Medicare to Cover Therapeutic CGM, Sets Criteria

Written by Kathleen Doheny

For Medicare patients on continuous glucose monitoring (CGM), the news is good.  The Centers for Medicare and Medicaid Services (CMS) will cover therapeutic continuous glucose monitoring (CGM), and have set the criteria that must be met. In the past, it has not been covered.

CMS announced the criteria decision March 23, following their January ruling about granting coverage for CGM. 1

The coverage decision ''is a game changer for our Medicare patients," says Amy Hess-Fischl, MS, RD, LDN, BC-ADM, CDE. She is program coordinator for the Teen and Adolescent Diabetes Transition Program at the University of Chicago's Kovler Diabetes Center and a member of the editorial board for EndocrineWeb.

The decision is ''long overdue," says J. Michael Gonzalez-Campoy, MD, PhD, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology in Eagan, MN, and a member of the editorial board for EndocrineWeb. "The medical literature clearly documents that enhanced monitoring improves outcomes in the treatment of diabetes."

The coverage is effective for service dates Jan. 12, 2017 and later, according to CMS.

The Four Criteria

The four criteria set down by CMS, all of which must be met for coverage, include that the patient must:

To meet the criteria, the system must be classified as a therapeutic CGM. That means users can make treatment decisions using the device. To date, the Dexcom G5 Mobile, by San Diego-based Dexcom, is the only system FDA approved to meet that criteria of being a therapeutic CGM.1

The Medicare decision coverage will not only save Medicare patients money, says Kevin Sayer, president and CEO of Dexcom. "They are going to learn more about their health than they ever have," he says. Many in the Medicare population may eat badly and not be active enough, he says. With CGM, they can see the consequences of a ''splurge'' meal right away. They can also see the value of a walk after lunch and the consequences of skipping dinner. Patients will make better decisions with the device, Sayer predicts.

Caregivers and family members will have less anxiety, too, he says, with CGM covered. "The ability to share data [from the device] should not be underestimated," he says. Family and other loved ones can keep an eye on blood sugar status and remind the patients to stay healthy.

Costs, Before and After Coverage

Before the Medicare coverage, ''a typical patient [without coverage] would spend $2500 to $4000 a year,''  Sayer says. That includes the cost for the transmitter, about $800 to $1000 a year, and sensors.

Dexcom's G5 Mobile has an externally worn glucose sensor that measures blood sugar levels continuously. It displays the values every five minutes. A small, flexible metal wire or sensor is inserted just below the skin, generating a small electrical signal in response to the amount of sugar there. The signal is converted to a glucose reading.

About 98% of commercial payers have coverage for CGM, Sayer says. Patients typically pay a copay of about 20%, he says.

The turning point for the Medicare coverage, he says, came with the FDA approved label change allowing consumers to make dosing decisions based on the therapeutic testing results with the CGM.

For the older adult population, Sayer says, ''the sensor is giving you a tool that the body loses. Your body loses the ability to detect the low [blood sugar], some [people] more than others."

A Patient Weighs In

Carrolyn Barloco, 65, of San Antonio, TX, says the decision will save her at least $1500 a year. The retired nurse had enjoyed reimbursement for the CGM while she was on her husband Tom's private insurance. That was about to change when she transitioned to Medicare. She is glad it did not.

One advantage, she says, is the ''share'' feature, which allows users to share the blood glucose readings with up to five different people. "He just showed me my blood sugar is 67 and going sideways," she says, referring to the trends displayed by the device. It was time for lunch.

Expert Perspectives

For the people now on Medicare who had access to coverage for CGM previously under private insurance, the decision ''is a great win for them to have this amazing tool back in their lives again without an out of pocket cost," says Hess-Fischl.

They are not the only group who will benefit, she adds. "This is also amazing for all those [without coverage] who may not have been able to pay for this," she says. "Hypoglycemia is a killer and if we can save people's lives with this little miracle device, this will make it easier for people who live with diabetes, and those of us who collaborate with them to improve their care."

The newer technologies ''decrease the risk of extreme glycemic derangements in the short term, and the risk of the chronic complications of diabetes in the long term,'' Dr. Gonzalez-Campoy says. " Although there has been a focus on the cost of the newer technologies, and this has delayed the decisions to implement coverage, giving patients access will result in tremendous cost saving to the US healthcare system.  With CGM coverage patients will have fewer 911 calls, less absenteeism from work, and eventually incur fewer costs for chronic complications of diabetes.''

Savings on health services, such as hemodialysis, care for the blind, amputation care and rehabilitation from vascular events will pay for the cost of this technology, he says. "For individual patients, the quality of life is significantly improved by this technology," he adds. 

 

Sources

1. https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf

2. https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors

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