I have recently been contacted more times than I can count by Veterans with the “What if I go SVR during my claim?” or the “How will this affect my rating now that I am cured?” Quite simple, actually. 38 CFR Part 4 dictates what is required for what percentage but some other guidelines apply depending on your claim date and your residual symptoms. Let’s analyze the possibilities all the way from very old to very new and the permutations of “residuals”.
An old example would be me. Due to VA’s recent munificence, I am a twenty year protected Vet and am bulletproof. My claim date of March 1994 guaranteed that but there are other metrics to gauge this by too.
If you are over ten years with P&T with a protected DIC for the oke-san, again, the DIC cannot be rescinded. VA would rarely try to disturb this or your P&T via the five-year rule.
If your claim is five years and older with 100%P&T, again this is a substantially protected position to defend. The five-year language in 38 CFR §3.344(c) is benign towards those who are not going to improve:
(c) Disabilities which are likely to improve. The provisions of paragraphs (a) and (b) of this section apply to ratings which have continued for long periods at the same level (5 years or more). They do not apply to disabilities which have not become stabilized and are likely to improve. Reexaminations disclosing improvement, physical or mental, in these disabilities will warrant reduction in rating.
And then there are the less than five year crowd who emailed me.
Many of you, including attorneys, tend to overlook some of the meat in 38 CFR § 3.340 that you can ultimately use to extract a P&T or 100% schedular rating you can turn into P&T. Read the fine print:
b) Permanent total disability. Permanence of total disability will be taken to exist when such impairment is reasonably certain to continue throughout the life of the disabled person. The permanent loss or loss of use of both hands, or of both feet, or of one hand and one foot, or of the sight of both eyes, or becoming permanently helpless or bedridden constitutes permanent total disability. Diseases and injuries of long standing which are actually totally incapacitating will be regarded as permanently and totally disabling when the probability of permanent improvement under treatment is remote. Permanent total disability ratings may not be granted as a result of any incapacity from acute infectious disease, accident, or injury, unless there is present one of the recognized combinations or permanent loss of use of extremities or sight, or the person is in the strict sense permanently helpless or bedridden, or when it is reasonably certain that a subsidence of the acute or temporary symptoms will be followed by irreducible totality of disability by way of residuals. The age of the disabled person may be considered in determining permanence.
We have a shifting dynamic on this that ensures a case-by case basis for grants, downward ratings or revisions but the age milestones are protections that are “backflow preventers”. We know that once we hit the TDIU or 100% schedular wall, we are generally rescheduled for a final C&P to ascertain any improvement after two years. Absent any, we get the P&T designation and a small umbrella of protection. The five-year mark, although an arbitrary milestone, is generally accepted as the boundary of good taste for trying to claw back your protections accorded you via the P&T rating.
And then there are the newly rated. And the liver transplant crowd like Leigh. And on and on. Let’s take Hepper 74 in the “Get High or Die” state of Colorado. We share that left-handed tobacco distinction as I live in the Soviet Socialist Republic of Washington. Randy is blowing a Stage 4 on the hepometer like me. He is recently TDIU and on appeal for 100% schedular under DC 7354. He’s getting on the Sovaldi Bus this morning. I’m one day ahead of him. My DEROS (Date of Return Off Sovaldi) is December 23, 2014. On paper, at least, but more about that in a minute.
Randy runs the risk of falling into the newly rated but not P&T group-i.e. less than five years. He need not worry. Even if he slays the dragon during his BVA appeal, the Shedden elements were and are met that he filed with the disability and the claim is predicated on what he had at the beginning, not what transpired in between or where he is when the appeal is finally granted. Given that the BVA is more backed up than a monkey who ate a pound of cheese, he’ll probably be on the cusp of five years by then anyway. And then we are going to mention residuals. But first, all you transplant folks.
Leigh of the East, my trooper who has slogged all the way to the CAVC just to extract her abbreviated c-file, is our poster child for liver transplant claims. Her claim is wisely grounded in an HCV claim rather than one of the convoluted cirrhosis claims under Diagnostic Code 7312. The transplant just cements the gravity of how bad the HCV actually became. When you have to drop a new engine in or replace the transmission on a newer model car, you know it was defective for a long time. Looking back for the predominant risk factor is not a complicated exercise in forensics for those of us who served in the 60-90s. And then the residuals…
Here’s the big kicker in all these cases and brings them together. HCV, Interferon and Ribavirin treatments over the decades have taken their toll. Some of us have thyroid cancers, hypothyroidism, Diabetes Mellitus Type 2, Cryoglobulinemia, Porphyria Cutanea Tarda, kidney stones like hailstorms, Rheumatoid Arthritis, Fibromyalgia, gastrointestinal issues like Crohn’s or Ulcerative Colitis, ad nauseum. In short, but for the disease and the horrible side effects of the treatment, we wouldn’t be sailing on this ship. Residuals are the jetsam that has washed up on our beaches and now infest us.
