What if my Insurance Won't Pay?
Insurance coverage for medical treatments and prescription drugs is a critical issue for carcinoid cancer/neuroendocrine tumor patients. The Carcinoid Cancer Foundation is delighted to partner with Laurie Todd, “The Insurance Warrior,” to bring you cutting-edge information about how to fight your insurance company if your claim is denied. Please visit this page often as we will frequently add new information.
Visit Laurie’s website, www.theinsurancewarrior.com, and learn more about this remarkable woman and all she has achieved for patients.
Excerpt 18:
Experimental: Seize Their Weapons
When a treatment is denied because it is "Experimental/Investigational," people
assume that there is no way to challenge it. This ruling came down to Moses on
the mountaintop. It is official. The treatment is inscribed on some sort of
"Experimental List," yes?
 Recently a patient said to me, "My surgery was denied because it is considered experimental." "Considered experimental by whom?" I asked.
People—I am asking for a paradigm shift. Insurance company propaganda is very,very powerful and convincing. The initial approach is to make you feel comfortable, nurtured, and cared for.
Then, when you are in Big Medical Trouble, and the insurer does not want to pay for your treatment, the propanda switches. You are made to feel powerless, hysterical, and weak. Acme Insurance rolls our their full arsenal. We are official, we get to decide, we have the last word.
If you hack through all of the bureaucratic mumbo-jumbo, the message from your insurer is:
"We know what is best for you, and we hold divine power over your life and death."
What does "Experimental/Invesigational" mean? It means whatever Acme
Insurance says it means. It means that they don't want to pay for it.
Purpose
Your insurer will deny your treatment with a letter. The denial letter from Acme
Insurance is your Rosetta Stone, your gold mine—the foundation upon which you
will build your appeal. Next, you will see how I confront their reason for
denial in the Sample Appeal.
THIS TREATMENT IS NOT EXPERIMENTAL
In their denial letter, Acme states that this treatment is "Experimental," and they
offer their definition. The one missing step? Acme does not offer any proof that
cytoreductive surgery and HIPEC fits into or meets this definition in any way.
Let's examine Acme's own definition:
Experimental or Investigational Services: A Service is experimental or investigational for a
Member's condition if any of the following statements apply to it as of the time the Service
is or will be provided to the Member. The Service:
FDA Approval
i. cannot be legally marketed in the United States without the approval of the U.S.
Food and Drug
Administration (FDA) and such approval has not been granted;
ii. is the subject of a current new drug or new device application on file with the FDA;
The FDA approves drugs, medical equipment, and vaccines. The FDA does not
deal with surgical procedures.
The machine used to deliver the HIPEC is FDA-approved (510(k) number K993330).
The drug that Dr. Sugarbaker uses for the HIPEC—mitomycin C—is FDA approved
(ANDA numbers 064106, 064117, 064144, 064180).
Intraperitoneal administration of this drug is an "off-label" use. Physicians are
invited to use drugs in ways not specified in the FDA approval to market; the FDA
simply requires that the physician have a well-established clinical rationale for
doing so. Surely it is clear by now that Dr. Sugarbaker, who has published 452
peer-reviewed medical journals on this topic, has his facts clearly in place.
Clinical Trial?
iii. is provided as part of a Phase I or Phase II clinical trial, as the experimental or
reasearch arm of a Phase III clinical trial or in any other manner that is intended to
evaluate the safety, toxicity or efficacy of the Service;
iv. is provided pursuant to a written protocol or other document that lists an
evaluation of the Service's safety, toxicity or efficacy as among its objectives;
v. is subject to the approval or review of an Institutional Review Board (IRB) or
other body that approves or reviews research concerning the safety, toxicity or
efficacy of Services;
vi. is provided pursuant to informed consent documents that describe the Service as
experimental or investigational or in other terms that indicate that the Service is
being evaluated for its safety, toxicity or efficacy;
My treatment with Dr. Sugarbaker is not part of a clinical trial. It is not subject to
approval by an IRB, and I was not given any document to notify me that it was part
of a clinical trial. There is no "informed consent" associated with this treatment. It
is not part of a clinical trial.
Prevailing opinion among experts
vii. is part of a prevailing opinion among experts as expressed in the published
authoritative medical or scientific literature that (A) use of the Service should be
substantially confined to research settings or (B) further research is necessary
to determine the safety, toxicity or efficacy of the Service;
Surgical oncologists are the experts on disseminated abdominal cancers. In
January 2006, surgical oncologists from all over the world met at the first
International Symposium on Regional Cancer Therapies Snowmass, Colorado.
It was at this conference that the surgical oncologists began the process of
standardizing their methods of patient selection, surgical approach, and delivery of
HIPEC. By June of 2006, the experts had come together to make an official
statement about this treatment:
(Esquivel J, Sticca R et al. Cytoreductive surgery and hyperthermic intraperitoneal
chemotherapy in the management of surface malignancies: a consensus statement.
