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Hi,

Dr. Tom Gross in SC met with Blue Cross/Blue Shield to get the cormet 2000 covered and they did.

You can reach his nurse, Lee Webb, at , Midlands Orthopaedics in Columbia,SC on Tues and Thurs. Lee has handled all the correspondence with the FDA concerning the Cormet 2000 program.

She could possibly give you some insight on how they approached BC/BS.

Good Luck!

Jack

Florence, SC

an all call!

Hello All,

The last resort in my effort to get coverage from UnitedHealthcare of

Wisconsin is to hire a litigator.

The first step will be to submit a letter to UHC that is backed up with

solid research, testimony and any other documentation indicating that m/m

resurfacing is not unproven. (Current definitions of this term plus

criteria for assigning it are hard to determine, and seem vague at best.)

Therefore, if anyone out there knows of a reference from medical literature

- this can include non- US studies - I can use it! Even if the reference

points to m/m resurfacing as an option with a strong chance of matching the

longevity & effectiveness of THR - I can use it!

Please forward any references you may know of - even if they're a long shot

- as soon as possible. This is my 11th hour. Many, many thanks!

Cate

_______________________________________________________

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Here is a letter that may help, but it was short on the references

you seek. Hope it helps

Dear J***,

As the denied party referred to in Rule XVI, J.1.(B) this is my

reply to the WC carrier's denial of Dr. Treacy's surgery and to Dr.

Tal***'s May 4th and June 8th, 2001 opinions and is meant to serve as

a request for the WC carrier's final decision about the WC carrier's

authorization of Dr. Ronan Treacy's treatment.

I've seen two correspondences/opinions from Dr. Tal*** dated May

4, 2001 and June 8, 2001. The opinions seem to directly contradict

each other. In order to promote a better understanding of the issues,

please note the following terms as they relate to the hip:

acetabulum/acetabular: the pelvic side of the hip

joint...the " socket " that accepts/articulates with the femoral head.

articulates: the joint surfaces sliding or moving in relation to

each other.

hemiarthroplasty: a prosthesis replacing one articulating surface

(one-piece), i.e. either the femoral head or the acetabulum.

bipolar: a prosthesis that replaces the femoral head and has an

additional " bearing " below its articulating surface, in the hollow

portion of its articulating femoral shell, similar to the way a

piston in an engine connects to its connecting rod.

Birmingham Hip Resurfacing: (BHR) a full resurfacing device, like

the Conserve PLUS, which includes both femoral and acetabular

replacement components. It is available in the U.K. and many other

countries, but not in the U.S. It may be considered a Total Hip

Arthroplasty device because it has a femoral and an acetabular

component.

Conserve Hip©: © is a limited resurfacing device. Since it

replaces only the femoral side of the joint it is also considered a

hemiarthroplasty device. It is always available for use by

orthopedic surgeons.

Conserve PLUS Hip©: (C+) a full resurfacing device, also billed

to insurances as Total Hip Arthroplasty, because it includes both

femoral and acetabular replacement components. Its availability

varies depending on the status of FDA IDE trials and the length of

the patient waiting lists.

femoral: of the femur

full resurfacing: (Conserve PLUS or Birmingham Hip Resurfacing)

(two-piece) a full resurfacing includes a femoral device just as a

limited resurfacing does, but it also includes a replacement of the

acetabular side of the joint with an acetabular " cup. "

limited resurfacing: (Conserve Hip) (one-piece) the prosthesis

replaces the surface cartilage of only the femoral head. It doesn't

include an acetabular component. It is a small device that would fit

in the palm of your hand. It preserves bone and delays THR.

Total Hip Arthroplasty: (THR) a prosthesis replacing both

articulating surfaces, i.e. both the femoral head and the acetabulum.

Primary THR: is a patient's first THR.delays the insertion of a

fully stemmed device into the long femoral canal.

Proximal femur: a portion of the femur closer to the pelvis,

below the femoral head and neck.