Sovaldi is much like a birth control pill. It interrupts one of the six reproductive cycles of the disease and makes it easier for the human immune system to spot and eradicate the one version of the bug left. HCV is like a chimera that constantly metamorphoses ever so slightly so as to make itself unrecognizable. The Sovaldi does a “freeze-frame” on it and prevents any new mutations from evolving. As such, the side effects of Sovaldi alone are reportedly negligible. The Ribavirin and the Interferon are a different matter entirely. Hundreds of thousands of you are still alive to report that much.
Back in the old days, Mark (Hepsick) can tell you about the Interferon roundups. It was akin to surviving a nuclear war and left you slightly decayed and glowing in the dark. That was just the Interferon in its own right. The newer combination with Ribavirin was even more insidious and brought you to your knees whether you achieved SVR or not. Worse, the success rate was like Las Vegas. It almost killed him and he has many residuals that would render the majority of us 100% disabled in their own right. The HCV just ensures it’ll be a bad hair day every day. Removing the virus doesn’t obviate the need for the insulin shots and the dietary vigilance needed to stay afloat nor does it resolve the deep arthritic aches and pains we will always suffer from. These will never disappear but merely be magnified later in life. This is one of the primary reasons VA is going to have a hard time downrating you after SVR. Additionally, what, exactly is SVR? Will it come back in two or three years? Nobody knows. Sovaldi and the whole class of NS5A inhibitors haven’t even been around for three years yet. We’re in relatively uncharted waters yet our doctors would have us believe we’re sailing around in our own bathtubs.
As for some of the autoimmune issues generated by HCV, my doctors smile and say noncommittal things like “Well, I guess we have our fingers crossed on that one” or “It will be interesting to see if they resolve after treatment.” Not one has said “We don’t have an escape hatch built into this for you AIH guys. Sorry.” The current game plan, much like the old one, is damn the torpedoes and full speed ahead. And once you start, you can’t stop. We now know there is a strong correlation between things like AIH and HCV but the danger of treatment is compounded by the danger of death. In the interests of science, we are apparently requested to “go along with it” unless it threatens to kill us. Sweet.
Things got so crazy in 2010 that my VA “hepatologist” ARNP Eileen Hanson greeted me for my 3 month check up and said “Wonderful news, Buckwheat! We have a cure called Telaprevir. We use it in conjunction with Ribavirin and Interferon”. This is the triple-drug wonder therapy that almost killed WGM down in Texas after two doses back in 2012. He’s clinging to life and his residuals are right off the map. His wife had to quit work to become his full-time caregiver. Eileen also knew I was Interferon-intolerant. Hell, that never stopped VA nurses or doctors. One size fits all in their book.
When I found out about Sovaldi (or Sofosbuvir) last spring, I immediately got in line for the trials. To my chagrin, Gilead didn’t want any AIH guys to queer the results for acceptance. Only a select few were chosen that fit into narrow parameters in order to arrive at a good outcome (early acceptance by the FDA). Someone like me (with AI issues) who tried this might upset the applecart so I was given the wave-off. However, the doctor hastily insisted that once Gilead Science launched the drug commercially that I could promptly get in line for treatment. Seems rather strange to prescribe drugs like that. We know the effects of Interferon and Ribavirin on autoimmune issues. I got a first-hand, close-up look at it in 2007 and and it almost killed me with one dose. What is remarkable is that everyone in the medical field seems to think Ribavirin is benign and only attacks the virus itself, or in the alternative, amplifies the action of Sovaldi. I disagree-as do my pharmacist and any number of folks who have eaten it for long periods of time. Read this:
Ribavirin tablets are contraindicated in:
- Women who are pregnant. Ribavirin tablets may cause fetal harm when administered to a pregnant woman. Ribavirin tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17)].
- Men whose female partners are pregnant.
- Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
- In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see Drug Interactions (7.1)].
Ribavirin tablets and peginterferon alfa-2a combination therapy is contraindicated in patients with:
- Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before treatment [see Warnings and Precautions (5.3)].
