By Amy Killelea, Christine Monahan, and Zeynep Celik
Prior authorization processes are increasingly being criticized by patient and provider groups for creating barriers to necessary care. As state policymakers begin to more actively regulate prior authorization and other utilization management techniques used by insurers, one response is to require that insurers justify their coverage and prior authorization policies using evidence-based clinical guidelines. Translating clinical guidelines into coverage policies is a complex endeavor, and many insurers claim they already do this, while also balancing cost considerations. Getting this translation right, however, can have major ramifications, particularly for conditions like diabetes that require access to a range of devices, medications, and other services to ensure optimal health outcomes. Lessons learned from how diabetes clinical guidelines are translated into coverage policies and the impact on patient access when there are gaps in that translation process are relevant for reform efforts that seek to tether utilization management decisions to discernable clinical standards.
How Do Clinical Guidelines Articulate the Standard of Care for Diabetes?
More than 30 million people have been diagnosed with diabetes in the United States, including two million individuals diagnosed with Type 1 diabetes, an autoimmune disease that prevents the pancreas from making insulin and requires constant insulin treatment for survival. Approximately six million people diagnosed with Type 2 diabetes also use insulin to manage their blood glucose levels. To maintain optimal health and avoid life-threatening complications, people living with insulin-requiring diabetes must have access to a range of diabetes medications, devices, and ancillary services. Recognizing the complexity of diabetes management, medical societies publish and regularly update guidelines to help clinicians provide evidence-based care. These guidelines can also inform private insurance coverage policies. However, whether plan coverage policies are aligned with clinical guidelines often depends on how those guidelines are translated into policy terms.
For diabetes management, two societies publish clinical guidelines commonly used in practice: the American Diabetes Association (ADA) Standards of Care in Diabetes and the American Association of Clinical Endocrinologists (AACE) Clinical Practice Guidelines. The recommendations from these two entities are not in conflict, but may include slightly different details and practice considerations because of their different audiences (see Table 1). The ADA standards are intended for a wide range of clinicians, including primary care providers, while the AACE guidelines are primarily for specialists in endocrinology. The different audiences reflect a slightly different intended use for each set of guidelines. For instance, the ADA guidelines are intended to allow for more individualized care and treatment decisions because of the wide range of provider types using the guidelines, while the AACE guidelines are somewhat more prescribed for tailored specialist decision making.
| Table 1: ADA and AACE Clinical Guidelines | |||
| Medical Society | Frequency of updates | Audience | General vs. Prescriptive |
| ADA Standard of Care | Annual | Wide range of clinicians, including specialists and primary care providers | Lists medications and devices available without specific order or recommendation |
| American Association of Clinical Endocrinologists (AACE) Clinical Practice Guidelines | No fixed update period | Primarily endocrinologists | Includes more prescriptive step-wise list of medications and devices |
How Do Carriers Translate Clinical Guidelines into Coverage Standards?
The ADA and AACE design their guidelines primarily to guide clinicians in their provision of care. However, the guidelines – and the evidence on which they’re based – can also inform plan coverage standards, including medical necessity criteria and utilization management policy. Health insurers often publish coverage criteria documents for different interventions or diseases, spelling out the circumstances under which specified services will be covered.
Insurer coverage criteria should be based on medical necessity criteria tethered to an evidence base for a particular intervention. However, translating clinical evidence and guidelines into coverage policies is a complex endeavor, and patient and provider groups argue that insurers can sometimes get it wrong, leading to denials of care that can harm patients. In addition, clinical guidelines are occasionally silent on certain areas relevant for insurance plan designs. For instance, guidelines are often agnostic as to whether particular formulations of medications or types of devices should be preferred on a plan’s formulary. Furthermore, they typically do not include an assessment of the relative cost of each intervention as compared to its value. Insurers (acting on their own behalf or as administrators of self-insured employer health plans), on the other hand, weigh cost along with safety and efficacy of particular interventions. An important caveat is that payer cost analyses aren’t fool-proof, and many argue they fail to take into account the full value of expensive interventions, including reduced total cost to the health care system.
Because of the complexity of this translation exercise, carriers and employers commonly contract with third-party vendors to conduct a comprehensive evidence review and make recommendations with regard to coverage criteria. Two of the most widely used vendors are InterQual (owned by Optum, an arm of United Healthcare) and MCG. These vendors use clinical experts to review peer-reviewed evidence and then publish guidelines to inform coverage policies. While InterQual and MCG may reference medical society guidelines – including the ADA Standard of Care and AACE Clinical Practice Guidelines – they conduct a full and independent evaluation of the evidence base.
The process of translating clinical evidence and guidelines into coverage policy terms has major implications for access to care. Take access to continuous glucose monitors (CGMs), for instance. CGMs have made it much easier for people to accurately monitor their blood glucose levels without the need for frequent finger pricks. The advances in CGM technology mean that there are multiple devices currently on the market with different attributes that may appeal to different patients. The ADA now recommends early initiation of CGMs as the standard of care for anyone using insulin, regardless of diabetes type. However, as CHIR’s forthcoming research will show, carrier coverage criteria still vary in whether they require individuals to demonstrate they were experiencing difficulty achieving glycemic targets before the plan will approve CGM coverage. Patients and providers argue that this extra step before a plan will cover a CGM is not based on evidence, is not aligned with clinical guidelines, and makes CGMs harder to access.
Other patient groups have pointed out similar disconnects between clinical guidelines and coverage standards, particularly in the mental health and behavioral health space, where advocates have identified concerning misalignment between plan utilization management practices and well-accepted mental health and substance use disorder medical standards.
What Role Do State Insurance Regulators Have in Address Possible Disconnects Between Insurance Coverage Standards and Clinical Guidelines?
State legislatures and insurance regulators are responding to the growing calls for reforms to utilization management to ensure that coverage decisions do not inappropriately or arbitrarily deny access to clinically recommended care. Ensuring that plan utilization management policies are based on sound clinical evidence is increasingly a part of those broader reform efforts.
A recent CHIR issue brief catalogued state legislation on prior authorization, noting which laws regulated the substantive coverage criteria that plans use to determine whether a service should be covered or not. To ensure that plans are tethering utilization management processes to a sound clinical evidence base, some states (e.g., Alaska and Colorado) have required plans to reference clinical guidelines and/or peer-reviewed evidence to justify prior authorization decisions. Others (e.g., Delaware and Indiana) have required plans to ensure that a provider with requisite expertise in the service at issue review final prior authorization decisions. While these reforms do not dictate the specific coverage criteria a plan must use, they attempt to put guardrails around plan processes to tie them more closely to accepted standards of care. These reforms are not specific to diabetes, but could help to encourage plans to base their coverage policies on an updated evidence base, which is especially important as diabetes care advances.
While states only have purview over the fully insured private insurance market and cannot regulate larger self-insured employer benefits, these laws are nonetheless having an impact on both insurance practices and patient experiences.
As the policy debates around prior authorization and utilization management continue, the underlying clinical evidence used to justify an adverse coverage decision is likely to remain a focus point for patients, providers, and regulators.
