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

2021

the same day. Additionally, the requirements for copays and deductibles for these services

are a barrier to access to DSMT and increase disparities in diabetes care.

Recommendation 6.1: The National Clinical Care Commission recommends that

CMS update the 2000 Medicare Quality Standards that govern diabetes self-

management training (DSMT) and establish a process for ongoing review, updating,

and revision, with broad input from persons and parties affected by these standards.

CMS should ensure that eligibility, documentation, and reimbursement requirements

are clearly defined and that they are consistently applied across all parties involved

in accreditation, billing, and reimbursement, including Medicare Administrative

Contractors and auditors. Updates should include a reduction in administrative

burden regarding standards, documentation, and reimbursement requirements for

DSMT programs.

The administrative burden associated with meeting the NSDSMES and low reimbursement

rates from CMS make it difficult for DSMT programs to remain financially viable. Medicare

Administrative Contractors have at times misinterpreted the DSMT reimbursement

requirements and auditors have requested documentation that exceeds the accrediting

organization requirements. These requirements should be reevaluated to align with current

evidence-based care.

The Commission recommends the following changes in CMS regulations related to DSMT

to improve access and engage more people with diabetes:

• Allow the initial 10 hours of DSMT to remain available beyond the first 12 months

from diagnosis until fully utilized.^{237, 238}

• Allow for six additional hours (instead of two hours) of DSMT, if necessary.^{232, 239}

• Allow MNT and DSMT to be delivered on the same day.

• Eliminate copays and deductibles (cost sharing) for DSMT.²⁴⁰

• Expand the types of providers who can refer for DSMT (for example, podiatrists,

specialists treating diabetes-related complications, and emergency medicine

physicians).^241-243

• Allow community-based sites to provide DSMT.

• Standardize the data collection required to simplify the process and ensure

consistency across DSMT programs. CMS should ensure that all relevant partners

including claims adjudicators follow a consistent approach throughout the audit

and oversight processes to ensure better alignment with the purpose and scope of

high-quality DSMT programs of all types and sizes.

Report to Congress

Benefits of Community-Based Diabetes Educaton Programs

Rationale

Community-based diabetes education programs modify the formal approach used by

DSMT. They are commonly offered in group settings and in diverse locations including

schools, work sites, community centers, or places of worship. These programs generally

are led by trained public health workers who come from the communities they serve and

self-identify as community health workers, promotores de salud (the Spanish term for

community health workers), community health representatives, community health advisors,

or other related titles.²⁴⁴ Classes are generally tailored to meet the unique scheduling,

cultural, educational, and language preferences of the communities being served. These

programs are not intended to replace formal DSMT but can serve as an avenue to increase

access to DSMT and other health care resources.

Evidence supports the effectiveness of community-based diabetes education programs for

diverse groups of participants, including minority Medicare beneficiaries.^245-248 However,

these programs are often supported by grant funding,^{246, 249} and do not have a sustainable,

direct source of reimbursement. Innovative collaborations between community-based

diabetes education programs and accredited DSMT²⁵⁰ programs can be complementary

and help organizations meet quality standards.²⁵¹

Recommendation 6.2: The National Clinical Care Commission recommends that

CMS develop reimbursement mechanisms for community-based diabetes education

programs, as a complement to existing accredited/recognized DSMT programs, when

evidence shows that these programs improve diabetes outcomes.

Focus Area 2. Improve Access to Effective Diabetes Devices

Background

Management of diabetes involves maintaining blood glucose at near-normal levels,

especially in young and otherwise healthy patients in whom early intensive control has long-

term beneficial effects. To achieve this goal, some patients may need to monitor their blood

glucose levels by pricking their fingers and inject insulin several times a day. However,

these finger prick glucose levels do not fully capture the dynamic changes in blood glucose

levels that occur throughout the day; and the finger pricking is uncomfortable. People

with diabetes also face the specter of severe hypoglycemia (dangerous low blood glucose

levels resulting from some diabetes treatments), which can lead to altered mental status,

unconsciousness, seizures, or even death.

Many technologic advances have emerged to facilitate self-management and improve

the quality of life for patients with diabetes. These include insulin pumps and continuous

Department of Health and Human Services

2021

glucose monitors (CGM). Insulin pumps continuously deliver small amounts of insulin into

the tissue under the skin in a way that mimics how the pancreas normally works. They also

allow for frequent adjustments to the amount of insulin being administered. CGM devices

collect glucose information through frequent and painless sampling of the fluid in the tissue

under the skin. These devices measure glucose levels and display trends throughout the

day and night. This information allows patients to modify lifestyle choices and diabetes

medications (sometimes in real-time), and some devices alert patients to blood glucose

trends that suggest impending hypoglycemia. Newer pumps, when combined with CGM

devices, automatically adjust insulin delivery without direct patient input (that is, they

function as an “artificial pancreas”).

Growing evidence suggests that these devices can provide a wide range of benefits

to patients with diabetes, including improved glucose control and reduced glucose

variability. Patient-reported outcomes suggest that use of these devices can lead to a

better understanding of and control over blood glucose changes and reduce patients’ fear

of hypoglycemia. Additionally, using these advanced technologies can help reduce the

burden of diabetes-related care, diabetes distress, and acute diabetes complications.^252-254

Rationale

Diabetes devices are underutilized by patients with diabetes who could benefit from their

use. There are many reasons for this underutilization. Administrative burdens exist for

both patients and clinicians in obtaining and maintaining insurance coverage for these

devices. Additionally, CMS eligibility requirements are not interpreted or applied uniformly

across parties involved with eligibility review and approval. Furthermore, CMS coverage

of blood glucose testing supplies is not aligned with eligibility requirements for diabetes

technologies. Of great concern, eligibility requirements and coverage are lagging behind

the evolving evidence of their effectiveness.^{255, 256}

Recommendation 6.3: The National Clinical Care Commission recommends that

CMS use existing processes to update and regularly reevaluate (at least every three

years) eligibility requirements for various diabetes devices leading to appropriate

coverage determinations when there is sufficient evidence to support such national

determinations. CMS should ensure that, to the extent there are national requirements

established, eligibility, documentation, and reimbursement requirements are clearly

defined, and that they are consistently applied across all parties involved, including

Medicare Administrative Contractors and auditors. In evaluating the data to revise

eligibility requirements, CMS should evaluate the current evidence, including

published, peer-reviewed evidence, and consider both glycemic benefits and non-

glycemic benefits (including patient-reported outcomes, which may include quality-of-

life and diabetes distress).

Report to Congress

There is currently a National Coverage Determination (NCD)²⁵⁷ for infusion pumps and a

Local Coverage Determination (LCD)²⁵⁸ for CGM. Stakeholders report that the eligibility

criteria for NCD and LCD are outdated and do not reflect the current evidence on who

would benefit from access to diabetes technologies.^259-261 CMS eligibility requirements for

diabetes technologies need to be updated to better reflect the patient population for whom

these technologies are “medically reasonable and necessary.”

Given that evidence continues to evolve, CMS should regularly reevaluate and revise its

coverage criteria. CMS currently has a process to review and revise NCDs. The process

can be initiated internally or by external requests. From the perspectives of patients and

providers, this process is not optimally utilized to keep CMS coverage criteria current with

the evolving data. By using existing processes to regularly evaluate new data, CMS can

ensure that appropriate patients are able to use the reasonable and necessary diabetes

technologies to manage their diabetes in a timely manner. The National Clinical Care

Commission believes that regularly revisiting the evidence at intervals of no more than

every three years is a reasonable timeframe to allow for meaningful new evidence to accrue

while still being frequent enough so that patients’ access to diabetes technologies are not

unreasonably delayed.

Examples of existing requirements that may pose barriers to patients and providers and

suggestions to address these barriers are described below.

1. Glucose and C-peptide* and auto-antibody levels should be removed as eligibility

criteria for insulin pumps.

2. Frequent blood glucose testing (that is, four times per day) should be removed as

an eligibility criterion for insulin pumps.

3. Multiple daily injections of insulin should be removed as an eligibility criterion for

CGM.

4. For durable medical equipment suppliers, Medicare Administrative Contractors

and auditors should better align their interpretation and application of eligibility

and reimbursement requirements. Coverage determinations should be written

clearly so that the interpretation is consistent.

5. In-person follow-up visits should not be required to maintain eligibility for diabetes

devices. Virtual care (for example, telephone or video visits) may be sufficient to

accomplish the same monitoring goals.

* C-peptide (or connecting peptide) is produced by the pancreas in equal amounts to insulin. A low or absent

C-peptide level in the setting of an elevated blood glucose level reflects low or absent insulin production, and

thus may indicate type 1 diabetes or patients with diabetes whose pancreases can no longer produce insulin.

