IpubMD - Appeal Review
Title: Sample Appeal
Subject: Sample Cyberknife Appeal
Author: Mr. Monteagudo Al
Body:

 

(Patient Name)

CyberKnife Treatment for Prostate Cancer

 

 

 

 

 

APPEAL

 

 

 

 

Prepared by (name of preparer)


 March 17, 2011

 Erin Hoeflinger

 President & CEO

 Anthem BCBS Ohio

 Mason, Ohio 45040

 Dear Ms. Hoeflingler:

 I am writing to you about the continuous denial of Stereotactic Body Radiation Therapy (SBRT) CyberKnife treatment for my prostate cancer. I was diagnosed with prostate cancer in 2008. Thankfully, it was caught in the early stages and very treatable. After discussing the treatment options with my doctor, he chose to have Stereotactic Body Radiation Therapy (SBRT) at the CyberKnife treatment center in Lexington, Kentucky.

 As you may know, this particular treatment is non-invasive and it only requires a 4 or 5- course fraction of radiation treatment. All of the other treatment options for prostate cancer carry many more potential risks, potential for greater side effects, longer treatment and recovery time and coincidentally cost more to the insurance company.

 I have followed all of Anthems appeal protocols, however it is clear that everyone involved in the appeal process thus far is not interested in looking at the objective facts that we are presenting to them or that can be found by researching the scientific data that is available. They are simply relying on their interpretation of the outdated Anthem policy and citing CyberKnife (SBRT) treatment as experimental/investigative.

 I implore you to read through the information that is presented in prior appeals as well as the new information that is included in this packet. In the matter of a couple of weeks, I have been able to obtain 30 cases of precedent to show that this is NOT an experimental or investigative treatment. Anthem, as well as other insurance companies, have covered CyberKnife/SBRT treatment for these particular cases of precedent. Please refer to the complete list of precedent cases included in this packet.

 This continued denial is extremely unreasonable, unconscionable and simply not based on the science and data that has been presented to Anthem. Instead, Anthem is relying on outdated information contained in their policy, which actually conflicts with your own Anthem Federal health care policy. Anthem Federal covers this treatment. Please refer to the letter I have obtained that is written by a customer care specialist from Anthems Federal program allowing CyberKnife (SBRT) treatment for prostate cancer.

 This letter is dated May 20, 2008, it states, CyberKnife radiotherapy is appropriate for the treatment of prostate cancer and is supported by peer review journals. This letter further states, CyberKnife is consistent with current good medical practice and is not primarily for the comfort of the patient, the family, or the provider. We have submitted this letter in every appeal. How can this be ignored? It is a major contradiction.

 Prostate cancer is becoming increasingly common (the #2 form of cancer in men) and Anthem is driving up the cost of health care by refusing to cover a more cost effective option that the CyberKnife (SBRT) treatment offers for men with prostate cancer. Anthem is becoming a major part of the problem with health care in our country instead of helping to be part of the solution. When Wellpoint and Anthem merged in 2004, some physicians as well as the American Medical Association, spoke out by saying that merging two insurance giants could potentially cause problems for the people that depend on them. We are certainly witnessing that warning become a reality.

 Anthem is setting a dangerous industry standard where they can dictate to their insured what treatment options to choose from by only covering certain treatment options without regard for the patients choice, health or well being. This decision should be left solely to the patient and their doctors.

 Anthems own website states, At Anthem Blue Cross and Blue Shield, we understand our health connects us to each other. What we all do impacts those around us. So Anthem is dedicated to delivering better care to our members, providing greater value to our customers and helping improve the health of our communities. What part of this statement is actually true? Anthem is not offering coverage for the most cost effective, cutting edge, acceptable treatment for prostate cancer for patients. Instead, they are sticking with a catastrophic expense of $65,000.

 Anthem further claims on their website that health and safety are a top priority. Anthem also claims that they are an accredited health plan that meets or exceeds national standards for quality care. The national standard of care indicates that most health care policies (United Health Care, Aetna, Medicare, VA policies), as proved in the cases of precedent provided, cover CyberKnife (SBRT) treatment for prostate cancer.

 The other question that presents itself is why would Anthem deny this treatment, but then cover it sometimes for people in other parts of the country? I found 10 cases of precedent where Wellpoint subsidiaries such as Anthem BCBS, Blue Cross Blue Shield have covered this treatment for their insured. It is yet another contradiction found within Anthem and one that simply cant be ignored.

 The bottom line is that Anthem is not living up to their own promises with the people that rely on them. It is unacceptable that Anthem has not covered this treatment for me, yet all the while picking and choosing which patient will be covered and which patient will not be covered. The manner in which Anthem has conducted itself in regards to this particular issue is unethical and unconscionable. We ask that you please correct this blatant injustice.

 In this document, I will prove the following facts

  • SBRT/Cyberknife treatment is not experimental/investigative, which is proven by the abundance of clinical evidence that makes this treatment statistically significant and well documented for patients with early stage prostate cancer.
  •  This treatment is not Experimental by Anthems own definition.
  •  Wellpoint subsidiaries such as Anthem, Blue Cross Blue Shield, etc have paid for this treatment many times over the last five years.
  •   All of the major insurers including Anthem Federal (FEP), Blue Cross Blue Shield, Blue Shield California, Aetna, United Health Care, Cigna, Medicare, Humana, Great West, Screen Actors Guild Health Plan - routinely pay for SBRT/Cyberknife treatment.
  •   Denial of our claim goes against Anthems own promises to their customers.
  •   CyberKnife treatment was approved by the FDA in 2001 for all tumors where radiation therapy is indicated.
  • CyberKnife treatment is an improvement in technology. It is not a new technology altogether, therefore making the claim of experimental/investigative invalid.
  • Level 1 appeal offered spurious proof.
  • Anthems Independent Medical Review violated the law.

 I am submitting new evidence in this appeal that proves SBRT has better outcomes than conventional treatment. Further conclusive results of this study will be addressed in the outcome and proof section.

  A January 2011 study, Stereotactic Body Radiotherapy for low risk prostate cancer: Five Year Outcomes by Freeman and King, published in Radiation Oncology, a well respected peer-reviewed journal, which states,

 The current analysis is the first report of 5-year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles.

 I appreciate your time and attention as you carefully review this information. I have factually disputed your denial of my SBRT/CyberKnife treatment by providing clear and objective evidence that supports coverage of this treatment. I expect that Anthem will make a fair and honest decision to reverse their denial.

 Thank you kindly for taking the time to read my letter and considering this urgent issue.

 Sincerely,

 (Patient Name)

 Anthem ID #

 Enclosures

 

 

Personal Information/(Patient Name)------------------------------------------

 

I am a prostate cancer survivor. I am now ?? years old. I have been married for ?? years. I have ? children. My youngest child is ? years old. I own a small business that performs ????? work. I am a certified ???? that has worked very hard all of my life. I volunteer in my community. Cyberknife treatment will allow me to keep my small business running even in this struggling economy. I am now facing a difficult time in my life because Anthem has denied the most effective therapy that will allow me to continue working during and after each session.

 

 

 

THE TREATMENT (SBRT)-------------------------------------------------
Stereotactic Body Radiation Therapy CyberKnife Treatment for prostate cancer


SBRT CyberKnife is unique in that it uses a compact linear accelerator (LINAC) mounted on an image-guided robotic arm to deliver multiple beams of radiation to a target. The ability of SBRT CyberKnife to shape the profile of radiation to conform to the patients individual anatomy allows for maximum sparing of surrounding normal tissues. The CyberKnife accomplishes this by accurately cross-firing approximately 150 beams of radiation at the target from multiple directions.

Gold fiducial markers are placed in the prostate under transrectal ultrasound guidance for image-guided positioning and motion tracking. A treatment planning CT scan is then completed to differentiate the prostate and other vital surrounding structures. Patient positioning and target tracking are accomplished by registering the location of the fiducials in the real time images to their location in the planning CT. The robotic portion of the Cyberknife system automatically corrects the accelerators aim to account for both translational and rotational movement of the patient or prostate during the treatment.

The CyberKnife technology represents an improvement upon the most advanced conventional radiation therapy techniques, Intensity Modulated Radiotherapy (IMRT). Similar to IMRT, the CyberKnife can produce a highly conformal dose distribution which "matches" the shape of the prostate and spares adjacent normal anatomy (bladder and rectum).

However, the CyberKnife differs from IMRT significantly in that it is much more spatially precise in delivering radiation. Because of such accuracy the CyberKnife enables a course of radiotherapy to be "hypofractionated".

 

Summary of the Treatment -----------------------------------------------------------

To summarize the above explanation - this treatment is non invasive and it only requires a 4 or 5 fraction course of radiation therapy. It offers a better quality of life with minimal or no side effects, no anesthesia and it costs less than all of the other treatments offered for prostate cancer.

Experts Opinion on the Treatment

According to a letter submitted to the NCCN (National Cancer Coalition Network) Guidelines panel on July 2, 2010 by a panel of experts including: Chen, Coleman, Collins, Freeman, Fuller, Katz, King, Ma, Masterson-Gary, Meier, Ponsky, Presty, Wong,

SBRT/Cyberknife treatment for prostate cancer is safe and clinically effective, less costly than alternative external beam therapies for our patients and healthcare system, and offers the patient a more efficient course of treatment with comparable side effects to other forms of radiotherapy. (See Attachment #4)

According to a letter submitted on May 15, 2008 by Donald Fuller, MD, Christopher King, MD, Ph.D., Iris C. Gibbs, MD, Douglas Wong, MD, Ph.D. CyberKnife Robotic Radiosurgery as Definitive Treatment for Prostate Cancer.

 

Conclusion: To avoid coverage confusion, it (CyberKnife SBRT) should be regarded as an improvement to an existing modality (radiotherapy) rather than classified as a completely new intervention. Our reasons for recommending robotic radiosurgery include the following: FDA Approval, Medicare Coverage,

Dosimetry, Hospitalization (lack of), Toxicity (lack of), Efficacy, Cost, and Benefits over other radiotherapeutic methods. (See Attachment #10)

Conclusion (cont): Considering all of the above points, it is not surprising that a substantial number of our referring physicians and prostate cancer patients are selecting CyberKnife as their treatment of choice. This has been an available treatment option to Medicare beneficiaries in both Northern and Southern California for several years. We respectfully submit that this is simply the next generation application of high precision ionizing radiation in the treatment of this disease, with a reasonable cost profile, compared with other contemporary radiation methods.

 List of the Experts-------------------------------------------------------------------- 

   Ronald Chen, MD, MPH, Assistant Professor, Radiation Oncology, University of North Carolina, Chapel Hill, NC

   Cardella Coleman, MD Associate Chief, Radiation Oncology, Sinai Hospital of Baltimore, Baltimore, MD

   Sean Collins, MD, Ph.D, Instructor, Radiation Oncology, Georgetown University Hospital, Washington, DC.

