Re: HBO Legislation in TX

December 30, 2002

Tammy you are correct. Also if you read House bull 1676 it only applies to

those insurance company's that are listed at the beginning of the bill.

Medicaid and Chips according to Texas Department of Insurance is not

included. Now with Medicaid you can get an Advocacy Attorney to fight it and

probably win the case. However with Chip's we are running into problems with

that. One reason is the State of Texas say's Chip's does not have a EPSDT

clause in it like Medicaid does. This Bill was not intended to be this way.

However I do have several people including myself that were told by Katy

Crisman when this bill was making it's way through the legislature that

Chip's and Medicaid would be included. Now or some reason Katy say's she

never said that. But oh well she is the one that has to live with the lie. So

when you are trying to access house bill 1676 read the first part of the bill

it will say something like this bill applies only to. Katy Crisman was very

knowledgeable when it came to pointing out the negativity of the bill I can

tell you that. Also what you must remember is none of them are your friends

at eh insurance Company or the Texas Department of insurance. IF you think

they are trying to help you think twice. We have been down that road. e

Creacy and myself was told several times just present this information and I

think we can help we did and they wanted more and more and more nothing was

good enough. Hellerstedt Medical director at Chip's and Medicaid said

word for word and I quote. " IM the Director for Medicaid and Chip's until I

see documented Proof in Peer reviewed medical Journals More than just one

document I mean several I will not cover this procedure " . We showed him

enough proof that this works we showed him enough he did not care. We also

showed him and he has access to the records of Katy medical bill's before and

after HBOT his reply was that was to be expected after a brain injury. IM

like what she laid for three years with no improvement and after HBOT she

makes a miraculous recovery and now you tell me it was expected anyway. Well,

needless to say I need not say no more regarding this man.

I find it interesting that some of the people that work very close to these

people told us word for word these people had no business in the position

they were in. The man that told me that works very close to the Commissioner.

He not only told me he told e as well. IM not afraid to repeat what hey

told me and who told me. Chet Brook's was the one that told me and e

that needed another JOB.

January 2, 2003

Les, I have to Disagree not from the HBOT stand point but overall HB 1676 did

nothing for those who need it the most. You as well as me know that most

individuals that are disabled or have a chronic illness are on Medicaid and

Chip's. HB 1676 does not pertain to these types of insurance coverage. Texas

Department of Insurance has made that clear. I don't want to be rude and

Please don't take it that way. But before we make statements that HB1676 did

what it was intended to do talk to those who are trying to access the bill.

Also there are a few parents that have tried to access the bill that were

denied because the insurance company told them that CP was not acquired. Now

the Dr. stated the injury was aquired. So we still have a long way to go.

When legislatures go to bat for us a lot of times they get lost in the way.

They forget to follow up with the ones who are seeking coverage from there

work. When you go to bat for someone you go to hit a homerun, not to get to

first base. First base is OK, at least we are on the field. However what good

is being on the field if you never make it home.

We will be seeking a new bill. One that will define all our needs. We will

prevail. I have spoken with e we will be working to get something up. We

both are very determined to do so. e is a very hard for runner. She is

dedicated to all of those who need this coverage and is always there to help

with this type of madness. She has helped many of my friends. I look forward

to working with her and seeking a person to fight the fight that so

desperately needs to be won. We will win.

You know the sad thing is the local news stations can talk about anything

that is negative or trash or flat out junk. But you ask them to cover a cause

so important as this and they turn a cold shoulder. I often wonder if there

in with the insurance industry to block all of our efforts. I send letters to

them every week to get a response hopefully one day they will want to know

about our kid's and the madness that is taking place. If there is someone on

the list that want or can provide some type of coverage and wants to help

contact em My number and address is below.

Darin

105 Creekview Ln

Crandall Tx. 75114

972-427-8825

January 2, 2003

Dear Tammy and friends,

I am glad so see through this listserve your continuing diligent work

on behalf of your loved ones.

I wanted to make a quick clarification regarding HB 1676.

The purpose of HB 1676 was to require insurance coverage of medical

treatment of acquired brain injuries. This was a much needed bill,

because insurance companies were refusing to treat the chronic rehab

needs of persons with these injuries. (This is a story that each of you

are very experienced in.) HB 1676 solves that problem.

In regards to HBOT, however, there is another rub. Texas law reqires

that insurance coverage be " medically necessary. " HB 1676 did not

override that provision. Therefore, HBOT still has to overcome the

" experimental " label with which the medical establishment still views

this treatment.

I hope this helps. Please contact me if I can be of any assistance.

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> fred_tam@... 12/29/02 02:00AM >>>

Hi Dawn:

HB 1676 was such a promising bill and many were excited about its

approval and passage through the TX House and Senate and to have it

signed into law by the Governor. It is currently in effect but due to

certain wording in it - I believe it leaves the insurance company or

Medicaid in charge of deciding if it is Medically Necessary or not which

takes away the authority of the actual physician. I am sure that there

are many on this list that know the finer details. I believe that many

people felt betrayed.

We will not give up because we have seen wonderful changes in our son

following HBO and we have been told that he needs more treatments.

Thanks so much!! Tammy

January 2, 2003

Dear Darin,

Thanks for the further clarification. It was good to chat with you a

while ago also.

HB 1676, like any other legislation passed by the Texas Legislature,

only pertains to insurance regulated by Texas. Texas does not regulate

Medicaid (a federal program) and it does not regulate ERISA plans

(federally authorized self-insurance plans used by big employers).

Thanks again!!

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> Bry8825@... 01/02/03 10:15AM >>>

Les, I have to Disagree not from the HBOT stand point but overall HB

1676 did

nothing for those who need it the most. You as well as me know that

most

individuals that are disabled or have a chronic illness are on Medicaid

and

Chip's. HB 1676 does not pertain to these types of insurance coverage.

Texas

Department of Insurance has made that clear. I don't want to be rude

and

Please don't take it that way. But before we make statements that

HB1676 did

what it was intended to do talk to those who are trying to access the

bill.

Also there are a few parents that have tried to access the bill that

were

denied because the insurance company told them that CP was not

acquired. Now

the Dr. stated the injury was aquired. So we still have a long way to

go.

