To Whom it May Concern,

Re:  Appeal # xxxxx

I want to bring to your
attention an inconsistency in the TRICARE policies regarding total hip
resurfacing and FDA-approved devices.  Over the last 6-months I have been
evaluated and clinically qualified as meeting all the criteria and
indications for a Birmingham Hip Resurfacing procedure and I have obtained
the clinical recommendations of (1) two Active Duty Military Treatment
Facility (MTF) Orthopedic Surgeons, (2) a TRICARE Network Orthopedic
Surgeon, and (3) a nationally recognized Orthopedic Surgeon, all supporting
this procedure and this FDA-approved device for the treatment of my
condition.  Unfortunately, the current TRICARE policy does not support this
procedure as being a “proven” treatment and I need your help to change this
for me and all TRICARE beneficiaries who would benefit from the Birmingham
Hip Resurfacing system and all other FDA-approved surgically implanted
devices associated with hip resurfacing arthroplasty.

In accordance with 32 CFR
199.10, I am requesting a formal policy modification and “hierarchy of
evidence” review of “refereed medical and scientific reliable evidence”
contained and referenced herein, supporting:

[1] The revision of TRICARE
Policy Manual (TPM) Chapter 4, Section 6.1, Paragraph 5.0 EXCLUSIONS,
subparagraph 5.15, TO MODIFY OR REMOVE:

“Total hip resurfacing (HCPCS
code S2118) for treatment of degenerative hip disease is unproven”,
change to read: “Total hip resurfacing with non-FDA approved
devices for treatment of degenerative hip disease is unproven.” and;

[2] Surgical procedure S2118
[Metal-on-metal hip resurfacing, including acetabular and femoral
components] be designated in all references as “PROVEN” only for all
FDA-approved devices/procedures and removed from the “No Government Pay
List” according to the published reliable evidence date as described in 32 CFR 199.2., further;

[3] Health Net denial of Appeal
# 84513 dated 26 March 2015 (Exhibit 1) be overturned and approved.

RATIONALE:

TPM Chapter 4, Section 6.1
Musculoskeletal System, Authority 32 CFR 199.4 (c)(2) and (c)(3), 4.0
POLICY, subparagraph 4.1, states:

“Services and supplies required
in the diagnosis and treatment of illness or injury involving the
musculoskeletal system are covered. U.S. Food and Drug Administration
(FDA) approved surgically implanted devices are also covered.”

On 9 May 2006, the FDA approved
the Birmingham Hip Resurfacing (BHR) System.  (Exhibit 2)  Further,
the FDA BHR approval states:

” . . . The sale, distribution,
and use of this device are restricted to prescription use in accordance with
21 CFR 801.109 within the meaning of section 520(e) of the Federal Food,
Drug, and Cosmetic Act (the act) under the authority of section
515(d)(1)(B)(ii) of the act. FDA has also determined that, to ensure the
safe and effective use of the device, the device is further restricted
within the meaning of section 520(e) under the authority of section
515(d)(1)(B)(ii), (1) insofar as the labeling specify the requirements
that apply to the training of practitioners who may use the device as
approved in this order and (2) insofar as the sale, distribution, and
use must not violate sections 502(q) and (r) of the act . . .”

 The FDA approval stipulates the
prescription and safe and effective use [PROCEDURE] of the device and limits
the use of the device to practitioners who have received specific device
training.  Therefore, the FDA approval of any device satisfies and is
consistent with, TPM Chapter 4, Section 6.1 Musculoskeletal System,
Authority 32 CFR 199.4 (c)(2) and (c)(3), 4.0 POLICY, subparagraph 4.1,
“Services and supplies required in the diagnosis and treatment of illness or
injury involving the musculoskeletal system are covered. U.S. Food and
Drug Administration (FDA) approved surgically implanted devices are also
covered.”

Moreover, the device and
procedure are inextricably conjoined by law under the FDA approval and
published restrictions for use.  The device cannot be used nor prescribed by
practitioners who lack the training on the use [PROCEDURE].  Accordingly,
the TPM Chapter 4, Section 6.1, Paragraph 5.0 EXCLUSIONS, subparagraph 5.15
“Total hip resurfacing (HCPCS code S2118) for treatment of degenerative
hip disease is unproven” is in conflict with the clause, “FDA
approved surgically implanted devices are also covered”.  Designation of
ALL total hip resurfacing procedures as unproven whether they involve an FDA
approved device or not contradicts TPM policy.  If this exclusion should
remain in the TPM, at a minimum it should be clarified to include a
reference to non-FDA approved devices. e.g. “Total hip resurfacing with
non-FDA approved devices for treatment of degenerative hip disease is
unproven.”  This change would also be consistent with the rest of the
leading commercial healthcare policies, several of which will be offered as
Exhibits later in this appeal.

