Comments

  • Anonymous 01/11/2009 7:51pm

    Please let all America know about their governments failure to provide quality health care and adding cost to both the patient and Medicare,
    I was diagnosed with prostate cancer (PCa) in Aug. of 2007. My PSA was 4.0 ng/ml, a biopsy revealed a stage T1c adenocarcinoma involving the right mid to right apex with a Gleason score of 3+3; in 3 of 12 cores.

    I discussed all treatment options with my family doctor at Stanford, surgeons and radiation Oncologists. All options (Proton, IMRT various surgery options, ADT, and Cyro) were reviewed with my wife. The considerations were risk of side effects, cure rate, recovery and treatment time, procedure risk (infection, anesthesia, etc). Treatment with the CyberKnife was my choice.

    CyberKnife treatment was scheduled but denied by my insurer. I spent the next 7 months researching the CyberKnife appealing the denial. The insurance denial was covered by CBS [url]http://cbs5.com/investigates/CyberKnife.blue.shield.2.716740.html[/url]

    After six denials, an Independent Medical Review (IMR) was requested from the CA Dept. of Managed Health Care. The state of CA was provided hundreds of pages of literature. I was very fortunate and the IMR overturned the insurers’ denial. Two months after treatment the insurer changed their coverage policy and added SBRT/CyberKnife coverage. Some of the clinical studies provide form the IMR were included by the insurer as rational for the treatment.

    It is now almost 8 months post CyberKnife treatment. I am 110% of pre-treatment base line for all related functions. The plus 10% is from improved urinations. Before treatment I would get up 3-4 times a night now I typically get up once. My PSA at the six month follow up was 1.09 ng/ml. SBRT/CyberKnife has treated my prostate cancer and has improved my quality of life.

    I am now an advocate for prostate cancer patients and am a founder of ZERO The Project to End Prostate cancer.

    HHS/CMS has failed to implement the MMA fo 2003 with Medicare coverage for prostate cancer patients. Regulations and the intent of the MMA are not being followed by some of the Medicare contractors Noridian, Trailblazer and Palmetto GBA.

    The NY Times article addresses this issue.

    I have copied my testimony given to CMS and Palmetto on Nov. 18, 2008 as well as a 2nd written testimony in response to the meeting on the 18 on Nov..

    “Official Testimony of Fred, Patient
    On
    SBRT Treatment of Cancer of the Prostate
    Palmetto GBA/Medicare Open Draft LCD meeting
    November 18, 2008

    Good morning Palmetto GBA administrators, doctors and other interested parties. Thank you for allowing me to discuss Medicare coverage of SBRT/CyberKnife for treating prostate cancer.
    My name is Fred K and I am a small business owner. I am testifying on behalf of myself as an interested party, a prostate cancer patient treated with the CyberKnife and a prostate cancer advocate. I am also a founder of ZERO the Project to End Prostate Cancer.

    I was diagnosed with prostate cancer (PCa) in Aug. of 2007. My PSA was 4.0 ng/ml, a transrectal ultrasound-guided biopsy revealed a stage T1c adenocarcinoma involving the right mid to right apex with a Gleason score of 3+3; in 3 of 12 cores.

    I discussed all treatment options with my family doctor, doctors at Stanford, Surgeons and Radiation Oncologists. I reviewed all options with my wife. As a father of a nine year old son, Business owner, treatment recovery time was an important consideration. I have a clogged artery which made the risk of surgery higher than I was willing to consider.

    I selected SBRT/CyberKnife treatment option for prostate cancer at Stanford. Their clinical trial data, started Dec. 2003, was very encouraging with ZERO biological failures and minimal side effects (my research suggested the CyberKnife is at least as effective as IMRT). My CyberKnife treatment was five days of one hour sessions with no recovery time (IMRT is five days per week for eight weeks). I was advised of and understand the long term risk of radiation side effects and felt the advantages of SBRT/CyberKnife treatment far out weighted the long term risk.

    I completed CyberKnife treatment (May 7, 2008) by Dr. Christopher King. Fourteen days post CK treatment there were minimal side effects. I continued to work every day during and after treatment.
    It is now over six months post CyberKnife treatment. I am 110% of pretreatment base line for all related functions. The plus 10% is from improved urinations. Before treatment I would get up 3-4 times a night now I typically get up once. My PSA at the six month follow up was 1.09 ng/ml. SBRT/CyberKnife has treated my prostate cancer and has improved my quality of life.