When legislatures go to bat for us a lot of times they get lost in the

way.

They forget to follow up with the ones who are seeking coverage from

there

work. When you go to bat for someone you go to hit a homerun, not to

get to

first base. First base is OK, at least we are on the field. However

what good

is being on the field if you never make it home.

We will be seeking a new bill. One that will define all our needs. We

will

prevail. I have spoken with e we will be working to get something

up. We

both are very determined to do so. e is a very hard for runner.

She is

dedicated to all of those who need this coverage and is always there to

help

with this type of madness. She has helped many of my friends. I look

forward

to working with her and seeking a person to fight the fight that so

desperately needs to be won. We will win.

You know the sad thing is the local news stations can talk about

anything

that is negative or trash or flat out junk. But you ask them to cover a

cause

so important as this and they turn a cold shoulder. I often wonder if

there

in with the insurance industry to block all of our efforts. I send

letters to

them every week to get a response hopefully one day they will want to

know

about our kid's and the madness that is taking place. If there is

someone on

the list that want or can provide some type of coverage and wants to

help

contact em My number and address is below.

Darin

105 Creekview Ln

Crandall Tx. 75114

972-427-8825

January 2, 2003

In a message dated 1/2/03 11:32:38 AM Central Standard Time,

les.breeding@... writes:

> Thanks for the further clarification. It was good to chat with you a

> while ago also.

>

> HB 1676, like any other legislation passed by the Texas Legislature,

> only pertains to insurance regulated by Texas. Texas does not regulate

> Medicaid (a federal program) and it does not regulate ERISA plans

> (federally authorized self-insurance plans used by big employers).

>

> Thanks again!!

>

> Les

>

> --

> Les Breeding

> Legislative Director

> Office of Rep. Lon Burnam

> P.O. Box 2910

> Austin Texas 78768-2910

> (512)463-0740

> les.breeding@...

>

Les, Clarify to the folk's what a ERISA plan is. Texas Chip's program for

one. I know you said you guy's are working to get chip's included. Can you

also elaberate a little on how Chip's works. I thought it would be bound by

the same rules as Medicaid IM finding out that is not true. However I thought

if the plan was receiveing federal dollars it was bound by the medicaid for

childrens law. How can they have to different standards here. Jump in

here and explain to him what IM trying to ask. Chip's is a childrens

insurance plan but it is not bound by the EPSDT why is that I don't

understand.

Darin

January 2, 2003

Ed wonderful Job. Glad to see there are still a few that are on the list

willing to say what needs to be said. I was beginning to think that everyone

turned and walked away. I can now see there still is a fire within the group.

Darin

January 3, 2003

Greetings,

Mr. Breeding, please don't insult my intelligence any more with your attempts to

do justice to the backdraft damage that was done to 1676. The term " acquired "

was applied after the Bill passed and already into the implementation process.

I'm afraid that your disregard for children is crystal clear. And no, I didn't

read past the 1st paragraph, because of the term " acquired " . The behind closed

door " work session " that created this after the fact bombshell was a shameful

act of " paid-off politics " . I am sure glad your job is secure now. What's the

going rate for sell-outs these days? You'll notice I am speaking only for

myself and on my daughters behalf. Why do you stay on this list lurking in the

shadows? Why do you bother? You acheived the results dictated to you by those

who would buy your tactics to sabotage a law that would have opened up our cause

to national attention. Now it has only become a nightmare for you. Enjoy your

rest.

Marlena Orndorff

LES BREEDING <les.breeding@...> wrote:Dear Tammy and friends,

I am glad so see through this listserve your continuing diligent work

on behalf of your loved ones.

I wanted to make a quick clarification regarding HB 1676.

The purpose of HB 1676 was to require insurance coverage of medical

treatment of acquired brain injuries. This was a much needed bill,

because insurance companies were refusing to treat the chronic rehab

needs of persons with these injuries. (This is a story that each of you

are very experienced in.) HB 1676 solves that problem.

In regards to HBOT, however, there is another rub. Texas law reqires

that insurance coverage be " medically necessary. " HB 1676 did not

override that provision. Therefore, HBOT still has to overcome the

" experimental " label with which the medical establishment still views

this treatment.

I hope this helps. Please contact me if I can be of any assistance.

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> fred_tam@... 12/29/02 02:00AM >>>

Hi Dawn:

HB 1676 was such a promising bill and many were excited about its

approval and passage through the TX House and Senate and to have it

signed into law by the Governor. It is currently in effect but due to

certain wording in it - I believe it leaves the insurance company or

Medicaid in charge of deciding if it is Medically Necessary or not which

takes away the authority of the actual physician. I am sure that there

are many on this list that know the finer details. I believe that many

people felt betrayed.

We will not give up because we have seen wonderful changes in our son

following HBO and we have been told that he needs more treatments.

Thanks so much!! Tammy

January 3, 2003

Les Breeding,

We greatly appreciate your support and input regarding HBOT for our kids

with CP, TBI and autism through the Texas Legislation that originated out

of your offices.

Let's look at the facts of FDA / medical research so that we can require

accountability from Health Care Providers within their own system of

determining reimbursements for treatments

RE At 0955 AM 1/2/2003 -0600, you wrote

In regards to HBOT, however, there is another rub. Texas law requires

that insurance coverage be " medically necessary. " HB 1676 did not

override that provision. Therefore, HBOT still has to overcome the

" experimental " label with which the medical establishment still views

this treatment.

First, let's look at how medical providers view experimental medicine

" HBO therapy continues to be the primary standard of care for these

indications even though no controlled trial has shown the efficacy of

HBO " (page six of the Blue Cross Technology Evaluation Center on

Hyperbaric Oxygen Treatment for Wound Healing - Part III)

It is Blue Cross's position that HBO continues to be used and reimbursed

for specific applications despite the lack of controlled studies. This

specifies their position that they readily reimburse for those

" experimental " applications of HBO technology.