Department of Health and Human Services

2021

6. The approval process for continued access to diabetes devices should be

streamlined when patients transition to Medicare from other insurance coverage.

In addition, hypoglycemia avoidance and patient quality of life should be considered in

establishing and revising coverage determinations for diabetes devices.

While growing evidence supports the short-term benefits of insulin pumps, CGMs, and

artificial pancreas systems, data on longer-term clinical benefits and cost-effectiveness

are needed to support CMS as the agency considers whether to establish new or modify

existing NCDs. Given that the available data are insufficient to support using these devices

among all patients with diabetes, identifying the gaps in evidence is important to inform

future research. To enhance transparency regarding where those gaps exist, CMS should

include a summary (as part of the NCD) of the additional information needed for the agency

to determine if a technology is “medically reasonable and necessary.” This information

could help facilitate research to fill those gaps.

Patient Testimonial:

A 65-year-old man has had type 1 diabetes since he was 2 years old and recently

transitioned to Medicare. He has used an insulin pump and CGM for years with good

blood glucose control. Upon transitioning to Medicare, he was told by his clinician that

Medicare regulations require him to prove that he has type 1 diabetes to continue receiving

supplies for his insulin pump and CGM. Specifically, he was told he needs fasting blood

work to measure C-peptide, which is usually very low in type 1 diabetes. He lives in a rural

community and must drive two hours to get his blood work done. Because of his diabetes

and the long travel time, he was unable to fast, and as a result, the results of his blood work

were deemed invalid despite the C-peptide level being undetectable. He had to repeat

the test but developed hypoglycemia during fasting for the test. To treat the hypoglycemia,

he had to take supplemental glucose, which elevated his blood glucose but unfortunately

invalidated the C-peptide results. On his third attempt, he lied about fasting so that his

C-peptide results could be deemed valid. During this time, he ran out of supplies for his

pump and CGM, which have been integral to the management of his diabetes.

Report to Congress

Patient Testimonial:

A 68-year-old man had his pancreas removed as a treatment for pancreatic cancer. As

a result, he does not make insulin. His physician determined that an insulin pump with

advanced features would allow for better blood sugar control and minimize treatment

complexity while maximizing quality of life. However, the patient does not meet CMS

criteria for an insulin pump because he does not have autoantibodies and his C-peptide

level is detectable. As an advocate for the patient, the doctor has to work with the device

manufacturer to obtain a loaner pump as a compassionate measure without any guarantee

that the device will continue to be available if the manufacturer chooses to no longer

provide it.

Health Care Provider Experiences:

• A physician is required to document in the medical record that an older adult with

diabetes has more than one year of life expectancy before the patient is allowed to

receive the prescribed device and supplies.

• A physician documents that a patient is performing blood glucose testing four

times per day, as required by CMS criteria to obtain a CGM device. However, the

request for the device was denied when the patient’s glucose meter data download

shows an average of 3.9 blood glucose tests per day.

• A supplier of durable medical equipment requires the treating physician to change

phrases and addend the medical record to meet supplier requests, even when the

same language was previously accepted by the same supplier.

• A physician is required to document in the medical record that a patient who is

already using a CGM device is also performing blood glucose testing four times

per day using a blood glucose meter. However, meter-based testing is impossible

for the patient because Medicare no longer covers blood glucose meters and

supplies when a patient begins to use a CGM device. The patient’s only option is to

purchase these supplies on their own.

Department of Health and Human Services

2021

Focus Area 3. Team-Based Care

Increasing the Health Care Workforce

Background

Person-centered, team-based care is critical to improving the lives of people with diabetes.

The National Academy of Medicine defined team-based care as “The provision of health

services to individuals, families, and/or their communities by at least two health providers

who work collaboratively with patients and their caregivers—to the extent preferred by each

patient—to accomplish shared goals within and across settings to achieve coordinated,

high-quality care”.^{262, 263} Team-based care is one of the most effective ways to ensure that

people with diabetes have their care needs met and attain improved overall health and

wellbeing.^264-268

Person-centered, team-based care facilitates access to care and delivery of essential health

care services. A recent AHRQ report entitled “Creating Patient-centered Team-based Primary

Care”²⁶⁵ described person-centered care as relationship-based, making the person feel

known, respected, engaged, and knowledgeable. Fundamental to this approach is the

belief that, when clinical practices draw on the expertise of a variety of team members,

people are more likely to get the care and support they need.^{265, 269} Competing demands

such as coexisting medical and behavioral health conditions, multiple medications, general

preventive care, social factors, and/or stressors often impede the ability of people with

diabetes to manage diabetes effectively.^{270, 271} These complexities also interfere with a single

health care provider’s ability to offer high-quality, guideline-recommended care. One of

the most effective approaches to address these gaps in care and improve outcomes is to

empower non-physician providers to work as part of an inter-professional care team and

assist patients with diabetes.^264-268

People with diabetes are most likely to seek care at primary care practices, and this setting

is optimal to develop sustained relationships, coordinate care among specialists, and

address family, social, and mental health needs. Thus, integrating inter-professional team-

based care into primary care is critical.^{265, 269} The composition of person-centered care teams

can vary but should reflect the diversity of the communities served by the primary care

practice. Working in conjunction with a physician, team members often include (1) nurses,

(2) dieticians, (3) social workers, (4) integrated behavioral health specialists, (5) clinical

pharmacists, (6) care coordinators, (7) medical assistants, and/or (8) community health

workers (CHWs).

For this report, the Commission focuses on key aspects of person-centered, team-based

care that have the greatest potential to (1) improve diabetes outcomes, patient experience,

and provider experience, and (2) reduce health care cost; and that may be addressed by

federal agencies.

Report to Congress

Rationale

For practices to implement team-based care, they need access to an appropriately trained

workforce, adequate reimbursement to support the team, and assistance and support in

incorporating the team into their practice.

Team-based care requires a trained health care workforce that reflects the needs of

communities

The numbers of primary care clinicians, behavioral health specialists, dentists, and other

team members are insufficient to meet the needs of people with diabetes, especially in rural

and underserved settings.²⁷² Since a large proportion of trainees stay in the area where they

train, location of training programs has important implications.^{272, 273} Several deficiencies and

barriers in federal efforts impeded the development of an adequate workforce for team-

based care:

• Lack of a global assessment of primary health care workforce needs.

• Lack of standardized data collection to demonstrate the impact of training on

health care workforce needs.

• Agencies that support training programs are not required to address health care

workforce needs identified by HRSA.

• Limits are placed on the types of health care professional trainees that are

allowed in certain HRSA training programs, making it challenging to provide

interprofessional training.

Health care professional training is primarily supported by CMS with graduate medical

education payments to teaching hospitals (about $11 billion annually). Each teaching

hospital is allowed to determine the specialty training it provides. This flexibility helps

individual health care systems meet their immediate hospital workforce needs; however,

those needs often do not align with local or national health care workforce needs.²⁷² This

flexibility also has the potential unintended consequence of training more specialists and

fewer primary care providers.

HRSA provides a health workforce assessment that describes the supply, demand,

distribution, and education of the U.S. health care workforce.²⁷⁴ HRSA also manages more

than 70 HHS workforce programs and aligns its programs to meet workforce needs. Despite

a recent increase in funding for the HRSA National Health Services Corp, the number

of trainee positions funded by HRSA is still inadequate to meet the workforce needs of

underserved communities.

Department of Health and Human Services

2021

Adequate reimbursement is required for practices to implement and sustain

team-based care

The lack of reliable reimbursement for team members limits practices’ ability to develop

and implement such practices. This is especially problematic for CHWs, clinical pharmacists,

and behavioral health specialists, all of whom can help improve outcomes for people with

diabetes, if they are included as part of team-based care. Value-based payment models

have the potential to support the inclusion of additional team members. There are a variety

of innovative ways in which these value-based payment models might incentivize and

support the inclusion of additional team members. Centers for Medicare and Medicaid

Services/Center for Medicare and Medicaid Innovation (CMS/CMMI) are currently testing

value-based payment models and initiatives.

Technical assistance is needed by primary care practices to implement team-based care

Implementing team-based care requires a change in the approach to and design of care

delivery. Primary care practices, especially small and medium-sized practices, do not have

the expertise and/or resources for this transformation. Technical assistance (or practice

consultation and coaching) can facilitate practice transformation and the adoption of

evidence-based practices, quality improvement, and system changes.^275-279 The Primary

Care Extension Program (PCEP) was established by the Accountable Care Act to provide

this type of technical assistance but lacks funding. AHRQ has used limited funds to support

PCEPs in a small number of states. These demonstration projects have shown improvements

in implementing disease prevention strategies and integrating elements of team-based

care by participating primary care practices.^280-282 Additional funding would allow the

extension of this model to all states, accelerating the uptake of team-based care.

