¹⁷¹ with an emphasis on creating a coordinated,

interdisciplinary research program. The plan and subsequent action led to a world-class

research program that has resulted in a deeper understanding of the epidemiology of

diabetes, discoveries into diabetes causes and its complications, and significant advances

in clinical prevention and treatment. This research has focused on understanding the basic

biology of diabetes and its complications and intervening at the individual patient level in

clinical settings. More recently, NIH, through the Diabetes Mellitus Interagency Coordinating

Committee, updated its strategic plan to guide diabetes-related research and nutrition

research.¹⁷² These investments have helped advance the field even further and have

informed and improved the clinical prevention and care for individuals at risk for or with in

the U.S. and globally.

However, since the National Commission on Diabetes issued its report in 1975, our

understanding of the diabetes epidemic has evolved, and there now is a greater

appreciation of the interactions between social and environmental conditions, stress,

health behaviors, and diabetes incidence, diabetes complications, and related disparities.

The population-level burden of type 2 diabetes, in large part, is a consequence of the

unhealthy social and environmental conditions prevalent in U.S. society (see Figure 2.

The National Clinical Care Commission Framework for Diabetes Prevention and Control,

Chapter 3). There is an urgent need to leverage and coordinate research across a range

of federal “non-health” departments and agencies to answer critical questions related to

the social and environmental drivers of diabetes. Especially needed is research to evaluate

the effects of social and environmental policy changes and related programs on diabetes

outcomes. Resultant discoveries have the potential to benefit not only the general public

but also those at risk for diabetes (that is, preventing or delaying type 2 diabetes among

those with prediabetes) and those with established diabetes (that is, preventing or delaying

complications in those with diabetes). Such research will also help ensure that clinicians can

provide high-quality, integrated clinical care and that patients can successfully self-manage

diabetes.

Report to Congress

Recommendation 4.10: The National Clinical Care Commission recommends federal

investments in research that will yield discoveries that generate population-level

benefits in the prevention and control of type 2 diabetes, with a particular focus on

elucidating and changing the social and environmental conditions associated with

greater risk of diabetes and its complications.

•

4.10a. The U.S. Department of Agriculture (USDA), the U.S. Environmental

Protection Agency (EPA), the U.S. Department of Transportation (DoT), the

Federal Trade Commission (FTC), the Federal Communications Commission

(FCC), the Food and Drug Administration (FDA), and others should fund

research into how their policies and practices affect diabetes risk and

management and could be changed or (if/when beneficial) amplified to better

prevent and control diabetes.

•

4.10b. The National Institutes of Health (NIH) and the Centers for Disease

Control and Prevention (CDC) should support large-scale natural experiments

research—including cost-effectiveness analysis—to inform the evidence

base related to social and environmental policies that prevent and control

type 2 diabetes. Special focus should be paid to “health in all policies”

types of interventions relevant to non-health agencies’ activities and other

public health (non-clinical) interventions. The Centers for Medicare &

Medicaid Innovation (CMMI) or alternative federal entities should support

demonstration projects in collaboration with non-health agencies related to

influencing social determinants of health, reducing diabetes risk, improving

diabetes control, and preventing complications (for example, USDA’s SNAP

interventions, the U.S. Department of Housing and Urban Development’s

housing interventions, EPA and freshwater interventions, DoT and walkability

interventions).

•

4.10c. Investments in research training need to be made by NIH, CDC, and

non-health agencies to enhance the workforce skilled in the competencies

needed to carry out health impact assessments and related simulation work.

•

4.10d. NIH should expand its initiative on Precision Nutrition to (1) include

clinical trials that can inform critical population health questions related

to which foods, beverages, ingredients, and additives promote/prevent

the development of type 2 diabetes; (2) include studies of communication

interventions and (counter) marketing practices to inform which practices

work best for which sub-populations with respect to changing dietary patterns

to prevent type 2 diabetes, and which practices elevate diabetes risk; (3)

expand the definition of “precision” to go beyond targeting the individual to

include targeting cultural and geographic entities (neighborhoods).

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•

4.10e. NIH should encourage that nutrition and metabolic research accurately

quantify water intake and use this information to better study the associations

between water consumption and health across the lifespan. USDA should

develop methods to incorporate water consumption into USDA Food Patterns

(water is a beverage that currently is not a contributor to USDA food groups

or subgroups).

•

4.10f. NIH should support research (in collaboration with other federal

agencies) to better understand the role of (1) exposures related to

environmental pollutants, toxins, contaminants, unclean water, and endocrine

disrupting chemicals on metabolic function and diabetes risk; and (2) life

course trauma (including interpersonal violence, discrimination, racism,

and disability) on metabolic function and diabetes risk, and associated

interventions to reduce exposure to such trauma and/or mitigate the effects of

trauma on diabetes outcomes.

Report to Congress

Chapter 5: Diabetes Prevention in

Targeted Populations

Background

In this chapter the National Clinical Care Commission addresses diabetes prevention in

persons at high risk of developing diabetes, especially those with prediabetes, a state

associated with an increased risk of type 2 diabetes and cardiovascular disease. We also

address research needs for preventing type 1 and type 2 diabetes. Recommendations

included in this chapter were built upon those of the previous chapters. Implementing

recommendations presented in previous chapters such as improving access to health care,

making positive changes in food and agricultural policies, enhancing nutritional assistance

programs, and improving the built environment (see Chapters 3 and 4) will benefit all

people in the U.S. including those with prediabetes.

Prediabetes

Prediabetes is a metabolic state in which blood glucose levels are higher than normal but

not high enough to be classified as diabetes. The American Diabetes Association criteria

define prediabetes as either a fasting plasma glucose of 100-125 mg/ dL (impaired fasting

glucose [IFG]), a 2-hour post challenge glucose level of 140-199 mg/dL (impaired glucose

tolerance [IGT]), or an HbA1c value of 5.7% to 6.4%.¹⁷³

Prediabetes is prevalent in the U.S. CDC estimates that 88 million adults (about 34.5% of

the U.S. population over the age of 18) and 18% of teenagers have prediabetes.^{2, 8} Most

persons with prediabetes are unaware that they have this condition; only about 15%

of persons with prediabetes reported being told by a health professional that they had

prediabetes.² Overweight and obesity are strong risk factors for developing prediabetes.