Ann of Surg Oncol Jan 2007; 14(1):128-33.)
The paper covers "Materials and methods, Rigorous diagnostic work-up, Variables
associated with increased chances of having a complete cytoreduction." The
experts estimate the number of patients who could be helped by this treatment:
"In the United States an estimated 50,000 patients annually will present with or develop peritoneal carcinomatosis from primary colorectal cancer, gastric cancer, appendiceal cancer and ovarian cancer."
The following institutions participated in the Consensus Statement:
Akademiska University Hospital, Uppsala, Sweden
Altru Hospital, University of North Dakota, Grand Forks, ND, USA
Baltimore-Washington Medical
Baylor University Medical Center, Dallas, TX, USA
Beebe Medical/Christiana Care, Lewes, DE, USA
Charite Hospital Campus Mitte, Berlin, Germany
Creighton University Medical School, Omaha, NE, USA
Dekalb Medical Center, Decatur, GA, USA
Dorothy E. Schneider Cancer Center, San Mateo, CA, USA
Fairview University Medical Center, Minneapolis, MN, USA
First Surgical University Hospital, Belgrade, Serbia
H Lee Moffitt Cancer Center, Tampa, FL, USA
Helen F. Graham Cancer Center, Newark, DE, USA
Hospital General Universitario Gregorio Maranan, Madrid, Spain
Hospital San Jaime, Torrevieja, Spain
Hospital medica Sur, Tlalpan, Mexico
Hospital de San Pablo, Barcelona, Spain
Hospital Virgen de la Nieves, Granada, Spain
Hospital Torrecardenas, America, Spain
Institut Gustave Roussy, Villjuif, France
Instituto Nacional De Cancerlogia, Distrito Federal, Mexico
Johns Hopkins Hospital, Baltimore, MD, USA
Lousiana State University, Shreveport, LA, USA
Maine Medical Center, Portland, ME, USA
Mills-Peninsula Health Services, Burlingame, CA, USA
Medical School of Crete University Hospital, Herakleion, Greece
Miami Valley Hospital, Xenia, OH, USA
MD Anderson Espana, Madrid, Spain
Mercy Medical Center, Baltimore, MD, USA
National Cancer Institute of Milan, Milan, Italy
National Cancer Institute of USA, Bethesda, MD, USA
Netherlands Cancer Institute, Amsterdam, Holland
North Hampshire Hospital, Basinstoke, United Kingdom
Ospedale San Giovanni, Bellinzona, Switzerland
Ospedale S. Camillo-Forlanini, Rome, Italy
Policlinica San Jose, Vitoria, Spain
Roswell Park Cancer Center, Buffalo, NY, USA
St. Agnes Hospital, Baltimore, MD, USA
St. George Hospital, Sydney, Australia
St. Luke's Hospital, Bethlehem, PA, USA
Sharp Healthcare Hospital, San Diego, CA USA
Soroka University Medical Center, Beer Sheva, Israel
Surgical Departement Kantonsspital, St. Gallen, Switzerland
Surgical Oncology Associates, Newport News, VA, USA
Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
University of Iowa, Iowa City, IA, USA
University of Louisville, Louisville, KY, USA
University of Lyon, Lyon, France
University of Maryland, Baltimore, MD, USA
University of Medicine and Dentistry of New Jersey, Neward, NJ, USA
University of Pittsburgh Medical Center, Pittsburgh, PA, USA
University of Regensburg, Regensburg, Germany
University of Washington, Seattle, WA, USA
Wake Forest University, Winston-Salem, NC, USA
Walnut Creek Kaiser Permanente, Walnut Creek, CA USA
Walter Reed Army Medical Center, Washington, DC, USA
Washington Hospital Hospital Center, Washington, DC, USA
The overwhelming consensus among expert surgical oncologists is that complete
cytoreduction—including peritonectomy procedures, and combined with heated
intraperitoneal chemotherapy is now standard of care for disseminated abdominal
cancers. This treatment should be offered to carefully selected patients whose
disease is confined to the abdomen, and according to Dr. Sugarbaker's Prior
Surgery Score (PSS), and his Peritoneal Cancer Index (PCI).
When the insurer denies your treatment as "experimental"—where do you start?
First, go to your benefits booklet, or the insurer's website, and find their definition
of "Experimental/Investigational." If you can't find the definition in either place,
call Acme Insurance, and tell them to fax it to you—today. If we don't giver
insurance companies time limits, they will never move fast enough for us.
Next, read the definition. Study it. Your are going to refute every part of their
definition of "Experimental," and prove that your treatment is "Standard of Care."
Don't be afraid of insurance company definitions. What you say is just as valid as
what they say.
