January 2011  |  Volume 2, Number 1

Current FDA Approval Status of Avastin 

The FDA's position on Avastin for use in treating metastatic breast cancer has been closely watched by patients, the medical community, politicians and benefits professionals. The FDA's position is critical, since the overwhelming majority of employer-sponsored benefit plans require FDA approval as a pre-condition for covering any particular treatment. Therefore, what the FDA decides determines what the benefit plan will reimburse.


Other plans mirror Medicare's stance on what constitutes an eligible charge. For example, when Medicare approved heart transplants, many employer-sponsored plans updated their provisions to include the coverage. A similar situation occurred when Medicare determined that it would no longer reimburse hospitals for "never events" (for example, surgery on the wrong body part).

At this time, the FDA has taken the first step toward withdrawing its approval of Avastin for the treatment of metastatic breast cancer. In response, one of Avastin's manufacturer's, Genetech, has stated that it will appeal the decision. In the meantime, CMS (The Offices of Medicare and Medicaid), has stated that it has not changed its position and will continue to reimburse the expense pending the final FDA decision.

Click on the chart to enlarge.

In This Issue
Current FDA Approval Status
Final Regulations Provide Clarification of GINA
Contracts, Compliance & Research Updates
HR & Benefit Essentials
More information regarding Health Care Reform and other benefit resources is available on the HR & Benefit Essentials Web site, available to BSG clients under the "Resources" menu of their HR Express Web site. BSG subscribes to this service for your benefit. If you would like more information regarding this resource please contact your account management team at BSG.
Final Regulations Provide Clarification of GINA Title II Provision

The Equal Employment Opportunity Commission (EEOC) has issued a final rule to implement Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA).

Title II of GINA, which took effect on November 21, 2009, prohibits the use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information. According to the EEOC, the purpose of the final regulations is to implement the various provisions of Title II consistent with Congress's intent, to provide some additional clarification of those provisions, and to explain more fully those sections where Congress incorporated by reference provisions from other statutes.

The final rule is effective January 10, 2011. To view the regulations, please click here. FAQs for small businesses related to Title II of GINA and the EEOC's final rule can be found by clicking here. Additional information on GINA is available on the HR & Benefits Essentials Web site here.


Contracts, Compliance & Research Updates
Health Care Tax Credit Extended

The Health Coverage Tax Credit (HCTC) pays 80% of health insurance premiums for qualified individuals and their families. This tax credit was included in ARRA (American Recovery and Reinvestment Act), but was set to expire on December 31, 2010.  In mid-December, both the House and the Senate approved the Omnibus Trade Act of 2010, extending the tax credit until February 13, 2011. President Obama has signed the bill.

The IRS maintains a Web site to monitor the status of the Health Coverage Tax Credit, and explain its provisions. You can visit it by clicking here.

Exposure to Tobacco Smoke Causes Immediate Damage, Says New Surgeon General's Report

On Thursday, December 9, 2010, Surgeon General Regina Benjamin announced the publication of How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease. This report reveals new scientific findings about how deadly cigarettes are and how quickly they can damage your body.

"The chemicals in tobacco smoke reach your lungs quickly every time you inhale causing damage immediately," Benjamin said in releasing the report.  "Inhaling even the smallest amount of tobacco smoke can also damage your DNA, which can lead to cancer."

The report also explains why it is so difficult to quit smoking. According to the research, cigarettes are designed for addiction. The design and contents of current tobacco products make them more attractive and addictive than ever before. Today's cigarettes deliver nicotine more quickly and efficiently than cigarettes of many years ago.

Tobacco smoke contains a deadly mixture of more than 7,000 chemicals and compounds, of which hundreds are toxic and at least 70 cause cancer. Every exposure to these cancer-causing chemicals could damage DNA in a way that leads to cancer. Exposure to smoke also decreases the benefits of chemotherapy and other cancer treatments. Smoking causes more than 85% of lung cancers and can cause cancer almost anywhere in the body. One in three cancer deaths in the U.S. is tobacco-related.

The report describes how the delicate lining of the lungs becomes inflamed as soon as it is exposed to the chemical mixture in cigarette smoke. Over time, the smoke can cause chronic obstructive pulmonary disease including emphysema and chronic bronchitis.

Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack. The report describes how chemicals from tobacco smoke quickly damage blood vessels and make blood more likely to clot. The evidence in this report shows how smoking causes cardiovascular disease and increases risks for heart attack, stroke, and aortic aneurysm.

Smoking causes many other harmful effects throughout the body, including making it harder for diabetics to control their blood sugar.  Smoking makes it harder for women to get pregnant and can cause a miscarriage, preterm delivery, low birth weight, as well as damage to fetal lungs and brain tissue. Babies who are exposed to secondhand smoke are more likely to die from sudden infant death syndrome, the report finds.

"This report makes it clear - quitting at any time gives your body a chance to heal the damage caused by smoking," the Surgeon General said. "It's never too late to quit, but the sooner you do it, the better."

Fortunately, there are now more effective ways to help people quit than ever before. Nicotine replacement is available over the counter and doctors can prescribe medications that improve the chances of successful quit attempts. Smokers can also call 1-800-QUIT-NOW for help.

Click here to get the fact sheet.

To download the report, click here.

View the Public Service Announcement by clicking here.

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The preceding is not intended to be and is not offered as legal advice. We are prohibited from the practice of law. Compliance is the responsibility of the employer or Plan sponsor and affected employees who should seek their own legal counsel regarding questions about information presented in this newsletter.

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