Re: [MedicaidforHDOT] Medicaid Denial/Botox

[Guest guest]

>Darin: thank you for the offer of help. I appreciate it. For now,

>however, I am putting all work on our pending hearing on hold until I

>know exactly what the reason for denial will be. So far, we've been

>told it might be because we used an out of plan provider, or because

>HBOT is considered experimental or because HBOT treats developmental

>delays and treatment for developmental delays are directly excluded,

>or because..... As you can see, each of these denials will require a

>different approach so, at this point, I am just driving myself crazy

>by jumping from issue to issue with no real clear path. I am going

>to hold off until I get the formal denial and then move forward. May

>I call you then, when I have a better handle on this whole

>situation?

>

>BTW, I was told by the medical director that the only issue I need to

>address in the hearing is the reason for denial, nothing else. I had

>expressed my concern that we'd be denied on the basis of reason " a "

>but even if I adequately addressed reason " a " , the committee would

>then say, " Well, we had reasons b, c and d that we feel also preclude

>us from covering your son's treatments. " I was concerned that I'd be

>trying to hit a moving target but I was told this will not be the

>case - can anyone else tell me what their experiences have been with

>this sort of hearing? I feel like I am still going to need to

>address issues such as the science of HBOT for brain injuries, the

>research, the phsyiology of the brain, etc. Comments?

>

>Lynn

>

Lynn,

I got this yesterday from the FDA, concerning the Pediatric Rule. The

Pediatric Rule was an FDA mandate that every new drug for children had to

first go through clinical trials before the drug could be approved. Much of

this is discussed in the pdf from

medicaid/files/Off-label_Use_In_Children.PD

F , Off-label_Use_In_Children.

This is an extremely well-researched, well-documented legal brief written

on the legalities of the Pediatric Rule, and takes the side that the FDA

has no authority to enforce the Pediatric Rule, which the US Circuit Court

in DC (one step below the US Supreme Court, which agreed with this brief in

October, 2002).

Now, what this means is that drug companies do not have to first have a

clinical trial before their products can be prescribed to and administered

to children.

In other words, the standard of practice in pediatric medicine is to

prescribe treatments and drugs OFF-LABEL.

However, even if the Pediatric Rule had gone into effect, there are times

when the FDA mandate for clinical trials can be waived, including:

(ii) Necessary studies are impossible or highly impractical

because, e.g., the number of such patients is so small or

geographically dispersed; or

Now, it's impossible to do a double-blind controlled study of HBOT for cp

children. This has been discussed at length and decided by the Undersea and

Hyperbaric Medical Society--and published in the UHMS peer-reviewed medical

journal. Two versions of this article can be downloaded from

HDO-documentation/files/ . Look under the

section that begins with " UHMS. "

This means that their reasons for denial are totally invalid.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

The following information comes directly from the Pediatric Rule. You may

read the rule in its entirety at

http://www.fda.gov/ohrms/dockets/98fr/120298c.txt

© Waivers--(1) General. FDA may grant a full or partial waiver of

the requirements of paragraph (a) of this section on its own initiative

or at the request of an applicant. A request for a waiver must provide

an adequate justification.

(2) Full waiver. An applicant may request a waiver of the

requirements of paragraph (a) of this section if the applicant

certifies that:

(i) The product does not represent a meaningful therapeutic benefit

over existing therapies for pediatric patients and is not likely to be

used in a substantial number of pediatric patients;

(ii) Necessary studies are impossible or highly impractical

because, e.g., the number of such patients is so small or

geographically dispersed; or

(iii) There is evidence strongly suggesting that the product would

be ineffective or unsafe in all pediatric age groups.

(3) Partial waiver. An applicant may request a waiver of the

requirements of paragraph (a) of this section with respect to a

specified pediatric age group, if the applicant certifies that:

(i) The product does not represent a meaningful therapeutic benefit

over existing therapies for pediatric patients in that age group, and

is not likely to be used in a substantial number of patients in that

age group;

(ii) Necessary studies are impossible or highly impractical

because, e.g., the number of patients in that age group is so small or

geographically dispersed;

(iii) There is evidence strongly suggesting that the product would

be ineffective or unsafe in that age group; or

(iv) The applicant can demonstrate that reasonable attempts to

produce a pediatric formulation necessary for that age group have

failed.

(4) FDA action on waiver. FDA shall grant a full or partial waiver,

as appropriate, if the agency finds that there is a reasonable basis on

which to conclude that one or more of the grounds for waiver specified

in paragraphs ©(2) or ©(3) of this section have been met. If a

waiver is granted on the ground that it is not possible to develop a

pediatric formulation, the waiver will cover only those pediatric age

groups requiring that formulation. If a waiver is granted because there

is evidence that the product would be ineffective or unsafe in

pediatric populations, this information will be included in the

product's labeling.

```````````````````````````````````````````````````````

" Rarely do we find men who willingly engage in hard, solid thinking. There

is an almost universal quest for easy answers and half-baked solutions. "

--The Reverend Luther King, Jr.

