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Introduction

Diabetes is a complex, multi-organ chronic disease that requires continuous medical and educational care. It is imperative for health care professionals (HCPs) to understand that risk-reduction strategies associated with diabetes go well beyond glycemic control. Continuous patient self-management education and support are necessary for the prevention and reduction of acute and chronic complications affiliated to diabetes.^1,2

For the past 25 years, each January the American Diabetes Association (ADA) publishes the Standards of Medical Care in Diabetes, which has been referred to as the Go-To reference guide for HCPs who practice in and care for people with diabetes. It provides clinicians, patients, researchers, and payers with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care. Although the clinical management of the patient is most commonly reviewed and referenced, diabetes self-management education and support (DSME/S) remains the cornerstone of therapy.^1,2 Keep in mind that the patient’s self-management does not stop after the health care visit, but is an ongoing, lifetime process. Clinicians must realize that patients spend less than 5% of their lives in medical offices/clinics/pharmacies. Therefore, the majority of time patients spend managing their diabetes is done on their own.^2-4

A key element of the Standards of Medical Care in Diabetes supports patient referral to a DSME/S program, preferably one that is accredited or recognized.¹ The 2 main accrediting bodies for DSME/S programs are the ADA and the American Association of Diabetes Educators (AADE).^5,6 Historically, most accredited/recognized programs were located in institutional health systems and individual physician’s offices. Over the past 2 decades, however, there has been an increase in the number of independent and chain community pharmacies that have established ADA- or AADE-accredited/recognized DSME/S programs.

As the role of the pharmacist continues to evolve and expand, focusing on team-based, patient-centered care, community pharmacies strive to obtain accreditation/recognition for DMSE/S programs. This allows pharmacists to practice at the top of their training, providing optimal therapeutic and self-management for patients with diabetes in an accessible, convenient location. In addition, accredited/recognized programs will allow the pharmacy to bill for reimbursement of DSME/S services.^5,6

DSME/S

There are several terms that are commonly used in the literature to describe diabetes self-management, including education, training, and/or support. In this article, the term diabetes self-management education/support or, more likely, DSME/S will be used because it is the most current representation of the patient-centered process accepted by experts in the field.

By definition, DSME/S is an evidence-based intervention that facilitates the knowledge, skill, and ability necessary for people with prediabetes or diabetes to optimize their ability to self-manage the disease and its related conditions.^1,2 This process incorporates patients’ individual needs, goals, and life experiences. The overall objectives of DSME/S are to assist patients so they are able to make informed decisions and incorporate self-care behaviors, as well as adopt problem-solving skills through active collaboration with their health care team to improve clinical outcomes, health status, and quality of life.⁷ This includes activities that assist the person with prediabetes or diabetes in implementing and sustaining the health behaviors needed to manage his or her condition on an ongoing (lifetime) basis beyond and outside of formal training and classes.^1,8

DSME/S is a critical element of care for people with prediabetes or diabetes and is necessary to prevent or delay the complications related to diabetes and has elements related to lifestyle changes that are also essential for those with prediabetes as part of the effort to prevent the progression to diabetes. The National Standards for Diabetes Self-Management Education and Support are designed to define quality DSME/S and assist HCPs with providing evidence-based education and self-management support.²

These standards are applicable to educators/instructors in various practice settings, including community pharmacies, and are used for programs seeking accreditation/recognition. The standards also serve as a guide for non-accredited/recognized programs.

There are 10 standards for DSME/S programs and this model will help guide interested HCPs and health care systems when envisioning, developing, implementing, and monitoring their programs.

Standard 1: Internal Structure

One of the first steps in establishing a DSME/S program is to develop an organizational structure, mission statement, and program goals. Forming an advisory board with a diverse group of health care and lay members with common interests will help create clear goals and objectives for the program. Each member should have a defined role, along with written commitments that outline responsibilities and lengths of terms.⁹ Documentation of the organizational structure can help members understand their appropriate role, channels of communication, and program policies.¹⁰

Table 1 shows a sample advisory board structure. In community pharmacies, often the pharmacy district manager/supervisor, 1 or 2 pharmacists (in-charge and/or staff), pharmacy technician, and/or a store employee who serve(s) on an advisory board for the DSME/S program. The pharmacists on the advisory board may or may not be educators/instructors in the curriculum.

