Bipartisan Senate & House Diabetes Caucuses Co-Chairs Urge VA to Improve Veterans’ Access to Lifesaving Diabetes Management Technology

August 18, 2021

**The letter comes after CMS heeded the lawmakers’ call earlier this year to stop requiring four finger stick tests prior to initiating continuous glucose monitoring therapy**

(Manchester, NH) – Yesterday, U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) and Representatives Diana DeGette (D-CO) and Tom Reed (R-NY), Co-Chairs of the Senate and Congressional Diabetes Caucuses, sent a letter to Secretary of Veterans Affairs Denis McDonough urging the VA to stop requiring veterans to use the medically unnecessary four finger stick tests prior to initiating continuous glucose monitoring (CGM) therapy.

In their letter, the lawmakers highlighted their successful call earlier this year to the Centers for Medicare and Medicaid Services to remove the burden of this test on Medicare beneficiaries before they can start CGM therapy. They called on the VA to make a similar change to its criteria to ensure more veterans can access this convenient and lifesaving diabetes management and care technology.

“We appreciate the on-going efforts of the Veterans Health Administration (VHA) to provide more efficient and effective health care services to our growing veteran populations,” wrote the Co-Chairs. “While the agency has made good strides toward that end, we also are concerned about achieving greater parity between federal health programs to ensure that our veterans enjoy the benefits afforded to Medicare beneficiaries.”

They concluded, “For these reasons, we write to express support for increased access to appropriate diabetes care and recommend that VHA consider making a similar change to its criteria for use to provide veterans the same access to valuable healthcare technologies… This access will help improve their quality of life and even holds the potential to reduce health care costs.”

Many people with diabetes must monitor their blood glucose levels throughout the day to control the disease and maintain overall health. If blood glucose levels are not properly monitored, patients can suffer from hyperglycemia and hypoglycemia, which can cause more serious health issues such as ketoacidosis or unconsciousness and require costly hospitalizations.

However, studies show that only one in three patients with diabetes comply with blood glucose monitoring (BGM) as prescribed. Aversion to repeated finger sticks and the time it takes to perform a traditional blood glucose reading are two commonly-cited patient complaints that contribute to low BGM compliance rates. Traditional BGM testing also has therapeutic limitations because it only provides point-in-time readings and does not warn of pending hypoglycemia. Continuous glucose monitoring provides a continuous real-time measurement of blood glucose levels. Research is nearly universal in showing CGM helps lower A1C in patients with diabetes and can prevent and aid in the detection of hyperglycemia and hypoglycemia.

As co-chairs of the Senate Diabetes Caucus, Shaheen and Collins have worked together to increase awareness of the threats posed by diabetes, invest in research and improve access to treatment options. Shaheen and Collins have consistently held insulin manufacturersinsurers and pharmacy benefit managers accountable for the skyrocketing cost of life-saving insulin.

The full letter can be read here and below.

 

Dear Secretary McDonough:

 

As Co-Chairs of the Senate and House Diabetes Caucuses, we write to urge you to ensure that veterans have access to the diabetes management and treatment technologies that they need. We supported a recent review of Medicare coverage policy for continuous glucose monitors (CGMs), where Medicare ultimately decided to eliminate the four times-per-day testing criterion as a requirement for coverage for CGMs. We strongly urge you to replicate this coverage change in the veterans’ health benefit and eliminate the requirement for patients to show that they need to test their blood glucose levels four or more times per day in order to be eligible for CGM coverage.

The medical standard for treating diabetes varies depending on the type (1 or 2), as well as the individual’s overall health. A key element of treatment is the frequent monitoring of blood glucose levels. Persons with diabetes need to monitor blood glucose levels throughout the day, with some needing to check at least 10 times.[1] Regular monitoring is recommended to ensure the patient is in an established, safe glycemic range. If not properly managed, patients can suffer from hyperglycemia and hypoglycemia, which can cause more serious health issues such as ketoacidosis or unconsciousness and require costly hospitalizations.

However, studies show that only one in three patients with diabetes comply with blood glucose monitoring (BGM) as prescribed.[2] Aversion to repeated finger sticks and the time it takes to perform a traditional blood glucose reading are two commonly-cited patient complaints that contribute to low BGM compliance rates. Traditional BGM testing also has therapeutic limitations because it only provides point-in-time readings and does not warn of pending hypoglycemia.

Continuous glucose monitoring provides a continuous real-time measurement of blood glucose levels. A small electrode, part of a glucose sensor, is inserted under the skin to measure glucose levels in tissue fluids. The glucose information is transmitted to a reader that displays the user’s glucose value. Research is nearly universal in showing CGM helps lower A1C in patients with diabetes and can prevent and aid in the detection of hyperglycemia and hypoglycemia.

On June 3rd, Medicare announced that it will update its local coverage determination (LCD) policy removing the frequent testing requirement on July 18, 2021. Medicare’s Durable Medical Equipment Administrative Contractors (DME MACs) concluded, “there is no evidence to support that frequent SMBG (more than 4 times per day) as a prerequisite for initiating CGM use is predictive of improved health outcomes.” The DME MACs cited consensus clinical practice guidelines and consistent clinical evidence found through its literature review of randomized controlled trials and systematic reviews with meta-analyses to support this decision.  This decision and change strikes a reasonable balance between wanting more frequent testing and monitoring, and the real-world challenges of testing compliance.

We appreciate the on-going efforts of the Veterans Health Administration (VHA) to provide more efficient and effective health care services to our growing veteran populations. While the agency has made good strides toward that end, we also are concerned about achieving greater parity between federal health programs to ensure that our veterans enjoy the benefits afforded to Medicare beneficiaries.

For these reasons, we write to express support for increased access to appropriate diabetes care and recommend that VHA consider making a similar change to its criteria for use to provide veterans the same access to valuable healthcare technologies.

Together we can help ensure that veterans with diabetes have access to the full range of devices and technologies that they need to manage their conditions. This access will help improve their quality of life and even holds the potential to reduce health care costs. Thank you for your attention to this issue.

Sincerely,

 

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[1] ADA Standards of Care in Diabetes 2016. “Self-Monitoring of Blood Glucose for Patients with Insulin Intensive Regimens”

[2] Haak, Thomas, et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Therapy 8.1 (2017): 55-73.