viperfred’s Actions

 
Subscribe

viperfred’s Letters to Congress

No letters to Congress written yet.

viperfred’s Comments

viperfred 12/27/2008 11:57pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
**
Augusta, Georgia 30903-1476

Dear Palmetto J1 Management,

Please find enclosed my Testimony and comments regarding SBRT/CyberKnife treatment for prostate cancer. What is at stake is the cost of treatment to the insurer, insured and the patient’s quality of life. I just do not understand how the new MAC can remove treatment previously provided. And the CyberKnife is covered in other jurisdictions. Please do whatever you can to help Medicare patients keep the option.

Your attention and support is very much appreciated.

Please contact me should you have any questions or comments.

Best Regards,

Fred

**
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.
**

Additional Comments by Fred Kinder,
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

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

**
Peace On Earth and Good Health to All!

viperfred 12/27/2008 10:17pm

Please give Medicare cancer patients equal access to treatment options.

J1 Part B Medical Affairs
PO Box 147
Augusta, Georgia 30903-1476

Dear Palmetto J1 Management,

Please find enclosed my Testimony and comments regarding SBRT/CyberKnife treatment for prostate cancer. What is at stake is the cost of treatment to the insurer, insured and the patient’s quality of life. I just do not understand how the new MAC can remove treatment previously provided. And the CyberKnife is covered in other jurisdictions. Please do whatever you can to help Medicare patients keep the option.

Your attention and support is very much appreciated.

Please contact me should you have any questions or comments.

Best Regards,

Fred

Additional Comments by Fred Kinder,
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

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

viperfred 12/27/2008 10:08pm

Please enforce the HHS/CMS MMA of 2003 requlations and require Medicare Contractors to provide prostate cancer patients all treatment options.

December 11, 2008

J1 Part B Medical Affairs
PO Box 147
Augusta, Georgia 30903-1476

Dear Palmetto J1 Management,

Please find enclosed my Testimony and comments regarding SBRT/CyberKnife treatment for prostate cancer. What is at stake is the cost of treatment to the insurer, insured and the patient’s quality of life. I just do not understand how the new MAC can remove treatment previously provided. And the CyberKnife is covered in other jurisdictions. Please do whatever you can to help Medicare patients keep the option.

Your attention and support is very much appreciated.

Please contact me should you have any questions or comments.

Best Regards,

Fred

Additional Comments by Fred Kinder,
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

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

viperfred 12/27/2008 10:00pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

Peace On Earth and Good Health to All!

viperfred 12/27/2008 9:44pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

Peace On Earth and Good Health to All!

Moderated Comment

viperfred 12/27/2008 4:40pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

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 and call CMS management. Find the 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-mal 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!

viperfred 12/27/2008 4:35pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

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 and call CMS management. Find the 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-mal 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!

viperfred 12/27/2008 4:29pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer link follows: http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

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 and call CMS management. Find the 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-mal 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!

viperfred 12/27/2008 4:24pm

New York Times 12-17-2008 about Medicare coverage of prostate cancer http://www.nytimes.com/2008/12/17/health/policy/17knife.html?pagewanted=1&_r=1&em
I gave testimony at the following meeting regarding Medicare coverage of prostate cancer.
“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 >>>>>> 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.
a. Some patients live in rural areas with limited or no local treatment centers.
b. Some patients have medical conditions that make surgery a high risk.
c. Some patients have limited mobility making treatment very difficult.
d. Some patients continue to work full time and this trend is increasing. Making treatment recovery and time away from work an important factor.
e. Some patients have limited financial resources that limit treatment options due to cost of travel, food and lodging.
7. The majority of Medicare Contractors include SBRT/CyberKnife treatment for prostate cancer.
8. 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
Palmetto GBA, is not following the CMS requirement as it is has not selected the least restrictive Local Coverage Determination. The policy that has been implemented in the state of California has been taken from two states, NV and HI where there were no CyberKnife Facilities at the time the policy was written. In contrast, in California there are 9 CyberKnife facilities have been treating prostate cancer for several years. By implementing this policy in California, Palmetto will be restricting coverage. Not only is this not in line with the CMS statement of work or Palmettos own statements related to policy consolidation, it is not consistent with current medical practice in California. Speaking from a cancer patients’ point of view this is unconscionable. SBRT is arguably the best prostate cancer treatment option today.

