First Coast Medicare To Provide Case By Case Reimbursement For The Renessa(R) Treatment For Incontinence In Women

Novasys Medical, Inc., a developer of innovative therapies in women's health, announced that as of July 1, 2009, First Coast Service Options, Inc. ("First Coast"), a large regional Medicare carrier serving over 3 million beneficiaries in Florida, Puerto Rico and the U.S. Virgin Islands, has removed the non-surgical Renessa(R) treatment for women with stress urinary incontinence (SUI) from its noncovered services list and will be looking at claims for the Renessa procedure on an individual case by case basis.


On its Web site, First Coast states, "in order to provide an option for those physicians who are appropriately trained in treating women with stress urinary incontinence (SUI) and who are appropriately trained in performing the Renessa procedure, we will be removing Renessa from our noncovered LCD and we will be looking at claims for the Renessa procedure on an individual case by case basis." First Coast goes on to state that it "expects that providers submitting claims for Renessa are providing the services within the FDA approved guidelines and in accordance with the indications supported by peer-reviewed literature which limits its use to moderate to severe stress urinary incontinence (SUI) in females."


"We are very pleased with First Coast's decision," said Debra Reisenthel, Novasys Medical President and Chief Executive Officer, "as it enables access to this safe and effective treatment option for Medicare beneficiaries in Florida with moderate to severe SUI." First Coast joins Noridian Medicare, a large regional carrier administering benefits in nine states, in providing reimbursement for the Renessa procedure. Other private insurers, including AvMed and HealthFirst in Florida and Aetna US Healthcare nationwide, also cover this safe and effective non-surgical treatment for women who suffer from the debilitating effects of SUI.


Female Stress Urinary Incontinence


SUI is the involuntary leakage of urine associated with laughing, coughing, sneezing and recreational activities. The condition is caused by a variety of factors, most commonly childbirth, and often restricts the social, professional, and personal lives of a significant number of women. With currently available surgical and non-surgical SUI therapies, many patients and physicians have concerns about safety, recovery, compliance, and/or effectiveness.


The FDA-cleared Renessa System includes a small probe which a physician passes through the natural opening of the urethra (transurethral). The probe heats multiple small treatment sites in the submucosa of the bladder neck and upper urethra, denaturing the patient's own collagen in the tissue, thereby reducing or eliminating leaks. The Renessa treatment can be performed in the convenience of a physician's office using local anesthesia. There are no incisions, bandages or dressings required. Recovery is rapid and comfortable, with minimal post-procedure limitations. The Renessa treatment offers an option for women who have tried conservative therapies such as Kegel exercises or biofeedback without success, but who cannot have or do not desire an invasive surgical procedure. To date, over 350 urologists, urogynecologists and gynecologists in 40 states have been trained and have performed the Renessa procedure in over 2500 patients.


About Novasys Medical


Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI).


Source: Novasys Medical, Inc

Giuliani's, Romney's Views On Abortion Could Affect Their Chances Of Winning Republican Party Presidential Nomination

The Los Angeles Times and USA Today on Thursday examined how the abortion views of former New York City Mayor Rudy Giuliani (R) and former Massachusetts Gov. Mitt Romney (R) could affect their chances for winning the 2008 Republican Party presidential nomination. Summaries appear below.

Los Angeles Times: Romney's "rightward shift in abortion" rights will be a major challenge in his campaign, the Times reports. Although Romney has said that he supports overturning Roe v. Wade, the 1973 Supreme Court decision that effectively barred state abortion bans, during his Massachusetts gubernatorial campaign in 2002 he pledged to "protect a woman's right to choose," according to the Times. Romney's "ideological swerve" could raise doubts about whether he shares the core values, including opposition to abortion rights, held by many conservative evangelicals, who "dominate" the Republican primary elections, the Times reports (Finnegan, Los Angeles Times, 2/1).

USA Today: Although Giuliani in a recent USA Today/Gallup poll had more voter support than other candidates for the Republican nomination, his support of abortion rights and other social issues could cause him to lose the Republican nomination, USA Today reports. According to USA Today, one in five Republicans who participated in the poll said they did not know that Giuliani supports abortion rights and same-sex civil unions. When told about Giuliani's views on such issues, one in five Republican respondents said that would "rule him out as a candidate" (Page, USA Today, 2/1).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Criticism Of Popular Oral Contraceptive Yaz Could Harm Product's Appeal, New York Times Reports

The popular oral contraceptives Yaz and Yasmin have been tainted recently by safety concerns raised by researchers, health advocates and lawyers for plaintiffs who have filed lawsuits against manufacturer Bayer Healthcare, the New York Times reports. These groups argue that the drugs put women at higher risk for strokes, blood clots and other health problems than some other oral contraceptives. Citing warning letters FDA sent to the company, plaintiffs' attorneys contend that Bayer was aware or should have been aware of the problems. These new concerns could "rattle consumer confidence" and harm the drugs' image as the "go-to brands for women under 35," according to some industry analysts, the Times reports.

