Diabetes Clinical Pathways: Going Beyond Treatment Decisions

12/09/16
Issue
Affiliation

The Access Group, Berkeley Heights, NJ. 

Disclosures

Dr Stefanacci is the chief medical officer for The Access Group, a professional services firm focusing on managed markets in the pharmaceutical industry. He has received speaking fees from Allergan and Pfizer; serves on advisory boards for AbbVie, the ASCP Foundation, and the AMDA Foundation; and has provided consult- ing services to AstraZeneca, Baxter, Boehringer Ingelheim, Lundbeck, Otsuka, and Leo Pharma.

Dr Guerin is the senior director for Government Policy System and Analytics for The Access Group. 

Diabetes guidelines increasingly go beyond treatment recommendations to take into account quality measures for diabetes care that exist within new value-based systems, addressing the roles and responsibilities of diabetes clinical stakeholders and incorporating the use of innovative patient engagement tools. Because gaps in diabetes prevention and care relate to poor reimbursement for managing chronic conditions, clinical pathways for diabetes could build on diabetes care guidelines by addressing cultural differences and low health literacy of patients and the need for innovative tools and products to help patients overcome barriers to managing their diabetes.

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Diabetes guidelines today involve much more than simply identification of the “right” treatment. Instead, today’s diabetes guidelines are required to take into account the increasing quality measures, roles and responsibilities of diabetes clinical stakeholders, and the use of innovative patient engagement tools that all exist within new value-based systems. These systems include accountable care organizations, patient centered medical homes and comprehensive practice care, in addition to new alternative payment systems that may be developed by the Centers for Medicare & Medicaid Services (CMS).

Many of the quality measures for diabetes are derived from the American Diabetes Association (ADA) Standards of Care, which started with general practice recommendations and definitions about quality and expanded to develop specific clinical goals related to blood glucose, blood pressure, and lipid management. This produced care measures established through a collaboration of quality-based organizations which eventually became known as the Comprehensive Diabetes Care measure used in Health Plan Employer Data and Information Set (HEDIS).

Ongoing work with stakeholder organizations continues to refine approaches to diabetes care. For example, the National Diabetes Quality Improvement Alliance makes recommendations to the National Quality Forum regarding improvements in diabetes measures that are incorporated into many pay-for-performance quality programs.1

HEDIS data show that diabetes care is improving over time, but slowly. Currently, 21 million Americans have the disease, but almost half of them do not keep their blood glucose under control.2 The National Committee for Quality Assurance (NCQA) suggests that gaps in diabetes prevention and care relate to poor reimbursement for managing chronic conditions. Also, many physicians simply do not have the time or skills to teach patients behavioral strategies. There’s also a lack of programs that address cultural differences and low health literacy of patients, not to mention a need for innovative tools and products to help patients overcome barriers to managing their diabetes. As a result, diabetic guidelines require much more than direction on the right treatments.

Goals of Therapy 

While the goals of therapy for all diabetic patients are essentially the same, namely to avoid the consequences from both over and under treatment, the specific target can be very different for each patient. For older adults, those goals are mainly focused at avoiding hypoglycemic events which requires less aggressive glycemic control (Table 1).

glycemic targets

The American Geriatrics Society (AGS) recently recommended to avoid using medications to achieve hemoglobin A1c < 7.5% in most adults aged 65 years and older; moderate control is generally better.4 This recommendation was based on the fact that there is no evidence that using medications to achieve tight glycemic control in older adults with type 2 diabetes is beneficial. Among non-older adults, except for long-term reductions in myocardial infarction and mortality with metformin, using medications to achieve glycated hemoglobin levels < 7% is associated with harms, including higher mortality rates. Tight control has been consistently shown to produce higher rates of hypoglycemia in older adults.4

Given the long timeframe to achieve theorized microvascular benefits of tight control, glycemic targets should reflect patient goals, health status, and life expectancy. Reasonable glycemic targets would be 7.0–7.5% in healthy older adults with long life expectancy, 7.5–8.0% in those with moderate comorbidity and a life expectancy <10 years, and 8.0–9.0% in those with multiple morbidities and shorter life expectancy. The setting of more appropriate targets can go a long way in reducing hypoglycemic events.4

