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Evidence-Based Diabetes Management May 2016

A Medicare Appeal for CGM Coverage: One Patient's Never-Ending Story

Dan Patrick
The author, who has lived with type 1 diabetes for more than 50 years, shares his account of a successful appeal of Medicare's policy of refusing to pay for continuous glucose monitoring (CGM.)
Although most commercial insurers now cover continuous glucose monitoring (CGM) devices, payment for this technology is routinely denied for an important and growing group with diabetes: Medicare beneficiaries.1,2 This occurs despite the May 2015 statement from leading professional societies of endocrinologists that such denials are “imprudent” for patients on intensive insulin regimens with a history of hypoglycemic events or frequent hospitalization.3 While appealing for CGM coverage is not easy, some persons with type 1 diabetes (T1D) do try. Evidence-Based Diabetes Management asked Dan Patrick, an Ohio Medicare beneficiary, who this spring, became a 50-year Joslin Medalist,4 to share his story.

CMS has taken a profound, deeply troubling, and dangerous, clinically unsupported therapeutic directionthrough a local policy which effectively blocks the reimbursement for a CGM under a Medicare rule. Through an arduous appeal process, I managed to win coverage for my CGM. Here is my story.

  This spring, I reached the 50-year mark of living with T1D. For most of that time, I lived without CGM, but that changed more than 3 years ago. In 1999, our family adopted a puppy named Maggie, and for 10 years, she served as my sleeping service dog. Maggie would lick my face to wake me in advance of a dangerous hypoglycemic event, and the necessary corrections were made. In the fall of 2009, Maggie was diagnosed with T1D, which is relatively common in female dogs as they age.5

  For the next 3.5 years, I became her caregiver and never really slept to be prepared for hypo events. After Maggie passed, it was time for a different CGM model. Starting in January 2013, I began using a CGM system. I had not yet turned 65 when I started using CGM, so it was covered by commercial insurance.

  In 2014, when I reached 48 years as a patient with T1D, I had become unable to discern the onset of hypoglycemic events and was diagnosed with a condition called hypoglycemia unawareness.6 That same year, I turned 65 on May 4, 2014, and became eligible for Medicare effective May 1, 2014. At the time of my appeal, CMS’ policy for CGM coverage was spelled out in the Local Coverage Article: Glucose Monitors—Policy Article—January 2014 (A47238). (This article has since been removed from the CMS website, but a copy is available as an electronic appendix.7) In 2014, and in compliance with Medicare rules, I enrolled. There are clearly defined parameters for enrollment, with financial penalties the patient for noncompliance.8

  My Medicare enrollment was also required by my personal healthcare coverage, which changed from a private non-Medicare plan to a Medicare Advantage PPO plan (MAP). At this point, all medical information had to be refiled, even though I was still with the same insurance company and had the same identification number. At first it seemed that I would receive CGM under Medicare without any problems: this particular insurance company went so far as to suggest choices of medical pharmacies to supply the 3 required CGM components, and I chose an in-network pharmacy to reduce costs. A box of 4 CGM sensors arrived every 28 days, starting in May 2014.

  The bottom fell out, in August 2014, with the reorder of a CGM transmitter. The reason given when Medicare refused to pay was that the transmitter was not covered under my MAP insurance plan, in compliance with Medicare rule (A47238).

  It’s worth noting that I had no trouble receiving approval from the same insurer for use of a CGM in December 2012, which I began using it in January 2013. The approval process, under my private non-Medicare plan, had only involved processing by my endocrinologist. The necessary CGM components were all covered outside Medicare. What changed, before and after enrolling in Medicare, that a lifesaving medical piece of equipment was not necessary to manage my T1D condition? The answer was, and still is, nothing.

  I have been an active viewer of discussions and information regarding various denials by Medicare via the Diabetes Online Community (DOC). Denials for Medicare CGM reimbursement are increasing, creating serious negative impacts on families of persons with T1D. These continued actions have prompted introduction of federal legislation to overrule prior individual CGM Medicare denials.1,2

Members of the DOC have come together, and a Diabetes Patient Advocacy Coalition (DPAC) has been initiated, making it easy to keep policy makers’ attention on people with diabetes.9 While federal legislation was introduced to overrule prior CGM Medicare denials in 2013, there was no action in the 113th Congress (2013-2014).10 The 114th Congress (2015-2016) reintroduced the legislation; the current bills are S.804 in the Senate and H.R. 1427 in the House, with 273 co-sponsors. No action had been taken at press time.11

  Given the lack of Congressional action, this became a personal fight for my life. In 2014, after living with T1D for 48 years, I realized that it would be imperative to prepare objective documentation to support an appeal to CMS. At the start of my appeal, there was no real guidance on how to proceed for approval of a CGM.

