Thursday, August 25, 2016

Driving A Car on Dangerous, Worn Tires

Hello again. Blue Care Network.

It's me again. The guy you've added to "The List" on potential rabble-rousers, those you sound warning bells on whenever their name pops up in the call que or a written communication comes in. Yep, that guy.

We've done this dance before, you and I. Remember?

Letter to My Insurance Company: I'd Rather Not Die Today

If My Diabetes Devices Were Parts of a Car...

My inhaled insulin Rx request that you initially denied, and then changed your mind on. The other battles that I didn't care to continue, because even though it was a question of improving my health, it wasn't worth my sanity.

Yet amazingly, you don't seem to learn the lesson. Even though it's clear you have a pattern of "deny first" and thoughtfully-consider the request later on appeal, the cycle continues.

Alert your supervisors, because you're all in for another round.

A few weeks ago, my doctor's office called in a prescription for a new type of basal insulin. We had met earlier that day in his office, discussed my diabetes data and all of the medications I've been using. He and I both agreed, after analyzing my data and determining that my current and past insulins were not working effectively to achieve the desired outcomes that a change was in order.

We decided that Tresiba was unique, doing something that other insulins did not. It had good customer feedback from those who've used it, and the science shows it lasts 42 hours instead of how long the competing Lantus and Levemir last (sometimes not even the full 24 hours they are labeled for). Because of my specific situation, my doctor agreed this would have a better chance of lowering my glucose variability, stopping those dangerous Lows that I have been experiencing, and even improving my A1C more than we've been able to accomplish to date.

I was excited to find a medication that might actually help keep me healthier and limit some of the scary hypoglycemia and hyperglycemia I have been seeing.

Unfortunately, Blue Care Netowrk denied that prescription claim.

In your denial letter, you specifically stated:
"Coverage is provided in situations where the member has failed to achieve adequate blood glucose control with use of both Lantus AND Levemir for at least three months each. Coverage cannot be authorized at this time. The member must still try and fail Levemir for at least three months to meet coverage criteria."
Holy, hell. Did you seriously tell me to "try and fail" for an effective 6 months before starting a medication that my physician and I both agree has the likelihood to improve my health????


That is very concerning language, on so many fronts. It's like you telling me to continue drinking toxic water before you'll give me access to bottled water. "Hey, data shows your current water is not good for you, but we want you to use that for three months. AND THEN, go next door to the house that data shows also has less-than-ideal water, and use that for three months. ONLY THEN, will we make sure you have access to clean bottled water that's shipped in from outside the city."

Seriously, Blue Care Network. That is what your official denial letter says to me.

Here, let me put this in terms you may be able to better understand. Maybe a car analogy will help you better grasp the foolishness of your decision-making here:

If My Diabetes Management Was a Car... 

I currently own a car, and you've paid for the wheels and gas and some of the engine work that's been done on this during the past 8 months.

However, when I drive this car on the local side-streets or expressways, it's a bumpy ride. My car shudders, sometimes resulting in my loss of control of steering and acceleration.

In consulting with my expert mechanic, who examined the body of my car and spent time looking under the hood, he advised that I needed 4 new tires.

Realizing that this is a serious problem that endangers not only myself but other people on the road, I've decided to address this issue and buy new tires. That is what I've asked for you to help on, since you're in the business of helping your insured customers achieve better outcomes.

Instead, you questioned my mechanic's orders. You relied on the textbook answer that was written years before my current car was even manufactured on the line, and was written based on outdated auto mechanics.

Your logic: I should continue driving on what I have now, for at least three months. And if that doesn't work, I should not listen to my mechanic and I should rotate the tires in hopes they'll magically heal themselves and allow for a smoother ride. By your reasoning, that tire rotation is a "clinically equivalent" option to buying new tires.

"Try and fail," is the language you used in a denial letter. You also talked about cost management and how this is a basis for your decision-making.

In the meantime, I wonder what happens if my car stutters and stops on a busy interstate? If I am seriously injured in an auto accident as a result of my car not functioning properly? If I am unable to work and be a productive member of society, as a result of my car malfunctioning because you denied to fix it based on the expertise of a mechanical expert who has actually looked at my car and warned of these potential issues?

I doubt you'd be quick to cover those above scenarios, probably because of the same "cost containment" rationale. And I wouldn't be surprised if you offered up language in denying those expensive claims, along the lines of "You should've fixed this before it became dangerous."

No, Blue Care Network. You are the one making dangerous decisions here.

You are forcing me to drive down the road on dangerous, worn tires. I'm riding on danger, because you won't do what you're supposed to in helping me afford the best treatment that will keep me safe.