   Debra Freeman. MD, Medical Director, Naples Radiation Oncology, Naples, FL.

   Donald Fuller, MD, Radiation Oncology, Radiation Medical Group, San Diego, CA.

   Iris C Gibbs, MD, Associate Professor, Radiation Oncology, Stanford University Medical Center, Stanford, California.

   Alan Katz, MD, Radiation Oncology, Flushing Radiation Oncology, Flushing NY.

   Christopher R. King, MD, Associate Professor, Radiation Oncology, UCLA. Los Angeles, CA.

   Chang Ming Charlie Ma, Ph.D, FAAPM, Professor and Vice Chairman, Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA.

   Mary Ellen Masterson-Gary, MA, MS, Chief Medical Physicist, Cyberknife Center of Tampa Bay, Florida.

   Robert Meier, MD, Medical Director, Swedish Cancer Institute Northwest, Seattle, WA.

   Lee E. Ponsky, MD, Associate Professor, Urology, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.

   Joseph C. Presti, MD, Professor, Urology, Stanford University Medical Center, Stanford, CA.

   Douglas Wong, MD, Ph.D., MPH, Assistant Clinical Professor, Radiation Oncology, UCSF, San Francisco, CA.

The Treatment is supported by Dr. Alan Beckman---------------------------- 

   Alan Beckman, MD, Chief of Radiation Oncology, Central Baptist Hospital, Lexington, KY. My physician and CyberKnife Expert (See Attachment #5)

CyberKnife Treatment Centers------------------------------------------------------- 

 There are over 220 Cyberknife treatment centers around the world. They are located in North America, East Asia and Europe.

  • Over 100 hospitals in the United States have CyberKnife treatment centers.
  • The United States, Canada, France, Italy, Japan, China, South Korea, Taiwan, India, Turkey, Czech Republic, Poland, Germany, Greece, Spain, Netherlands, Switzerland, United Kingdom, Malaysia, Thailand and Vietnam all have CyberKnife centers.

American Cancer Society--------------------------------------------------------------- 

Prostate Cancer is the #2 form of Cancer in men 

  • The number of men treated with CyberKnife worldwide is over 100,000.
  • The number of men treated with CyberKnife for prostate cancer is over 4,000.

THE OUTCOME--------------------------------------------------------------- 

Expert Opinion on the Outcome----------------------------------------------------- 

  1. According to a letter submitted to the NCCN Guidelines panel on July 2, 2010 by a panel of experts including: Chen, Coleman, Collins, Freeman, Fuller, Katz, King, Ma, Masterson-Gary, Meier, Ponsky, Presty, Wong. (See Attachment #4)
    • Recently accepted abstracts for American Society for Radiation Oncology (ASTRO) 2010 from two of this submissions signatories (Drs. King and Katz) show 5-year actuarial disease-free survival of 96-98% with continued low rates of late toxicity (0-3% Grade 3+ urinary and 0% Grade 3+ rectal toxicity
    • Both the 2008 and 2010 AHRQ prostate cancer reports noted that available comparative data could not determine if one form of radiation therapy is superior to another form
    •   SBRT HDR* LDR EBRT

      Late toxicity (grade 3): urinary

       0-3%  2-9%  2-9%  1-2%

      Late toxicity (grade 3): rectal

       0-1%  0-1%  0-1%  1%

      Preserved sexual function

       80%, 81%, 87%  80-84% 80-84%
       46-84

      5 year biochemical disease free survival

       96%  89%  88%  85%
  2. Recently, Stanford reported a 100% disease free survival rate for early stage prostate cancer patients treated by the CyberKnife device with median follow up of 33 months, range of 6-45 months, with early side effects no worse than other prostate treatment options.
  3. Dr. Louis Schwartz, Overlook Hospital, states, The Cyberknife allows for a significantly reduced margin of radiation surrounding the prostate because of our new understanding of the unique radiation biology of prostate cancer. By using fewer but larger daily doses of radiation (called hypo-fractionation) we predict that side effects will be reduced compared with conventional external beam radiotherapy, and cure rates will potentially be higher. The accuracy of the CyberKnife allows us to give these large doses safely. (See Attachment #17)

    Why wouldnt a health insurance company want a higher cure rate for CANCER?

  4. Dr. Donald Fuller, Radiation Oncologist, states CyberKnife is the most sophisticated fully integrated target tracking system in clinical use today. It is the only system that delivers radiosurgical accuracy to continuously moving soft tissue body targets such as the prostate. (sub millimeter). (See Attachment #) (NOTE: Dr. Fuller has experience with IMRT, Cone Beam CT based IGRT, fiducial based kV X-Ray guided IGRT, ultrasound guided IGRT, permanent source prostate brachytherapy, HDR prostate brachytherapy, and Cyberknife. (See Attachment #11)

THE PROOF--------------------------------------------------------------- 

SBRT/CyberKnife Supported Documents 

 Since September 2010, more than 516 clinical and technical articles have been published in support of the clinical effectiveness of the CyberKnife system for tumors.

Peer reviewed medical literature The Evidence: 

 The recent clinical research study, Stereotactic body radiotherapy for low-risk prostate cancer: five-year outcomes by Freeman and King, was published in the nationally recognized peer-reviewed journal, Radiation Oncology in January of 2011: (See Attachment #9)

 PSA Response: PSA fell from a pre-treatment mean of 5.4 ng/mL to a mean post-treatment value of 0.34 ng/mL at last follow-up.

  ...patients tolerated treatments very well, resuming normal activities within one week of completion. Acute symptoms of dysuria, urinary urgency, frequency, nocturia and/or tenesmus typically resolved within one month of treatment completion. Late toxicities are summarized below.

  Late urinary and rectal toxicity on the RTOG scale for prostate patients after SBRT

 The current analysis is the first report of 5-year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles.

 This study is proof that the Five-year results of SBRT for localized prostate cancer demonstrate the efficacy and safety of shorter courses of high dose per fraction radiation delivered with SBRT technique

 This treatment meets and exceeds "generally accepted medical standards.

More peer reviewed medical literature-------------------------------------------- 

  • Long Term Outcomes from a Prospective Trial of Stereotactic Body Radiotherapy for Low-risk Prostate Cancer. Christopher King, PhD, MD, James D. Brooks, MD, Harcharan Gill, MD, Joseph C. Presti Jr, MD. , 1-21, (2009). Conclusion of Study: Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse free survival compares favorably with other definitive treatments. The current evidence supports consideration of SBRT among the therapeutic options for localized prostate cancer. Data was analyzed from 2003-2009.
  • Stereotactic Body Radiotherapy for Early Stage Prostate CA: PSA, Toxicity, and Erectile Function Outcomes from a Single Institution Study. Friedman J., Masterson McGary D., Spellberg D. 2009 CyberKnife Meeting, February (2009). Conclusion of Study: Hypofractional SBRT for localized prostate cancer was delivered by the Cyberknife Radiosurgery system in a minimally invasive fashion, resulting in short-term PSA response, minimal complications, and preservation of erectile function in the majority of patients.
  • Virtual HDR Prostate CyberKnife Radiosurgery: Efficacy, Toxicity and Quality of Life. Fuller D., Naitoh J., Reilly M., Lee C. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: No patient has relapsed. Median PSA level continues to drop with each successive evaluation.
  • CyberKnife Stereotactic Radiosurgery for the Treatment of Localized Prostate Cancer. Spellberg D., Freeman D., Masterson-McGary M., Friedland J. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: The CyberKnife System was capable of delivering high-dose, hypofractioned radiotherapy for prostate cancer in a minimally invasive fashion, with excellent short term PSA response and very low levels of complications.
  • Comparison of Different Treatment Schemes for Early Prostate Cancer: A Two Year Study. Katz et al. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: Thus far, PSA response and toxicity look favorable for all treatment regimens. There appears to be a difference among the different regimens in terms of efficacy at one year, with CK boost resulting in a lower mean PSA. However, CK used as a boost produces slightly greater rectal toxicity than monotherapy.
  • Stereotactic Radiotherapy for Organ confined Prostate Cancer: Early Toxicity and Quality of Life Outcomes from a Multi-Institutional Trial. Meier R., Beckman A., Kaplan I., Mohideen N., Shieh E., Henning G., Walz B., Cotrutz C., Sanda M. Proceedings of the 52nd Annual ASTRO Meeting. Conclusions: In a multi-institutional study evaluating image guided SRT in patients with organ confined prostate cancer, rates of serious acute and early-late toxicities have been modest. At one year follow up, decrements in genderual, urinary and bowel QOL appear within range of other radiotherapy modalities.
  • Quality of Life and Efficacy for Stereotactic Body Radiotherapy for Treatment of Organ Confined Prostate Cancer. Katz A.J., Santoro M. I.J. Radiation Oncology, Biology, Physics, Volume 78, Number 3, 123, Supplement (2010). Conclusions: At 42 months median follow up the absence of any biochemical failures, the minimal toxicity and the promising potency preservation rates are highly encouraging.
  • CyberKnife in the Treatment of Prostate Cancer: A Revolutionary System. Giuseppe M., De Renzis C. Eur Urol (2009), doi: 10.1016/j.eururo.2009.02.020. Conclusion: There are 94 Cyberknife platforms in the United States and 10 in Europe. The future of this frameless robotic radiosurgery may, indeed, be to use it not only as monotherapy but also in conjunction with other boosters after radiotherapy.
  • Stereotactic Body Radiotherapy: An Emerging Treatment Approach for Localized Prostate Cancer. Friedland J., Freeman D., Masterson-McGary M., Spellberg D. Technology in Cancer Research and Treatment, ISSN 1533-0346, Volume 8, Number 5, 387-391, October (2009). Conclusions: SBRT is an emerging treatment approach for early stage prostate cancer, made possible by technological advancements in radiation treatment delivery systems. Reported toxicity results, erectile function preservation and early PSA response are encouraging.
  • Stereotactic Body Radiotherapy for Organ Confined Prostate Cancer. Katz A., Santoro M., Ashley R., Diblasio F., Witten M. BMC Urology 2010, 10:1. http://www.biomedcentral.com/147-2490/10/1. Conclusions: Our results show that SBRT of early stage prostate cancer with rectal administration of amifostine can be performed with low acute toxicity. At a median of 30 month follow up for the 35 Gy dose level, the long term urinary and rectal toxicity are both low. EPIC QOL questionnaires also suggest that urinary, rectal and sexual QOL following SBRT may be comparable, if not better that that for EBRT, BT, and RP. Furthermore, at our facility SBRT is less costly (by roughly 15,000 US) than IMRT while being much less inconvenient for the patient than a 45 day course of IMRT.
  • CyberKnife Radiotherapy for Localized Prostate Cancer: Rationale and Technical Feasibility. King C., Lehmann J., Adler J., Hai J. Technology in Cancer Research and Treatment, ISSN 1533-0346, Volume 2, Number 1, 25-29, February (2003).
  • CyberKnife Radiosurgery for Early Carcinoma of the Prostate: A One Year Experience at Winthrop University Hospital. Katz et al. Presentation Abstracts, January (2008). Conclusions: CyberKnife as been shown to be very well tolerated. Initial PSA results are very encouraging
  • Virtual HDR Prostate CyberKnife Radiosurgery: Technical Evolution and Clinical Results One Year Following Introduction. Fuller D., Lee C., Hardy S., Haoran J. Presentation Abstracts, January (2008). Conclusions: We conclude that CK robotic radiosurgery is a noninvasive method to deliver radiation dose distributions that very closely resemble those delivered by using HDR brachytherapy.
  • CyberKnife Monotherapy as the Treatment of Early Prostate Cancer: The Naples Experience. Friedland J., Spellberg D., Masterson-McGary M., Pacheco A., Freeman D. Presentation Abstracts, January (2008). Conclusions: CyberKnife monotherapy is an exciting new treatment option for patients with low risk and low intermediate risk prostate cancer. Ongoing data collection is being performed for late toxicity assessment.
  • Stereotactic Radiotherapy for Localized Prostate Cancer: Early Results of a Phase II Clinical Trial with the CyberKnife. King C., Pawlicki T., Harcharan G., Brooks J., Prest Jr. J. Presentation Abstracts January (2008). Conclusions: Within the limitations of this ongoing prospective trial, we have demonstrated the safety and efficacy of hypofractional stereotactic radiotherapy as monotherapy for low risk prostate cancer. The acceptable early and late toxicity profile and PSA response are highly encouraging.
  • Red Journal Report Highlights CyberKnife Systems Flexibility in Treating Prostate Cancer. Focus on Radiosurgery. April (2008). Conclusions: Our study concluded that CyberKnife radiosurgery can offer the benefits of HDR brachytherapy non-invasively on an outpatient basis that is both easy to deliver and comfortable for patients.
  • Prostate Cancer: Rationale for Hypofractionated Radiation. Hannoun-Levi M. Focus on Radiosurgery, April (2008) Conclusions: Delivering a high dose to a small volume with a hypofractionated regimen, while minimizing dose to neighboring critical structures (essentially the anterior aspect of the rectum) is a therapeutic regimen that seems well suited to the particular biology of prostate cancer cells.
  • Intrafractional Motion of the Prostate During Hypofractionated Radiotherapy. Xie Y., Diajaputra D., King C., Hossain S., Lijun M., Xing L. Int. J. Radiation Oncology Biology Physics. Volume 72 No. 1. pp 236-246. (2008). Conclusions: With proper monitoring and intervention during treatment, the prostate shifts observed among patients can be kept within the tracking range of the CyberKnife.
  • First Five-Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. Debra E. Freeman, Christopher R. King. Radiation Oncology, January 2011. Conclusion of Study: The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach.

