Judge orders ins. To pay for ADR
 

LANDMARK RULING: JUDGE ORDERS INSURER TO PAY FOR ADR
Robin Young • Fri, August 23rd, 2013

“The Court concludes that CIGNA has failed to prove that two-level ADR is an experimental procedure excluded from the Plan’s coverage.” – U.S. District Court Judge Dolly M. Gee on July 31, 2013

Danica Dubaich was in agony. She had bilateral foot pain, low back pain, left arm and hand weakness, right thigh numbness, right hip pain and headaches. Her physician, Brian Rudin, M.D., diagnosed degenerative disc disease at L5-S1.

To confirm his diagnosis Dr. Rudin performed a discogram of Ms. Dubaich’s spine which clearly showed an annular tear at L5-S1. The discogram was consistent with an earlier MRI image which also indicated that pain was emanating from L5-S1.

Danica Dubaich was 44 years old when Dr. Rudin completed his diagnosis. Given her age and otherwise good health, Dr. Rudin thought Dubaich was a good candidate for a motion preserving implant—either Charité from DePuy or ProDisc-L from…well, DePuy/Synthes.

Of course, Dubaich’s insurer (CIGNA) rejected Dr. Rudin’s request for a pre-authorization of the motion preservation implant as being “not medically necessary.” Such rejections are so common that the appeal letters are now free on Internet gaming sites or the corner of 16th and Broadway from Nigerian street vendors. (That may be a slight exaggeration.)

CIGNA’s medical coverage policy document says that fusion is the reimbursable course of treatment for patients with Dubaich’s diagnosis.

But Dubaich did not want fusion. Neither did her doctor, Dr. Rudin.

So she fought back.

Here’s how Dubaich and her lawyers beat one of the largest insurance companies in America.

The Road to Justice Act I: DENY the Surgery

CIGNA’s Medical Coverage Policy states “CIGNA covers the surgical implantation of Charité or ProDisc-L…as medically necessary” when the medical criteria are met. In 2011, after exhausting all conservative treatment, Dr. Rudin submitted a pre-authorization for a two level ADR [artificial disc replacement] at L5-L5 and L5-S1.

CIGNA’s pre-authorization nurse denied Dr. Rudin’s request saying “documentation submitted does not confirm that disc degeneration has been confirmed on complex imaging studies such as magnetic resonance imaging or computerized tomography.”

Then CIGNA assigned a urologist to review Dubaich’s file. The good urologist then opined that the treatment should be denied as experimental.

Here’s his quote:

“Based upon current available information, coverage cannot be approved because there is insufficient scientific evidence to demonstrate the safety and/or effectiveness of any of the following in treating degenerative disc disease:

Charité or ProDisc-L lumbosacral intervertebral disc prosthesis when any of the following apply:

the planned procedure includes the combined use of a prosthesis and spinal fusion
simultaneous multi-level implantation is planned
the implant will be inserted outside of the L4-S1 region (Charité) or outside of the L3-S 1 region (ProDisc-L-L) [sic]
the individual has osteopenia or osteoporosis (T-score less than -1.0) –the individual has a history of a prior lumbar fusion

there is evidence on imaging studies the spine [sic] of any of the following:

degenerative spondylolisthesis of Grade 2 or greater infection
multi-level degenerative disc disease
nerve root compression or spinal stenosis
pars interarticularis defect with either spondylolysis or spondylolisthesis
scoliosis
severe facet joint arthrosis
spinal fracture
tumor
a lumbosacral disc prosthesis other than Charité or ProDisc-L.

At the present time, each is considered non-standard therapy and falls under the category of experimental/investigational/unproven. Your benefit plan does not cover experimental/investigational/unproven services.”

CIGNA issued its Initial Case Resolution Letter on July 11, 2011. Importantly, that letter did not state the reason for the denial nor anything about absence of medical necessity or lack of FDA approval.