In Dr. Ta***'s (my unsurance's hired medical gun) opinion dated

June 8th, he states, " ...it is still my opinion that a procedure such

as that recommended by Dr. Kin*** would be appropriate and locally

available. " " ...it is still my opinion that the most appropriate

procedure would be a replacement of both sides of the joint-

acetabular and femoral head- because of the pain relief available

with that type of procedure. It is also my opinion that the Conserve

hip, which is locally available, would be appropriate. " (my added

emphasis)

-Response:

1. Despite Dr. Tal***'s statement that it is still his opinion

that Dr. Kin***'s recommended hip, the Conserve hip is appropriate,

the June 8th letter is the first time he states that it is

appropriate. He certainly did not endorse of that type of surgical

device in his prior May 4th opinion .

2. I laud Dr. Tal***'s new June 8th opinion stating that the

Conserve hip, which resurfaces the femoral ball only, " would be

appropriate. "

3. His June 8th opinion goes on to say, " ...the most appropriate

procedure would be a replacement of both sides of the joint-

acetabular and femoral head- because of the pain relief available

with that type of procedure. "

-Response: The Birmingham Hip does include both acetabular and

the femoral head replacement components. The Birmingham Hip femoral

component is nearly identical in appearance to the Conserve Hip© Dr.

Tal*** now finds appropriate, but it also includes the matching

acetabular socket component as well, which addresses Dr. Tal***'s

concerns about pain relief.

4. Availability: -Response: The Conserve Hip© availability has

never been an issue. The Conserve Hip© is the prosthesis Dr. Kin***,

Dr. Kel** and Dr. Mont wanted to implant in me early on in this

saga. The point is that the WC carrier has until now denied and

delayed all my requests for such a device, and now my condition has

deteriorated to the point that my acetabulum now needs replacement

also. Availability is an issue with the Conserve PLUS ©, which is in

FDA IDE trials and the availability varies as the allotted amount

changes and as more and more desperate patients line up to get this

device. I was told at the time I had to cancel surgery with Dr.

Mont, that if I didn't get a Conserve PLUS © at the time of scheduled

surgery, May 5, 2001, that the Conserve PLUS © devices are in such

demand that the FDA allotment would be used up. Dr. Amstutz in Los

Angeles told me also that his allotment was long gone too...there

were no more to be had. Dr. Amstutz is a highly acclaimed surgeon,

as is Dr. Mont.

In his May 4th opinion, Dr. Tal*** states, " the rationale of delaying

a total hip arthroplasty is really not logical in my opinion because

if a revision is going to be necessary in 10 or twelve years what is

the advantage when the known longevity of a total hip arthroplasty is

in the range of 20 years without other complications. "

-Response: Dr. Harlan Amstutz is a leading proponent of resurfacing

and cites one of the primary features of resurfacing is that

it " preserves and maintains bone " and may delay a THR and revision,

perhaps indefinitely. Dr. Amstutz was recently the President of the

prestigious American Orthopaedic Association and is President-elect

of the International Hip Society. Dr. Amstutz is one of only five

American orthopaedic surgeons to be inducted into the Royal College

of Surgeons of England as an Honorary Fellow. Dr. Amstutz regularly

appears in the publication entitled " The Best Doctors in America. "

Would you agree Dr. Amstutz's rationale is likely to be logical?

To delay a fully stemmed Total Hip Arthroplasty (THR) is totally

logical to, and recommended by, most doctors. Many young patients,

(those below 60) are advised to live with the pain for as long as

they can in order to delay fully stemmed THR. There must be a reason

many doctors advise this. In fact, there are many reasons for

patients under sixty years to delay a full-stemmed hip arthroplasty.

1.The younger, heavier and more active a patient is when he

receives THR, the more revisions he is likely to receive during the

course of his lifetime due to wear, loosening and other

complications, such as infection.

2. Revisions, though necessary, have unique problems:

a. bone loss during revision

(Revision of BHR would result in a primary THR, which

would be done with an uncompromised femoral shaft.)

b. reduced longevity of the implanted joint

(Again, a BHR revision would revise to a primary THR)

c. reduced range of motion compared to primary THR

(BHR results in far better range of motion than most other

THRs)

d. increased likelihood of dislocations resulting in

hospitalization. (BHR patients have virtually no

dislocations. There has been but one, which resulted

from a recipient's fall from a ladder.)

3. Fully stemmed THR has its own unique problems, which are to be

avoided if possible:

a. Return to work and sport. THR results in many

restrictions that may prevent my return to an active

career as a construction electrician, which requires much

lifting, kneeling and flexibility to work in tight areas.