Further the term " investigational " only applies to the marketing of drugs

as determined by the The Food and Drug Law. As you are well aware of, over

90% of the drugs and medical applications provided to CP / TBI children

fall under the rubric of experimental and are reimbursed. Certainly, there

has never been a seizure drug ever researched on a child. Thus, every

seizure drug reimbursed by third party payers is " experimental " .

Thus, the term " experimental " is highly subjective and abusive terminology,

if not misleading and fraudulent when used to prevent

reimbursement. " Experimental " classification has never stopped

reimbursement for any medical innovation and specifically never prevented

reimbursement for HBO.

Second, as everyone in health care is aware of, HBO for CP is one of the

most arduously studied and researched areas of HBO. There are more studies

supporting HBOT for children than almost every other HBO application. This

cannot be escaped.

For example, look at the accepted HBO application for Cyanide

Poisoning. The Jains Textbook on HBO notes on page 184 that " Litvitz et al

(1983) reported the unsuccessful use of HBO in the case of cyanide

poisoning. Later, Trapp et al (1984) reported five case of cyanide

poisoning treated successfully by means of HBO. Anecdotal reports of nine

cases of cyanide poisoning reported to the UHMS indicate that HBO was

useful to eight of them (Kindwall & Goldman 1988). Scolnick et al (1993)

treated one patient with cyanide poisoning resulting from exposure to

substituted nitrile using HBO for residual symptoms after initial treatment

with sodium nitrite ad sodium thiosulfate.

Thus, we have 3 studies, 1 positive and 1 ancillary with a total of 5

patients demonstrating the efficacy of HBO for cyanide poisoning. Further,

there is little scientific basis for the 9 anecdotal patients provided by

Kindwall.

However, this information propelled HBO for cyanide poisoning out of the

realm of " experimental " to be reimbursed by all third party providers.

There are many other relevant examples of medical applications that are

reimbursed every single day that have never been published, or " researched " .

Regardless, compared to the volume of studies I provided to the California

Assembly in our hearing this is clearly remains within the realm of

" experimental " . We provided over approx. 500 peer reviewed and other

research papers supporting HBO for brain injuries (numbering well into the

thousands). For many anecdotal cases, before and after videos were either

provided, or were available upon request (numbering in the low thousands).

Second, the population numbers of children studied (noted above) far

outstrips almost any drug approved by the FDA. For example, let's look at

a recent study published by the New England Journal of Medicine on a

COMPLETED clinical trial that is to be submitted to the FDA for review

***

New England Journal of Medicine

Experimental Drug Shows Promise for MS

" Dr. Lars Ekman, president of research and development at Elan, said the

companies expect to seek approval for the drug at the end of 2003 in the

United States and Europe. Depending on the regulatory process, the drug

could be available as early as the end of 2004, he said.

In the MS study, 213 patients in the United States, Canada and the United

Kingdom were given six monthly infusions of one of two Antegren doses or a

dummy drug. Patients who received the dummy drug had about 10 new brain

lesions, compared to about one new lesion in those getting Antegren, a

reduction of about 90 percent. "

NOTE that the patients were divided

3 mg per kilogram (68 patients),

6 mg per kilogram (74 patients),

placebo (71 patients)

= 142 patients studied for response.

Also, they conducted a dosage study within this study group requiring the

higher number of participants.

***

Now, why is this important? Numbers of patients required for clinical

trials are directly proportional to the subjectivity of the results, and/or

the percentage of patients who can spontaneously recover. That is, if the

measurement of improvement is subjective, or if the amount of improvement

is nominal, or if a significant number of patients can spontaneously

recover, a valid FDA study needs higher numbers of patients to

statistically demonstrate its results.

First, because this study views MS recovery/improvement events fairly

subjectively and is difficult to measure, they need a " high " number of

patients to complete their study to support the statistical analysis of the

data. But, because they used brain lesion measurements to determine

changes and not just movement or other changes to measure improvements they

have a smaller number of patients in the study. So, this is a moderately

populated study.

Further note that this is an FDA study.... and its requirements are very

stringent. Therefore, the results of studies that bring applications from

the realm of " experimental " to the realm of accepted.

Also, note that this was an international study as required for Regulatory

Approval in Europe. HBO for brain injuries is standard of care in advanced

countries with a total population of 1.5 billion people for as long as 30

years. This is hardly and " experimental " classification.

The regulatory study requirements to bring an approved drug from Europe to

the US is nominal, at best.

Finally, the study only details " new " lesions, not improvements of the

person, or reduction of existing lesions. " There were marked reductions in

the mean number of new lesions in both natalizumab groups " whereas HBO has

clearly demonstrated the reduction of lesions in virtually every patient

who is treated for CP/TBI/Autism.

More importantly, these patients demonstrate clear clinical changes with

permanent, motor skill and speech improvements.

However, all of us parents know that every health care provider in the US

views our kids as hopeless, and specifically beat the drum that there is

nothing that can be done to change their outcome.

That is why they illegally refuse to provide physical and other therapies

that are clearly contracted and provided for within our insurance / HMO

contracts (hence the requirement of legislation such as yours). The " out "

that they use to prevent reimbursement is simply that these kids cannot

improve regardless of what is done for them.

Yet, simply viewing ONLY the McGill pilot study and its full randomized

multi-center study as well as the Army study (forgetting the 500 other

papers published) we have:

1 significant patient populations equal to the recent New England

Journal of Med.

2 significant improvements (nearly 100%)

3 significant (awe inspiring) and irrefutable clinical results

4 Minimal side-effect or safety concerns

Further, note the results of the Second International Symposium for HBO for

the CP and Brain Injured child. It had presentations for clinical

researchers from every continent on earth, representing almost every

diverse medical system. Every presentation was equally supportive, and had

nearly perfectly reproduced results. Something that even the best FDA

approved drugs do not achieve (often due to genetic dissimilarities of

diverse populations). Very, very few FDA approved drugs have results like

this demonstrated.

The largest of worldwide pharmaceutical studies include population sizes of

a thousand, or possibly two thousand patients, and will these studies will

be conducted in as many as 100 clinics, worldwide. Certainly, the

Symposium alone approaches those efforts.

