In Search of Reimbursement: A CGM Odyssey

by james s. hirsch

Will continuous glucose monitoring (CGM) revolutionize diabetes care? Companies are investing hundreds of millions of dollars. The Juvenile Diabetes Research Foundation (JDRF) has made a significant commitment; and at least one top diabetes expert, Jay Skyler, believes CGM will replace finger-stick tests in five years.

But the ultimate acceptance of CGM may hinge less on the technologists, the health care providers, or even the patients but on another group entirely - the insurers.

If insurers were principally interested in the health of its customers, it would gladly support a medical device that, when properly used, offers clear benefits. But private insurers are in business to make money; and public insurers, Medicare and Medicaid, already face spiraling health care costs.

So convincing payers that a medical device like continuous sensors - new, expensive, unproven over the long run - should be reimbursed will be difficult. I speak from experience.

This past summer, I was asked to use the DexCom SEVEN for a six-week trial. As I've previously written (diaTribe issue 5 Test Drive), I'm not a technology expert and did not particularly covet CGM, but my experience with this device was quite favorable. The system still has its glitches, but knowing in real-time what your blood sugar is - and which direction it's heading - could have life-saving advantages. The sensors' real power, in my judgment, is less physiological than psychological, forcing patients to be more engaged with their diabetes.

In my case, the DexCom SEVEN allowed me to fine-tune my overnight basal rates on my insulin pump, caught several lows before I did, and improved my control. Over the past 20 years or so, my A1c's have consistently been in the mid to high 6's. My A1c, using the sensors for only six weeks, was 6.1 (A1cs measure average blood sugars over three months). Put me on the SEVEN for three months, and I would easily post an A1c in the 5's, with little fear of hypoglycemia.

So when my trial with the SEVEN ended, I wanted to continue. If I were beginning from scratch, the start-up kit costs $800, which includes the receiver (which displays your glucose readings) and the transmitter (which attaches to your body and relays the numbers). I already had the equipment; I just needed to pay for the disposable sensors: each one costs $60 and lasts for seven days. If you wear one constantly, the cost is $240 a month, or $2,880 a year. Throw in extra glucose strips for calibrating the device, and you're looking at $3,000 a year.

I wouldn't say $3,000 would bankrupt our family, but it's enough to seek reimbursement - and certainly enough to deter many patients, perhaps myself included, from using CGM.

So I asked my insurer, Harvard Pilgrim HealthCare of New England, to cover the sensors. DexCom actually filed the paperwork, which is apparently standard among medical device companies - I've used three different insulin pumps, and each company had its own staff to deal with the insurers. As part of the application, my physician wrote a letter explaining why I needed a continuous sensor.

As it happens, my need was more than an amorphous appeal to "better control." Three years ago, I had passed out from hypoglycemia while driving on the highway. My son, then age 3, was in the backseat. The car veered off the highway and flipped over like a 4,400-pound pancake. Miraculously, no one was hurt or even scraped. My son vaguely remembers it like he would a roller coaster ride.

My doctor cited the incident in his letter, noting that I am "vulnerable to severe episodes characterized by confusion and loss of consciousness . . . [and] this device is necessary for Mr. Hirsch's well-being and safe care."

On September 12, Harvard Pilgrim sent me a letter rejecting my application. There was no information on why it was rejected, except that the service is not covered under my benefit plan.

The result wasn't surprising - we simply don't have enough clinical evidence to persuade payers of CGM's benefits. The technology is too new, and clinical trials are time-consuming and expensive. Some studies are taking place, with the JDRF's 10-site trial being the most ambitious. But until CGM's benefits - improved glycemic control and less hypoglycemia - are clearly documented in peer-reviewed journals, insurers will balk at reimbursement. (One positive note: The Centers for Medicare and Medicaid Services have issued billing codes for CGM, beginning January 1, which will ease the processing of claims; details can be found here.

Some patients have received coverage for CGM, but those decisions are made case by case. Policies vary by insurer and region. The best advice to any patient, once rejected, is to appeal, appeal, and - when all else fails - appeal again.

So after I was rejected, I appealed, writing a letter to Harvard Pilgrim on September 19. "You didn't indicate why [CGM] is a 'benefit exclusion,'" - I wrote, "but I would like to share why I believe the product is a necessary benefit."

I noted that the cost of maintaining tight glycemic control for type 1 diabetes (insulin, glucose meters, etc.) is relatively small compared to the cost of treating complications (kidney failure, heart disease, etc.), which is why most insurers cover these basic supplies. But even with improved pharmaceuticals and devices, achieving near-normal blood sugars is difficult because so many variables change glucose levels, the most obvious being food, exercise, and insulin. "Moreover, blood sugar levels vacillate wildly because of stress, anxiety, or mood changes. They fluctuate when your mother-in-law visits or when the Red Sox are playing the Yankees, when you're on a job interview or a date or a bumpy plane ride, when your favorite department store has a huge sale or when you're drawing to an inside straight. In other words, life changes your blood sugar."

I explained why CGM's "trend lines" are so important - patients not only know what their blood sugar is but where it's heading, and how that information can pre-empt a severe low or curtail an impending high. I also described my car accident, in which my son and I were required to visit an emergency room. "My son got a peanut butter and jelly sandwich; I got a Band-Aid. Our combined bill: $1,397, which our insurer covered."

I also discussed my experiences wearing the DexCom SEVEN, concluding, "If I had [the device] three years ago, I'm confident I would not have had the accident."

I acknowledged that the sensors are not cheap but wrote that I believed "they will ultimately save insurers money through fewer Emergency-Room visits, better glycemic control, and fewer complications . . . common sense should dictate that any product that reduces hypoglycemia and improves glycemic control is worth covering in full."

On October 17, Harvard Pilgrim rejected my appeal. The bizarre part was why.

Harvard Pilgrim said it "does not cover glucose monitoring systems that are not linked directly to an external ambulatory insulin infusion pump," and that a "Physician Advisor" had reviewed "the product information available on the Dexcom web site [and] determined that [the SEVEN] is not directly connected to an insulin infusion pump."

My first thought was: I hope Harvard Pilgrim did not pay this Physician Advisor a lot of money to learn something - that the SEVEN is not connected to a pump. I could have told them that for free.

My second thought was: What possible rationale does Harvard Pilgrim have for covering continuous sensors linked to an insulin pump, but not the sensors by themselves?

I called my "Appeals Analyst," Kay Frye, who said Harvard Pilgrim would only reimburse such a product if coverage were mandated by state law or if the product was included in the existing benefits negotiated by my wife's employer.

So I now had several options. I could move to another state, if any exists, that mandates CGM coverage. My wife can quit her job and find an employer who might include CGM in its benefits. I can sue Harvard Pilgrim. Or I can seek an external review by writing the Massachusetts Department of Public Health.

I am seeking the latter, and a DexCom manager is helping me prepare my appeal. Presumably, if the state health department deems that CGM is necessary for me, Harvard Pilgrim will relent.

I'll let you know my results. Until then, if you want some tips on how to win CGM coverage, check out JDRF's helpful web site.

Good luck.