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Anthem's SURG.00017 policy, prohibiting use of the CyberKnife for prostate cancer, is wrong.

By David Mullens, Esq.

The following brief was written for CyberKnife (R-SBRT) services provided in 2010. The arguments in favor of using the CyberKnife for prostate cancer in 2013 are even stronger. Anthem’s policy was and is opposed by ASTRO, by CMS/Medicare, by current medical literature, and by Anthem’s own definitions of “experimental/investigative” and “medically necessary.”

Arbitrator: ___________________, Esq.
Street, City, State, and zip.

 
Appellant: NAME OF CYBERKNIFE GROUP re
(first, last name of patient)

v.

Respondent: ANTHEM BLUE CROSS BLUE SHIELD OF (name of state)
 
Attorney for Plaintiff:
David D. Mullens
CA Bar No. 201283
The Law Office of David D. Mullens
378 Cambridge Ave., Suite C
Palo Alto, CA 94306
Phone Number: 650-320-9991
Fax Number: 650-320-9993
dmullens@mullenslawoffice.com
 
Pre-Arbitration Brief re (last name of patient)

Name of CyberKnife group (“Appellant”), by and through counsel, the Law Office of David Mullens, files this pre-arbitration brief regarding the December, 2010 claims denied for payment in the case of Mr. (first,last) Anthem Blue Cross Blue Shield ID Number: __________.

TABLE OF CONTENTS

  Pages
List of topic headings 2-7
Acronyms and words substituted for phrases 8
The (name of) CyberKnife Center’s overview of the dispute 9-12
Statement of the Case 9
How is Mr. (last name) doing? 9
There are two issues in this arbitration:
  1. Whether the Robotic Stereotactic Body Radiation Therapy (R-SBRT) used to treat Mr. (last name) was “experimental or investigative.”
  2. Whether the R-SBRT used to treat Mr. (last name) was “medically reasonable and necessary.”
9
The authorities relied upon by Anthem and by (name of CK center) tell the story of this dispute.
  1. Anthem relied on three articles. Two of the articles did not apply to Robotic, image-guided SBRT. The third article supported Robotic, image-guided SBRT for prostate cancer.
  2. The (name of CK center) relied on the CMS/Medicare and ASTRO policies on SBRT in effect at the time Mr. (last) was treated, and relied on the nearly identical definitions of “experimental/investigational” and “medically necessary” written by CMS/Medicare, by ASTRO, and by Anthem BC BS.
9-10
In December of 2010, when Mr. (last name) was treated, Medicare approved and paid for the R-SBRT treatment of prostate cancer. 10
In multiple ALJ hearings directly on point with the issues in (last name), the ALJs have uniformly found in favor of the doctors. 10
The ALJ decisions in favor of SBRT for prostate cancer should be given great weight by the arbitrator. 10-11
The American Society for Therapeutic Radiation and Oncology (ASTRO) Model Policy on SBRT, in effect when Mr. (last name) was treated, instructed insurance companies to pay for the SBRT treatment of prostate cancer. 11
Robotic SBRT is an improved version of an earlier form of external beam radiation therapy known as Intensity Modulated Radiation Therapy (IMRT), and IMRT is approved by Medicare, by ASTRO, and by Anthem for the treatment of prostate cancer. 11
Anthem Blue Cross Blue Shield of (Name of state) (Anthem) denied payment for (last name) based solely on Anthem’s SBRT policy in SURG.00017. 12
The Independent External Review doctor’s report (unintentionally) states R-SBRT for prostate cancer meets Medicare’s “medically reasonable and necessary” requirements for payment. 12
Summary of the (last name) pre-arbitration brief: In December of 2010, R-SBRT for prostate cancer met the standard of care for the treatment of prostate cancer; Anthem’s SURG.00017 policy on SBRT relied on three articles that were inapplicable to, or completely supportive of, R-SBRT for prostate cancer; and, based on Anthem’s own definitions, R-SBRT was not “experimental or investigative” and was “medically reasonable and necessary” for the treatment of prostate cancer. 12
Section I. 13
(Name of) CK center used a form of radiation therapy called Robotic Stereotactic Body Radiation Therapy (R-SBRT) to treat Mr. (last name’s) localized prostate cancer. 13
Radiation therapy can be administered in three different forms:
  1. External beam radiation therapy
  2. Brachytherapy, and
  3. Systemic radioisotope therapy
13
Over time, external beam radiation therapy has evolved from two dimensional radiation therapy (2D RT) to R-SBRT. 13
The treatment of prostate cancer with R-SBRT is different from the treatment of prostate cancer with IMRT:
  1. There is a difference in dose per treatment session (fraction);
  2. There is a difference in number of fractions per treatment plan; and
  3. There is a difference in treatment margins.
13-14
Here is a more detailed description of the R-SBRT treatment of prostate cancer. 14-15
All of Anthem’s denials were exclusively based on the SURG.00017statement: “Anthem considers SBRT to be investigational and not medically necessary for the treatment of primary or metastatic cancers of the kidney, prostate, liver, colon, and pancreas.” 15
Wellpoint frequently requests ASTRO’s guidance on the radiation oncology policies published by Anthem and by the BC BS Association members. 15
SURG.00017 wasn’t just out-of-date and incorrect regarding SBRT for prostate cancer. SURG.00017 was also out-of-date and incorrect regarding SBRT for lung, kidney, liver, pancreas, and renal cancer. 16
There are two groups of BC BS companies. Using identical definitions of “experimental/investigative” and “medically necessary”, one group of BC BS companies says SBRT for prostate cancer is not “experimental” or “investigative” and is “medically necessary.” The other group of BC BS companies says SBRT for prostate cancer is “experimental/investigative” and is not “medically necessary.” Both groups can’t be right. 17
BS of CA, the tenth largest insurance company in the country, changed their SBRT policy in 2008, after losing an Independent Medical Review decision and then conducting its own internal review. 17
Summary of Section I 18
Section II. 19
Payment was denied based on the version of SURG.00017 in effect when Mr. (last name) was treated. Copies of the three articles on prostate cancer cited in that version of SURG.00017 are enclosed. 19
The authorization and representation form for (name of CK center), the (name of CK center) -Anthem provider contract, and the treatment, billing, and appeal records for Mr. (last name) are enclosed. 19
The CV for the retained expert radiation oncologist, Dr. (first,last), and the CVs for the treating radiation oncologists and the treating radiation physicist are enclosed. 19
Section III. 20
The (last name) claim denial was appealed up to and including an Independent External Review (IER). The IER doctor supported R-SBRT for localized prostate cancer as “highly beneficial, with long lasting results, with little chance of harm, and as a cost effective way to treat prostate cancer.” However, the IER doctor denied payment because “alternate therapies were available.” 20
The IER doctor failed to address the correct issue: whether the provider met the national radiation oncology standard of care regarding the use of Robotic-SBRT for localized prostate cancer. 20
The IER doctor unintentionally supported SBRT for prostate cancer 20
Section 13.5.1 of the Medicare Program Integrity Manual lists the requirements for “medically reasonable and necessary” services and R-SBRT for prostate cancer meets these requirements. 21-22
The IER doctor denied payment for an invalid reason. 22
If Anthem is not held to the correct standard of care, Anthem can enforce any policy it wants to - no matter how wrong - and appeal of any claim denied under that policy would be futile. 23
Summary of Section III 24
Section IV. 25
In December of 2010, R-SBRT was approved for the treatment of localized prostate cancer by CMS/Medicare and by ASTRO, the two organizations that determine national coverage policies for radiation oncology. 25
Based on the numbers, CMS/Medicare sets the nationwide “clinical” standards regarding the use of SBRT for localized prostate cancer. 25
Based on the numbers, Anthem BC BS is a minor insurance entity in the treatment of prostate cancer. 25
CMS wrote the definitions for the Robotic SBRT radiation delivery codes, G0339 and G0340, in 2003 and has published those definitions in the HCPCS II Manual every year since 2004. 25
Through the Hospital Outpatient Prospective Payment System, CMS determines how R-SBRT is to be billed by every hospital in the country. 26
Medicare sets the “industry standard” regarding the use of Robotic SBRT for localized prostate cancer. 26
The correct outcome for this dispute has already been decided by CMS/Medicare. 26
In 2010, TrailBlazer, the Medicare Administrative Contractor for (Name of state), had a negative SBRT-for-prostate-cancer policy. 26
The 2010, the TrailBlazer SBRT-for-prostate-cancer claim denials were overturned by the Administrative Law Judges who uniformly found SBRT for localized prostate cancer was not “experimental/investigative” and was “medically reasonable and necessary.” 27
The ALJ decisions in favor of SBRT for prostate cancer should be given great weight by the arbitrator. 27-28
In August of 2010, ASTRO published its updated model Policy on SBRT, approving SBRT for prostate cancer. 28
Based on ASTRO’s August 2010 Model Policy for SBRT, TrailBlazer now allows SBRT for prostate cancer. 28
The ASTRO requirement for IRB study enrollment does not mean R-SBRT for prostate cancer is “experimental/investigative.” 28
The IRB studies on “CyberKnife and prostate cancer” are not designed to determine whether R-SBRT can be used for prostate cancer. The IRB studies are designed to determine the long term effects of R-SBRT and are designed to compare the long term results of R-SBRT to the long term results of HDR brachytherapy, IMRT, and surgical prostatectomy. 28-29
In 2010, WellPoint requested ASTRO’s comments on WellPoint’s SRS and SBRT policy but Anthem made no changes to SURG.00017 based on ASTRO’s recommendations. 29
In 2012, WellPoint again requested ASTRO’s comments on Wellpoint’s SBRT policy but again made no changes to SURG.00017 based on ASTRO’s repeated recommendations. 29
The “immobilization, organ localization, and precise dose delivery” issues cited by Buyyounouski are non-issues for R-SBRT. 30
Summary of Section IV 31
Section V 32
Two of the three articles used to support Anthem’s SBRT for prostate cancer policy in SURG.00017 were outdated and inapplicable to the R-SBRT provided for Mr. (last name). The third article supports R-SBRT for prostate cancer 32
The first paragraph on prostate cancer in SURG.00017 quotes an out-of-date 2007 article by Madsen on the use of non-Robotic SBRT, performed without real-time image guidance. 32
CMS states Robotic SBRT is far more complex than non-Robotic SBRT. 32-33
The second paragraph on prostate cancer in SURG.00017 quotes a 2009 article by King, supporting R-SBRT for localized prostate cancer. 33
The third and final paragraph on prostate cancer in SURG.00017 quotes a 2010 article by Buyyounouski. The selective Buyyounouski quote on “immobilization, organ localization and precise delivery” is inapplicable to R-SBRT. 34
Articles published before December of 2010 support the use of R-SBRT for localized prostate cancer. 34-36
Articles published after December of 2010 continue to support the use of R-SBRT for localized prostate cancer. 36-39
Summary of Section V 40
Section VI 41
Based on Anthem’s requirements regarding the “formation of medical policy” in Anthem’s ADMIN.00001, R-SBRT for localized prostate cancer was “medically necessary” and was not “investigational.” 41
ADMIN.00001 states Anthem’s medical policies are intended to reflect the current scientific data and clinical thinking. 41
Anthem’s “electronic literature search” in support of the SURG.00017 prostate policy was limited to three articles. 41
The BC BS Technology Evaluation Center has no policy on SBRT 41
The NCCN Guidelines were limited to the same three articles cited by Anthem and AHRQ had no data to compare the various types of external beam radiation in the treatment of prostate cancer. 42
CMS/Medicare, the “appropriate government regulatory body” approved R-SBRT for prostate cancer in 2010. 43
ASTRO, the “national physician specialty society” for radiation oncology, approved R-SBRT for prostate cancer in 2010. 43
Based on Anthem’s requirements regarding “investigational” in Anthem’s ADMIN.00005, and based on the Anthem Benefit Booklet specific to Mr. (last name), R-SBRT for localized prostate cancer was not “experimental/investigational.” 43-46
Based on Anthem’s requirements regarding “medically necessary” in Anthem’s ADMIN.00004, and based on the Anthem Benefit Booklet specific to Mr. (last name), R-SBRT for localized prostate cancer was “medically necessary.” 46-49
Summary of Section VI 50-51
Request for Relief 51
List of Attachments 52-56

 

Acronyms and words substituted for phrases
2D RT Two dimensional radiation therapy
3D CRT Three dimensional conformal radiation therapy
3D RT Three dimensional radiation therapy
ACR American College of Radiology
ADMIN.00001 The Anthem policy on the “formation of medical policy”
ADMIN.00004 The Anthem policy on “Medical Necessity Criteria”
ADMIN.00005 The Anthem policy on “Investigational Criteria”
AHRQ Agency for Healthcare Research and Quality
AMR Advanced Medical Reviews (the company that performed the IER)
Anthem Anthem Blue Cross Blue Shield of (Name of state)
ASTRO American Society for Therapeutic Radiation and Oncology
BCBSA Blue Cross Blue Shield Association
CED Coverage for Evidence Development
CyberKnife The Robotic SBRT unit made by Accuray
Experimental/Investigational “Experimental” and “Investigational” are terms of art identically defined both by CMS/Medicare and by Anthem.
FDA The Food and Drug Administration
F.R. The Federal Register
G0339 The HCPCS II radiation delivery code for the 1st day of therapy with Robotic Stereotactic Body Radiation Therapy
G0340 The HCPCS II radiation delivery code for the 2nd, 3rd, 4th, and 5th days of therapy with Robotic Stereotactic Body Radiation Therapy
HOPPS The Hospital Outpatient Prospective Payment System used by CMS/Medicare to announce the nationwide fees for G0339 and G0340
IER Independent External Review
IRB Institutional Review Board
IMRT Intensity Modulated Radiation Therapy
LCD Local Coverage Determination
Medically Reasonable and Necessary A term of art defined by CMS/Medicare and identical to the term “Medically Necessary” defined by Anthem
Medically Necessary A term of art defined by Anthem and identical to the term “Medically Reasonable and Necessary” defined by CMS/Medicare
NCD National Coverage Determination
NCCN National Comprehensive Cancer Network
RT Radiation Therapy
R-SBRT Robotic Stereotactic Body Radiation Therapy
SBRT Stereotactic Body Radiation Therapy
SEER/NCI Surveillance, Epidemiology, and End Results program of the National Cancer Institute
SSA The Social Security Act
SURG.00017 The Anthem BC BS medical policy on SBRT
TrailBlazer The Medicare Administrative Contractor for CO, NM, OK, and TX when (last name) was treated in 2010
www.clinicaltrials.gov The internet website that lists the clinicaltrials.gov IRB studies

 

OVERVIEW OF (NAME OF CK CENTER)’S BRIEF

Statement of the case

Mr. (first, last), a __ year old male with localized prostate cancer, was treated by (name of CK center) in December of 2010 with Robotic Stereotactic Body Radiation Therapy (R-SBRT). Mr. (last name) had a PPO plan and his plan benefits were administered by Anthem Blue Cross Blue Shield of (Name of state) (Anthem). Anthem denied payment, stating SBRT for prostate cancer was “investigational and not medically necessary.” (Name of CK center) argues the R-SBRT services provided for the treatment of Mr. (last name’s) localized prostate cancer were not “experimental/investigative” and that the R-SBRT services were “medically reasonable and necessary.”

How is Mr. (last name) doing?

Mr. (last name) is thrilled with the results of his CyberKnife treatment. He had no symptoms during or after his radiation and his PSA continues to fall. His declaration is enclosed as Attachment # __.

There are two issues in this arbitration.

The issues in this arbitration are:

  1. Whether the R-SBRT used to treat Mr. (last name’s) localized prostate cancer in December of 2010 was “experimental/investigative”; and
  2. Whether the R-SBRT used to treat Mr. (last name’s) localized prostate cancer in December of 2010 was “medically reasonable and necessary.”

The authorities relied upon by Anthem and by (Name of CK center) tell the story of this dispute.

