CMS announces 2006 Oncology Demonstration Program

On November 2, 2005 the Centers for Medicare and Medicaid Services (CMS) announced the [2006 Oncology Demonstration Program](http://www.cms.hhs.gov/media/press/release.asp?Counter=1717) designed to develop data on quality cancer patient care during visits for evaluation and disease management.

Medicare billing codes will be changed to take a broader outlook on supportive care visits beyond chemotherapy administration. Physicians who see a patient for an evaluation and management service (E & M) will be entitled to an additional $23 payment beyond the payment for the visit if they also iinclude the following information:

+ primary focus of the evaluation and management session
+ current disease state
+ whether current management adheres to clinical guidelines

For instance, the primary focus of the E & M service might be management of side effects, pain control or other palliative service, survelliance for cancer recurrence, or provision of end-of-life care. Doctors will be asked to characterize the spread of the cancer, as it is best known at the time.

Finally, physicians will be asked to report whether or not the patient’s management follows practice guidelines established by either the [American Society of Clinical Oncology](http://asco.org/ac/1,1003,_12-002130,00.asp) or the [National Comprehensive Cancer Network](http://www.nccn.org/professionals/physician_gls/default.asp). Guidelines may be reported as followed or not followed for a reason such a clinical trial protocol, patient preference or desire for a different treatment, or physician disagreement with the guidelines.

In a [Fact Sheet](http://www.cms.hhs.gov/media/press/release.asp?Counter=1717) released by CMS, designers of the demonstration project described its goals:

The 2006 demonstration meets our objective of having oncology payments increasingly focused on patient-centered care, rather than chemotherapy administration. In the 2006 demonstration, data collection and payments are linked to E&M provided by physicians to patients, rather than chemotherapy administration that may occur in the absence of an involved visit between doctor and patient. This demonstration also meets the objective of helping us learn to what extent Medicare beneficiaries are being treated in a manner that yields the best outcomes, understand clinical cancer scenarios where there is not clinical consensus among physicians on the relevance of specific guidelines, and ensure that due emphasis is placed on a multi-disciplinary, comprehensive approach to palliation and end of life care. Also, by focusing on evidence based practices, there is the potential that unnecessary services and tests will be reduced, lowering program costs and yielding better quality of life for Medicare beneficiaries with cancer.

A similar project in 2005 measured patient outcomes for three side effects of chemotherapy — controlling pain, managing nausea and vomiting, and reducing fatigue.

Posted by Kate Murphy on November 8th, 2005
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Disease-free survival at 3 years predicts overall survival from colon cancer at 5 years

Traditionally, overall survival five years after treatment has been the standard for measuring outcome of adjuvant clinical trials for colon cancer. However, a [meta-analysis](http://www.jco.org/cgi/content/abstract/JCO.2005.01.6071v1) of 18 randomized Phase III clinical trials evaluating adjuvant treatment involving nearly 21,000 patients found a close correlation between lack of recurrence at 3 years and overall survival at 5 years.

Eighty percent (80%) of recurrences occurred within the first 3 years, and 91% of patients who had cancer return within 3 years had died by the 5-year mark. Correlation between disease-free survival at 3 years (DFS) and overall survival at 5 years (OS) was 0.89.

In the pooled data. 12% of recurrences happened in the first year, 14% in the second, 8% in the third, 5% in the fourth, and 3% in the fifth year.

The research team, headed by Dr. Daniel J. Sargent, believes that the study provides evidence for using three-year disease free survival as a surrogate measure for overall survival. This would enable adjuvant research to be completed more quickly, providing critical answers to the best treatment for patients with stage 2 and 3 colon cancer.

In a [*Journal of Clinical Oncology* early release article](http://www.jco.org/cgi/content/abstract/JCO.2005.01.6071v1), published on the internet on October 31, 2005, they concluded:

In patients treated on phase III adjuvant colon clinical trials, DFS and OS are highly correlated, both within patients and across trials. These results suggest that DFS after 3 years of median follow-up is an appropriate end point for adjuvant colon cancer clinical trials of fluorouracil-based regimens, although marginally significant DFS improvements may not translate into significant OS benefits.

In the same issue of the *Journal of Clinical Oncology* Judith Abrahms from the Karmanos Cancer Institute at Wayne State University writes a [commentary](http://www.jco.org/cgi/reprint/JCO.2005.03.6186v1) that warns against over-generalizing the study results to all cancers or to all trials for colon cancer:

Although future studies of FU-based adjuvant therapy
for patients with stages II and III colon cancer may comfortably
use DFS3 years as a primary end point replacing OS5 years,
casual readers are cautioned against generalizing these results
to all colon cancer trials or to cancer clinical trials in
general. These results depend on specific features of the
disease and the current state of diagnosis and therapy.

Posted by Kate Murphy on November 5th, 2005
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MedWatch warns of alcohol use while on Avinza extended release morphine

The FDA and Ligard Pharmaceuticals notified health professionals and consumers of [label changes for Avinza™](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Avinza) on November 3, 2005. Avinza™ is an extended release form of morphine sulfate provided in capsules. Alcohol can cause a potentially fatal overdose of the drug. FDA MedWatch said,

“Ligand Pharmaceuticals Inc. and FDA notified healthcare professionals of revisions to BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections of the prescribing information to highlight and strengthen the warning that patients should not consume alcohol while taking Avinza. Additionally, patients must not use prescription or non-prescription medications containing alcohol while on Avinza therapy.

Ligard Pharmaceuticals, manufactures of Avinza™ issued a [Dear Health Professional Letter](http://www.fda.gov/medwatch/safety/2005/Avinza-ltr.pdf) to let them know of changes in the labeling. Included in that letter was the following addition to the *Black Box Warning* on the Avinza™ label.

Patients must not consume alcoholic beverages while on AVINZA therapy.
Additionally, patients must not use prescription or non-prescription medications
containing alcohol while on AVINZA therapy. Consumption of alcohol while taking
AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.

The [new Avinza label](http://www.fda.gov/medwatch/safety/2005/avinza_PI.pdf) with changes highlighted in yellow can be downloaded as a PDF.

Posted by Kate Murphy on November 5th, 2005
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Wake Forest webcast of surgery and IPHC for cancer spread to peritoneal cavity

[Edward A. Levine M.D.](http://www1.wfubmc.edu/gs/about/faculty/DrLevine.htm), professor of surgical oncology at Wake Forest Baptist Medical Center, will perform surgery with intraperitoneal hyperthermic chemotherapy and discuss the treatment of cancer that has spread into the abdominal cavity during a [free webcast on November 17](http://www.or-live.com/WFUBMC/1478/)

**Webcast**

+ Intraperitoneal Hyperthermic Chemotherapy for Persistant Cancer
+ November 17, 2005
+ 5 p.m. (Eastern Time)
+ [Connection information](http://www.or-live.com/WFUBMC/1478/)

Cancer that spreads from the colon into the abdominal (*peritoneal*) cavity is particularly difficult to treat. Tumors develop on the peritoneum itself and on the surfaces of abdominal organs. Cancer cells may circulate in the fluid inside the abdominal cavity.

Wake Forest, among other specialized surgical centers, has developed treatment that combines surgery to remove as much visible cancer as possible (*cytoreduction*) with pumping heated chemotherapy into the abdomen (*intraperitoneal hyperthermic chemotherapy or IPHC*). The technique has been successful in achieving long-term remissions for a percentage of carefully chosen patients.

[Science Daily](http://www.sciencedaily.com/releases/2004/02/040212085309.htm) reported on publication of Wake Forest research to treat peritoneal cancer in February, 2004.

Research results of the work of Dr. Levine, Dr. Perry Shen, and their colleagues at Wake Forest Baptist Medical Center were published in the [*Annals of of Surgical Oncology*](http://www.annalssurgicaloncology.org/cgi/content/abstract/11/2/178) in 2004 — *Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy With Mitomycin C for Peritoneal Carcinomatosis from Nonappendiceal Colorectal Carcinoma.*

Posted by Kate Murphy on November 5th, 2005
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Diabetes increases colorectal cancer risk

*Information from the 2005 American College of Gastroenterology Scientific Meeting*

Diabetics are 40% more likely than people without diabetes to develop colorectal cancer according to a [study reported on Monday](http://www.acg.gi.org/media/releases/ACG05Release_DiabetesRiskforCRC.pdf) at the [Annual Scientific Meeting](http://www.acg.gi.org/physicians/meetings/annualmtg/05meeting/program.asp#scientific) of the American College of Gastroenterology in Honolulu.

Researchers from Medical University of South Carolina in Charleston analyzed information from nearly 227,000 responses to the [National Health Information Survey](http://www.cdc.gov/nchs/nhis.htm) from 1997-2003. About 6% of people in those studies had diabetes.

After adjusting for other factors that influence the development of colorectal cancer including age, gender, race, obesity, alcohol and tobacco use, and physical activity the researchers concluded that people with diabetes have a risk of colorectal cancer 1.4 times those without the disease.

In an interview with [Reuter's Health](http://today.reuters.co.uk/news/newsArticle.aspx?type=healthNews&storyID=2005-11-03T003801Z_01_KRA302240_RTRIDST_0_HEALTH-DIABETICS-CANCER-DC.XML&archived=False) Dr. Donald Garrow from the research team explained that receptors for insulin are present on colon tissue and that is is possible that high levels of insulin create changes in colon cells that lead to colorectal cancer. He also told Reuters that cell culture studies suggest high blood sugar levels promote colorectal cancer growth.

Garrow said that the team is now evaluating whether or not diabetics need to begin colorectal cancer screening earlier than those at average risk and whether controlling blood glucose can make a difference in the development of colorectal cancer.

Read more articles about the study report on [*Medpage Today*](http://www.medpagetoday.com/Gastroenterology/ColonCancer/tb1/2052) and [Forbes.com](http://www.forbes.com/health/feeds/hscout/2005/11/01/hscout528835.html).

Posted by Kate Murphy on November 3rd, 2005
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