The Road to Justice ACT II: DENY the Science

Two days after CIGNA’s rejection, Dr. Rudin appealed. He told CIGNA that he’d personally performed more than 200 disc replacements. He also cited several recent studies including the 2011 study by Delamarter et al., (The Journal of Bone and Joint Surgery). Here it is:

“The full title of this study is Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Compared with Circumferential Arthrodesis for the Treatment of Two-Level Lumbar Degenerative Disc Disease. The study compared the efficacy of ProDisc-L ADR with that of spinal fusion for ‘the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1.’

Using ‘a composite regulatory FDA-guided end point consisting of ten criteria,’ the study found that 58.8% of the two-level ADR patients ‘met all ten criteria and were considered a study success,’ as compared to 47.8% of the spinal fusion patients. It found that ‘the mean improvement [in back pain, as measured by the Oswestry Disability Index (ODI)] from baseline was 52.4% in the [ADR] group compared with 40.9% in the [fusion] group.’ According to the study, its ‘results suggest that the ProDisc-L total disc replacement is an appropriate alternate treatment to lumbar arthrodesis in [the two-level degenerative disc disease] patient population.’”

Rudin also cited studies by Bertagnoli, Goldstein, Hannibal and others.

CIGNA kicked Rudin’s appeal to another physician, an orthopedic surgeon named Dr. Mino. He upheld the urologist’s decision adding that the quality and quantity of data in the current peer-reviewed scientific literature was inadequate to establish the clinical utility, safety and efficacy of the use of an intervertebral disk prosthesis in any of these clinical presentations.

(For other examples insurer bias, see “Lies, Damn Lies and Blue Cross Blue Shield of North Carolina”.)

Road to Justice ACT III: APPEAL to a Higher Authority

Rudin appealed again. This time CIGNA’s Benefit Appeals Committee responded saying that the matter had been previously reviewed and, relying solely on the urologist’s original evaluation while simultaneously ignoring Rudin’s studies, the committee ruled that ADR was experimental, investigational, etc. You know the drill.

So Danica Dubaich walked into the law offices of Russell Petti and Lisa Kantor and asked if they would help her appeal these CIGNA rulings in district court.

Fighting an insurer like CIGNA is expensive. If a patient can afford the litigation, they can afford the surgery—so no lawsuit. Petti and Kantor had to take the case on contingency. They get paid only if they win. At any point during the suit CIGNA can agree to reimburse, ending the suit, and Dubaich’s lawyers get nothing.

Petti and Kantor decided to represent Danica Dubaich anyway and filed a lawsuit against CIGNA saying that CIGNA was violating the Employee Retirement Income Security Act (ERISA) of 1974.

Under ERISA, workers who have insurance are covered for medical expenses which are determined to be medically necessary by the Plan Administrator (ERISA).

To be considered “medically necessary” under ERISA a treatment must:

Be consistent with the diagnosis
Meet quality medical practice standards
Be the most appropriate level of service (for example, in the case of hospital inpatient care, care that could not be appropriately provided on an outpatient basis)
Be recognized as an accepted medical practice and have received the required federal approval
Not be primarily for the comfort and convenience of the patient

The Plan excludes experimental and investigational treatments, listed under “General Medical Expenses Not Covered.” The specific language is as follows:
Research, experimental, investigational and unproven procedures, supplies, drugs and devices (Federal Drug Administration [FDA] approval does not necessarily mean a procedure or supply has been removed from the experimental list), with the exception of pre-certified clinical trials.

The term “experimental” is defined as follows:

Any medical procedure, equipment, treatment or course of treatment, or drugs or medicines that are:

limited to research
not proven in an objective manner to have therapeutic value or benefit
restricted to use by medical facilities capable of carrying out scientific studies
of questionable medical effectiveness or
would be considered inappropriate medical treatment

The Road to Justice ACT IV: CIGNA Exits Stage Left

Petti and Kantor filed the case in mid-2012 and over the course of the ensuing year fought it out. On July 31, 2013, United States District Court Judge Dolly M. Gee ruled. Here’s what Judge Gee said:

“As a general matter, CIGNA has made no showing that multi-level ADR is experimental.”

“CIGNA has not met its burden to show that multi-level ADR is limited to research. Dr. Rudin offered Dubaich the procedure and has personally performed approximately 200 multi-level disc replacements. Nothing in the record establishes that the procedure is limited to research. Therefore, on this record, it does not appear that multi-level ADR is limited to research.”