Recommendation 6.4: The National Clinical Care Commission recommends that steps

be taken to ensure an adequate workforce and to enhance and sustain team-based

care to improve outcomes for people with diabetes.

• Establish a process within HHS to routinely assess and identify all health care

workforce needs and ensure that training program funding across agencies is

directed to meet those needs.

• Ensure the Health Resources and Services Administration (HRSA) training

programs are designed to meet unmet needs in the team-based health care

workforce.

◊ Evaluate and address regulatory or statutory limitations on HRSA

training programs that affect the agency’s ability to meet the needs of

team-based care and new care models.

Report to Congress

◊ Increase funding for exemplary HRSA programs that support training

health care professionals in team-based care in medical shortage areas,

such as the HRSA National Health Services Corp.

• Identify and implement mechanisms for involvement of community health

workers, clinical pharmacists, and integrated (or collaborative) behavioral

health services in existing and future value-based models of care (alternative

payment models)

• Enhance funding to AHRQ through Primary Care Extension Programs and

other mechanisms to provide technical assistance to medical practices to

implement team-based care.

Patient Testimonial

Stephanie is a 37-year-old woman who has had type 2 diabetes for seven years. In 2017,

her blood glucose was consistently in the 300s and her physician referred her to work with

the clinical pharmacist to optimize her medication regimen. She subsequently had eight

visits during which the pharmacist helped her adjust her insulin doses. After 14 months, her

blood glucose improved to values consistently in the lower 100s, significantly reducing her

risk for many life-altering complications associated with diabetes.

Stephanie was ecstatic to see her hard work pay off and wanted to continue improving

her health only to be met with a significant financial barrier. When she went to pick up her

insulin at the pharmacy, her copay was over $900 for a one-month supply. Stephanie was

overwhelmed, frustrated, and confused. It turns out her new job had different insurance

coverage, which led to the surprising high cost. Stephanie was then faced with the decision

to resign from her job and apply for Medicaid to be able to afford her insulin or keep her

job and not be able to afford the insulin. She reached out to the clinical pharmacist who

connected Stephanie to a manufacturer insulin savings program, which could provide

her with an affordable monthly co-pay for the insulin. Through the help of the clinical

pharmacist, Stephanie reached her goal blood glucose levels, has avoided significant

complications, and has maintained affordable access to insulin.

Department of Health and Human Services

2021

Community Health Workers

Background

Many of the barriers to improving health outcomes for people with diabetes are economic,

social, and/or environmental. Overcoming these social determinants of health (SDOH)

requires connections between providers and community resources. Enhancing trust and

cultural competence is particularly relevant given the health disparities in communities

of color. CHWs serve as a liaison between health services and social services and the

community. CHWs are frontline public health workers who are trusted members of or have

a particularly good understanding of the community. To be most successful, CHW “natural

helper” skills take precedence over clinical skills.²⁸³ Community health worker interventions

have been shown to be cost effective in improving diabetes knowledge, lifestyle behaviors,

and diabetes health outcomes, especially in disadvantaged populations.^{284, 285} Given the

significant health disparities for people with diabetes, implementing effective strategies for

communities that are disadvantaged is particularly important.

Rationale

Despite CHWs’ contributions to the improved health outcomes of people with diabetes,^284,

²⁸⁵ uptake of CHWs by care teams has been low because of limited reimbursement and

barriers to implementation. CMS has recognized the role of CHWs. The CMS Final Rule

issued July 15, 2013 allowed Medicaid agencies to reimburse community-based preventive

services, including those provided by CHWs.²⁸⁶ However, most states have narrowly

interpreted this rule concluding that it only applies to medical preventive services and not

social, economic, and behavioral services. In addition, on January 7, 2021, CMS issued a

“roadmap” with guidance to state health officials. The roadmap was designed to drive the

adoption of strategies that address SDOH in Medicaid and the Children’s Health Insurance

Program.²⁸⁷ However, CHWs were not specifically mentioned in the roadmap.

In addition to reimbursement issues, organizations need assistance to integrate CHWs

into team-based care. The CDC has grants, toolkits, and online resources to assist health

care organizations, community organizations, and states in implementing and sustaining

a CHW workforce. Increased funding to CDC would accelerate the implementation and

sustainability of CHWs by addressing system and policy level barriers to integration at the

state level.

Report to Congress

Recommendation 6.5: The National Clinical Care Commission recommends that steps

be taken to enhance implementation and sustainability of community health workers

(CHWs) as critical members of diabetes care teams.

• CMS should clarify and build on the 2013 final rule, expanding the scope of

Medicaid-reimbursable services by CHWs to include social, behavioral, and

economic supports as part of covered services.

◊ Clarify that Medicaid funding is available for CHWs to address social

determinants of health (SDOH), building on the January 7, 2021 - CMS

SDOH Roadmap.

◊ Clarify that CHW qualifications should focus on life experience,

interpersonal skills as natural helpers, community membership, as well

as formal education or clinical training.

◊ Develop policies that require CHW services be delivered in accordance

with evidence-informed standards for CHW programs such as those

developed by the National Committee for Quality Assurance, the CDC

CHW Core Consensus (C3) Project, the Community Guide, and the

National Association of Community Health Workers (NACHW).

• Increase funding to CDC to expand programs to assist all states in

infrastructure development and processes to integrate CHW services in a

comprehensive, whole-person approach that includes economic, behavioral,

and social supports, as well as clinical and preventive services.

Focus Area 4. Expand Virtual Care

Background and Rationale

Diabetes prevalence is higher in rural and underserved communities than in urban areas.

People with diabetes living in rural and/or underserved communities have limited access

to health care facilities and specialty care and often endure long and difficult commutes or

lack the transportation needed to access guideline-recommended care. Travel and time

constraints keep many individuals from receiving diabetes education services, adequate

primary care, and specialty care. Additionally, Medicare beneficiaries using diabetes devices

(for example, insulin pumps and continuous glucose monitors) are required to have regular

interim medical visits to be approved for their ongoing use. The required in-person visits

pose additional challenges to individuals with work or family demands or disabilities.

Department of Health and Human Services

2021

During the COVID-19 Public Health Emergency, CMS issued waivers to allow the use of

telemedicine to facilitate data sharing, receipt of ongoing diabetes care and education, and

continued use of diabetes devices without in-person visits. The waivers are well received by

the medical community and patients and are helping patients receive needed care without

in-person visits.

Virtual care, a broader term than telemedicine, generally encompasses (1) use of web-

based portals for communication between patients and their care teams; (2) electronic

consultations between primary care and specialty clinicians; (3) telehealth clinic visits; (4)

data (from diabetes device) sharing between patients and their care teams; (5) diabetes

education classes for patients using technology-based platforms; and (6) real-time, peer-to-

peer consultations and mentoring for clinicians and care teams.

Virtual care, including telemedicine, can help care teams and patients access additional

resources and services,^{288, 289} and reduce the gaps in receipt of high-quality diabetes

care. Continuing access to and reimbursement for virtual care such as telemedicine

visits will allow clinicians to provide best-practice diabetes care to rural and underserved

communities.

Opportunities

To benefit from virtual care, patients with diabetes must have access to and subsequently

adopt digital connectivity and services. The federal government is working to expand

broadband access for those who lack digital connectivity and help them overcome barriers

to adoption.

The Commission identified additional federal programs and policies that have shown great

potential in helping deliver virtual care to a wide range of patients.

• The VA/DoD Virtual Medical Center (VA-VMC). The VA-VMC is a novel

program developed jointly by the Department of Veterans Affairs and Department

of Defense.²⁹⁰ This virtual approach to diabetes self-management education

and support (DSMES) helps patients overcome travel and schedule barriers by

providing access to real-time DSMES and peer support groups and a wealth of

educational materials. This program became the first nationally certified DSMES

program recognized by the American Diabetes Association. If used across federal

agencies (for example, through collaborative agreements), this program can deliver

virtual DSMES to patients who otherwise do not have access to DSMES services or

have travel and time constraints.

Report to Congress

• E-consults. CMS has implemented reimbursement codes for interprofessional

consultations conducted through electronic communication (known as

“e-consults”). E-consults are formal, synchronous or asynchronous, clinician-

to-clinician consultations without patient presence and occur within a shared

electronic health record or web-based portal. E-consults have been shown to

improve access to specialty care, avoid delays in care, reduce costs to patients

and the health care system, enhance clinician knowledge of how to better

evaluate and/or manage many conditions, and improve communication and

collaboration between clinicians. As an example, VA’s e-consults reduced response

time for specialty consults from an average of 34.4 to 2.4 days across several

specialties.^291-293

Recommendation 6.6: The National Clinical Care Commission recommends that

Congress support use of virtual care modalities in the following ways:

• Remove geographic and originating site restrictions so that CMS can provide

access to telehealth services as appropriate.