My physician has offered medical advice based on my patient data, and we have determined the best course of action. We understand that you're concerned about containing costs, as we all are. But we also know that this particular Tresiba Rx is the best option, and it's different than anything else out there. That's why we have asked you to cover this medication, something that isn't "clinical equivalent" to anything else but has the potential to keep me safe and healthy.

We have already started the appeals process for this particular prescription, and I trust based on past experiences with BCN that this will be overturned and approved sooner, rather than later. For example:
  • The nurse who who told me that (after I had complained about my Dexcom CGM sensors being denied and gotten Huffington Post coverage on that), she was instructed to take a second look at my Dexcom CGM supplies, which had been denied. And learned upon re-examination that "Oh, you were already using this device, so that's now been approved."
  • That you approved my Dexcom CGM sensors in February, but in May you denied the Receiver and Transmitter that is needed to operate this CGM system. As I wrote before: If My Diabetes Devices Were Car Parts, it was like you OK'd the 4 wheels and steering wheel, but not the body of the car needed to use those other parts.
  • Within an hour of appealing a denial related to my Lantus insulin (you know, the one you're now insisting I "try and fail," my Rx was approved. 
  • You had denied my Humalog originally because I needed to first try the competing fast-acting insulin Novolog. As I'd never used Novolog before, I opted to not fight on this and to try that insulin. Yet, amazingly, I learned that after I'd called my local pharmacy to fill the Novolog, you went ahead and approved the Humalog insulin anyhow -- despite how I had not met the "clinical criteria" you had told me to follow.
  • In one of those above situations where I was fighting BCN and appealing a denial, two of the BCN representatives I spoke with on the phone specifically told me that they weren't permitted to give me information about my own medical care or the decision-making on my claims, because I was not the prescribing doctor.... One of those reps had the mind to throw HIPAA privacy at me as a reason behind this BCN policy... (Yes, really!) A few more phone calls up the chain of command resolved this, with apologies from a supervisor.
All of this proves to me that your decision-making process is, by design, aimed at denials and making it more difficult for patients and providers to obtain coverage.

No, I don't think insurance companies should be in the practice of blindly approving anything and everything we ask for. Yes, there does need to be some oversight and cost-analysis weaved into this review process. However, even when physicians follow your clinical criteria to the letter, and submit documentation showing so, you have a policy to deny first.

My hope is to highlight the arbitrary nature of your policies and decision-making, to help you understand that they simply don't make sense and go against both common sense and medical standards.

To be clear, I'm not worried about myself, and obtaining this particular medication. My concern is more about the pattern of denial your insurance company seems to have. I'm troubled by that trend, and worried about other patients. Those who don't know that they don't have to take No for an answer, but they have options to appeal.

My own doctor has told me of situations where he has Rx'd particular items, only to find out at a patient's next visit that they ended up not ever using it because of an insurance denial. They either decided they weren't able to get coverage for that medication, or they weren't interested in appealing for what they needed. I can't even imagine how many doctors out there have a blanket policy within their practices of not appealing, simply because they don't have the time or resources to devote to that process.

That's wrong, in my opinion. And I believe it goes against the very definition of what you profess to be all about, in your mission statement on healthcare coverage for people who need it.

With that, I leave you my ask:

Please, listen to the doctors who are writing these prescriptions. They know what they're talking about, as physicians, and we trust their medical advice.

Friday, August 19, 2016

Manipulating My A1C and Looking Beyond That Number

As my endo read through the medical chart at a recent appointment, I sat there anxiously waiting for him to tell me my latest A1C. He scanned the notes and rattled off bits of information about prescriptions, before getting to the meat and potatoes (so to speak) of our visit.

If you were a fly on the wall at that moment, you would have seen me all jittery, leaning forward in the chair waiting for the words to emerge. After what seemed like an eternity, he spoke:

Your A1C is 7.7%
My heart sank. While not really much different than my previous result, it was a 10th of a percentage point higher than last time at 7.6. Sure, it was only a tiny change, but in my head a screaming voice of judgement shouted: "Your A1C went up!" I was beyond bummed, especially because I've been putting in a lot of effort over the past few months to do better.

Apparently, this A1C was telling me that I was in fact doing worse than before, even if just a little bit.

Then I began to doubt... was this an accurate A1C result?

Since I decided in mid-May to take a break from my insulin pump, my blood sugars have actually been spectacularly better. I'm now using Lantus twice a day for basal, combined with NovoLog for fast-acting and Afrezza inhaled insulin for ultra rapid-acting bolus insulin doses. The goal is of course to increase the amount of time my BGs are in range (70-180), and reduce the number of big spikes and dips in BG levels. I've started seeing more in-range time since mid-May, and I've been happy with my success.