FDA
When I ask people, "What does experimental mean?"—they always start by saying,
"Not FDA-approved?"
Let's get one thing straight. Insurance companies deny treatments that are FDA approved
every day of the week. And they routinely approve and offer treatments that
are not FDA-approved.
In order to get over the FDA stumbling block, we need to understand two key facts
about FDA approval:
1. There is no such thing as FDA approval.
2. FDA only regulates drugs, food, and medical devices.
3. Off-label use of drug and medical devices is perfectly acceptable.
There is no such thing as FDA Approval
What do I mean, "no such thing as FDA approval"? We imagine that the Food and
Drug Administration is busy conducting all sorts of studies and experiments.
When they are totally convinced that the drug or medical device is safe and
effective, they issue an approval. Therefore, if a drug or medical device is not FDA-
approved, it is not safe or effective, right?
Wrong. The FDA does not conduct tests or studies. It considers whatever
documentation the manufacturer supplies to it. Think about that for a minute.
Costmore Drug Company is submitting their new drug to the FDA. Costmore spent
a gazillion dollars developing a new drug. They send their paperwork and
documentation to the FDA. Do you think that any of Costmore Drug's own studies
will be so negative as to spoil their case with the FDA?
The FDA reviews the articles, studies, and rationales that the drug or device
manufacturer submits to them. If they feel that the drug or device is safe and
effective, they issue a "Clearance to Market.
"There is no such thing as an "Approval." A Clearance to Market simply means that
the drug company or device manufacturer is allowed to sell the drug or device to
the public.
Once again—behold the power of words. "Approval" sounds like a rock-solid stamp
of approval. "Clearance to market" does not carry the same power.
Let's say that, in their denial letter, your insurer says, "This treatment is
Experimental/Investigational. It is not FDA-approved."
FDA regulates food, drugs and medical devices
My requested treatment is a surgery with heated intraperitoneal chemotherapy
(HIPEC). I don't know how many times I have heard doctors, patients, and
insurers say, "The surgery is not FDA-approved, " or, "The HIPEC is not FDA-approved."
If you are going to argue your case, you need to know that FDA does not regulate
treatments, surgeries, or procedures.
I would like to be a fly on the wall when you point out to your insurance company,
"This procedure cannot be 'not-FDA-approved,' because the FDA doesn't regulate
surgeries or procedures." This is exactly what I do in the Sample Appeal.
When you point out such blunders to Acme Insurance, it is very embarrassing.
And embarrassing equals intimidating.
Off-label use of drugs and medical devices is perfectly acceptable
Let's say that your doctor prescribes an expensive drug, and the insurer denies it,
saying, "Such-and-such a drug is Experimental for this Use" (or this condition, or
whatever).
Just fire back with, "Such-and-such a drug is FDA-approved." Go to the FDA
website, get the appropriate numbers, and supply them.
Then, go on to say, "What we are talking about is off-label use of an FDA-approved
drug." Explain to them that physicians are welcome and invited by FDA to use
approved drugs and devices for purposes other than those specified on the FDA
Clearance to Martket. Point out that the FDA requires that the physician keeps
detailed clinical records of his off-label use, and your physician does this.
Knock out the FDA objection with one punch
In the appeal sample, I am requesting the heated intraperitoneal chemotherapy
(HIPEC). This treatment involves a medical device (the heat pump), a drug
(mitomycin C), and a procedure. Let's see how I deal with all three issues, wrap
them up in a big bow, and lay them at the feet of Acme Insurance:
FDA Approval
i. cannot be legally marketed in the United States without the approval of the U.S. Food and
Drug Administration (FDA) and such approval has not been granted;
ii. is the subject of a current new drug or new device application on file with the FDA;
The FDA approves drugs, medical equipment, and vaccines. The FDA does not deal with
surgical procedures.
The machine used to deliver the HIPEC is FDA-approved (510(k) number K993330).
The drug that Dr. Sugarbaker uses for the HIPEC—mitomycin C—is FDA-approved (ANDA
numbers 064106, 064117, 064144, 064180). Of course, intraperitoneal administration of
this drug is an "off-label" use. Physicians are invited to use drugs in ways not specified in
the FDA approval to market; the FDA simply requires that the physician have a well-established
clinical rationale for doing so. Surely it is clear by now that Dr. Sugarbaker, who has
published 449 peer-reviewed medical journals on this topic, has his facts clearly in place.
Is it a clinical trial?
This business about clinical trials appears in most definitions of "Experimental/
Investigational." In my sample definition , Acme Insurance devotes four
paragraphs to it.
You know that your treatment is not a clinical trial. But you must address it.
Your insurer denied your treatment for one stated reason: It is experimental. So,
you must address, answer, and debunk every word of their definition of
"experimental."
Forgive me, but this clinical trials material is just silly—and easily disposed of.