The prevalence of prediabetes also increases with age.

Persons with prediabetes are at higher risk of developing type 2 diabetes. Around 5% to

10% of people with prediabetes develop type 2 diabetes every year, and progression rates

vary depending on population characteristics and prediabetes definitions.^{174, 175} The rate of

progression is higher in those with both IFG and IGT compared to persons with only IFG or

IGT.^176-179 A study of over 77,000 persons with prediabetes found that the risk of developing

type 2 diabetes increased with higher HbA1c levels and with higher body mass index

(BMI).¹⁸⁰

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Diabetes Prevention in People With Prediabetes

There are effective ways of delaying or preventing the progression from prediabetes to type

2 diabetes. The Diabetes Prevention Program (DPP) study, published in 2002, showed that

a lifestyle intervention focused on a healthy diet, physical activity, and approximately 7%

weight loss reduced the incidence of type 2 diabetes in persons with prediabetes by 58%;

and metformin (a diabetes medication) reduced the incidence of type 2 diabetes by 31%.¹⁴

This translated to about six cases of type 2 diabetes prevented per 100 person-years for the

lifestyle intervention, and about three cases of type 2 diabetes prevented per 100 person-

years for metformin.¹⁴

Subsequent analysis of the DPP study determined that the lifestyle intervention was

effective in all persons with prediabetes, regardless of age, BMI, or baseline risk of

progression to type 2 diabetes.^{14, 181} In contrast, metformin was effective in younger persons,

individuals with a higher BMI, persons with a history of gestational diabetes, and persons at

higher baseline risk of progression to type 2 diabetes.^{14, 181, 182} The effectiveness of lifestyle

interventions and metformin has been confirmed by several other studies with prediabetes

defined by different criteria (persons with IFG or IGT).^183-186

Evidence also suggests that both the DPP lifestyle intervention and metformin are cost-

effective in preventing or delaying the onset of type 2 diabetes. In the U.S., interventions

that cost less than $50,000 to $100,000 per quality-adjusted life-year (QALY) gained are

generally considered to be cost-effective. The DPP lifestyle intervention, when implemented

in a small group format (with 10 participants per class), cost $13,200 per case of type

2 diabetes delayed or prevented and $27,100 per QALY gained, and metformin costs

$14,300 per case of type 2 diabetes delayed or prevented and $35,000 per QALY gained,

over three years (the length of the DPP study).^{187, 188}If the effects of the DPP lifestyle

intervention extend beyond the timeframe of when the intervention is delivered, and

studies suggest they do,¹⁸⁹ cost per QALY gained would further decrease. It has thus been

estimated that over 10 years, the DPP lifestyle intervention implemented in a group format

would cost $8,412 per QALY gained and metformin is slightly cost-saving (it had slightly

lower costs than not providing an intervention).¹⁸⁸ For comparison, intensive glycemic

control for patients with newly diagnosed type 2 diabetes costs approximately $41,000 per

QALY gained over a lifetime.

There are other compelling reasons for people with prediabetes to participate in a DPP

lifestyle program focused on diet, physical activity, and weight loss, aside from prevention

of type 2 diabetes. People with prediabetes are at increased risk of cardiovascular disease

(CVD), chronic kidney disease, and death from any cause.^190-192 Preventing CVD and

other adverse health outcomes therefore is an important goal of diabetes prevention

interventions. In the DPP study, the lifestyle intervention improved CVD risk factors (lower

blood pressure, lower triglycerides, higher HDL cholesterol) compared with placebo and

Report to Congress

metformin therapy.¹⁹³ Both lifestyle intervention and metformin were associated with

reductions in weight.¹⁴

The DPP and subsequent translation studies served as the model for the National DPP, the

CDC-supported national partnership of public and private organizations that provides a

high-quality lifestyle change program to persons with prediabetes to reduce their risk of

type 2 diabetes and improve their overall health. To date, the National DPP has supported

almost 2,000 CDC-recognized program delivery organizations across all 50 states, the

District of Columbia, Puerto Rico, the Virgin Islands, and several U.S. territories. These

organizations are offering the lifestyle change program in-person, online, via distance

learning platforms, or through a combination of these delivery modes to reach high-risk

populations. The National DPP has enrolled 561,509 adults at high risk for type 2 diabetes

in its lifestyle change program and supported numerous partner organizations in securing

health benefit coverage for the program.

Gaps and Opportunities

In 2018, an estimated 1.5 million new cases of diabetes were diagnosed among people

aged 18 and older in the U.S., and many of these new cases were preventable.² However,

the vast majority of persons with prediabetes have not enrolled in or participated in a

lifestyle change program or have not been prescribed metformin, despite the proven

efficacy and cost-effectiveness of the interventions in preventing type 2 diabetes.¹⁹⁴

Enrollment in lifestyle interventions has been limited due to individuals’ lack of awareness

of prediabetes, low referral rates by providers, insufficient availability of classes, including

online classes, and lack of insurance coverage.¹⁹⁵ Prescribing of metformin for type 2

diabetes prevention has been limited by the failure of the FDA to approve this medication

for diabetes prevention, lack of patient awareness of the potential role for metformin

and clinician awareness of the benefits of metformin, and clinicians’ assumptions that

patients would prefer not to take a medication for type 2 diabetes prevention.¹⁹⁵ This

represents a missed opportunity to (1) prevent type 2 diabetes, (2) help address racial and

ethnic disparities in the prevalence of diabetes, and (3) improve the health outcomes of

Americans.