Anthem denied payment of (name of CK center’s) claims based on SURG.00017, Anthem’s “Medical Policy” on the subject of SBRT. In December of 2010, SURG.00017 had only three paragraphs on prostate cancer and each paragraph was tied to a single article on the subject of SBRT for prostate cancer. The first paragraph cited a 2007 article by Madsen that described the use of non-Robotic SBRT, without real-time image guidance, for a small number of patients with prostate cancer. The second paragraph cited a 2009 article by King that was supportive of Robotic SBRT for prostate cancer. The third paragraph consisted of a single quote from an article by Byyounouski, and the quote was inapplicable to Robotic SBRT. See Section V.

On the other hand, (name of CK center) asserts the R-SBRT services provided for Mr. (last name) were not “experimental/investigative” and that the R-SBRT services were “medically reasonable and necessary”: based on the definitions of these phrases by the patient’s insurance handbook, by Anthem, by the Social Security Act, and by CMS/Medicare; based on Federal agency requirements through the Social Security Act, CMS, and Medicare regarding payment for R-SBRT services; based on the standard of care in December of 2010 as determined by CMS/Medicare and by the American Society for Therapeutic Radiation and Oncology (ASTRO); based on many peer-reviewed articles published before December of 2010; and based on multiple, uniformly favorable ALJ decisions regarding the exact same issues as are present in (last name of patient). See Sections I, III, IV, and V.

In December of 2010, when Mr. (last name) was treated, Medicare approved and paid for the R-SBRT treatment of prostate cancer.

Under §1862(a)(1)(A) of the Social Security Act, only “medically reasonable and necessary” services qualify for payment under Medicare. Under §13.5.1 of the Medicare Program Integrity Manual, a Medicare service must not be “experimental or investigative” and must be “medically reasonable and necessary” in order to qualify for payment. Under Medicare’s National Coverage Determination (NCD) 310.1, payment for an “experimental” service is prohibited. In December of 2010, when Mr. (last name) was treated, Medicare approved and paid for the R-SBRT treatment of prostate cancer. See Section III.

In multiple ALJ hearings directly on point with the issues in (last name), the ALJs have uniformly found in favor of the radiation oncologists.

In December of 2010, TrailBlazer, the Medicare Administrative Contractor for (Name of state), had a negative SBRT-for-prostate cancer policy. In multiple ALJ hearings directly on point with the issues in this arbitration, the Administrative Law Judges uniformly decided in favor of the doctors. The ALJs concluded R-SBRT for prostate cancer was not “experimental or investigational” and that R-SBRT for prostate cancer was “medically reasonable and necessary.” See Section IV.

The ALJ decisions in favor of SBRT for prostate cancer should be given great weight by the arbitrator.

Medicare’s National Coverage Determination (NCD) 310.1 prohibits payment for services that are “experimental / investigational.” As required in 42 C.F.R. § 405.1060(a)(4), NCDs are binding on ALJs. The only exception to this C.F.R. rule occurs when CMS publishes an NCD with CED (Coverage with Evidence Development) for a specific service. There is no NCD with CED for SBRT.

As required in §1862(a)(1)(A) of the Social Security Act, the ALJs must conclude a treatment is “medically reasonable and necessary” in order to award payment. The “medically reasonable and necessary” requirements are further codified in the Medicare Program Integrity Manual, Chapter 13, Section 13.5.1. Medicare’s “reasonable and necessary” requirements are the same as Anthem’s “medically necessary” requirements.

Aware of CMS/Medicare requirements for the evidence used to support LCD coverage policies, all of the ALJs were willing to overturn TrailBlazer’s unsupported denials. The CMS/Medicare evidence requirements for LCD coverage policies are detailed in the Medicare Program Integrity Manual, Chapter 13, Section 13.7.1.

Under 42 CFR § 405.1062, an ALJ must give “substantial deference” to an LCD policy that applies to a particular case, and must “explain the reasons why the policy was not followed.” The ALJs who authored the decisions in favor of the doctors gave substantial deference to L26835, but refused to apply TrailBlazer’s negative policy re SBRT for localized prostate cancer.

TrailBlazer’s negative 2010 SBRT-for-prostate-cancer policy was wrong for the same reasons Anthem’s policy is wrong: The national radiation oncology standard of care supported the use of SBRT for prostate cancer. Not insignificantly, TrailBlazer now approves SBRT-for-prostate-cancer, based on ASTRO’s August, 2010 Model Policy statement.

Although copies of the ALJ decisions for the cases in which I was the attorney for the Appellant/provider are the only decisions enclosed, it may reasonably be inferred other SBRT-for-prostate-cancer appeals have also been decided in favor of other radiation oncology groups represented by other attorneys. See Section IV.

The ASTRO Model Policy on SBRT, in effect when Mr. (last name) was treated, instructed insurance companies to pay for the SBRT treatment of prostate cancer.

The American Society for Therapeutic Radiation and Oncology published a Model Policy on SBRT in August of 2010, stating all insurance companies should pay for the SBRT treatment of prostate cancer. Although Anthem will claim ASTRO’s requirement for enrollment in an IRB study implies R-SBRT for prostate cancer was investigational, a review of Anthem’s definition of “investigational” combined with the CMS/Medicare prohibition against payment for investigational services yields a different conclusion: The Robotic SBRT used for Mr. (last name) was not investigational. See Section IV.

Robotic SBRT is an improved version of an earlier form of external beam radiation therapy known as IMRT, and IMRT is approved by Medicare, by ASTRO, and by Anthem for the treatment of prostate cancer.

Robotic Stereotactic Body Radiation Therapy, a form of external beam radiation therapy, reflects the continuing evolution of external beam radiation therapy from 2D Radiation Therapy (RT), to 3D RT, to 3D Conformal RT, to Intensity Modulated Radiation Therapy (IMRT), to Robotic SBRT – the form of radiation therapy used by (name of CK center) to treat Mr. (last name’s) localized prostate cancer in December of 2010. The high energy radiation produced with R-SBRT is exactly the same type of high energy radiation produced with IMRT. The difference between IMRT and R-SBRT is the greatly improved accuracy of R-SBRT that allows higher doses of radiation, with greater radiobiologic effect, to be placed on the cancerous prostate. See Section I.

Anthem denied payment for (last name) based on the SBRT policy in SURG.00017, and that policy relied on three articles. Two of the articles were out of date and/or inapplicable to R-SBRT and the third article supported R-SBRT for prostate cancer.

Anthem Blue Cross Blue Shield of (Name of state) (Anthem) denied payment based on Anthem’s SURG.00017 medical policy regarding SBRT. No other reason for denial has been offered. In turn, the SURG.00017 prostate policy was supported by three articles. The first article, by Madsen, was published in 2007 on the subject of non-Robotic, non-image guided SBRT. Because R-SBRT is both “robotic” and “image guided”, R-SBRT should be distinguished from the SBRT used by Madsen. The second article, by King, supported R-SBRT for prostate cancer. The third paragraph consisted of a short quote from an article by Buyyounouski, and the quote had nothing to do with R-SBRT. The three articles relied upon by Anthem to support the prostate policy section of SURG.00017 were outdated and/or inapplicable, or completely supportive of R-SBRT for prostate cancer. See Section II.

1 “ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics

The IER doctor’s report (unintentionally) stated R-SBRT for prostate cancer meets all of Medicare’s requirements for payment.

The Anthem denial for (last name) was appealed up to and including an Independent External Review (IER). The IER doctor supported R-SBRT for localized prostate cancer as “highly beneficial, with long lasting results, with little chance of harm, and as a cost effective way to treat prostate cancer.” As a result, the IER doctor (unintentionally) stated R-SBRT met all of the Medicare requirements for payment. However, instead of approving the R-SBRT for (last name), the IER doctor denied payment because “alternate therapies were available.” See Section III.

Summary of the (last name) pre-arbitration brief

At the time of Mr. (last name’s) treatment, and by the “preponderance of the evidence” standard applicable to this dispute:

  1. R-SBRT was approved for the treatment of localized prostate cancer by CMS/Medicare and by the American Society of Therapeutic Radiation and Oncology (ASTRO), the two organizations that determine national coverage policies for radiation oncology (Section IV);
  2. Anthem’s SBRT for prostate cancer policy was outdated and inapplicable to the R-SBRT provided for Mr. (last name) (Section V); and
  3. 3. Based on Anthem’s own definitions, and based on Federal agency (CMS/Medicare) definitions, the R-SBRT provided for Mr. (last name) was “medically reasonable and necessary” and was neither “experimental nor investigative” (Section VI).

Section I.

(Name of CK center) used a form of radiation therapy called Robotic Stereotactic Body Radiation Therapy (R-SBRT) to treat Mr. (last name’s) localized prostate cancer.

Radiation therapy can be administered in three different forms.

Radiation therapy can be divided into the following categories: external beam radiation therapy, brachytherapy, and systemic radioisotope therapy. For a description of these three types of radiation therapy, please see p. 5-7 of Attachment #1. The radiation therapy at issue, R-SBRT, is a form of external beam radiation therapy where the radiation is delivered from a source outside the body. See Attachments # 2, 3, 4 for descriptions of external beam radiation therapy and R-SBRT (CyberKnife® by Accuray).

Over time, external beam radiation therapy has evolved from two dimensional radiation therapy (2D RT) to R-SBRT.

Here is a simple overview of the characteristics of each Radiation Therapy (RT) platform in the evolution from 2D, to 3D, to 3D conformal, to IMRT, to R-SBRT:

  1. 2D RT: radiation delivered on the x and y axes (height and width)
  2. 3D RT: radiation delivered on the x, y, and z axes (height, width, and depth)
  3. 3D Conformal RT: radiation delivered on the x, y, and z axes + shaping the x-ray beam to the shape of the tumor
  4. IMRT: all of the characteristics of 3D conformal + delivering the beam as thousands of individual “beamlets” of varying intensity
  5. Robotic-SBRT: all of the characteristics of IMRT + real time imaging of the patient during treatment that allows a computer to control the position of a robotic arm and the aim of an x-ray gun (at the end of the robotic arm) that fires the x-ray beam with precise accuracy, even if the prostate is moving during treatment. For a good overview of R-SBRT and the use of R-SBRT for prostate cancer, see Attachments # 4, 5, 6.

The treatment of prostate cancer with R-SBRT is different from the treatment of prostate cancer with IMRT.

First, there is a difference in dose per treatment. With R-SBRT, a very large dose of radiation is given at each treatment session (fraction).

The a/ß ratio number for the tissue being treated reflects the sensitivity of that particular tissue to radiation. See Attachments #8, 9. The lower the a/ß ratio number, the more sensitive that tissue/cancer is to higher doses of radiation administered in fewer sessions. The higher the a/ß ratio number, the more sensitive that tissue/cancer is to lower doses of radiation administered over many sessions.

The a/ß ratio number for prostate is low, between 1.5 and 3.0, and this favors fewer treatments with higher doses of radiation at each session. See Attachments #10, 11, 13. With R-SBRT, the dose of radiation is usually between 6.75 and 9.5 Gy/fraction. See Attachments #10, 11, 125.

With IMRT, a lower dose of radiation is usually given at each treatment session, usually between 1.5 and 2.0 Gy/fraction . See Attachment # 13.

Despite the low a/ß ratio of prostate, and because IMRT results in the exposure of adjacent structures (bladder and rectum) to radiation, IMRT for prostate cancer is given at lower doses over many treatment sessions.

Second, there is a difference in number of treatments per treatment plan. By definition, R-SBRT is given in no more than 5 treatments. See the definitions of the radiation delivery codes G0339 and G0340 in Attachment #14. IMRT for prostate cancer is usually given in 42 to 45 treatments. However, when regular dose IMRT is coupled with several fractions of boost dose IMRT, the total number of treatments may be reduced to 30.

Third, there is a difference in treatment margins. With robotic precision, R-SBRT places the treating x-ray beam on the prostate, with planned 3-5 mm margins overlapping the edges of the prostate. The overlapping 3-5 mm margins are included in the treatment plan in order to avoid missing any microscopic, extra-capsular extension of the prostate cancer. But the only reason the 3-5 mm treatment plan margins can be reliably achieved, to an accuracy of less than 1 mm, is because R-SBRT is able to couple robotic precision with ongoing image guidance during treatment.

The treatment margins with IMRT are planned anywhere between 5mm-10mm (1cm) beyond the margins of the prostate.

Here is a more detailed description of the R-SBRT treatment of prostate cancer.

The R-SBRT treatment module has two low energy x-ray cameras, one on either side of the patient. When used to treat prostate cancer, these low energy x-ray cameras send images of the prostate approximately every 40 seconds to a high speed computer that controls the position of a robotic arm (like the robots in a car assembly line) that can move in any direction (up and down, forwards and backwards, in and out) and the aim of the “linac”, a miniature linear accelerator (x-ray gun) at the end of the robotic arm. See Attachments # 4, 5, 6.

Two weeks before the R-SBRT treatment sessions, tiny gold (fiducial) seeds are surgically implanted in the patient’s prostate. In addition, pre-treatment MRI and CT scans are performed after placement of the gold fiducial seeds and these images are transferred to the high speed R-SBRT computer before the R-SBRT treatment sessions begin.

Due to the flow of urine into the bladder and/or the movement of gas in the rectum, the prostate moves during treatment even though the patient lies perfectly still. See Attachment #15. During the R-SBRT treatment sessions, the low energy x-ray images of the prostate are sent to the high speed computer, telling the computer exactly where the prostate is in the three dimensions of space, at that moment in time. The low energy x-ray images are usually taken at 40 second intervals because enough movement of the prostate to require reacquisition of the targeted prostate does not occur more frequently than once every 40 seconds.

The high speed computer compares the low energy x-ray camera images with the MRI and CT images. The computer then adjusts the position of the robotic arm and the aim of the x-ray gun so precisely that the margins of the treating x-ray beam are less than 1 mm from the edges of the planned treatment volume.

2 An important exception is made when a boost dose of IMRT, precisely delivered with a CyberKnife unit modified to provide IMRT, is given as part of an IMRT treatment plan. When a boost dose of IMRT is given as part of a prostate cancer treatment plan, the dose of radiation may be as high 6.5 to 7.0 Gy/fraction for several fractions. See the discussion of CPT code 77301 (IMRT planning code) in the 6th edition of the “Principles of CPT Coding”, published by the American Medical Association, Attachment #12.

All of Anthem’s denials were exclusively based on the SURG.00017statement: “Anthem considers SBRT to be investigational and not medically necessary for the treatment of primary or metastatic cancers of the kidney, prostate, liver, colon, and pancreas.”

(Name of CK center) is a contracted Anthem BC BS of (Name of state) provider. See Attachment #16. The pre-authorization requests for the use of R-SBRT for Mr. (last name), the post-treatment claims for payment, and the post-treatment appeals were all denied based solely on Anthem’s SURG.00017 policy on SBRT. See Attachments #17-22. The denials included the statement: “Anthem considers SBRT to be "investigational and not medically necessary for treatment of primary or metastatic cancers of the kidney, prostate, liver, colon, and pancreas based on SURG.00017.”

Wellpoint frequently requests ASTRO’s guidance on the radiation oncology policies published by Anthem and by the Blue Cross Blue Shield Association members.

Wellpoint has requested ASTRO’s comments on Anthem’s and the Blue Cross Blue Shield Association’s medical policies regarding: PET and PET/CT Fusion (RAD.00002), Brachytherapy (RAD.00014), IMRT of the breast and lung (#8.01.46), SRS and SBRT (SURG.00017), Accelerated Breast Irradiation after Breast-Conserving Surgery for Early Stage Breast Cancer (policy 00.00.00ABI), IMRT of the Prostate (#8.01.47), SRS and SBRT (policy #6.01.10), IMRT of the Abdomen and Pelvis (policy #8.01.49), IMRT for Cancer of the Head and Neck or Thyroid (policy #8.01.48), and Charged-Particle Radiation Therapy (policy #8.01.10). ASTRO has posted all of its responses to the Anthem and the Blue Cross Blue Shield Association policies on the ASTRO website and those responses are enclosed as Attachments # 23-32.