```````````````````````````````````````````````````````

Freels

2948 Windfield Circle

Tucker, GA 30084-6714

770/491-6776 (phone and fax)

707/220-7224 (efax, sends fax as email attachment)

mailto:dfreels@...

http://www.freelanceforum.org/df

[Guest guest]

, your comments address the issues of whether or not it even

matters if HBOT is considered experimental/off-label, and I am not

concerned about the fact that we used an out-of-plan provider as I

tried to get the hospital to treat my son and was denied. However, I

think our biggest issue may be if we are rejected because the HBOT

addresses issued related to developmental delays. I do not disagree

with that; however, our plan is willing to pay for botox and has, in

the past, paid for one therapeutic device that allows my son to sit

better and paid for a surgery to correct his strabismus. I have also

been told that they would pay for additional PT for a period of 6

weeks if my son has the botox injections. The need for all of these

items that have been paid for or would be paid for stem from his

developmental delays; therefore, how is the HBOT any different?

Again, I plan to wait and see what the formal reason for rejection is

and address that. I will file your note away and pull it out if they

claim HBOT is experimental/off-label.

Lynn

> > > I got this yesterday from the FDA, concerning the

Pediatric Rule. The Pediatric Rule was an FDA mandate that every new

drug for children had to first go through clinical trials before the

drug could be approved. Much of this is discussed in the pdf from

> medicaid/files/Off-

Label_Use_In_Children.PDF , Off-label_Use_In_Children. This is an

extremely well-researched, well-documented legal brief written

on the legalities of the Pediatric Rule, and takes the side that the

FDA has no authority to enforce the Pediatric Rule, which the US

Circuit Court in DC (one step below the US Supreme Court, which

agreed with this brief in October, 2002). Now, what this means is

that drug companies do not have to first have a clinical trial before

their products can be prescribed to and administered to children.

In other words, the standard of practice in pediatric medicine is to

prescribe treatments and drugs OFF-LABEL. However, even if the

Pediatric Rule had gone into effect, there are times when the FDA

mandate for clinical trials can be waived, including: (ii) Necessary

studies are impossible or highly impractical because, e.g., the

number of such patients is so small or geographically dispersed; or <

Now, it's impossible to do a double-blind controlled study of HBOT

for cp children. This has been discussed at length and decided by the

Undersea and Hyperbaric Medical Society--and published in the UHMS

peer-reviewed medical journal. Two versions of this article can be

downloaded from HDO-

documentation/files/ . Look under the section that begins with " UHMS. "

This means that their reasons for denial are totally invalid. <

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

>

>

>

> The following information comes directly from the Pediatric Rule.

You may

> read the rule in its entirety at

> http://www.fda.gov/ohrms/dockets/98fr/120298c.txt

>

> © Waivers--(1) General. FDA may grant a full or partial waiver of

> the requirements of paragraph (a) of this section on its own

initiative

> or at the request of an applicant. A request for a waiver must

provide

> an adequate justification.

> (2) Full waiver. An applicant may request a waiver of the

> requirements of paragraph (a) of this section if the applicant

> certifies that:

> (i) The product does not represent a meaningful therapeutic

benefit

> over existing therapies for pediatric patients and is not likely to

be

> used in a substantial number of pediatric patients;

> (ii) Necessary studies are impossible or highly impractical

> because, e.g., the number of such patients is so small or

> geographically dispersed; or

> (iii) There is evidence strongly suggesting that the product

would

> be ineffective or unsafe in all pediatric age groups.

> (3) Partial waiver. An applicant may request a waiver of the

> requirements of paragraph (a) of this section with respect to a

> specified pediatric age group, if the applicant certifies that:

> (i) The product does not represent a meaningful therapeutic

benefit

> over existing therapies for pediatric patients in that age group,

and

> is not likely to be used in a substantial number of patients in that

> age group;

> (ii) Necessary studies are impossible or highly impractical

> because, e.g., the number of patients in that age group is so small

or

> geographically dispersed;

> (iii) There is evidence strongly suggesting that the product

would

> be ineffective or unsafe in that age group; or

> (iv) The applicant can demonstrate that reasonable attempts to

> produce a pediatric formulation necessary for that age group have

> failed.

> (4) FDA action on waiver. FDA shall grant a full or partial

waiver,

> as appropriate, if the agency finds that there is a reasonable

basis on

> which to conclude that one or more of the grounds for waiver

specified

> in paragraphs ©(2) or ©(3) of this section have been met. If a

> waiver is granted on the ground that it is not possible to develop a

> pediatric formulation, the waiver will cover only those pediatric

age

> groups requiring that formulation. If a waiver is granted because

there

> is evidence that the product would be ineffective or unsafe in

> pediatric populations, this information will be included in the

> product's labeling.

>

>

>

>

>

>

>

> ```````````````````````````````````````````````````````

> " Rarely do we find men who willingly engage in hard, solid

thinking. There

> is an almost universal quest for easy answers and half-baked

solutions. "

>

> --The Reverend Luther

King, Jr.

>

> ```````````````````````````````````````````````````````

>

>

> Freels

> 2948 Windfield Circle

> Tucker, GA 30084-6714

> 770/491-6776 (phone and fax)

> 707/220-7224 (efax, sends fax as email attachment)

> mailto:dfreels@m...

>

> http://www.freelanceforum.org/df