Reducing the incidence and prevalence of diabetes in the U.S. is a public health priority,

and ensuring that type 2 diabetes prevention interventions are available to all persons with

prediabetes and are equitably implemented in all populations at risk should be a crucial

component to addressing this priority. Achieving these goals will require a sustained focus

on enhancing federal policies and programs related to diabetes prevention, including

improving the awareness and diagnosis of prediabetes, and ensuring the availability

of, access to, utilization of, and sustainability of evidence-based diabetes prevention

interventions.

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Organizational Success: Federal Programs Can Successfully

Prevent Type 2 Diabetes

By maintaining a focus on type 2 diabetes prevention, the Indian Health Service was able to

consistently lower the prevalence of diabetes in American Indian and Alaska Native adults,

the population with the highest prevalence of type 2 diabetes in the U.S., for four years,

dropping from 15.4% in 2013 to 14.6% in 2017.^{196, 197}

Recommendations

Focus Area 1. Raise Public Awareness About Prediabetes and the

National DPP

Background and Rationale

Since 2016 CDC has collaborated with the Ad Council on a national public service

campaign to raise awareness about prediabetes. The campaign website has links to a

brief self-administered test for risk of prediabetes and locations where the National DPP

lifestyle change program is offered. As of June 30, 2021, 4.1 million unique individuals

visited the Prediabetes Awareness Campaign website and 3.7 million completed the risk

test.¹⁹⁸ Nevertheless, among people with prediabetes, gaps in awareness of the condition

and familiarity with the National DPP remain substantial. The CDC 2020 National Diabetes

Statistics Report showed that only 15.3% of adults with prediabetes (based on level of

fasting blood glucose or HbA1c) reported having been told they had prediabetes by a

health professional.² The National Health and Nutrition Examination Survey revealed that

levels of awareness were especially low for young and early middle-aged adults, men, and

individuals of Asian or Hispanic ancestry. Analyses of another nationally representative

study, the National Health Interview Survey, found that only 4.9% of adults diagnosed with

prediabetes by a physician were advised to participate in a diabetes prevention program.

These results underscore the need to improve awareness of prediabetes and the National

DPP among both patients and clinicians.¹⁹⁹

Recommendation 5.1: The National Clinical Care Commission recommends

increasing support to CDC for its campaign to raise awareness of prediabetes and

promote enrollment in the National DPP lifestyle change program.

• To more effectively reach populations disproportionately affected by type 2

diabetes risk, CDC should use multiple methods including social media to

increase awareness of prediabetes and the opportunity to delay or prevent

type 2 diabetes.

Report to Congress

• CDC should continue tracking visits to the Do I Have Prediabetes campaign

page and completions of the prediabetes risk test, with an expanded focus on

the degree to which populations at increased risk are being reached in order

to reduce disparities in awareness and engagement in interventions.

Organizational Success: National Alliance for Hispanic Health

Incorporates Cultural Adaptations to Support Type 2 Diabetes

Prevention Success

The National Alliance for Hispanic Health (NAHH), a CDC grantee, works with several affiliate

sites to engage and enroll persons of Hispanic or Latinx descent who are at high risk for

type 2 diabetes in the National DPP lifestyle change program. One of NAHH’s affiliates,

the Hispanic Federation, worked to create culturally relevant materials for their community

members in central Florida, representing groups from Puerto Rico, Mexico, and several

Central and South American countries.

Acknowledging the cultural differences across these diverse groups and incorporating

them into the program curriculum has enabled participants to better understand and

embrace the lifestyle change program. The Hispanic Federation built on the foundation of

the Spanish version of the CDC’s PreventT2 curriculum and adapted it for their participants

in interactive ways, incorporating local foods. They offered healthy potlucks and invited

participants to bring dishes from their countries so that everyone could learn new recipes

and share a piece of their culture. As a result, many participants also formed friendships and

found exercise partners, which further supported their lifestyle change goals. These cultural

adaptations helped improve participant retention and overall satisfaction with the program,

resulting in a combined weight loss of over 500 pounds across 170 program participants.

Focus Area 2. Expand Coverage for Screening/Diagnostic

Testing Used to Identify Individuals With Prediabetes

Background and Rationale

Currently there are three widely accepted tests with established criteria for diagnosing

prediabetes: fasting blood glucose, the oral glucose tolerance test, and HbA1c.

Furthermore, the 2021 U.S. Preventive Services Task Force (USPSTF, an independent panel

of scientific experts) recommendations²⁰⁰ and the 2021 American Diabetes Association

Standards of Medical Care in Diabetes²⁰¹ both recommend fasting blood glucose, oral

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glucose tolerance tests, and HbA1c as appropriate for clinicians to consider in screening

for and diagnosing prediabetes and diabetes. However, Medicare does not cover the cost

of HbA1c testing for prediabetes screening, contributing to low rates of screening. The

two tests that are covered (fasting blood glucose and oral glucose tolerance tests) present

logistical barriers (that is, they require fasting by the patient and an extended visit) to

identifying patients with prediabetes. These logistical issues do not apply to HbA1c testing.

Recommendation 5.2: The National Clinical Care Commission recommends that the

Centers for Medicare & Medicaid Services provide coverage for hemoglobin A1c

testing when used to screen for prediabetes.

Focus Area 3. Adopt and Promote Clinical Quality Measures for

Screening and Follow-Up of Abnormal Blood Glucose

Background and Rationale

In 2019 a technical expert panel convened by the American Medical Association proposed

three electronic clinical quality measures for review by the National Quality Forum to

monitor and improve quality of care for patients with prediabetes. The proposed measures

are:

• Screening patients aged 40 and older with a BMI > 25 kg/m²for abnormal blood

glucose at least once in the previous three years.^*

• Providing one of the following interventions for patients with prediabetes during

the 12 months following determination of abnormal blood glucose.

◊ Referral to a CDC-recognized diabetes prevention program

◊ Referral to Medical Nutrition Therapy with a registered dietitian

◊ Prescription of metformin

• Retesting patients’ blood glucose in the year after they were identified with

prediabetes.