• Make permanent the ability for Federally Qualified Health Centers and Rural

Health Centers to provide services by telehealth.

• Make permanent the telehealth waiver for Diabetes Self-management

Education and Support (DSMES)/Diabetes Self-Management Training (DSMT);

and

• Maintain coverage for audio-only visits to comply with the Executive Order on

Advancing Racial Equity and Support for Underserved Communities.

Telehealth is safe and effective when compared to in-person visits for diabetes education

and clinical care.^294-298 For those with limited digital literacy or access, telephone visits have

shown equivalent benefits to video visits.²⁹⁹ Telehealth serves as an important option for

patients to receive individualized and optimized diabetes care. It can help improve clinical

outcomes and lower costs.

Department of Health and Human Services

2021

Telementoring to Improve Access to High-Value Care for People

With Diabetes

Background

Practices affiliated with the Indian Health

The Extension for Community

Service (IHS) and with HRSA serve

Healthcare Outcomes (Project

patient populations with a prevalence

ECHO) based at the University

of diabetes that exceeds the national

of New Mexico is an example

average.^{300, 301} Patients served in such

of successful telementoring

settings may also find it more difficult

programs. Its hub-and-spoke

to receive specialty care.^302-304 Front

model enables capacity building

line primary care clinicians serving

through ongoing, knowledge-

these patients are often responsible for

sharing between geographically

delivering ongoing care but may not

isolated care teams and a faculty

have all the tools and specialty expertise

of specialty care experts.

needed. Virtual care such as technology-

enabled collaborative learning and

capacity building or telementoring programs can help the clinicians access specialty care

expertise effectively and more cost-efficiently. Several federal departments and agencies

such as VA, CMS, IHS, AHRQ,³⁰⁵ and HRSA have already begun using telementoring to help

meet the needs of the patients they serve, though to a limited extent.

Rationale

IHS and HRSA both face challenges to maximize the benefits of telementoring for people

with diabetes. Despite having conducted pilot projects, each agency has limited capacity to

continue or expand these programs. Funding for technology-enabled collaborative learning

and capacity building was offered to IHS and HRSA through legislation,³⁰⁶ but competing

demands for managing other health issues have reduced the funding available for

addressing diabetes care. In addition, neither IHS nor HRSA has the internal administrative

capacity to administer large demonstration projects of hubs (specialty experts) and spokes

(primary care teams) and collect data to monitor effectiveness. Collaboration between

CMMI, which has administrative expertise, and an entity experienced in diabetes care

telementoring will enhance the effectiveness of demonstration projects within both IHS and

HRSA.

Recommendation 6.7: The National Clinical Care Commission recommends that the

Centers for Medicare & Medicaid Innovation (CMMI) fund a demonstration project

with the Health Resources and Services Administration (HRSA) and the Indian Health

Service (IHS) that utilizes a technology-enabled collaborative learning and capacity

building model (for example, Project ECHO-type model) to support uptake and

Report to Congress

implementation of diabetes care best practices among primary care providers and

care teams. The project should include training of community health workers, payment

for both hub and spoke participants’ time, collection and analysis of interim data, and

utilization of a shared-services approach for training on the telementoring model,

infrastructure, and data collection to inform broader implementation.

• In collaboration with HRSA, provide diabetes-related telementoring to

small or rural health clinics (spokes) to include focus on social determinants

of health and behavioral health issues that impact diabetes outcomes

and leverage existing academic center hubs to support uptake and

implementation of diabetes care best practices.

• In collaboration with IHS and tribal and urban Indian clinics, create supportive

learning and mentorship relationships to assist in implementing diabetes

care best practice and leverage the existing Tribal Epidemiology Centers and

academic center hubs.

The demonstration projects should include reimbursement for clinicians and members of

the care team to attend mentoring sessions because this is an extension of patient care.

Data collection should be designed to assess impacts on patient outcomes, clinician and

care team satisfaction, and associated health care costs. If successful, expansion of this

model may improve the receipt of high-quality, individualized diabetes care and optimize

health outcomes for a large segment of the population that is largely underserved.

This recommendation is specific for HRSA and IHS to develop demonstration projects of

clinician-to-clinician mentoring using a virtual platform to help improve access to diabetes

specialty care for the patients they serve.

Focus Area 5. Hypoglycemia Safety and Quality Measure

Background

Quality of care is often tracked with quality measures to ensure favorable outcomes across

populations. Such quality measures are often used by health systems and payers to drive

performance and quality improvement. Quality measures for diabetes primarily focus on

improving glucose control because the degree and duration of hyperglycemia are directly

related to the risk of long-term diabetes complications (for example, blindness, end-

stage kidney disease, and amputations). However, for many older adults with advanced

complications and comorbidities and for people with limited life expectancy, such treatment

goals have modest benefits and carry increased risk.

Department of Health and Human Services

2021

Rationale

Severe hypoglycemia (dangerously low blood glucose levels) is not uncommon among

people treated with some diabetes medications including insulin. The risk of attendant

harms (for example, falls, fractures, hospitalizations, and death) from severe hypoglycemia

are increased in older adults. Therefore, less intensive glucose targets should be applied to

older adults with diabetes who are taking medications that increase risks of hypoglycemia,

but who are unable to recognize and/or appropriately treat hypoglycemia (for example,

patients with dementia), and to individuals across the life span with clinical conditions that

limit life expectancy (for example, patients with metastatic cancer). In such persons, the risks

from hypoglycemia, treatment burden, and costs may outweigh any potential benefits. Such

potential overtreatment lies at the intersection of low-value practices and patient safety and

should be discouraged.

Current federal quality measures focus solely on avoiding high blood glucose levels.

However, treatment approaches that relax glucose control in some older adults or those

with limited life expectancy are widely considered high-quality diabetes care. Nonetheless,

clinicians often treat such patients to achieve lower blood glucose levels, which is an

unintended consequence of current quality measures. In doing so they may minimize or

overlook the potential risks of hypoglycemia to the individual. Therefore, a quality measure

that focuses on avoiding hypoglycemia needs to be developed and applied to patients with

diabetes in whom hypoglycemia poses short-term risks for major complications.

Recommendation 6.8: The National Clinical Care Commission recommends that

CMS develop and implement a quality measure to assess potential overtreatment,

inappropriate treatment, or risk of harm among Medicare beneficiaries with diabetes

and life-limiting conditions to reduce the incidence of severe hypoglycemia and

improve patient safety.

Focus Area 6. Insulin Affordability

Background

Insulin is essential for life and for the survival of patients with type 1 diabetes. In type 1

diabetes, the pancreas makes so little insulin that without insulin treatment the person will

develop dangerously high blood glucose levels, a condition termed diabetic ketoacidosis.

Diabetic ketoacidosis is a medical emergency that almost always requires hospitalization

and can be fatal. For other people with diabetes, their bodies make enough insulin to avoid

ketoacidosis but not enough to control their blood glucose levels. These individuals require

insulin to control glucose levels over time to avoid the chronic complications of diabetes. At

least 7 million people in the U.S. require insulin to manage their diabetes and for many of

these people, insulin is life-sustaining. Having access to insulin day in and day out is critical

for managing diabetes and essential to achieving a long and healthy life.

Report to Congress

Rationale

Diabetes treatment with insulin became available in the 1920s. Over time, major advances

in the way insulin is formulated have enhanced its effectiveness. Many of these changes

have long since moved from being proprietary and patent-protected. Despite this, the cost

of insulin has increased dramatically at a rate that far exceeds the rate of inflation, making it

unaffordable for many patients with diabetes. In 1999 a vial of insulin lispro (Humalog®) cost

$21 and in 2019 it cost $332.³⁰⁷ A person with diabetes can require several vials of insulin

each month, and the monthly cost for insulin can exceed $1,000. This does not include the

costs for the supplies needed to administer insulin and to monitor blood glucose levels.

The high cost of insulin poses a tremendous barrier to optimal diabetes treatment. At

least one in four individuals treated with insulin report rationing³⁰⁸ their insulin while even

more make significant trade-offs in other aspects of their lives (for example, food, housing,

transportation, etc.) to purchase the insulin they need.

Opportunities

Part D Senior Savings Model

In January 2021, CMMI launched a new approach for pharmacy payment called the Part D

Senior Savings Model.³⁰⁹ The model is testing the impact of offering Medicare beneficiaries

a choice of enhanced Part D plan options that have lower out-of-pocket costs for insulin.

