Wednesday, December 17, 2008

Things I didn't know about Medicare

It uses private insurance companies for regional contractors

Go read The Evidence Gap in todays paper where a few other things pop up.

I'm botherd by things like using treatments that have been untested:
CyberKnife, made by Accuray of Sunnyvale, Calif., was allowed onto the market by the Food and Drug Administration in 1999 as a treatment for brain and spine tumors. Two years later the F.D.A. authorized it for use throughout the body. Accuray, as well as hospitals and clinics that operate the CyberKnife machines, which cost $3 million to $5 million, have been promoting their use on various cancers, including lung and pancreatic cancer — and, increasingly, prostate cancer.

According to Accuray, patients can get by on fewer treatments because the machines deliver highly focused beams of radiation at heavier doses than conventional systems. But some leading radiation oncologists worry that the cumulative radiation that CyberKnife delivers over a course of prostate treatments — ultimately lower than what patients would receive in standard therapy — is not adequate to treat the disease.

“They are basically pushing the envelope,” said Dr. William R. Lee, a radiation oncologist at Duke University. “If they’re right, it’s going to be an important advance. If they’re wrong, there’s a potential for a big downside.”

With about 80 patients studied under the regimen in published peer-reviewed research over five years, the results for CyberKnife are promising. Yet, because prostate cancer is frequently slow-growing, Dr. Lee argues that five-year data with so few patients may not be very meaningful. Others raise concerns that high daily doses may increase radiation side effects that can show up years after treatment.

The board of the radiation oncology society, the American Society for Therapeutic Radiology and Oncology, or Astro, has called CyberKnife promising, but raised questions this year about the evidence supporting its use in prostate cancer, saying “there is not sufficient or mature data to demonstrate equivalency to existing standard treatment modalities.”


Also I have a huge problem with selling a medical treatment to consumers directly:
Citing the variety of proven treatments for prostate cancer, one member of the Astro board, Dr. Louis Potters of North Shore-Long Island Jewish Health System, said that advertising CyberKnife directly to consumers could confuse patients, who have to choose the best treatment from an already bewildering array of options.

“Patients are becoming commodities and prostate cancer is the ultimate example,” Dr. Potters said.
They aren't exactly experts. And will often want more, wrong, or unproven treatments.

2 comments:

  1. 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 radiation[19]:

    “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
    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(SM) 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(SM) 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

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    Replies
    1. Cyberknife can deliver radiation with an extraordinary precision saving the surrounding critical organs of unnecessary exposure.

      Skin Cancer Treatment

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