Medicare must consider the fundamental right of patients to make decisions for themselves in consultation with their doctors and families. Patients should have access to treatments that offer better quality of life, that are less invasive, limit time away from work, provide fewer limitations for recovery, less time spent in treatment, that are more convenience and far less costly not only in terms of coinsurance obligations but also the cost of travel to and from treatment facilities, and offer better biological cure rate and fewer side effects. All these factors favor prostate cancer treatment with SBRT/CyberKnife and are the patients unalienable rights to choose.

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 and call CMS management. Find the 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-mal 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!

viperfred 10/18/2008 5:25pm

FAX COVER SHEET

Date: October 17, 2008
HHS OIG
TO: Operator zz
Confidential Material Enclosed

FAX Number: 202 619 1381
Subject: Medicare Abuse Trailbalzer and Palmetto

From: Fred Kinder
408 home
408 cell
408 office
408 office fax

Dear Operator 19,

Thank you for taking time to listen to my concerns about Palmetto GBA and Trailblazer. I sincerely appreciate your help in this matter.

These new Medicare providers, Trailblazer and Palmetto, have removed a treatment option (SBRT/CyberKnife) for prostate cancer that is one if not the very best and most cost effective. Medicare had covered treatment of prostate cancer by the CyberKnife but effective de. 15, 2008 that treatment option is no longer available in the Palmetto region. In June of 2008 Trailblazer removed SBRT/Cyberknife as a treatment option. The alternate external beam treatment (IMRT) will cost Medicare a %100 more than SBRT/CyberKnife. This will also increase the patients’ side effects, and reduce cure rates. IMRT requires 40 days of treatment the SBRTCyberKnife requires 5 days of treatment.

In my opinion this is criminal. Their actions increase the cost to Medicare and lower the quality and may result in death due to failure of cure by IMRT.

I have attached my letter to the Whitehouse to fight the decline in medical care while increasing cost.

Best Regards,
Fred
Page 11 (s)
If you have any questions please feel free to contact me.

October 13, 2008
President George W. Bush
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Dear Mr. President,

I am very concerned about the economic crisis.

It seems criminal for a Medicare service provider to eliminate a cancer treatment option that would same the country tens of millions of dollars and benefit cancer patients at the same time. Medicare providers Palmetto in California and Trailblazer (TX, OK, CO and NM) are increasing Medicare cost and providing lower quality medical care. Both have eliminated stereotactic body radiation therapy (SBRT)/CyberKnife coverage for prostate cancer treatment. The previous Medicare providers covered SBRT for prostate cancer. The alternative external beam treatment, IMRI, will double the cost to Medicare and increase the cost for patient’s transportation and lodging (if required) by 800%. Trailblazer stopped paying for prostate cancer treatment with SBRT June 13, 2008. Effective Dec. 15, 2008 Palmetto will stop treatment of prostate cancer and cancer of the pancreas.

Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right.

Please consider the actions of these Medicare providers and take corrective action to save millions of dollars and improve medical treatment for cancer patients. In my opinion both of these providers should have their contracts suspended for cause.

My e-mail below to Daniel R. Levinson, Inspector General has the details for the specifics in California.

Please feel free to have a staff member contact me at any time.

Best Regards,

Fred
Saratoga CA 95070
408

Date: Sun, 12 Oct 2008 20:43:44 -0700
To: HHSTips@oig.hhs.gov
From: Fred Kinder <fred@usea.com>
Subject: Medicare Abuse by Palmetto Government Benefits Administrators (GBA) /California
Cc: Senator Barbara Boxer, Senator Dianne Feinstein, Senator Hillary Rodham Clinton, KPIX Craig Franklin
Bcc: Accuray Susan Thompson, Accuracy Catherine_Bonetti, Accuray Debra Mills, Accuray Jim English, Doctor Adler, Doctor Clinton_Medbery, Doctor LaNasa_Peter, Dr. Alan Katz, Dr. D. Fuller, Dr. King Stanford, Dr. Spunberg

Office of the Inspector General
HHS TIPS Hotline
P.O. Box 23489
Washington, DC 20026
Mr. Daniel R. Levinson