In 2001, FDA approved Yasmin, which contains drospirenone, a progestin that can increase the body's potassium levels. According to the drug's label, the potassium increase may put women with liver and kidney problems at higher risk for serious health problems. Yaz, which also contains drospirenone and a lower dose of estrogen, was approved in 2006 as both a contraceptive and a treatment for premenstrual dysphoric disorder and moderate acne. The drugs' popularity is due in part to multimillion-dollar advertising campaigns, and together Yasmin and Yaz brought in about $1.8 billion in worldwide sales in 2008 for Bayer.

FDA in October 2008 sent Bayer a warning letter for running two false and misleading TV
ads about Yaz. FDA said the ads overstated Yaz's efficacy, promoted it for conditions -- like premenstrual syndrome -- for which it is not approved, and downplayed serious risks associated with the drug. Bayer
agreed in February 2009 to spend $20 million on a corrective ad campaign to address the misimpressions from the original campaign.

FDA sent another warning letter to Bayer in August 2009, this time regarding deviations from quality control standards at a manufacturing plant in Germany that makes drospirenone and other hormone ingredients used in the pills sold in the U.S. The letter said methods used by the facility to calculate variability in ingredients did not meet U.S. standards.

According to Bayer, the company has been served with 74 lawsuits brought by women who say they developed health problems after taking Yasmin or Yaz. According to the Times, because the drugs' labels warn of the risk of blood clots and stroke, the plaintiffs could have difficulty winning on the argument that Bayer should have issued stronger warnings. The plaintiffs might be more likely to prevail if lawyers are permitted to use the FDA warning letters to argue that misleading advertisements enticed women to take the pills, exposing them to health risks that they might not have otherwise encountered, the Times reports. Michael Santoro, an associate professor at Rutgers Business School who has studied ethics in the drug industry, said past warnings from FDA about advertising and quality control raise questions about Bayer's approach to complying with government guidelines.

An FDA spokesperson said the agency is reviewing the safety of oral contraceptives through a study designed to identify the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives. Meanwhile, officials with Bayer said the company plans to vigorously defend itself against the lawsuits. Bayer also is conducting a postmarket study comparing Yaz's safety with that of other oral contraceptives (Singer, New York Times, 9/26).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

Minister Gallagher Renews Advice To Women Not To Drink Alcohol In Pregnancy, Ireland

Mr Pat the Cope Gallagher T.D., Minister for Health Promotion and Food Safety, last week highlighted the risk of alcohol consumption and pregnancy. Minister Gallagher stated 'I wish to endorse the advice being given by the Department of Health and Children's Chief Medical Officer. It is essential that women are provided with all the relevant information for a safe and successful pregnancy. Therefore, women need to be aware of the risk associated with alcohol consumption during pregnancy. As the evidence does not specify a safe level of alcohol consumption, the best advice to women is not to consume alcohol if pregnant or trying to conceive.'


Following publication of the report entitled 'The Coombe Women's Hospital Study of Alcohol, Smoking and Illicit Drug Use, 1988-2005' in March this year, Mary Harney TD, Minister for Health and Children asked the Chief Medical Officer (CMO) in the Department of Health and Children to consider the data presented in the Study particularly with respect to the finding that most pregnant women drink alcohol. The Study found that 1 in 10 women reported drinking more than 6 units of alcohol per week in pregnancy and that this pattern was more pronounced in younger women. The CMO also reviewed the available international evidence including that from the Surgeon General in the United States and more recently from the Department of Health in the United Kingdom.


The Chief Medical Officer has concluded that:


- Alcohol consumption by pregnant women in Ireland poses a risk to unborn babies

- There is no known safe level of alcohol consumption during pregnancy

- Alcohol offers no benefits to pregnancy outcomes

- It is in the child's best interest for a pregnant woman not to drink alcohol during pregnancy


The CMO is now providing unambiguous advice in relation to alcohol consumption and pregnancy.


'Given the harmful drinking patterns in Ireland and the propensity to 'binge drink', there is a substantial risk of neurological damage to the foetus resulting in Foetal Alcohol Spectrum Disorders (FASD). Alcohol offers no benefits to pregnancy outcomes. Therefore, it is in the child's best interest for a pregnant woman not to drink alcohol during pregnancy.' the CMO said.


The Health Service Executive will commence work on updating and disseminating information materials for use by the general public and medical professionals to include the CMO's advice that women should avoid alcohol before and during pregnancy and while breastfeeding. The HSE will also meet with relevant stakeholders with regard to developing and implementing education initiatives for health professionals on this issue.


The Department of Health and Children is consulting with relevant stakeholders on the proposal to introduce a requirement that alcohol containers and promotional materials carry a label with a health warning about drinking alcohol during pregnancy. Today's strengthened advice is issued to coincide with the Foetal Alcohol Spectrum Disorders Awareness Day which takes place on the 9th day of the 9th month each year (9th September).


A person having any concerns in relation to the CMO's advice on alcohol consumption and pregnancy should contact their General Practitioner or local maternity service provider.


Background


Foetal Alcohol Spectrum Disorders (FASD) is the umbrella term used to describe the range of effects that can be caused by maternal alcohol exposure. Children identified as suffering from FASD can show signs of behavioural, intellectual and physical difficulties including learning difficulties, poor language skills, poor memory skills and attention problems.

dohc.ie/