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2011-09-14 - Oplinc Fast Facts
2011-09-12 - Politics and Physicians Payments
2011-07-14 - Safe Chemotherapy Administration
Feedback needed on ASCO/ONS standards for Safe Chemotherapy Adminstration.
2011-05-20 - State Legislative Healthcare Exchanges
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2011-04-17 - ASCO Summary of ACO Proposed Rule
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2010-08-16 - ASCO in Action
ASCO is pleased to bring you the first ASCO in Action Brief, an extension of the increasingly popular ASCO in Action section of ASCO’s website. In an effort to further serve our members’ informational needs, the ASCO in Action Brief highlights timely information on ASCO’s public policy and clinical affairs initiatives and includes a feature article on a selected topic or issue of current interest/concern to oncologists. Topics addressed in each brief will include health care reform and access; research policy and regulation; practice management; and quality of care issues. The ASCO in Action Brief will be used on occasion to provide a more in depth review of high impact issues than is typically presented in daily news summaries. For regular updates on ASCO’s public policy and clinical affairs efforts, please visit ASCO in Action on ASCO.org.
2010-06-25 - Receive a FREE ASCO University Educational Module!
From oncology nurses to practice administrators to oncologists, every cancer care professional has a home at ASCO.
The American Society of Clinical Oncology knows that providing the best cancer care requires a team effort. Through multiple membership categories, ASCO works daily to deliver resources for the entire oncology staff.
2010-06-25 - Oncology Practice Insider
Well, it's a good news/bad news story. The good news, of course, is that we finally have a Medicare payment patch, retroactive to June 1. And more good news is that this patch includes a 2.2% increase for the next six months. But the bad news is that this is only a six month fix and doesn't even take us through the end of the year. Keep SGR on your "to do list" - follow the updates from ASCO and other professional societies and be prepared to get involved when needed. Happy summer!
News Article
2010-05-12 - Health care law's massive, hidden tax change
An all-but-overlooked provision of the health reform law is threatening to swamp U.S. businesses with a flood of new tax paperwork.
Section 9006 of the health care bill -- just a few lines buried in the 2,409-page document -- mandates that beginning in 2012 all companies will have to issue 1099 tax forms not just to contract workers but to any individual or corporation from which they buy more than $600 in goods or services in a tax year.
FDA Approval
2010-04-16 - Erlotinib (Tarceva)
On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
FDA
2009-05-11 - FDA MedWatch - Tarceva
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.
FDA Approval
2009-03-30 - U.S. Food and Drug Administration today approved Afinitor
FDA Approves Drug for an Advanced Form of Kidney Cancer
The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.
Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.
"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."
Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).
While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.
A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.
The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.
Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.
CDC
2009-02-18 - New Fact Sheet: Peanut Product Recall and Cancer Patients
New Fact Sheet: Peanut Product Recall and Cancer Patients
The Centers for Disease Control and Prevention (CDC) has been receiving reports of illnesses caused by a type of bacterium known as Salmonella enterica, strain Typhimurium. The U.S. Food and Drug Administration (FDA) has confirmed that peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) are sources of the illnesses. Due to this contamination, all peanut products produced by PCA on or after January 1, 2007 have been recalled.
Because cancer patients with impaired immune systems are more likely to become severely ill from a Salmonella infection than others, the National Cancer Institute (NCI) developed a new Fact Sheet, Peanut Product Recall and Cancer Patients, to address the special concerns of cancer patients and their healthcare providers.
• View NCI's Peanut Product Recall and Cancer Patients Fact Sheet:
http://www.cancer.gov/cancertopics/factsheet/Support/peanut-recall
• For a searchable list of recalled products, visit the FDA Web site:
http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm
For more additional information about this and other cancer-related topics, please visit the NCI Web site at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
Insurance News
2009-01-09 - UHC Herceptin Policy
UnitedHealthcare has removed the requirement to submit a pathology report to obtain coverage for trastuzumab. This change is effective for claims submitted after January 1, 2009. Herceptin claims that were submitted in 2008 that are pending payment will require the submission of the pathology report showing over expression of the HER2 gene. The pathology reports should be faxed to (915) 231-1970 and you should use the dedicated fax cover sheet.
