Great news for Heather, a young woman who now has hope for a brighter MS-free future after HSCT. This happened for her because her insurance company
agreed to pay for her treatment.
Apparently, I have the rare insurer that refuses to pay. Knowing my MS was at a critical tipping point toward permanent disability, I paid for HSCT myself, stopping the attacks rather than waiting in a wheelchair and getting worse. My life savings or my life? I chose life. The treatment worked, getting me out of the wheelchair and off all MS drugs. But getting my money back would sure be nice, too.
I figured BC_BS Minnesota would come to it's senses on an appeal. After three appeals, it appears I was wrong about BC_BS. Though I wonder if the insurer recognizes how much money it is saving them now that I am off all MS drugs and invasive dialysis treatments.
Trying to follow the correct channels, I'm now getting kicked back and forth between the State of Minnesota Chamber of Commerce and US Department of Labor review boards. They are trading excuses to not touch my case, and keep pointing me back to the insurer. I'll give it one more week, and try one last time with BC_BS. Then it will be time to call in an attorney to represent me. What a pain,
An inch-thick packet of information awaits any review board that will look at it. The cover letter for that package is reproduced below.
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This is an appeal for an external
review of my previous denials by Blue Cross and Blue Shield of Minnesota for
Autologous Hematopoietic Stem Cell Therapy (AHSCT) for patients with
Inflammatory Multiple Sclerosis Failing Alternative Approved Therapy, provided
by Dr. Richard Burt at Northwestern Memorial Hospital.
My Previous Drug Treatments Failed
I
was diagnosed with multiple sclerosis (MS) in 2007. Since that time, my EDSS (0-10
disability score) rose slowly, then rapidly, from 2 to 6.5 despite my
neurologist upgrading me from the first-line MS injectable drug, Betaseron, to
the more powerful infusion drug, Tysabri, in 2009. MS lesions on my brain,
brain stem and spinal cord increased in number over time. MRI scans also revealed enhancing
(inflammatory) lesions. After 2 years on Tysabri infusions, a blood test showed
I had switched from JC virus negative, to JC virus positive. JC virus is
present in over half the world’s population and normally causes no harm. But if
a patient is on Tysabri, the presence of JC can create an unacceptable risk of the
deadly brain infection PML. So my neurologist took me off Tysabri with a plan
to put me on the oral MS drug BG-12. Unfortunately, the IV and oral steroids I
was treated with as an intermediary protective measure while we waited for FDA
approval of BG-12 did not stop the progression of my aggressive/active MS.
Wheelchair-Bound
MRI
scans showed continued MS lesion development and my disability increased rapidly.
In early June 2013, I woke up one morning and couldn’t move my legs. My
neurologist prescribed a wheelchair and a semi-permanent catheter installed in
my chest to allow weekly blood plasma exchanges (PLEX). PLEX is a costly,
time-consuming and temporary rescue treatment, but for six months, it did
remove enough of my autoimmune antibodies to provide some relief from the MS
inflammation. So I was able to walk with a cane most days. In the meantime, my
neurologist predicted the worst and ordered an electric wheelchair for me. I
did not want to accept permanent disability, so I sought other options.
Fortunately my scientific literature review revealed Dr. Richard Burt’s established
treatment protocol with AHSCT. Dr. Burt has a 10-year track record of
successfully treating patients with MS and other autoimmune disorders at
Northwestern University Hospital in Chicago.
HSCT — An Effective and Proven Way to
Stop My MS Attack
My MS was aggressive / active as described by my MS
neurologist, and by Dr. Burt after he examined my medical records and MRI. My rapid increase in EDSS score, from
virtually no disability to sometimes wheelchair-bound, was a direct consequence
of the many enhancing lesions (indicative of the inflammatory nature of
relapsing-remitting MS - “RRMS”). Dr.
Burt and I agreed that treatment with HSCT was medically necessary for me.
Urgent Action Was Required and Taken
PLEX
was not totally stopping my MS attacks. Continued attacks would eventually
cause permanent nerve damage and disability. After my request for pre-approval
and appeals for HSCT were rejected by BC_BS, I made the decision to move ahead
with HSCT treatment at my own expense. My out of pocket expense now stands at
$166,000. But I am now out of the
wheelchair and not using any MS drugs. Other MS symptoms such as painfully burning
hands, double vision and bladder incontinence have disappeared. These
improvements are consistent with Dr. Burt’s previous patients, who show 10-year
MS remission.
I respectfully ask that you give consideration to the
following in assessing your review of my case:
I.
Aggressive nature of my Relapsing
Remitting Multiple Sclerosis made HSCT medically necessary.
II.
Failed two conventional MS drugs.
III.
IV and oral steroids unable to stop the
MS progression that was likely to degrade into permanent secondary progressive
stage with further nerve damage.
IV.
Urgent time horizon given age and possibility
of disease advancing to more progressive stage
V.
Credentials of reviewer for BC_BS unknown
or not appropriate.
VI.
Other BC_BS insurers have approved
AHSCT for patients.
VII.
Cost effective compared to expensive MS
drugs and emergency rescue treatments.
VIII. AHSCT
is the only treatment modality that has been clinically proven to halt 100% of RRMS
progression and reverse disability in 80% of patients.
IX.
Dr. Burt’s AHSCT treatment should not
be considered “Investigative” due to the long safety and efficacy profile of
the current protocol.
X.
Strong consideration needs to be given
to the “Medically Necessary” language of my insurance contract.