Also, note that the recent International Hyperbaric Congress had a

" pro-con " debate. The results of this debate is demoralizing to the most

head strong naysayer. No medical or scientific reason was given suggesting

HBO for brain injuries is ineffective, nor could any study be presented to

support this position. Only peer reviewed research demonstrating its

unique, fundamental, and generic benefits to brain injuries.

The third party payer responses to these studies were that these children

recovered due to a placebo effect. (this has been ardently attacked by the

study researchers). The medicaid file list has a 25 page report

listing hundreds of studies that there is not placebo effect with CP

children. This shows that a placebo effect is, in fact, impossible.

So, which is it? Do these kids always spontaneously improve with a minimal

attention from their parents, or are they absolutely hopeless and should be

left to die? Is HBO experimental and not to be reimbursed, or to be the

primary standard of care for these indications even though no controlled

trial has shown the efficacy of HBO (as noted by Blue Cross)?

These positions are obviously contradictory in the extreme and solely

self-serving.

Further, the Army Studied clearly demonstrated the time savings of care

giving for these children. Specifically demonstrating the general health

improvements and physical movement improvements for these children. This is

a major issue for every governmental group (ALTA Regional and Medi-Cal here

in California) managing these children (who account for the highest cost

burden within our care system. That is, these care costs are driving the

state deficit here in California today.

Also, within the 500 or so research papers provided to the California

Assembly there were a number of studies demonstrating dramatic improvements

in brain scans (SPECT imaging) in nearly 100% of treatment groups. That is

quantitative digital measurements of the lesion changes.

Again, these results are conclusive and while they cannot be submitted to

the FDA because of the lack of proprietary technology (future profits to

pay for submittal costs), the efficacy of HBO for general wound healing

(reimbursed every day by Blue Cross and every other health care provider)

is well accepted as well beyond " experimental " by third party payers with

far less substantial scientific basis.

Further, the ethical issues of conducting such research and delaying

treatments in this realm was fully debated and demonstrated by the UHMS' s

own internal Ethics Committee with their internal Ethics report, and their

public report. The UHMS ethics committee presented that it is unethical to

withhold treatments from patients despite the inability to fully conduct

double blinded, or other studies.

Also, the Federal Government has recently declined the request of several

pharmaceutical companies to allow them to conduct drug studies on children

for drugs they are developing for those children. This was done on for

clear medical ethics reasons. Experimental studies cannot be performed on

children, especially these handicapped children. It is illegal. (How was

McGill and the Army and all the other studies conducted? Because HBO is

known and established to be safe and effective. Therefore, legal and ethical).

Finally, we must look at the medical ethics of denying care for children in

need. Regardless of whether the application is " experimental " or

not. Clearly, where the applications are safe and proven; and the

application saves money, the ethics of denying care in unsupportable, if

not willfully negligent, if not criminal.

And the final point HBO is approved by the FDA, and has been for 50 years,

or so. HBO is safe, it is used on a daily basis throughout the world for

brain injuries and it is required by Medicaid Law (third party payers often

follow Medicaid's lead for reimbursement decisions).

The classification of " experimental " is clearly a fraudulent ruse and truly

does not exist for HBO for brain injury applications for children.

HBO is well past " experimental " and the sole method of preventing

reimbursement is tactics of fraud (e.g. State of Georgia verses Jimmy

Freels), and to throw each of the kids into the Medicaid programs, whereby

the private third party payers have no costs - only the public bears the

costs. (as you know, Federal Medicaid paragraph 5 requires reimbursement

for HBO for CP when prescribed by a physician.

Les, thank you for your attention to this information. Please forward it

to whomever presents you with the fallacy of " experimental " applications do

not get reimbursed, as well as HBO for pediatric brain injuries is

" experimental " .

Below is some illuminating discussions of this HBO " experimental "

classification

(be certain to download the link an expert document by the Food and Drug

Law Institute)

A hyperbaric chamber is an FDA approved class II medical device to deliver

an FDA approved drug (Yes-in the US medical grade oxygen is classified as a

drug in the federal code of regulations). The chamber is simply a delivery

system- no different than an oxygen tank delivering oxygen through a mask

at normal pressure. All the chamber does is change the dosage because of

the pressure increase. Yet the insurance industry says this is

experimental/investigational to do this in the case of a brain injury. You

can use this delivery system to deliver the drug for the diagnosis of

carbon monoxide poisoning but not for the diagnosis of traumatic brain injury.

This is like saying you can use a syringe (a medical device that is simply

a delivery system) to deliver a pain killer for a gun shot wound to the

leg, but you can not use the syringe to deliver the same painkiller for a

spinal cord injury. The insurance company would be laughed out of court if

they said this-yet this is exactly what they are doing in the case of HBOT

for brain injuries

Further, this person notes in a response to another person

You wrote

{For example--in the practice of Medicine, the majority of prescribed

medications are prescribed off-label, with some estimates as high as 70%.

In pediatric medicine that number is over 80%.

In pediatric neurology that number hovers just under 100%. Even more

astounding, those medications prescribed for brain-injured children are NOT

FDA approved for pediatric use.

That's how off-label they are.

We are seeking the off-label use of High-Dosage Oxygen for our children.

We have been frequently turned down for the reason that HDO is considered

either " experimental and investigational " or " alternative. " }

As you know I recently wrote the summation for my case. In researching for

the summation I came across the following document. It fully explains the

term " off-label " and " investigational " . The article is from The Food and

Drug Law Journal. You will be blown away when you read the article.

The term investigational only applies to the marketing of drugs. The FDA

has nothing to do with the practice off medicine only the marketing of

drugs and devices. If you want to win approval for a new drug or device you

have to go through certain procedures with the FDA and you must " label " for

what indications you plan on " marketing " the drug or device for. Until that

drug or device is approved it is considered investigational. Once it has

been approved it can be marketed only for the indications on the " label "

you submitted and won approval for, however it can be prescribed for any

indication- those indications on the label and any indication not listed on

the label and hence " off-label " . As you mentioned many drugs and devices

are prescribed for " off-label " indications everyday. A company can not

market (or advertise) the drug or device for and " off-label " indication,

but a doctor can prescribe it for an off-label indication.