Herceptin claims submitted after January 1, 2009, will continue to be subjected to two reimbursement policies that may impact the reimbursement: the National Comprehensive Cancer Network (NCCN) policy and the Maximum Dosage Edit policy. Both of these policies address Herceptin claims and are posted on the unitedhealthcareonline web site.
UnitedHealthcare launched the Herceptin policy requiring submission of pathology reports in early 2006 based on an audit showing that 12 percent of the patients being treated with trastuzumab did not have over-expression of the HER2 gene. Our last audit in September 2008, demonstrated that less than 1 percent of the submissions failed to show over- expression.
Our medical policy hasn\'t changed - treatment of patients with under-expression is still inappropriate. We believe the recent audit demonstrates that this quality parameter is being followed and no longer requires the quality check.
There are other critical issues with HER2 gene expression testing. Studies show that concordance between local laboratories and a central laboratory with quality controls can be poor.*
The College of American Pathology has established accreditation for HER2 gene testing, but participation in the accreditation process is voluntary.
UnitedHealthcare contracts with two national laboratories that meet the ASCO / CAP guideline recommendations and proficiency testing for HER2, Genezyme and Laboratory Corporation of America (LabCorp). We encourage the use of laboratories that meet these standards. If you don\'t know the accreditation status of your current lab for HER2, we would encourage retesting, or a second opinion, from either of these laboratories for your patients who are UnitedHealthcare enrollees.
*Reddy et al, Clin Breast Ca, 2006: 153-157
https://www.unitedhealthcareonline.com/b2c/CmaAction.do?channelId=59e12bb4510f0110VgnVCM100000c520720a____#
New Article
2009-01-08 - Reports of Increases in Melanoma Incidence are Real
Reports of Increases in Melanoma Incidence Are Real
By John Gever, Senior Editor, MedPage Today
Published: January 08, 2009
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.
FREMONT, Calif., Jan. 8 -- Increases seen in the annual incidence of melanoma appear real, not an artifact of better diagnosis of thinner lesions, researchers here said.
The overall rate of new diagnoses of malignant melanoma rose 3.1% a year from 1992 to 2004, with statistically significant increases for every histologic type and thickness, including lesions greater than 4 mm thick, reported Eleni Linos, M.D., M.P.H., of the Northern California Cancer Center, and colleagues online in the Journal of Investigative Dermatology.
The highest rates and the greatest mean annual increases were seen in white men 65 and older. New annual diagnoses in this group rose from about 74 per 100,000 in 1992 to 126 per 100,000 in 2004, a mean annual increase of 4.5% (P0.05).
Action Points
Explain to interested patients that malignant melanoma is the most dangerous form of skin cancer and is believed to result from exposure to ultraviolet light.
Explain that UV exposure also contributes to premature aging of the skin.
The results appear to debunk arguments that improved surveillance, diagnostic scrutiny, and regular screening are responsible for the rise in melanoma incidence reported in earlier studies.
Dr. Linos and colleagues also found that melanoma incidence was rising about equally in all socioeconomic status groups.
Because people at the lower end of the socioeconomic ladder have reduced access to healthcare, including skin cancer screening, a smaller increase in that group would be expected if the apparent incidence rates were dictated by the extent of screening and surveillance, Dr. Linos said in an interview.
That apparent incidences have risen equally among high- and low-status groups points to a genuine, biological increase in melanoma risk, she said.
The findings highlight "the need for continued, detailed surveillance of melanoma occurrence, which in turn underscores the importance of complete and accurate reporting . . . by hospitals and private physicians," the researchers wrote.
Some 291 million patient-years of data contained in the CDC's Surveillance Epidemiology and End Results (SEER) registry through 2004 served as underpinning for the study.
The researchers also drew on a SEER data subset in California that included socioeconomic data, which were not collected nationwide.
Some 93% of the 70,596 new cases of malignant melanoma recorded in the SEER registry occurred in non-Hispanic whites.
Rates in men were generally about 50% greater than in women, a difference that did not change appreciably during the 13-year study period.
Among non-Hispanic whites of all ages, the mean annual increase in diagnosis of melanoma tumors of 1 mm thickness or less was 4.84% in men and 4.68% in women.
The corresponding incidence increases for tumors thicker than 4 mm were 4.1% and 3.3%, respectively.