    Expert Opinion on the Proof----------------------------------------------------------- 

     According to a letter submitted to the NCCN Guidelines panel on July 2, 2010 by a panel of experts including: Chen, Coleman, Collins, Freeman, Fuller, Katz, King, Ma, Masterson-Gary, Meier, Ponsky, Presty, Wong. (See Attachment #4)

    • Most of the literature that has been published on SBRT with image guidance and motion tracking/compensation for prostate cancer has appeared within the last 2-3 years. Based on these clinical publications:
      1. Large commercial payers (e.g. Aetna, Blue Shield of California, United Health Care) and government payers including the Veterans Administration and the majority of regional Medicare contractors cover SBRT for localized prostate cancer treatment.
      2. Four out of the last four Medicare contractors to review data for SBRT finalized policies allowing access to SBRT for the treatment for prostate cancer

    Anthems Policy Definitions------------------------------------------------------------ 

    • Anthems definition of Radiosurgery - A form of radiation therapy, which involves various technologies, to create highly focused beams of radiation to increase the accuracy of treatment. This definition clarifies that radiosurgery is not surgery, but a form of radiation therapy; and should be classified as such, by Anthems own definition.
    • Anthems definition of Stereotactic - Stereotactic: Refers to the precise positioning of tumors and other lesions in three-dimensional space which allows for increased accuracy of treatment; for example, radiation therapy can be done stereotactically, as a number of precisely aimed beams of ionizing radiation are aimed from several directions to converge on a tumor.
    • Anthems definition of SBRT - A type of external radiation therapy that uses special equipment to position an individual and precisely deliver radiation to tumors in the body (except the brain). This clarifies that SBRT is a form of radiation therapy and should not be classified as a surgical policy, by Anthems own definition.
    • Anthems definition of Proton Beam Therapy - A focused beam of high-energy positively charged particle radiation (proton particles) used in radiation therapy. Proton beam therapy can be given with or without stereotactic techniques. Anthem classifies proton beam therapy as a radiation therapy.
    • Anthems definition of IMRT including description/scope - Intensity modulated radiation therapy (IMRT) refers to a technique of external conformal radiation planning and delivery, in which non-uniform intensity beams produce unique radiation dose distributions that are intended to better target the lesion with better sparing of surrounding normal tissue than with conventional radiation therapy (RT), thereby limiting side effects. IMRT also allows for dose escalation, when clinically appropriate, which can potentially improve local control of a tumor.

    Anthems Medical Policy---------------------------------------------------------------- 

    Inconsistencies in Anthems Policy 

    • Anthem classifies SBRT (Stereotactic Body Radiotherapy) and SRS (Stereotactic Radiosurgery) as a surgery policy (SURG.00017) rather than a radiation treatment policy (RAD). This is another inaccuracy found within Anthems policy. Anthems own description of SBRT is not consistent with a surgical policy. It is consistent with a radiation therapy policy.
    • Anthems description of SBRT and SRS - Stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT) are non invasive treatments where high doses of focused radiation beams are precisely delivered to intracranial and extracranial targets, thus sparing adjacent tissue and structure from irradiation. The technique differs from conventional radiation therapy (RT), which involves exposing large areas of tissue to relatively broad fields of radiation over a number of sessions. Fractionated stereotactic radiosurgery refers to multiple sessions of SRS over several days.

    Anthems SBRT & SRS policy acknowledges that CyberKnife treatment is an improvement in technology and offers the highest therapeutic ratio (See Attachment #25) 

    • Anthems Stereotactic Radiosurgery policy (SURG.00017) acknowledges the following: The CyberKnife system is used primarily for SBRT. This system delivers high dose radiation via a moving gantry. The CyberKnife has to compensate functional body movements. To accommodate for movement, the CyberKnife incorporates real time imaging and fiduciary placement markers that are used to continually triangulate the geometric position of the target lesion within the body. A microprocessor calculates fiduciary displacement caused by movement and compensates for radiation delivery during the treatment process.
    • Anthems Stereotactic Radiosurgery policy (SURG.00017) further states, When stereotactic radiation therapy is delivered over a course of days, rather than a single session, the technique is referred to as fractionated stereotactic radiotherapy. The rationale for fractionation of radiosurgery is the same as that for conventional radiation. It results in the highest therapeutic ratio (highest destruction of tumor cells with the lowest effect on normal adjacent tissue and structures) The tumor and the normal tissues respond differently to high single doses vs. multiple smaller doses of radiation. Single large doses can irradiate normal tissue more than several smaller doses. Multiple smaller doses can destroy tumor cells while sparing the normal tissues. However, until recently, fractionation was not possible using stereotactic techniques due to the inability to precisely reposition for tumor target location. Radiosurgery technology has been improved and is now equipped to relocate the target tumor and permit fractionation.
    • In general, the technical advances in radiotherapies in recent years have been accepted and rapidly implemented without any evidence based on comparison of clinical outcome. Why hasnt this been the case with SBRT/CyberKnife treatment? Anthem clearly acknowledges this advancement in their policy and they further go on to admit that it offers the best outcome (therapeutic ratio), but refuse to implement it as an option for the millions of men they insure. In addition, they continue to incorrectly classify this treatment as surgery when it is clearly radiation therapy, by their own admission.

    SBRT Compared to other Treatment therapies----------------------------- 

    (See Attachment #19) 

    SBRT (SURG.00017), IMRT (RAD.00041), Proton Beam (RAD.00015), Brachytherapy (RAD.00014) 

    • SBRT is less expensive than IMRT ($11K vs. $19K) per 2010 Medicare estimate based on Advisory Board Company analysis.
    • IMRT is generally viewed as a technical improvement to External Beam Radiation Therapy (EBRT). IMRT is radiation therapy as is Cyberknife treatment. Under that rationale, wouldnt it stand to reason that Cyberknife is also a technical delivery improvement to EBRT. This is recognized in Aetnas medical policy. (See Attachment #7)
    • High radiation treatment is a covered procedure for prostate cancer when it is delivered via brachytherapy. HDR Brachytherapy is the delivery of high radiation via small preloaded seeds that are inserted into the prostate.
    • CyberKnife is able to deliver radiation doses similar to that delivered by HDR Brachytherapy. CyberKnife is simply a different delivery option. How can you say that high radiation treatment is experimental/investigative when you already routinely reimburse for high radiation treatment for prostate cancer?
    • SBRT Treatment time for prostate cancer is 1 week (4-5 treatments) compared to IMRT, which is 8-9 weeks (40-44 treatments).
    • The overall cost of Cyberknife (SBRT) treatment is significantly less, 25-50%, than other treatments.

    In summary, radiation therapy has been in use for over 100 years and as our technology has evolved over time, there have been improvements in the delivery and targeting of the radiation. Cyberknife treatment for prostate cancer is one of those improvements in technology that we are lucky enough to have available to the male population. In the simplest terms possible, Cyberknife technology is radiation with better delivery and control. It is able to aim the radiation beam from significantly more angles, and compensates for the movement of the prostate as well as various other organs. 

    Anthems SBRT Policy compared to Anthems IMRT policy--------------- 

    • Why is SBRT held to a different standard than IMRT when they are both radiation therapy?
    • There is an abundance of peer reviewed medical literature on SBRT/CyberKnife treatment for prostate cancer. However, Anthem chooses to cite one 2007 study, one 2009 study and one 2010 study that relate to SBRT/CyberKnife treatment. This is misleading. It is not an accurate portrayal of the cumulative data that is available on SBRT/CyberKnife treatment.
    • There are more questions and concerns raised in Anthems assessment of their own IMRT policy than in their SBRT policy, but they are covering IMRT and not SBRT.
    • The only 2010 study referenced in Anthems SBRT policy is written by Buyyounouski. It relays ASTROs position on SBRT/CyberKnife treatment. The study states, Emerging Technology Committee of ASTRO reviewed the current literature for treatment of prostate cancer with SBRT. Based on the available clinical studies, SBRT requires continuing clinical development in the areas of immobilization, organ localization and precise dose delivery. Long term data are needed to address radiation dosing and toxicity. ---------The truth of the matter is that there is long term data available and ASTRO & AHRQ acknowledge it by accepting the following:

    Long term data is available and acknowledged by ASTRO and AHRQ--(See Attachment #4 & Attachment #9) 

    1. Recently accepted abstracts for American Society for Radiation Oncology (ASTRO) 2010 from two of this submissions signatories (Drs. King and Katz) show 5-year actuarial disease-free survival of 96-98% with continued low rates of late toxicity (0-3% Grade 3+ urinary and 0% Grade 3+ rectal toxicity
    2. Both the 2008 and 2010 AHRQ prostate cancer reports noted that available comparative data could not determine if one form of radiation therapy is superior to another form.
    3. The recent 5 year study was published in January 2011 confirming that SBRT/CyberKnife treatment for prostate cancer is comparable to other available therapies, with equal or better toxicity profiles. Stereotactic Body Radiotherapy for Low Risk Prostate Cancer: Five Year Outcomes. Freeman and King.