“CIGNA has not met its burden to show that multi-level ADR lacks therapeutic benefit. The Delamarter Study found two-level ADR to have better reduced back pain than spinal fusion, and the Bertagnoli Study found that two-level ADR eliminated instances of severe back pain and improved ranges of motion.”

“CIGNA has not met its burden to show that multi-level ADR is restricted to use by medical facilities capable of carrying out scientific studies.”

“CIGNA has not met its burden to show that multi-level ADR is of questionable medical effectiveness. All the studies Dr. Rudin submitted found equal or better success in two-level ADR as single-level ADR. CIGNA does not dispute that single-level ADR is medically effective. CIGNA has not demonstrated that two-level ADR is not similarly effective.”

“CIGNA has not met its burden to show that multi-level ADR would be considered inappropriate medical treatment. Dr. Rudin stated that Dubaich specifically is a good candidate for multi-level ADR. CIGNA has not rebutted Dr. Rudin’s assessment.”

“The Court concludes that CIGNA has failed to prove that two-level ADR is an experimental procedure excluded from the Plan’s coverage. When confronted with Dr. Rudin’s evidence that two-level ADR is not experimental, CIGNA merely stated that the quality and quantity of such evidence is inadequate.”

With that, Judge Gee ruled that Danica Dubaich was entitled to coverage for a multi-level ADR.

She is now enjoying her two new Pro-Disc-Ls.

Curtain Call

Having persevered in this landmark case, Dubaich’s lawyers are now preparing to challenge other cases of rejection of proper medical care by healthcare insurers including rulings based on Milliman guidelines. We look forward to reporting on more patient, physician and scientifically sound rulings.

Thanks for such great news!

This judgment makes absolute perfect sense and definitely a step in the right direction. I've copied and added to my cumulative file of weapons for BCBS.
Thank you for sharing.

Laura

Thank you.
 

Thank you,

This will be copied and will try my best to pass this along, it is amazing what the political winds will do.

There is money in this and not to make waves, but this DePuy, is the only company 'two' discs that has approval here in the USA

??

Danica loves her new disks...I am awaiting the same surgery from the same surgeon with big A as my insurance company.

I have just submitted all of my data to BlueCard Worldwide International for
my M6-C sandwich. I defy all FDA approval here in the U.S. (M6 device, and adjacent to a prior fusion), but am thinking positively that they will see the light.
I will update as I await a response from the "powers that be."

LauraB,

My wife had a cervical fusion and cervical ADR (M6-C) this past Dec 2012. We have Federal BC/BS. We are Appealing their denial of coverage. Maybe we can compare notes.

Gary (message sent 15 Oct 2013)

Gary,
I have been turned down by BC/BS of IL. Their response was that I had not undergone the non-invasive prerequisite treatments. I submitted five years of injections, physical therapy, traction, neurotomy, a discogram indicating radiculopathy. Apparently the thick packet intimidated them enough that they didn't both to read....just responded that once again that surgery wasn't necessary. I do believe that it may have been due to the request for ADR from a Chicago surgeon (?)
I am more than pleased to share whatever response (hopefully positive) with the forum. I am anxiously awaiting to hear.
(personal note - I did respond to your PM)

Wow, Laura, I'm sorry to hear about your denial... Makes no sense. Why did BCBS reimburse me and deny others?? Seems there is no rhyme or reason to approvals and denials.
Hope you are doing well. We just got back from Spain and I'm trying to catch up. Have over a 1000 emails in my box - I bet 80% of them are junk! but I still have to wade through them.
Let's catch up soon!

Denial
 

Here I have VA/BCBS, they will not allow an out of country surgeon.

Gee I wonder why, next they will tell me I need a Fusion.

Wrong Answer, I have another referral to the Physical, and a (another) referral to a NS, will see what happens, I will go for an ADR, actually more than one.

This is unbelievable, the FDA in this country needs to be Disbanded.

I wonder if some politician like Waxman, who was one of the authors of the ACA, are in charge of this, they have "NO" medical background.