Anthem and the Blue Cross Blue Shield Association rely on ASTRO, the national authority on radiation oncology coverage policies, for guidance as to which radiation therapy services should be allowed for each type of cancer. As the parent specialty organization for radiation oncology, ASTRO provides this oversight for all of the insurance entities.

SURG.00017 wasn’t just out-of-date and incorrect regarding SBRT for prostate cancer. SURG.00017 was also out-of-date and incorrect regarding SBRT for lung, kidney, liver, pancreas, and renal cancer.

All of the Medicare LCDs, including the TrailBlazer Local Coverage Determination (LCD) L26835 (4R-24AB-R4) version for (Name of state) in effect from 10-18-10 to 12-31-10, approved SBRT for primary and metastatic tumors of the lung, kidney, liver, pancreas and adrenal gland. See Attachments #33-46.

The ASTRO Model Policy on SBRT, in effect in December of 2010, also approved SBRT for primary and metastatic tumors of lung, kidney, liver, pancreas and adrenal gland. See Attachment #47.

Anthem BC BS of (Name of state) is a subsidiary of Wellpoint, Inc. See Attachment #48. In a letter dated November 18, 2010, ASTRO, responded to a request from Barbara J. Brown, the “Corporate Medical Policy Analyst” at Wellpoint’s Office of Medical Policy and Tech Assessment. Ms. Brown had asked for ASTRO’s comments on Anthem’s SBRT policy and the letter stated ASTRO was “surprised” to see SBRT labeled “investigational” (by Anthem) for the treatment of lung, kidney, liver, pancreas and adrenal tumors. See Attachment #26.

ASTRO did not comment on its SBRT policy for prostate cancer in the November 18, 2010 letter to Barbara J. Brown, apparently because ASTRO’s August 2010 Model Policy on SBRT already included the statement that “payment should be made for the SBRT treatment of prostate cancer.” See Attachment #47.

In a second letter dated March 19, 2012, ASTRO sent another response to Barbara J. Brown at Wellpoint’s Office of Medical Policy and Tech Assessment. Wellpoint apparently requested ASTRO’s comments on Wellpoint’s SRS (policy # 6.01.10) and SBRT (policy # 6.01.R-14). The March 19, 2012 ASTRO letter referred Ms. Brown back to ASTRO’s November 18, 2010 letter regarding the use of SBRT for liver, kidney, adrenal, and pancreas tumors. See Attachment # 29.

The second (March 19, 2012) letter from ASTRO apparently did result in a Wellpoint review of its SBRT policy. Highmark BC BS of Delaware subsequently approved SBRT for “primary and metastatic tumors of the lung, liver, kidney, adrenal gland, pancreas and prostate” in policy number 6.01.R-14, effective as of 04/01/2012. See page six of Attachment # 99.

In addition to being in conflict with other BC BS Association members regarding the treatment of prostate cancer, Anthem’s SURG.00017 was and is out of date regarding the national radiation oncology standards for the SBRT treatment of lung, kidney, liver, pancreas and adrenal tumors.

There are two groups of BC BS companies. One group says SBRT for prostate cancer is not “experimental” or “investigative” and is “medically necessary.” The other group says SBRT for prostate cancer is “experimental/investigative” and is not “medically necessary.” Both groups can’t be right.

Anthem Blue Cross Blue Shield and the Blue Cross Blue Shield Association companies use nearly identical definitions for “experimental/investigative” and “medically necessary.” However, there are two groups of BC BS companies. One group says SBRT for the treatment of prostate cancer is not “experimental or investigative” and that SBRT is “medically necessary” for the treatment of prostate cancer. The other group says just the opposite.

What is the difference between the two groups? The group of BC BS companies that now approve SBRT for prostate cancer changed their SBRT policy: when their SBRT policy was successfully challenged, as occurred with Blue Shield of California in 2008; when a request was made to WellPoint to act as intermediary with ASTRO in order to obtain guidance regarding correct SBRT coverage policies, as occurred with Highmark BC BS of Delaware; or when the company simply conducted its own internal review of SBRT for prostate cancer, as occurred with BC BS of New Jersey. In all three cases the change in SBRT policy was directly attributable to the change in ASTRO policy in August of 2010, approving SBRT for prostate cancer. The Highmark BC BS of Delaware’s # 6.01.R-14 policy is enclosed as Attachment # 99. The BC BS of New Jersey’s policy 044 is enclosed as Attachment # 101.

BS of CA, the tenth largest insurance company in the country, changed their SBRT policy in 2008 after losing an Independent Medical Review decision and then reviewing its policy on SBRT for prostate cancer.

According to a U.S. News and World report, in 2011 Blue Shield of CA was the tenth largest insurance company in the U.S. See Attachment # 67. In 2008, a BS of CA policy holder with prostate cancer, Mr. Fred Kinder, challenged the BS of CA policy on SBRT for prostate cancer. Mr. Kinder lost all of the internal appeals and then requested an Independent Medical Review (IMR), conducted by the CA Department of Managed Health Care. Two out of the three radiation oncologists who reviewed his case concluded the use of the CyberKnife was “likely to be more beneficial than any standard therapy.” See Attachments # 148-151.

After losing the IMR decision, BS of CA reviewed its policy on SBRT for prostate cancer and published a revised policy, effective July 7, 2008.

Summary of Section I.

R-SBRT is a form of external beam radiation therapy, is capable of precision not possible with earlier forms of external beam radiation, and is part of a continuum in the evolution from 2D, to 3D, to 3D conformal, to IMRT, to R-SBRT.

Academically and clinically, R-SBRT has distinct advantages over IMRT in the treatment of localized prostate cancer. With a very low a/ß ratio, prostate cancer is more sensitive to very high doses of radiation administered in fewer treatment sessions with R-SBRT, as opposed to lower doses administered over many treatment sessions with IMRT.

As noted in every version of the TrailBlazer LCD L26835 for (Name of state): “SBRT is a treatment that couples a high degree of anatomic targeting accuracy and reproducibility with very high doses of extremely precise, externally generated, ionizing radiation, thereby maximizing the cell-killing effect on the target (prostate) while minimizing radiation-related injury in adjacent normal tissues (bladder and rectum).” See Attachments #33-41.

Using Anthem’s definitions of “experimental, investigational, and medically necessary”, several BC BS Association member companies have approved SBRT for prostate cancer. For example, Highmark BC BS of Delaware’s # 6.01.R-14 policy and BC BS of New Jersey’s policy 044 both approve SBRT for prostate cancer.

A key difference between Anthem and the BC BS Association companies that have favorable SBRT-for-prostate cancer policies is this: The BC BS Association companies that have made the effort to review the subject have changed their policy. By contrast, Anthem continues to rely on a small number of out-of-date or inapplicable articles to justify an old and incorrect policy.

In 2008, BS of CA, the tenth largest health insurance company in the country, changed its policy on SBRT for prostate cancer. The BS of CA SBRT-for-prostate cancer policy was challenged by Mr. Fred Kinder, a BS policy holder and a subsequent Independent Medical Review decided in favor of Mr. Kinder. BS of CA then conducted its own internal review and based on that review, BS of CA changed its policy to approve SBRT for prostate cancer.

The Anthem denials for (last name) were consistently based only on the SURG.00017 policy. According to CMS/Medicare and ASTRO, Anthem’s Medical Policy, SURG.00017, was out-of-date and incorrect regarding R-SBRT for prostate, lung, kidney, liver, pancreas, and adrenal cancer.

Section II.

Payment was denied based on the version of SURG.00017 in effect when Mr. (last name) was treated.

Anthem’s written policy on SBRT is titled: SURG.00017. The version of SURG.00017 in effect at the time of Mr. (last name’s) treatment is enclosed. See Attachment #60. Copies of all of the articles cited in SURG.00017 on the subject of SBRT for prostate cancer are also enclosed. See Attachments #10, 11, 13.

Although substantively unimportant, the apparent incorrect use of “SURG” for a policy on ionizing radiation is a comment on Anthem’s effort in writing its SBRT policy: The Anthem BC BS policy on SBRT is the only Anthem policy on ionizing radiation (incorrectly) labeled as a Surgery (“SURG”) policy instead of a Radiology (“RAD”) policy. See Attachment #61.

Copies of the (name of CK center) authorization and representation form and the (name of CK center)-Anthem provider contract are enclosed along with the treatment, billing, and appeal records for Mr. (last name).

All of the following documents are enclosed: Copies of the (name of CK center) authorization and representation form and the (name of CK center)-Anthem PPO provider agreement (See Attachments # 142 and 16); the pre-treatment examination, PSA, and prostate biopsy findings (See Attachment #17); the pre-treatment consultation with Dr. (last name of treating radiation oncologist) (See Attachment #49); the (name of CK center) -“treatment book” for Mr. (last name) (See Attachment #50); the billing records (claims) submitted to Anthem for Mr. (last name’s) R-SBRT services (See Attachment #51) and; the post-treatment appeals submitted to Anthem along, with Anthem’s responses (See Attachments #52-55).

The CVs for the retained expert radiation oncologist, Dr. (first, last) and the CVs for the treating radiation oncologists and the treating radiation physicist are enclosed.

The CVs for the retained expert radiation oncologist, Dr. (first, last) for the treating doctors: Dr. (first, last), and for the treating radiation physicist, Dr. (first, last) are enclosed as Attachments # 56-59.

Section III.

The denial was appealed up to and including an Independent External Review (IER). The reviewing doctor supported R-SBRT for localized prostate cancer as “highly beneficial, with long lasting results, with little chance of harm, and as a cost effective way to treat prostate cancer.” However, the IER doctor denied payment because “alternate therapies were available.”

The IER doctor failed to address the correct issue: whether the R-SBRT for (last name) met the national standard of care for the treatment of localized prostate cancer.

Dr XXXX’s review of the R-SBRT used for Mr. (last name) failed to address the correct issue. The question for the Independent External Reviewer was not whether the provider met Anthem’s requirements for payment. The correct question/issue was whether the provider met the national radiation oncology standard of care regarding the use of Robotic-SBRT for localized prostate cancer. Dr. XXXX’s report infers the R-SBRT did meet that national standard.

The IER doctor unintentionally supported SBRT for prostate cancer.

In his "Peer Reviewer Final Report", see Attachment #54, Dr. XXXX states: "The patient's case should meet each of the following criteria to qualify for an exception to the (SURG.00017) guideline:

  1. There is an absence of available alternate therapies: (not met);
  2. The degree of benefit expected from the service is high;
  3. The benefit from receiving the service is for a substantial period of time;
  4. The degree of potential harm to the member from service being requested is low; and
  5. The cost effectiveness of the service is present. Emphasis added.
  6. Dr. XXXX’s IER report also states:

  7. The notes indicate that this patient has a large prostate which cannot be implanted using brachytherapy. Therefore, as there are other options available, this patient does not meet criteria for an exception to medical policy.
  8. As this is the case, Anthem's determination of SBRT for treatment of prostate cancer as not medically necessary is appropriate."

When Dr. XXXX states “there is significant benefit from the use of SBRT for prostate cancer, the benefit derived from the SBRT will last for a long time, the possibility of potential harm from the SBRT is low, and the use of SBRT for prostate cancer is cost effective”, Dr. XXXX is stating SBRT for prostate cancer meets all of the requirements for "medically reasonable and necessary" services as defined by CMS/Medicare in Section 13.5.1 of the Medicare Program Integrity Manual. See Attachment #62.

Section 13.5.1 of the Medicare Program Integrity Manual specifies the requirements for medically reasonable and necessary services.

Section 13.5.1 is a more specific list of the requirements for a medical service to be considered “reasonable and necessary” under Section 1862(a)(1)(A)of the Social Security Act. The § 13.5.1 requirements are listed in the version of the (Name of state) LCD, L26835, in effect when Mr. (last name) was treated. See page 3 of Attachment #38. Here are the §13.5.1 requirements and how they are met by Robotic-SBRT for prostate cancer.

Safe and effective: The results with Robotic-SBRT for localized prostate cancer, published before Mr. (last name)was treated, were at least as good, “if not better”, than the results with other forms of conventional radiation therapy. Please see the Katz, Fuller, Bolzicco, and Aluwini articles on Robotic-SBRT (Attachments # 106, 108, 109, 113, 114, 115).
Not experimental or investigational: On August 10, 2001 the Accuray CyberKnife System, for Stereotactic Radiosurgery/Radiotherapy, was approved by the FDA: “To provide treatment planning and image guided stereotactic radiosurgery (Robotic SRS) and precision radiotherapy (Robotic SBRT) for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.” See Attachment # 63.
In August of 2010 ASTRO stated all insurance companies should pay for SBRT used to treat prostate cancer. See Attachment #47.
CMS/Medicare has a National Coverage Determination (NCD 310.1) that prohibits payment for the experimental / investigational component of any treatment. See Attachment # 64. In December of 2010, R-SBRT for localized prostate cancer was LCD-approved for payment by Medicare in CA, HI, NV, IA, KS, MO, NE, FL, DE, DC, MD, NJ, and PA. See Attachments # 42-46. In December of 2010, other states without published LCDs on SBRT, approved and paid for the SBRT treatment of localized prostate cancer. Those states included: IN, MI, AL, GA, TN, CT, NY, ME, MA, NH, RI, and VT.
Furnished in accordance with accepted medical standards: In August of 2010 ASTRO published its updated Model Policy on SBRT and stated: “all insurance companies should pay for SBRT for localized prostate cancer.” See Attachment #47. By December of 2010, several Medicare Administrative Contractors had already published LCDs approving SBRT for localized prostate cancer: Those MACs included: Palmetto (J1) L28301 [CA, HI, NV] (See Attachment #42); Wisconsin Physician Services (J5) L28366 [IA, KS, MO, NE] (See Attachment #44); First Coast Service Options (J9) L30366 [FL] (See Attachment #46); and Highmark (J12) L30277 [DE, DC, MD, NJ, PA] (See Attachment #45).
By December of 2010 other Medicare Administrative Contractors were paying for SBRT for localized prostate cancer without any LCD policy. Those MACs included: National Government Services (J8) coverage with no policy [IN, MI]; Cahaba (J10) coverage with no policy [AL, GA, TN]; National Government Services (J13) coverage with no policy [CT, NY]; and National Heritage Insurance Company (J14) coverage with no policy [ME, MA, NH, RI, VT]
By December of 2010 other insurance entities had adopted Robotic-SBRT for primary prostate cancer. The enclosed CHAMPVA Policy Manual states: “the CyberKnife System is indicated for stereotactic radiosurgery (R-SRS) and precision radiotherapy (Robotic-SBRT) for conditions anywhere in the body when radiation treatment is indicated.” See page 5 of Attachment #65. By December of 2010 Robotic-SBRT for primary prostate cancer had also been adopted by Blue Shield of California, the tenth largest insurance company in the U.S. See page 3 of Attachment #66 & page 1 of Attachment # 67).
Furnished in an appropriate setting: Whether R-SBRT is performed in a hospital or a freestanding center, Accuray (the manufacturer of the CyberKnife), has designed one and only one “setting” for the CyberKnife. Every CyberKnife treatment module is identical, right down to the placement of the low energy x-ray cameras mounted on both sides of the CyberKnife treatment table. See Attachment # 5.
Furnished by qualified personnel: There is no difference in the personnel (radiation oncologist, physicist, nurses, and technicians), and no difference in the tasks performed by the members of the radiation oncology team – whether Robotic-SBRT is performed in a hospital affiliated CyberKnife unit or is performed in a freestanding CyberKnife unit.
Meets but does not exceed the patient’s medical need: Robotic-SBRT precisely destroys the cancerous prostate while sparing the surrounding tissues and structures
At least as beneficial as an existing alternative: By December 2010, the five year results with Robotic-SBRT were at least as good as, “if not better”, than the results with other forms of conventional radiation therapy. Compared to 3D Conformal RT and compared to IMRT, Robotic-SBRT is far more precise and is therefore able to place a much higher dose of radiation on the targeted prostate cancer at each treatment session – with greater radiobiologic effect, and requires far fewer treatment sessions for a complete course of treatment. See Attachments # 6, 11, 15, 108, 110-117, 119-128, 131, 133. Based on the prostate cancer patients who were treated with external beam radiation in 2012, if 100% of those patients had been treated with Robotic-SBRT, instead of 100% (theoretically) treated with IMRT, the “cost savings would approach $250,000,000.” See page e34s of Attachment # 68.