    Contradiction of Anthems SBRT, IMRT and Proton Beam Policies---- 

    SBRT, IMRT, Proton Beam are all forms of radiation therapy 

    • Anthems SBRT policy acknowledges that radiosurgery technology has been improved and is now equipped to relocate the target tumor and permit fractionation.
    • Anthems last review date of the SBRT and SRS policy was 11/18/10. They neglected to include an important study released in 2009 by Christopher R. King as a reference in their policy. This study would be particularly beneficial in proving that long term data exists and reinforces SBRT/CyberKnife treatment as comparable to other prostate cancer treatment options. (See Attachment #21)
    • Anthems medical policy for Proton Beam Therapy recognizes that there is no evidence to suggest it is clinically superior to IMRT. IMRT is a similar radiation modality for localized prostate cancer. Proton Beam Therapy is approved and it is substantially more expensive than IMRT or SBRT/CyberKnife treatment. SBRT/CyberKnife treatment for prostate cancer is also a form of radiation therapy and it is more cost effective than IMRT or Proton Beam. All 3 treatments are forms of radiation therapy, so the question remains, Why is SBRT/CyberKnife categorized under a surgical policy?

    Anthems assessment of their own IMRT policy-------------------------------- 

    • Anthems assessment of IMRT in their IMRT policy - It has been hypothesized that IMRT may improve treatment outcomes by permitting escalated tumor doses without increasing normal tissue toxicity (bowel/bladder). There is evidence from randomized controlled trials showing a dose-response relation above 68 Gy for local and biochemical control of prostate cancer. For these reasons, radiation oncologists have hypothesized that IMRT may provide improved clinical outcomes over 3D-CRT. However, since IMRT aims radiation at the tumor from more directions and subjects more normal tissue to low-dose radiation than conventional EBRT or 3D-CRT, concern has been raised that IMRT might actually increase the risk of late effects of radiation therapy.
    •  

    • This assessment raises questions and concerns regarding IMRT treatment, but it is still acceptable to Anthem as a covered treatment. The issue is raised that the increased dose of radiation required for IMRT (75-80 Gy) might lead to an increased risk of other cancers. IMRT uses 2X the radiation dose of SBRT/CyberKnife treatment.
    •  

    • Why would Anthem want to potentially expose people to unnecessary side effects when SBRT is proven to have lower toxicity profiles?
    •  

    • In addition, Anthems IMRT policy states that IMRT aims radiation from more directions and subjects more normal tissue to low dose radiation, which makes it a concern that IMRT could potentially increase the risk of late effects radiation therapy. In addition, Anthems policy states that a treatment plan with improved precision, when directed towards a moving target, may result in inadequate radiation delivery as the moving target moves in and out of the treatment zone.
    •  

    • In comparison to SBRT/CyberKnife treatment, SBRT/CyberKnife treatment is proven to be more accurate and precise and takes into account the moving target that is the prostate, thus reducing this risk raised by IMRT therapy.
    •  

    • Recent article in the NY Times, Radiation Beam Strays, Harming instead of Helping. Published December 28, 2010. The article stated that some IMRT equipment was modified to function like SRS/SBRT and there were some significant failures. Scores of patients received overdoses due to operator error and safety issues. They tried to mix and match treatment delivery systems, which harmed many patients.
    •  

    Anthem Federals Letter dated May 20, 2008 from Karen S. (Customer Care Representative for Anthems Federal Employee Program/CC to Don Gilvin (See Attachment #1)------------------------------ 

    This letter is from a customer care representative of Anthems own Federal Employee Program (FEP). It states in the letter, CyberKnife radiotherapy is appropriate for the treatment of prostate cancer and is supported by peer review journals. This letter further states, CyberKnife is consistent with current good medical practice and is not primarily for the comfort of the patient, the family, or the provider.

    How can Anthem Federal allow CyberKnife (SBRT) treatment and my Dads Anthem BCBS policy call it Experimental/Investigative? The simple answer is that CyberKnife treatment for prostate cancer is NOT Expermental and it is NOT Investigative.

    This letter is attached and it is imperative to read it to get the full grasp of the contradiction. It was sent directly to Central Baptist Hospital in Lexington, Kentucky. We obtained a copy of it directly from the hospital with the patients name crossed out for privacy reasons.

    (See Attachment #1)

    Cyberknife is NOT experimental--------------------------------------- 

    31 Cases of Precedent 

    --------------------------------------------------------------------------------------- 

    Major Insurer - Wellpoint, Inc subsidiaries - Anthem BCBS/Anthem Federal (FEP) CASES OF PRECEDENT #1 through #13 

    Anthem Federal (FEP) cites approval for stereotactic radiosurgery as a covered service under the Blue Cross and Blue Shield Service Benefit Plan. 

    Blue Shield of California medical policy, effective 7/7/08, making SRS medically necessary and effective for localized prostate cancer of low to medium risk. (See Attachment #6) 

    1. Fred Kinder treatment date May 2008

      Diagnosis Prostate Cancer

      Blue Shield California pays for SBRT to Stanford Hospital California.

    2. Name protected by medical privacy treatment date May 2009

      Diagnosis - Prostate Cancer

      Anthem BCBS California pays for SBRT to Stanford Hospital, CA.

    3. Name protected by medical privacy treatment date May 2010

      Diagnosis - Prostate Cancer

      Blue Cross Blue Shield North Carolina pays for SBRT to UNC, Chapel Hill, North Carolina/Dr. Chen.

    4. Name protected by medical privacy treatment date February 2010 Diagnosis - Prostate Cancer Blue Shield pays for SBRT to Fresno Community Hospital/Dr Wong.
    5. Name protected by medical privacy treatment date February 2010

      Diagnosis - Prostate Cancer

      Blue Cross Care First pays for SBRT to Virginia Hospital Center.

    6. Name protected by medical privacy treatment date August 2008

      Diagnosis - Prostate Cancer

      Anthem Connecticut pays for SBRT to Shelton, Connecticut Hospital.

    7. Name protected by medical privacy treatment date May 2009

      Diagnosis - Prostate Cancer

      Anthem BCBS pays for SBRT to Via Cristi Cyberknife Center, Wichita, Kansas, Dr. David Bryant as a supplement to Medicare.

    8. Name protected by medical privacy treatment date February 2009

      Diagnosis Prostate Cancer

      Anthem Blue Cross Blue Shield Virginia/Care First pays for SBRT to Virginia Hospital Arlington.

    9. Name protected by medical privacy Treatment date July 2010

      Diagnosis - Prostate Cancer

      Anthem pays for SBRT to UCSF Hospital, San Francisco California.

    10. Name protected by medical privacy Treatment date November 2007

      Diagnosis - Prostate Cancer

      Blue Cross Blue Shield pays for SBRT to CyberKnife center in Naples, Florida as a supplement to Medicare.

    11. Name protected by medical privacy Treatment date April 2009

      Diagnosis - Prostate Cancer

      Anthem pays for SBRT to St. Raphaels Hospital in New Haven, Connecticut.

    12. Name protected by medical privacy Treatment date October 2010

      Diagnosis - Prostate Cancer

      Blue Cross Blue Shield Mass. pays for SBRT to St. Francis Hospital, Dr. Shumway, Hartford, Connecticut as a supplement to Medicare.

    13. Name protected by medical privacy Treatment date March 2011

      Diagnosis Prostate Cancer

      Blue Cross Blue Shield pays for SBRT to Michigan Hospital.

    14. ------------------------------------------------------------------------------------------------------------ 

      Major Insurer Cigna, United Health Care, Aetna, Humana Cases of Precedent #14 through #24 

      United Health Care officially retired their SRS/SBRT policy effective January 1, 2010. (See Attachment #20) When a document is retired, it means that no pre or post service reviews are necessary and all codes in the policy are covered. Stereotactic Robotic Radiosurgery codes G0339 and G0340 are included in the policy. 

      Aetna policy, released 10/19/07, making Stereotactic Radiosurgery medically necessary for localized malignant tumors. 

    15. Name protected by medical privacy Treatment date January 2011

      Diagnosis Prostate Cancer

      Humana pays for SBRT to Central Baptist Hospital/Dr. Alan Beckman as a supplement to Medicare.

    16. Name protected by medical privacy Treatment date August 2007

      Diagnosis Prostate Cancer

      Humana pays for SBRT to Winthrop Hospital, Mineola,

      New York/Dr. Alan Katz as a supplement to Medicaid.

    17. Name protected by medical privacy Treatment date February 2009

      Diagnosis Prostate Cancer

      Cigna pays for SBRT to Arlington Virginia Hospital.

    18. Name protected by medical privacy Treatment date 2005

      Diagnosis Prostate Cancer

      United Health Care pays for SBRT to Dr. Debra Freeman, Tampa Bay CyberKnife Center, Tampa Bay, Florida.

    19. Name protected by medical privacy Treatment date June 2010

      Diagnosis Prostate Cancer

      United Health Care pays for SBRT to Beth Israel Hospital,

      Boston, Massachusetts as a supplement to AARP Medicare.

    20. Name protected by medical privacy Treatment date June 2009

      Diagnosis Prostate Cancer

      United Health Care pays for SBRT to UNC/Chapel Hill Hospital.

    21. Name protected by medical privacy Treatment date November 2008

      Diagnosis Prostate Cancer

      Aetna pays for SBRT to Overlook Hospital, Summit, New Jersey as a supplement to Medicare.

    22. Name protected by medical privacy Treatment date February 2008

      Diagnosis Prostate Cancer

      United Health Care pays for SBRT to Naples, Florida CyberKnife Center/Dr. Jay Friedland.

    23. Name protected by medical privacy Treatment Date September 2010

      Diagnosis Prostate Cancer

      Oxford Health Plan/United Health Care pays for SBRT to Long Island New York Hospital.

    24. Name protected by medical privacy Treatment date October 2010

      Diagnosis Prostate Cancer

      Aetna pays for SBRT.

    25. Name protected by medical privacy Treatment date March 2008.

      Diagnosis Prostate Cancer

      United Health Care pays for SBRT to Naples Community Hospital, Naples Florida.