Recent surveys conducted among clinicians indicate significant gaps in awareness of CDC-

recognized lifestyle change programs and referrals to such programs for management

of prediabetes.^202-204 Studies of electronic medical records conducted after publication of

the 2015 USPSTF guidelines on screening for type 2 diabetes prevention found marked

* The USPSTF now recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years

who have overweight or obesity. (https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/

screening-for-prediabetes-and-type-2-diabetes)

Report to Congress

variation by clinic in levels of screening, frequent failure to document a diagnosis of

prediabetes when the diagnostic criteria had been met, and low levels of referral for

individual or group behavioral intervention.^{202, 205} These findings underscore the salience of

the proposed quality measures to monitor and improve the timely diagnosis of prediabetes

and implementation of preventive measures.

The opportunity to identify and counsel patients at risk for type 2 diabetes may be missed

during an acute or routine visit because of competing priorities or incomplete information

available at the time. Nevertheless, as testing for abnormal blood glucose or HbA1c has

become more common, opportunities exist to leverage retrieval of testing results so

that appropriate referrals can be made. To facilitate better adherence to the proposed

guidelines, administrative and clinical data can be queried to create a registry of patients

at higher risk or already meeting the criteria for prediabetes (that is, on the basis of BMI

and history of hypertension, abnormal blood glucose, or HbA1c results). Clinic staff could

contact patients in the registry to discuss prediabetes, offer definitive diagnostic testing, and

provide opportunities to enroll in the National DPP lifestyle change program. The patient’s

medical record could be flagged for reinforcement of these messages at future visits.

Projects that have retrieved results from the medical record to systematically identify and

report patients with prediabetes have shown improvement in referrals to the National DPP

lifestyle change program.^{206, 207}

Recommendation 5.3: The National Clinical Care Commission recommends that

all federal agencies that directly deliver or influence the delivery of medical care

should implement the 2019 American Medical Association-proposed prediabetes

quality measures related to screening for abnormal blood glucose, intervention for

prediabetes, and retesting of abnormal blood glucose in patients with prediabetes.^*

• These agencies should implement a process for systematically using

administrative and clinical data to identify patients at risk for or already

meeting criteria for prediabetes and to ensure appropriate referral and

follow-up.

• To support implementation of these measures, quality-improvement programs

should be introduced to improve performance and reduce disparities.

* The USPSTF now recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years

who have overweight or obesity. (https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/

screening-for-prediabetes-and-type-2-diabetes)

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Focus Area 4. Support Metormin Use for Type 2 Diabetes Preventon

Background and Rationale

Metformin has been approved by FDA for the treatment of type 2 diabetes mellitus since

1995.²⁰⁸ Accumulating clinical evidence supports the use of metformin for delaying the

onset of type 2 diabetes in individuals with prediabetes who are at high risk.²⁰⁸ However,

metformin does not have an FDA-approvedindication for prediabetes. Prescribing

metformin for prediabetes currently is considered an “off label” use and, hence, the use of

metformin in patients with prediabetes is infrequent.

Because of the availability of multiple generic versions of metformin, pharmaceutical

companies have little financial incentive to pursue an FDA approval for metformin to be

used in patients with prediabetes. While data could be submitted to FDA for review through

other means without participation of a pharmaceutical company (for example, a Citizen’s

Petition), as outlined in 21CFR 10.30, organizations interested in pursuing an FDA indication

for metformin to be used for prediabetes are hesitant to take on the responsibilities

because of the costs and amount of work involved with filing a Citizen’s Petition.²⁰⁹ Pursuing

an approval from FDA would require the applicant to collect, analyze, and organize

data to show the safety and effectiveness of metformin in patients with prediabetes. A

comprehensive synthesis of available data currently is not available.

Recommendation 5.4: The National Clinical Care Commission recommends that

funding be provided to NIH to collect, analyze, and summarize the available data

from the Diabetes Prevention Program study describing the effectiveness and safety

of metformin for type 2 diabetes delay or prevention in patients with prediabetes,

including subpopulations most likely to benefit. Such a summary (with safety and

efficacy data) should then be used to inform an appropriate submitter’s request

for FDA to review and consider an indication for the use of metformin in high-risk

patients with prediabetes.

Focus Area 5. Ensure Insurance Coverage for Diabetes

Prevention Interventions

Background and Rationale

The National DPP lifestyle change program is effective at preventing or delaying the

progression from prediabetes to diabetes; however, participant referrals and enrollment

remain low compared to the need, and most persons with prediabetes are not referred

to or enrolled in the program.¹⁹⁴ Section 2713 of the Affordable Care Act requires private

health plans to cover certain evidence-based preventive services and to eliminate cost-

sharing for preventive care. These services include evidence-based preventive services

recommended by USPSTF based on the strength of the scientific evidence.²¹⁰ The current

Report to Congress

USPSTF recommendation on screening for type 2 diabetes includes the following as part of

its recommendation: “Clinicians should offer or refer patients with prediabetes to effective

preventive interventions.” The recommendation notes that “lifestyle interventions that focus

on diet, physical activity, or both and metformin have demonstrated efficacy in preventing

or delaying progression to diabetes in persons with prediabetes.”²⁰⁰ Private insurers are not

consistently providing coverage for the National DPP lifestyle change program, a proven

effective diabetes prevention intervention. This contributes to its under-implementation and

underutilization and results in greater numbers of preventable cases of type 2 diabetes.

Recommendation 5.5: The National Clinical Care Commission recommends,

consistent with provisions of the Patient Protection and Affordable Care Act, that all

insurers be required to provide coverage for participation in and completion of a

CDC-recognized diabetes prevention program for those who are eligible.