The IER doctor denied payment for an invalid reason.

Dr. XXXX did not deny the SBRT for prostate cancer because SBRT was “experimental or investigational.” Dr. XXXX did not deny the SBRT for prostate cancer because SBRT was not “medically necessary.” Dr. XXXX denied the SBRT because “other therapies were available.” With no disrespect intended, the fact that other therapies were available was an invalid reason to deny R-SBRT for Mr. (last name’s) prostate cancer.

If Anthem is not held to the correct standard of care, Anthem can enforce any policy it wants to - no matter how wrong - and appeal of any claim denied under that policy would be futile.

If all levels of appeal of denied Anthem claims, including Independent External Review, are to be limited to the application of Anthem’s policy - no matter how erroneous the Anthem policy may be - any and all appeals of claims denied by Anthem would be futile.

When a national radiation oncology standard of care has been established by CMS/Medicare and ASTRO, Anthem’s policies should comply with that national standard of care, and that includes Anthem’s policy on SBRT.

Moreover, Anthem’s SBRT policy does not conform to Anthem’s definitions of “experimental”, “investigational”, and “medically necessary.” As a result, Anthem’s SBRT-for-prostate cancer policy should not be followed by the Arbitrator.

Summary of Section III.

Dr. XXXX, the IER doctor, explained how the R-SBRT for (last name’s) prostate cancer met CMS/Medicare’s “medically reasonable and necessary” requirements under Section 1862(a)(1)(A)of the Social Security Act.

Dr. XXXX explained why R-SBRT for prostate cancer is not “experimental / investigational.”

Dr. XXXX applied the wrong standard to the R-SBRT services at issue. The issue was not whether R-SBRT for prostate cancer met Anthem’s out-of-date and incorrect standards. The issue was whether R-SBRT for prostate cancer met the national radiation oncology standard of care for the treatment of localized prostate cancer. According to the CMS/Medicare and ASTRO policies in effect when Mr. (last name) was treated, according to other BC BS Association medical policies that were based on the ASTRO Model Policy for SBRT, and according to Anthem’s own definitions of “experimental/investigational” and “medically necessary”, R-SBRT did meet the radiation oncology standard of care for the treatment of localized prostate cancer.

If a payment denial is strictly based on an incorrect Anthem medical policy, and the denial is mechanically and inappropriately sustained at all levels of appeal, appeal of that denial will be futile unless Anthem is held to the correct standard of care.

If Anthem is not held to the correct national standard of care, Anthem can enforce any policy it wants to, no matter how wrong and how inappropriate that policy may be.

Section IV.

By the “preponderance of the evidence” standard applicable to this dispute, at the time of Mr. (last name’s) treatment, R-SBRT was approved for the treatment of localized prostate cancer by CMS/Medicare and by the American Society of Therapeutic Radiation and Oncology (ASTRO), the two organizations that determine national coverage policies for radiation oncology.

Based on the numbers, CMS/Medicare sets the nationwide “clinical” standard regarding the use of SBRT for localized prostate cancer.

Localized prostate cancer is a disease primarily of Medicare-aged beneficiaries. According to the American Cancer Society, there were 217,730 new prostate cancer cases in 2010 and the median age at diagnosis was 68. Attachment #69.

According to SEER/NCI (Surveillance, Epidemiology, and End Results program of the National Cancer Institute), 81% of prostate cancer cases are localized and 58.2% of the men newly diagnosed with prostate cancer each year are Medicare beneficiaries. See Attachment # 70.

Based on this data:

81% of 217,730 = 176,361 patients with newly diagnosed, localized prostate cancer in 2010;
58.2% of 176,361 = 102,642 Medicare patients with newly diagnosed, localized prostate cancer in 2010; and
176,361-102,642 = 73,719 non-Medicare patients with newly diagnosed, localized prostate cancer in 2010

Based on the number of men with newly diagnosed localized prostate cancer in 2010 who were Medicare beneficiaries, Medicare set the clinical standard for the treatment of localized prostate cancer. The 73,719 non-Medicare patients newly diagnosed with prostate cancer in 2010 were divided as to insurance coverage between all of the non-Medicare entities: Medicaid, the VA Hospital system, Kaiser, Aetna, Cigna, Humana, United Healthcare, Anthem BC BS companies, non-Anthem BC BS companies, etc. In addition, Anthem BC BS (WellPoint) insurance was available in only 14 states (CA, CO, CT, GA, IN, KY, ME, MO, NH, NV, NY, OH, VA, and WI). See page 3 of Attachment # 71.

Based on the numbers, Anthem BC BS is a minor insurance entity in the treatment of prostate cancer.

It is reasonable to infer Anthem BC BS insured no more than 5-10% of the non-Medicare patients newly diagnosed with prostate cancer in 2010. If 10% of the 73,719 non-Medicare men diagnosed with localized prostate cancer in 2010 were Anthem patients, Anthem insured 7,372 of those patients. As a result, Anthem BC BS is a minor insurance entity in the treatment of prostate cancer. Based on these numbers, CMS/Medicare determined the radiation therapy coverage policy for more than 14 times as many patients newly diagnosed with localized prostate cancer as did Anthem BC BS in 2010.

CMS wrote the definitions for the Robotic SBRT radiation delivery codes in 2003 and has published those definitions in the HCPCS II Manual every year since 2004.

CMS wrote the definitions for the Robotic SBRT delivery codes, G0339 and G0340 in 2003 and has published those definitions in the HCPCS II Manual every year since 2004. See Attachment #14.

Through the Hospital Outpatient Prospective Payment System (HOPPS), CMS determines how the G0339 and G0340 codes for R-SBRT are to be used by every hospital-affiliated radiation oncology center in the United States.

Every insurance “company” in the United States, including all of the Anthem BC BS companies, follows the CMS rules regarding the use of G0339 and G0340 by hospital radiation oncology departments. The Hospital OPPS rules are published twice yearly by CMS in the Federal Register. Copies of the rules from 2004-2010 are enclosed as Attachments # 72-82.

CMS repeatedly states in the Federal Register that Robotic SBRT is far more complex than non-Robotic SBRT and that this difference in complexity results in higher fees for Robotic SBRT.

Medicare sets the industry standard regarding the use of R-SBRT for localized prostate cancer.

Because Medicare providers see and treat a majority of prostate cancer patients nationwide, because the Medicare Administrative Contractors (MACs) must use evidence-based medicine to formulate coverage decisions, because the MACs rely on the “specialty society” (ASTRO) that establishes national radiation oncology coverage policies, because the MAC medical directors also rely on input from local radiation oncology, Carrier Advisory Committee (CAC) representatives, and because CMS/Medicare strictly requires the correct use of the Robotic SBRT delivery codes G0339 and G0340, Medicare sets the “industry standard” regarding the use of Robotic SBRT for localized prostate cancer.

The correct outcome for this dispute has already been decided by CMS/Medicare.

By December of 2010, all of the Medicare Administrative Contractors for CA, HI, NV, IA, KS, MO, NE, FL, DE, DC, MD, NJ, and PA had LCDs allowing R-SBRT for localized prostate cancer. See Attachments #42-46). In addition, by December of 2010 other Medicare Administrative Contractors were paying for SBRT for localized prostate cancer without any LCD policy, including: IN, MI, AL, GA, TN, CT, NY, ME, MA, NH, RI, and VT.

In 2010, TrailBlazer, the Medicare Administrative Contractor for (Name of state), had a negative SBRT-for-prostate-cancer policy.

In 2010, some MACs did have LCDs prohibiting the use of R-SBRT for localized prostate cancer. For this arbitration, the best example would be TrailBlazer, the Medicare Administrative Contractor (MAC) for (Name of state). See Attachment #38.

The 2010, the TrailBlazer SBRT-for-prostate-cancer claim denials were overturned by the Administrative Law Judges who uniformly found that SBRT for localized prostate cancer was not experimental or investigative and was medically reasonable and necessary.

Based on the version of L26835 in effect, TrailBlazer denied every 2010 SBRT for prostate cancer claim submitted for payment. However, those denials led to Administrative Law Judge hearings and those hearings have been uniformly decided in favor of the Appellant providers. The ALJs concluded Robotic-SBRT was medically necessary for localized prostate cancer and that Robotic-SBRT for localized prostate cancer was not experimental / investigative. These redacted ALJ written decisions, along with decisions on identical issues from other MAC jurisdictions, are included as Attachments # 83-93.

The ALJ decisions in favor of SBRT for prostate cancer should be given great weight by the arbitrator.

The ALJ decisions in favor of SBRT for prostate cancer should be given great weight by the arbitrator because:

  1. Medicare’s National Coverage Determination (NCD) 310.1 prohibits payment for services that are “experimental / investigational.” See Attachment # 64. NCDs are binding on ALJs. See 42 C.F.R. § 405.1060(a)(4) enclosed as Attachment # 94. The only exception to this rule occurs when CMS publishes an NCD with CED (Coverage with Evidence Development) for a specific service. There is no NCD with CED for the SBRT treatment of prostate cancer.
  2. Based on § 1862(a)(1)(A) of the Social Security Act, the ALJs must conclude a treatment is “medically reasonable and necessary” in order to award payment. The “medically reasonable and necessary” requirements are further codified in the Medicare Program Integrity Manual, Chapter 13, Section 13.5.1. See Attachments #95 & 62. Medicare’s “reasonable and necessary” requirements are the same as Anthem’s “medically necessary” requirements.
  3. Based on CMS/Medicare requirements for the evidence used to support LCD coverage policies, all of the ALJs were willing to overturn TrailBlazer’s unsupported denials. The CMS / Medicare evidence requirements for LCD coverage policies are detailed in the Medicare Program Integrity Manual, Chapter 13, Section 13.7.1. See Attachment # 96.
  4. TrailBlazer’s negative 2010 SBRT-for-prostate-cancer policy was wrong for the same reasons Anthem’s policy is wrong: The national radiation oncology standard of care supported the use of SBRT for prostate cancer.
  5. Based on 42 CFR § 405.1062, an ALJ must give “substantial deference” to an LCD policy that applies to a particular case, and must “explain the reasons why the policy was not followed.” See Attachment # 97. The ALJs who authored the decisions in Attachments # 83-93 gave substantial deference to the LCDs’ negative coverage policies regarding SBRT for prostate cancer but refused to apply the negative policies re SBRT for localized prostate cancer.
  6. Although copies of ALJ decisions for the cases in which I was the attorney for the Appellant/provider are the only decisions enclosed, it may reasonably be inferred other SBRT-for-prostate-cancer appeals have also been decided in favor of other radiation oncology groups represented by other attorneys.

The American Society for Therapeutic Radiation and Oncology (ASTRO) approves R-SBRT for prostate cancer.

In August of 2010 ASTRO published its updated model Policy on SBRT. That policy is enclosed as Attachment #47.

Here is ASTRO’s 2010 policy statement on SBRT for prostate cancer: “SBRT is currently under investigation for other indications, including the primary treatment of prostate cancer (ICD-9 code 185). An insurer should cover treatment of these patients entered on IRB approved clinical trials.” Emphasis added.

Based on ASTRO’s August 2010 Model Policy for SBRT, TrailBlazer now allows SBRT for prostate cancer.

Not insignificantly, TrailBlazer, later changed its SBRT-for-prostate-cancer policy and now allows SBRT for prostate cancer. See p. 3 of Attachment # 41. The change was based on ASTRO’s August 2010 change in policy.

The ASTRO requirement for IRB study enrollment does not mean R-SBRT for prostate cancer is “experimental/investigative.”

Just as there are www.clinicaltrials.gov IRB studies regarding R-SBRT (CyberKnife) and prostate cancer, there are www.clinicaltrials.gov IRB studies regarding 3D Conformal RT and prostate cancer, www.clinicaltrials.gov IRB studies regarding IMRT and prostate cancer, and www.clinicaltrials.gov IRB studies regarding radical prostatectomy and prostate cancer. See Attachments #102-105. The fact that these www.clinicaltrials.gov IRB studies exist does not mean 3D conformal RT, IMRT, R-SBRT, and/or radical prostatectomy are considered “experimental or investigational” in the treatment of prostate cancer.

The IRB studies on “CyberKnife and prostate cancer” are not designed to determine whether SBRT can be used for prostate cancer.

The www.clinicaltrials.gov IRB studies on “CyberKnife and prostate cancer” are not designed to determine whether Robotic SBRT (CyberKnife) can be used for the treatment of prostate cancer. The IRB studies listed on the www.clinicaltrials.gov website, regarding R-SBRT (CyberKnife) and prostate cancer, are being conducted: to determine the “long term effects” of R-SBRT for localized prostate cancer; to study “homogeneous dose distribution” for organ confined prostate cancer; to use R-SBRT to “emulate HDR Brachytherapy Dosimetry” for localized prostate cancer; to study the use of R-SBRT for “locally recurrent prostate cancer”; to study R-SBRT as a “boost to External Beam Radiation Therapy” for prostate cancer; to create a “Multi-Institutional Registry” for long term follow-up of patients treated with R-SBRT for localized prostate cancer; and to compare the relative long term effectiveness of “R-SBRT versus radical prostatectomy” for localized prostate cancer. All of the clinicaltrials.gov studies are “retrospective.” They are designed for long term follow-up of CyberKnife-treated prostate cancer and/or are designed to answer other questions. These IRB CyberKnife/prostate cancer studies are not “prospective”: They are not designed to determine whether R-SBRT can be used to treat prostate cancer.

In December of 2010 Palmetto (L28301) and Highmark (L30277) both used a variation of this ASTRO wording. See Attachments 42 & 45. In December of 2010 both Palmetto and Highmark were paying the G0339 and G0340 codes for prostate cancer. In December of 2010, under CMS/Medicare law, if SBRT for prostate cancer had been “experimental” or “investigational” Palmetto and Highmark could not and would not have paid these radiation delivery codes for prostate cancer.

In 2010 WellPoint requested ASTRO’s comments on WellPoint’s SBRT policy but made no changes to SURG.00017 based on ASTRO’s recommendations.

In a letter from ASTRO to WellPoint, dated November 18, 2010, ASTRO apologized for the “delay” in responding to WellPoint’s request for “ASTRO’s comments on WellPoint’s position that SBRT is considered investigational for the kidney, prostate, liver, colon, and pancreas.” See Attachment # 26. The fact that WellPoint was seeking ASTRO’s comments on WellPoint’s coverage policies reflects ASTRO’s national position of authority in overseeing radiation oncology coverage policies.

Using WellPoint’s definition of “medically necessary”, the ASTRO letter was politely critical of WellPoint’s failure to list SBRT as medically necessary for “pancreas cancer, primary liver cancer, and lung and liver metastases.” The fact that ASTRO did not mention prostate cancer in the November 18th letter is easily explained. Three months earlier, in August of 2010, ASTRO published its Model Policy on SBRT for prostate cancer. See Attachment # 47. The fact that there was a “delay” in responding to WellPoint’s questions implies the original WellPoint letter was sent much earlier than the November 18, 2010 response from ASTRO. As a result, there was no need to respond to WellPoint’s question regarding prostate cancer because ASTRO had already posted its position on prostate cancer in the ASTRO Model Policy re SBRT.

In 2012 WellPoint again requested ASTRO’s comments on WellPoint’s SBRT policy, but again Anthem made no changes to SURG.00017 based on ASTRO’s recommendations.

In a letter from ASTRO to WellPoint, dated March 19, 2012, ASTRO responded to WellPoint’s request for “ASTRO’s comments on WellPoint’s position that SBRT is considered investigational for the kidney, prostate, liver, colon, and pancreas.” See Attachment #29. ASTRO referred WellPoint back to the November 18, 2010 letter on the same topics.