      ------------------------------------------------------------------------------------------------------------ 

      Medicare and Other Insurance Groups Cases of Precedent - #25 through #31 

      Medicare Region 5 states SBRT of the prostate is covered as a monotherapy for patients with low risk and low/intermediate risk prostate cancer. (Attachment #18) 

      Medicare Region 5 includes: Ohio, Illinois, Indiana, Michigan, Minnesota, Wisconsin 

    26. Name protected by medical privacy Treatment date December 2008 Diagnosis Prostate Cancer Screen Actors Guild Health Plan pays for SBRT to Palm Beach, Florida.
    27. Name protected by medical privacy Treatment date March 2010

      Diagnosis Prostate Cancer

      Alaska Care pays for SBRT to Swedish Hospital, Seattle, Washington.

    28. Name protected by medical privacy Treatment date 2007

      Diagnosis Prostate Cancer

      Medicare pays for SBRT to Naples CyberKnife Center.

    29. Name protected by medical privacy Treatment date August 2010

      Diagnosis Prostate Cancer

      Great West pays for SBRT to Denver Hospital.

    30. Name protected by medical privacy Treatment date August 2010

      Diagnosis Prostate Cancer

      Medicare pays for SBRt to Cleveland Hospital in August 2010.

    31. Name protected by medical privacy Treatment date January 2010

      Diagnosis Prostate Cancer

      Ucare Minnesota pays for SBRT to St. Josephs Hospital, St. Paul,

      Minnesota/Dr. McBride as a supplement to Medicare.

    32. Name protected by medical privacy Treatment date February 2010

      Diagnosis Prostate Cancer

      Amerihealth pays for SBRT to Univeristy of PA, Trenton, PA, Dr. Williamson.

      We understand that these are all different insurance entities. However, it simply adds to the mountain of proof that CyberKnife treatment for prostate cancer (SBRT) is considered one of the standards of care for this disease, and that all of these insurers recognize this, and have been funding this treatment routinely for at least five years.

       

    FDA Approval-------------------------------------------------------------------------------- 

    CyberKnife received FDA 501(k) clearance in 1999 to provide treatment planning and image guided robotic radiosurgery for tumors of the head and neck. In 2001, CyberKnife received 501(k) clearance to treat tumors anywhere in the body where radiation treatment is indicated. (See Attachment #2)
    • The common name of the CyberKnife System is Linear Accelerator for Radiation Therapy.
    • On the FDA 501(k) clearance document, the device description is the following: The CyberKnife system is a treatment planning, imaging, and delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy and implanted fiducials with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient to verify treatment position and alignment. The patient support system provides for positioning and alignment of the patient.
    • The intended use classified on the FDA 501(k) clearance document states the following: To Provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    • All FDA approvals are authorized by the FDA. The FDA is a division of the Department of Health and Human Services (a Public Health Service).

      CyberKnife Treatment is not Experimental by Anthems own definition------------------------------------------------------------------------------------- 

      Anthem states in their first and second level appeal that this treatment is experimental/investigative, and they offer their definition. However, they are neglecting to actually offer any proof that CyberKnife treatment (SBRT) for prostate cancer fits into or meets this definition in any way.

        Anthems Denial Claims Cannot be legally marketed in the United States without the final approval of the Food and Drug Administration (FDA), or other licensing or regulatory agency, and such final approval has not been granted.

       

      • FACT - CyberKnife was given 501(k) clearance in 2001 to treat tumors anywhere in the body where radiation treatment is indicated.

    Anthems Denial Claims Has been determined by the FDA to be contraindicated for the specific use.

    • FACT - CyberKnife was given 501(k) clearance in 2001 to treat tumors anywhere in the body where radiation treatment is indicated. (This would obviously include the prostate)

Anthems Denial Claims Is provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service or supply.

  • FACT - Examples of the most recent study conclusion proving that CyberKnife (SBRT) treatment is an acceptable treatment for treating prostate cancer efficiently and successfully.  

  • EVIDENCE - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) and neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.  

Anthems Denial Claims Is provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service or supply as Experimental/Investigative, or otherwise indicate that the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation.

  • FACT - CyberKnife was given 501(k) clearance in 2001 to treat tumors anywhere in the body where radiation treatment is indicated. (This would obviously include the prostate)
  • EVIDENCE - Fuller D., Lee C., Hardy S., Haoran J. Virtual HDR Prostate CyberKnife Radiosurgery: Technical Evolution and Clinical Results One Year Following Introduction. Presentation Abstracts, January (2008). Conclusions: We conclude that CK robotic radiosurgery is a noninvasive method to deliver radiation dose distributions that very closely resemble those delivered by using HDR brachytherapy.
  • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

Information further considered by Anthem in their DENIAL-------------- 

ANTHEMS DENIAL CLAIM - The scientific evidence is conclusory concerning the effect of the service on health outcomes.

  • Fuller D., Naitoh J., Reilly M., Lee C. Virtual HDR Prostate CyberKnife Radiosurgery: Efficacy, Toxicity and Quality of Life. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: No patient has relapsed. Median PSA level continues to drop with each successive evaluation.
  • Spellberg D., Freeman D., Masterson-McGary M., Friedland J. CyberKnife Stereotactic Radiosurgery for the Treatment of Localized Prostate Cancer. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: The CyberKnife System was capable of delivering high-dose, hypofractioned radiotherapy for prostate cancer in a minimally invasive fashion, with excellent short term PSA response and very low levels of complications
  • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

    Anthems Denial Claims - The evidence demonstrates the service improves net health outcomes of the total population for whom the service might be proposed by producing beneficial effects that outweigh any harmful effects.

    • Friedman J., Masterson-McGary D., Spellberg D. Stereotactic Body Radiotherapy for Early Stage Prostate CA: PSA, Toxicity, and Erectile Function Outcomes from a Single Institution Study. 2009 CyberKnife Meeting, February (2009). Conclusion of Study: Hypofractional SBRT for localized prostate cancer was delivered by the Cyberknife Radiosurgery system in a minimally invasive fashion, resulting in short-term PSA response, minimal complications, and preservation of erectile function in the majority of patients.
    • Fuller D., Naitoh J., Reilly M., Lee C. Virtual HDR Prostate CyberKnife Radiosurgery: Efficacy, Toxicity and Quality of Life. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: No patient has relapsed. Median PSA level continues to drop with each successive evaluation.
    • Spellberg D., Freeman D., Masterson-McGary M., Friedland J. CyberKnife Stereotactic Radiosurgery for the Treatment of Localized Prostate Cancer. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: The CyberKnife System was capable of delivering high-dose, hypofractioned radiotherapy for prostate cancer in a minimally invasive fashion, with excellent short term PSA response and very low levels of complications
    • Katz A.J., Santoro M. Quality of Life and Efficacy for Stereotactic Body Radiotherapy for Treatment of Organ Confined Prostate Cancer. I.J. Radiation Oncology, Biology, Physics, Volume 78, Number 3, 123, Supplement (2010). Conclusions: At 42 months median follow up the absence of any biochemical failures, the minimal toxicity and the promising potency preservation rates are highly encouraging.
    • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) and neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.  

    Anthems Denial Claims - The evidence demonstrates the service has been shown to be as beneficial for the total population for whom the service might be proposed as any established alternatives.

    • EVIDENCE -Red Journal Report Highlights CyberKnife Systems Flexibility in Treating Prostate Cancer. Focus on Radiosurgery. April (2008). Conclusions: Our study concluded that CyberKnife radiosurgery can offer the benefits of HDR brachytherapy non-invasively on an outpatient basis that is both easy to deliver and comfortable for patients.
    • EVIDENCE - Friedman J., Masterson-McGary D., Spellberg D. Stereotactic Body Radiotherapy for Early Stage Prostate CA: PSA, Toxicity, and Erectile Function Outcomes from a Single Institution Study. 2009 CyberKnife Meeting, February (2009). Conclusion of Study: Hypofractional SBRT for localized prostate cancer was delivered by the Cyberknife Radiosurgery system in a minimally invasive fashion, resulting in short-term PSA response, minimal complications, and preservation of erectile function in the majority of patients.
    • EVIDENCE - Fuller D., Naitoh J., Reilly M., Lee C. Virtual HDR Prostate CyberKnife Radiosurgery: Efficacy, Toxicity and Quality of Life. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: No patient has relapsed. Median PSA level continues to drop with each successive evaluation.
    • EVIDENCE - Spellberg D., Freeman D., Masterson-McGary M., Friedland J. CyberKnife Stereotactic Radiosurgery for the Treatment of Localized Prostate Cancer. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: The CyberKnife System was capable of delivering high-dose, hypofractioned radiotherapy for prostate cancer in a minimally invasive fashion, with excellent short term PSA response and very low levels of complications.
    • EVIDENCE - Katz et al. Comparison of Different Treatment Schemes for Early Prostate Cancer: A Two Year Study. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: Thus far, PSA response and toxicity look favorable for all treatment regimens. There appears to be a difference among the different regimens in terms of efficacy at one year, with CK boost resulting in a lower mean PSA. However, CK used as a boost produces slightly greater rectal toxicity than monotherapy.
    • EVIDENCE - Meier R., Beckman A., Kaplan I., Mohideen N., Shieh E., Henning G., Walz B., Cotrutz C., Sanda M. Stereotactic Radiotherapy for Organ confined Prostate Cancer: Early Toxicity and Quality of Life Outcomes from a Multi-Institutional Trial. Proceedings of the 52nd Annual ASTRO Meeting. Conclusions: In a multi-institutional study evaluating image guided SRT in patients with organ confined prostate cancer, rates of serious acute and early-late toxicities have been modest. At one year follow up, decrements in genderual, urinary and bowel QOL appear within range of other radiotherapy modalities.
    • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

    Anthems Denial Claims - The evidence demonstrates the service has been shown to be as beneficial for the total population for whom the service might be proposed as any established alternatives.  