Focus Area 6. Support All Proven-Effective Delivery Modes for

Evidence-Based Diabetes Prevention Interventions

Background and Rationale

Federal agencies use a variety of modes (for example, in-person, online, and distance

learning [telehealth]) to deliver evidenced-based interventions to delay or prevent type

2 diabetes.²¹¹ Other diabetes-related interventions, such as the Department of Defense

Diabetes Center of Excellence Virtual Diabetes Self-Management Education, have also been

successfully implemented in a fully virtual platform. Despite efforts within federally-funded

health care programs, access to evidence-based type 2 diabetes prevention interventions

needs to be further improved. Additionally, coverage of proven-effective delivery modes

varies across private and public payers. Promoting and improving coverage for evidence-

based type 2 diabetes prevention interventions through a variety of delivery modes would

help improve access.

Recommendation 5.6: The National Clinical Care Commission recommends that

Congress promote coverage for all proven-effective modes of delivery (for example,

in-person, online, and distance learning [telehealth]) for evidence-based interventions

that produce successful participant outcomes that meet or exceed those of the

National DPP quality standards.

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Focus Area 7. Improve Medicare Diabetes Prevention

Program Coverage

Background and Rationale

Section 1115A of the Social Security Act²¹² established the Center for Medicare and

Medicaid Innovation (CMMI) to test innovative payment techniques and service delivery

models. The Medicare Diabetes Prevention Program (MDPP) was one of the models tested.

Based on the positive results, MDPP was officially expanded in scope and duration in 2016.

This expansion was implemented into practice in 2018. The MDPP expanded model is

currently being evaluated,²¹³ based on factors such as quality of care delivered, patient

outcomes, and costs. MDPP services are covered services under the model expansion,

pending results of the evaluation.²¹⁴ However, based on findings from the original DPP

study, subsequent translation studies demonstrating the program’s effectiveness in non-

clinical settings, and the results of the 15-year DPP Outcomes Study, the DPP lifestyle

intervention has already been studied extensively and has substantial evidence supporting

its effectiveness across settings and populations.

Additionally, full virtual delivery of the MDPP is not currently included under the expanded

model. This may limit CMS’s ability to enroll a sufficient number of Medicare beneficiaries

to evaluate the expanded model. It is also inconsistent with the National DPP, which allows

virtual delivery and requires virtual delivery organizations to meet the same CDC national

quality standards and achieve the same participant outcomes as in-person delivery

organizations. During the COVID-19 pandemic, CMS issued flexibilities allowing for virtual

delivery of MDPP services; however, it is unclear whether the flexibilities will remain after the

pandemic.

Finally, there is a once-in-a-lifetime limit on the MDPP service.²¹⁵ However, various factors

may affect participants’ ability to fully engage in or complete the program, which may

warrant an individual’s need to repeat the program or re-enroll at a future date.

Recommendation 5.7: The National Clinical Care Commission recommends that

the Medicare Diabetes Prevention Program (MDPP) be approved as a permanent

covered benefit (not only a model expansion service) and that coverage of MDPP be

expanded to include virtual delivery. Furthermore, the “once in a lifetime” limit on

participation in the MDPP should be removed.

Report to Congress

Focus Area 8. Streamline and Harmonize the National DPP

and MDPP

Background and Rationale

In response to the growing rate of type 2 diabetes in the U.S., Congress authorized CDC

to establish the National DPP in 2010.²¹⁶ The National DPP provides a framework for type 2

diabetes prevention efforts based on (1) a trained workforce of lifestyle coaches; (2) national

quality standards supported by the CDC Diabetes Prevention Recognition Program; (3)

a national network of program delivery organizations sustained through public/private

payer coverage; and (4) participant referral and engagement. The CY 2017 Physician Fee

Schedule (PFS) final rule enables National DPP program delivery organizations with full or

preliminary CDC recognition to enroll as MDPP suppliers.²¹⁴ However, some organizations

in rural and underserved areas experience challenges achieving preliminary or full CDC

recognition and applying to become MDPP suppliers because of administrative burdens

associated with the CDC recognition process and the CMS payment requirements. There

are minor differences between MDPP and the National DPP program structure, including

blood glucose eligibility criteria, allowable service delivery modalities, and requirements for

ongoing maintenance sessions, making it difficult for a provider organization to deliver both

the National DPP and MDPP.

Recommendation 5.8: The National Clinical Care Commission recommends that

CDC continue its efforts to streamline the National DPP recognition process while

maintaining quality, and that CMS streamline its payment process for the MDPP.

Differences in program eligibility, delivery modalities, and duration between the

National DPP (led by CDC) and the MDPP (led by CMS) should also be eliminated or,

at a minimum, reduced.^*

Focus Area 9. Update the MDPP Payment Model

Background and Rationale

The CY 2017 and 2018 Physician Fee Schedule (PFS) final rules^{214, 217} established the benefit

structure and payment rates for the MDPP based on a diabetes prevention program model

test conducted by the YMCA of the USA (Y-USA) from 2013 to 2015. The payments are

adjusted annually by the 12-month percent change in the Consumer Price Index U.S. city

* The National Clinical Care Commission notes that the CMS CY 2022 Physician Fee Schedule Proposed Rule,

which if adopted, may better align the duration of the MDPP and National DPP, and would increase MDPP

payment for participants who attend at least 9 sessions, was recently posted for public comment. (https://www.

govinfo.gov/content/pkg/FR-2021-07-23/pdf/2021-14973.pdf)

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average (CPI-U) for the period ending June 30th of the year preceding the update year. The

current MDPP payment model offers reimbursement only when participants reach certain

attendance and weight loss benchmarks.

Under this model, program delivery organizations assume a level of risk and may be under-

resourced to cover the upfront costs associated with program certification, marketing,

and participant engagement and enrollment. While large, primarily virtual program

delivery organizations have been able to negotiate different payment schedules and/or

rates with other insurers and employers that address some of the barriers in the current

MDPP reimbursement model, smaller organizations have not been able to do so. Current

reimbursement rates may not fully incentivize program delivery organizations to apply

to become MDPP suppliers as only a limited number of eligible organizations with CDC

preliminary or full recognition have applied to become MDPP suppliers. This limits the

availability of programs for people with prediabetes. The reimbursement rates may also

have a disproportionate impact on smaller and rural programs.