The “immobilization, organ localization, and precise dose delivery” issues cited by Buyyounouski are non-issues for R-SBRT.

As applied to R-SBRT, the claim made by Anthem in SURG.00017 regarding the Buyyounouski 2010 article is inaccurate. While non-Robotic SBRT does require “continuing clinical development in the areas of immobilization, organ localization and precise dose delivery”, these are non-issues for R-SBRT. R-SBRT requires no “immobilization” of the patient. R-SBRT uses surgically-placed, gold fiducial seeds that are implanted in the prostate before radiation therapy along with real time image guidance - for “organ localization.” During treatment, the x-ray cameras image the prostate approximately every 40 seconds and send that imaging information to the high speed computer. Based on the position of the fiducial seeds, the high speed computer determines exactly where the prostate is in space, in real time. Based on the position of the prostate in the three dimensions of space, the high speed computer adjusts the position of the robotic arm and the aim of the linac. Based on the high speed computer’s confirmation that the prostate has been acquired, that the angle of attack/position of the robotic arm is correct, and that the linac is exactly aimed at the margins of the prostate, the R-SBRT beam is fired, with accuracy that emulates the “precise dose delivery” achieved with High Dose Rate Brachytherapy. See the Fuller papers (Attachments #106, 108, 109).

For an in-depth discussion why Robotic SBRT does not require “continuing clinical development in the areas of immobilization, organ localization and precise dose delivery”, see the articles above and the comments made by the radiation oncologists in the internet-posted CMS/Medicare transcript of the 04/21/2010 MEDCAC Meeting on Localized Prostate Cancer at http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=54&fromdb=true. A condensed version of the quotes from the CAC meeting is available as Attachment #110.

The radiation oncology CAC representatives participating in the 2010 MEDCAC meeting made the following points: the CyberKnife (R-SBRT) requires no immobilization because the CyberKnife tracks the exact location of the prostate in real time during treatment and the precision of dose delivery with the CyberKnife emulates the precision of dose delivery with High Dose Rate Brachytherapy.

Summary of Section IV

The “industry standard” regarding the use of SBRT for prostate cancer is set by CMS/Medicare and CMS/Medicare approves the use of SBRT for localized prostate cancer. By December 2010, LCDs published by the Medicare Administrative Contractors approved R-SBRT for localized prostate cancer. Other MACs without LCDs on SBRT followed the policies of MACs that approved SBRT for prostate cancer and paid the G0339 and G0340 codes for the treatment of prostate cancer.

By December 2010, the Administrative Law Judges who heard the R-SBRT for prostate cancer denials were ruling in favor of the R-SBRT providers. In addition, because the Social Security Act and the Medicare Program Integrity Manual prohibit payment for “experimental” or “investigational” services, and because every Medicare Administrative Contractor in the country now pays for R-SBRT for localized prostate cancer, Anthem’s continued assertion that R-SBRT for prostate cancer is “experimental / investigational” is frankly wrong.

In an acknowledgement of ASTRO’s authority to determine correct coverage policies for radiation oncology nationwide, Anthem sent ASTRO letters requesting ASTRO’s comments on Anthem’s coverage policies. In a response letter from ASTRO, dated November 18, 2010, ASTRO was politely critical of Anthem’s SBRT policies regarding pancreatic, liver, and lung cancer. The ASTRO letter was silent as to prostate cancer because ASTRO had already published its SBRT Model Policy, clearly stating Anthem should pay for the SBRT treatment of prostate cancer.

The ASTRO Model Policy statement that all insurers should pay for the SBRT treatment of localized prostate cancer where the patient is enrolled in an IRB approved clinical trial, refers to IRB studies that are retrospective, looking backwards at the long-term results of SBRT for prostate cancer. If the IRB studies were prospective, asking whether SBRT can be used for prostate cancer, Medicare would not have paid for the R-SBRT treatment of localized prostate cancer and Medicare did pay for the R-SBRT treatment of localized prostate cancer in December of 2010.

As noted by the radiation oncologists at the 04/21/2010 MEDCAC Meeting on Localized Prostate Cancer, the immobilization, organ localization, and precise dose delivery issues cited by Byyounouski remain as issues for non-Robotic SBRT but are non-issues for R-SBRT.

What is most puzzling about Anthem’s policy is the fact that Anthem’s policy is bad for everyone. Long after Medicare and ASTRO have decided the correct SBRT-for-prostate-cancer coverage policy: Anthem’s patients are still being denied a form of radiation therapy that is far more accurate and more radiobiologically effective than its predecessors, 3D CRT and IMRT; Anthem’s providers are still being denied payment for Robotic-SBRT services that meet national radiation oncology standards; and Anthem continues to pay $10,000 more for each patient for the older and less accurate form of radiation therapy – IMRT – than Anthem would pay for a full course of Robotic-SBRT for localized prostate cancer. The cost analysis for IMRT and R-SBRT is included as Attachment #68.

Section V

By the “preponderance of the evidence” standard applicable to this dispute, at the time of Mr. (last name’s) treatment: Two of the three articles used to support Anthem’s SBRT for prostate cancer policy in SURG.00017 were outdated and inapplicable to the R-SBRT provided for Mr. (last name). The third article supports R-SBRT for prostate cancer.

The 11/18/2010 version of Anthem’s Medical Policy SURG.00017, in effect in December of 2010 when Mr. (last name) was treated for localized prostate cancer, contained three paragraphs on SBRT for prostate cancer. See Attachment #60).

The first paragraph on prostate cancer in SURG.00017 quotes an out-of-date 2007 article by Madsen on the use of non-Robotic SBRT, performed without real-time image guidance.

The first (SURG.00017) paragraph on the use of SBRT for prostate cancer focused on a 2007 study (submitted for publication in June of 2006) by Madsen in which non-Robotic-SBRT was used on 40 patients. Because the range on follow-up was 12-60 months, with a median of 41 months, the actual starting date for the Madsen study was 2001. No real-time image guidance was used during treatment and the post-treatment GI and GU toxicity results reflected this lack of targeting accuracy. Madsen used 1.5 as the a/ß ratio number for prostate and Madsen clearly illustrated how the Biologically Equivalent Dose (BED) of SBRT can be converted into an equivalent IMRT plan (i.e. number of fractions and dose per fraction).

The first paragraph on prostate in SURG.00017

One feasibility study was found by Madsen and colleagues (2007) which evaluated the feasibility and toxicity of stereotactic hypofractionated accurate radiotherapy (SHARP) for localized prostate cancer. Forty men in a Phase I/II trial of SHARP were treated for localized prostate cancer using 33.5 Gy in 5 fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions. Noncoplanar conformal fields and daily stereotactic localization of implanted fiducials were used for treatment. Genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated by American Urologic Association (AUA) score and Common Toxicity Criteria (CTC). Prostate-specific antigen (PSA) values and self-reported sexual function were recorded at specified follow-up intervals. The median follow-up is 41 months (range, 21-60 months). Acute toxicity Grade 1-2 was 48.5% (GU) and 39% (GI); 1 acute Grade 3 GU toxicity. Late Grade 1-2 toxicity was 45% (GU) and 37% (GI). No late Grade 3 or higher toxicity was reported. Twenty-six men reported potency before therapy; 6 (23%) have developed impotence. Median time to PSA nadir (lowest value) was 18 months with the majority of nadirs less than 1.0 ng/mL. The actuarial 48-month biochemical freedom from relapse is 70% for the American Society for Therapeutic Radiology and Oncology (ASTRO) definition and 90% by the alternative nadir plus 2 ng/mL failure definition. This feasibility study was the first of Phase I and II clinical trials for prostate SBRT. Larger studies are needed to demonstrate efficacy of this clinical application.

It is the use of Robotic-SBRT for localized prostate cancer that is at issue. Because the Madsen study was limited to the use of non-Robotic-SBRT (without real-time image guidance), the Madsen paper was out-of-date and inapplicable when applied to the Robotic-SBRT provided for Mr. (last name).

CMS states Robotic SBRT is far more complex than non-Robotic SBRT.

The differences between Robotic and non-Robotic-SBRT are not just “mechanical.” CMS states Robotic-SBRT is far more complex than non-Robotic-SBRT, and CMS requires different billing codes and different levels of reimbursement for Robotic and non-Robotic-SBRT. See Attachments #72-82.

Every year since 2003 CMS has published proposed and final rules on Stereotactic Radiosurgery in the Federal Register, and every year since 2003 CMS has restated the following: “The CMS authored HCPCS II G codes (G0339 and G0340) must be used to bill for the delivery of Robotic-SBRT; the G0339 and G0340 codes were written to reflect the technical complexity required to provide Robotic-SBRT services; the AMA authored, HCPCS I, non-Robotic-SBRT code, 77373, must not be used by hospitals to bill for Robotic-SBRT services; and the G0339 and G0340 codes are reimbursed at much higher rates than the 77373 code on the OPPS (hospital) fee schedule as a reflection of the increased resources required to provide Robotic-SBRT services, as compared to non-Robotic-SBRT services.” The Federal Register proposed and final rules are enclosed as Attachments #72-82.

The second paragraph on prostate in SURG.00017 is limited to an article by King that was completely supportive of R-SBRT for prostate cancer.

The second SURG.00017 paragraph on prostate cancer inaccurately cites the wrong author, but accurately states the excellent results obtained by Dr. Christopher King. Dr. King concluded: “no biochemical failures along with good early and late GI and GU toxicity profiles.”

Gill and colleagues (2009) reported interim results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer. Forty-one low-risk prostate cancer men with 6 months minimum follow-up received SBRT alone using the CyberKnife. Using the Radiation Therapy Oncology Group (RTOG) toxicity criteria and prostate-specific antigen (PSA) response, the early (less than 3 months) and late (greater than 6 months) urinary and rectal toxicities were compiled. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 men with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. five consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 men (29%) occurring at 18 months (median) after treatment. At last follow-up, no one had a PSA failure regardless of biochemical failure definition. Of 32 men with 12 months minimum follow-up, 25 (78%) achieved a PSA nadir less than or equal to 0.4 ng/mL. The early and late toxicity profile and PSA response for prostate SBRT are highly encouraging. Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles. Emphasis added.

Anthem BC BS incorrectly cites “Gill” as the author of this article on pages 6 and 14 of SURG.00017. The real author was Christopher King, PhD, MD. Dr. King used Robotic-SBRT (the CyberKnife©) in his study and his results, as noted in the Anthem policy, were excellent. In August of 2010, based in part on King’s 2009 article, ASTRO changed its policy on the use of SBRT. In the August of 2010 policy, enclosed as Attachment #47, ASTRO stated all insurance companies should pay for SBRT for prostate cancer.

Dr. King’s 2011 follow-up paper, (Attachment #111), also published in the Int. J. Radiation Oncology Biology Physics, confirms continuation of the excellent biochemical control rates and low toxicity profiles reported in his 2009 paper. The statement: “Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles” was and is consistent with the fact that retrospective studies are ongoing regarding all forms of external beam radiation used to treat localized prostate cancer.

The third paragraph on prostate in SURG.00017 quotes a portion of the Buyyounouski article that does not apply to R-SBRT.

The 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 (Buyyounouski, 2010).

On the first page of the 2010 Emerging Technology Committee Note (article), Buyyounouski states: “Clinical…data available after March 26, 2008 are not included in this review.” See Attachment #13. Emphasis added. The portion of Anthem’s no-SBRT-for-prostate-cancer policy based on the data in Buyyounouski article was out-of-date by December of 2010.

In addition, Buyyounouski’s concerns regarding “Immobilization, organ localization, and precise dose delivery” were non-issues for Robotic-SBRT, the treatment received by Mr. (last name) in December of 2010. See the comments of the CAC representatives on this topic in Attachment #110.

Articles published before December of 2010, supported the use of R-SBRT for localized prostate cancer.

Between March of 2008 and December of 2010, many articles supporting the use of SBRT for prostate cancer were published. Here are some of those articles.

Fuller et al. Virtual HDR. CyberKnife Treatment for Localized Prostatic Carcinoma: Dosimetry Comparison with HDR. Brachytherapy and Preliminary Clinical Observation. Int J Radiation Oncology Biol Phys. 2008; Vol 70; 5:11588-1597. (10 patients) (Attachment #106)

High dose rate (HDR.) brachytherapy is a precise and powerful hypofractionation (few treatment sessions with large doses of radiation administered at each treatment session) radiation delivery mechanism, and its efficacy for prostate cancer (is) established. The primary drawback of HDR. brachytherapy is that it is an invasive procedure requiring hospital admission, anesthesia, nursing support, and narcotic analgesia to place and manage the indwelling transperineal HDR. catheters (see the clinical photo below), and deal with their attendant pain and risk of Infection and thromboembolism.

Prostate brachytherapy catheters
HDR. prostate brachytherapy catheters

By contrast, CyberKnife (Robotic SBRT) is a noninvasive method to deliver radiation dose distributions that very closely resemble those delivered with HDR. brachytherapy. Emphasis and photograph added.

Wiegner et al. Sexual Function after Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial. Int. J. Radiation Oncology Biol. Phys., Vol 78, No 2, pp. 442-448, 2010 (32 patients) (Attachment #107). The rates of erectile dysfunction appear comparable to those reported for other modalities of radiotherapy. Xie et al. Intrafractional Motion of the Prostate During Hypofractionated Radiotherapy. Int. J. Radiation Oncology Biol. Phys., Vol 72, No 1, pp. 236-246, 2008 (21 patients) (Attachment #15)

Xie et al. Intrafractional Motion of the Prostate During Hypofractionated Radiotherapy. Int. J. Radiation Oncology Biol. Phys., Vol 72, No 1, pp. 236-246, 2008 (21 patients) (Attachment #15)

Intrafractional organ motion (motion of the prostate during the radiation treatment session) has long been recognized as one of the major limiting factors of prostate dose escalation in conformal radiation therapy. Our study shows the importance of real-time image guidance and motion-compensation techniques such as the robotic linear accelerator used in CyberKnife during hypofractionated prostate radiation treatment. Given the magnitude and random nature of prostate motion as well as recent technical advancements in various related fields, real-time monitoring of prostate position to compensate for the motion should be part of future prostate radiation therapy to ensure adequate dose coverage of the target while maintaining adequate sparing of adjacent structures.

Friedland et al. Stereotactic Body Radiotherapy: An Emerging Treatment Approach for Localized Prostate Cancer. Tech Cancer Research Treatment. 2009; Vol 8; 5:387-392. (112 patients) (Attachment #112)

The potential benefits and risks of SBRT for prostate cancer were recently examined by the Emerging Technologies Committee (ETC) of ASTRO. In their report, the committee stated that SBRT should not be attempted without “some mechanism for optimization of immobilization” and “precise, daily real time organ localization”. The CyberKnife robotic radiosurgery system monitors the continual intrafraction motion of the prostate using real time imaging and provides translational and rotational movement correction, setting it apart from other conventional radiation delivery systems. Emphasis added.

Katz et al. Stereotactic Body Radiotherapy for Organ-Confined Prostate Cancer. BMC Urology. 2010; Vol 10;1. (304 patients) (Attachment #113)

Our results show that (Robotic) SBRT of early stage prostate cancer…can be performed with low acute toxicity. At a median 30-month follow-up for the 35 Gy dose level, the long-term urinary and rectal toxicity are both low. EPIC QOL (quality of life) questionnaires also suggest that urinary, rectal and sexual QOL following (Robotic) SBRT may be comparable, if not better than that for EBRT (External Beam Radiation Therapy including 3D Conventional Radiation and IMRT), BT (Brachytherapy) and RP (Radical Prostatectomy). 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. Emphasis added.

Bolzicco et al. Image-Guided Stereotactic Body Radiation Therapy for Clinically Localized Prostate Cancer: Preliminary Clinical Results. Technology in Cancer Research and Treatment. 2010; Vol 9, Number 5:473-477. (45 patients) (Attachment #_114_)

SBRT, combined with enhanced technologies, including the CyberKnife, allows the beams to be targeted more precisely to the prostate, while exposing the rectum and the bladder to the smallest possible doses of radiation. Low toxicity and encouraging biochemical control support the use of SBRT in early-stage prostate cancer.