As a corollary to medication treatment for diabetes, many facilities are still using modified diets and dietary restrictions for their diabetic residents. Nutrition has consistently been ranked as highly important to residents in the long-term care continuum. The American Dietetic Association published a position paper in 2010 on liberalization of diets in long-term care, stating: “There is no evidence to support prescribing diets such as no concentrated sweets or no sugar added for older adults living in health care communities, and these restricted diets are no longer considered appropriate.”5 Most experts agree that using medication rather than dietary changes can enhance the joy of eating and reduce the risk of malnutrition for older adults in health care communities. For many older adults residing in health care communities, the benefits of less-restrictive diets outweigh the risks. The use of a more liberalized approach produces several benefits, including better intake, lower incidence of unintended weight loss, more consistent blood glucose levels, and, perhaps most important, quality of life for residents. These individualized goals of therapy developed by these associations need to be incorporated into diabetes care guidelines.

Population-Based Care 

In a study of 23,000 diabetic patients, most of the quality and pay-for-performance programs they were participating in centered on poorly controlled patients with HbA1c ≥9%. However, this analysis showed that the typically targeted high-risk population was highly dynamic, had sizable turnover and—importantly—was a relatively small subpopulation of patients.6

Two other studies showed that increased interactions with a clinical pharmacist; regular primary care visits; and screenings for blood glucose, cholesterol levels, kidney function, and eye exams that include some incentives can significantly affect diabetes management in patient populations. In turn, this can lower health risks and reduce related health care costs.7,8

As the management of diabetes care improves due to continuing efforts to refine quality measures, implementation of pay-for-performance programs, and the development of innovative products, additional advancements can be made by simply expanding the scope of the target populations, increasing discussions with diabetic patients, and implementing appropriate screening. Together, these are a leap forward for disease management into true population health.

Value-Based Diabetes Programs 

Because of the prevalence of uncontrolled diabetes and related health care costs, several value-based programs seek to monitor and manage key factors of the disease. For example, the Medicare Advantage Five Star Rating program provides bonuses to Medicare Advantage plans for several therapeutic areas with four measures related to diabetes (eye exam, kidney disease monitoring, blood sugar control, and medication adherence to diabetes medications).9

Medicare Accountable Care Organization (ACO) models provide bonuses or penalties based on performance on quality measures and cost controls. These quality measures include hemoglobin A1c control, eye exams, in addition to an all-cause unplanned admission rating for patients with diabetes.10 An interesting point pertaining only to Medicare ACOs is the quality and costs assessments do not include the cost of Medicare Part D drugs, these are not included in the total cost of care. This means that prescribers in these ACOs can simply prescribe the best treatments purely from a clinical standpoint. Commercial ACOs, like those offered by Aetna and Cigna, provide bonus and shared savings programs using diabetes-related measures as well.11

Also, the new Medicare Access and CHIP Reauthorization Act’s Quality Payment Program (QPP) scheduled to begin on January 1, 2017, is a significant piece of legislation providing significant bonuses and penalties for Medicare physicians. The program mandates penalties and payments associated with most health care specialty areas. For diabetes, physicians are measured on several of the standard diabetes measures (eg, A1c, eye exam, foot exam) in addition to practice improvement activities such as on-site diabetes educators, patient self-management training, and group visits with patients with diabetes.12,13

It is important to note that CMS-managed programs may experience significant changes as the new US Presidential administration takes control in 2017.

Treating Diabetes in Assisted Living Facilities 

Older adults come to assisted living (AL) facilities for assistance, and an increasing number are coming specifically for diabetes management help. More than 25% of Americans aged 65 years and older have type 2 diabetes, and another 50% have a condition known as prediabetes (blood glucose levels that are higher than normal but not yet high enough to be diagnosed as diabetes). The number of AL residents with diabetes is significant and growing. By 2050, as many as 30% of adults in the US could have diabetes if current trends hold, compared with 10% currently, according to the CDC citing the increased odds of developing type 2 diabetes with age, increasing obesity, population growth of minority groups and higher risk and people with diabetes living longer.14

In addition to the increased numbers of older diabetic patients, their care needs are significant as well. Older diabetics have higher rates of amputation, heart attack, visual impairment, and kidney disease. They seek emergency care for blood-sugar crises at twice the rate of the general diabetes population. These consequences of poor management are often immediate and costly, often forcing transfer out of the home into the AL community (ALC). This can occur from either blood sugars being too low or too high. In the case of hyperglycemia there are several symptoms which could force an AL diabetic resident outside of their home in the AL to a nursing home because of worsening of their health requiring increased care needs. These issues from hyperglycemia could include blurred vision, new or increased confusion, lethargy, weight loss and/or worsening incontinence.14

