January 17, 2006
Harvard Pilgrim Health Care
1600 Crown Colony Drive
Quincy MA 02169-9777

Re: Appeal of denied coverage, HP0412161-00

Dear HPHC Representative:

I am requesting for voluntary member reconsideration.
Following is an explanation of my medical condition and
history. In a letter dated December 23, 2005, HPHP denied my
requested authorization for a total hip resurfacing.

My Condition and History

I have DX with degenerative arthritis of the left hip, which
restricted my normal activities. I could no longer walk
fast, getting in and out of my car was more difficult and
climbing stairs and performing my job was becoming awkward.
I’m a single parent with full physical custody of my three
children. Caring for my three children, working full time
and performing routine household chores is becoming
increasingly difficult. I had been unable to participate in
many of the sporting activities I used to enjoy such as
martial arts 3 times a week and ice hockey two times a week.
I was an assistant coach for both my son’s hockey teams and
can no longer run practices. The pain, of course, has
increased, and I am taking prescription pain killers and
anti-inflammatory meds daily.(Naeurontin 1200 mg/day,
Naproxen 1000 mg/day)

Other than that, I am in excellent shape at age 39, 5’10 and
190#. I’ve generally been blessed with excellent health and
have had no major illnesses. My bone density is good. My
only significant problem was deterioration of the cartilage
in my left hip (x-rays reveal the right hip has no
significant deterioration). Now because of my condition I
have gained 25 pounds and I’m starting to feel pain in my
right knee and right hip from over compensating for my left
hip.

Surgical Options

I am aware that the most common treatment for this condition
is a total hip replacement (THR). That strikes me as an
extremely radical procedure for a problem of deteriorated
cartilage – analogous to using a sledge hammer to drive in a
finishing nail. I was also very concerned that a THR would
substantially limit my participation in various activities
that are a vital part of my life.

My extensive research determined that hip resurfacing is an
option that is widely thought to be preferable to THR for
persons of my age, lifestyle and expected longevity.
5-8,10,11In June of 2005, I sought further review and advice
from Dr. Thomas Gross, a noted expert in hip surgery and
replacement. He discussed the pros and cons of the options
available and indicated that I’m exactly the type of person
who would benefit greatly from resurfacing.

Basis for My Decision

For young, active people, hip resurfacing offers the
following advantages: 5-8,10,11

· The femoral head is largely preserved and is only shaped.

· Femoral canal is preserved. THR substantially invades the
femoral canal.
· The femoral canal is not exposed—which means far less fat
and marrow is released into the bloodstream, thus reducing
the likelihood of deep vein thrombosis.
· Femoral bone loss is totally avoided.
· The risk of microfracture of the femur is eliminated.
· The larger size of implant “ball” reduces the risk of
dislocation significantly.
· Stress is transferred in a natural way along the femoral
canal and through the head and neck of the femur. With the
standard THR, some patients experience thigh pain as the
bone has to respond and reform to less natural stress
loading.
· Use of metal rather than plastic reduces osteolysis and
associated early loosening risk.
· Use of metal has low wear rate with expected long implant
lifetime.
· There are significantly fewer wear particles—which reduces
the risk of periprosthetic osteolysis and attendant aseptic
loosening of the device.
· Corrin Clinical trails 98% survivorship over 1-5 yrs. 13
· Royal Orthopaedic Hospital Birmingham England Research by
Dr. Paul Pynsent PhD. 1,324 Hybrid Resurfacing March 94-
September 2000 98.8% survivalship. 10
· Acitvities in 206 resurfacing patients surveyed 10