Table 1. Sample List of Advisory Board Members for a DSME/S Program in a Pharmacy
Member	Health care discipline
Program coordinator	Any diabetes-trained health care professional (usually pharmacist, nurse, dietitian)
Program educator/instructor	Any diabetes-trained health care professional (usually pharmacist, nurse, dietitian)
Other health care providers (usually 2–4 people from various disciplines)	Any diabetes-trained health care professional (usually pharmacist, nurse, dietitian)
Nonhealth care person with interest in diabetes	Layperson, pharmacy technician, store manager/employee, medical assistant, community health worker
Person with diabetes	Layperson or external health care provider (not affiliated with the program.)
DSME/S = Diabetes Self-Management Education and Support

Figure 1 provides a sample of a pharmacy DMSE/S program organizational structure.

Figure 1. Sample DSME/S Program Structure for Pharmacy

DSME/S = Diabetes Self-Management Education and Support

Standard 2: External Input

In an effort to provide quality assurance, DSME/S programs are required to seek ongoing input and review from external stakeholders and experts, which helps to keep the program and staff current on diabetes trends. The goal is to ensure the program is up-to-date, patient-centered, and culturally relevant, in addition to being responsive and appealing to patients.¹¹ The advisory board is the ideal resource for ensuring program effectiveness and excellence. It is beneficial for at least 1 member, or several on the advisory board, to have expertise in diabetes management so he or she can provide current and emerging information regarding trends and developments in the fields of education and care. This would include changes in program structure, delivery, and assessment, in addition to advancements in pathophysiology and pharmacotherapy. Although the standards do not make a recommendation as to the frequency of advisory-board meetings, best business practice suggests an annual meeting at the minimum. This will be required for the accreditation/recognition process and recertification.

Standard 3: Access

Knowledge of the population that the program will serve and the best format for delivery are essential to the curriculum’s success. Many people with prediabetes or diabetes do not even realize there are structured educational programs available to help them with the management of their diabetes.¹¹In addition, access to these programs can be challenging for many people. Considerations in program design must include the populations’ demographics, such as ethnic/cultural background, sex, age, formal education, health literacy/numeracy, family support, and type of diabetes.¹²

Patients commonly experience lengthy wait times (e.g., more than 3 months) when attempting to secure an open seat in an outpatient health-system program. This consideration has led many patients to neglect or forget to enroll, thereby never receiving any structured guidance in the self-management of their disease. Pharmacies are an ideal venue to help close this gap and well-established DSME/S programs can offer group and individual visits to meet the needs of patients. Easy access to a pharmacist in-between scheduled DSME/S appointments allows for optimal continuity of care. Pharmacy programs should have a referral list of other HCPs or resources readily available for patients in need. This list may include dietitians, primary care providers, endocrinologists, podiatrists, ophthalmologists, retina specialists, dentists, behavioral and mental health specialists, physical therapists, etc.

Standard 4: Program Coordination

Every DSME/S program must have a coordinator who is responsible for the planning, implementation, evaluation, management, and continuous quality improvement of the educational services.² As diabetes education and care evolve, the coordinator ensures that the program adapts to the changes. This includes updating the curricula or educational process, assisting program educators/instructors with continuing education or advancement, and maintenance of current referral or resource lists to help patients navigate the health care system. Theoretically, the coordinator should be an expert in the field of diabetes and its related conditions.^2,4 Though it is not mandatory, the coordinator is often a Certified Diabetes Educator (CDE) or board certified in advanced diabetes management (BC-ADM). In many pharmacy programs, the coordinator also serves on the advisory board and as the DSME/S provider/educator at one or more community pharmacy locations within the company.

Standard 5: Instructional Staff

In an ideal program, the instructional staff is an inter-professional team, which includes a pharmacist, a nurse, and a dietitian, at a minimum.^5,6 In many programs, though, especially those that are pharmacy-based, the team is small and may only have 1 or 2 HCP educators/instructors.¹³ The standards suggest that the DSME/S program consists of 1 educator/instructor or more to provide education and care for patients. At least 1 instructor must be a pharmacist, a nurse, or a dietitian with training and experience pertinent to DSME/S or with certification in diabetes education and care, such as a CDE or BC-ADM.^5,6 It is acceptable for other health care workers such as pharmacy technicians or community health personnel to contribute to the program, provided they have received appropriate training in the disease and have supervision and support. For example, a pharmacy technician may assist with scheduling patient appointments, blood-glucose-monitor training, and billing for services.

