Nuances of Payer Coverage, Challenges of Patient Adherence in Diabetes Care

Trials have shown that intensive interventions can greatly improve outcomes for many patients with type 2 diabetes (T2D). However, in a world of finite resources, caregivers and payers have struggled to adopt such ambitious methods .

How can they do better? What affordable and achievable strategies might translate exciting discoveries into improved care? The American Journal of Managed Care gathered some of the nation’s most respected researchers and clinicians to discuss such issues from the standpoint of both provider and payer. The panel discussion took place ahead of the annual meeting of Patient-Centered Diabetes Care on April 7, 2016, in Teaneck, New Jersey.

Taking part were panelists Zachary Bloomgarden, MD, professor at the Ichan School of Medicine at Mount Sinai; Michael Gardner, MD, medical director at the Cosmopolitan International Diabetes and Endocrinology Center at the University of Missouri; John A. Johnson, MD, MBA, senior medical director at WellCare Health Plans; and Robert A. Gabbay, MD, PhD, FACP, senior vice president and chief medical officer at Joslin Diabetes Center. Dennis P. Scanlon, PhD, professor of health policy and administration at Penn State University, served as moderator.

Their discussion came amid important clinical and reimbursement news. Physicians were still sorting through the implications of SPRINT (Systolic Blood Pressure Intervention Trial),¹ which, in late 2015, found that persons with high cardiovascular (CV) risk without diabetes benefited from a targeted systolic blood pressure of 120 mm Hg. Two diabetes medications, empagliflozin and liraglutide, had been shown to have CV benefits in separate trials.^2,3 In addition, just 2 weeks prior, HHS Secretary Sylvia Mathews Burwell announced plans for Medicare to start funding the Diabetes Prevention Program, to help prevent those with prediabetes from progressing to full-blown disease.⁴

The panelists began by acknowledging the size of the problem. The American Diabetes Association estimates that nearly 28 million Americans have T2D and another 90 million American adults have prediabetes.⁵This patient population, everyone agreed, is far too large for the nation’s 5000 endocrinologists— so primary care physicians, who spend only a tiny fraction of their training on diabetes, will continue to treat the vast majority of T2D cases.

“The role of the endocrinologist now is to take the most severely affected patients, take the most complex patients, and to tune them up and return them to their primary care provider,” said Gardner. “But we also need to be reaching out to the primary care providers and providing education on the fundamentals of diabetic care.”

Gardner then discussed an outreach program that appears both effective and affordable: a weekly teleconference that allows primary care providers from anywhere in Missouri to call in with case-based questions for endocrinologists at the university. Each discussion helps an individual patient and educates all the doctors on the line about some facet of diabetes care. There is, of course, nearly unlimited information available to primary care physicians who wish to learn about T2D, but the panelists found it unrealistic to expect true expertise from people charged with treating dozens of conditions—particularly given the complexity of T2D, the tendency of studies to produce apparently contradictory results, and the need to treat different patients with different regimens.

“That’s where professional societies and specialists have a role, to be able to sift through the data and interpret it,” said Gabbay. “I think the other area where we can make more strides are decision-support tools for providers at the pointof- care that would say, ‘Based on these characteristics, the patient you’re seeing fits into a character that’s very similar to the SPRINT study group¹ or another study group. And therefore, here’s what would be recommended.’ I think there’s a little bit of that [now], and I think you’re going to see a whole lot more of that in the near future.”

The panelists had mixed feelings about the potential of payer programs that use billing data to question treatment plans that appear to deviate from standards of care or to warn physicians about medications that might not work for a particular patient. They agreed that payers have useful information that physicians often lack (like the knowledge that a patient is taking another medication that could interact with a prescribed treatment), but they also worried that physicians might object to payer “meddling” and questioned the sophistication of the systems that exist today.

“We have to make sure that those guidelines [that spur payer interventions] are not 18 years old,” said Bloomgarden. “I’m still getting e-mails or letters from various pharmacy benefit managers saying, ‘Here’s a patient with diabetes who is not receiving an ACE [angiotensin-converting enzyme] inhibitor or an ARB [angiotensin receptor blocker]. Why not?’ Of course they do not know that the patient has had hypercalcemia and was intolerant of those medicines or has low blood pressure. So we really need to somehow integrate the journal findings in the latest developments, in the latest understanding of professional societies, into what we provide to clinicians to help them manage their patients.”

The ultimate goal, everyone agreed, is to provide highly customized care based upon the latest research findings. Rather than using guidelines that urge physicians to start nearly all

patients on metformin and then choose randomly among dozens of second-line therapies, physicians would use algorithms that considered comorbidities and other patient characteristics to select the most appropriate treatment progressions for each individual.

“There actually has been a nice step forward in terms of the [treatment progression summaries] with ACE [American College of Endocrinology], in particular, showing these agents have these strengths, strength of effect, and also risk of side effect, and giving them some ranking. The previous guidelines have sort of been metformin and then anything else,” said Gardner, who went on to discuss how individual patient concerns should influence treatment options. “Sometimes [it requires] sitting down and talking with that patient, [and asking,] ‘Well why aren’t you doing insulin? What are your concerns? What are your priorities? Is your priority to get your A1C [glycated hemoglobin] down? Or is your priority not to have these side effects, not to have hypoglycemia? Do you live alone? Do you have some cognitive challenges?’ And trying to build a treatment program for them, which is really what patient-centered care is all about.”