If a company like Merk realizes that a drug has been found to work for some

indication other than they won approval for, they can submit forms to have

that indication approved by the FDA. If it won approval then Merk could

advertise the drug for this new indication. At the time Merk submits the

paper work for the off-label indication to be approved then that indication

becomes investigational or experimental. Why would a drug company want to

go through the approval process if the drug can already be prescribed for

the off-label indication? If they could advetise the drug for this new

indication it could be a windfall of money to the company.

In conclusion there are only two times when a drug or device is considered

" investigational " a) When it is submitted for its original approval from

the FDA or when a company submits the drug to be approved for a new

indication not on the original labeling.

HDOT has won its original approval from the FDA. Since no Company is asking

to " market " HDOT for the indication of traumatic brain-injuries it is

clearly not investigational. It is simply an off-label use of a FDA

approved procedure and this happens everyday in every hospital and every

doctor's office all across America.

A link to the journal article is below. It is well worth reading.

http//www.fdli.org/pubs/Journal%20Online/53_1/art9.pdf

J. Nemeth

President, CEO

Spectrum Events

916-856-7044 x 339 Phone

916-856-7040 Fax

January 3, 2003

Yes, Ed they Luann Bernam's Office compromised the Bill to get it Passed. We

will be posting Letters from Senator Cains Office, Lt. governor Bill

Ratliff's Office and Rick 's office to Montemayor TDI (Texas Dept.

of Insurance) Urging him to reflect the legislative intent of the bill to

include Hyperbaric's.

January 3, 2003

Dear Ed,

Thanks for your note. I appreciate you distilling so much information

into your response. It was very enlightening.

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> nemeth@... 01/02/03 07:14PM >>>

Les Breeding,

We greatly appreciate your support and input regarding HBOT for our

kids

with CP, TBI and autism through the Texas Legislation that originated

out

of your offices.

Let's look at the facts of FDA / medical research so that we can

require

accountability from Health Care Providers within their own system of

determining reimbursements for treatments

RE At 0955 AM 1/2/2003 -0600, you wrote

In regards to HBOT, however, there is another rub. Texas law requires

that insurance coverage be " medically necessary. " HB 1676 did not

override that provision. Therefore, HBOT still has to overcome the

" experimental " label with which the medical establishment still views

this treatment.

First, let's look at how medical providers view experimental medicine

" HBO therapy continues to be the primary standard of care for these

indications even though no controlled trial has shown the efficacy of

HBO " (page six of the Blue Cross Technology Evaluation Center on

Hyperbaric Oxygen Treatment for Wound Healing - Part III)

It is Blue Cross's position that HBO continues to be used and

reimbursed

for specific applications despite the lack of controlled studies. This

specifies their position that they readily reimburse for those

" experimental " applications of HBO technology.

Further the term " investigational " only applies to the marketing of

drugs

as determined by the The Food and Drug Law. As you are well aware of,

over

90% of the drugs and medical applications provided to CP / TBI children

fall under the rubric of experimental and are reimbursed. Certainly,

there

has never been a seizure drug ever researched on a child. Thus, every

seizure drug reimbursed by third party payers is " experimental " .

Thus, the term " experimental " is highly subjective and abusive

terminology,

if not misleading and fraudulent when used to prevent

reimbursement. " Experimental " classification has never stopped

reimbursement for any medical innovation and specifically never

prevented

reimbursement for HBO.

Second, as everyone in health care is aware of, HBO for CP is one of

the

most arduously studied and researched areas of HBO. There are more

studies

supporting HBOT for children than almost every other HBO application.

This

cannot be escaped.

For example, look at the accepted HBO application for Cyanide

Poisoning. The Jains Textbook on HBO notes on page 184 that " Litvitz

et al

(1983) reported the unsuccessful use of HBO in the case of cyanide

poisoning. Later, Trapp et al (1984) reported five case of cyanide

poisoning treated successfully by means of HBO. Anecdotal reports of

nine

cases of cyanide poisoning reported to the UHMS indicate that HBO was

useful to eight of them (Kindwall & Goldman 1988). Scolnick et al

(1993)

treated one patient with cyanide poisoning resulting from exposure to

substituted nitrile using HBO for residual symptoms after initial

treatment

with sodium nitrite ad sodium thiosulfate.

Thus, we have 3 studies, 1 positive and 1 ancillary with a total of 5

patients demonstrating the efficacy of HBO for cyanide poisoning.

Further,

there is little scientific basis for the 9 anecdotal patients provided

by

Kindwall.

However, this information propelled HBO for cyanide poisoning out of

the

realm of " experimental " to be reimbursed by all third party providers.

There are many other relevant examples of medical applications that are

reimbursed every single day that have never been published, or

" researched " .

Regardless, compared to the volume of studies I provided to the

California

Assembly in our hearing this is clearly remains within the realm of

" experimental " . We provided over approx. 500 peer reviewed and other

research papers supporting HBO for brain injuries (numbering well into

the

thousands). For many anecdotal cases, before and after videos were

either

provided, or were available upon request (numbering in the low

thousands).

Second, the population numbers of children studied (noted above) far

outstrips almost any drug approved by the FDA. For example, let's look

at

a recent study published by the New England Journal of Medicine on a

COMPLETED clinical trial that is to be submitted to the FDA for review

***

New England Journal of Medicine

Experimental Drug Shows Promise for MS

" Dr. Lars Ekman, president of research and development at Elan, said

the

companies expect to seek approval for the drug at the end of 2003 in

the

United States and Europe. Depending on the regulatory process, the drug

could be available as early as the end of 2004, he said.

In the MS study, 213 patients in the United States, Canada and the

United

Kingdom were given six monthly infusions of one of two Antegren doses

or a

dummy drug. Patients who received the dummy drug had about 10 new brain

lesions, compared to about one new lesion in those getting Antegren, a

reduction of about 90 percent. "

NOTE that the patients were divided

3 mg per kilogram (68 patients),

6 mg per kilogram (74 patients),

placebo (71 patients)

= 142 patients studied for response.

Also, they conducted a dosage study within this study group requiring

the

higher number of participants.