    • EVIDENCE -Red Journal Report Highlights CyberKnife Systems Flexibility in Treating Prostate Cancer. Focus on Radiosurgery. April (2008). Conclusions: Our study concluded that CyberKnife radiosurgery can offer the benefits of HDR brachytherapy non-invasively on an outpatient basis that is both easy to deliver and comfortable for patients.
    • EVIDENCE - Friedman J., Masterson-McGary D., Spellberg D. Stereotactic Body Radiotherapy for Early Stage Prostate CA: PSA, Toxicity, and Erectile Function Outcomes from a Single Institution Study. 2009 CyberKnife Meeting, February (2009). Conclusion of Study: Hypofractional SBRT for localized prostate cancer was delivered by the Cyberknife Radiosurgery system in a minimally invasive fashion, resulting in short-term PSA response, minimal complications, and preservation of erectile function in the majority of patients.
    • EVIDENCE - Fuller D., Naitoh J., Reilly M., Lee C. Virtual HDR Prostate CyberKnife Radiosurgery: Efficacy, Toxicity and Quality of Life. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: No patient has relapsed. Median PSA level continues to drop with each successive evaluation.
    • EVIDENCE - Spellberg D., Freeman D., Masterson-McGary M., Friedland J. CyberKnife Stereotactic Radiosurgery for the Treatment of Localized Prostate Cancer. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: The CyberKnife System was capable of delivering high-dose, hypofractioned radiotherapy for prostate cancer in a minimally invasive fashion, with excellent short term PSA response and very low levels of complications.
    • EVIDENCE - Katz et al. Comparison of Different Treatment Schemes for Early Prostate Cancer: A Two Year Study. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: Thus far, PSA response and toxicity look favorable for all treatment regimens. There appears to be a difference among the different regimens in terms of efficacy at one year, with CK boost resulting in a lower mean PSA. However, CK used as a boost produces slightly greater rectal toxicity than monotherapy.
    • EVIDENCE - Meier R., Beckman A., Kaplan I., Mohideen N., Shieh E., Henning G., Walz B., Cotrutz C., Sanda M. Stereotactic Radiotherapy for Organ confined Prostate Cancer: Early Toxicity and Quality of Life Outcomes from a Multi-Institutional Trial. Proceedings of the 52nd Annual ASTRO Meeting. Conclusions: In a multi-institutional study evaluating image guided SRT in patients with organ confined prostate cancer, rates of serious acute and early-late toxicities have been modest. At one year follow up, decrements in genderual, urinary and bowel QOL appear within range of other radiotherapy modalities.
    • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

    Anthems Denial Claims The evidence demonstrates the service has been shown to improve the net health outcomes of the total population for whom the service might be proposed under the usual conditions of medical practice outside clinical investigatory settings.

    • FACT Prostate cancer is the #2 form of cancer in men.
    • EVIDENCE - Katz et al. Comparison of Different Treatment Schemes for Early Prostate Cancer: A Two Year Study. 2009 CyberKnife Meeting. February (2009). Conclusion of Study: Thus far, PSA response and toxicity look favorable for all treatment regimens. There appears to be a difference among the different regimens in terms of efficacy at one year, with CK boost resulting in a lower mean PSA. However, CK used as a boost produces slightly greater rectal toxicity than monotherapy.
    • EVIDENCE - Meier R., Beckman A., Kaplan I., Mohideen N., Shieh E., Henning G., Walz B., Cotrutz C., Sanda M. Stereotactic Radiotherapy for Organ confined Prostate Cancer: Early Toxicity and Quality of Life Outcomes from a Multi-Institutional Trial. Proceedings of the 52nd Annual ASTRO Meeting. Conclusions: In a multi-institutional study evaluating image guided SRT in patients with organ confined prostate cancer, rates of serious acute and early-late toxicities have been modest. At one year follow up, decrements in genderual, urinary and bowel QOL appear within range of other radiotherapy modalities. Initial PSA responses are encouraging.
    • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

    Information considered or evaluated by Anthem to determine if it is Experimental/Investigative------------------------------------------------------------ 

    Published authoritative, peer reviewed medical or scientific literature, or the absence thereof

    • FACT - Since September 2010, more than 516 clinical and technical articles have been published in support of the clinical effectiveness of Cyberknife system for tumors.

    Evaluations of national medical associations, consensus panels, and other technology evaluation bodies.

    • See all CyberKnife supported document included in the Proof section of this document.
    • The American Society for Radiation Oncology (ASTRO) 2010 recently published abstracts that show the 5 year disease free survival of 96-98% with continued low rates of late toxicity (0-3% Grade 3+ urinary and 0% Grade 3+ rectal toxicity). (See Attachment #4)

    Documents issued by and/or filed with the FDA or other federal, state or local agency with the authority to approve, regulate, or investigate the use of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service or supply.

    • FACT - CyberKnife was given 501(k) clearance in 2001 to treat tumors anywhere in the body where radiation treatment is indicated. (This would obviously include the prostate.

    Consent documents and/or written protocol used by the treating Physician, other medical professionals, or facilities or by other treating Physicians, other medical professional or facilities studying substantially the same drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service or supply.

    • EVIDENCE - Letter of support and treatment protocol from CyberKnife Center at Central Baptist Hospital, Lexington, Kentucky. (See Attachment #5)
    • EVIDENCE - According to a letter submitted on May 15, 2008 by Donald Fuller, MD, Christopher King, MD, Ph.D., Iris C. Gibbs, MD, Douglas Wong, MD, Ph.D. CyberKnife Robotic Radiosurgery as Definitive Treatment for Prostate Cancer. Conclusion: To avoid coverage confusion, it (CyberKnife SBRT) should be regarded as an improvement to an existing modality (radiotherapy) rather than classified as a completely new intervention. Our reasons for recommending robotic radiosurgery include the following: FDA Approval, Medicare Coverage, Dosimetry, Hospitalization (lack of), Toxicity (lack of), Efficacy, Cost, and Benefits over other radiotherapeutic methods. (See Attachment #10)
    • EVIDENCE - According to a letter submitted to the NCCN Guidelines panel on July 2, 2010 by a panel of experts including: Chen, Coleman, Collins, Freeman, Fuller, Katz, King, Ma, Masterson-Gary, Meier, Ponsky, Presty, Wong, SBRT/Cyberknife treatment for prostate cancer is safe and clinically effective, less costly than alternative external beam therapies for our patients and healthcare system, and offers the patient a more efficient course of treatment with comparable side effects to other forms of radiotherapy. (See Attachment #4)

    The opinion of consulting Providers and other experts in the field.

    • EVIDENCE - According to a letter submitted on May 15, 2008 by Donald Fuller, MD, Christopher King, MD, Ph.D., Iris C. Gibbs, MD, Douglas Wong, MD, Ph.D. CyberKnife Robotic Radiosurgery as Definitive Treatment for Prostate Cancer. Conclusion: To avoid coverage confusion, it (CyberKnife SBRT) should be regarded as an improvement to an existing modality (radiotherapy) rather than classified as a completely new intervention. Our reasons for recommending robotic radiosurgery include the following: FDA Approval, Medicare Coverage, Dosimetry, Hospitalization (lack of), Toxicity (lack of), Efficacy, Cost, and Benefits over other radiotherapeutic methods. (See Attachment #10)
    • EVIDENCE - According to a letter submitted to the NCCN Guidelines panel on July 2, 2010 by a panel of experts including: Chen, Coleman, Collins, Freeman, Fuller, Katz, King, Ma, Masterson-Gary, Meier, Ponsky, Presty, Wong, SBRT/Cyberknife treatment for prostate cancer is safe and clinically effective, less costly than alternative external beam therapies for our patients and healthcare system, and offers the patient a more efficient course of treatment with comparable side effects to other forms of radiotherapy. (See Attachment #4)
    • EVIDENCE - Conclusive results of the 5 year data - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.

    NCCN National Comprehensive Care Network-------------------------------- 

    • About the NCCN It is an alliance of 21 of the worlds leading cancer centers. The alliance works together to develop treatment guidelines for most cancers, and dedicated to research that improves the quality, effectiveness, and efficiency of cancer care.
    • The NCCN has no opinion on SBRT/CyberKnife treatment for prostate cancer in their guidelines.
    • Anthem cites the NCCN as a reference in their policy as well as a reference in their denial letters.

    NCCN Panel Expert Embraces SBRT/CyberKnife  

    Treatment as his treatment of choice 

    • One of the experts on the panel for the NCCN is Thomas A Farrington. He is listed as the patient advocate on the NCCN panel. He had SBRT/CyberKnife treatment for his prostate cancer in July 2009.
    • Thomas A Farrington makes comments supporting his CyberKnife treatment I will be making a statement at this meeting (referring to the MEDCAC meeting held on April 21, 2010 ) about the CyberKnife treatment which is also a topic at this meeting. For those of you who may not be aware I had a recurrence last year after 9 years. While we were at the AUA meeting in Chicago last year I discovered CyberKnife on the exhibit floor. I was due to begin hormone treatment soon after the meeting. After returning to Boston and more tests it was determined that I had suffered an oligo metastases and CyberKnife was an option to target the identified spot of the recurrence with its precision radiation. My PSA had risen to 2.5 more than doubling in just 4 months. My Cyberknife treatment was performed in July 2009. In October the PSA had been reduced to 0.6, then to 0.2 in January and I just had my last PSA on Tuesday of this week where it remains at 0.2. I have received no treatment other than Cyberknife, and suffered
    • no side effects. I have been truly blessed and look forward to the meeting on the 21st as I believe the Cyberknife treatment can serve as a unique treatment for prostate cancer. Maybe I will see some of you there as well. (See Attachment #22)

    Fox Chase Cancer Center, UCSF Helen Diller Family Comprehensive Cancer Center, Stanford Comprehensive Cancer Center and University of Tennessee Cancer Institute are all members of the NCCN alliance and all have CyberKnife centers in their facility. 

      The four institutions listed above provide SBRT/CyberKnife treatment for prostate cancer routinely and at high volumes.
      The question is When any NCCN statement is absent regarding SBRT/CyberKnife treatment for prostate cancer, how are we to determine what their position is on this treatment?

      THE ANSWER IS:

      BY THEIR ACTIONS.

    Fox Chase Cancer Center, Philadelphia, Pennsylvania---------------------- 

    • Fox Chase Cancer Center is one of the leading cancer research and treatment centers in the US. It was founded in 1904 and it was the nations first cancer hospital. Fox Chase became one of the first institutions to be designated as part of the NCCN in 1974. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, treatment, and community outreach.
    • Fox Chase Cancer Center purchased the CyberKnife system in December 2008. It seems they are following their trend as leaders in their field. They were the first cancer hospital in the nation and still one of the leading cancer research and treatment centers in the US.

    UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California--------------------------------------------------------------------- 

    • The University of California, San Francisco is an international leader in cancer research and patient care. The mission of UCSF Cancer Centers clinical program is to provide comprehensive care through multidisclipinary collaboration and integrated services, to advance cancer therapies through clinical research, and to train future leaders in the treatment of patients with cancer.
    • The University of California started offering CyberKnife treatment in March 2003. This center is also following their trend as international leaders in their field.

    Stanford Comprehensive Cancer Center------------------------------------------ 

    • Stanford University is an international leader in cancer research and patient care. The mission of the Stanford Clinical Cancer Program is to provide comprehensive care through multidisciplinary collaboration and integrated services, to advance cancer therapies through clinical research, and to train future leaders in the treatment of patients with cancer.
    • Stanford is one of 4 facilities that own 2 CyberKnife systems. Stanford was the first to purchase and use the CyberKnife this groundbreaking device. They are clearly international leaders in the field of cancer treatment and patient care.