The clinical research required
for FDA certification and approval is significant and clearly supports the
“hierarchy of evidence” review of “refereed medical and scientific reliable
evidence” as having been conducted continuously and throughout the FDA
approval process.  The Summary of Safety and Effectiveness Data is at (Exhibit
2b) and states:
“. . . the use of this device
for the labeled indications has been shown to be reasonably safe and
effective . . .”

I have not included all the
studies I have discovered supporting the FDA approvals for all resurfacing
devices, as the printed pages would be in the thousands.  However, a
reasonable person reviewing the preponderance of the clinical evidence
should conclude that total hip resurfacing (with FDA approved devices) is
proven and is an acceptable alternative and treatment for degenerative hip
disease.  Attached is the FDA Executive Summary Memorandum on Metal-on-Metal
Hip Implant Systems, dated 27 June 2012 (Exhibit 3) and Appendix J,
Supporting Documents for FDA Literature Review for both total hip
replacement and hip resurfacing (Exhibit 4).  I don’t expect that you
will read the hundreds of cited studies contained in these exhibits, and
they are included by reference herein, but I do expect you to conclude that
with FDA approval of a device included therein by default is exhaustive
clinical research on the procedure as well.  That certainly is the case with
hip resurfacing and I include the last three exhibits as evidence of a
conclusive review of both metal-on-metal total hip replacement and
resurfacing.  The bottom line is that metal-on-metal hip resurfacing is
“proven” and comparable to total hip replacement approved by device by the
FDA.

TPM Policy Manual Chapter 1,
Section 1.2 EXCLUSIONS, Authority: 32 CFR 199.4(g), paragraph 8.0, states:

” . . . The contractor(s) shall
routinely review the hierarchy of reliable evidence as defined in 32 CFR
199.2 and bring to TRICARE Management Activity (TMA) attention drugs,
devices, medical treatments, or procedures that they believe have moved from
unproven to proven . . .”

I offer as reliable evidence
the medical policies of the three TRICARE Managed Care Support Contractors
who administer and provide beneficiary services under TRICARE.  While in
their commercial practices they routinely review the hierarchy of reliable
evidence, it is not clear that this research and evidence has been brought
to the attention of TRICARE. All three TRICARE contractors consider the use
of FDA-approved metal-on-metal prosthesis for total hip resurfacing
arthroplasty “medically necessary” and “proven” for their private health
insurance beneficiary coverage. The scientific rationale compiled and
referenced in each respective private health insurance medical policies
listed below are based on well controlled studies of clinically meaningful
endpoints, published in refereed medical literature and are hereby included
and referenced in their entirety as Exhibits of this appeal:

[1] United Healthcare Medical
Policy, HIP RESURFACING ARTHROPLASTY, Policy Number: 2011T0503G, Dated 1
December 2011, (Exhibit 5):

ALE” . . . Hip resurfacing
arthroplasty (HRA) with U.S. Food and Drug Administration (FDA)

approved devices is proven
for the treatment of hip disease in patients who are younger

than age 65 and who meet the
following criteria . . .”

[2] Health Net National Medical
Policy on Hip Resurfacing, Policy Number: NMP280 Effective Date*: July 2006,
Updated: March 2015. (Exhibit 6): 

” . . . Health Net considers
the use of FDA approved metal-on-metal prosthesis for total hip
resurfacing arthroplasty (HRA) medically necessary in patients who meet . .
.”

[3] HUMANA Medical Coverage
Policy, Policy Number: CLPD-0389-005, Revised Date: 26 Jan 2012, (Exhibit
7):

” . . . Humana members MAY be eligible under the Plan for a partial or total
hip resurfacing arthroplasty using an FDA-approved device for the following
indications . . .”

I offer as additional evidence
further industry review of surgical procedure S2118 [Metal-on-metal hip
resurfacing, including acetabular and femoral components].  There is
overwhelming evidence that the use of an FDA-approved device/procedure
should not be designated as “Unproven” and should be removed from the “No
Government Pay List” according to the published reliable evidence date as
described in 32 CFR 199.2..  The following policies and studies are provided
for your review and consideration:

[1] Blue Cross Federal under
Anthem Medical Policy#: SURG.00051, Review Date: 14 Aug 2014, (Exhibit 8)
” . . . Total hip resurfacing arthroplasty (HRA), using an
FDA-approved/cleared prosthesis, is considered medically necessary in fit,
active individuals who . . .”