Aluwini et al. CyberKnife stereotactic radiotherapy as monotherapy for low- to intermediate-stage prostate cancer: early experience, feasibility, and tolerance. J Endourol. 2010;24:865-869. (10 patients) (Attachment #115)

Our data on using the CyberKnife for early-to-intermediate-stage prostate cancer demonstrate that this course is well tolerated, with an acceptable, expected percentage of acute urinary, bowel and rectal symptoms. The percentages of urinary and rectal acute toxicities were similar to those reported by patients treated with conventionally fractionated courses. Also, from our experience with the same hypofractionated course(4x9.5Gy) in the HDR. brachytherapy setting, we noticed that the CyberKnife hypofractionated stereotactic radiotherapy course caused even less urinary toxicity.

Katz et al. Stereotactic Body Radiotherapy as Boost for Organ-Confined Prostate Cancer. Technology in Cancer Research and Treatment. 2010; Vol. 9, No. 6, December 2010. (73 patients) (Attachment #116)

Articles published after December of 2010 continue to support R-SBRT for localized prostate cancer.

Articles published after December of 2010 continue to support the use of SBRT for prostate cancer.

Katz et al. Stereotactic Body Radiation therapy for low- and low-intermediate-risk prostate cancer: Is there a Dose Effect? Frontiers in Oncology 2011; 1: 49 (82 patients) (Attachment #117).

Overall, the highly favorable PSA response, limited biochemical failures, limited toxicity, and limited impact on quality of life in these low- to intermediate-risk patients are supportive of excellent long-term results for CyberKnife delivered SBRT.

Townsend et al. Acute Toxicity After CyberKnife-Delivered hypofractionated Radiotherapy for Treatment of Prostate Cancer. American Journal of Clinical Oncology February 2011 - Volume 34 - Issue 1 - pp. 6-10 (50 patients) (Attachment #118)

Recent analysis of the radiobiological properties of the prostate tumors suggests that their alpha/beta ratio may be as low as 1.5 Gy, indicating that they (prostate cancer cells) are more sensitive to higher doses of radiation per fraction. This low ratio is the rationale for hypofractionation of definitive therapy (fewer number of fractions), resulting in an attractive treatment option with respect to treatment duration and logistics.

Radiation therapy for treatment of prostate cancer has evolved over the years, with the goal being to achieve high conformality to the prostate whereas avoiding surrounding sensitive tissues such as the bladder and rectum. High-dose rate (HDR.) brachytherapy has gained popularity and has been used…as monotherapy in patients with low-risk prostate cancer. HDR. brachytherapy is, however, an invasive procedure with the associated risks of infection, bleeding, and reactions to anesthesia. It has been shown that HDR. dosimetry can be closely replicated in a minimally invasive manner with the use of stereotactic body radiation therapy (SBRT). One platform that delivers (Robotic) SBRT is the CyberKnife System…A unique feature of the CyberKnife is its ability to track the motion of the prostate in real time during radiation treatment by imaging the positions of 3 to 4 gold fiducial seeds placed in the prostate prior to treatment planning. Depending on the motion of the prostate, the machine automatically repositions the robotic arm-mounted linear accelerator in response to variations in target position and delivers 100 to 200…pencil beams (of radiation) to the prostate, limiting the dose to the surrounding tissues. The radiation treatment is delivered in a hypofractionated regimen: The total dose is low relative to the conventional dose, but the dose per fraction is increased so the biologic effect to the tumor may be greater. In this article, we assess the acute gastrointestinal (GI) and genitourinary (GU) toxicities in 48 men with prostate cancer treated with the CyberKnife.

In general, the acute toxicities established in our study were more frequent for GU than for GI symptoms, similar to what has been reported in the literature for IMRT. Additionally, the results from our study show that (the)…results for both GU and GI symptoms were comparable to or lower than those that have been reported for either IMRT or 3D-CRT and HDR. brachytherapy. Roughly about a third to a half of patients experienced grade =2 toxicity in both IMRT and 3D-CRT studies, whereas that percentage in our study is lower. Emphasis added.

Freeman et al. Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer: Five-Year Outcomes. Radiation Oncology. 2011. (41 patients) (Attachment #¬¬ 119)

Prostate cancer is thought to have unique radiobiology, characterized by a low a/ß ratio relative to surrounding normal tissues. A growing body of evidence from clinical studies using hypofractionated radiation provides support that the a/ß ratio for prostate cancer is lower than that for the bladder and rectum, and that consequently a therapeutic gain could be achieved using fewer, high-dose fractions. Stereotactic body radiotherapy (SBRT) has recently emerged as an alternative technique to deliver hypofractionated radiotherapy to the prostate, comparable in many respects to HDR. brachytherapy, but with a non-invasive approach.

This report demonstrates that SBRT can achieve high rates of durable disease control for patients with low-risk prostate cancer while resulting in low levels of bladder and rectal toxicity. The current results extend prior independently conducted studies by the authors, demonstrating the potential of SBRT monotherapy to provide durable disease control with few serious complications in low-risk prostate cancer patients. Our 5-year progression-free survival rate of 93% compares favourably with that obtained with surgery, LDR. or HDR. brachytherapy. In addition, both disease control and toxicity outcomes with SBRT compare favourably to other treatments for low-risk prostate cancer.

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 travel costs and lost work time, allowing a more immediate return to normal, daily routines, and potentially reducing health care costs. Emphasis added.

Boike et al. Phase I Dose-Escalation Study of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer. J Clin Onc 2011;2020-2026. (45 patients) (Attachment #120)

Prostate cancer may be uniquely appropriate for treatment with hypo-fractionation (large does per fraction) because of a lower a/ß ratio (~1.5) for prostate cancer that similar to normal tissue late effects. Groups of 15 patients received 45 Gy, 47.5 Gy, and 50 Gy (by SBRT) in five fractions (45 total patients). Dose escalation has been completed without dose-limiting toxicity.

McBride et al. Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: Preliminary results of a multi-institutional phase I feasibility trial. Cancer 2011 (in press). (45 patients) (Attachment #121)

At 4 centers, 45 patients with NCCN-defined, low-risk prostate adenocarcinoma were enrolled in a phase 1, multi-institutional (CyberKnife) trial. The median follow-up was 44.5 months. There were no biochemical failures. In a select population, extreme hypofractionation with stereotactic radiosurgery was safe and effective for the treatment of low-risk prostate adenocarcinoma.

Kang JK et al. Image-guided stereotactic body radiation therapy for localized prostate cancer. Tumori 2011;94:43-48. (44 patients) (Attachment #122)

Between October 2002 and December 2007, 44 patients suffering from localized adenocarcinoma of the prostate were treated with SBRT using CyberKnife at the Korea Cancer center Hospital. The (5 year) biochemical failure-free rate of the low-risk and intermediate risk patients was 100%. SBRT using CyberKnife for localized prostate cancer is safe and well tolerated.

King et al. Long-Term Outcomes from a Prospective Trial of Stereotactic Body Radiotherapy for Low-risk Prostate Cancer. Int J Radiation Oncology Biol Phys. 2011. (67 patients) (Attachment #111)

This study shows that clinically significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse-free survival at 4-years compares favorably with those for radical prostatectomy, conventional external beam RT, or permanent brachytherapy. These findings support the radiobiological basis for prostate cancer hypofractionation.

Jarbari et al. Stereotactic Body Radiotherapy as Monotherapy or Post-External beam Radiotherapy Boost for Prostate Cancer: Technique, early Toxicity, and PSA Response. Int. J. Radiation Oncology Biol. Phys., Vol 82, No 1, pp. 228-234, 2012 (38 patients) (Attachment #123_)

Early UCSF (University of California San Francisco) results with SBRT monotherapy and post-EBRT boost for PCa demonstrate acceptable PSA response and minimal toxicity. PSA nadir with SBRT boost appears comparable to those achieved with HDR brachytherapy boost.

Katz et al. High doses of stereotactic body radiotherapy for patients with organ-confined prostate cancer shows high relapse-free survival. PDF of press release and abstract from the ASTRO meeting on October 30, 2012, Available at https://www.astro.org/News-and-Media/News-Releases, 2012 (1,101 patients) (Attachments # 124 & 125).

The study included 1,101 patients from eight institutions who were treated with focused stereotactic body radiotherapy between 2003 and 2011. All patients received CyberKnife stereotactic body radiotherapy, and the median dose was 36.25 Gy (35- 40 Gy range) delivered either with four or five fractions: this is equivalent to a range of 90-110 Gy in conventional fractionation, assuming an alpha/beta ration of 1.5 Gy. Patients were segmented into low-, intermediate - and high-risk categories, comprised of 59 percent, 30 percent, and 11 percent, respectively, in each group. For low- and intermediate-risk cases, these results compare favorably with other modalities at five years.
“Therapy options for patients with organ-confined prostate cancer can be time consuming and costly with traditional radiotherapy methods,” said Alan Katz, MD, JD, lead author of the study and a radiation oncologist at Flushing Radiation Oncology in Flushing, N.Y. “We found that higher doses of stereotactic radiotherapy with fewer fractions yielded great results in terms of tumor control. Our results show that additional standard radiation treatment added to SBRT is probably unnecessary, even with high-risk patients.”

Katz et al. High doses of stereotactic body radiotherapy for patients with organ-confined prostate cancer shows high relapse-free survival. Lecture slides available at https://www.astro.org/News-and-Media/Media-Resources/Press-Kits/Annual-Meeting-2012/News-Briefing-Four.aspx#.UN381jjp5QA.email (Attachment #126).

Meier et al. Intermediate-risk patients with organ-confined prostate cancer have high cancer-free survival rate after stereotactic body radiation therapy. PDF of press release and abstract from the ASTRO meeting on October 30, 2012, Available at https://www.astro.org/News-and-Media/News-Releases/2012/Intermediate-risk-patients-with-organ-confined-prostate-cancer-have-high-cancer-free-survival-rate-after-stereotactic-body-radiation-therapy.aspx#.UN4CS4i-qlY.email 2012 (129 patients) (Attachment #127-128).

Patients with intermediate-risk, organ confined prostate cancer, at a median age of 69, are at risk for progression and spread of the disease, when it becomes more difficult to treat. Our study demonstrates very promising cancer control rates and few side effects from SBRT.

Meier et al. Intermediate-risk patients with organ-confined prostate cancer have high cancer-free survival rate after stereotactic body radiation therapy. Lecture slides available at https://www.astro.org/uploadedFiles/Main_Site/News_and_Media/Media_Resources/Press_Kits/Annual_Meeting_2012/Meier ASTRO Press Slides revised FINAL.pdf (Attachment #129).

Summary of Section V

Anthem’s SURG.00017 medical policy contained three paragraphs on the subject of SBRT for prostate cancer. The statements in all three paragraphs were either out-of-date, inaccurate, or both regarding the Robotic-SBRT used to treat Mr. (last name’s) localized prostate cancer.

The Madsen study cited in the first paragraph was performed with non-Robotic-SBRT and with no image guidance during treatment. As a result, the post-treatment GI and GU toxicity profiles were less than stellar.

The 2009 King study cited in the second paragraph, but erroneously attributed to “Gill” by Anthem, used Robotic SBRT for localized prostate cancer and the results were excellent. King had no biochemical failures and very modest GI and GU toxicity. King’s 2011 follow-up study revealed continued excellent results.

The third paragraph cited a paper by Byyounouski in which all data available after March 2008 was excluded. On this fact alone, the Byyounouski paper was out-of-date regarding the R-SBRT used in December of 2010 for Mr. (last name). In addition, Byyounouski’s substantive concerns regarding immobilization, organ localization, and toxicity were and are significant issues for non-Robotic-SBRT, but were non-issues for Robotic-SBRT, as noted in the 2010 MEDCAC meeting.

Between March of 2008 and December of 2010, when Mr. (last name) was treated with Robotic-SBRT, many articles supporting the use of Robotic-SBRT for prostate cancer were published. Articles published after December of 2010 continue to support the use of R-SBRT for prostate cancer

Section VI.

At the time of Mr. (last name’s) treatment and by the “preponderance of the evidence” standard applicable to this dispute: Based on Anthem’s own definitions, R-SBRT for localized prostate cancer was medically necessary and was not experimental or investigative.

ADMIN.00001 states Anthem’s medical policies are intended to reflect the current scientific data and clinical thinking.

The anthem medical policy formation policy ADMIN.00001, see Attachment # 130, states the following.

Medical policies are intended to reflect the current scientific data and clinical thinking. To reach decisions regarding the medical necessity or investigational status of services, the Medical Policy & Technology Assessment Committee (MPTAC) relies on the medically necessary or investigational criteria in the following policies:

ADMIN.00004 Medical Necessity Criteria
ADMIN.00005 Investigational Criteria

In evaluating the medical necessity or investigational status of a service, the committee may include, but not limit their consideration, to the following additional information: electronic literature searches; independent technology evaluation programs and materials published by professional associations, such as the BC BS Association (BCBSA); technology assessment entities; appropriate government regulatory bodies; and national physician specialty societies and associations. Emphasis added.

The policies of CSM/Medicare and ASTRO represented the “current scientific data and clinical thinking” as of December 2010 and those policies supported R-SBRT for prostate cancer.

Anthem’s “electronic literature search” in support of the SURG.00017 prostate policy was limited to three articles.

As to “electronic literature searches”, the three source articles cited in SURG.00017, see Attachment # 60, are available online. The Madsen article was out-of-date and inapplicable to R-SBRT, the King article supported R-SBRT for prostate cancer, and the quotes from the Buyyounouski article did not apply to R-SBRT. All of the other articles cited in this brief, published in 2010 and before, were available online as well.

The BC BS TEC has no policy on SBRT

As to “independent technology evaluation programs and materials published by professional associations, such as: BC BS Association (BCBSA)”, the BC BS Association Technology Evaluation Center (TEC) has no policy on SBRT.

The NCCN Guidelines were limited to the same three articles cited by Anthem and AHRQ had no data to compare the various types of external beam radiation in the treatment of prostate cancer.

As to “technology assessment entities”, the following two publications were available in December of 2010.

  1. The NCCN Guidelines: A group of nationally recognized radiation oncologists, urologists, and medical physicists sent a letter to the NCCN Guidelines Panel in July of 2010. See Attachment #131. The letter was ignored.

    The subsequent 2011 NCCN Guidelines were limited to the same three articles cited in the Anthem BC BS policy. For the same reasons the Anthem BC BS policy was wrong, the NCCN Guidelines were wrong. The NCCN Guidelines are enclosed as Attachment # 132.

  2. The AHRQ Technology Assessment “Comparative evaluation of radiation treatments for clinically localized prostate cancer” was published in August 2010. See Attachment # 133. Significantly, two of the three articles cited by Anthem in SURG.00017 were expressly excluded by AHRQ (i.e. the Madsen and King articles) and the third article, by Dr. Buyyounouski, isn’t mentioned at all in the AHRQ technology assessment.

    In addition, the first “invited” reviewer of the AHRQ evaluation article succinctly stated: “no data exists that would allow such a comparative evaluation” (of radiation treatments for clinically localized prostate cancer). See Reviewer 1 comments on the first page of Attachment # 134. In an attempt to respond to Reviewer 1, the AHRQ author states: “Asking a different set of key questions (but within the same topic) could very well have resulted in a different set of studies. The studies selected are those studies relevant for our set of key questions, which focused on *comparative* evidence, but are not necessarily representative of all the studies within the field.” See the Author Response comments on the first page of Attachment # 134.

    The third invited reviewer politely makes the point on page four of Attachment # 134 that “the Canadian-sponsored START trial will not have answers (to the questions asked by AHRQ) until 2023!” On the same page the AHRQ author tried to defend use of the START trial in the AHRQ article by stating: “The START trial was discussed in the future Research section of the report.”