    The key messages I hope to impart to you today are:
    1. The previous Medicare contractor in California, NHIC, provided coverage for SBRT/CyberKnife treatment for prostate cancer.
    2. SBRT/CyberKnife treatment for prostate cancer is consistent with the Presidents statement from his press conference announcing the MMA of 2003. With this law, we’re giving older Americans better choices and more control over their health care, so they can receive the modern medical care they deserve.
    3. SBRT/CyberKnife treatment for prostate cancer is consistent with Mark B. McClellan, M.D. PhD Administrator. “Our nation has made a promise, a solemn promise to America’s seniors. We have pledged to help our citizens find affordable medical care in the later years of life.”
    4. As outlined in the CMS Statement of Work for the Palmetto Medicare Jurisdiction (J1), and on Palmettos Website: The MAC shall select the least restrictive Local Coverage Determination (LCD) from the existing LCDs on a single topic when consolidating LCDs. CMS has identified that there may be instances where the decision to implement “no policy” would meet the definition of the “least restrictive LCD”.
    5. There are no prostate cancer treatment options without serious risk of permanent side effects and biological failure.
    6. The patient in consultation with his doctor(s) must decide what treatments are appropriate for their unique circumstance.
    7. Some patients live in rural areas with limited or no local treatment centers.
    8. Some patients have medical conditions that make surgery a high risk.
    9. Some patients have limited mobility making treatment very difficult.
    10. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
    11. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
    12. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
    13. Blue Shield of California the largest insurer in the state, in July of 2008, added SBRT/CyberKnife to their policy for treatment of prostate cancer.

    All of the above support Medicare coverage of SBRT/CyberKnife treatment for cancer of the prostate.
    Please consider the fundamental right of patients to make treatment decisions for themselves in consultation with their doctors and families, and for the patients well being and overall quality of life.

    I have no financial interest in Accuray Inc., Stanford University Medical Center or any other medical provider.

    Thank you for this opportunity to appear before you today.”
    END

    Additional Comments by Fred,
    Patient, and a Founder of ZERO, The Project to End Prostate Cancer
    On SBRT Treatment of Cancer of the Prostate
    Palmetto GBA/Medicare Open Draft LCD meeting, November 18, 2008
    Submitted: Dec. 10, 2008

    Deep concerns about the process
    Thank you for the opportunity to speak at the recent open meeting held in Los Angeles on November 18th. While I appreciated the opportunity, I would like to state for the public record that I was very disappointed with the failure to provide adequate seating for the registered attendees. Standing room only for physicians and patients who traveled hundreds of miles to provide expert testimony was unacceptable.
    Registration for the meeting was required1, but unregistered representatives from drug companies, with no interest in the policies on the agenda, were allowed to sit at the conference table. By contrast, most registered attendees who came to give testimony or make clinical presentations had to stand in the conference room and adjacent rooms, where it was difficult to hear what was being discussed. No audio-visual aid was available, so we could not see charts and other evidence. Since presentations were solicited in advance, it is hard to explain this as poor planning; it was certainly a formidable deterrent to those who wanted to speak.
    This illustrates Palmetto’s lack of consideration and respect for Doctors and patients, and indeed for the reconsideration process that CMS has mandated. Given this lack of courtesy and the way in which I and others were treated when we attempted to ask questions during the meeting, it is hard to avoid the conclusion that Palmetto is simply going through the motions of “reconsideration”, and that its mind is already made up. I hope that events prove me wrong, but I am deeply concerned.

    While I also appreciate Palmetto’s stated concern “to save money” as the reason for the chosen locale, this statement seems disingenuous as the savings to Medicare for one patient to be treated with SBRT (vs. a course of IMRT treatment in the physician office), would have paid for a professional conference room and hotel rooms for all attendees.
    The meeting was held at PCRI, an organization whose website advertises the benefits of IMRT and is conspicuously silent on SBRT. The Palmetto Medical Director is listed as a board member of PCRI. I leave it to others better qualified than I to consider whether this raises issues of ethics or of conflict of interest.

