BREAKING NEWS! CMS has announced new proposed mandated reporting on Diabetes Harm Measures, including severe Hypo and Hyperglycemic events. Learn More

Decades of clinical research has shown that optimal glycemic management in the hospital can improve patient safety. On August 13th, the Centers for Medicare & Medicaid Services (CMS) published new rules that recognize the significance of that body of evidence and introduce important steps towards ensuring hospitals across the country focus on improving safety, outcomes and costs by more effectively managing hyperglycemia and hypoglycemia among patients in their care.

The new CMS rules are significant because this is not a small problem. One-third of all hospitalized patients – not just the 34 million Americans living with diabetes and 84 million with prediabetes – require insulin therapy to regulate high blood sugars during their stay. There are many reasons that lead to patients needing insulin. For example, in patients without diabetes, stress hyperglycemia can occur when a person’s body is under duress and oftentimes occurs after surgery. In addition, prescribing steroids – like dexamethasone, one of the most common treatments for COVID-19 – causes insulin resistance and frequently elevates blood sugar levels.

Poor glycemic management can increase a patient’s risk for infection, recurrent admission to the hospital and extend the length of stay. One episode of severe hypoglycemia can add an additional $10,000 to the cost of a stay. Insulin therapy is the standard of care for treating hyperglycemia in the hospital but, when administered without safety guardrails or best-practice dosing protocols, can contribute to patient harm: insulin is involved in 16.3% of medication error reports for high-alert medications in acute care settings, more than any other medication type.

Despite these realities, hospitals historically have not done a good job managing patients’ blood sugar. The measures CMS has adopted provide the incentive to address the challenges and make glycemic management a priority.

You Can’t Improve If You Don’t Measure

At a basic level, most hospitals have no idea of their hypoglycemia or hyperglycemia rates, and the new CMS rules take a giant step towards making sure that changes. These rules provide a critical starting point to finally answer calls the American Diabetes Association and others have been making for two decades to hold hospitals to the standard of care for glycemic management.

Specifically, the new rules mandate that hospitals begin tracking:

  • Severe hyperglycemia – defined as the percentage of hospital days with one blood glucose reading greater than 300 mg/dL (excluding the first 24 hour period after admission)
  • Severe hypoglycemia – defined as the percentage of patients having one blood glucose reading less than 40 mg/dl during their stay, within 24 hours of administration of insulin (or other antihyperglycemic agents).

The new hyperglycemia rule is intended to measure untreated and prolonged hyperglycemia that could inhibit a patient’s ability to recover, while the hypoglycemia rule is intended to measure hospital-caused adverse drug effects.

Hospital leadership will need to collect and view their glycemic management data, and as this process is standardized throughout the industry, they will see how their outcomes compare to other institutions. This mandate will also make hospitals accountable to the public, who will be able to view results online and identify how different hospitals manage patient safety. The bottom line is, it creates a much-needed incentive to prioritize change management and address the challenges of optimal glycemic management that hospitals have struggled to address.

The Challenges Are Real

There are multiple reasons many hospitals have struggled to implement system-wide processes for glycemic management to this point.

Properly managing blood glucose is very complex and needs to be personalized for each patient based on their insulin sensitivity, how much they’re eating (or not eating) and a number of other fluctuating patient-specific factors. Providers and specialists tend to focus on a patient’s primary reason for admission, and while managing blood glucose is an underlying factor that could impact many of those conditions, it’s usually fourth or fifth on the problem list.

Persistent in-hospital hyperglycemia is largely preventable, and studies have shown that target blood glucose levels can be consistently achieved (using a variety of protocols) within as little as six hours for ICU patients using IV insulin and within two days for non-ICU patients using standard subcutaneous basal-bolus insulin regimens. However, many providers avoid treating uncontrolled hyperglycemia that persists during a hospital stay out of fear that improperly managed insulin therapy will lead to an overcorrection that causes severe hypoglycemia.

When insulin therapy is ordered for a patient, the methods used in many hospitals to adjust insulin dosing are severely outdated. For IV insulin infusions, many still calculate insulin doses manually using paper protocols or digitized calculators, which are simple but aren’t personalized for each patient’s unique needs. For basal-bolus insulin regimens, oftentimes the difficulty of placing orders for every adjustment means that patients stay on the same dose even if it’s not optimal or keeping them in target range.

Another common method is the use of sliding scale insulin only to manage hyperglycemia, which is confusing to use and has never been clinically proven to prevent hyperglycemia – in fact, sliding scale as monotherapy has been proven to be dangerous. These approaches all go against recommendations from the American Diabetes Association to avoid sliding scale insulin only, and use validated written or computerized dosing protocols for care in the hospital.

The Road Ahead

There is not much time for hospitals to prepare for these measures, and given the timeline of quality improvement initiatives, very little time to get started on efforts to improve their glycemic management programs.

Hospitals need to start collecting data on January 1, 2023, and after they gather the first year of data, CMS will likely require the data be reported in February 2024 (based on the history of similar measures). This timeline gives hospitals just over a year to plan and implement these measures.

While some hospitals don’t think this is enough time – and said so during an open comment period before the rules were adopted – the fact that CMS outright dismissed these comments validates the importance and urgency being placed on these new measures. In fact, CMS has even indicated that these rules will get tougher over time and has implied that severe hypoglycemia is mostly avoidable and should be a “never event” even for seriously ill patients in the hospital.

Severe hypoglycemia related to insulin, and untreated, prolonged hyperglycemia can be largely avoidable in the hospital, and it’s a future Glytec has been working towards since it was founded in 2006. Our company has been beating the drum on the challenges and importance of glycemic management in the hospital setting since then, and we’re encouraged by the fact that CMS is now putting its influence behind this issue too. It will have far-reaching impacts on safety, outcomes and costs.

You can take action now, and we are here to help you. Please reach out with your questions or to request a consultation.

 

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