    The Public Review Comments to the AHRQ evaluation article includes a statement by Anita McGlothlin of the American College of Radiology. Ms. McGlothlin states on page 4 of Attachment # 135: “The American College of Radiology (ACR) representing over 32,000 diagnostic radiologists, radiation oncologists, medical physicists, interventional radiologists, and nuclear medicine physicians appreciate this opportunity to submit comments on the draft report titled “Radiation Therapy for Localized Prostate Cancer: An Update.” The ACR fully endorses the American Society for Radiation Oncology (ASTRO) recommendations.” Emphasis added.

CMS/Medicare, the “appropriate government regulatory body” approved R-SBRT for prostate cancer in 2010.

As to “appropriate government regulatory bodies”, CMS/Medicare sets the national standards for the radiation therapy treatment of prostate cancer. In 2010, 58.2% of the men newly diagnosed with prostate cancer were Medicare beneficiaries. Medicare’s evidence-based coverage policies are written by the individual MACs in consultation with the radiation oncologists who serve as Carrier Advisory Committee representatives to the MACs. The 2010 National MEDCAC meeting participants were strongly in favor of R-SBRT for prostate cancer. See Attachment # 136.

In addition, CMS/Medicare prohibits payment for services that are experimental or investigative. As a clear demonstration of the fact that R-SBRT was not experimental or investigative in December of 2010, MACs were paying for the R-SBRT treatment of prostate cancer and the ALJs were ruling in favor of Appellant providers in the states, such as (Name of state), where negative SBRT-for-prostate-cancer LCD policies were based on the assertion that SBRT was not medically necessary. See Section IV of this brief.

ASTRO, the “national physician specialty society” for radiation oncology, approved R-SBRT for prostate cancer in 2010.

As to “national physician specialty societies”, ASTRO (the American Society for Therapeutic Radiation and Oncology) published an official Model Policy on SBRT in August of 2010, stating all insurance companies should pay for the SBRT treatment of localized prostate cancer. See Section IV of this brief.

The clear intent of Anthem’s medical policy formation policy ADMIN.00001 is captured in the first sentence of the policy: “Medical policies are intended to reflect the current scientific data and clinical thinking.” Based on the “current” scientific data and clinical thinking in December of 2010, R-SBRT for Mr. (last name’s) localized prostate cancer was entirely appropriate.

Based on Anthem’s ADMIN.00005 Investigational Criteria policy, R-SBRT for localized prostate cancer was not “experimental/investigative.”

The Anthem ADMIN.00005 Investigational Criteria, See Attachment # 136, states the following.

"Investigational" means that the procedure, treatment, supply, device, equipment, facility or drug (all services) does not meet the WellPoint Technology Evaluation Criteria because it does not meet one or more of the following criteria:
  • have final approval from the appropriate government regulatory body; or
  • have the credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community which permits reasonable conclusions concerning the effect of the procedure, treatment, supply, device, equipment, facility or drug (all services) on health outcomes; or
  • be proven materially to improve the net health outcome; or
  • be as beneficial as any established alternative; or
  • show improvement outside the investigational settings.
In addition to the above criteria, the Medical Policy & Technology Assessment Committee (MPTAC) will consider recommendations of national physician specialty societies, nationally recognized professional healthcare organizations and public health agencies, and in its sole discretion, may consider other relevant factors, including information from the practicing community.

For Mr. (last name), the above “investigational” definition is incorporated in the more exhaustive definition of “Experimental/Investigational” found on pages 91-92 of the Anthem Benefit Booklet published for the (Name of state) 2010 PERA (Public Employees' Retirement Association) PPO plans. See Attachment # 137.

Using the order of the topics presented in the Anthem Benefit Booklet definition of Experimental / Investigational, (name of) CK center’s response to each Anthem statement is as follows.

  1. The use of Robotic-SBRT has the final approval of the Food and Drug Administration for the treatment of cancer anywhere in the body. See Attachment # 63.
  2. The use of Robotic-SBRT has not been determined by the FDA to be contraindicated for the treatment of localized prostate cancer.
  3. The use of Robotic-SBRT for Mr. (last name) was not provided as part of a clinical research protocol or clinical trial. Although the long term results (i.e. follow up PSA levels and bladder and bowel toxicity reports) of Mr. (last name’s) treatment will be tracked and submitted to a National registry in Florida under a Clinical Trials.gov study, the actual treatment of his prostate cancer was not experimental or investigative.

    The ClinicalTrials.gov information regarding the “Multi-Institutional Registry for Prostate Cancer Radiosurgery” is enclosed. See Attachment #138. The “Investigator Notice of IRB Approval Package” sent to Dr. (last name of the treating radiation oncologist) is enclosed. See Attachment #139. The “Patient Information and Informed Consent” documents for the “Multi-Institutional Registry for Prostate Cancer Radiosurgery” study is enclosed. See Attachment #140.

    Treatment of Mr. (last name’s) prostate cancer with Robotic-SBRT was not experimental because Medicare does not pay for the experimental component of any treatment and Medicare pays for the Robotic-SBRT treatment of localized prostate cancer. Every MAC in the U.S. now pays for the R-SBRT treatment of localized prostate cancer. In December of 2010 TrailBlazer did not pay for the R-SBRT treatment of localized prostate cancer but those denials were routinely overturned by the ALJs. Based on the TrailBlazer LCD and the evidence presented at the ALJ hearings, the ALJs found R-SBRT to be “medically reasonable and necessary” for the treatment of localized prostate cancer. In January of 2012, TrailBlazer finally changed its policy, based on ASTRO’s August 2010 policy statement, and now pays for the R-SBRT treatment of localized prostate cancer.

    The studies listed on the clinicaltrials.gov website re R-SBRT and prostate cancer are retrospective, not prospective. Prospective studies are performed to determine whether a treatment is appropriate for a condition. By contrast, retrospective studies are performed to determine long term results of approved treatments as well as to compare the results of different treatments. The clinicaltrials.gov studies re R-SBRT for prostate cancer have been completed or are underway to determine long term results or to compare R-SBRT to other forms of treatment for prostate cancer, e.g. R-SBRT vs. surgical prostatectomy.

  4. The use of Robotic-SBRT for Mr. (last name) was not provided for the purpose of evaluating the safety, toxicity, or efficacy of Robotic-SBRT. The Robotic-SBRT was provided for the purpose of eradicating his prostate cancer.
  5. The use of Robotic-SBRT for Mr. (last name) was not provided subject to review and approval of an Institutional Review Board (IRB) or other body serving a similar function. Page two of the registry informed consent document states: “You do not have to take part in this study to receive treatment for your prostate cancer.” Emphasis added. See page 2 of Attachment #140.
  6. The Robotic-SBRT was not provided pursuant to informed consent documents that described the Robotic-SBRT service as experimental or investigational. See Attachment #140.
  7. The Robotic-SBRT was not provided pursuant to informed consent documents that indicated the safety, toxicity or efficacy of the Robotic-SBRT service was under evaluation. See Attachment # 140.
  8. The scientific evidence concerning the effect of the Robotic-SBRT on health outcomes of patients with localized prostate cancer is conclusive. That is, the effect of the Robotic-SBRT on health outcomes of patients with localized prostate cancer is as “conclusive” as the effect of 3D Conformal RT, IMRT, HDR. Brachytherapy, and Proton Beam RT on health outcomes of patients with localized prostate cancer. See Attachments #6, 11, 106-126, 131.
  9. The scientific evidence does demonstrate that Robotic-SBRT improves the net health outcomes of the total population for whom the service might be proposed as (well as) any established alternatives. See Attachments #6, 11, 106-126, 131.
  10. The scientific evidence demonstrates Robotic-SBRT does 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. See Attachments #6, 11, 106-126, 131.
  11. The use of Robotic-SBRT for localized prostate cancer is supported by controlled clinical trials published in authoritative, peer-reviewed United States medical journals. See Attachments #6, 11, 106-126, 131.
  12. The use of Robotic-SBRT for localized prostate cancer is supported by the evaluations of national medical associations, consensus panels and other technology bodies.
     a. See the Medicare Carrier Advisory Committee comments on R-SBRT for localized prostate cancer, Attachment # 110.
     b. ASTRO’s evaluation of R-SBRT for localized prostate cancer resulted in the August 2010 Model Policy, approving SBRT for prostate cancer. See Attachment # 47
  13. The use of Robotic-SBRT for localized prostate cancer is supported by the documents issued by the FDA. See Attachment # 63.
  14. The use of Robotic-SBRT for localized prostate cancer is supported by the documents published by several IRB studies. See Attachment # 102.
  15. 15. The use of Robotic-SBRT for localized prostate cancer is supported by the consent documents used by other radiation oncologists providing the same service.
  16. 16. The use of Robotic-SBRT for localized prostate cancer is supported by the written protocols used by other radiation oncologists providing the same service.
  17. The medical records for Mr. (last name) substantiate the use of Robotic-SBRT for the treatment of his localized prostate cancer was not experimental or investigational. See Attachments # 14, 49, 50 and 52.

Based on Anthem’s ADMIN.00004 Medical Necessity Criteria policy, R-SBRT was “medically necessary” for the treatment of Mr. (last name’s) localized prostate cancer.

The Anthem ADMIN.00004 Medical Necessity Criteria, See Attachment # 141, is defined as follows.

"Medically Necessary" services are procedures, treatments, supplies, devices, equipment, facilities or drugs (all services) that a medical practitioner, exercising prudent clinical judgment, would provide to a covered individual for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
  • in accordance with generally accepted standards of medical practice; and
  • clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the covered individual's illness, injury or disease; and
  • not primarily for the convenience of the covered individual, physician or other health care provider; and
  • not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that covered individual's illness, injury or disease.
For these purposes, "generally accepted standards of medical practice" means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, national physician specialty society recommendations and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors.

For Mr. (last name), the above “Medically Necessary” definition is incorporated in a more exhaustive definition of “Medically Necessary” found on page 95 of the Anthem Blue Cross and Blue Shield (Anthem) Benefit Booklet published for the (Name of state) 2010 PERA (Public Employees' Retirement Association) PPO plans. See Attachment # 137.

Following the order of the topics presented in Anthem’s Benefit Booklet definition of “Medically Necessary”, (name of) CK center’s response to each Anthem statement is as follows.

  1. The use of Robotic-SBRT for the treatment of Mr. (last name’s) localized prostate cancer was “medically appropriate.”
  2. There is no disagreement on whether the use of radiation therapy for Mr. (last name’s) localized prostate cancer was medically appropriate. The disagreement revolves around the use of R-SBRT, as opposed to other forms of radiation therapy (e.g. 3D Conformal RT, IMRT, or HDR Brachytherapy) for his prostate cancer.

    IMRT replaced 3D Conformal RT for prostate cancer because IMRT can place a higher dose of radiation on the targeted prostate with less radiation exposure of the surrounding structures (e.g. bladder and rectum). R-SBRT is replacing IMRT for prostate cancer because R-SBRT can place a higher dose of radiation on the targeted prostate with less radiation exposure of the surrounding structures (e.g. bladder and rectum). In addition, because of the low a/ß ratio of prostate cancer cells, the use of much higher doses of radiation administered in fewer treatment sessions results in a greater radiobiologic effect at the cancer site.

  3. Treatment of Mr. (last name’s) localized prostate cancer was obtained from a board certified radiation oncologist.
  4. Dr. (last name of treating radiation oncologist) of (name if CK center) provided the radiation therapy for Mr. (last name). See Attachments # 17, 49, 50, 52 and 57.

  5. The radiation therapy was provided in accordance with applicable medical standards.
  6. In December of 2010, Medicare Administrative Contractors allowed R-SBRT for localized prostate cancer. Here is a list of the MACs with LCDs on SBRT that were favorable regarding R-SBRT for localized prostate cancer. Wisconsin Physician Services (WPS) L28366 - see Attachment #44; Palmetto GBA L28301 - see Attachment # 42; Highmark L30277 - see Attachment # 45; and First Coast Service Options (FCSO) L30366 - see Attachment # 46.

    In December of 2010,TrailBlazer, the Medicare Administrative Contractor for (Name of state), prohibited R-SBRT for localized prostate cancer in L26835. However, the Administrative Law Judges who have heard and ruled on the subsequent appeals flowing from the TrailBlazer denials have decided in favor of the radiation oncologists providing R-SBRT for prostate cancer. In just those cases where I have represented the providers, the ALJs have decided in favor of the providers for 204 out of 204 fully appealed radiation delivery codes (G0339 and G0340) denied by TrailBlazer for the treatment of prostate cancer. Those ALJ decisions are included as Attachments # 83-93.

    Not unexpectedly, the TrailBlazer (R-SBRT for localized prostate cancer) policy was changed by TrailBlazer in January of 2012 to cover prostate cancer, largely based on ASTRO’s August 2010 change in policy. See Attachment # 41.

  7. The use of Robotic-SBRT was known to be effective, as proven by scientific evidence, in materially improving health outcomes for patients with localized prostate cancer.
  8. See the articles published by December of 2010, substantiating the use of R-SBRT for localized prostate cancer. See Attachments # 5, 6, 8, 10, 13, 106, 110, 112, 113, 114, 115, 118, 131.

  9. Once the diagnosis of prostate cancer was established, and a decision was made to treat the cancer with radiation therapy, outpatient radiation therapy was the most appropriate level of service that could safely be provided and which could not be omitted consistent with recognized professional standards of care.
  10. Mr. (last name) decided on radiation therapy for his cancer instead of surgery. Once the decision was made in favor of radiation therapy, his treatment would have been provided on an outpatient basis regardless of the type of radiation therapy used.

  11. The use of R-SBRT was cost-effective compared to alternative interventions, including: 3D conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Proton Beam therapy.
  12. The R-SBRT was thousands of dollars less expensive than 3D Conformal RT, IMRT, and Proton Beam RT. See Attachment #68.

  13. The use of Robotic-SBRT was not experimental or investigational.
  14. R-SBRT was approved by the FDA for the treatment of cancer anywhere in the body on August 10, 2001. See Attachment #63. In addition, Medicare does not pay for any experimental or investigational treatment and Medicare now pays, nationwide, for the R-SBRT treatment of localized prostate cancer.

    Although there are at least 10 www.clinicaltrial.gov studies re the CyberKnife (R-SBRT) and prostate cancer, these are not prospective studies designed to determine whether R-SBRT can be used for localized prostate cancer. They are all retrospective studies designed: to compare the difference in long term effects between surgery and R-SBRT; to duplicate the dosimetry and treatment schedule of HDR Brachytherapy; to follow the PSA levels, and bladder and bowel toxicities over many years, etc. There are similar lists of retrospective studies regarding radical prostatectomy for prostate cancer, 3D Conformal RT for prostate cancer, IMRT for prostate cancer, and Proton Beam for prostate cancer listed on the www.clinicaltrial.gov website.

    The only time Medicare allows payment for an experimental part of a treatment is when CMS publishes an NCD (National Coverage Determination) with CED (Coverage with Evidence Determination). Otherwise, Medicare does not allow payment for the “experimental” component of any treatment. There is no NCD with CED for the R-SBRT treatment of prostate cancer.

    The above listed Medicare Contractors paid for the R-SBRT radiation delivery codes, G0339 and G0340, submitted for the treatment of prostate cancer in December of 2010, because R-SBRT for localized prostate cancer was not considered experimental/investigational.

  15. The Robotic-SBRT was not provided for the convenience of the doctor, the patient, or the patient’s family.
  16. Although R-SBRT is more convenient for the patient (and the patient’s family) because the entire treatment is completed in 5 as opposed to 45 treatment sessions, the choice of R-SBRT treatment for Mr. (last name’s) cancer was not made on the basis of convenience.