Recommendation 5.9: The National Clinical Care Commission recommends that

funding be provided to support the testing of new payment models that allow for

greater upfront payments and more equitable risk-sharing between CMS and MDPP

program delivery organizations. In addition, there should be an increase in payment

levels to MDPP program delivery organizations to make MDPP programs financially

sustainable.^*

* The National Clinical Care Commission notes that the CMS CY 2022 Physician Fee Schedule Proposed Rule, which

if adopted, may better align the duration of the MDPP and National DPP, and would increase MDPP payment

for participants who attend at least 9 sessions, was recently posted for public comment. (https://www. govinfo.

gov/content/pkg/FR-2021-07-23/pdf/2021-14973.pdf)

Report to Congress

Focus Area 10. Enhance Medicaid Coverage of the National DPP

Background and Rationale

Medicaid coverage for the National DPP lifestyle change program is a state-level decision.

Since 2012, only 16 states have enacted varying levels of Medicaid coverage of the National

DPP through Medicaid State Plans, 1115 waivers, pilots with Medicaid managed care

organizations (MCOs), and additional mechanisms.²¹⁸ State Medicaid Agencies, or MCOs in

the case of voluntary coverage, determine the types of delivery modes (for example, in-

person, online, distance learning/telehealth) that will be covered.

However, there are variations across states in terms of (1) whether the National DPP lifestyle

change program will be made a covered benefit under that state’s Medicaid program,

(2) delivery modes covered, and (3) the level of reimbursement authorized. Additionally,

risk factors for type 2 diabetes are higher in Medicaid beneficiaries, a population that is

vulnerable to the limitations in services available to them.

Recommendation 5.10: The National Clinical Care Commission recommends that

financial incentives be provided for state Medicaid programs to cover the National

DPP lifestyle change program and other evidence-based type 2 diabetes prevention

interventions that produce successful participant outcomes that meet or exceed those

of the National DPP quality standards. This should include coverage of all proven

modes of delivery (that is, in-person, online, and distance learning or telehealth) that

produce successful participant outcomes.

Focus Area 11. Support Federal Programs Focusing on Diabetes

Prevention

Background and Rationale

An estimated 34.2 million Americans (about one in 10 Americans of all ages including

one in seven adults) have diabetes, and 88 million people aged 18 years or older (more

than one in three adults) have prediabetes. American Indians and Alaska Natives have

the highest prevalence of diabetes of any racial and ethnic group.² The Special Diabetes

Program for Indians (SDPI) was established by Congress in 1997 in response to the type 2

diabetes epidemic among American Indians and Alaska Natives. The SDPI is coordinated by

the Indian Health Service (IHS) Division of Diabetes with guidance from the Tribal Leaders

Diabetes Committee, and it provides funds for diabetes treatment and prevention to IHS,

Tribal, and urban Indian health programs across the U.S.²¹⁹ The SDPI supports diabetes

prevention and treatment among American Indians and Alaska Natives with great success.

By maintaining a focus on diabetes prevention and through funds from the SDPI, the IHS

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was able to lower the prevalence of diabetes in American Indian and Alaska Native adults

consistently for four years, dropping from 15.4 percent in 2013 to 14.6 percent in 2017.^196,

¹⁹⁷ However, funding for this program has not increased since 2004.

There are also geographic disparities in diabetes prevalence. Alabama has the highest

prevalence of diabetes (13.2%) among all U.S. states; the U.S. regions with the highest

diabetes prevalence are in the Southeast and Appalachia.²²⁰ Rural areas of the U.S. also

have a higher prevalence of diabetes and generally have less medical infrastructure

compared to urban areas.^{221, 222} HRSA’s Delta States Rural Development Network Grant

Program provides network development grants to the eight states in the Mississippi Delta

for network and rural health infrastructure development.²²³ The program requires grantees

to focus on diabetes, cardiovascular disease, and obesity, but not specifically on type 2

diabetes prevention. Given the higher burden of diabetes in the Southern U.S. and the

proven effectiveness of diabetes prevention interventions, providing additional resources to

HRSA’s Delta States Rural Development Network Grant Program would allow the program

to include type 2 diabetes prevention as a focus, while not detracting from the program’s, or

HRSA’s, other important aims.

Recommendation 5.11: The National Clinical Care Commission recommends

• Funding for the Special Diabetes Program for Indians (SDPI) in five-year

increments so that evidenced-based tribal diabetes prevention programs

have the resources to (1) sustain the effort to combat diabetes and its

complications; (2) develop additional culturally appropriate, high-impact type

2 diabetes prevention interventions; and (3) evaluate outcomes.

• An increase in SDPI funding to address inflation costs, which have consumed

more than 34% of the program’s resources since 2004, the last year Congress

increased funding for the Special Diabetes Program. In the future, annual

increases in funding should, at a minimum, address the costs of inflation.

• An increase in funding to HRSA’s Delta States Network Grant Program to allow

the program to include type 2 diabetes prevention as a focus.

Report to Congress

Organizational Success: A Special Diabetes Program for

Indians (SDPI) Grantee Provides Diabetes Prevention Services

to a Rural, Underserved Community

The Lake County Tribal Health Consortium is an SDPI grantee providing the National

DPP lifestyle change program in rural Northern California. Lake County is a medically

underserved area that ranks at the bottom of California’s 58 counties for poorest health as

assess by death from all causes. By percentage, the county has one of the largest Native

American populations in the state, with members from over 100 recognized tribes, creating

a uniquely diverse tribal community. The Consortium feels honored to provide diabetes

prevention services to its community, helping them prevent diabetes and its complications

and feel and live better. Several recent participants in Lake County Tribal Health

Consortium’s diabetes prevention program shared the following thoughts:

“The teacher and other people in class we all help each other and learn new things to help

each other and learn new things to help each other in our journeys.”