(BHR and other resurfacing has allowed people to return to

all manner of job and sport, including high-level judo,

rugby, badminton and ballet dancing.)

b. Osteolysis (bone loss) in the joint area which results

from polyethylene debris if a polyethylene

acetabular " cup " is used. (BHR has no polyethylene

components.)

c. Bone loss from stress shielding. This happens because

the femur is prevented from flexing slightly under weight

bearing, which is necessary to maintain healthy bones.

This is why people are encouraged to prevent osteoporosis

by exercising and by being physically active. All

resurfacing procedures allow this necessary flexion of the

proximal femur.(BHR completely eliminates stress shielding

of the proximal femur and beyond.)

d. Thrombo-embolism, a potentially fatal complication of

THR because of the pressure exerted in the femoral canal

during insertion of a typical large stemmedTHR.

(BHR employs a much smaller stem, which doesn't enter the

femoral canal, avoiding thrombo-embolism)

e. Leg Lengthening

(BHR has shown superior results in this area.)

f. Prosthesis Wear: Most THRs have a problem with the

polyethylene liner that will wear out, requiring revision.

(BHR has no polyethylene components, and is it likely to

never wear out during a lifetime of use.)

g. Cost -BHR costs less than $15,000, which includes the

BHR surgery device, surgeon, surgery room,

anesthesiologist, up to 30 days in private hospital, in

hospital prescriptions, 14 days at a rehabilitation

facility, if needed. If the rehab facility isn't needed,

then the cost will be less than $13,000. (exchange rate

today.) Airfare is less than $700. (I'm willing to forego

and not request re-imbursement for airfare.)

Dr. Tal*** discourages the use of a bipolar device.

-Response: The only surgeon who has recommended a bipolar

device to me is Dr. Cav***, yet the WC carrier encourages me

to have Dr. Cav*** as my medical provider. He referred me to

Dr. Kel** for resurfacing.

Dr. Tal*** voices concern in both his opinions that the surgery

can be done locally.

Response: The issue of having surgery done locally vs. in England

is not an issue resulting from my actions, but rather, the WC

carrier's actions. The carrier has previously denied authorization

for the local Conserve hip surgery I requested (by Dr. Kel**), but

now found appropriate by Dr. Tal***. When my acetabular cyst then

appeared, I scheduled a possible Conserve PLUS © surgery with Dr.

Mont, but again the carrier declined to authorize the Conserve PLUS ©

hip when it was available. So finally, now, I turn to the Birmingham

Hip, because it is now the best, most appropriate of all options, is

certainly available, but in England. Perhaps the carrier is

concerned about the cost of travel. I'm willing to absorb that cost.

It is a small price to pay for the best prosthesis available, one

projected to last a lifetime. Perhaps the carrier is concerned about

runaway costs. The price is fixed and includes up to 30 days in the

hospital, an unheard-of arrangement in the US.

In closing I would like to note that Dr. Tal***'s June 8, 2001

opinion states, " ...it is still my opinion that a procedure such as

that recommended by Dr. Kin*** would be appropriate and locally

available. It is still my opinion that the most appropriate

procedure would be a replacement of both sides of the joint-

acetabular and femoral head-because of the pain relief available with

that type of procedure. "

Response: Birmingham Hip Resurfacing addresses these concerns!

It resurfaces the femoral head as Dr. Kin*** would do (before the

acetabular cyst) and it also replaces the acetabular component. I do

not understand why Dr. Tal*** would object to the solution that

addresses these issues, as raised by all of these doctors: Dr.

Kin***, Dr. Kel***, Dr. Mont, Dr. Amstutz and Dr. Treacy, and by Dr.

Tal*** himself.

Sincerely,

***Webster***

Ps. If the final decision from the carrier is received as a denial,

please request a hearing from an administrative law judge or the

Workers Compensation director for an impartial hearing to determine

whether there has been " unreasonable denial of pre-authorization "

that " may subject the payer to penalties under section 8-43-304

*.R.S. " as is stated in

Rule XVI, I.3.

I believe there has been one unreasonable denial already of

Dr. Kel***'s surgery, since Dr. Tal*** believes a Conserve hip

is " appropriate. " A denial of Dr. Treacy's surgery may constitute

another unreasonable denial.

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