The program is available to beneficiaries who receive Part D coverage through stand-alone

prescription drug plans or Medicare Advantage Prescription Drug plans. Beneficiaries have

broad access to multiple types of insulin at a maximum copay of $35 per insulin per month

in the deductible, initial coverage, and coverage gap phases of the Part D benefit.

Participating pharmaceutical manufacturers pay the 70% discount in the Part D coverage

gap for the insulins they market. Part D sponsors are also required to encourage healthy

behaviors and medication adherence through rewards and incentive programs. The

Medicare Part D Senior Savings model has the potential to reduce out-of-pocket costs and

provide stable, predictable copays for the insulins. This offers an opportunity for CMMI to

conduct widespread testing and rigorous evaluation of the Part D Senior Savings Model,

and if effective, encourage its broad implementation by CMS.

The above program serves as a promising, intermediary step. However, this does not apply

to all Medicare beneficiaries with diabetes. For example, those who are using insulin pumps

have their insulin covered by Medicare Part B and cannot take advantage of the Part D

Senior Savings Model, nor can people with other forms of insurance or no insurance. Much

more needs to be done to reduce the cost of insulin, a life-sustaining medication.

Recommendation 6.9: The National Clinical Care Commission recommends that

federal policies and programs remove cost barriers to ensure that insulin is affordable

for all people with diabetes and that no one with diabetes who needs insulin cannot

get it because of cost.

Department of Health and Human Services

2021

Curbing major price escalations for insulin and

“The adverse outcomes

making it more accessible will involve policies

associated with diabetes, and

and programs of several federal agencies. The

the resulting costs of care,

Commission’s recommendation is based on

can be reduced with effective

what needs to be done, with recognition that

treatments, preventive strategies,

how to accomplish this will be a complex task

and diabetes self-management

with many steps and components.

education and support.”

Possible interventions to make insulin

American Diabetes Association

accessible and affordable for people with

diabetes:^{307, 310-312}

•

Cap maximum price increases for insulin at no more than the rate of inflation.

•

Limit out-of-pocket costs without increasing premiums or deductibles through one

or more of the following policies:

◊ Limit cost sharing to a copay of no more than $35.

◊ Provide first-dollar coverage.

◊ Cap costs at no more than $100 per month.

•

Develop a payment model for Medicare Part B beneficiaries in addition to Part D

that lowers out-of-pocket costs for insulin.

•

Provide “safety net” measures and laws providing immediate access to insulin in

emergency circumstances, especially for people with type 1 diabetes who are

unable to afford insulin.

•

Allow government negotiation of drug prices.

•

Eliminate rebates or ensure that rebates that are paid by a manufacturer to

Pharmacy Benefit Managers are transparent and passed on to patients without

increasing premiums or deductibles.

•

Reform the regulatory and legal processes to facilitate introducing biosimilar

insulins to create marketplace competition.

•

Eliminate anticompetitive arrangements including pay-for-delay, shadow pricing,

“evergreening” of patents (that is, patent extensions for minor changes in the

formulation or mode of delivery) and limit re-labeling brand drugs as “authorized

generics” of the parent pharmaceutical company.

Report to Congress

Patient Testimonial

--Andrew (Drew) Wickman

“ I was diagnosed with ‘sugar diabetes’ at the age of 3

in 1949. I’ve seen a lot of changes over the last 72 years.

I’ve gone from urine testing with a test tube and Clinitest

tablets to finger sticks and then continuous glucose

monitors. Insulin has gone from NPH U40 beef/pork insulin

to genetically modified Humalog. Delivery has gone from

a glass syringe and a needle as big as a pipe, which came

with cleaning wires and a sharpening stone, to an insulin

pump/CGM loop system. I remember buying a vial of insulin

for $1.40 and not having or needing insurance. Now without

Medicare and insurance through my employer I couldn’t afford to have type 1 diabetes. I’ve

been fortunate to have suffered from only one complication in all these years. My Diabetic

Retinopathy was treated with laser surgery and has been stable since around 1980 with only

minimal loss of peripheral vision. I’m happy, healthy and active at the age of 74 and now my

concerns involve Medicare regulations which are apparently made for people who live in

cities and not for rural residents.”

Department of Health and Human Services

2021

Focus Area 7. Coverage for Secondary Prevention

Background

Once diabetes is diagnosed, treatment goals are directed to maintaining health and

preventing damage to the heart, eyes, kidneys, and nerves. Diabetes complications are

the greatest cause of morbidity and mortality and the largest contributor to the cost of

diabetes.³¹³ If complications are present, the cost of diabetes care is three times higher than

when there are no complications.³¹⁴

Prevention strategies fall into three categories: primary prevention aimed at preventing

a disease before it occurs, secondary prevention aimed at reducing the impact of a

disease once it has occurred, and tertiary prevention aimed at reducing disability and

restoring function in someone with a complication of the disease. Much can be done to

avert (primary prevention), delay (secondary prevention), or mitigate (tertiary prevention)

the complications of diabetes, particularly by adhering to evidence-based guidelines.

Unfortunately, nearly two-thirds of people with diabetes are not receiving secondary

or tertiary prevention care, putting them at risk for avoidable health care utilization and

costs.²³¹

As a provision of the Affordable Care Act, health insurers are required to cover, at no

cost to the patient, primary prevention services that the U.S. Preventive Services Task

Force recommends as Grade A or Grade B. However, secondary prevention strategies

(for example, diabetes self-management education and support) and tertiary prevention

strategies (for example, eye exams to identify diabetic retinopathy in its earlier stages and

allow treatment to prevent blindness) are not treated similarly, even if they are highly cost-

effective.

Rationale

Providing pre-deductible coverage (that is, coverage at no cost to the patient) for some

of the most critical secondary and tertiary prevention services for diabetes offers an

opportunity to help close existing care gaps and the associated human and financial costs

of diabetes complications. This is especially true for those with health disparities and the

uninsured or under-insured. The causes for these treatment gaps are multifactorial and

include patient-, clinician-, and health system-related factors. Lack of affordability, however,

is a major patient-related factor that prevents optimized care and better outcomes. For

most patients, including Medicare beneficiaries, secondary and tertiary prevention services

require cost sharing (that is, copays) as part of the coverage. For people with diabetes, and

especially those with lower incomes, cost sharing reduces treatment adherence. Removing

cost sharing enhances adherence to prevention services and therapies.³¹⁵ A consequence

of reduced adherence resulting from medication cost sharing is increases in health care

utilization and costs from emergency department visits and hospital stays.³¹⁶ There are many

Report to Congress

high-value secondary and tertiary prevention treatments and services that can delay the

onset and progression of and disability associated with diabetes complications, but their

use is often limited by cost.

Recommendation 6.10: The National Clinical Care Commission recommends

that HHS establish a process to determine and regularly reevaluate high-value

diabetes services and treatments to be fully covered (pre-deductible) by health

insurance based on their ability to prevent development or progression of diabetes

complications.

Some examples of services and treatments to consider for pre-deductible coverage:

• Equipment and supplies for self-monitoring blood glucose and continuous glucose

monitoring

• Diabetes Self-Management Training (DSMT) (Medicare) / Diabetes Self-

Management Education and Support (DSMES) (other than Medicare)

• Retinal exams (“diabetes eye exam”)

• Shoes and foot orthotics for people with diabetes who have lost sensation in their

feet because of nerve damage from diabetes

• Certain high-value medications shown to reduce heart disease and kidney failure in

patients with diabetes. These medications include sodium-glucose co-transporter-2

inhibitors, glucagon-like peptide-1 receptor agonists, angiotensin-converting

enzyme inhibitors, angiotensin receptor blockers, and mineralocorticoid receptor

antagonists

Focus Area 8. Research Needs

Evaluation of Barriers to Diabetes Self-Management Education and Support

The underutilization of DSMES is multifactorial, with barriers at the health system, clinician,

and patient levels. Some of the barriers have been identified, but research is needed to

uncover and understand additional barriers.²³² In addition, research is needed to test

approaches to address these barriers and improve referral to and uptake of DSMES.

Critical to the research process is stakeholder engagement, to understand the perspectives

of payers, providers, referring clinicians, and people with diabetes, with the goal of

developing and disseminating effective approaches to increase utilization of and continued

engagement with DSMES. Research should test and identify innovations that are able to

increase DSMES utilization, are feasible and acceptable to diverse patient populations and

relevant stakeholders, and have the potential to be sustained.

100

Department of Health and Human Services

2021

Recommendation 6.11: The National Clinical Care Commission recommends that the

National Institutes of Health prioritize funding for research to identify and address

factors that affect referrals to and patient uptake of DSMES such as patient-, clinician-,

and systemic-level barriers, quality measures and incentives, and patient-reported

outcomes and perspectives.