    University of Tennessee Cancer Institute---------------------------------------- 

    • The University of Tennessee Cancer Institute provides general oncology care and consultations for difficult cases. Specialized multidisciplinary clinics bring doctors from different disciplines together to provide medical, surgical and radiotherapy care to the patient in a single geographic area.
    • The immediate goal of this collaboration is to provide the best possible care for oncology patients in this region of the country, through two cancer centers and eight additional clinical sites, while the long-term objective is to help eradicate cancer through innovative research. The collaboration includes other major healthcare and research institutions in and around Memphis.
    • The University of Tennessee Cancer Institute acquired their CyberKnife system in 2005. In January 2010, their CyberKnife underwent a one-million-dollar upgrade that features more sophisticated treatment planning and delivery. They continue to be on the forefront of cancer treatment as leaders in their field.

    Anthem BCBS Website------------------------------------------------------------------- 

    Broken Promises  

    The following quotes are directly from Anthems website. Every time Anthem uses words meant to make customers feel safe and cared-for, they portray themselves as keepers of this unwritten contract. The bottom line is that Anthem is not living up to their own promises with the people that rely on them

    The following statements are from Anthems website: (See Attachment #3)

    1. At Anthem Blue Cross Blue Shield we understand our health connects us to each other. What we all do impacts those around us. So Anthem is dedicated to delivering better care to our members, providing greater value to our customers and helping improve the health of our communities

      This is not an accurate or ethical mission statement made by Anthem. Anthem�s misconduct with my case is unconscionable. Anthem�s mission statement should be changed to state that they will only deliver their promises some of the time and only pay when they feel like it as proved in our cases of precedent.

        It is true that what we all do impacts those around us. However, they are denying coverage for the most cost effective, cutting edge, acceptable treatment for prostate cancer.

       

        Anthem is NOT delivering better care to their members and certainly NOT providing greater value to their customers and NOT helping to improve the health of the community.

       

        Anthem is denying coverage for CyberKnife treatment. As stated above, Cyberknife treatment is the most cost effective, cutting edge treatment. Cyberknife treatment costs less than all of the other treatments that are offered and covered by Anthem. Since prostate cancer is the #2 form of cancer in men, Anthem is driving up the cost of health care by denying this treatment option to their customers.

       

      This is not an accurate or ethical mission statement made by Anthem. Anthems misconduct with my case is unconscionable. Anthems mission statement should be changed to state that they will only deliver their promises some of the time and only pay when they feel like it as proved in our cases of precedent.

       

       

    2. Anthem further claims that, health and safety are a top priority. They say that they are an accredited health plan that meets or exceeds national standards for quality care.

      This is not an accurate statement made by Anthem. They are NOT meeting national standards for quality care.

        Based on the cases of precedent included, Anthem is not meeting the national standard for quality care.

        Anthem is not making health a top priority for their customers.

        Based on the most recent study conclusion included in this document, it concludes that CyberKnife treatment allows a more immediate, return to normal daily routine. It also concludes that the toxicity profile is equal or better to other forms of treatment. (Stereotactic Body Therapy for Low Risk Prostate Cancer Five Year Outcomes. January 2011. Freeman and King See Attachment #9)

    3.  

    Hayes Brief----------------------------------------------------------------------------------- 

    Anthem relies on Hayes as a reference in their medical policies. They cite various Hayes briefs in their policy for SBRT/Cyberknife treatment for prostate cancer.

    Ann Melamed MA, RN, CNOR, a clinical research specialist from Hayes acknowledges that their brief called CyberKnife Robotic Radiosurgery System (Accuray, Inc.) for Lung Cancer and other Non Neurological Conditions is out of date. It is not available for purchase because it was last published over 3 years ago and some material is outdated. It was written February 6, 2008 and recently archived on March 6, 2011.

    • It has at least one inaccuracy within the brief. It is inaccurate and misleading due to the fact that CyberKnife was given FDA 501(k) clearance in 2001 not 2007 for all areas of the body where radiation therapy is indicated.
    • The actual brief states, The CyberKnife Radiosurgery System received initial FDA 510(k) approval (K984563) on July 14, 1999, and has received nine subsequent 510(k) approvals. In the most recent approval on September 21, 2007 (K072504), the CyberKnife Robotic Radiosurgery System was approved for treatment planning and image-guided radiosurgery of lesions or conditions anywhere in the body provided that radiation therapy is indicated.

     

     

    Independent Medical Review Outcomes------------------------------------------- 

     

    Examples of CyberKnife treatment appeals being overturned. (See Attachment #8) 

    1. MN07-7345 : This ruling stated Although CyberKnife treatment is relatively new treatment, this technique is more conformal in terms of dose delivery than any other available method of delivery. The use of CyberKnife is medically appropriate and indicated in this case and should be authorized. (See Attachment #8)
      • Anthem Blue Cross approved the appeal and deemed it medically necessary for CyberKnife treatment for prostate cancer on May 22, 2009. (See Attachment #23)
    2. E108-7831 : This ruling stated, Two physician reviewers found that a short course of high fraction radiation treatments that will deliver the biological equivalent to 40 IMRT treatments is well advised considering the radiobiology of prostate cancer. Participation in the CyberKnife clinical trial for the treatment of prostate cancer would be considered optimal treatment according to NCCN guidelines. (See Attachment #8)

    Example of CyberKnife treatment being denied because Radiation Oncologists who reviewed the case who were not familiar with the benefits of CyberKnife treatment. They were simply not qualified to make an assessment. 

    • This finding is exactly the reason that Dr. Donald Fuller, Cyberknife Centers of San Diego, states that CyberKnife is too complicated for even some radiation oncologists to fully understand the benefits.

  • MN07-0926 : The reviewers findings state, This technology has most commonly been applied to craniospinal tumors because of the bony landmarks necessary for the machine to work properly. This statement does not relate to the CyberKnife treatment for prostate cancer because CyberKnife for prostate cancer uses gold fiducials, which is similar to what is used with IMRT.

Appeal Process with Anthem---------------------------------------------------------- 

CyberKnife treatment for prostate cancer is a specialized and skilled treatment that must be performed by an experienced radiation oncologist trained to use the CyberKnife system. As such, the peer that is appropriately qualified to review is someone with direct clinical experience and/or knowledge of the treatment in question. (SBRT/CyberKnife)

Level 1 Appeal

  • Level 1 Appeal Denial states that our appeal was reviewed by Anthems physician consultant who specializes in Internal Medicine and Nephrology.
  • This physician is also the President of a Medical Consulting Firm.

 

Definition of Internal Medicine and Nephrology------------------------------- 

 

  • Internal medicine is the medical specialty dealing with prevention, diagnosis, and treatment of adult diseases. Physicians specializing in internal medicine are called internists. They are especially skilled in the management of patients who have undifferentiated or multi-system disease processes. Internists care for hospitalized and ambulatory patients and may play a major role in teaching and research.
  • Nephrology deals with the study of the function and diseases of the kidney.

 

Definition of Radiation Oncologist-------------------------------------------------- 

  • A radiation oncologist is a doctor who specializes in the treatment of cancer patients, using radiation therapy as the main modality of treatment. Radiation can be given as a curative modality, either alone or in combination with surgery and/or chemotherapy.

Doctor of Internal Medicine/Nephrology is not qualified------------------- 

  • This reviewer who evaluated my first appeal is woefully unqualified to render an opinion on this treatment.
  • The appropriate expertise would be direct clinical experience performing the treatment in question (SBRT/CyberKnife). A clinical peer for Dr. Beckman is another radiation oncologist that understands or has training with the CyberKnife system.

Level 2 Appeal 

Level 2 Appeal Denial states that the appeal was reviewed by a medical director representative, RN from utilization management, RN from medical policy and a service consultant from operations.

RN from Utilization Management Utilization management is the collection, assessment and monitoring of data that pertains to patient services and treatment. UM activities evaluate many aspects of patient care, such as the timeliness of services, the number of bed days used in a hospital, the amount of medication prescribed and a patients recovery time.

This person is supposed to ensure appropriate and cost effective care for patients. The RN from Utilization Management defers to the Medical Director for final determination.

  • This reviewer who evaluated my level 2 appeal is woefully unqualified to render an opinion on this treatment. In addition, a RN is not an MD. RNs are even less qualified to render their opinion on radiation therapy.
  • This reviewer who evaluated my level 2 appeal is also woefully unqualified to render an opinion on this treatment. In addition, a RN is not an MD. RNs are even less qualified to render their opinion on radiation therapy.
  • This reviewer who evaluated my level 2 appeal is also woefully unqualified to render an opinion on this treatment. Medical Directors do not have any direct knowledge or training on SBRT/CyberKnife treatment.
  • It becomes redundant to give explanations as to why each member of the appeal panel is not qualified. As previously stated, the appropriate expertise would be direct clinical experience performing the treatment in question (SBRT/CyberKnife). A clinical peer is another radiation oncologist that understands or has training with the CyberKnife system. Anything less than that renders the reviewers opinion invalid and inappropriate.
  • It is not appropriate to introduce a new reason for denial in a level 2 appeal. Medical Necessity was not a reason for denial in the level 1 appeal and should not be introduced at this point, whether directly or indirectly.
  • After reading the independent medical review report, it is obvious that the only data taken into account was from the insurer or from information the physicians obtained on their own. This is a clear violation of the law.
  • CyberKnife treatment for prostate cancer is proven to be the most costeffective treatment of all treatment options for prostate cancer. This was not taken into consideration in the independent review. This is a clear violation of the law.
  • The independent review neglected to include that this treatment was approved in 2001 for all areas of the body where radiation treatment is indicated. This is a relevant document. In addition, they chose to cite NCCN (National Cancer Coalition Network) guidelines, which offer no opinion on this treatment, which makes this irrelevant to this review.
  • Physician #1 cited only 2 references in his review. The NCCN and a study from 2005 as references. Of all of the 516 articles that were published on this treatment since September 2010, this physician chose to reference a study from 2005?
  • Physician #3 cited only 2 references in his review. The NCCN and a study from 2009. There are more than 516 articles that have been published since September 2010, this physician chose to reference one study from 2009?
  • A long term data study was published in January 2011. This study disproves most of what each physician claimed that participated in the independent review. This study concluded that - The current analysis is the first report of 5 year outcomes of SBRT for low-risk prostate cancer, and biochemical disease control is comparable to other available therapies, with equal to or better toxicity profiles. In addition, the treatment can be completed in a time period that is notably shorter (1-2 weeks) than conventional radiotherapy (8-9 weeks) an neither hospitalization nor surgical recovery is involved. These characteristics of SBRT may benefit patients by reducing health care costs. We look forward to a future multicenter studies that will examine outcomes with this treatment approach. (Debra E. Freeman, Christopher R. King. First Five Year Outcomes Published on Cyberknife Radiosurgery for Prostate Cancer. January 2011.
  • It is a violation of the law to ignore this study when it is the most relevant to the treatment in question and a published opinion of nationally recognized medical experts.
  •  
    • This physician cites 2 references that were reviewed to aid in his review. One was the NCCN guidelines. NCCN guidelines offer no opinion on SBRT/CyberKnife treatment for prostate cancer. The second reference was a study from 2005, which is extremely outdated. There are hundreds of other studies that are more recent, which would have been more appropriate for review.
    • This physician further claims that there is no published data on the long term efficacy and safety of CyberKnife treatments for prostate cancer. He goes on to claim that there are no publications in peer reviewed journals. This is not a truthful statement. There is actually an abundance of this data that has been published for many years. See the list of studies included and referenced all over this entire packet of information. They specifically speak to the safety and efficacy of SBRT/CyberKnife treatment for prostate cancer. In addition, we could provide hundred and hundreds of pages of studies that contradict this doctors statement.
  •  

    Physician #1 This physician has a sub specialty in Radiation Oncology,which does not make this person qualified to render an opinion on SBRT/CyberKnife treatment for prostate cancer. No direct clinical experience performing the treatment in question. Physician is licensed to practice in Illinois and Michigan. Medicare in both states cover SBRT/CyberKnife treatment for prostate cancer.