[2] AETNA Clinical Policy
Bulletin: Joint Resurfacing, # 0661, Review Date: 16 Jan 2015, (Exhibit 9)

” . . . Aetna considers metal-on-metal hip resurfacing by
means of a Food and Drug Administration (FDA)-approved device (e.g.,
Birmingham Hip Resurfacing (BHR) System, Cormet 2000) a medically necessary
alternative to total hip arthroplasty for physically active non-elderly
(less than 65 years of age) adult members when the following criteria are
met . . .”

[3] Mortality Rates at 10 Years
After Metal-on-Metal Hip Resurfacing Compared with Total Hip Replacement in
England, Medscape.com British Medical Journal 2013 BMJ Publishing Group,
(Exhibit 10)

” . . . Patients with hip osteoarthritis undergoing
metal-on-metal hip resurfacing have reduced mortality in the long term
compared with those undergoing cemented or uncemented total hip replacement
. . .”

[4] The Outcomes of Hip
Resurfacing Compared to Standard Primary Total Hip Arthroplasty in Men, BMC
Musculoskelet Disord. 2013;14(161)   2013 BioMed Central, Ltd., (Exhibit 11)

” . . . When patients meet the
appropriate selection criteria in the hands of experienced and high-volume
arthroplasty surgeons, hip resurfacing provides excellent results at short-
to mid-term follow-up . . . Results of our study are in agreement with
previous reports showing comparable clinical results of hip resurfacing
to standard total hip arthroplasty . . .”

Finally, I have become aware
that TRICARE has within the last 2-years approved the BHR procedure for
beneficiaries around the country.  This inconsistency is due to the TPM
policy that contradicts itself.  FDA approved devices are covered for
surgical implantation, but not for hip resurfacing procedure?  Moreover,
there currently are Active Duty surgeons trained on the BHR and performing
the associated procedure for surgical implantation of the FDA-approved BHR
device on TRICARE beneficiaries at military treatment facilities.  These
doctors are legally within the scope and license to practice by having the
necessary credentialing and requisite training on the BHR device.  This fact
by itself ratifies the BHR procedure as being “proven” as no Institutional
Review Board (IRB) requirements for “unproven” or “experimental” procedures
under “Protection of Human Subjects” are necessary for the use of an
FDA-approved device by an appropriately credentialed and trained
provider within the bounds of their clinical practice.

Thank you for giving me the
opportunity to appeal and correct this inconsistency for all TRICARE
beneficiaries.  For your convenience, I have included all the documents on a
USB drive – you may throw it away if you can’t use it.  I only hope this will
help you do your job to complete your paperwork to change the TRICARE
policy. Accordingly, please contact me if there is anything additional I
could provide that will accomplish my objective to overturn and approve the
Health Net denial of Appeal # xxxxx dated 26 March 2015 (Exhibit 1)

Very Respectfully,
 

EXHIBITS:

1. Health Net denial of Appeal
# xxxx dated 26 March 2015 (Exhibit 1)

2. FDA approval of Birmingham
Hip Resurfacing (BHR) System. 9 May 2006 (Exhibit 2)

3. FDA Summary of Effectiveness
Findings BHR PMS: Po4oo33, 9 May 2006 (Exhibit 2b)

4. FDA Executive Summary
Memorandum on Metal-on-Metal Hip Implant Systems, dated 27 June 2012
(Exhibit 3)

5. Appendix J, Supporting
Documents for FDA Literature Review for both total hip replacement and hip
resurfacing (Exhibit 4)

6. United Healthcare Medical
Policy, HIP RESURFACING ARTHROPLASTY, Policy Number: 2011T0503G, Dated 1
December 2011, (Exhibit 5)

7. Health Net National Medical
Policy on Hip Resurfacing, Policy Number: NMP280 Effective Date*: July 2006,
Updated: March 2015. (Exhibit 6)

8. HUMANA Medical Coverage
Policy, Policy Number: CLPD-0389-005, Revised Date: 26 Jan 2012, (Exhibit 7)

9. Blue Cross Federal under
Anthem Medical Policy#: SURG.00051, Review Date: 14 Aug 2014, (Exhibit 8)

10. AETNA Clinical Policy
Bulletin: Joint Resurfacing, # 0661, Review Date: 16 Jan 2015, (Exhibit 9)

11.  Mortality Rates at 10
Years After Metal-on-Metal Hip Resurfacing Compared with Total Hip
Replacement in England, Medscape.com British Medical Journal 2013 BMJ
Publishing Group, (Exhibit 10)

The Outcomes of Hip
Resurfacing Compared to Standard Primary Total Hip Arthroplasty in Men, BMC
Musculoskelet Disord. 2013;14(161)   2013 BioMed Central, Ltd.