Running
Fishing
Hill walking
Dry skiing
Archery
Hunting
Clay pigeon shooting
Weight training
Yoga
Motorcycling
Tennis
Real tennis
Squash
Circle dancing
Tread mill
Football
Power walking
Horse riding
Gym
Skiing
Skittles
Circuit training
Golf
Rowing
Motor racing
Table tennis
Water Skiing
Greek dancing
Surfing
Jogging
Snooker
Flat green bowling
Sailing
Chi Kung
Cycling
Basket ball
Rock climbing
Mountain biking
Paragliding
Fencing
Rugby
Hockey
Walking
Badminton
Diving
Cricket
Aerobics
Fell walking
Swimming
· Dr Pynsent 5 year Published study of resurfacing devices
with a 99.7% survivorship. 11
· Dr Back 3 year Published study of resurfacing devices with
a 99.14% survivorship. 12
· Dr. Treacy 5 year Published study of resurfacing devices
with a 99% survivorship. A

Conversely, THR, the surgery that Harvard Pilgrim would
readily accept:

· Unnecessarily and inexcusable removes about 4 inches and 6
to 8 ounces of perfectly healthy bone,
· Substantially invades the femoral canal, which among other
things increases the risk of deep vein thrombosis,
· Introduces an additional 8+ inches of metal into my body
extending 6” or more into the femur, and
· Presents risks of its own including the risk of
micro-fracture of the femur.

Also, and of considerable importance, a person my age is
faced with the possibility that he or she will outlive a THR.
5-8,10,11Actuarial tables put my median life expectancy at
44 more years, with a 25% chance of surviving 50.4 years. A
resurfacing can be revised to a THR.5-8,10,11 A revision to
a prior THR is difficult with uncertain results.

Finally, I have considerable confidence in Dr. Gross. As you
must surely know, he has performed many THR’s and over 700
resurfacings. Indeed, he only recommends hip resurfacing to
those patients (fewer than 20% of his patients) who he
believes are particularly well suited for and could vastly
benefit from resurfacing. He has advised me that I am one of
those patients.

Why Dr. Gross in South Carolina? Hip resurfacing is not done
in the Boston area. My only other options are to go out of
country (UK, Belgium, Canada, or India).

Putting Together Approved Components

Total hip resurfacing is not a radical departure from
established procedures. Indeed, the major parts are all
approved by the FDA and otherwise covered by Harvard
Pilgrim:

· The exact metal on metal that I’m requesting is approved
by the FDA and covered by Harvard Pilgrim for THR.
· The exact acetabular shell I’m requesting to use has been
approved by the FDA and is covered by Harvard Pilgrim for
THR.
· The femoral head shell is approved for partial hip
resurfacing
· Biomet Orthopedics, Inc. is well established, highly
regarded manufacturer whose products are approved and
covered for THR.

We are not breaking new ground here, and this is not a
significant departure from accepted practice. All we are
doing is putting together approved parts and procedures in a
manner that is far more beneficial than a radical THR for
some patients.

The FDA does not classify this as an experimental device or
procedure. The Biomet Recap Press-fit Head Resurfacing
Devise is a Class II device. The Biomet Magnum acetabular
component is a Class III devise. The Recap and Magnum are
501(K) FDA approved and covered by many plans. 3,4 Medicare
has recognized the inherent benefits and provides coverage
for this procedure. Many insurance companies also recognize
the benefits and provide full or part coverage:

· Aetna 9
· CIGNA
· United Healthcare
· Humana
· Kaiser
· HealthNet
· Tricare
· Various HMO plans around the country.

Indeed, some Blue Cross units including BC/BS of CA have
covered resurfacing including:

· Blue Cross/Blue Shield of Missouri
· BlueCross/BlueShield of Michigan

In terms of cost, this procedure is no more expensive than
total hip replacement.