“I liked having an instructor that was in our level of understanding in the struggles of weight

loss.”

“The instructor was awesome! I learned a lot from [him/her]! I love how the group came

together. I was not embarrassed about my weight. I would recommend the program

to everybody. I do plan on staying in the group to further my education about weight,

diabetes, and fitness.”

Focus Area 12. Diabetes Prevention Research Recommendations

Recommendations for Type 2 Diabetes Prevention Research

Background and Rationale

The National DPP was authorized by Congress in 2010 with an evidence-based lifestyle

change program as its foundation.²¹¹ The National DPP lifestyle change program was

developed based on the DPP study, a large NIH- and CDC-funded national research project

that included adults of all ages and racial/ethnic groups in whom type 2 diabetes is more

common. The DPP study demonstrated that for people with prediabetes who are at high

risk of developing type 2 diabetes, an intensive lifestyle intervention of healthy diet, physical

activity, and approximately 7% weight loss can significantly reduce the risk of developing

type 2 diabetes by 58% over a 2.8-year period. The study also demonstrated that metformin

can reduce the risk of developing type 2 diabetes by 31% over 2.8 years.¹⁴

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In spite of these remarkable outcomes, the majority of people with prediabetes have not

participated in a diabetes prevention program such as the National DPP lifestyle change

program, and are not taking metformin.¹⁹⁴ Without intervention, the risk of persons with

prediabetes developing type 2 diabetes persists and even increases over time. For

example, in the DPP study, 29% of the participants in the placebo group progressed to type

2 diabetes over a 3-year period, and 62% progressed to type 2 diabetes over 15 years.^{14, 189}

While the best way to prevent the progression from prediabetes to type 2 diabetes in

the long term is currently uncertain, the DPP study showed that weight loss was highly

correlated with diabetes prevention. However, many people in the lifestyle intervention

group who lost weight ultimately regained the weight after completing the clinical trial.²²⁴

The majority of people with prediabetes who would benefit from metformin are not taking

the medication.¹⁹⁴ The reasons for not using metformin for prediabetes likely include (1)

physicians not wanting to use medication to treat people with prediabetes, (2) physicians’

and patients’ lack of awareness of the benefit of using metformin, (3) concerns about

possible side effects of metformin, (4) concerns about lack of FDA approval for use in

prediabetes, or (5) a combination of these reasons. Further studies on metformin uptake

and alternative medication choices are needed for people with prediabetes. There are also

disparities in implementation and uptake of diabetes prevention programs, which may be a

result of social, geographic, financial, or cultural barriers, or other reasons.

Additionally, people with prediabetes are a heterogeneous group. Individuals have

different physiologic abnormalities that contribute to dysglycemia (abnormal blood glucose

levels). As a result, some people with prediabetes may develop type 2 diabetes and

other complications (such as cardiovascular disease and kidney failure) more quickly than

others.²²⁵More research is needed to better identify people with prediabetes who are at

high risk of developing type 2 diabetes and diabetes complications so that screening and

interventions can be tailored to maximize effectiveness. Research to assess the performance

of screening tests and efficacy of interventions across racial and ethnicity populations is also

needed.²²⁶

Recommendation 5.12: The National Clinical Care Commission recommends funding

type 2 diabetes prevention research to discover how to ensure that all individuals at

high risk of developing type 2 diabetes are able to lower their risk for diabetes and its

complications. Examples of areas for further research include:

• What impediments prevent participation in effective diabetes prevention

programs for communities with the greatest needs?

• Are programs that combine both lifestyle intervention and metformin to

prevent diabetes more effective than programs with either lifestyle change or

metformin alone?

Report to Congress

• What is the best number, frequency, duration, and content of lifestyle

intervention sessions to successfully prevent diabetes in the long term?

• What are the barriers to long-term maintenance of weight loss for those

people who successfully completed a diabetes prevention program?

Finally, dissemination and implementation research is needed to determine how best to

promote the use of effective in-person and virtual diabetes prevention programs. Such

efforts should aim to understand and address barriers at multiple levels, including system

policies, health care provider referrals, and patient uptake.

Recommendations for Type 1 Diabetes Prevention Research

Background and Rationale

It is not well understood why people develop type 1 diabetes. Approximately 30% of

patients with new onset type 1 diabetes present with diabetic ketoacidosis (DKA).^{227, 228}

DKA is a serious yet avoidable acute metabolic complication that can lead to coma and

even death. Evidence suggests that some interventions (such as immune modulators

and monoclonal antibodies) may be able to delay or prevent type 1 diabetes.²²⁹ Better

understanding of the causes of type 1 diabetes can help identify those at high risk before

they develop type 1 diabetes complications such as DKA.

In 1998 Congress passed the Special Statutory Funding Program for Type 1 Diabetes

Research, also known as the Special Diabetes Program (SDP). This program has resulted

in substantial progress in type 1 diabetes research and development of innovative

collaborative research consortia and clinical trials networks. SDP funded research studies

such as the Environmental Determinants of Diabetes in the Young (TEDDY) and the Type

1 Diabetes TrialNet have improved our understanding of the basic biology of type 1

diabetes and are making strides to discover new treatment and prevention modalities.^229,

²³⁰ Additional research is needed to leverage emerging data from TEDDY and TrialNet to (1)

develop precise and effective screening programs that can be used to identify people at

high risk for type 1 diabetes who might benefit from interventions, and (2) advance research

to prevent type 1 diabetes. Further study is also needed on efficient and cost-effective

methods for screening the general population for risk of developing type 1 diabetes.

The SDP was originally funded at five-year intervals but the program has most recently been

funded for shorter intervals, sometimes on an annual basis. Short-term funding inhibits

the opportunities for significant research progress because it limits the ability to plan and

initiate long-term research projects. Sustained multiyear funding is needed to use federal

dollars most effectively; maximize research opportunities for long-term studies such as

TEDDY and TrialNet; and pursue new promising treatment and prevention studies and trials.