The panelists also debated the proper consideration of treatment costs. Gardner and Bloomgarden argued that some payers encouraged medically inferior treatments by refusing (at least initially) to pay for options that produced demonstrably superior outcomes. For example, Gardner said, headto- head trials show that glucagon-like peptide-1 receptor agonists produce less weight gain and less hypoglycemia (and often better glycemic control) than insulin glargine; however, some payers won’t cover the newer medications unless the insulin somehow fails to reduce blood sugar. Bloomgarden argued that such restrictions could actually increase longrun costs by creating inferior outcomes. That said, Gardner acknowledged that formulary controls were understandable (and probably necessary) given that pharmaceutical companies charge large premiums for new medications that are sometimes only modestly better than far cheaper generics.

Speaking for his own company, Johnson said that physicians and patients were often steered toward particular medications in each drug class—especially in Medicare and Medicaid—but that it was unusual for them to be steered toward particular classes. “At WellCare, we do make an attempt to make the most cost-effective agent in the different classes available to our members. And where there’s justification to say there’s an exclusion and you need to take an alternate path, with the documentation, we’ve had no issues with approving that,” he said. “The important thing is the medications are tools, and when you’re operating in the government-sponsored space, you want to make sure that you’re stewards of the state and the federal government’s money, and we’re using that wisely to make available to our members the most cost-effective agents.”

The panelists all acknowledged that few patients today receive individualized care based on the latest research. They also acknowledged that it would be a challenge getting primary care providers to deliver such care, even if guidelines made it relatively easy. Most primary practices today do not even reach out every 6 months to schedule appointments with patients whose A1C is over 9%, Gabbay said, even though such outreach is easy to do and research indicates that it significantly improves outcomes.

Indeed, although getting care providers to adopt best practices in a timely fashion is nearly as hard as getting patients to comply with treatment regimens, the panelists believe that the move to replace service-based payments with outcomebased payments will motivate providers to adhere closer to best practices. They also believe that efforts to pay for outcomes rather than inputs may help spur a transition from a model of diabetes care that relies mostly on physicians and prescription drugs to a model that also uses other care providers to improve patient lifestyles.

“If you look at all the evidence, there have been significant improvements in diabetes care by moving toward a patientcentered medical home model,” Gardner said. “But that, in and of itself, is not the full answer because, again, only a portion of healthcare happens within that practice. And small practices may not have all of the different types of professionals that can help. So you mentioned diabetes educations and dieticians. The typical primary care practice isn’t going to have that embedded in the practice, and that’s where centers of excellence can, in diabetes, be able to send people, educators, dietitians, to various primary care practices once a week or whatever that model might look like.”

Such visits from experts who could develop diet and exercise programs for patients could occur in person or online. Another model for practices that are too small to employ fulltime nutritionists, counselors, and personal trainers might be to contract on a per-patient basis with independent local providers and use electronic health record systems to coordinate care. Physicians would use their outcome-based fees to pay the other service providers. In many cases, however, providers may have a simpler option: sending patients to use the support services offered by the payers who run their health plans.

“On the managed care side, in the government-sponsored space, we offer case and disease management programs that are interdisciplinary teams that partner with the provider,” Johnson said. “For example, we may have a pharmacist, a nurse, a social worker, and a community health worker who help us locate our members in the community who have diabetes and connect them to those resources. So that is a benefit that we offer our most vulnerable at-risk members. In the commercial space, it’s generally offered to the employers as an add-on benefit.”

Using such programs on the worst-off patients, the panelists agreed, would ideally be a stepping stone toward using them on all willing patients who have T2D and then on willing members of the much larger patient population with prediabetes. But the path toward such care will not be an easy one.

“The dilemma is that we’ve all known for decades that physical activity and healthy diet will prevent the development of diabetes, and the Diabetes Prevention Program that Michael mentioned, the [Diabetes Prevention Program] absolutely showed that actually it’s better than medication in preventing the development of diabetes,” Bloomgarden said. “But delivering that intervention is tremendously difficult, and it requires a high level of interaction between healthcare providers, not necessarily tremendously trained, but individuals who will encourage people to eat right and exercise right. And getting that daily exercise; walking the 10,000 steps; limiting your diet, is just very hard for many people to do.”1. Wright JT Jr, Williamson JD, Whelton PK, et al; The SPRINT Research Group. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015;373(22):2103- 2116. doi:10.1056/NEJMoa1511939.

2. Zimman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015; 373(22):2117- 2128. doi:10.1056/NEJMoa1504720.

3. Victoza significantly reduced the risk of major adverse cardiovascular events in the LEADER trial [press release]. Plainsboro, NJ: Novo Nordisk; March 4, 2016. http://www.prnewswire. com/news-releases/victoza-significantly-reduced-the-risk-of-major-adverse-cardiovascularevents- in-the-leader-trial-300231181.html. Accessed May 31, 2016.

4. Independent experts confirm diabetes prevention model supported by Affordable Care Act saves money [press release]. Washington, DC: HHS; March 23, 2016. http://www.hhs.gov/ about/news/2016/03/23/independent-experts-confirm-diabetes-prevention-model-supported- affordable-care-act-saves-money.html. Accessed May 4, 2016.

5. National Diabetes Statistics Report, 2014: estimates of diabetes and its burden in the United States. CDC website. http://www.cdc.gov/diabetes/pubs/statsreport14/nationaldiabetes- report-web.pdf. Published 2014. Accessed May 4, 2016.