***

Now, why is this important? Numbers of patients required for clinical

trials are directly proportional to the subjectivity of the results,

and/or

the percentage of patients who can spontaneously recover. That is, if

the

measurement of improvement is subjective, or if the amount of

improvement

is nominal, or if a significant number of patients can spontaneously

recover, a valid FDA study needs higher numbers of patients to

statistically demonstrate its results.

First, because this study views MS recovery/improvement events fairly

subjectively and is difficult to measure, they need a " high " number of

patients to complete their study to support the statistical analysis of

the

data. But, because they used brain lesion measurements to determine

changes and not just movement or other changes to measure improvements

they

have a smaller number of patients in the study. So, this is a

moderately

populated study.

Further note that this is an FDA study.... and its requirements are

very

stringent. Therefore, the results of studies that bring applications

from

the realm of " experimental " to the realm of accepted.

Also, note that this was an international study as required for

Regulatory

Approval in Europe. HBO for brain injuries is standard of care in

advanced

countries with a total population of 1.5 billion people for as long as

30

years. This is hardly and " experimental " classification.

The regulatory study requirements to bring an approved drug from Europe

to

the US is nominal, at best.

Finally, the study only details " new " lesions, not improvements of the

person, or reduction of existing lesions. " There were marked

reductions in

the mean number of new lesions in both natalizumab groups " whereas HBO

has

clearly demonstrated the reduction of lesions in virtually every

patient

who is treated for CP/TBI/Autism.

More importantly, these patients demonstrate clear clinical changes

with

permanent, motor skill and speech improvements.

However, all of us parents know that every health care provider in the

US

views our kids as hopeless, and specifically beat the drum that there

is

nothing that can be done to change their outcome.

That is why they illegally refuse to provide physical and other

therapies

that are clearly contracted and provided for within our insurance / HMO

contracts (hence the requirement of legislation such as yours). The

" out "

that they use to prevent reimbursement is simply that these kids cannot

improve regardless of what is done for them.

Yet, simply viewing ONLY the McGill pilot study and its full randomized

multi-center study as well as the Army study (forgetting the 500 other

papers published) we have:

1 significant patient populations equal to the recent New England

Journal of Med.

2 significant improvements (nearly 100%)

3 significant (awe inspiring) and irrefutable clinical results

4 Minimal side-effect or safety concerns

Further, note the results of the Second International Symposium for HBO

for

the CP and Brain Injured child. It had presentations for clinical

researchers from every continent on earth, representing almost every

diverse medical system. Every presentation was equally supportive, and

had

nearly perfectly reproduced results. Something that even the best FDA

approved drugs do not achieve (often due to genetic dissimilarities of

diverse populations). Very, very few FDA approved drugs have results

like

this demonstrated.

The largest of worldwide pharmaceutical studies include population

sizes of

a thousand, or possibly two thousand patients, and will these studies

will

be conducted in as many as 100 clinics, worldwide. Certainly, the

Symposium alone approaches those efforts.

Also, note that the recent International Hyperbaric Congress had a

" pro-con " debate. The results of this debate is demoralizing to the

most

head strong naysayer. No medical or scientific reason was given

suggesting

HBO for brain injuries is ineffective, nor could any study be presented

to

support this position. Only peer reviewed research demonstrating its

unique, fundamental, and generic benefits to brain injuries.

The third party payer responses to these studies were that these

children

recovered due to a placebo effect. (this has been ardently attacked by

the

study researchers). The medicaid file list has a 25 page report

listing hundreds of studies that there is not placebo effect with CP

children. This shows that a placebo effect is, in fact, impossible.

So, which is it? Do these kids always spontaneously improve with a

minimal

attention from their parents, or are they absolutely hopeless and

should be

left to die? Is HBO experimental and not to be reimbursed, or to be

the

primary standard of care for these indications even though no

controlled

trial has shown the efficacy of HBO (as noted by Blue Cross)?

These positions are obviously contradictory in the extreme and solely

self-serving.

Further, the Army Studied clearly demonstrated the time savings of care

giving for these children. Specifically demonstrating the general

health

improvements and physical movement improvements for these children.

This is

a major issue for every governmental group (ALTA Regional and Medi-Cal

here

in California) managing these children (who account for the highest

cost

burden within our care system. That is, these care costs are driving

the

state deficit here in California today.

Also, within the 500 or so research papers provided to the California

Assembly there were a number of studies demonstrating dramatic

improvements

in brain scans (SPECT imaging) in nearly 100% of treatment groups.

That is

quantitative digital measurements of the lesion changes.

Again, these results are conclusive and while they cannot be submitted

to

the FDA because of the lack of proprietary technology (future profits

to

pay for submittal costs), the efficacy of HBO for general wound healing

(reimbursed every day by Blue Cross and every other health care

provider)

is well accepted as well beyond " experimental " by third party payers

with

far less substantial scientific basis.

Further, the ethical issues of conducting such research and delaying

treatments in this realm was fully debated and demonstrated by the

UHMS' s

own internal Ethics Committee with their internal Ethics report, and

their

public report. The UHMS ethics committee presented that it is unethical

to

withhold treatments from patients despite the inability to fully

conduct

double blinded, or other studies.

Also, the Federal Government has recently declined the request of

several

pharmaceutical companies to allow them to conduct drug studies on

children

for drugs they are developing for those children. This was done on for

clear medical ethics reasons. Experimental studies cannot be performed

on

children, especially these handicapped children. It is illegal. (How

was

McGill and the Army and all the other studies conducted? Because HBO

is

known and established to be safe and effective. Therefore, legal and

ethical).

Finally, we must look at the medical ethics of denying care for

children in

need. Regardless of whether the application is " experimental " or

not. Clearly, where the applications are safe and proven; and the

application saves money, the ethics of denying care in unsupportable,

if

not willfully negligent, if not criminal.

And the final point HBO is approved by the FDA, and has been for 50

years,

or so. HBO is safe, it is used on a daily basis throughout the world

for

brain injuries and it is required by Medicaid Law (third party payers

often

follow Medicaid's lead for reimbursement decisions).

The classification of " experimental " is clearly a fraudulent ruse and

truly

does not exist for HBO for brain injury applications for children.