Dear Mr. Levinson, Inspector General

California Medicare provider Palmetto Government Benefits Administrators (GBA) just re-released their policy guide lines for cancer treatment by stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) in draft form. Palmetto is removing a cancer treatment by SRS/SBRT/CyberKnife for the Prostate and Pancreas. This will result in higher cost to Medicare, higher cancer failure rates adding to patient suffering and additional treatment (adding cost), higher incidence of side effects reducing the quality of life for patients. This treatment was covered by the previous Medicare administrator. Why would, SRS/SBRT, the best External Beam (EB) radiation treatment for prostate cancer be removed? The new policy now covers an External Beam radiation option (IMRT) that cost a 100% more than SRS/SBRT , has increased side effects and a lower cancer cure rate. Why? Also consider the Palmetto EB option (IMRT) requires 40 days of treatment. The SRS/SBRT by CyberKnife requires 5 days of treatment. The cost of patient travel and inconvenience is 800% higher as the result of the irresponsible actions of Palmetto.

Palmetto was provided medical evidence by experts in the field (see attachment) for reconsideration before they re-released their policy changes. Their final comment period runs from Oct 30 thru Dec 15, 2008.

The Center for Medicare and Medicaid (CMS) mission statement is as follows:

CMS’ mission is to ensure health care security for its beneficiaries. A major component in achieving this mission is the successful administration of Original Medicare, or Fee-for-Service (FFS) Medicare. Medicare Contracting Reform (or section 911 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) is a major component in achieving this mission. Section 911 mandates that the Secretary for Health & Human Services replace the current contracting authority to administer the Medicare Part A and Part B FFS programs, contained under Sections 1816 and 1842 of the Social Security Act, with the new Medicare
Administrative Contractor authority. Through the implementation of Medicare Contracting Reform, CMS will establish a premier health plan that allows for comprehensive, quality care and world-class beneficiary and provider service.

In summary the Palmetto changes are not in compliance with CMS Medicare Reform. World-class treatment for early state prostate cancer is SRS/SBRT. Their changes will also cost Medicare additional millions of dollars and reduce the patient’s quality of life. Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right. In my opinion Palmetto is acting as a Doctor (do they have a license to practice medicine?) for Medicare patients. If they are, then their actions are in violation of the Hippocratic Oath. Is Palmetto acting as a Doctor?

As a result of my personal fight with Blue Shield of California for prostate cancer treatment by the CyberKnife I have become a prostate cancer advocate for research, education, screening and treatment. The story with Blue Shield can be viewed at the following CBS link http://cbs5.com/investigates/CyberKnife.blue.shield.2.716740.html . FYI, Blue Shield of California added the CyberKnife as a treatment option for prostate cancer July of 2008,

Please enforce the CMS policies on Palmetto so they can not remove SRS/SBRT as a cancer treatment option for prostate and pancreas cancer.

Contact me if you have any questions.