Examples of research approaches to be tested include:

• Address social determinants of health and racial and systemic inequities that

prevent populations disproportionately burdened with diabetes from engagement

in DSMES.

• Use novel care delivery paradigms that may involve integration and collaboration

of community and clinic systems to broaden referral and uptake of DSMES.

• Enhance health care system processes to ensure provider understanding of the

need for DSMES and provide support for making and increasing referrals.

• Improve provider communication with people with diabetes and foster shared

decision making to encourage uptake and engagement in DSMES.

• Leverage and engage key family members and peer support to enhance

engagement of people with diabetes in the DSMES process.

Implementation Research for Team-based Care

There is a need to study implementation strategies to accelerate adoption of team-based

care to improve diabetes outcomes. Such implementation research attempts to close

the gap between knowing and doing (documented as a 17-year gap by the Institute of

Medicine) by identifying and addressing barriers to the uptake of new, proven health

interventions.^{317, 318} Historically, funding for dissemination and implementation research has

not been prioritized by federal agencies. Research should be supported by federal agencies

to study new models of care delivery and ways to enhance uptake of team-based care.

Recommendation 6.12: The National Clinical Care Commission recommends

increased funding for implementation research across federal agencies (for example,

AHRQ, NIH, CMS, HRSA, IHS, CDC, VA, and DoD) to better translate team-based care

into practice and test new team-based care models and payment systems to improve

diabetes care and outcomes.

Research is needed to identify the best ways to implement team-based care and eliminate

delays in implementation. As an example of an implementation research project, an HHS

Office of Minority Health grantee initiated a project to train staff at 20 federally qualified

Report to Congress

101

health centers in the MidWest Clinicians’ Network, a member organization of health centers

across 10 Midwestern states, to offer group visits for patients with diabetes. While diabetes

group visits have been shown to be effective in improving health outcomes (such as blood

sugar and blood pressure control, and quality of life), there is limited research on how

to integrate diabetes group visits into community health centers serving disadvantaged

populations and their cost-effectiveness. If successful, these study results could be scaled

to the 140 community health centers in the MidWest Clinicians Network and to other

community health centers across the U.S.³¹⁹ Research projects such as this can provide

important new information on barriers and facilitators to implementation and dissemination

of team-based care.

Impact of Digital Connectivity as a Social Determinant of Health

Diabetes is more prevalent in communities with low internet connectivity, lower incomes,

lower achieved education levels, and older age. Indeed, there is an inverse relationship

between the prevalence of diabetes and the degree of broadband connectivity. Digital

connectivity, or lack of it, is associated with not only access to health care but also education

and distance learning, employment such as remote work, job searches, online applications,

training, and much more. This suggests that digital connectivity is a “super” social

determinant of health because it amplifies the impact of other social factors.^320-323 There

is an urgent need to both accelerate broadband access and understand the barriers to

adoption of digital resources to improve health and health outcomes and reduce disparities

for those at risk for or living with diabetes. Further, investigation of the mechanisms of how

digital connectivity is associated with health is critical to improving health outcomes.

Recommendation 6.13: The National Clinical Care Commission recommends that

digital connectivity be investigated as a social determinant of health affecting the

development and progression of diabetes.

• The Federal Communications Commission (FCC), the U.S. Department

of Agriculture (USDA), and the U.S. Department of Health and Human

Services (HHS) should expand the scope of an inter-agency memorandum

of understanding (MOU) beyond the Rural Telehealth Initiative or establish

another mechanism to bring together the appropriate federal agencies to

share information on and investigate (1) the relationship between digital

connectivity and health; and (2) the types of digital services and the level of

adoption of digital services needed to make a positive impact on health.

• FCC should conduct research to better understand the associations of digital

connectivity, diabetes prevalence, and improved diabetes health outcomes.

102

Department of Health and Human Services

2021

Chapter 7: Looking Forward

Diabetes is a serious clinical and public health problem. The disease and its complications

affect tens of millions of Americans of all ages, lead to preventable suffering and death,

impact families, pose an enormous financial burden on our nation’s health care system

and on society, and contribute to health inequities. Despite clinical, public health, and

government efforts, the number of Americans with diabetes and its complications has

grown each year, and diabetes costs continue to rise. To reverse these trends and to protect

the health and wellbeing of Americans, the National Clinical Care Commission believes

that our nation needs (1) a National Diabetes Strategy informed by this report to leverage

the work of federal programs and (2) an Office of National Diabetes Policy to further

develop the National Diabetes Strategy, monitor its implementation, and report progress to

Congress and to the American people.

Develop and Implement a National Diabetes Strategy

The National Clinical Care Commission 2021 Report to Congress and the Secretary of

Health and Human Services provides a framework for a comprehensive National Diabetes

Strategy and includes specific recommendations for both health- and non-health-related

agencies to better address the diabetes epidemic.

The National Clinical Care Commission recommends that the National Diabetes Strategy

prioritize the following:

• Enhance collaboration and coordination across all federal agencies on matters that

impact diabetes prevention and treatment.

• Influence social and environmental conditions by improving dietary quality,

marketing oversight, food labeling, and the ambient and built environments.

• Ensure that achieving health equity is a goal of all federal policies and programs

that impact people at risk for and with diabetes.

• Improve access to comprehensive, high-quality, and affordable health care for

people at risk for and with diabetes.

• Make medications accessible and affordable for people with diabetes.

• Prevent diabetes in those at high risk by increasing awareness of prediabetes and

ensuring that those with prediabetes have access to lifestyle intervention programs.

Report to Congress

103

• Reduce regulatory barriers for key diabetes treatments, expand the health care

workforce, and implement policies that facilitate safe and effective care for people

at risk for or with diabetes.

The Commission also urges Congress to promptly implement the Commission’s

recommendations to prevent and control diabetes, to improve the health outcomes of

millions of Americans with diabetes, and to protect the health and wellbeing of current and

future generations of Americans at risk for developing diabetes.

Establish an Office of National Diabetes Policy

Over the past decades, the federal government has invested substantial health care

resources to combat the diabetes epidemic in the U.S. As highlighted in the report, some

of the federal programs have made great strides in helping control diabetes and improve

patients’ health outcomes. However, the Commission finds that the federal agencies’ and

departments’ policies and programs that impact both health care and non-health functions

should be further leveraged to improve efficiency and to maximize the impact of federal

resources, and that a national office focusing on policies and programs to address the

diabetes epidemic is needed to ensure coordination across all agencies and departments.

To develop, implement, and monitor the National Diabetes Strategy built upon the

National Clinical Care Commission’s recommendations, the Commission recommends

Congress create an Office of National Diabetes Policy (as described in Chapter 3). The

Office of the National Diabetes Policy should coordinate federal policies and programs

that have an impact on diabetes across agencies and departments and evaluate, monitor,

and report progress on the implementation of the National Clinical Care Commission’s

recommendations and the development and implementation of the National Diabetes

Strategy to Congress and the public on an annual basis.

The National Clinical Care Commission urges Congress and the Secretary of Health and

Human Services to promptly enact these recommendations and implement a long-term

strategy to combat this growing health crisis and help the more than 100 million Americans

with or at risk for diabetes.

104

Department of Health and Human Services

2021

Appendices

Appendix A. National Clinical Care Commission

Commission Chair

William H. Herman, MD, MPH

Professor of Medicine and Epidemiology, Co-Director, Michigan Center for Diabetes

Translational Research, University of Michigan, Ann Arbor, MI

Public Members (Special Government Employees)

Shari Bolen, MD, MPH

Director, Population Health Research Institute, Associate Professor of Medicine, Department

of Population and Quantitative Health Sciences, MetroHealth System, Case Western Reserve

University, Cleveland, OH

John Boltri, MD, FAAFP

Chair and Professor, Department of Family and Community Medicine, Northeast Ohio

Medical University College of Medicine, Rootstown, OH

J. William Cook IV, MD, FACP

Primary Care Internal Medicine, President and Clinical Dyad Leader, Ascension Medical

Group, Baltimore, MD

Ayotunde Dokun, MD, PhD, FACE

Associate Professor of Medicine and Endocrinology; Director, Division of Endocrinology

and Metabolism, Carver School of Medicine, University of Iowa, IA

Jasmine Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE

Clinical Associate Professor, Purdue University College of Pharmacy, Indianapolis, IN

Carol Greenlee, MD, MACP, FACE

Faculty Co-Chair, Center for Medicare and Medicaid Innovation Transforming Clinical

Practice Initiative (2015-2019); Western Slope Endocrinology, Grand Junction, CO

Meredith Hawkins, MD, MS

Director, Global Diabetes Institute, Albert Einstein College of Medicine, Bronx, NY