Literature supports the inter-professional team approach, with pharmacists, nurses, and dietitians collaboratively designing the curricula to be used as well as offering education and care for patients.^2,14 The expert consensus also supports postgraduate training in diabetes for HCPs entering this field.^14,15 Many HCP college/school curricula provide basic knowledge and training in diabetes, which is insufficient for DSME/S programs. But this additive training is essential for the delivery of a quality program, with certification being a method that can assist pharmacists in demonstrating their mastery of the disease. The National Certification Board of Diabetes Educators (NCBDE) oversees the process for CDEs whereas the AADE furnishes the BC-ADM examination.¹⁴ Pharmacists – as well as other HCPs – are eligible for both credentials, although they appear to be underutilized in the field of diabetes, accounting for less than 10% of the more than 17,000 CDEs in the United States. It is not mandatory for pharmacists to be certified to be employed as educators/instructors in DSME/S programs. However, these pharmacists have to complete postgraduate training in diabetes education and care, such as an intensive continuing education program to advance their knowledge and skills.

Standard 6: curricula

The DSME/S curricula should all be current and reflect evidence-based guidelines. Also, the curricula should be extensive and in-depth, with each patient being educated individually. Therefore, every curriculum should be adaptable to every patient. The DSME/S program should be available to patients with prediabetes or diabetes as well as to their families.^8,16 When the patient’s family, friends, and/or caregivers learn and comprehend the same information as the person him- or herself, encouragement and accord are provided beyond the DSME/S session.

Over the years, several standardized curricula have been developed and published and are available to purchase for DSME/S programs. However, some DSME/S program teams prefer to create their own curricula. In either case, the curricula should include key courses with specific learning objectives that utilize effective teaching strategies.¹⁷ Most published programs include the following core topics^16-18:

• overview of the diabetes process
• diabetes treatment options
• nutritional management (or healthy eating)
• exercise and physical activity
• managing hypoglycemia and hyperglycemia
• diabetes medications
• self-monitoring and how to use the results
• preventing, detecting, and treating acute complications
• preventing, detecting, and treating chronic complications
• foot, skin, and dental care
• preconception care, pregnancy, and gestational diabetes
• developing coping strategies to deal with stress and psychosocial issues
• developing a personal plan for health behavioral change
• family and social support
• health care system and community resources.

In addition to the core curriculum, many programs will add topics to enhance the personalized approach to patient care and education. In all cases, the topics and teaching steps should be tailored to the individual patient, inclusive of age, type of diabetes, cultural factors, and health literacy/numeracy.¹⁹ Many community pharmacy DSME/S programs will have educational materials available for patients outside the formal sessions. For example, if a patient enrolled in the pharmacy DSME/S program is picking up a prescription for a skin irritation, the DSME/S pharmacist educator/instructor may provide verbal and written education regarding diabetes and skin care during that point-of-care consultation.

Standard 7: Individualization

Individualized treatment and self-management plans are necessary for optimal health and wellness outcomes. For most people with diabetes, health behavioral change is essential to self-management and control of the disease.¹⁹ There is no one-size-fits-all approach to managing diabetes. The AADE developed 7 self-care behaviors known as the AADE7, which are recognized as guiding principles for DSME/S program participants.²⁰ These include the following:

• Healthy eating
• Being active
• Monitoring
• Taking medication
• Problem solving
• Healthy coping
• Reducing risk

DSME/S program educators/instructors must work with each patient on an individualized basis to create an education and support plan that is specialized for that person. The plan should include health behavioral changes that the patient has identified as important to him or her and are ready (motivated) to be set in motion.^15,17,19 Pharmacists should embrace motivational interviewing skills and techniques to help assess patients’ readiness for change, identify potential barriers, and develop an approach to overcome obstructions and/or ambivalence. The key is for patients to problem-solve themselves and create their own behavioral change plans that will fit into their daily lives.

Successful health behavioral change will require monitoring along with follow up visits.^2,21 This will allow educators/instructors to reassess their patients’ progress and work with them to adopt other interventions, if needed. With the technologic advancements, pharmacists have the ability to follow up with patients through a variety of modalities, such as telephone appointments, web-based sessions, and text messaging as well as the traditional, face-to-face (in-person) appointments.^21,22

All assessment, educational, and interventional plans must be documented in the patients’ health records to allow for optimal follow-up, especially between multiple instructors or locations. For example, if a patient is enrolled in a DSME/S program at a pharmacy that offers education at 2 different locations and the patient attends individual or group sessions at both places, all educators/instructors are required to thoroughly document patient assessment, planning, and progress. Providing documentation of the patients’ plan and progress to other health care team members is also warranted, thereby allowing for the entire medical team to be on the same page in offering collaborative support for the patient.