Best Regards,

Fred
Saratoga, CA 95070
Cell 408

CyberKnife Robotic Radiosurgery as Definitive Treatment for Prostate Cancer:
May 15, 2008
Donald B. Fuller, M.D. Iris C. Gibbs, M.D.
Radiation Oncologist Radiation Oncologist
CyberKnife Centers of San Diego Stanford Cancer Center
Radiation Medical Group 875 Blake Wilbur Dr.
2466 First Ave, Stanford, CA 94305-5847
San Diego, CA 92101
Christopher R. King, M.D., Ph.D. Douglas S. Wong, M.D., Ph. D.
Radiation Oncologist Radiation Oncologist
Stanford Cancer Center California Cancer Center
875 Blake Wilbur Dr. CC-G213 Dept. of Radiation Oncology
Stanford, CA 94305-5847 7257 N. Fresno St.
Fresno, CA 93720-2950
Greetings:
Collectively we represent a group of ABR Board Certified Radiation Oncologists with
expertise and extensive experience in 3DCRT, IMRT, IGRT, HDR Brachytherapy, 125I
permanent source brachytherapy, 103Pd permanent source brachytherapy and 131Cs
permanent source brachytherapy. We have prepared this document in support of
CyberKnife robotic radiosurgery as definitive prostate cancer treatment. Although the
evidence may be regarded by some as preliminary, it is our opinion that robotic
radiosurgery is likely to be at least as safe and effective as any other radiation method in
the treatment of this disease. To avoid coverage confusion, it should be regarded as an
improvement to an existing modality (radiotherapy) rather than classified as a completely
new intervention. Our reasons for recommending robotic radiosurgery include the
following:
1. FDA approval
a. In 2001, the FDA cleared the CyberKnife device for use throughout the
body, wherever therapeutic radiation is indicated. This makes perfect
sense, as CyberKnife robotic radiosurgery simply represents a very precise
and powerful method of ionizing radiation delivery. The FDA 510(k)
clearance was based on use of Varian’s Clinac as the predicate device.
2. Medicare Coverage
a. In 2003, CMS recognized stereotactic radiosurgery as inclusive of prostate
cancer. To quote the CMS Manual System Department of Health &
Human Services (DHHS), Pub. 100-20 One-Time Notification Centers for
Medicare & Medicaid Services (CMS), Transmittal 32 Date: DECEMBER
19, 2003, CHANGE REQUEST 3007, I, B, 4. Billing for Stereotactic
Radiosurgery:
“Stereotactic radiosurgery (SRS) is a form of radiation therapy for
treating abnormalities, functional disorders, and tumors of the brain

viperfred 10/18/2008 5:21pm

October 13, 2008
President George W. Bush
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Dear Mr. President,

I am very concerned about the economic crisis.

It seems criminal for a Medicare service provider to eliminate a cancer treatment option that would same the country tens of millions of dollars and benefit cancer patients at the same time. Medicare providers Palmetto in California and Trailblazer (TX, OK, CO and NM) are increasing Medicare cost and providing lower quality medical care. Both have eliminated stereotactic body radiation therapy (SBRT)/CyberKnife coverage for prostate cancer treatment. The previous Medicare providers covered SBRT for prostate cancer. The alternative external beam treatment, IMRI, will double the cost to Medicare and increase the cost for patient’s transportation and lodging (if required) by 800%. Trailblazer stopped paying for prostate cancer treatment with SBRT June 13, 2008. Effective Dec. 15, 2008 Palmetto will stop treatment of prostate cancer and cancer of the pancreas.

Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right.

Please consider the actions of these Medicare providers and take corrective action to save millions of dollars and improve medical treatment for cancer patients. In my opinion both of these providers should have their contracts suspended for cause.

My e-mail below to Daniel R. Levinson, Inspector General has the details for the specifics in California.

Please feel free to have a staff member contact me at any time.

Best Regards,

Fred
Saratoga CA 95070
408

Date: Sun, 12 Oct 2008 20:43:44 -0700
To: HHSTips@oig.hhs.gov
From: Fred Kinder <fred@usea.com>
Subject: Medicare Abuse by Palmetto Government Benefits Administrators (GBA) /California
Cc: Senator Barbara Boxer, Senator Dianne Feinstein, Senator Hillary Rodham Clinton, KPIX Craig Franklin
Bcc: Accuray Susan Thompson, Accuracy Catherine_Bonetti, Accuray Debra Mills, Accuray Jim English, Doctor Adler, Doctor Clinton_Medbery, Doctor LaNasa_Peter, Dr. Alan Katz, Dr. D. Fuller, Dr. King Stanford, Dr. Spunberg

Office of the Inspector General
HHS TIPS Hotline
P.O. Box 23489
Washington, DC 20026
Mr. Daniel R. Levinson

Dear Mr. Levinson, Inspector General

California Medicare provider Palmetto Government Benefits Administrators (GBA) just re-released their policy guide lines for cancer treatment by stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) in draft form. Palmetto is removing a cancer treatment by SRS/SBRT/CyberKnife for the Prostate and Pancreas. This will result in higher cost to Medicare, higher cancer failure rates adding to patient suffering and additional treatment (adding cost), higher incidence of side effects reducing the quality of life for patients. This treatment was covered by the previous Medicare administrator. Why would, SRS/SBRT, the best External Beam (EB) radiation treatment for prostate cancer be removed? The new policy now covers an External Beam radiation option (IMRT) that cost a 100% more than SRS/SBRT , has increased side effects and a lower cancer cure rate. Why? Also consider the Palmetto EB option (IMRT) requires 40 days of treatment. The SRS/SBRT by CyberKnife requires 5 days of treatment. The cost of patient travel and inconvenience is 800% higher as the result of the irresponsible actions of Palmetto.