Shannon Idzik, DNP, ANP-BC, FAAN, FAANP

Associate Dean and Professor, Doctor of Nursing Practice Program, University of Maryland

Baltimore School of Nursing, Baltimore, MD

Report to Congress

105

Ellen Leake, MBA

Chair, Juvenile Diabetes Research Foundation, International Board of Directors, Jackson, MS

Dean Schillinger, MD

Professor, University of California San Francisco School of Medicine; Chief, Division of

General Internal Medicine, San Francisco General Hospital, San Francisco, CA; Co-Director,

DREAMS Center for Diabetes Translational Research

David Strogatz, PhD, MSPH

Director, Center for Rural Community Health, Bassett Research Institute, Bassett Health Care

Network, Cooperstown, NY

Federal Members (Regular Government Employees)

William Chong, MD

Associate Director for Clinical Affairs, Office of Generic Drugs, Center for Drug Evaluation

and Research, U.S. Food and Drug Administration, Department of Health and Human

Services

Paul R. Conlin, MD

Chief, Medical Service, Veterans Affairs Boston Healthcare System, Department of Veterans

Affairs

Naomi Fukagawa, MD, PhD

Director, Beltsville Human Nutrition Research Center, United States Department of

Agriculture

Barbara Linder, MD, PhD

Senior Advisor, Childhood Diabetes Research, National Institute of Diabetes and Digestive

and Kidney Diseases, National Institutes of Health, Department of Health and Human

Services

Aaron Lopata, MD

Chief Medical Officer, Maternal and Child Health Bureau, Office of the Associate

Administrator, Health Resources and Services Administration, Department of Health and

Human Services

Barry Marx, MD

Director, Office of Clinician Engagement, Center for Clinical Standards and Quality, Centers

for Medicare & Medicaid Services, Department of Health and Human Services

Pat Schumacher, MS, RD

Chief, Program Implementation Branch, Division of Diabetes Translation, National Center

for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and

Prevention, Department of Health and Human Services

106

Department of Health and Human Services

2021

Donald Shell, MD, MA

Director, Disease Prevention, Disease Management and Population Health Policy and

Oversight, Office of the Assistant Secretary of Defense for Health Affairs, Department of

Defense

CAPT Jana Towne, RN, BSN, MHA

Nurse Consultant, Division of Diabetes Treatment and Prevention, Office of Clinical and

Preventive Services, Indian Health Service, Department of Health and Human Services

Howard Tracer, MD

Medical Officer, U.S. Preventive Services Task Force Program, Center for Evidence and

Practice Improvement, Agency for Healthcare Research and Quality, Department of Health

and Human Services

CAPT Samuel Wu, PharmD

Public Health Advisor, Office of Minority Health, Department of Health and Human Services

Designated Federal Officer

Kara Elam, PhD, MPH, MS

Designated Federal Officer for the National Clinical Care Commission, Office on Women’s

Health, Office of the Assistant Secretary for Health, Department of Health and Human

Services

HHS Support Staff

Clydette Powell^*, MD, MPH, FAAP

Technical Advisor for the National Clinical Care Commission, Medical Officer, Office on

Women’s Health, Office of the Assistant Secretary for Health, Department of Health and

Human Services

Erika Kim, PharmD

Health Care Policy Fellow, Office on Women’s Health, Office of the Assistant Secretary for

Health, Department of Health and Human Services

* A special acknowledgment: The Commission especially acknowledges Dr. Clydette Powell who supported the

Commission from its inception.

Report to Congress

107

Appendix B. National Clinical Care Commission

Subcommittees

Prevention—General Population Subcommittee

Ann Bullock, MD (Former Co-Chair, retired)

Former Director, Division of Diabetes Treatment and Prevention, Office of Clinical and

Preventive Services, Indian Health Service, Department of Health and Human Services

Aaron Lopata, MD (Co-Chair)

Chief Medical Officer, Maternal and Child Health Bureau, Office of the Associate

Administrator, Health Resources and Services Administration, Department of Health and

Human Services

Dean Schillinger, MD (Co-Chair)

Professor, University of California San Francisco School of Medicine; Chief, Division of

General Internal Medicine, San Francisco General Hospital, San Francisco, CA; Co-Director,

DREAMS Center for Diabetes Translational Research

J. William Cook IV, MD, FACP

Primary Care Internal Medicine, President and Clinical Dyad Leader, Ascension Medical

Group, Baltimore, MD

Naomi Fukagawa, MD, PhD

Director, Beltsville Human Nutrition Research Center, United States Department of

Agriculture

Jasmine Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE

Clinical Associate Professor, Purdue University College of Pharmacy, Indianapolis, IN

Carol Greenlee, MD, MACP, FACE

Faculty Co-Chair, Center for Medicare and Medicaid Innovation Transforming Clinical

Practice Initiative (2015-2019); Western Slope Endocrinology, Grand Junction, CO

William H. Herman, MD, MPH

Professor of Medicine and Epidemiology, Co-Director, Michigan Center for Diabetes

Translational Research, University of Michigan, Ann Arbor, MI

CAPT Jana Towne, RN, BSN, MHA

Nurse Consultant, Division of Diabetes Treatment and Prevention, Office of Clinical and

Preventive Services, Indian Health Service, Department of Health and Human Services

108

Department of Health and Human Services

2021

Prevention—Targeted Population Subcommittee

Ann Albright, PhD, RD (Former Co-Chair, retired)

Former Director, Division of Diabetes Translation, Centers for Disease Control and

Prevention, Department of Health and Human Services

John Boltri, MD, FAAFP (Co-Chair)

Chair and Professor, Department of Family and Community Medicine, Northeast Ohio

Medical University College of Medicine, Rootstown, OH

Howard Tracer, MD (Co-Chair)

Medical Officer, U.S. Preventive Services Task Force Program, Center for Evidence and

Practice Improvement, Agency for Healthcare Research and Quality, Department of Health

and Human Services

Naomi Fukagawa, MD, PhD

Director, Beltsville Human Nutrition Research Center, United States Department of

Agriculture

Shannon Idzik, DNP, ANP-BC, FAAN, FAANP

Associate Dean and Professor, Doctor of Nursing Practice Program, University of Maryland

Baltimore School of Nursing, Baltimore, MD

Ellen Leake, MBA

Chair, Juvenile Diabetes Research Foundation, International Board of Directors, Jackson, MS

Barbara Linder, MD, PhD

Senior Advisor, Childhood Diabetes Research, National Institute of Diabetes and Digestive

and Kidney Diseases, National Institutes of Health, Department of Health and Human

Services

Barry Marx, MD

Director, Office of Clinician Engagement, Center for Clinical Standards and Quality, Centers

for Medicare & Medicaid Services, Department of Health and Human Services

Pat Schumacher, MS, RD

Chief, Program Implementation Branch, Division of Diabetes Translation, National Center

for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and

Prevention, Department of Health and Human Services

Donald Shell, MD, MA

Director, Disease Prevention, Disease Management and Population Health Policy and

Oversight, Office of the Assistant Secretary of Defense for Health Affairs, Department of

Defense

Report to Congress

109

David Strogatz, PhD, MSPH

Director, Center for Rural Community Health, Bassett Research Institute, Bassett Health Care

Network, Cooperstown, NY

CAPT Samuel Wu, PharmD

Public Health Advisor, Office of Minority Health, Department of Health and Human Services

Treatment and Complications Subcommittee

Paul R. Conlin, MD (Co-Chair)

Chief, Medical Service, Veterans Affairs Boston Healthcare System, Department of Veterans

Affairs

Carol Greenlee, MD, MACP, FACE (Co-Chair)

Faculty Co-Chair, Center for Medicare and Medicaid Innovation Transforming Clinical

Practice Initiative (2015-2019); Western Slope Endocrinology, Grand Junction, CO

Shari Bolen, MD, MPH

Director, Population Health Research Institute Associate Professor of Medicine, Department

of Population and Quantitative Health Sciences, MetroHealth System/Case Western Reserve

University

William Chong, MD

Associate Director for Clinical Affairs, Office of Generic Drugs, Center for Drug Evaluation

and Research, U.S. Food and Drug Administration, Department of Health and Human

Services

Ayotunde Dokun, MD, PhD, FACE

Associate Professor of Medicine and Endocrinology; Director, Division of Endocrinology

and Metabolism, Carver School of Medicine, University of Iowa, IA

Jasmine Gonzalvo, PharmD, BCPS, BC-ADM, CDE, LDE

Clinical Associate Professor, Purdue University College of Pharmacy, Indianapolis, IN

Meredith Hawkins, MD, MS

Director, Global Diabetes Institute, Albert Einstein College of Medicine, Bronx, NY

William H. Herman, MD, MPH

Professor of Medicine and Epidemiology, Co-Director, Michigan Center for Diabetes

Translational Research, University of Michigan, Ann Arbor, MI

110

Department of Health and Human Services

Appendix C. Summary of the National Clinical Care

Commission’s Recommendations

Foundational Recommendations (Chapter 3)

Recommendation 3.1: The National Clinical Care Commission recommends the

creation of the Office of National Diabetes Policy (ONDP) to develop and implement a

national diabetes strategy that leverages and coordinates work across federal agencies

and departments to positively change the social and environmental conditions that are

promoting the type 2 diabetes epidemic. The National Clinical Care Commission further

recommends that the ONDP be established at a level above the U.S. Department of Health

and Human Services (HHS) and be provided with funding to facilitate its effectiveness and

accountability.