- Hepatic decompensation (Child-Pugh score greater than or equal to 6) in cirrhotic CHC patients coinfected with HIV before treatment [see Warnings and Precautions
Seems this is some pretty serious stuff if it is in the same class as Thalidomide.
Ribavirin is contraindicated in the presence of autoimmune disorders and especially autoimmune hepatitis (AIH). That much we know. Doctors try to decouple that by saying this interesting phenomenon of runaway autoimmune syndrome is due solely to Interferon. Nevertheless, the Ribavirin monogram specifically mentions it as a culprit. How, then, can the doctors feel comfortable about prescribing it knowing full well they could be condemning the patient to death? Simple. They recite their little mantras like “Extremely interesting it will be to see how your body reacts. Yessssss. If there is a problem, we can discontinue the prophylaxis. Mmmmm. Put you on Budesonide (steroids) and Imuran (immune suppressant) we shall. Yesssssssss.”
In all this rush to medicate, nobody considers the double whammy. Consumption of the two drugs above (prednisone and Imuran) suppresses the autoimmune function of the body- the very white blood cells combatting the HCV infection. Unfortunately, by suppressing one, you allow the other to run amok unimpeded. Someone should acquaint these boys with Newton’s Third law of Medical Physics. The current medical philosophy says pretty much what it said in the 90s and the 00’s- let’s run them down the Interferon cattle chute helter skelter and see how many make it. Sure, there’ll be some casualties but what the hey? We all benefit. Now they want to do a similar cattle drive to the Sovaldi ranch and brand us again -with the same, known drugs that cause blindness and DM2. Nary a one of them blinks an eye when queried about the inherent dangers. I doubt they understand the concept.
There are some interesting studies out with all the different combinations of how you can take Sovaldi. Gilead even ran a trial of twelve weeks using only Sovaldi. This Electron2 trial, as it was called, had a success rate of 64% or 16 of the 25 subjects attained SVR-in a mere twelve weeks. This trial only included Genotype 3 subjects. The GS-7977 trials (all three of them) attained a uniform 82% using Sovaldi and Ribavirin for 24 weeks. Read more simply, in DickandJaneSpeak, it means adding Ribavirin and twelve weeks onto the treatment only resulted in an increase of 18% success in the recipients. If I didn’t know any better, I’d say someone was stuck with a shit ton of Ribavirin and looking for a place to unload it before the financial bottom falls out of it as it has with Interferon and Telaprevir/Boceprevir.
I’m on day 2 of the treatment so it will be interesting to see how things play out. The AIH is always at the back of my mind. I’ve waited 7 years for this and am not inclined to wait any longer. The danger of another napalm strike on top of the AIH to my immune system lurks in the wings with Ribavirin and the doctors consider this “a remote possibility” and “We’ll cross that bridge when we get to it”. Hold the phone, dude. We’ve arrived at the Rubicon and you’re behind me at the other end setting fire to it. How does that work?
One last observation. We talk of time as in 30 days have September, April, June and November. Apparently, in MedicalWorld, there are always 28 days in a Sovaldi month. Sovaldi comes in 28-pill bottles. Over six months, that amounts to twelve pills (or twelve days). On the Nasdaq exchange that translates out to $12,000.00 based on Gilead’s sales price of $1000.00 per pill. Who says there isn’t shrinkage in the medical sense? If Medicare gets billed $180,000.00 for my six month treatment, who gets to rake off the $12 K? Is this like a VA bonus regardless of whether or not you achieve SVR? I asked my Sovaldi minder ARPN Tobi how that works. I got the same identical shrug of the shoulders as I did when I asked what happens if my AIH goes apeshit on Ribavirin.
One thing is certain. VA will not move too soon on this. There seems to be a movement afoot at the BVA that signals an acceptance of the jetguns as the cause of this disease. It may be a fluke as there are so few of us left. Chances are that they will poke and prod a few, newer cases or ones in the pipeline in an attempt to set some kind of strictures on the newly-healed. Considering the number and severity of the residuals, I think it will be short lived. What’s to be gained from downgrading your Hepatitis C from 60% to 40% if you just turn around and file for fibromyalgia, rheumatoid arthritis, hypothyroidism and Cryoglobulinemia and end up back at the same rating of 100% combined or TDIU? It’s six of one and half a dozen of the other. Besides, the VHA has taken the liberty of admitting all these residuals are part and parcel of HCV and Interferon therapy. What’s to be gained? Well, boy howdy. You haven’t been around the VA as long as I have. Watch. These chowderheads can’t leave well enough alone.