Palmetto was provided medical evidence by experts in the field (see attachment) for reconsideration before they re-released their policy changes. Their final comment period runs from Oct 30 thru Dec 15, 2008.

The Center for Medicare and Medicaid (CMS) mission statement is as follows:

CMS’ mission is to ensure health care security for its beneficiaries. A major component in achieving this mission is the successful administration of Original Medicare, or Fee-for-Service (FFS) Medicare. Medicare Contracting Reform (or section 911 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) is a major component in achieving this mission. Section 911 mandates that the Secretary for Health & Human Services replace the current contracting authority to administer the Medicare Part A and Part B FFS programs, contained under Sections 1816 and 1842 of the Social Security Act, with the new Medicare
Administrative Contractor authority. Through the implementation of Medicare Contracting Reform, CMS will establish a premier health plan that allows for comprehensive, quality care and world-class beneficiary and provider service.

In summary the Palmetto changes are not in compliance with CMS Medicare Reform. World-class treatment for early state prostate cancer is SRS/SBRT. Their changes will also cost Medicare additional millions of dollars and reduce the patient’s quality of life. Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right. In my opinion Palmetto is acting as a Doctor (do they have a license to practice medicine?) for Medicare patients. If they are, then their actions are in violation of the Hippocratic Oath. Is Palmetto acting as a Doctor?

As a result of my personal fight with Blue Shield of California for prostate cancer treatment by the CyberKnife I have become a prostate cancer advocate for research, education, screening and treatment. The story with Blue Shield can be viewed at the following CBS link http://cbs5.com/investigates/CyberKnife.blue.shield.2.716740.html . FYI, Blue Shield of California added the CyberKnife as a treatment option for prostate cancer July of 2008,

Please enforce the CMS policies on Palmetto so they can not remove SRS/SBRT as a cancer treatment option for prostate and pancreas cancer.

Contact me if you have any questions.

Best Regards,

Fred
Saratoga, CA 95070
Cell 408

viperfred 10/18/2008 5:20pm

October 13, 2008
President George W. Bush
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500

Dear Mr. President,

I am very concerned about the economic crisis.

It seems criminal for a Medicare service provider to eliminate a cancer treatment option that would same the country tens of millions of dollars and benefit cancer patients at the same time. Medicare providers Palmetto in California and Trailblazer (TX, OK, CO and NM) are increasing Medicare cost and providing lower quality medical care. Both have eliminated stereotactic body radiation therapy (SBRT)/CyberKnife coverage for prostate cancer treatment. The previous Medicare providers covered SBRT for prostate cancer. The alternative external beam treatment, IMRI, will double the cost to Medicare and increase the cost for patient’s transportation and lodging (if required) by 800%. Trailblazer stopped paying for prostate cancer treatment with SBRT June 13, 2008. Effective Dec. 15, 2008 Palmetto will stop treatment of prostate cancer and cancer of the pancreas.

Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right.

Please consider the actions of these Medicare providers and take corrective action to save millions of dollars and improve medical treatment for cancer patients. In my opinion both of these providers should have their contracts suspended for cause.

My e-mail below to Daniel R. Levinson, Inspector General has the details for the specifics in California.

Please feel free to have a staff member contact me at any time.

Best Regards,

Fred
Saratoga CA 95070
408

Date: Sun, 12 Oct 2008 20:43:44 -0700
To: HHSTips@oig.hhs.gov
From: Fred Kinder <fred@usea.com>
Subject: Medicare Abuse by Palmetto Government Benefits Administrators (GBA) /California
Cc: Senator Barbara Boxer, Senator Dianne Feinstein, Senator Hillary Rodham Clinton, KPIX Craig Franklin
Bcc: Accuray Susan Thompson, Accuracy Catherine_Bonetti, Accuray Debra Mills, Accuray Jim English, Doctor Adler, Doctor Clinton_Medbery, Doctor LaNasa_Peter, Dr. Alan Katz, Dr. D. Fuller, Dr. King Stanford, Dr. Spunberg