NONE.

While they have Dr's as Commissioners, we can rest assured, that some politician is telling them what and to whom, the approvals are given.



Jerry

Fda
 

Commissioner’s Page

• Globalization
  FDA works to transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment.

HUH?


I thought this was the



United States


FDA?

I have just sent a 40 page, professionally bound and printed brief to BCBS appealing their denial for a multilevel ADR using the M6-C device.

I hope to hear back from them soon.

http://www.spinecarealliance.org/wp-...ay-for-ADR.pdf

Jerry,

I think this might be GOOD news. They may finally be realizing that our healthcare is so far behind-the-times, they are willing to be a part of a global health care standard that will bring more modern medical technology to the United States seamlessly. This is would good for all of us. They have to see how people have been taking their problems(and there MONEY) overseas due to our ancient health care system that has a huge Berlin Wall between it and the rest of the world. Hopefully the FDA is looking to knock that wall down and give people a reason to stay and put trust into our health, and give flexibility to advancing medicines. SOMETHING HAS TO GIVE SOMEDAY.

VA Fusion
 

Thank you again 2Confused,

Sure enough, all that time and the VA will only consider a fusion, two weeks in a bed and 3 months with a brace.

They say it is not recommended, and are seeing more failures?

Not to say the Charite and ProDisc are NOT working, but I have talked to a few and these are tearing up their facet joints.

I had another MRI, in mid Jan, and the report from the person doing the eval of the MRI, said I had significant deterioration of the facet joints, and I have only had decompression surgery.

There are MANY people that have the M6, and are doing real well.

If anyone knows someone that has the M6, (especially in the Lumbar, in my case) and have had an MRI post op, a couple of years later, let me know if they have nn improvement in the adjoining areas, or at least not worsening.

I submitted my BC international claim this week and suspect I will get the Usual response, investigational.

Will post as I can.

Worldwide Blue
 

Hi all....
I have no real answers, but I understand there are others who have received anywhere from 60% to 100% reimbursement from Worldwide Blue...
Keep appealing!!!!

If it is of any help to anyone, PubMed has dozens of studies about ADR.
There is definitely no lack of information that ADR works! If I get denied during precertification for my lumbar ADR I plan on printing out all of the studies and sending it in. ( not that I think they would take the time to read them )

I also read somewhere awhile ago that most of the time the "doctors" on the insurance review board are either not reviewing cases that are in their field of specialty, or are old school, some are even retired, and you have the right to know who is reviewing your case.

But as far as PubMed goes, I just did a search for artificial lumbar disc and tons of studies came up - most with positive results.

It just flabberghasts me that Europe has been doing ADR since the 80's and the insurance companies here have such a hard headed approach to it. It's all about how they can make the most money - gag.

Jerry5,

The artificial disc is contraindicated if the facet joints have significant wear. That is why I was told, by top surgeons, my best chance would be a 1 level fusion at L5/S1, and ADR at L4/5.
However I have to switch insurance because there has been no luck with Oxford covering this procedure.

Good luck with your insurance, though!
Reqmt

Reqmt: I just had a fusion at the L5-S1 due to my bone density test a few weeks beforehand. I was so disappointed that I couldn't get the ADR but to be honest, I was kind of relieved because I didn't feel a warm fuzzy about the Pro-Disc L. It's been a week now and I feel great. I think I may have full mobility but don't want to rush things. I will have to wait until my surgeon gives me the go ahead or when I am in PT.

As far as the ADR is concerned, I also had a multi-level ADR at the C5-7 using the Mobi-C and that seems to be going great as well. All done in the USA and my insurance is covering everything but my co-pay of $11.00 per day for three days in the hospital. A friend came over yesterday and couldn't believe that I was up, dressed, cooking Tortilla soup and the house was spotless.

I believe it all has to do with the surgeon you choose. I don't see a reason to have to go all the way to Europe to get these procedures done and pay out of your pocket. If your insurance denies you then keep on fighting. It took three appeals for me before I won.

I am happy with my choice and haven't looked back. Whatever you do keep fighting. Good luck!