If your treatment were a clinical trial, you would know it. They would have you fill
out forms, sign disclaimers, and so on.
The most obvious sign that your treatment is a clinical trial? YOU DON'T HAVE
TO PAY FOR IT. The treatment in most clinical trials is at cost to you.
I believe that insurers put all of this legalese about clinical trials into their
definition of "experimental" just to make it longer and more intimidating. Here is
how I dispose of it in the Sample Appeal:
Clinical Trial?
iii. is provided as part of a Phase I or Phase II clinical trial, as the experimental or research
arm of a Phase III clinical trial or in any other manner that is intended to evaluate the safety,
toxicity or efficacy of the Service;
iv. is provided pursuant to a written protocol or other document that lists an evaluation of
the Service's safety, toxicity or efficacy as among its objectives;
v. is subject to the approval or review of an Institutional Review Board (IRB) or other body
that approves or reviews research concerning the safety, toxicity or efficacy of Services;
vi. is provided pursuant to informed consent documents that describe the Service as
experimental or investigational or in other terms that indicate that the Service is being
evaluated for its safety, toxicity or efficacy;
My treatment with Dr. Sugarbaker is not part of a clinical trial. It is not subject to
approval by an IRB, and I was not given any document to notify me that it was part
of a clinical trial. There is no "informed consent" associated with this treatment.
It is not part of a clinical trial.
Consensus of Experts
Here is the part of the sample definition that calls for a consensus of experts:
vii is part of a prevailing opinion among experts as expressed in the published authoritative
medical or scientific literature that (A) use of the Service should be substantially confined
to research settings or (B) further research is necessary to determine the safety, toxicity or
efficacy of the Service;
"Experts"
"Published authoritative medical or scientific literature"
"Substantially confined to research settings"
"Safety, toxicity, efficacy"
They are trying to scare you with official-sounding words. Don't be afraid—you will
engage in a little game of "dueling experts" with Acme Insurance, and you will win.
I will deal with Acme's experts later in the Sample Appeal. Here, as I hammer
through their definition, I will first supply "prevailing opinion" that will completely
blow theirs out of the water.
Who are your experts?
Know that Acme Insurance hasn't thought about who the experts are for your
treatment. Think about it yourself, and get one jump ahead of them.
Let's say that you have colon cancer, and you have been denied and extremely
expensive drug—Erbitux. Who are the experts on colon cancer, and where are
there views and opinions to be found?
1. If you have a helpful in- or out-of-network doctor, ask him where you might
find a consensus statement about your requested treatment.
2. Go Googling. Try phrases like "erbitux expert agreement," or "consensus
erbitux oncologists."
3. Go to the NIH database of medical journal articles
(http://www.ncbi.nlm.nih.gov/pmc?term=medical%20journal%20articles).
4. Search for "erbitux colon cancer," or some other likely phrase, and browse
the abstracts. If you see a likely title, find the full-text article, and read it.
Either the article itself may mention agreement among experts, or one of the
articles found in the footnotes may contain some statement of consensus or
agreement that this is an effective treatment for colon cancer.
5. Find the website for the professional group or association of medical
oncologists. Search the website for news of consensus statements. Or, send
them an email, and ask if such a consensus statement exists.
Once you have found some type of consensus or agreement among your
professionals, do as I do on pages 101-102. Read and understand this statement,
then quote the very best parts in your appeal.
I am fortunate enough to have in my files a consensus statement signed by the
most respected surgical oncologists in the world for the treatment for which I
appeal most often—cytoreductive surgery and HIPEC.
This statement lists the names of all signers. Plus, it lists the names of their
institutions. In this case, the names of the institutions are more powerful than the
names of the doctors.
Once again, we behold the power of names.
The appeal from which this section was taken was for an HMO; they denied this
treatment as experimental. One of their very own HMO facilities appears on this
list, with their own surgeon-expert endorsing the treatment. Huge gold nugget for
the appeal.
********
When it comes to consensus statements— the motto is the same as the motto for
Insurance Warrior-ing in general. Never say never, search until you find what you
need.
Don't worry about what you don't have. Take what you DO have, and use it to best
advantage.
If the reason for their denial is "It's experimental"—you need to go after that word
with everything you've got.
When I began my own appeal process in 2005, I read and reread my HMOs
definition of "experimental." I was delighted to discover how vague it was, how
unfounded, how easy to shoot down.
Grab the word that your insurer has used to deny your treatment—be it
"experimental," "out of network," or "not medically necessary." Then deconstruct it,
and turn it to your advantage in your appeal.
To purchase Laurie’s book and CD, click here: http://theinsurancewarrior.com/thebookandthecd.html
The insurance information presented on The Carcinoid Cancer Foundation website is a collaboration between the Foundation and Laurie Todd.
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