Standard 8: Ongoing Support

The key to a successful and personalized diabetes education and care plan is ongoing support. Although patients do not spend an extensive amount of time with their health care team, it is important for these individuals to understand that their team is highly supportive and willing to work with them in managing their diabetes. Therefore, consistent, frequent communication among the team’s members and the patient is necessary to achieve the best possible health outcomes.²³

Recent studies suggest that most patients’ initial health and behavioral improvements begin to diminish after 6 months.³ For that reason, long-term strategies are necessary and DSME/S programs have to furnish education and care well beyond the initial training sessions. Over time, the type of DSME/S may change, so programs should include behavioral, educational, psychosocial, and clinical services to address the individual’s evolving needs.¹⁷ Pharmacists are a unique community-based resource for patients to utilize for continued care and support.

Standard 9: Patient Progress

Monitoring progress to assess whether patients are achieving their personal self-management goals and meeting clinical and other health outcomes is a useful method of evaluating the DSME/S programs’ usefulness and efficacy. Differences in behaviors, health beliefs, culture, and emotional responses can impact how patients perceive, understand, and engage in self-managing their diabetes.^24-26 Therefore, the time needed to achieve personal goals will vary from patient to patient. Follow-up intervals and teaching/learning strategies must be adapted to account for these differences. It is common that frequent follow-ups and shorter time intervals between visits are required in the beginning of diabetes education and care, but the intervals may lengthen as the patient becomes more confident and achieves his or her personal and clinical goals.^24-26 Although third-party payment structures may govern the frequency of DSME/S visits, community pharmacists are uniquely positioned to assist patients who are between formal sessions because of their accessibility, especially if patients use the DSME/S pharmacy for their prescriptions or other services as well.

Standard 10: Quality Improvement

The DSME/S program providers and coordinator should routinely assess the quality and effectiveness of the program and identify any gaps in service. The program must also adapt to advances in knowledge, education, and care along with trends in the changing health care environment.^2,26 The Institute for Healthcare Improvement suggests the following 3 key questions to guide improvement²⁷:

• What are we trying to accomplish?
• How will we know a change is an improvement?
• What changes can we make that will result in an improvement?

Many programs will develop their own quality improvement assessment tool, such as patient surveys, prescriber questionnaires, and educator/instructor performance evaluations.

Once the areas for improvement have been identified, a reasonable and measurable timeline for implementation should be documented and followed to the finish line.

Standards of Medical Care in Diabetes Recommendations for DSME/S

The 2016 Standards of Medical Care in Diabetes include a comprehensive section, Foundations of Care, which includes DSME/S, nutrition, physical activity, smoking cessation, immunizations, psychosocial care, and medications.¹ A referral by prescribers to DSME/S services is highly suggested and necessary for programs to bill for services. The 2016 Standards of Medical Care in Diabetes recommendations regarding DSME/S include¹:

• “All people with diabetes should participate in DSME/S to facilitate the knowledge, skill, and ability necessary for diabetes self-care and assist with implementing and sustaining skills and behaviors needed for ongoing self-management, at diagnosis and as needed thereafter.”
• “Effective self-management, improved clinical outcomes, health status, and quality of life are key outcomes for DSME/S and should be measured and monitored as part of care.”
• “DSME/S should be patient-centered, respectful, and responsive to the individual patient’s preferences, needs, and values, which should guide clinical decisions.”
• “DSME/S programs should have the necessary elements to the curriculum that are needed to prevent the onset of diabetes and tailor the content when prevention is the primary goal.”
• “Since DMSE/S can result in cost savings and improved outcomes, programs should be adequately reimbursed by third-party payers.”

The Chronic Care Model

Over the past few decades, diabetes care has evolved from provider-driven management to a team-based approach, with the patient as the team’s most significant member. With the infusion of the Chronic Care Model (CCM), a more patient-engaged focus supports the framework for improving the quality of diabetes care.²⁸ As the pharmacist’s role expands to include more direct patient care responsibilities, pharmacists have to be aware of their roles within the CCM and how they will interface with community pharmacy DSME/S programs. There are 6 core elements of the CCM, which include^21,28:

1. Delivery system design.
   This is a proactive, chronic-care (as opposed to reactive, acute care), team-based avenue to health care. Health, wellness, and prevention services can help reduce such chronic diseases as diabetes and their related conditions and complications.
2. Self-management support system.
   As mentioned earlier, patients spend minimal time with their health care team during the overall life span. By including the patient (and his or her family and/or caregivers) in the therapy-plan decision-making process, that individual takes an active role in his or her health and well-being, thereby resulting in greater adherence and improved long-term outcomes.
3. Decision support.
   Treatment and care plans have to be developed and implemented using current evidence-based, effective-care guidelines.
4. Clinical-information systems.
   Through the use of registries or electronic medical records, HCPs can identify people at risk and implement prevention, health, and wellness pathways that provide population-specific and patient-specific support.
5. Community resources and policies.
   Partnerships within and outside the health care system allow for greater outreach to all communities, including those at high risk for suboptimal health and disease. Implementation of awareness, education, and prevention programs as well as access to care and support can improve healthy lifestyles and effectively prevent or reduce chronic diseases/conditions.
6. Health care systems.
   Proper and appropriate use of coordinated team-based care through a quality-oriented culture can improve overall health care and lessen costs.

Redefining the roles of the health care delivery team and promoting self-management on the patient’s part are fundamental to successful implementation of the CCM. Collaborative inter-professional teams are best suited to provide care for people with chronic diseases/conditions and to facilitate their self-management.^4,21,29 The foundation of successful diabetes management includes ongoing (long-term) individualized lifestyle and behavioral changes, patient commitment, assessment of the person’s level of understanding about the disease, and his or her level of preparedness for self-management.

Accreditation/Recognition

To be paid for DSME/S services, the program must be accredited. As previously mentioned, the AADE and ADA are the 2 main accrediting organizations. The Centers for Medicare and Medicaid (CMS) will provide reimbursement to DSME/S programs for Medicare beneficiaries under certain conditions.³⁰ In addition, many other health insurers cover and reimburse accredited/recognized programs as well, so pharmacists have to know that this payment is fee for service and not affiliated with prescription coverage, which is separate and distinct. Often, patients will have their prescriptions filled at a different pharmacy from where they receive their DSME/S service because of third-party-plan dictates. However, patients can choose their DSME/S program provider granted the patient has a prescriber referral.

CMS benefits cover³⁰:

• up to 10 hours of diabetes-related education/training within a consecutive 12-month period following the submission of the first claim for the benefit. This includes 1 hour for either group or individual sessions and/or 9 hours for group-only sessions.
• up to 2 hours of follow-up sessions each year after the initial 12-month cycle.
• the sessions may be in any combination of 30-minute increments.

The CMS will also cover additional hours of individual education/training based on:

• no group session being available within 2 months of the initial DMSE/S order from the prescriber
• the patient has special needs that require individual, as opposed to group, sessions
• additional insulin administration training is warranted.

HCPs who are eligible for DSME/S reimbursement once they have received AADE or ADA recognition and obtained a site provider number include³⁰:

• private provider practices
• hospital outpatient facilities
• outpatient clinics
• skilled nursing facilities
• home health agencies
• federally qualified health centers
• pharmacies
• durable-medical-equipment suppliers

Pharmacies that have multiple stores providing DSME/S services would receive a CMS provider number for each individual site, with reimbursement going to that facility.

The process for obtaining accreditation from the ADA or the AADE is similar, but there are several notable variations. The titles for the programs are the Education Recognition Program (ERP – 8th ed.) for the ADA and the Diabetes Education Accreditation Program (DEAP) for the AADE. Both accreditation organizations use the National Standards for Diabetes Self-Management Education 2012 as their source for guiding standards.^5,6 Table 2 compares other key entities that are required from each program.