    Request: Palmetto include SBRT as a treatment option for prostate cancer.
    Doctor Lurvey stated at this LCD meeting that he did not care what dose was delivered by IMRT, as that was up to the patients’ doctor.2 While I agree that patients and their doctors should make the treatment choice, increasing the dose of IMRT without clinical studies to verify patient safety translates into Medicare paying for investigational IMRT treatments.
    IMRT is considered investigational and no better than 3D-RT. As stated by the California Technology Assessment Forum (CTAF)20:

    “IMRT for prostate cancer was an agenda item at two prior CTAF meetings where discussion focused on a technology assessment that concluded IMRT for prostate cancer was investigational. The investigational status was based on the lack of evidence from controlled trials proving that IMRT provided any incremental benefit over the conventional 3D conformal radiation therapy (3D-CRT). However, advocates of IMRT pointed out that IMRT should not be considered a new form of radiation therapy subject to distinct technology assessment. Furthermore, advocates pointed out that dose planning studies of IMRT documenting reduced radiation to normal tissues were an acceptable surrogate outcome.”
    When a patient is treated by IMRT the treatment center submits a code for payment. The dose received by the patient defined varies from treatment center to treatment center. Based on the success of the SBRT, using the CyberKnife, and HDR Brachytherapy for treating prostate cancer with a higher dose of ionizing radiation, IMRT centers are increasing their doses. There have been no randomized trials to define what dose is the most effective and the long term risk, or side effects.

    For the treatment of prostate cancer, no one therapy has been proven to be more safe or effective than any other (for example, look at the government’s own agency AHRQ’s February 2008 report on prostate cancer alternatives3). Therefore, each patient in consultation with their physician should be allowed to make the choice of treatment that is best for them that weighs effectiveness and adverse events (such as sexual dysfunction, and urinary and bowel injury).
    Despite the lack of any definitive or conclusive evidence which demonstrates the superiority of one therapy over another, it is documented in the literature that treatment of localized cancer of the prostate by HDR Brachytherapy and SBRT have cure rates as good as or better than IMRT, 3D-RT, Proton Therapy and Surgery. At one, two, three and four years, the CyberKnife at its worst, is no worse than IMRT and Proton therapy which ASTRO advertises on their website for treating prostate cancer.4-17
    Prostate cancer is the number two cancer of men. There is no doubt that millions of dollars are at stake. Unfortunately, there seems to be a misconception that providing SBRT as an option for the treatment of prostate cancer is somehow financially driven. It’s actually the other way around – IMRT18 is far more lucrative a business than SBRT.
    Look at the facts:
    1. The doctor receives less pay for 4-5 SRS/SBRT visits vs. 40 IMRT visits.
    2. Medicare pays far more for IMRT in a physician office setting, which is where roughly one third of IMRT procedures are performed. Even in the hospital outpatient setting, where Medicare currently reimburses about the same for IMRT and SBRT, Medicare will pay several thousand dollars more for IMRT in 2009.
    3. The patient cost of treatment (deductible/copay), transportation, food and lodging is much less for SBRT than IMRT.
    4. Proton Therapy is the most expensive of all treatments “and shows no benefit over other forms of radiation”.19
    5. Blue Shield of California, the largest insurer in the state of California, policy covers CyberKnife for treatment of prostate cancer (attached).
    In its October 31, 2008 Report titled “Final CMS Rules Look Positive For Radiation Oncology, Neutral for Others” Oppenheimer reported:
    Radiation Oncology. There are roughly 30 commonly used codes. Most important is that the key IMRT code (77418) will be up 18% y/y for HOPPS (and up 13% from proposed), as IGRT, which was incorrectly bundled in ‘08 with no adjustment, is now finally being reflected in payments. So total IMRT+IGRT goes from $403 in CY07 to $348 in CY08 to $411 in CY09. For PFS, 77418 is down 14% y/y. Most other IMRT-related codes are up double digits.
    By contrast, Oppenheimer reports that for Stereotactic radiosurgery (SRS), the final robotic SRS codes are generally down in line with proposed rules, with first fraction (G0339) down 3% and 2nd–5th fraction (G0340) down 10% (HOPPS). Reimbursement for Elekta’s Gammaknife (77371) is down 5% (HOPPS), while other SRS codes are flat to slightly up (both from proposed and y/y).
    At the ASTRO 2008 Annual Meeting, ASTRO’s President-elect, Dr. Anthony Zietman, M.D. gave a presentation on proton radiation for early prostate cancer. Dr. Zietman spoke on results from a phase I/II clinical trial in which it failed to show any benefit over other forms of radiation19:

    “Proton radiation has unquestioned value for treatment of certain rare cancers, said Dr. Zietman. However, the technology has yet to demonstrate any advantages over other forms of radiation therapy for common malignancies, such as lung and prostate cancer, where proton radiation centers would recoup the capital investment.

    “The problem is that most patients in the United States treated with proton beam are treated for prostate cancer,” he said. “It’s the economic driver of the proton avalanche.”
    Given the lack of any demonstrated superior outcomes for Proton Therapy why does Palmetto allow proton therapy to be covered for the treatment of prostate cancer and not SBRT? Before Palmetto implemented the non-coverage policy of prostate cancer for SBRT it had been covered in California under the exact same circumstances as proton beam therapy. Unlike SBRT, Palmetto continues to cover proton beam despite any evidence to support its superiority over SBRT or any other forms of radiation therapy.

    As a cancer patient and as a concerned citizen, I believe that my government should make available all treatment options including SBRT, not just those that are backed by vested financial interests. I feel very strongly about a patient’s right to make an informed choice for their treatment. Every treatment has risk; and from my extensive research every other option has higher risk of death, infection or biological failure. It must be the patients’ choice in consultation with our doctors to select the treatment that best meets our specific limitations or medical needs.
    Best Regards,

    Fred Kinder
    Prostate Cancer Patient
    A ZERO founder The Project to End Prostate Cancer________________________________________
    References
    1 The Palmetto GBA Website stated: Palmetto GBA encourages individuals interested in attending the open meeting to register early. Registration will be closed 2 business days prior to the meeting or once space limitations are reached, whichever comes first. Individuals seeking to present information at the Open Draft LCD meeting should submit a request via E-mail to J1B.Policy@PalmettoGBA.com along with a copy of their presentation.
    2 IMRT 81-86 Gy Http://books.google.com/books?id=4NbOoKYvrwsC&pg=PA327&lpg=PA327&dq=prostate+cancer+imrt++86+Gy&source=web&ots=NLu0ibF4j5&sig=2xsTw9NWDbiSNr_mj-i0Ay_wO3Y&hl=en&sa=X&oi=book_result&resnum=4&ct=result
    3 AHRQ’s February 2008 report on prostate cancer alternatives link: http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79
    4 http://www.joearrington.org/Prostate_article.pdf
    5 http://www.medicalnewstoday.com/articles/55980.php

    6 http://jnci.oxfordjournals.org/cgi/content/full/96/18/1358

    7 http://www.ncbi.nlm.nih.gov/pubmed/18164858?dopt=Abstract

    8 Grills IS, Martinez AA, Hollander M, Huang R, Goldman K, Chen PY,
    Gustafson GS. High dose rate brachytherapy as prostate cancer monotherapy7
    reduces toxicity compared to low dose rate palladium seeds. J Urol. 2004
    Mar;171(3):1098-104.

    9 Fuller DB, Naitoh J, Lee C, Hardy S, Jin H. Virtual HDR CyberKnife
    Treatment for Localized Prostatic Carcinoma: Dosimetry Comparison With HDR
    Brachytherapy and Preliminary Clinical Observations. Int J Radiat Oncol Biol
    Phys. 2008 Apr 1;70(5):1588-97. http://www.ncbi.nlm.nih.gov/pubmed/18374232?dopt=AbstractPlus

    10 King CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized
    prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat.
    2003 Feb;2(1):25-30 http://www.ncbi.nlm.nih.gov/pubmed/12625751

    11 Hara W, Patel D, Pawlicki T, Cotrutz C, Presti J, King C. Hypofractionated
    stereotactic radiotherapy for prostate cancer: early results. Int J Radiat Oncol
    Biol Phys. 66(3)(supplement):S324-325, 2006.