For whites younger than 65, increases in annual incidence appeared to be greater for thin lesions than for thick ones.
In men, the mean annual increase was 3.42% for tumors of 1 mm thickness or less versus 1.96% for lesions thicker than 4 mm.
Mean annual increases in women were 4.33% for the thinnest tumors and 1.40% for the thickest.
In the 65-and-older population, rates of increase did not differ markedly between thin and thick lesions, nor between men and women.
Significant increases in annual incidence were also seen for different histologic types, with the largest occurring for lentigo maligna melanomas:
Superficial spreading: 7.6 per 100,000 in 1992; 8.5 per 100,000 in 2004
Nodular: 1.5 per 100,000 in 1992; 1.7 per 100,000 in 2004
Lentigo maligna: 1.2 per 100,000 in 1992; 2.0 per 100,000 in 2004
But mortality rates did not mirror the increases in new diagnoses, Dr. Linos and colleagues found.
Age-adjusted death rates declined significantly for men and women younger than 65 (1.0% and 0.9%, respectively, P0.05).
They increased by 1.9% for older white men and 0.8% for older white women (P0.05 for both).
But these increases were substantially smaller than those seen in new diagnoses, which averaged 4.5% for older men and 3.8% for older women.
The researchers were at a loss to explain the lack of correlation between incidence rates and mortality.
They noted that treatment has not undergone major innovations. Moreover, they said, "although the influence of a stage distribution shift toward thinner, more curable tumors has occurred in recent decades, the incidence of thicker melanoma [accounting for most deaths] has not declined."
Dr. Linos and colleagues also had no explanation for the increased annual incidence over time, although they noted that it was consistent with trends reported in other countries.
Other researchers have contended that increased exposure to ultraviolet radiation, such as sun-tanning indoors and outdoors, are responsible.
Dr. Linos and colleagues said their data tend to refute explanations involving more efficient detection. But they do not shed light on other specific causal mechanisms.
The study was supported by the National Institutes of Health and the California Department of Public Health.No potential conflicts of interest were reported.
Primary source: Journal of Investigative Dermatology
Source reference:
Linos E, et al, "Increasing burden of melanoma in the United States," J Invest Dermatol 2009; DOI: 10.1038/jid.2008.423.
Find this article at:
http://www.medpagetoday.com/HematologyOncology/SkinCancer/12377
Medicare
2009-01-06 - Medicare Proposes Easing Rules for Cancer PET Scans
Greetings!
Medicare Proposes Easing Rules for Cancer PET Scans
By Aliza Marcus
Jan. 6 (Bloomberg) -- Medicare has proposed making it easier for cancer patients to get an advanced imaging test early to help guide their treatment, by lifting a data-gathering requirement.
Under the proposal announced today, Medicare would cover an initial examination with positron emission tomography, or PET scan, without requiring that doctors collect information on the patient and whether the exam helped improve treatment, Medicare said today in an e-mailed statement.
Evidence gathered since the requirement in 2005 convinced Medicare, the U.S. health program for the elderly and disabled, of the benefit of the scans. The revision for PET scans is the first time Medicare reviewed data from a new program called Coverage with Evidence Development, according to the statement.
"We look forward to patients gaining greater access to new technologies while enhancing the evidence physicians use to make treatment recommendations," said Kerry Weems, Medicare's acting administrator, in an e-mailed statement.
Medicare will make a final decision in April. Companies that make the scans include General Electric Co., based in Fairfield, Connecticut, and Siemens AG, based in Munich.
Images produced by the PET scans help give information about chemical activity inside organs and tissues, according to a definition on the Mayo Clinic's Web site. Medicare said the tests help cancer specialists determine whether a growth is benign or malignant and how much a tumor has grown.
To contact the reporter on this story: Aliza Marcus in Washington at amarcus8@bloomberg.net
CMS
2008-11-03 - ESA Policy
Trailblazer has issued a final policy on ESA's. The full text of the information can be found at: http://www.trailblazerhealth.com/Tools/Notices.aspx?DomainID=1&ID=12758&referral=2782
FDA Approval
2008-10-15 - approval of denileukin diftitox (Ontak®, Eisai Medical Research)
On October 15, 2008, the U. S. Food and Drug Administration converted the approval of denileukin diftitox (Ontak®, Eisai Medical Research) solution for intravenous use for the treatment of persistent or recurrent CD-25 positive cutaneous T-cell lymphoma from accelerated approval to regular approval following confirmation of an improvement in progression-free survival (PFS) and overall response rate (ORR).