  17. Robotic-SBRT was not otherwise subject to any exclusion under the patient’s plan.

Summary of Section VI

The R-SBRT used to treat Mr. (last name’s) prostate cancer was not experimental / investigational. By the preponderance of the evidence standard, at the time Mr. (last name) was treated:

  1. R-SBRT (Accuray CyberKnife®) had the final approval of the FDA for the treatment of prostate cancer.
  2. Mr. (last name’s) R-SBRT was not provided as part of a clinical trial.
  3. The use of R-SBRT was not provided for the purpose of evaluating the safety, toxicity, or efficacy of R-SBRT.
  4. The use of R-SBRT was not provided for the purpose of evaluating the safety, toxicity, or efficacy of Robotic-SBRT.
  5. The use of Robotic-SBRT for Mr. (last name) was not provided subject to review and approval of an Institutional Review Board (IRB) or other body serving a similar function.
  6. The Robotic-SBRT was not provided pursuant to informed consent documents that described the Robotic-SBRT service as experimental or investigational.
  7. The Robotic-SBRT was not provided pursuant to informed consent documents that indicated the safety, toxicity or efficacy of the Robotic-SBRT service was under evaluation.
  8. The scientific evidence concerning the effect of the Robotic-SBRT on health outcomes of patients with localized prostate cancer is conclusive.
  9. The scientific evidence does demonstrate that Robotic-SBRT improves the net health outcomes of the total population for whom the service might be proposed as any established alternatives.
  10. The scientific evidence does demonstrate Robotic-SBRT 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.
  11. The use of Robotic-SBRT for localized prostate cancer is supported by controlled clinical trials published in authoritative, peer-reviewed United States medical journals.
  12. The use of Robotic-SBRT for localized prostate cancer is supported by the evaluations of national medical associations, consensus panels and other technology bodies.
  13. The use of Robotic-SBRT for localized prostate cancer is supported by the documents issued by the FDA.
  14. The use of Robotic-SBRT for localized prostate cancer is supported by the documents published by several IRB studies.
  15. The use of Robotic-SBRT for localized prostate cancer is supported by the consent documents used by other radiation oncologists providing the same service.
  16. The medical records for Mr. (last name) substantiate the use of Robotic-SBRT for the treatment of his localized prostate cancer was not experimental or investigational.

The R-SBRT used to treat Mr. (last name’s) prostate cancer was medically necessary. By the preponderance of the evidence standard, at the time Mr. (last name) was treated:

  1. The use of Robotic-SBRT for the treatment of Mr. (last name’s) localized prostate cancer was “medically appropriate.”
  2. Treatment of Mr. (last name’s) localized prostate cancer was obtained from a board certified radiation oncologist.
  3. The radiation therapy was provided in accordance with applicable medical standards.
  4. The use of Robotic-SBRT was known to be effective, as proven by scientific evidence, in materially improving health outcomes for patients with localized prostate cancer.
  5. Outpatient radiation therapy was the most appropriate level of service that could safely be provided and which could not be omitted consistent with recognized professional standards of care.
  6. The use of R-SBRT was cost-effective compared to alternative interventions
  7. The use of Robotic-SBRT was not experimental or investigational.
  8. The Robotic-SBRT was not provided for the convenience of the doctor, the patient, or the patient’s family.
  9. Robotic-SBRT was not otherwise subject to any exclusion under the patient’s plan.

Request for relief

The arbitrator should overrule Anthem’s decision and should order Anthem to pay 80% of the case rate ($xx,xxx) allowed under the (name of CK center) -Anthem contract for the medically reasonable and necessary R-SBRT services provided to Mr. (last name).

(Name of CK center) requests the Arbitrator award payment in (Name of CK center’s) favor for its reasonable attorneys’ fees and court costs as well as two times the covered benefits pursuant to (citation to statute).

(Name of CK center) requests the Arbitrator award payment in (Name of CK center’s) favor for pre-and post-judgment interest beginning 90 days after the initial claims for services were submitted to Anthem.

(Name of CK center) requests the Arbitrator award payment in (Name of CK center’s) favor for all costs of the arbitration, including costs of the arbitrator and for the service of JAMS.

(Name of CK center) requests the Arbitrator award payment in (Name of CK center’s) favor for all expert witness costs and fees, all photocopying costs, deposition and transcript costs, all administrative and filing fees, as well as all other costs and expenses available under law.

(Name of CK center) requests the Arbitrator award payment in (Name of CK center’s) favor for all other relief as justice requires.

List of Attachments

1 Wikipedia: Radiation Therapy
2 Wikipedia: The different Types of External Beam Radiotherapy
3 Wikipedia: The CyberKnife
4 Accuray Summary: The Robotic Stereotactic Radiosurgery Treatment of Prostate Cancer
5 Kilby. The CyberKnife Robotic Radiosurgery System in 2010
6 Katz. CyberKnife Radiosurgery for Prostate Cancer. 2010
7 Hossain. Dose Gradient Near Target. 2010
8 Brenner. Toward Optimal External-Beam Fractionation for Prostate Cancer. 2000
9 Fowler. The Radiobiology of Prostate Cancer Including New Aspects of Fractionated Therapy. 2005
10 Madsen. Stereotactic Hypofractionated Accurate Radiotherapy of the Prostate 2007
11 King. Stereotactic Body Radiotherapy for Localized Prostate Cancer 2009
12 Principals of CPT Coding
13 Buyyounouski. Stereotactic Body Radiotherapy for Primary Management of Early-Stage PC. 2010
14 CMS Definition of G0339 & G0340
15 Xie. Intrafractional Motion of the Prostate During Hypofractionated Radiotherapy. 2008
16 (Name of CK center) -Anthem PPO Provider Agreement
17 10-08-10 Request for Pre-Authorization
18 10-20-10 Anthem Pre-Treatment Authorization Denial
19 11-02-10 Expedited Pre-Authorization Appeal
20 11-12-10 Anthem Pre-Treatment Authorization Denial
21 11-12-10 Request for level 2 Appeal by Teleconference
22 12-09-10 Anthem Level 2 Pre-Treatment Denial
23 04-28-10 ASTRO's response to WellPoint re RAD.00002
24 08-04-10 ASTRO's response to WellPoint re RAD.00014
25 08-06-10 ASTRO's response to WellPoint re Policy #8.01.46
26 11-18-10 ASTRO's response to WellPoint re SURG. 00017
27 12-15-10 ASTRO's response to WellPoint re Policy #00.00.00ABI
28 01-25-11 ASTRO's response to WellPoint re Policy #8.01.47
29 03-19-12 ASTRO's response to WellPoint re Policy #6.01.10
30 03-27-12 ASTRO's response to WellPoint re Policy #08-01-49
31 03-29-12 ASTRO's response to WellPoint re policy #8.01.48
32 12-20-12 ASTRO's response to WellPoint re policy #8.01.10
33 TrailBlazer LCD, L26835 4R-24AB on SBRT (03/01/08 – 07/02/08)
34 TrailBlazer LCD, L26835 4R-24AB-R1 on SBRT (07-03-08 – 02/14/10)
35 TrailBlazer LCD, L26835 4R-24AB-R2 on SBRT (02/15/10 – 05/06/10)
36 TrailBlazer LCD, L26835 4R-24AB-R3 on SBRT (05/07/10 – 09/09/10)
37 TrailBlazer LCD, L26835 4R-24AB-R4 on SBRT (09/10/10 – 10/17/10)
38 TrailBlazer LCD, L26835 4R-24AB-R4 on SBRT (10/18/10 – 12/31/10)
39 TrailBlazer LCD, L26835 4R-24AB-R5 on SBRT (01/01/11 – 01/13/11)
40 TrailBlazer LCD, L26835 4R-24AB-R6 on SBRT (01/14/11 – 06/30/11)
41 TrailBlazer LCD, L26835 4R-24AB-R8 on SBRT (07/01/11 – 01/29/12)
42 Palmetto LCD, L28301 on SBRT as of (07/01/10 – 01/26/11)
43 Novitas LCD, L32670 (11/19/12 – current)
44 Wisconsin Physicians Services LCD, L28366 on SBRT (01/01/10 – 04/24/11)
45 Highmark LCD, L30277 on SBRT (10/28/09 – 04/30/12)
46 First Coast Service Options LCD, L30366 on SBRT as of (10/05/09 – 12/31/10)
47 ASTRO August 2010 SBRT Model Policy
48 Anthem BC BS of (Name of state) is a subsidiary of WellPoint
49 12-09-10 New Patient Consultation report for (last name of patient)
50 Treatment Book for (last name of patient)
51 Billing Records for (last name of patient)
52 03-22-11 Post-Treatment Appeal
53 08-10-11 Request for Independent External Review
54 11-02-11 Advanced Medical Reviews - Peer Review Final report (Independent External Review)
55 05-15-12 letter to XXXX Notifying Anthem BC BS of Impending arbitration
56 Medical expert’s CV
57 Treating doctor’s CV
58 Treating doctor’s CV
59 Medical Physicist’s CV
60 Anthem's Policy SBRT- SURG.00017 as of 11/18/2010
61 Anthem Policy by Category RAD & SURG
62 Medicare Program Integrity Manual Section, Chapter 13 – LCDs, Section 13.5.1
63 FDA approval for CyberKnife (07/10/01)
64 NCD for Routine Costs in Clinical Trials 310.1
65 CHAMPVA Policy Manual
66 Blue Shield of California SBRT Policy (07/07/08)
67 Top 25 US Insurance Companies
68 Hodges. Cost-effectiveness of SBRT v. IMRT for prostate cancer. 2012
69 Cancer Facts and Figures 2010
70 SEER (Surveillance Epidemiology and End Results) Stat Fact Sheets: Prostate
71 Anthem BC B is in 14 states (CA, CO, CT, GA, IN, KY, ME, MO, NH, NV, NY, OH, VA, WI)
72 68 FR 75442
73 69 FR 65682
74 70 FR 42674
75 70 FR 68516
76 71 FR 49506
77 71 FR 67960
78 72 FR 42628
79 72 FR 66580
80 73 FR 68502
81 74 FR 60316
82 75 FR 71800
83 ALJ Zatopa decision in ALJ # 1-481623187
84 ALJ Zatopa decision in ALJ # 1-484151801
85 ALJ Zatopa decision in ALJ # Multiple
86 ALJ Bockhold decision in ALJ # Multiple
87 ALJ Kelton decision in ALJ # 1-606253682
88 ALJ Koldewey decision in ALJ # 1-708662531
89 ALJ Koldewey decision in ALJ # 1-754168531
90 ALJ Koldewey decision in ALJ # 1-782901324
91 ALJ Koldewey decision in ALJ # 1-782648785
92 ALJ Canter decision in ALJ # 1-939848517
93 ALJ Smith decision in ALJ# 1-923865168
94 42 CFR 405.1060 Applicability of National Coverage Determinations (NCDs)
95 1862(a)(1)(A) Social Security Act (No payment for services that are not reasonable and necessary)
96 Medicare Program Integrity Manual Section 13.7.1 - Evidence Supporting LCDs
97 42 CFR 405.1062 (ALJs are not bound by LCDs but will give substantial deference…)
98 Highmark BC BS of Delaware Policy 6.01.10
99 Highmark BC BS of Delaware Policy 6.01.R-14
100 Anthem and WellPoint Complete Merger
101 Horizon BC BS of New Jersey policy 044
102 ClinicalTrials.gov - CyberKnife Prostate Cancer
103 ClinicalTrials.gov - 3D Conformal RT and Prostate Cancer
104 ClinicalTrials.gov - IMRT and Prostate Cancer
105 ClinicalTrials.gov - Radical Prostatectomy and Prostate Cancer
106 Fuller. Virtual HDR CyberKnife Treatment for Localized Prostatic Carcinoma. 2008
107 Wiegner. Sexual Function after SBRT for Prostate Cancer. 2010
108 Fuller – ASTRO 2011: Follow up of Virtual HDR SBRT for localized prostate cancer
109 Fuller – ASTRO 2012: Follow up of SBRT for low and intermediate risk prostate cancer emulating HDR brachytherapy dose distribution
110 04-21-10 Transcript of MEDCAC meeting on comparative evaluation of radiation treatments for clinically localized prostate cancer. 2010
111 King. Long-Term Outcomes From Prospective Trial of SBRT for Low-Risk Prostate Cancer. 2011
112 Friedland. SBRT: An Emerging Treatment Approach for Localized Prostate Cancer. 2009
113 Katz. SBRT for Organ-Confined Prostate Cancer. 2010
114 Bolzicco. Image-Guided SBRT for Clinically Localized Prostate Cancer: Preliminary Results. 2010
115 Aluwini. CK Stereotactic Radiotherapy as Monotherapy for Low- to Intermediate-Stage PC: Early Experience, Feasibility, and Tolerance. 2010
116 Katz. SBRT as Boost for Organ-Confined prostate Cancer. 2010
117 Katz. SBRT for low and low -Intermediate Risk Prostate Cancer. 2011
118 Townsend. Acute Toxicity After CK- Delivered Hypofractionated Radiotherapy for Treatment of Prostate Cancer. 2010
119 Freeman. SBRT for low-risk Prostate Cancer: Five Year Outcomes. 2011
120 Boike. Phase I Dose-Escalation Study of SBRT for Low- and Intermediate- Risk Prostate Cancer. 2011
121 McBride. Hyprofractionated SBRT in Low-Risk Prostate Adenocarcinoma. 2011
122 Kang. Image-Guided SBRT for Localized Prostate Cancer. 2011
123 Jabbari. SBRT as Monotherapy or Post-External Beam Radiotherapy Boost for Prostate Cancer 2011
124 ASTRO 2012 - High Doses of SBRT for Patients with Organ-Confined PC Shows High Relapse-Free Survival
125 ASTRO 2012 - 5 yr. Biochemical Control Rates for SBRT for Organ Confined PC: A Multi-Institutional Pooled Analysis
126 ASTRO 2012 - Prostate SBRT Pooled Analysis Lecture slides
127 ASTRO 2012 - Intermediate-Risk with Organ-Confined PC have High Cancer-Free Survival rate after SBRT
128 ASTRO 2012 - SBRT for Intermediate-risk Organ-Confined PC Interim Toxicity and Quality of Life Outcomes from a Multi-Institutional Study (Meier)
129 ASTRO 2012 - SBRT for Intermediate-risk Organ-Confined PC Interim Toxicity and Quality of Life Outcomes from a Multi-Institutional Study
130 Anthem Policy ADMIN.00001: Medical Policy Formation
131 07-02-10 letter to the NCCN from 13 Radiation Oncology Professors and Radiation Physicists
132 NCCN Guidelines for Prostate Cancer 3.2011
133 08-13-10 AHRQ Technology Assessment. (excluded 2 of the 3 articles relied upon by Anthem)
134 Oct. 2010 AHRQ update: Invited Peer Reviewer Comments. “No adequate data to answer the three questions posed”
135 Public Review Comments to the AHRQ. “The American College of Radiology endorses ASTRO’s recommendations.”
136 Anthem Policy ADMIN.00005: Investigational Criteria
137 (Name of state) 2010 Public Employee Retirement Association (PERA) Benefit Guide
138 ClinicalTrials.gov- Muti-Institutional Registry for Prostate Cancer Radiosurgery
139 Investigator Notice of IRB Approval package re the CyberKnife Registry for prostate cancer
140 (last name of patient) IRB Consent for the CyberKnife Registry
141 Anthem Policy ADMIN.00004: Medical Necessity Criteria
142 The client authorization and representation form for (name of CK center)
143 patient consent form (from a different CK center)
144 BC BS staff Bios
145 04-17-13 ASTRO Model Policy on SBRT
146 Medicare: Reasonable and Medically Necessary Care (Marquette Elder’s Advisor)
147 White Paper- Prostate Cancer and SBRT
148 07-07-08 Blue Shield policy re SRS and SBRT
149 04-02-08 letter from Blue Shield re Authorization of CyberKnife treatment for Kinder’s prostate cancer
150 04-02-08 CA Department of Managed Health Care decision re Kinder
151 04-15-08 letter from Blue Shield to Kinder
152 Goodman v Sullivan, 891 F.2d 449: “The Secretary of HHS prohibits payment for an experimental or investigational treatment.”
153 a/ß ratio in the Anthem articles

Please email me at dmullens@mullenslawoffice.com  if you have any questions regarding this brief.

Disclaimer: Information contained in this newsletter does not constitute legal advice and is not a substitute for the professional judgment of an attorney.

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