  Denial of coverage for the transmitter came in a letter, which arrived in October 2014 and clearly referenced the specific Local Policy (A47238). It is interesting that the MAP made no reference to any communications with my endocrinologist and considered my initial appeal to be from the patient only. How is it that the endocrinologist was removed from the discussion regarding my life with T1D? The blatant disregard of my medical condition, without consulting the specialist who handles my care, made no sense. I decided to assemble the documentation for review and consult with my endocrinologist for this appeal. This action continued through the first level of appeal with the MAP, and the second level would be with the independent reviewer of Medicare claims, Maximus Federal Services.

  Maximus’ mission is very specific: they are appeals experts. Medicare retains Maximus to review files and decide on the accuracy of a Medicare Advantage health plan’s decision—Maximus works for Medicare, not the plan.12 What was frustrating at this stage was that Maximus’ charge was not to look at the facts—which is what my physician and I assembled—but to look at the narrow question of what constituted Medicare policy, and whether the health plan had applied it.

To me, and to all persons with T1D, facts matter. My professional and personal life has a clear focus on measured data, to document my progress in striving to obtain a goal at hand. How can I clearly and conclusively document how CGM achieve a personal outcome of near normal glucose levels with minimized hypoglycemic events? The challenge for all T1Ds is to reduce hypoglycemic events, especially at night. Needless to say, Maximus ruled against allowing coverage, and the next step—Level 3—would be before an administrative law judge.

  Interestingly, to address the fears of parents of children with diabetes, a new tool has been introduced by Dexcom: Dexcom G5, which has been approved by the FDA for children as young as age 2.13 Thus, young children have an approved tool to manage their diabetes, but those over age 65 are denied Medicare coverage for CGMs. How absurd. My CGM had already proved to be an assistance in dealing with nighttime hypoglycemic events. The need for evidence to overturn a policy requires a review of the policy to present cogent points against it.

  I obtained a printout of Local Policy (A47238). The article reads: Local Coverage Article: Glucose Monitors – Policy Article – January 2014 (A47238). Under the section, Non-Medical Necessary Coverage and Payment Rules, the following line has been added: Continuous glucose monitors (A9276-A9278) are considered precautionary and therefore non-covered under the DME benefit.7 

A9276-A9278 are the billing codes for sensors, the transmitter, and the receiver. DME stands for Durable Medical Equipment. The Local Coverage Article applies to 7 states: Illinois, Indiana, Kentucky, Michigan, Minnesota, Ohio, and Wisconsin.

  The actions taken by MAP raise serious questions regarding the use of age and geographical factors. The most thought-provoking and compelling question becomes: on what basis  is the Local Coverage Article an absolute, offering no ability for a successful appeal for this lifesaving monitoring system? Failed appeals, thus far, outnumber permanent successes. 

  It is important in an appeal process to clearly define the terms. Medicare did not define or describe CGMs. My choice for a CGM was a Dexcom product. The Dexcom G4 Platinum Continuous Glucose Monitoring System was approved by FDA’s Medical Devices section on October 5, 2012. The FDA wrote the following under: What will it (Dexcom G4 Platinum) accomplish:14

  “People with diabetes can use the tracking and trending glucose information to help understand patterns in their glucose levels, and be alerted when glucose values are approaching potentially dangerous high (hyperglycemic) and/or dangerous low (hypoglycemic) levels. When used along with a blood glucose meter to obtain a more accurate reading of actual blood glucose levels, the Dexcom G4 PLATINUM can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.”

  The most troubling word in this short Local Article is “precautionary," which is the basis for Medicare denying CGM coverage as a DME. This is a statutory term, and CMS bases its interpretation on FDA labeling that calls for a self-monitoring blood glucose test with CGM before an insulin dose. But this narrow reading flies in face of evidence and expert opinion. While the term “precautionary” draws a blank via an internet search under medical definitions, it takes on a totally different meaning with requirements when defined as a precautionary principle. This is a precautionary approach, and the objective is to set policy that is not harmful; the burden of proof rests with Medicare.

  Can Medicare supply sound evidence with clinical consensus that removing reimbursement coverage for T1D using CGM will not cause any harm to the individual, their family, the community, and the public? CMS cannot. The website Children With Diabetes, offers an excellent product discussion on CGMs that includes a list of more than 40 links that offer support for the importance of CGM, including clinical studies.16

  The journal Endocrine Practice reported a study, in December 2014, which found that patients older than 65 years achieve a significant and durable improvement in glycemic control when using CGM, comparable with younger patients. In fact, the reduction in severe hypoglycemia may be of particular benefit to older patients.17 And in May 2015, after a review of the evidence, the American Association of Clinical Endocrinologists and the American of College of Endocrinology issued a joint statement calling it “imprudent” for payers to deny coverage for high-risk patients with intense insulin regimens, a history of hypoglycemia or hospitalizations, or other risk factors.3

 
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