2009 Medicare Prescription Drug Plan Options

For Immediate Release:	Thursday, September 25, 2008
Contact:	CMS Office of Public Affairs 202-690-6145

CMS REMINDS MEDICARE BENEFICIARIES TO REVIEW AND COMPARE THEIR CURRENT DRUG COVERAGE

Today, CMS Acting Administrator Kerry Weems announced the 2009 Medicare prescription drug and Medicare Advantage plan options. Approximately 97 percent of beneficiaries enrolled in a stand-alone prescription drug plan (PDP) will have access to Medicare drug and health plans in 2009 whose premiums would be the same or less than their coverage in 2008.

“As we enter the fourth year of the Medicare Part D prescription drug program, we continue to see high satisfaction rates among beneficiaries and high participation among plans,” said Weems. “However, plans do change their offerings from year to year. Some beneficiaries may see significant premium increases or changes, such as reduced coverage in the gap, if they stay in the same prescription drug plan in 2009. We encourage individual beneficiaries to review how their plans are changing and what other options are available to them to determine which plan best meets their needs.”

In every state, beneficiaries will have access to at least one prescription drug plan with premiums of less than $20 a month, except for beneficiaries living in Alaska who will have access to one prescription drug plan at $23 a month. Those who qualify for the full Medicare subsidy will pay no premiums or deductibles in these plans. The national average monthly premium for the basic Medicare drug benefit in 2009 is projected to average approximately $28.

Beneficiaries will continue to have access to prescription drug plans that offer a wide range of design options, including zero deductible plans. Plans with coverage in the gap for generics are available in every state.

In 2009, 100 percent of beneficiaries will have access to a Medicare Advantage plan. Many beneficiaries will continue to have access to Medicare Advantage plans that have prescription drug coverage (MA-PDs) and more than 93 percent of people with Medicare will have access to a MA-PD for a $0 premium and with a $0 drug deductible.

Marketing of 2009 plans will begin October 1 under new marketing requirements. “These new requirements are meant to protect Medicare beneficiaries from deceptive or high-pressure marketing tactics by insurance companies and their agents,” said Weems.

This fall CMS will be conducting numerous outreach events to help new beneficiaries and help those already enrolled understand their plan choices. “We want to make sure that every beneficiary knows where to go for individualized advice and counseling,” said Weems.

Details about the specific plans in each region will be available mid-October at www.medicare.govand 1-800-MEDICARE. Open enrollment for prescription drug coverage begins November 15 and ends December 31. Beneficiaries who want to review their current coverage as well as the other options available to them will have access to information and assistance from many sources including:

• A notice of any coverage changes from their current prescription drug plan, by October 31^st ,
• The enhanced Medicare Drug Plan Finder, available in mid-October;
• Toll free information available 24/7 at 1-800-MEDICARE (1-800-633-4227);
• The annual Medicare & You 2009 handbook that explains Medicare coverage, to be mailed in October; and
• Local organizations such as the State Health Insurance Assistance Programs and thousands of other Medicare partner organizations that will provide personalized assistance throughout the fall.

The list of national stand-alone prescription drug plans and state specific fact sheets can be found at: http://www.cms.hhs.gov/center/openenrollment.asp

The Link to the 2009 Landscape Data: http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/

“Beneficiaries should expect to hear from the health and prescription drug plans in their communities and should be assured that CMS has new oversight tools available to ensure they have a positive experience,” said Weems.

Tags: MEDICARE, Medicare Prescription Drug Plan

Melamine Contamination Advisory Update By FDA

FOR IMMEDIATE RELEASE Statement September 26, 2008

Media Inquiries: Stephanie Kwisnek, 301-827-0955 Consumer Inquiries: 888-INFO-FDA

FDA Updates Health Information Advisory on Melamine Contamination

The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are:

• Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
• Mr. Brown Arabica Instant Coffee (3-in-1)
• Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
• Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
• Mr. Brown French Vanilla Instant Coffee (3-in-1)
• Mr. Brown Mandhling Blend instant Coffee (2-in-1)
• Mr. Brown Milk Tea (3-in-1)

The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.

As of September 25, 2008, the FDA testing of milk based products imported into the United States from China has not found melamine contamination.

The FDA is working with regulatory agencies in other countries. The New Zealand Food Safety Authority reports that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA recommends that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.

To date, the FDA is not aware of any illnesses in the United States stemming from consumption of either White Rabbit Creamy Candy or the Mr. Brown instant coffee and milk tea products.

Individuals who have experienced any health problems after consuming either White Rabbit Creamy Candy or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.

Background

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,400 retail markets and have not found Chinese infant formula present on shelves in these markets.

The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.

The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.

In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

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Additional Information

QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (Sept. 26, 2008)

Tags: Melamine Contamination, FDA Advisory, Mr. Brown instant coffee, Mr. Brown instant milk tea

FDA Posts First Quarterly Report Of Potential Safety Issues On Drugs.

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

"My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Drugs that appear on the agency's new AERS-based table, titled "Potential Signals of Serious Risks/New Safety Information," are identified by FDA reviewers based on reports from the FDA's AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA's Web site today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA's Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA's Web site every three months.

"Over the past two years, FDA has become much more proactive in our communication about possible safety problems," Woodcock said. "Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues."

Related links:

Web posting, "Potential Signals of Serious Risks/New Safety Information"

Tags: FDA, Drug Safety, AERS

DNA Test to Measure Hepatitis B Virus Levels Approved By FDA.

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual’s response to therapy. (The baseline level of hepatitis B virus should decrease with successful treatment.) The test is used with other clinical findings, such as results from biochemical and serological testing.

“Measuring a patient’s HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”

HBV is the most serious type of viral hepatitis, infecting about two billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5,000 die from hepatitis B-related complications.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70 percent of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.

Tags: FDA Approval, Drug Approvals, nucleic acid test for hepatitis B virus, viral DNA, COBAS TaqMan HBV Test, World Health Organization, Roche Diagnostic Division

TNF-Blocker Drug Manufacturers Must Highlight Risk of Fungal Infections

FOR IMMEDIATE RELEASE September 4, 2008

Media Inquiries: Susan Cruzan, 301-827-6242 Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
Agency invokes new authorities under FDAAA to alert patients and prescribers to risk

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

FDA today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 to require manufacturers of TNF inhibitors to make safety-related changes to prescribing information, or labeling.

“Under the FDA's new authorities, we can require safety label changes and a risk evaluation and mitigation strategy, known as REMS, when the agency becomes aware of new safety information,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research. “Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks.”

Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.

Patients taking TNF blockers should be aware that they are more susceptible to serious fungal infections. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention. To assist in the diagnosis, those being treated with TNF blockers should tell their health care professionals where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover.

FDA has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys (the fungus is commonly found in those areas). In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.

The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The FDA also has received reports of cases of coccidioidomycosis and blastomycosis, including deaths, in patients treated with TNF blockers.

TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the Medication Guides to the FDA within 30 days or to provide a reason why they do not believe labeling changes are necessary.

If they do not submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.

Medication Guides will become part of a REMS for Humira and Remicade and are already part of a REMS for Enbrel and Cimzia. The manufacturers for all four of these drugs will also be required to educate prescribers about the risks.

For more information: http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm

Tags: Humira, Cimzia, Enbrel, Remicade, FDA Announcement, Drug Labeling, fungal infections, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease