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Reimbursement and Managed Care News for November 2007

By Stanton R. Mehr
Published: Tuesday, Jun 29, 2010
Off-Label Use of Oncology Medications

The List of Acceptable Evidence Based Oncology Journals Broadens


It is widely recognized that oncologists often experiment by treating cancer with medications that are not specifically approved for the neoplasm or carcinoma being managed. The Centers for Medicare and Medicaid Services acknowledges that payment for oncology medications cannot be limited solely to oncology indications for agents that are approved by the Food and Drug Administration.

In 1993, the federal government constructed a list of journals that it believed was a good source of credible, evidence-based data on evolving indications for oncology meds. However, the list had not been updated in 14 years. As a result, it recently added 14 journals to its list of sources for deemed acceptable oncology articles on off-label indications. New additions to that list, last updated in 1993, are based on recommendations of the American Society of Clinical Oncologists. The Table lists the additions to this group of peer-reviewed information outlets, which is part of chapter 15, section 50.4.5 of the Medicare Benefit Policy Manual, Publication 100-02.

  Journals added to the list of acceptable publications for  

  information on off-label information
  Annals of Oncology
  Biology of Blood and Marrow Transplantation
  Bone Marrow Transplantation
  Gynecologic Oncology
  Clinical Cancer Research
  International Journal of Radiation, Oncology, Biology, and

  Physics
  Journal of NCCN
  Radiation Oncology
  Annals of Surgical Oncology
  Journal of Urology
  Lancet Oncology



   Unlabeled Use for Anti-Cancer Drugs: Medical Literature Used to Determine Medically Accepted Indications for Drugs and Biologicals Used in Anti-Cancer Treatment: Transmittal 78. Centers for Medicare and Medicaid Services (www.cms.hhs.gov/transmittals/ downloads/R78BP.pdf), September 21, 2007.





More Work to Do on Breast Cancer Guideline Adoption

Medical practice variation has long been known to be a national and local problem, which results in serious quality of care gaps. Oncology practice apparently is not immune to these quality dilemmas, according to recently released data.

Guidelines for hormone receptor–positive breast cancer have been in place since 2002 from the National Comprehensive Cancer Network (NCCN), but a basic component of these guidelines is followed by just more than one half of the NCCNmember institutions, according to investigators from the Dana-Farber Cancer Institute in Boston. If this is the case in NCCN institutions, what is the situation in the average community oncologists’ practice?

The researchers evaluated the cancer care of 3,190 women diagnosed with hormone receptor–positive, node-negative breast cancer (tumor size > 1 cm) and treated at one of eight member NCCN institutions. Fifty-six percent of the women evaluated received adjuvant chemotherapy, which is advocated by the guidelines as backed by solid evidence of benefit.

A logistic regression analysis revealed that adjuvant chemotherapy was less often used in women with tumors smaller than 2 cm (48%) compared with women with larger tumors (83%). There was considerable variation in chemotherapy use from one treatment facility to another (range of guideline compliance, 47%–65%).

Data from before 2002 and after the introduction of the guideline illustrated just how variable the practices were. The investigators found that just after introduction of the guidelines, institutional response ranged from a 25% decrease in prescription of adjuvant chemotherapy to an increase of 28%.


  Hassett MJ: Chemotherapy use for hormone receptor–positive, node-negative breast cancer. Presented at the 2007 Breast Cancer Symposium of the American Society of Clinical Oncology, San Francisco, September 17, 2007.





Multiple Biopsies Are Needed to Diagnose Prostate Cancer

The use of prostate-specific antigen (PSA) screening yields many false-positive (as well as false-negative) results. Ordinarily, a positive PSA test will be followed by needle biopsy of the prostate. What is the rate of cancer diagnosis by this method, and how many biopsies over the years should Medicare Advantage plans be prepared to cover in a patient in whom cancer has not been found previously?


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34th Annual Miami Breast Cancer Conference® Clinical Case Vignette Series™May 25, 20182.0
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