Timing

My condition, as you well know, did worsen with time. As the
arthritis progresses, the quantity of bone available for
fixation will diminish. A delay due to lack of insurance
coverage will irretrievably damage me. In addition, further
delays will dramatically impact my life. For example:

· Delay would further reduce my physical activities, which I
believe have been a vitally important factor in my otherwise
good health.
· Delay would make it more difficult to perform the daily
tasks necessary to care for my three children ages
10,12,&14.
· Delay could soon limit my driving. Some day it may be
impossible to drive because the OA affected my left hip and
leg. (standard shift)
· Delay is making it increasingly difficult to continue to
work full time due to intense pain from prolonged sitting,
standing & walking all of which are necessary in my job as a
mechanical engineer in an Air Force Super lab.
· Delay increases the likelihood of a dangerous fall. My leg
gives out many times a day.
· I was concerned that the awkward gait from severe limping
would increase the likelihood of downstream damage to my leg
and other joints.
· Delay would necessitate the continued use of pain relief
medications, any of which poses risks for long-term use.
· Bone will deteriorate from the bone-on-bone contact.

My Appeal

I respectfully request an independent medical review. I also
request that you consider the information that I’ve provided
above, my personal situation, the fact that my primary care
provider had already pre-authorized the surgery and the fact
that so many plans recognize resurfacing as accepted
practice. It is a logical, reasonable and, in cases like
mine, preferable approach that does nothing more than
combine materials and techniques that are approved by the
FDA and widely accepted in the medical community.

Finally, note that I would be satisfied with any of the
following settlements with BSC:

· coverage of the requested hip resurfacing using the Biomet
Recap and Magnum
· Harvard Pilgrim’s coverage of costs limited to costs that
would be approved for a THR.

It seems to me that this is a quite reasonable position that
gives Harvard Pilgrim some options. I hope you will respond
favorably to my initiative.

Sincerely,

John Williamson

Reference:
3) FDA 510(K)#K023188 Recap December 11, 2002

4) FDA 510(K)#K042037 Magnum October 1, 2004

5) Nation Institute of Clinical Excellence (NICE)
NICE recommends the selective use of metal to metal hip
resurfacing 2002/34/44
19 June 2002

6) John E.P Metcalf, Jess Cawley, and Tim J Band, Cobalt
Chromium Molybdenum Metal –on- metal
Resurfacing Orthopaedic Hip Devices , Medical Device
Manufacturing & Technology 2004

7) K.A. DeSmet, C Pattyn, R.Verdonk, Early results of
primary Birmingham hip resurfacing
using hybrid metal on metal couple. Hip International / vol
12 no. 2, 2002/pp 158-162.

8) Canadian Coordinating Office for Health Technology
Assessment (CCOHTA)
Issue 65 March 2005

9) Aetan Clinical Policy Bulletin Number 0661 December 23,
2005 Hip Resurfacing.

10) Royal Orthopaedic Hospital Birmingham England Research
by Dr. Paul Pynsent PhD.
1,324 Hybrid Resurfacing March 94- September 2000 ,

11) Metal-on-Metal Resurfacing of the Hip in Patients Under
the Age of 55″
J. Danial, P. B. Pynsent, and D. J. W. McMinn, The Journal
of Bone and Joint
Surgery, volume 86-B, pp. 177 – 184, March, 2004

10&RESULTFORMAT=&author1=Pynsent&andorexactfulltext=
and&searchid=1137513467664_1317&FIRSTINDEX=0&sortspec=
relevance&resourcetype=1&journalcode=jbjsbr

12) Early Results of Primary Birmingham Hip Resurfacings: An
Independent
Prospective Study of the First 230 Hips”
D. L. Back, R. Dalziel, D. Young, and A. Shimmin, The
Journal of Bone and
Joint Surgery, volume 87-B, pp. 324 – 329, March, 2005

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and&searchid=1137513467664_1317&FIRSTINDEX=0&sortspec=
relevance&resourcetype=1&journalcode=jbjsbr
13) Corin 5 year trial data 98% https://surfacehippy.info

Other studies

A) R. B. C. Treacy, C. W. McBryde, and P. B. Pynsent
Birmingham hip resurfacing arthroplasty: A MINIMUM FOLLOW-UP
OF FIVE YEARS
J Bone Joint Surg Br, Feb 2005; 87-B: 167 – 170.

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1736&FIRSTINDEX=0&sortspec=
relevance&resourcetype=1&journalcode=jbjsbr