Table 2. Recognition Requirement Comparisons
Item	AADE	ADA
Cost	1 – 10 sites: $800 11 – 20 sites: $1200 > 20 sites: contact AADE	1st site: $1100 Additional sites: $100 for each site
Renewal fees	Same as initial cost	Same as initial cost
Initial application	- Online or paper - Supporting documentation materials must be submitted within 2 wk - Telephone interview or onsite audit with DEAP auditors	- Online only - contact ADA to be added to the system - Supporting documentation materials must be submitted within 2 wk
Renewal application	- submit reaccreditation application - submit supporting documentation, including 1 de-identified patient chart and most recent copy of advisory-board-meeting minutes - 10% of sites are randomly selected for audit	- submit supporting documentation, including licenses and certifications of instructors and proof of CE credits for noncertified instructors - some sites are randomly selected for audit
Program criteria	- at least 1 patient has completed program through follow-up, and documentation for patient is submitted - no outcome data required - documentation of educational process	- reporting period up to 6 months prior to application submission - application must be submitted no more than 3 mo after reporting period ends - at least 1 patient seen during reporting period - at least 2 outcomes must be tracked for program effectiveness: 1. patient goals, measures, and attainment and 2. other outcomes such as clinical, metabolic, or quality of life, with measure of attainment.
Application processing	2 – 8 wk Valid for 4 y	First-come, first-served. May take up to 30 d Valid for 4 y Annual status report required
Audits	5% of initial applications annually 10% of current accredited sites 10% of sites seeking reaccreditation Auditors are volunteers Program will receive 2 wk notice	5% of  currently recognized sites annually Auditors are volunteers Program will receive 2 wk notice
AADE = American Association of Diabetes Educators; ADA = American Diabetes Association; CE = continuing education; DEAP = Diabetes Education Accreditation Program; mo = months; wk = weeks; y = years

Once a pharmacy program achieves recognition, the certificate of accreditation/recognition and the National Provider Identification (NPI) must be submitted to the local CMS provider enrollment department. Once received and processed, the pharmacy is officially recognized by the CMS for DSME/S program services under Medicare Part B. If the pharmacy already has an NPI for Part D, a different form (CMS-855B) is required for submission to become a Part B provider. Although a pharmacist can be the coordinator and/or educator/instructor for the program, he or she cannot bill Medicare or other third-party payers independently since pharmacists are not currently recognized as providers. The billing has to be done under the pharmacy’s (not the pharmacist’s) NPI number that is assigned to the DSME/S program.

Prescribers must refer patients for DSME/S. Therefore, the community pharmacy program must receive a referral from the prescriber for the patient to submit a third-party claim for reimbursement. The pharmacy program, however, can also accept self-payment directly from patients who do not have a referral. The self-payment must equal the amount that Medicare would reimburse. To generate DSME/S business, the pharmacy and/or pharmacists have to market their services to local physicians and nonphysician prescribers so patients can be referred to the pharmacy program. Pharmacists may schedule appointments with prescribers and their staff for the sole purpose of informing them of the pharmacy DSME/S program. Providing an information packet inclusive of the pharmacy services offered and sample referral forms can be beneficial and increase referrals. The referral order must include the following to be submitted for reimbursement:³⁰

• a statement of need for DSME/S for a patient with a diagnosis of prediabetes or diabetes
• a plan of care and length of time that DSME/S services are required
• expected health outcomes
• barriers that would require individual (as opposed to group) sessions
• the signature of the treating prescriber.

The program coordinator usually processes the billing for services to the CMS or other third-party payers. The standard billing codes are those used in the Healthcare Common Procedure Coding System (HCPCS). The CMS usually reimburses at 80%, with the patient having a 20% copayment, though various plans may differ. Table 3 shows billing codes and the fee schedule for DSME/S.³⁰

Table 3. HCPCS Coding
Initial DSME/S
HCPCS Code	Description	Allowable U	Base Fee
G0108	Individual DSME/S 1 h allotted - billable in 30-min increments (1 U = 30 min)	2 U = 1 h	$48.46 – $68.11 (individual)
G0109	Group DSME/S >2 in group 9 h allotted billable in 30-min increments (1 U = 30 min)	18 U = 9 h	$12.02 – $18.43 (group)
DSME/S Each Year After Initial Year
HCPCS Code	Description	Allowable U
G0108 and/or G0109	Individual and/or group DSME/S 2 h allotted - billable in 30-min increments (1 U = 30 min)	4 U = 2 h	$48.46 – $68.11 (individual) $12.02 – $18.43 (group )
DSME/S = Diabetes Self-Management Education and Support; h = hours; HCPCS = Healthcare Common Procedure Coding System; min = minutes; U = units

STAR ratings

As the United States health care system evolves, there is a move toward rewarding positive outcomes while reducing or eliminating unnecessary services. Implementing strategies to measure costs associated with quality outcomes such as patient health and wellness are being utilized through various quality metrics systems. The score then states the amount reimbursed to the health plan providers, health systems, and other HCPs and health-related programs, including pharmacists and pharmacies. The CMS’s goal is to provide services that achieve consensus-based performance measures at an affordable cost.³¹