Conversely, the relationship between hypoglycemic events and dementia may be bidirectional, as shown in a recent study of older adults with diabetes mellitus (DM).14 Hypoglycemia commonly occurs in patients with diabetes mellitus (DM) and may negatively influence cognitive performance; in turn, cognitive impairment can compromise DM management and lead to hypoglycemia.15 This is consistent with a growing body of evidence that DM may increase the risk for developing cognitive impairment, including Alzheimer disease and vascular dementia, and there is research interest in whether DM treatment can prevent cognitive decline. When blood glucose declines to low levels, cognitive function is impaired and severe hypoglycemia may cause neuronal damage. Research on the potential association between hypoglycemia and cognitive impairment has produced conflicting results.15

Conclusion 

The pervasive nature of diabetes demands monitoring and management and control from several stakeholder perspectives in order to improve quality care and reduce costs. Practice guidelines that include patient education, system-wide monitoring, and provider incentives and penalties are a few of the controls our health care system provides to achieve better care. As practice guidelines evolve to be more effective within the changing health care environment, so too will the management of this disease.

References

1.    Clark NG. A word about quality of care in diabetes. National Committee of Quality Assurance website. http://www.ncqa.org/PublicationsProducts/OtherProducts/QualityProfiles/FocusonDiabetes/AWordAboutQualityofCareinDiabetes.aspx. Accessed November 6, 2016.

2.    Ali MK, McKeever Bullard K, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999–2010. N Engl J Med. 2013;368(17):1613-1624.

3.    National Committee of Quality Assurance. Addressing the quality gaps in diabetes prevention and care. http://www.ncqa.org/PublicationsProducts/OtherProducts/QualityProfiles/FocusonDiabetes/AddressingtheQualityGaps.aspx. Accessed November 6, 2016.

4.    American Geriatrics Society. Five things physicians and patients should question. The American Geriatrics Society. http://www.americangeriatrics.org/files/documents/Five_Things_Physicians_and_Patients_Should_Question.pdf. Accessed November 8, 2016.

5.    American Dietetic Association. Position of the American Dietetic Association: liberalization of the diet prescription improves quality of life for older adults in long-term care. J Am Diet Assoc. December 2005;105(12):1955-1965. www.andjrnl.org/article/S0002-8223(05)01742-6/pdf. Accessed November 8, 2016.

6.    Courtemanche T, Mansueto G, Hodach R, Handmaker K. Population health approach for diabetic patients with poor A1C control. Am J Manag Care. 2013;19(6):465-472. 

7.    Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S. Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care. 2005;11(14):253-260.

8.    Study: UnitedHealthcare’s diabetes health plan can lead to improved health, more effective disease management, better cost control [press release]. Minneapolis, MN: UnitedHealth Group; January 10, 2013. http://www.unitedhealthgroup.com/newsroom/ articles/news/unitedhealthcare/2013/0110uhcstudydiabetes.aspx. Accessed March 3, 2016.

9.    Centers for Medicare and Medicaid Services. Part C and D performance data. cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html. Accessed November, 7, 2016.

10.    Centers for Medicare and Medicaid Services Accountable Care Organization 2016 program quality measure narrative specifications. January 13, 2016.

11.    Lewis VA, Colla CH, Schpero WL, Shortell SM, Fisher ES. ACO contracting with private and public payers: a baseline comparative analysis. Am J Manag Care. 2014;20(12):1008-1014. 

12.    Centers for Medicare & Medicaid. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf. Accessed August 3, 2016.

13.    Administration takes first step to implement legislation modernizing how Medicare pays physicians for quality [news release]. Washington, DC: Department of Health and Human Services; April 27, 2016. http://www.hhs.gov/about/news/2016/04/27/administration-takes-first-step-implement-legislation-modernizing-how-medicare-pays-physicians.html. Access August 9, 2016. 

14.    Stefanacci RG, Haimowitz D. Assisting for better diabetes management. Geriatr Nurs. 2013;34(5):418-420. 

15.    Yaffe K, Falvey CM, Hamilton N, et al. Association between hypoglycemia and dementia in a biracial cohort of older adults with diabetes mellitus.JAMA Intern Med. 2013; 173(14):1300-1306.