HBO is well past " experimental " and the sole method of preventing

reimbursement is tactics of fraud (e.g. State of Georgia verses Jimmy

Freels), and to throw each of the kids into the Medicaid programs,

whereby

the private third party payers have no costs - only the public bears

the

costs. (as you know, Federal Medicaid paragraph 5 requires

reimbursement

for HBO for CP when prescribed by a physician.

Les, thank you for your attention to this information. Please forward

it

to whomever presents you with the fallacy of " experimental "

applications do

not get reimbursed, as well as HBO for pediatric brain injuries is

" experimental " .

Below is some illuminating discussions of this HBO " experimental "

classification

(be certain to download the link an expert document by the Food and

Drug

Law Institute)

A hyperbaric chamber is an FDA approved class II medical device to

deliver

an FDA approved drug (Yes-in the US medical grade oxygen is classified

as a

drug in the federal code of regulations). The chamber is simply a

delivery

system- no different than an oxygen tank delivering oxygen through a

mask

at normal pressure. All the chamber does is change the dosage because

of

the pressure increase. Yet the insurance industry says this is

experimental/investigational to do this in the case of a brain injury.

You

can use this delivery system to deliver the drug for the diagnosis of

carbon monoxide poisoning but not for the diagnosis of traumatic brain

injury.

This is like saying you can use a syringe (a medical device that is

simply

a delivery system) to deliver a pain killer for a gun shot wound to the

leg, but you can not use the syringe to deliver the same painkiller for

a

spinal cord injury. The insurance company would be laughed out of court

if

they said this-yet this is exactly what they are doing in the case of

HBOT

for brain injuries

Further, this person notes in a response to another person

You wrote

{For example--in the practice of Medicine, the majority of prescribed

medications are prescribed off-label, with some estimates as high as

70%.

In pediatric medicine that number is over 80%.

In pediatric neurology that number hovers just under 100%. Even more

astounding, those medications prescribed for brain-injured children are

NOT

FDA approved for pediatric use.

That's how off-label they are.

We are seeking the off-label use of High-Dosage Oxygen for our

children.

We have been frequently turned down for the reason that HDO is

considered

either " experimental and investigational " or " alternative. " }

As you know I recently wrote the summation for my case. In researching

for

the summation I came across the following document. It fully explains

the

term " off-label " and " investigational " . The article is from The Food

and

Drug Law Journal. You will be blown away when you read the article.

The term investigational only applies to the marketing of drugs. The

FDA

has nothing to do with the practice off medicine only the marketing of

drugs and devices. If you want to win approval for a new drug or device

you

have to go through certain procedures with the FDA and you must " label "

for

what indications you plan on " marketing " the drug or device for. Until

that

drug or device is approved it is considered investigational. Once it

has

been approved it can be marketed only for the indications on the

" label "

you submitted and won approval for, however it can be prescribed for

any

indication- those indications on the label and any indication not

listed on

the label and hence " off-label " . As you mentioned many drugs and

devices

are prescribed for " off-label " indications everyday. A company can not

market (or advertise) the drug or device for and " off-label "

indication,

but a doctor can prescribe it for an off-label indication.

If a company like Merk realizes that a drug has been found to work for

some

indication other than they won approval for, they can submit forms to

have

that indication approved by the FDA. If it won approval then Merk could

advertise the drug for this new indication. At the time Merk submits

the

paper work for the off-label indication to be approved then that

indication

becomes investigational or experimental. Why would a drug company want

to

go through the approval process if the drug can already be prescribed

for

the off-label indication? If they could advetise the drug for this new

indication it could be a windfall of money to the company.

In conclusion there are only two times when a drug or device is

considered

" investigational " a) When it is submitted for its original approval

from

the FDA or when a company submits the drug to be approved for a new

indication not on the original labeling.

HDOT has won its original approval from the FDA. Since no Company is

asking

to " market " HDOT for the indication of traumatic brain-injuries it is

clearly not investigational. It is simply an off-label use of a FDA

approved procedure and this happens everyday in every hospital and

every

doctor's office all across America.

A link to the journal article is below. It is well worth reading.

http//www.fdli.org/pubs/Journal%20Online/53_1/art9.pdf

J. Nemeth

President, CEO

Spectrum Events

916-856-7044 x 339 Phone

916-856-7040 Fax

January 3, 2003

Dear Ms. Orndorff,

I am sorry that you feel that way.

The word " acquired " was added to HB 1676 when it was on the House

floor. It was a compromise that Rep. Burnam made because of opposition

in the House which threatened the passage of HB 1676. Many in the House

argued that the bill could include any and every type of mental

disorder, such as even dyslexia. Our amendment took care of their

objections and we were able to get it through the Legislature without

further amendments. It was not a change that we wanted to make, but it

was necessary to get the bill passed.

This was not an easy bill to pass. It took a lot of effort and a lot of

lobbying by our coalition. It is what is referred to as a " health

mandate, " meaning that the bill required insurance companies to increase

their coverage, which not only insurance companies dislike, but the

business community forcefully opposes.

Another thing to keep in mind is that this bill is not a " HBOT " bill,

it is a brain injury bill. A very wide coalition of health

professionals, survivors, and their families supported this bill. Some

were interested in HBOT. Most were not. This coalition hung together

through the passage of the bill and through the rule making process. The

rules were satisfatory to all of the coalition except for the HBOT

community, who had hoped to be able to get more out of it.

Insurers not only do not want to insure HBOT, they do not want to cover

treatment for therapies that have been medically established for 30

years -- therapies such as cognitive therapy and other normal,

traditional rehab therapies.

We never felt that this bill would be a miracle pill for HBOT. We knew

that HBOT still had to overcome the medically necessary hurdle, which

every other therapy in Texas has had to overcome.

Confusion on this point has occurred because Rep. Ehrhardt (a co-spnsor

of the bill and the family member of a brain injury survivor who used

HBOT and other therapies) personally hoped that the bill world be able

to achieve medical coverage for HBOT. Unfortunately, she did not

directly comunicate that to us during the legislative process. Even if

she had and we changed the bill to add an HBOT mandate, I doubt that we

could have secured passage of the bill. We just barely passed the bill

as it was.