I. Aggressive nature of disease as
evidenced by:
o New
and enhancing brain, brain stem and spinal cord MS lesions
o Successive
contrast-enhanced MRI’s from 2007 through 2013 yielded new and enhancing
lesions.
o Rapid
increase in EDSS score in 2013
II.
Failure
of Betasron injections, then Tysabri infusions
o Tysabri
is a very powerful infusion MS medication with better results, but higher risks,
when compared to interferon.
o Many
patients have been treated successfully on Tysabri.
o I
tested positive for the JC virus, making Tysabri use a high mortality risk as
was discussed with my MS neurologist.
III. Intravenous
and oral steroids did not stop the lesions from accumulating
o Commensurate
with the new lesions were increasing symptomatic signs
o In
approximately two years I had progressed from minimal disability to an EDSS
score of 6.5, sometimes requiring a wheelchair.
IV. Late-onset
RRMS, at age 48, generally does not bode well
o The
aggressive degenerative nature of the disease typically leads to the more
progressive, permanently disabling types such as Secondary Progressive MS
o The
disease is treated better when in the RRMS stage and my RRMS was not being
halted by the conventional treatments.
V.
Credentials of Blue Cross Blue Shield of MN
review inappropriate
o The
medical reviewer was Board Certified in Internal Medicine.
o An
immunologist (such as Dr. Burt), hematologist, oncologist or an autoimmune transplant
specialist would be the appropriate authority on the efficacy of AHSCT for
autoimmune diseases.
VI.
Various BC_BS providers, including Kansas,
North Carolina, Illinois, NE New York and Kansas City have approved AHSCT for
patients.
o Many
other non BC_BS providers have approved AHSCT for autoimmune patients including
Aetna, Humana and Priority Health
o Medicare
and Medicaid have also approved AHSCT for autoimmune disease patients
VII. Cost
effective
o My
one-time cost of AHSCT is $166,000.
o The
annual cost of an MS immune-modulating drug is approximately $55,000. These drugs merely slow the disease and come
with often-severe side effects.
o Weekly,
per-session cost of plasma exchange is approximately $3,000.
o Full
brain and spine MRI scans several times a year are approximately $3,500 each.
o Under
conventional treatment, the aggressive form of chronic MS requires ever-increasing
costs and leads to premature, permanent disability.
o AHSCT
halts MS, with no further need for MS drugs. In less than three years, AHSCT has
a better return on investment and better health results than the conventional
treatment.
VIII. AHSCT is the only clinically proven
treatment modality that has been able to halt 100% of MS disease progression
and reverse 80% of the symptoms, especially in the RRMS stage
o The
disease modifying drugs only slow down the progression at best.
o AHSCT
offers a better health outcome to the patient (and a more cost-effective
alternative).
o My
RRMS and active MS, as evidenced by the enhancing lesions, indicative of inflammation,
was ideally suited for AHSCT to stop the MS progression
IX.
Reviewers,
administrators and physicians, once educated, understand that patients never
need to be on expensive disease modifying medications ever again
o AHSCT
has been used worldwide (i.e. Europe, Canada and Australia to treat autoimmune
diseases) with great efficacy and safety.
o The
treatment modality at Northwestern has been over 11 years in production and is
now considered one of the best facilities in the world providing AHSCT for
autoimmune diseases.
o I
have met and spoken to several other transplant patients with very good
outcomes, while all have discontinued the use of their MS therapies.
X.
Dr.
Burt’s AHSCT has been over 11 years in development and should not be considered
“investigative”. The Phase I / II trials
commenced in 2003 for RRMS. Prior trials
were conducted on Primary Progressive MS patients. Trials now have moved into
Phase III.
o Reliable
evidence exists that Dr. Burt’s AHSCT treatment at Northwestern is NOT
considered investigative and thus meets the “Investigative” language exception
per my contract. Thus, reliable evidence
has indeed shown the treatment is safe and effective for the treatment of a
particular patient.
o Dr.
Burt has authored various articles in medical literature attached hereto
containing such evidence; these examples are part of my submission.
o I
have personally met with and communicated with at least five patients in Dr.
Burt’s previous patients who have had their MS progression halted safely while
experiencing symptomatic improvements.
o BC_BS
did not appropriately and completely apply the medically necessary exceptions
to “investigative” per my contract; consequently, I have been aggrieved by
their coverage rejection. They refused to meet with Dr. Burt when he offered to
explain the procedure and my condition to them.
XI.Blue
Cross and Blue Shield of MN, in all of their treatment denials have focused
singularly on the ‘investigative’ language of my contract, even though I feel
HSCT not considered ‘investigative’ based on the aforementioned points, while
not considering the “medically necessary’ language of my contract.
o I
have presented various arguments above why my aggressive form of MS meets the
definition of “medically necessary.”
o My
active and aggressive MS has not responded to the disease modifying drug
therapies, including IV steroids.
o Notwithstanding
treatment with currently available MS therapy my disease progression has accelerated
as evidenced by various MRI’s and increased EDSS score
o AHSCT
is more cost-effective than the current disease modifying drugs. In fact, all patients receiving AHSCT stop
using the MS disease modifying medication – one of the factors that are
considered in the ‘medically necessary’ language of my contract. AHSCT avoids sustained yearly high medical
drug costs.
o AHSCT
treatment conducted at Northwestern by Dr. Burt is based on credible scientific
evidence published in peer-reviewed medical literature generally recognized by
the relevant medical community.
Based on the aforementioned, I respectfully appreciate your
time in considering my review for an adverse benefit determination as is my
case. You will also find additional
supporting information attached herein to support my appeal. Please contact me if you have any questions. I look forward to your decision.
Sincerely,
Wayne Wenzel