Additionally, the SDP funding for type 1 diabetes research has been level at $150M since

2004.

Department of Health and Human Services

Chapter 6: Treatment and

Complications

Background

Diabetes is a complex metabolic condition that impacts personal choices, affects quality of

life and life expectancy, and requires substantial health system resources.

There are several types of diabetes that have different causes, but all result in elevated

blood glucose levels (that is, hyperglycemia). Severe hyperglycemia itself can be life

threatening (for example, diabetic ketoacidosis), and when present over longer periods

of time, chronic hyperglycemia can damage the heart and blood vessels, eyes (diabetic

retinopathy), kidneys (diabetic nephropathy), and nerves (diabetic neuropathy). These

may result in heart attack, stroke, vision loss, kidney failure, and amputations. Diabetes

complications can be prevented or delayed by comprehensive diabetes care that includes

optimal control of blood glucose, blood pressure, and cholesterol levels. Lifestyle

modifications and medications are cornerstones of diabetes treatment, and both must be

coupled to ongoing self-management.

Standards of medical care for diabetes are

regularly updated and disseminated to

Diabetes care is preventive

provide evidence-based guidance on diabetes

care. Long-term health care

treatment. Despite these guidelines, only about

costs for people with diabetes

one in three people with diabetes achieve

are lower when they have the

guideline-recommended levels of care.²³¹

medications, devices, and

This is especially true among those who are

services they need to manage

younger, socioeconomically disadvantaged,

their disease.

and have inadequate health insurance.

The Commission has focused on the gap

Consensus Statement on U.S.

between available resources and the use of

Health Care Reform for People

those resources by people with diabetes. The

with Diabetes, November 2020

Commission’s priority areas related to diabetes

treatment and complications and specific

recommendations have been designed to

narrow this gap.

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Achieving and maintaining optimal health and wellbeing while living with diabetes requires

that patients and their caregivers

• Have access to and understand information about diabetes, its management, and

its potential complications;

• Participate collaboratively with health care providers in selecting treatments that are

consistent with their unique characteristics and goals of care; and

• Have the skills, confidence, psychosocial and material support to perform the

necessary self-management tasks.

In addition, health systems must proactively deliver high-quality individualized diabetes

care and community resources must support the self-management needs of individuals with

diabetes.

Given the complexity of treating diabetes and its complications, the Commission has

elected to focus on several factors at the levels of persons with diabetes, clinical practices,

health care systems, and government policies that have the greatest likelihood of improving

the delivery of high-quality care to all Americans with diabetes.

Recommendations

Focus Area 1. Diabetes Self-Management Training

Reduce Administrative Barriers to Diabetes Self-Management Training

Background

Substantial knowledge and skills are required by people with diabetes to manage their

disease. Diabetes affects all aspects of an individual’s life. People with diabetes are expected

to make healthy dietary choices; engage in regular physical activity; perform frequent

monitoring; take medications consistently; deal with psychological and financial stresses of

having a chronic, life-threatening disease; and proactively seek and obtain ongoing medical

care. Diabetes self-management education and support (DSMES) facilitate the knowledge

and the skills necessary to manage diabetes on a daily basis. DSMES is designed to help

people with diabetes learn, integrate, and maintain these vital behaviors as part of their

overall treatment program. Diabetes self-management training (DSMT) is the Medicare

benefit that covers DSMES services to Medicare beneficiaries.

Report to Congress

DSMT improves confidence and quality of life for people with diabetes, and is cost-

effective²³² in reducing hospital admissions, readmissions, and the risk of complications.^233,

²³⁴ Standard DSMT curricular content is delivered by diabetes care and education specialists

and addresses the causes of diabetes, common treatments, and strategies to incorporate

healthy eating, taking medications appropriately, monitoring blood glucose levels,

and preventing complications. DSMT also imparts healthy coping and problem-solving

skills. DSMT uses a person-centered approach based on individual needs and cultural

characteristics and is provided by accredited programs that meet and maintain established

standards.

Despite robust evidence demonstrating the effectiveness of DSMT, fewer than five percent

of Medicare beneficiaries with a new diagnosis of diabetes receive DSMT. There is strong

evidence that increased participation in DSMT significantly reduces spending through

prevention of emergency room visits and inpatient hospitalizations due to diabetes

complications. Disparities in access to DSMT by age, sex, race, language, and availability of

DSMT providers contribute to inequities.⁶¹

Underutilization of DSMT is multifactorial. Contributing factors may include outdated

standards, burdensome administrative requirements, and inconsistent auditing processes.

These factors contribute to a shortage of diabetes care and education specialists and a lack

of programs in some geographic areas that have a high prevalence of diabetes.²³⁵

Rationale

Medicare coverage for DSMT was first established in 2000. CMS quality standards for

DSMT²³⁶ were established then but have not been updated since. According to CMS

regulations, either the CMS quality standards for DSMT or the National Standards for

Diabetes Self-Management Education and Support (NSDSMES) govern the development,

delivery, and maintenance of accredited and recognized DSMT programs. Even though

the NSDSMES quality standards have regularly been revised, each iteration must align

with the CMS quality standards, which themselves need to be updated as they no longer

align with evidence-based best practices. For example, DSMT services do not allow use

of HbA1c as a criterion for diagnosis of diabetes, even though this is the most commonly

used test to diagnose and monitor diabetes. Additionally, coverage for DSMT is limited to

a maximum of 10 hours within the first year after a diagnosis of diabetes and a maximum

of two hours per year in subsequent years. Given the evolving nature of diabetes over

the life of an individual, these limited hours do not allow for individualized education and

support and limit the impact of DSMT. Other diabetes-related, CMS-covered benefits,

such as Medical Nutrition Therapy (MNT), allow for additional hours based on a person’s

individualized educational needs.²³² However, this flexibility is not available for DSMT. These

reimbursement restrictions for DSMT also prevent MNT and DSMT from being provided on

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Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications (2021) - page 2