The Medicare star rating system is a part of the CMS’s efforts to define, measure, and reward quality health care. Approximately one-half of the STAR-rating performance measures can be influenced directly by community pharmacists working with payers who have to meet the quality measures, which are medication use, adherence, and chronic-disease outcomes.^31,32

Medicare Part A (hospital insurance) and Medicare Part B (medical insurance) have been administered primarily by the federal government, whereas Medicare Advantage plans (Medicare Part C) are administered by private insurers regulated by the government.³³ Medicare prescription drug plans (Part D) add comprehensive prescription drug coverage to Medicare; these plans are referred to as PDPs.^33-35 The CMS created the STAR rating system in 2007 as a way to inform beneficiaries about the plans’ performance.^36,37 The STAR ratings incorporate data from Healthcare Effectiveness Data and Information Set (HEDIS) quality measures, Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys, Medicare Health Outcomes Survey (HOS), and the CMS’s administrative data.^36,38

The quality of the health care plans is evaluated on a scale of 1 to 5 STARS with 5 STARS being the highest rating. Currently, there are only a small number of plans that have received a 5-STAR summary rating from the CMS, with most plans receiving 3 to 3.5 STARS.

Plans are rated according to the types of services offered.³⁹ The hospital and medical (Parts A and B) plans covering health services measure performance include³⁹:

Staying healthy (screenings, tests, and vaccines)

• Managing chronic conditions (including DSME/S programs)
• Member experience with the health plan, including ratings of member satisfaction
• Member complaints, problems getting services, and improvement in the health plan's performance
• Health plan customer services

The STAR summary and overall ratings show indicators of quality of care, access to care, responsiveness, and beneficiary satisfaction, and they are intended to simplify plans for beneficiaries to compare and contrast them.^38,40 The new system for performance measures holds particular importance for pharmacists. Of the 10 measures, 8 are related directly or indirectly to medication therapy and, therefore, have the potential to be improved through pharmacist education and care interventions. Three of the measures are health services measures in the Managing Chronic Conditions domain:

1. Diabetes care—blood-sugar controlled (i.e., plan members with diabetes whose blood sugar is under control)
2. Diabetes care—cholesterol-controlled (i.e., plan members with diabetes whose cholesterol is under control)
3. Controlling blood pressure (BP)

Part D performance measures are for Drug Pricing and Patient Safety, which include³⁹:

• High-risk medication (plan members 65 years of age and older who received prescriptions for certain drugs with a high risk of side effects, when there may be safer drug choices)
• Diabetes treatment (using the kind of BP agent that is recommended for people with diabetes)
• Part D medication adherence for oral diabetes medications (taking oral diabetes drug as directed)
• Part D medication adherence for hypertension (taking BP medication as directed)
• Part D medication adherence for cholesterol (taking statins as directed).

All 5 of the Part D performance measures were developed by the Pharmacy Quality Alliance (PQA), a consensus-based nonprofit partnership established in April 2006 with more than 100 members comprising health plans, pharmacy benefit management companies, professional associations, federal agencies, pharmaceutical manufacturers, consumer advocates, technology/consulting groups, and universities.⁴¹ The PQA maintains the Alliance-supported performance measures and updates the drug-code lists for the measures every 6 months. PQA-supported measures account for 45% of the Part D plan summary rating in 2013 and have been increasing ever since.⁴¹

High STAR ratings are also important for reasons not directly related to payments. Plans that receive 5 STARS may market to and enroll Medicare beneficiaries throughout the year and are not limited to the specified open-enrollment period.^42,43 The Medicare.gov website highlights 5-STAR plans with a special icon to encourage beneficiary enrollment in these plans.⁴⁰ Conversely, plans that receive fewer than 3 STARS for 3 or more consecutive years are designated by a warning symbol.³⁷ Beneficiaries enrolled in low-ranked plans are notified and given the option to switch to higher quality plans.⁴³ Since 2014, plans with fewer than 3 STARS for the past 3 consecutive years will not be permitted to enroll beneficiaries through the Medicare website and run the risk of being dropped from Medicare altogether.³⁷

Currently, the STAR ratings are tracking individual pharmacy outcomes; however, plans to track individual pharmacists’ performance are being developed. Pharmacists who are providing such patient-centered education and care as DSME/S programs and similar services should be on track to receive a high STAR rating, thereby increasing reimbursement and revenue to their pharmacies.