•

3.1a. The ONDP should include, but not be limited to, departments and agencies

outlined in the National Clinical Care Commission Report to Congress, including

the U.S. Department of Agriculture, the U.S. Department of Transportation, the U.S.

Department of Education, the U.S. Department of Justice, the U.S. Department of

Defense, the U.S. Department of Labor, the U.S. Department of the Treasury, the

Federal Trade Commission, the Federal Communications Commission, the U.S.

Department of Housing and Urban Development, the Federal Bureau of Prisons,

the U.S. Environmental Protection Agency, the Bureau of Indian Education, the

Bureau of Indian Affairs, the U.S. Department of Veterans Affairs, and the U.S.

Department of Health and Human Services, among others.

•

3.1b. ONDP’s responsibilities should include: (1) overseeing the implementation

and monitoring of the NCCC recommendations; (2) ensuring action, collaboration,

and coordination among federal agencies with respect to trans-agency approaches

to delaying, preventing, and controlling type 2 diabetes; (3) making

recommendations to the executive and legislative branches regarding actions they

can take to delay, prevent, and better treat type 2 diabetes; (4) advancing a health-

in-all-policies (HiAP) agenda with respect to diabetes; and (5) providing resources

and employing Health Impact Assessments (HIAs) for relevant policies across non-

health departments and agencies.

•

3.1c. HHS should also establish an entity within the Office of the Secretary of

HHS to (1) coordinate work across HHS to better prevent and treat diabetes; and

(2) serve in the ONDP to foster broad, trans-agency collaborative work between

HHS and non-HHS federal agencies aimed at positively changing the social and

environmental contexts that are driving the type 2 diabetes epidemic.

112

Department of Health and Human Services

2021

Recommendation 3.2: The National Clinical Care Commission recommends that federal

policies and programs be designed to ensure that all people at risk for and with diabetes

have access to comprehensive, high-quality, and affordable health care and that no one at

risk for or with diabetes who needs health care cannot get it because of cost.

Recommendation 3.3: The National Clinical Care Commission recommends that

achieving health equity be a component of all federal policies and programs that affect

people at risk for and with diabetes. Specifically, the National Clinical Care Commission

recommends:

• Federal agencies consider and evaluate the impact on health disparities of all

new, all revised, and selected existing policies and programs that affect diabetes

prevention, diabetes, and the complications of diabetes.

• Federal agencies ensure the collection and use of data to assess the impact of

those policies and programs on health disparities and modify the policies and/or

programs as needed to reduce health disparities.

Recommendations for Population-Level Diabetes Prevention and

Control (Chapter 4)

Recommendation 4.1: The National Clinical Care Commission recommends that the

USDA SNAP program be enhanced to both reduce food insecurity and improve nutrition

sufficiency, both of which will help prevent type 2 diabetes and diabetes complications.

•

4.1a. Implement SNAP-wide fruits and vegetables incentives demonstrated to

be effective by the Gus Schumacher Nutrition Incentive Program (GusNIP) for all

beneficiaries, by providing at least a 30% incentive on the purchase of fruits and

vegetables to improve dietary quality.

•

4.1b. Eliminate sugar-sweetened beverages from allowable SNAP purchases.

•

4.1c. Improve and expand SNAP-Education to provide diabetes and nutrition

education and awareness programs for beneficiaries to increase fruit and vegetable

consumption, reduce added sugars consumption (especially sugar-sweetened

beverages), and increase media/marketing literacy, as well as increase its support

for policy, systems, and environmental approaches to improve dietary quality.

•

4.1d. Incentivize testing and implementation of innovative state-level policies,

practices, and programs to enhance the access to and receipt of SNAP benefits by

eligible individuals and households, and to reduce geographic, racial, ethnic, and

linguistic disparities in SNAP enrollment and retention.

Report to Congress

113

•

4.1e. Sustain efforts to ensure that SNAP benefit allotments are adequate to

allow for both food and nutrition security to help prevent and manage diabetes

among beneficiaries and implement a process to regularly assess and update the

adequacy of SNAP benefits with respect to lowering diabetes risk and managing

diabetes.

Recommendation 4.2: The National Clinical Care Commission recommends that USDA

non-SNAP feeding programs be better leveraged to prevent diabetes in women, children,

and adolescents by (1) enhancing Special Supplemental Nutrition Program for Women,

Infants, and Children (WIC); (2) further harnessing the National School Lunch and Breakfast

Programs to improve dietary quality; and (3) expanding the Summer Nutrition Programs and

the Fresh Fruit and Vegetable Program.

•

4.2a. Further strengthen the WIC program by sustaining the evidence-based,

prescriptive WIC food package; expand funding for breastfeeding peer counseling

services (see also Recommendation 4.7); invest in improvements to information

systems and technology to enable greater access and service for WIC participants.

•

4.2b. Maintain the nutrition standards found to be salutary in the Healthy Hunger-

Free Kids Act (HHFKA) and provide adequate funding for schools to (a) purchase,

prepare, and serve healthy, quality foods and beverages for school meals and

snacks to meet the HHFKA nutrition standards and (b) deliver training and technical

assistance to support maintenance and attainment of HHFKA nutrition standards,

and skills to run a program to effectively prevent diabetes.

•

4.2c. In collaboration with the U.S. Department of Education, the US Department

of the Interior, the U.S. Environmental Protection Agency, USDA should ensure that

all students in public and tribal schools have reliable access to safe, appealing, and

free drinking water. This could be accomplished through a combination of federal

incentives and possibly tying receipt of funding for school-based food programs in

the future.

•

4.2d. Prohibit the sale of calorically dense and nutrient-poor foods, including

sugar-sweetened beverages, on public school campuses; and employ an incentive

program to enable schools to cover essential costs such as those for physical

activity/athletic programs previously underwritten by the sale of such unhealthy

foods and beverages. Receipt of federal funds for school-based food programs

should be tied to implementation of such restrictions.

•

4.2e. Strengthen, increase funding for, and improve access to and participation

in summer feeding programs, including partnerships and collaboration between

public and private sectors, to promote innovation in rural areas and other high-risk

areas where participation has been low. Funding for these programs should be

increased to enable scaling to meet population needs.

114

Department of Health and Human Services

2021

Recommendation 4.3: The National Clinical Care Commission recommends that

resources be provided to the USDA to create an environmentally friendly and sustainable

U.S. food system promoting the production, supply, and accessibility of foods such as

“specialty crops” (fresh fruits, dried fruits, vegetables, tree nuts) that will attenuate the risk for

type 2 diabetes and the complications of diabetes.

•

4.3a. Significantly expand and increase funding for the USDA Specialty Crop Block

Grants to support the safe production and distribution of food and drive demand

through education for specialty crops to increase dietary diversity as an aid to help

people prevent and/or control diabetes.

•

4.3b. Significantly increase funding for the USDA Specialty Crop Research Initiative

grants to improve specialty crop production efficiency, handling and processing,

productivity, and profitability (including specialty crop policy and marketing) over

the long term in a sustainable manner.

•

4.3c. Significantly expand and increase funding for the USDA evidence-based

Healthy Food Financing Initiative, a federal effort to improve food access and health

in low-income, underserved communities and communities of color in urban and

rural areas that supports farmers and healthy food retailers to improve access to

nutritious, affordable, and fresh food.

•

4.3d. Funding and expansion should be implemented by 2030 to achieve

population-wide benefits.

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.

Report to Congress

115

•

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 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 healthcare

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).

116

Department of Health and Human Services

2021

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.

•

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.

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.

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

should be provided for federal programs that promote and support breastfeeding to

overcome persistent societal and employment-based obstacles to breastfeeding.

Report to Congress

117

•

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, the

Maternal, Infant, and Early Childhood Home Visiting Program; 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.

•

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.

118

Department of Health and Human Services

Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications (2021) - page 3