Denileukin diftitox was originally approved in 1999 under the accelerated approval program for this indication based on durable, objective responses in an open-label study comparing two different doses. A further description of the FDA accelerated approval regulations is at http://www.fda.gov/cder/guidance/5645fnl.htm.
ASCO
2008-10-08 - ASCO letter regarding Medicare carrier coverage of new off-label compendia
Compendia Letter
FDA
2008-10-07 - Nebion HLX-8 Magnetic Resonance Device
FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpal tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured discs, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.
2008-10-07 - VIDAZA
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIDAZA safely and effectively. See full prescribing information for
VIDAZA.
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CMS
2008-09-26 - Medicare Part B Drug and Biological Average Sales Price (ASP)
The Centers for Medicare & Medicaid Services (CMS) has made available the Medicare Part B Drug and Biological Average Sales Price (ASP) Payment Amounts for October 1, 2008 to December 31, 2008 on the CMS website at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01a_2008aspfiles.asp#TopOfPage
FDA Approval
2008-09-26 - Alimta® Injection
On September 26, 2008, the U. S. Food and Drug Administration (FDA) approved pemetrexed injection (Alimta® Injection, Eli Lilly and Company) for use in combination with cisplatin therapy for the initial treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Pemetrexed is not indicated for treatment of patients with squamous cell lung carcinoma.
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2008-09-19 - iobenguane I 123
On September 19, 2008, the US Food and Drug Administration (FDA) approved iobenguane I 123 injection (AdreView, GE Healthcare), a diagnostic radiopharmaceutical, for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
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CMS
2008-09-17 - ASP+6% Q4
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2008-09-12 - Rituxan Important Saftey Alert
Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurological manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated
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CMS
2008-08-29 - CMS Manual System
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2008-08-29 - CMS Manual System- Medicare Claims processing
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FDA Approval
2008-08-22 - Romiplostim for Subcutaneous Injection
On August 22 2008 the Food and Drug Administration approved romiplostim for subcutaneous injection for the treatment of Thornbocytopenia in patients with Chronic immune thornbocytopenic purpura who have had insufficient response to corticosteriods, immnunoglobulins, or splenectomy.
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FDA
2008-07-30 - Important Information for Physicians about Changes Affecting the FDA-Approved Use of Erythropoiesis Stimulating Agents (ESAs)
On July 30, 2008, the U.S. Food and Drug Administration (FDA) sent a “Complete Response
and Safety Labeling Change Order” to the sponsors of the ESAs, ordering changes to the ESA
package inserts (“labels”). For the first time, the FDA used its statutory authority to order a
sponsor to make revisions to a product label.
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FDA Approval
2008-03-20 - A Message From The FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur
On March 20, 2008, the Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA®, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with chronic lymphocytic leukemia (CLL).
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Label Changes
0000-00-00 - Erythropoietin Stimulating Agents (ESAs)
The Food and Drug Administration (FDA) announced today the following proposed changes to the approved labeling for the use of erythropoietin stimulating agents (ESAs). The label will be final in 15 days, unless an administrative appeal is requested which could take "up to" 30 days before the label is complete. The manufacturers of ESAs may recommend further adjustments for FDA consideration during that time, but changes from today's proposal, if any, are expected to be minor.
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FDA Approval
0000-00-00 - FDA Approves Drug that Boosts Stem Cells
December 18, 2008
FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants
The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.
Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin's lymphomas. Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell.
Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy. G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream.
"Collecting the millions of cells needed for a bone marrow transplant can take hours or days," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy."
In two randomized clinical trials - one in patients with non-Hodgkin's lymphoma, the other with multiple myeloma - Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with patients receiving G-CSF alone.
The most commonly reported adverse reactions in these trials and other smaller studies were diarrhea, nausea, fatigue, injection site reactions, headaches, joint pain, dizziness and vomiting.
Mozobil is manufactured by Genzyme Corp., Cambridge, Mass.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01929.html