  •  
    • Recently accepted abstracts for American Society for Radiation Oncology (ASTRO) 2010 from two of this submissions signatories (Drs. King and Katz) show 5-year actuarial disease-free survival of 96-98% with continued low rates of late toxicity (0-3% Grade 3+ urinary and 0% Grade 3+ rectal toxicity (See Attachment #4)
    • Both the 2008 and 2010 AHRQ prostate cancer reports noted that available comparative data could not determine if one form of radiation therapy is superior to another form. (See Attachment #4)
    • The recent 5 year study was published in January 2011 confirming that SBRT/CyberKnife treatment for prostate cancer is comparable to other available therapies, with equal or better toxicity profiles. Stereotactic Body Radiotherapy for Low Risk Prostate Cancer: Five Year Outcomes. Freeman and King. (How can Physician #1 state that there is no published data on long term efficacy and safety of CyberKnife for prostate cancer) His statement proves he is not qualified to render an opinion on this treatment. He is clearly not up to date on the current information regarding this treatment.
  •  

     

  •  
    • This physician contradicts himself in his assessment. He states that, SBRT is not more likely to be more beneficial than standard therapies. He then states that standard treatments are more beneficial as they have low side effects.
    • The facts are that all treatment options for prostate cancer are proven not to be more beneficial than the other. The reason that SBRT/CyberKnife treatment is a treatment of choice for many men is that the treatment is non invasive and it only requires a 5 fraction course of radiation therapy. All of the other treatment options have a greater risk of side effects not low side effects as Physician #2 suggests.
  •  

    Physician #2 This physician is a Radiation Oncologist, however, not qualified to render an opinion on SBRT/CyberKnife treatment for prostate cancer due to no direct clinical experience performing the treatment in question.

    Physician #2 statements give a clear indication that he is not qualified to render an opinion on this treatment. He is clearly not up to date on the current information regarding this treatment.

  •  
    • Recently accepted abstracts for American Society for Radiation Oncology (ASTRO) 2010 from two of this submissions signatories (Drs. King and Katz) show 5-year actuarial disease-free survival of 96-98% with continued low rates of late toxicity (0-3% Grade 3+ urinary and 0% Grade 3+ rectal toxicity (See Attachment #4)
    • Both the 2008 and 2010 AHRQ prostate cancer reports noted that available comparative data could not determine if one form of radiation therapy is superior to another form. (See Attachment #4)
    • The recent 5 -year study was published in January 2011 confirming that SBRT/CyberKnife treatment for prostate cancer is comparable to other available therapies, with equal or better toxicity profiles. Stereotactic Body Radiotherapy for Low Risk Prostate Cancer: Five -Year Outcomes. Freeman and King. (How can Physician #2 state that there is a lack of medical literature when the 5 year study was published confirming the majority of the studies findings prior to the 5 year data.)
  •  

  •  
    • This physician cites the NCCN guidelines, which offer no opinion on SBRT/CyberKnife treatment for prostate cancer.
    • This physician only cites one study released in 2009. This is not a representative study sample of the more than 516 clinical and technical articles that are available to support the clinical effectiveness of the CyberKnife treatment.
    • This physician neglects to include or mention the recent 5 year study that was published in January 2011. This study confirms that SBRT/CyberKnife treatment for prostate cancer is comparable to other available therapies, with equal or better toxicity profiles.
  •  

  • According to Donald J. Palmisano, MD, who is the past president of the American Medical Association, he warns that big insurance plans could be in a better position to dictate patient care against doctors wishes. He goes on to say that, a great concentration of patients under one owner, that its not in the patients best interest.
  • The statements and observations made by Dr. Palmisano and the American Medical Association in 2004 are certainly ringing true in my Dads situation. There is simply no accountability nor care for my Dads best interest or his choice. His choice for treatment should be up to him and his Doctor. Anthem is not my Dads doctor nor have they ever examined him.

RN from Medical PolicyThey ensure medically appropriate, high quality, cost effective care. The RN from Medical Policy also defers to the Medical Director for final determination.

The consistency with the RNs job descriptions is to ensure cost effective high quality care for patients. SBRT/CyberKnife treatment for prostate cancer falls into the category of high quality, cost effective care, yet they still chose to uphold Anthems unreasonable denial.

Medical Director - It is largely a generic term used to describe a physician who has responsibility for the medical control and direction of various types of organizations, including hospital departments, blood banks, clinical teaching services and others. A medical director is a physician who is usually employed by a hospital to serve in a medical and administrative capacity as head of the organized medical staff.

RN Utilization Management, RN Medical Policy & Medical Director not qualified------------------------------------------------------------------------------------------------ 

Anthem introduces a new reason for denial in their level 2 appeal denial letter: Not Medically Necessary 

The LAW---------------------------------------------------------------------- 

Ohio Revised Code

Ohio Revised Statute 3923.67 sets forth the Request for external review of coverage denial. In paragraph (8), the statute states, In making its decision, an independent review organization conducting the review shall take into account all of the following:

(a)Information submitted by the insurer, the insured, the insureds provider, and the health care facility rendering the health care service, including the following:

(i)The insureds medical records;

(ii)The standards, criteria, and clinical rationale used by the insurer to make its decision.

(b)Findings, studies research, and other relevant documents of government agencies and nationally recognized organizations, including the national institute of health or any board recognized by the national institutes of health, the national cancer institute, the national academy of sciences, the United States food and drug administration, the health care financing administration of the United States department of health and human services, and the agency for health care policy and research;

( ) Relevant findings in peer reviewed medical or scientific literature, published opinions of nationally recognized medical experts, and clinical guidelines adopted by relevant national medical societies.

9 (b) The independent review organizations decision shall include a description of the insureds condition and the principal reasons for the decision and an explanation of the clinical rationale for the decision.

(E)The independent review organization shall base its decision on the information submitted under division

(D) (8) of this section. In making its decision, the independent review organization shall consider safety, efficacy, appropriateness, and cost-effectiveness.

The VIOLATION----------------------------------------------------------------------------- 

According to the law, 3923.67 (8) (a), the independent review organization must take into account information from the insurer (Anthem), the insured (Greg Lester), the insureds provider (Dr. Beckman), and the health care facility (Central Baptist Hospital CyberKnife Center).

According to the law, 3923.67 (E), the independent review organization shall base its decision on the information submitted under division (D) (8) of this section. In making its decision, the independent review organization shall consider safety, efficacy, appropriateness, and cost effectiveness.

According to the law, 3923.67 (b), Findings, studies research, and other relevant documents of government agencies and nationally recognized organizations, including the national institute of health or any board recognized by the national institutes of health, the national cancer institute, the national academy of sciences, the United States food and drug administration, the health care financing administration of the United States department of health and human services, and the agency for health care policy and research

According to the law, 3923.67 (c), relevant findings in peer reviewed medical or scientific literature, published opinions of nationally recognized medical experts, and clinical guidelines adopted by relevant national medical societies.

Independent Review Organization (IRO) Permedion 3 panel review------------------------------------------------------------------------------------------ 

FACTS that prove Physician #1 is not familiar with SBRT CyberKnife Treatment for prostate cancer-------------------------------------------------------- 

Physician #2 statements contradict what ASTRO and AHRQ reports from 2008 and 2010.

Physician #3 This physician has a sub specialty in Radiation Oncology, which does not make this person qualified to render an opinion on SBRT/CyberKnife treatment for prostate cancer. No direct clinical experience performing the treatment in question. Physician is licensed to practice in Tennessee. Medicare in this state covers SBRT/CyberKnife treatment for prostate cancer.

Summary of IRO----------------------------------------------------------------------------

The physicians affiliated with the IRO each stated their opinion on whether CyberKnife treatment was medically necessary. They all said that other treatments would have been more beneficial and/or appropriate. This treatment was not denied by Anthem because of medical necessity. It was denied because it was deemed experimental/investigative by Anthem. Medical necessity and Experimental/Investigative are not the same. It is inappropriate for the doctors that are participating in my IRO to advise that another treatment would have been more beneficial when medical necessity is not the issue.

Anthem and Wellpoint merge into the largest health plan in 2004-----

This merger, which was effective November 30, 2004, created the insurance giant that is Wellpoint, Inc. There are approximately 28 million members across 13 states. All in all, there are approximately 88 million people that are covered under the Blue Cross Blue Shield Brands. (See Attachment #16)

Personal Observations noted through extensive research of SBRT/CyberKnife--------------------------------------------------------------------------

It is inconvenient for a doctor to buck the system, especially one that has financial interests by participating in an Independent Review that is paid for by the insurance company.

Doctors, especially older physicians cant keep up with the cutting edge Cyberknife technology, which is offered all over the world.

Closing Summary--------------------------------------------------------------------------

Radiation, whether EBT, IGRT, IMRT, Brachytherapy or SBRT generates ionizing radiation that is precisely directed toward a target. It is physical energy, which when delivered in sufficient quantity, will prove lethal for the targeted tissue. This holds true for tissue that resides anywhere in the body, whether the head, chest, abdomen or pelvis. It is the doctors job to decide which radiation method optimizes the target versus normal healthy tissue. Those that are educated about that delicate balance between the target and healthy tissue understand that in many circumstances, the Cyberknife device is the modality that optimizes that balance better than any other radiation delivery technology available. Part of the problem that then makes this a major issue is that most physicians are not educated about this cutting edge technology that delivers radiation therapy.

In conclusion, we are now concentrating on getting our story out to the media. The failure of health care in our country is a major interest to people of our nation. This story is going to be of particular interest to the media as it will definitively expose Anthems failure to provide cost effective health care to the people that rely on them. Our story proves that Anthem is unwilling to cover cost effective, cutting edge technology for prostate cancer, which is proven to help rather than harm the male population. In addition, it will prove the real reason why Wellpoint, Inc is raising premiums across the board. It is simply because they are not interested in the best interest of the millions of people they insure, but only for their own profit.



Reference:
1. Medicare and CyberKnife
2. Pamletto SBRT Open Meeting Testimony

Attachments:
Supporting Articles:
1. Medicare and CyberKnife
2. Pamletto SBRT Open Meeting Testimony