Smith & Nephew BHR Brimingham Hip Resurfacing

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Pat Walter

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TRICARE Appeal Letter
« on: July 14, 2015, 08:58:39 PM »
An interested person submitted this letter to help people with their appeals to TRICARE:

http://www.surfacehippy.info/appeal-letter-tricare-2015.php



 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.. 
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

rickrefs

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Re: TRICARE Appeal Letter
« Reply #1 on: March 25, 2016, 08:15:43 PM »


Please view the following link: http://manuals.tricare.osd.mil/pages/DisplayManualFile.aspx?Manual=TP08&Change=160&Type=AsOf&Filename=C4S6_1.PDF 


Finally, got it done.  TRICARE APPROVED:





  • 4.10  [/color]Hip resurfacing (CPT[/size][/color]2 [/size][/color]procedure codes 27125 and 27130, and HCPCS S2118) with an FDA[/size]
[/color]approved device is proven for the treatment of Degenerative Joint Disease (DJD) of the hip in patients who are less than 65 years old and who meet all of the following criteria:[/size]
  • [/color]Have chronic, persistent pain and/or disability;[/size][/color]Are otherwise healthy and active;[/size][/color]Have normal proximal femoral bone geometry and bone quality; and[/size][/color]Would otherwise receive a conventional Total Hip Replacement (THR), but are likely to outlive a conventional THR implant systemís expected life.
    VR

    Rick
    [/size]
[/color]
« Last Edit: May 16, 2016, 08:41:00 PM by rickrefs »

Hip Talk About Hip Resurfacing

Re: TRICARE Appeal Letter
« Reply #1 on: March 25, 2016, 08:15:43 PM »

 

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