By the way, there have been no " closed door " sessions. Members of the

HBOT community were at every meeting of the coalition. I also made sure

that members of the HBOT community were at every meeting with the Texas

Department of Insurance. As one example, we invited Dr. Harch to

attend one of the more important of those meetings.

I hope that this helps. Our office will continue to be interested in

advocating for brain injury survivors. I will continue to try to be

helpful as I can to the HBOT community also.

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> morndorff@... 01/02/03 06:27PM >>>

Greetings,

Mr. Breeding, please don't insult my intelligence any more with your

attempts to do justice to the backdraft damage that was done to 1676.

The term " acquired " was applied after the Bill passed and already into

the implementation process. I'm afraid that your disregard for children

is crystal clear. And no, I didn't read past the 1st paragraph, because

of the term " acquired " . The behind closed door " work session " that

created this after the fact bombshell was a shameful act of " paid-off

politics " . I am sure glad your job is secure now. What's the going

rate for sell-outs these days? You'll notice I am speaking only for

myself and on my daughters behalf. Why do you stay on this list lurking

in the shadows? Why do you bother? You acheived the results dictated

to you by those who would buy your tactics to sabotage a law that would

have opened up our cause to national attention. Now it has only become

a nightmare for you. Enjoy your rest.

Marlena Orndorff

LES BREEDING <les.breeding@...> wrote:Dear Tammy and

friends,

I am glad so see through this listserve your continuing diligent work

on behalf of your loved ones.

I wanted to make a quick clarification regarding HB 1676.

The purpose of HB 1676 was to require insurance coverage of medical

treatment of acquired brain injuries. This was a much needed bill,

because insurance companies were refusing to treat the chronic rehab

needs of persons with these injuries. (This is a story that each of

you

are very experienced in.) HB 1676 solves that problem.

In regards to HBOT, however, there is another rub. Texas law reqires

that insurance coverage be " medically necessary. " HB 1676 did not

override that provision. Therefore, HBOT still has to overcome the

" experimental " label with which the medical establishment still views

this treatment.

I hope this helps. Please contact me if I can be of any assistance.

Les

--

Les Breeding

Legislative Director

Office of Rep. Lon Burnam

P.O. Box 2910

Austin Texas 78768-2910

(512)463-0740

les.breeding@...

>>> fred_tam@... 12/29/02 02:00AM >>>

Hi Dawn:

HB 1676 was such a promising bill and many were excited about its

approval and passage through the TX House and Senate and to have it

signed into law by the Governor. It is currently in effect but due to

certain wording in it - I believe it leaves the insurance company or

Medicaid in charge of deciding if it is Medically Necessary or not

which

takes away the authority of the actual physician. I am sure that

there

are many on this list that know the finer details. I believe that

many

people felt betrayed.

We will not give up because we have seen wonderful changes in our son

following HBO and we have been told that he needs more treatments.

Thanks so much!! Tammy

January 3, 2003

Les,

RE: At 01:08 PM 1/3/2003 -0600, you wrote:

>We just barely passed the bill as it was.

I was under the impression that the bill passed the House with no

abstentions and then passed the Senate by a unanimous vote.

Am I misinformed on this?

Thanks.

Ed Nemeth

J. Nemeth

President, CEO

Spectrum Events

916-856-7044 x 339 Phone

916-856-7040 Fax

January 3, 2003

Sir: Again you are muddying the truth. I may not have been there, but I had

personal telephone conversations with 2 individuals that were there testifying

and 1 close relative of Rep. Erhardt and I had at least 2 telephone

conversations and their intent was always to include HBOT as one of many

therapies included in this bill. Most of the people who showed up to testify

before the legislature were supporters of HBOT and could speak from personal

experience, that's why they were there.

I could go back and review all the communication I have on file and repost it if

you would like.

You obviously had a different take on the process. Maybe your " take " influenced

your take. Your spin is very important to you. It should be. I have copies of

the language of the bill as it was presented to the legislators that voted. I

have the victory emails that said the only thing they had to wait for was the

effective date. Then your offices got involved in the implementation. Those

you claim from the HBOT camp were not invited, but had to force their way in by

shaming you on this list. The truth is you've been dragging your heels the

whole way. Your interest seems to be wholly proactive as long as you can appear

to be in support of HBOT for brain injury. What goes on behind the closed doors

of staff meeting are a completely different story.

I ask you the question again: If " nobody " wanted to include HBOT in this bill,

and if insurance companies don't want to pay for HBOT, isn't it a waste of your

time to be responding to this list? If as you say, you don't have any medical

proof of the efficacy of low pressure HBOT in brain injury, then why do you

continue to insert your " justifications " when the HB 1676 subject comes up? You

seemed to have all the answers you needed before, you seemed to have all the

input you needed during the implementation process. I still suggest that the

HBOT community that you listened to was the military influence from San

and not those who have been practicing this therapy for this indication.

No matter what Dr's, Senators, or Reps. name you want to drop the reality is

that those who were involved informed me personally of your distincitve efforts

to exclude " our " experts from those meetings.

This bill and it's implications was interpreted as inclusive of any therapy.

The " medically necessary " phrase along with the " acquired " word was added after

the fact. This bill was not doomed as you say. Not until the Insurance

commissioners office got involved.

No insurance company wants to pay for anything, that's no secret, but that is

also no reason to exclude HBOT from this bill.

Federal Medicaid law has no implications on Texas state law? Since when does

Texas have no responsibility to implement Federal mandates? I have understood

that while different states have different names for their programs, that

Federal Medicaid law is still to be implemented by the individual state, and it

is not up to the state to reinterpret the law but to implement it.

I'll bow out of this discussion now. It continues to go nowhere.

Those of you who would like me to forward all that I have regarding this subject

to you, I will be happy to. It might take me a while to compile it all, but

I'll be happy to do it.

As long as those who are in positions of decision making continue to spin

reality to their benefit, we'll go nowhere.

Take care all.

LES BREEDING <les.breeding@...> wrote:Dear Ms. Orndorff,