    12 King CR, Brooks J, Gill H, Cotrutz C, Pawlicki T, Presti JC. Stereotactic Body
    Radiosurgery for Localized Prostate Cancer: PSA results and Toxicity of a Phase
    II Clinical Trial. Int J Radiat Oncol Biol Phys. 2008 in press.

    13 Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic
    hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five
    fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol
    Phys. 67(4):1099-105. Mar 15 2007

    14 Fuller DB, Lee C, Hardy S, Jin H. Virtual HDR CyberKnife Radiosurgery:
    Technical Evolution and Clinical Results One Year Following Introduction.
    CyberKnife Society Annual Meeting. January 2008, Scottsdale AZ.

    15 Bill-Axelson A, Holmberg L, Ruutu M, Häggman M, Andersson SO, Bratell S,
    Spångberg A, Busch C, Nordling S, Garmo H, Palmgren J, Adami HO, Norlén
    BJ, Johansson JE; Scandinavian Prostate Cancer Group Study No. 4. Radical
    prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med.
    2005 May 12;352(19):1977-84.

    16 Fuller, DB, Lee, C., et al. Prospective Evaluation of CyberKnife® Radiosurgery
    of Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy
    Dosimetry. http://www.accuray.com/Clinical-Development/Clinical-Studies.aspx

    17 Meier, R., Cotrutz, C., et al. Prospective Evaluation of CyberKnife® Stereotactic
    Radiosurgery of Low and Intermediate Risk Prostate Cancer: Homogenous Dose
    Distribution. http://www.accuray.com/Clinical-Development/Clinicalstudies.
    Aspx
    18 N.Y. Times IMRT Article http://www.nytimes.com/2006/12/01/business/01beam.html?_r=1&ei=5070&em=&en=b2cbba99f87b9209&ex=1165122000&adxnnl=1&pagewanted=all&adxnnlx=1228563777-s9lnjfHy/nh4vi/sySQKGw
    19 Proton Therapy link: http://www.medpagetoday.com/MeetingCoverage/ASTRO/11076http://www.medpagetoday.com/MeetingCoverage/ASTRO/11076
    20 CTAF link to meeting: http://www.ctaf.org/content/general/detail/700

    HHS/CMS has a site to give them feed back. Let them know how you feel about taking away a cancer treatment in some states while others allow it. This is an example of the incompetence of our government (HHS/CMS). Let them know how you feel using this link to CMS feed back http://questions.cms.hhs.gov/cgi-bin/cmshhs.cfg/php/enduser/ask.php?p_prods=8,9,536

    Write to CMS management and call them. You can find their names of the Orig Chart(1) link and then enter the name in the Employee Directory(2) to get the phone number, fax number, e-mail address and mailing address. Send your comments to Palmetto management(3), Sent your comments by e-mal and fax to the president(4), Send you comments to the Senators and Representatives (5) and Open Congress allows you to post comments for each Senator and Representative.(6)

    1. HHS/CMS Medicare Organization Chart http://www.cms.hhs.gov/CMSLeadership/50_OrganizationalChartASP.asp#TopOfPage
    2. Employee Directory http://directory.psc.gov/employee.htm
    3. Palmetto GBA Board of Directors
    3.1 President and COO – Bruce.Hughes@palmettogba.com
    3.2 President COO Gov. Programs Blue Shield Blue Cross of SC – William.Horton@palmettogba.com
    3.3 Management link http://www.palmettogba.com/palmetto/aboutarea.nsf/officers.htm
    3.4 Medical directors – HARRY.FELICIANO@palmettogba.com , ARTHUR.LURVEY@palmettogba.com
    4. Whitehouse – http://www.whitehouse.gov/contact/
    5. U.S. Gov. elected officials – http://www.senate.com/
    6. Opencongress http://www.opencongress.org/bill/110-sr667/show#comments

    Peace On Earth and Good Health to All!

  • WLBANNING 01/23/2010 1:26am

    Ionizing radiation has inured thousands of our military including cancer and whole list of items that cannot be addressed unless congree acts on these injuries.WLBANNING

  • johnbaldwin 03/15/2011 9:13pm

    I hope the congress acts now on these kind of incidents. ASAP

    John Baldwin
    medical transcription services


Track with MyOC