Conclusion

The role of the community pharmacist moving toward a greater focus on patient-centered education and care. Given the significant societal burden imposed by diabetes, pharmacists have to take action in educating and supporting patients with the self-management of their disease. Instruction and patient care in diabetes are essential to improve disease outcomes and decrease complications. Studies on pharmacist-implemented diabetes programs have shown a positive effect on clinical, humanistic, and economic outcomes. Community pharmacists are uniquely positioned to develop and implement DSME/S programs, allowing for improved access to care, delivering optimal patient treatment, taking an active role on the health care team, and performing competently at the level for which they have been trained.

2017 Updates to the National Standards for Diabetes Self-Management Education and Support The 2017 Standards Revision Task Force, which was jointly convened by AADE and ADA, updated the National Standards for Diabetes Self-Management Education and Support to reflect a focus on the individual with diabetes and helping these individuals develop problem-solving skills and attain ongoing decision-making support from multiple sources considering the limited time spend with primary care providers. These updated standards are: STANDARD 1 - Internal Structure: The provider(s) of DSMES services will define and document a mission statement and goals. The DSMES services are incorporated within the organization - large, small, or independently operated. STANDARD 2 - Stakeholder Input: The provider(s) of DSMES services will seek ongoing input from valued stakeholders and experts to promote quality and enhance participant utilization. STANDARD 3 - Evaluation of Population Served: The provider(s) of DSMES services will evaluate the communities they serve to determine the resources, design, and delivery methods that will align with the population's need for DSMES services. STANDARD 4 - Quality Coordinator Overseeing: DSMES Services A quality coordinator will be designated to ensure implementation of the Standards and oversee the DSMES services. The quality coordinator is responsible for all components of DSMES, including evidence-based practice, service design, evaluation, and continuous quality improvement. STANDARD 5 - DSMES Team: At least one of the team members responsible for facilitating DSMES services will be a registered nurse, registered dietitian nutritionist, or pharmacist with training and experience pertinent to DSMES, or be another health care professional holding certification as a diabetes educator (CDE) or Board Certification in Advanced Diabetes Management (BC-ADM). Other health care workers or diabetes paraprofessionals may contribute to DSMES services with appropriate training in DSMES and with supervision and support by at least one of the team members listed above. STANDARD 6 - Curriculum: A curriculum reflecting current evidence and practice guidelines, with criteria for evaluating outcomes, will serve as the framework for the provision of DSMES. The needs of the individual participant will determine which elements of the curriculum are required. STANDARD 7 - Individualization: The DSMES needs will be identified and led by the participant with assessment and support by one or more DSMES team members. Together, the participant and DSMES team member(s) will develop an individualized DSMES plan. STANDARD 8 - Ongoing Support: The participant will be made aware of options and resources available for ongoing support of their initial education, and will select the option(s) that will best maintain their self-management needs. STANDARD 9 - Participant Progress: The provider(s) of DSMES services will monitor and communicate whether participants are achieving their personal diabetes self-management goals and other outcome(s) to evaluate the effectiveness of the educational intervention(s), using appropriate measurement techniques. STANDARD 10 - Quality Improvement: The DSMES services quality coordinator will measure the impact and effectiveness of the DSMES services and identify areas for improvement by conducting a systematic evaluation of process and outcome data. Reference: Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for Diabetes Self-Management Education and Support. Diabetes Care. 2017;40(10):1409-1419. 2018 Standards of Medical Care in Diabetes Updates DSMES is included in the Lifestyle Management section of the Standards of Medical Care in Diabetes -2018. This section also discusses nutrition therapy, physical activity, smoking cessation, psychosocial issues, and diabetes distress. Recommendations related to DSMES include: In accordance with the national standards for diabetes self-management education and support, all people with diabetes should participate in diabetes self-management education to facilitate the knowledge, skills, and ability necessary for diabetes self-care and in diabetes self-management support to assist with implementing and sustaining skills and behaviors needed for ongoing self-management. There are four critical times to evaluate the need for diabetes self-management education and support: at diagnosis, annually, when complicating factors arise, and when transitions in care occur. Facilitating appropriate diabetes self-management and improving clinical outcomes, health status, and quality of life are key goals of diabetes self-management education and support to be measured and monitored as part of routine care. Effective diabetes self-management education and support should be patient centered, may be given in group or individual settings or using technology, and should help guide clinical decisions. Because diabetes self-management education and support can improve outcomes and reduce costs, adequate reimbursement by third-party payers is recommended. Reference: American Diabetes Association. 4. Lifestyle management: Standards of Medical Care in Diabetes - 2018. Diabetes Care. 2018;41(Suppl. 1):S38–S50.

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