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By Rob Schlissberg, President, Cardinal Health at-Home Solutions

At Cardinal Health, we are committed to advocating for both our customers and our patients to ensure equitable access to healthcare. For those of us at Cardinal Health at-Home Solutions – a market-leading medical supplies provider serving people with chronic and serious health conditions in the U.S. – we advocate specifically for the patients who receive healthcare in the home, and for the providers who care for them.

Today, I want to share some of the work we’re doing to support Medicare patients who have diabetes.

First, some background: According to the American Diabetes Association, one in five Medicare beneficiaries has diabetes. Yet, under Medicare, there are gaps in the coverage of Continuous Glucose Monitors, commonly called CGM devices. CGMs are clinically proven digital devices that provide patients with key information about their glucose levels throughout the day. According to the National Institutes of Health (NIH), “good management of glucose greatly helps people with diabetes stay healthy and prevent complications of the disease. People who gain the largest benefit from a CGM are those who use it every day or nearly every day.”

The Centers for Medicare and Medicaid Services (CMS) relies on a network of private healthcare insurers – called MACs – to “serve as the primary operational contact between the Medicare FFS program and the health care providers enrolled in the program” – essentially to help process Medicare claims.

In October 2022, CMS proposed changes that are intended to close gaps in coverage to CGMs.  We are supportive of these proposed changes and encourage MACs to take additional actions to go farther to ensure provider and patient care. That’s why late last year, I submitted a letter to the MACs on behalf of at-Home Solutions, applauding the changes and providing a list of recommendations to further enhance patient access.

My primary recommendations and rationale are outlined below:

1. Current coverage criteria: Medicare requires a patient to be treated with insulin a minimum of three times daily to have a CGM device covered by insurance.
   Proposed CMS change: Expand coverage to include those treated with insulin once a day.
   Our additional recommendation: We’ve asked Medicare to indicate that all insulin administration methods including injection, Continuous Subcutaneous Insulin Infusion (CSII), and inhalation are noted explicitly as valid for the once-daily requirement for Medicare coverage.
2. Current coverage criteria: Medicare currently doesn’t consider a virtual appointment as a valid way for practitioners to assess a patient’s CGM data. However, the pandemic solidified the value and proved the integrity of telehealth visits – especially when treating older patients.
   Proposed change: Approve telehealth as an accepted way of assessing patients.
   Additional recommendation: We’ve asked Medicare to go a step further – by allowing practitioners to evaluate and document continued CGM adherence through remote evaluation of CGM data – in ongoing telehealth visits, for example. Eliminating both the physical appointment and telehealth appointment requirements will help address health disparities in CGM access and keep the door open to more flexible care delivery options that first were made available during COVID-19.
3. Current coverage criteria: Currently, if a healthcare practitioner prescribes CGM for off-label use, it may be eligible for Medicare coverage.
   Proposed change: The proposed changes indicate that Medicare coverage will only be available if practitioners prescribe CGM in exact accordance with its FDA indications.
   Additional recommendation: We do not support this proposed change because it creates unnecessary restrictions for use. As such, we’ve asked that off-label use continue to be eligible for coverage, which will respect the judgment of the prescribing physician.
4. Current coverage criteria: There are problematic, vague documentation requirements on recurrent level 2 hypoglycemic events. Level 2 events occur when a patient’s blood sugar level rises too high, which can impact cognitive function. Symptoms could include dizziness, confusion and seizures. In severe cases, called Level 3 hypoglycemia, a person is unable to function due to low blood glucose. If either event is left untreated, coma or even death could occur.
   Proposed change: Cover those patients who do not use insulin but have a history of hypoglycemic events.
   Additional recommendation: To ensure consistent and timely access to care, we've asked Medicare to clearly specify the medical documentation needed to meet this requirement, including removing the limitations to documentation that level 2 and/or level 3 hypoglycemic events have occurred. When a patient is equipped with a CGM device, they can better manage their glucose levels in real-time and prevent additional hypoglycemic events.

Finally, I’ve asked the MACs to act with urgency in approving these changes. President Biden and his administration plan to end the Public Health Emergency (PHE) for the COVID-19 pandemic on May 11. We’re asking CMS to approve these proposed changes before that happens, to prevent disruption and gaps in care for patients currently using CGMs that would not qualify under today's LCD but would qualify based on the proposed changes.

My at-Home Solutions team is deeply committed to helping our patients manage this complicated disease from home – an often-difficult journey for individuals that can have many twists and turns. Today, the healthcare industry has many advanced tools, including CGMs, that can make this journey smoother for patients and greatly improve quality of life.

We are proud to advocate on behalf of the millions of Americans impacted by this disease, many of them covered by Medicare. We firmly believe that the CMS’ proposed changes, when including our own recommendations, will improve patient outcomes.

Rob Schlissberg is President of Cardinal Health at-Home Solutions, a market-leading medical supplies provider serving people with chronic and serious health conditions in the United States. In this role, he is responsible for financial performance of the business, leading an executive team, driving operational change, and advocating for strategic partnership building. Schlissberg serves as a member of the Cardinal Health Operating Committee. Follow him on LinkedIn.