But I also reflected on how I'd been slacking some in the 2-3 weeks leading up to this particular appointment. My glucose variability had increased as I experienced more frequent higher BGs. So it was a bit of mixed picture.

Based on all of that, I believe that my most recent hemoglobin A1C result was somewhat "artificially inflated" from the highs in just the last few weeks -- not reflecting the improvement I've been seeing in my diabetes management over the past three months in full.

In my opinion, this A1C result was lying to me and those who make decisions about my healthcare based on this number.

Science proves that this is a possibility...

A1C Science

To dig into this topic, we spoke with Dr. Irl Hirsch at the University of Washington, a fellow T1 and well-known researcherand expert on glucose variability, who has long criticized relying on the A1C as the gold standard of diabetes management. He confirms that it’s definitely possibly to "manipulate" an A1C with short-term changes, in the fashion that I suspected for mine.

The A1C “is a test you can study for,” Hirsch says. “The latest science shows that yes, even though your A1C is an average of the past three months, 50% of your A1C is based on glucose in the last month.”

He cites several studies on this, going back a decade and further -- one of the more well-known being from 2008, when Dr. David Nathan found that recent glucose variability can impact an A1C result in people with T1D. The data from that study showed that the higher A1C levels, and among those with the highest glucose variability, the result could be off by as much as an entire percentage point!

Dr. Hirsch says that three studies now confirm the A1C doesn’t give the full picture of someone’s diabetes management trends. He points out that many things can impact an A1C result, from medications to iron deficiencies that can cause false A1Cs. Hirsch even notes that racial disparities exist in A1Cs, as scientific data now shows that for some reason in African-Americans, glucose binds more to hemoglobin and that can lead to A1Cs that are on average .3% higher than in Caucasian PWDs.

Hirsch says that someone with an A1C of 8.0% can have an average glucose ranging anywhere from 120 to 210.

“You’re basically throwing a dart,” he says. “We use this number to guide us on our diabetes, telling us whether it’s safe to get pregnant, the effect on complications, whether someone is ‘compliant’ or not, and now to determine how doctors get reimbursed. But it doesn’t show the entire picture, and you really have to look more closely at each patient.”

Ah ha, see?! We knew it!

Revisiting Standard Deviation

My endo agreed it was certainly possible my A1C was inflated, and in keeping with Hirsch's work, recommend I also look at my standard deviation that measures how much your BG levels bounce up and down. (Reminder: low SD is good, high SD is bad, because it indicates big swings.)

It's a bit of a confusing measure, but my doctor told me my deviation of 58 multiplied by 3 should be less than or equal to my average of 160 mg/dL, and mine came in just above that. So he described me as "borderline" but also said not to worry as I've been doing much better lately. That made me happy. It's important to note that you can also have a good A1C level with poor standard deviation in diabetes. So complex!

This all backs up what many of us have been preaching for many years: A1C is not the end-all, be-all measure for evaluating diabetes care. A low A1C that traditionally indicated "compliance" doesn't actually mean our blood sugars are staying in range as much as they should -- and it certainly doesn't take into account the dangerous Lows we may be experiencing. Same goes for the higher end of the scale.

On top of that, we're more than just a number, and there need to be other, more meaningful measures of "success" with diabetes.

FDA Looks "Beyond A1C"

Fortunately, I'm not the only one thinking about this. The FDA is soon holding a day-long public workshop on Diabetes Outcome Measures Beyond Hemoglobin A1C, facilitated by the agency's Centers for Drug Evaluation and Research (CDER), in partnership with JDRF, American Diabetes Association, American Association of Clinical Endos, JDRF, the DiaTribe Foundation and Scripps.

The meeting will delve into what the FDA should consider -- beyond A1C impact -- when evaluating new diabetes devices and drugs. This upcoming workshop follows the historic November 2014 webcast discussion between the FDA and Diabetes Online Community -- the one where so many people tuned in live that we ended up crashing the FDA's servers!

We're delighted to see this finally being officially addressed, as I personally can think back to my younger days when I'd say to my diabetes care team: "I'm not doing this for a better A1C, I'm doing this so that I am not having severe High or Low blood sugars!" Quality of life with diabetes is about keeping things steady, after all.

To me, I think it's important to look beyond A1C at three important data-points that are more reflective of how I'm doing:
  • Time In-Range: This is a key measure for me, because this is an indicator of how on track my diabetes management really is. 
  • Hypos: These are dangerous and can lead to scary situations where I lose the ability to think and treat myself, and possibly even consciousness. If these happen overnight, I might not ever wake up. So the fewer Lows, the better.
  • Glucose Variability: My blood sugars should be as smooth and steady as possible, since spikes and dips can lead to higher blood sugars and lows.
Personally, I just hope the FDA hears loud and clear: We are not just a number.