Office of the Inspector General
HHS TIPS Hotline
P.O. Box 23489
Washington, DC 20026
Mr. Daniel R. Levinson

Dear Mr. Levinson, Inspector General

California Medicare provider Palmetto Government Benefits Administrators (GBA) just re-released their policy guide lines for cancer treatment by stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) in draft form. Palmetto is removing a cancer treatment by SRS/SBRT/CyberKnife for the Prostate and Pancreas. This will result in higher cost to Medicare, higher cancer failure rates adding to patient suffering and additional treatment (adding cost), higher incidence of side effects reducing the quality of life for patients. This treatment was covered by the previous Medicare administrator. Why would, SRS/SBRT, the best External Beam (EB) radiation treatment for prostate cancer be removed? The new policy now covers an External Beam radiation option (IMRT) that cost a 100% more than SRS/SBRT , has increased side effects and a lower cancer cure rate. Why? Also consider the Palmetto EB option (IMRT) requires 40 days of treatment. The SRS/SBRT by CyberKnife requires 5 days of treatment. The cost of patient travel and inconvenience is 800% higher as the result of the irresponsible actions of Palmetto.

Palmetto was provided medical evidence by experts in the field (see attachment) for reconsideration before they re-released their policy changes. Their final comment period runs from Oct 30 thru Dec 15, 2008.

The Center for Medicare and Medicaid (CMS) mission statement is as follows:

CMS’ mission is to ensure health care security for its beneficiaries. A major component in achieving this mission is the successful administration of Original Medicare, or Fee-for-Service (FFS) Medicare. Medicare Contracting Reform (or section 911 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) is a major component in achieving this mission. Section 911 mandates that the Secretary for Health & Human Services replace the current contracting authority to administer the Medicare Part A and Part B FFS programs, contained under Sections 1816 and 1842 of the Social Security Act, with the new Medicare
Administrative Contractor authority. Through the implementation of Medicare Contracting Reform, CMS will establish a premier health plan that allows for comprehensive, quality care and world-class beneficiary and provider service.

In summary the Palmetto changes are not in compliance with CMS Medicare Reform. World-class treatment for early state prostate cancer is SRS/SBRT. Their changes will also cost Medicare additional millions of dollars and reduce the patient’s quality of life. Patients should be entitled to have a say in selecting the best treatment for their best quality of life and most important their life. This should be a fundamental right. In my opinion Palmetto is acting as a Doctor (do they have a license to practice medicine?) for Medicare patients. If they are, then their actions are in violation of the Hippocratic Oath. Is Palmetto acting as a Doctor?

As a result of my personal fight with Blue Shield of California for prostate cancer treatment by the CyberKnife I have become a prostate cancer advocate for research, education, screening and treatment. The story with Blue Shield can be viewed at the following CBS link http://cbs5.com/investigates/CyberKnife.blue.shield.2.716740.html . FYI, Blue Shield of California added the CyberKnife as a treatment option for prostate cancer July of 2008,

Please enforce the CMS policies on Palmetto so they can not remove SRS/SBRT as a cancer treatment option for prostate and pancreas cancer.

Contact me if you have any questions.

Best Regards,

Fred
Saratoga, CA 95070
Cell 408

viperfred 10/18/2008 5:10pm

To advance research and treatment improved imaging is very critical.

I think we can leard from the latest technology used in detecting breast cancer tumors. I have a concern about MRI’s as the area to focus because many older patients have metal replacement. Such has cobalt steel hips which I happen to have.


Number of Comments: 14
Average Comment Rating (0-10): 5.0
Comments Per Day: 0.01

viperfred’s Supported Bills

Bill Status Last Action
S.1734 PRIME Act (110th congress) Introduced Jun 28, 2007
S.Res.667 A resolution designating September 2008 as "National Prostate Cancer Awareness Month". (110th congress) Senate Passed Sep 18, 2008
S.1275 Thomas J. Manton Prostate Cancer Early Detection and Treatment Act of 2007 (110th congress) Introduced May 02, 2007

viperfred’s Opposed Bills

No opposed bills yet. You can vote "nay" at the top of any bill's page.