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Breast Cancer Legislation Subject of House Hearing

On October 7, the House Energy and Commerce Committee held a hearing on several breast cancer bills: the Breast Cancer Education and Awareness Requires Learning Young (EARLY) Act (H.R. 1740), Breast Cancer Patient Protection Act (H.R. 1691), Eliminating Disparities in Breast Cancer Treatment Act (H.R. 2279), and the Mammogram and MRI Availability Act (H.R. 995).

Sponsored by Rep. Debbie Wasserman Schultz (D-FL), the EARLY Act would authorize $9 million for FY2010 through FY2014 to educate young women about the occurrence of breast cancer in young women and the evidence-based methods to lower their risk of breast cancer, award grants and contracts to states agencies to carry out campaigns to raise awareness of breast cancer in young women, and carry out health education programs targeted toward “specific higher-risk populations of young women based on race, ethnicity, level of acculturation, and family history, including the African American and Ashkenazi Jewish populations under 40 years of age,” among other provisions.

The bill also would provide support for young women who already have been diagnosed with breast cancer.

The Breast Cancer Patient Protection Act, sponsored by Rep. Rosa DeLauro (D-CT), would require that health plans provide coverage for a minimum hospital stay for mastectomies, lumpectomies, and lymph node dissections for the treatment of breast cancer and coverage for secondary consultations. Specifically, the bill would prohibit a group health plan or health insurance provider from restricting benefits to less than 48 hours for any hospital stay resulting from a mastectomy or lumpectomy, or 24 hours in the case of a lymph node dissection. Coverage would not be required if the physician, in consultation with the patient, determines that a longer period of stay or outpatient treatment is not medically necessary.

The Eliminating Disparities in Breast Cancer Treatment Act, sponsored by Rep. Kathy Castor (D-FL), would require the secretary of Health and Human Services to implement a standard of treatment that would eliminate disparities in the care of breast cancer patients based on race, income, education status, and health insurance status. By October 1, 2010, the secretary shall have established a six-year breast cancer treatment quality performance system to “assess and publicly disclose, through the use of quality measures, the quality of care provided for the treatment of breast cancer by specified health care providers.” The quality measures would include “measures of patient outcomes, the process for delivering medical care related to such treatment, patient counseling and engagement in decision-making, patient experience of care, resource use, and practice capabilities, such as care coordination.”

Sponsored by Rep. Jerrold Nadler (D-NY), the Mammogram and MRI Availability Act would “require that group and individual health insurance coverage and group health plans provide coverage for annual screening mammography for women 40 years of age or older and mammograms and annual magnetic resonance imaging (MRI) for women at high risk for breast cancer if the coverage or plans include coverage for diagnostic mammography for women 40 years of age or older.” Under the bill, insurance companies would be prohibited from “deny[ing] coverage for annual screening mammography or annual magnetic resonance imaging on the basis that the coverage is not medically necessary or on the basis that the screening mammography or magnetic resonance imaging…is not pursuant to a referral, consent, or recommendation by any health care provider.”

“While all of these bills address concerns related to breast cancer, they all focus on different aspects of the disease from screening and early detection to treatment and quality improvement,” said Chair Frank Pallone (D-NJ). He continued, “And they all raise very important issues with respect to how breast cancer patients, or any other patients for that matter, are being treated in the medical environment we live in today.”

Rep. Wasserman Schultz said, “The EARLY Act will give ALL young women the tools and information they need to take more control of their health. It will raise awareness of their personal risks and the importance of paying attention to their breast health. It will encourage young women to be familiar with the look and feel of their breasts. By knowing what feels normal, a young woman has a better chance of knowing when something feels different and knowing when to see her doctor.” She continued, “The EARLY Act will teach young women and medical professionals about the importance of family history, warning signs of breast cancer, and predictive tools such as genetic testing that can help some high-risk women make informed decisions about their health. It will also provide grants to organizations dedicated to supporting young women diagnosed with breast cancer. These grants will help young women tackle the unique challenges [they face], such as fertility preservation, body image, and self esteem…as well as help them manage and understand their risks.”

Testifying on behalf of H.R. 1691, Rep. DeLauro said, “[This] is what the Breast Cancer Patient Protection Act is all about. It says that when it comes to a mastectomy, adequate recovery time in the hospital should not be negotiable. The last thing any woman should be doing at that time is fighting with her insurance company. This bill does not mandate a 48 hour hospital stay…nor does it set 48 hours as a maximum amount of time a woman can stay in the hospital. It simply ensures that any decision in favor of a shorter or longer hospital stay will be made by the patient and her doctor, and not an insurance company.” She added, “H.R. 1691 also includes other important protections for patients facing breast cancer, including access to second opinions, coverage of radiation therapy for women choosing a lumpectomy, and access to a third party review process before a rescission can take place. Along those lines, I am proud to support broader health reform legislation that would ban rescissions and institute numerous other insurance market reforms that protect and empower patients.”

Dr. Stephen Taplin, chief of the Applied Cancer Screening Research Branch at the National Cancer Institute within the National Institutes of Health, noted the persistence of disparities in breast cancer treatment among low-income women and women of color: “Despite the stabilization of screening in the population as a whole there are subpopulations in which screening rates are lower, and those are primarily defined by economic status and access to care. Apparent lower rates of screening among African Americans, Hispanics, and Asian/Pacific Islanders compared to white non-Hispanics disappear when socioeconomic status is taken into account. Women in lower socioeconomic groups are less likely to be screened, in large part because they do not have access to preventive care. People with less than 12 years education are the one group in the United States in which we have not seen a significant drop in breast cancer mortality.”

Dr. Taplin continued, “To address the challenge of prevention and care for low-income and underinsured populations, which, unlike the nation as a whole, have not experienced that reduction in breast cancer mortality rates, HHS’s [Health and Human Services’] Centers for Disease Control and Prevention (CDC) administers the National Breast and Cervical Cancer Early Detection Program (NBCCEDP). This program provides breast and cervical cancer screening to low-income, under- and uninsured women throughout the U.S. through grants to all 50 States, the District of Columbia, 12 American Indian tribes and tribal organizations, and five U.S. territories. The NBCCEDP is based on a public health model and encourages these populations to utilize the full screening process by incorporating public education, professional development, and outreach; assuring quality through tracking and surveillance; facilitating screening follow-up, patient navigation, and case management; and referral to treatment for these underserved women. Furthermore, the NBCCEDP is keeping pace with the practices in the field by offering reimbursement for digital mammograms. Ongoing studies indicate that over the past 15 years, the NBCCEDP has saved more than 100,000 life years, creating significant health impacts.”

“Breast cancer is the most common cancer among women, accounting for nearly one in four cancers diagnosed,” said Otis Brawley, chief medical officer for the American Cancer Society. Dr. Brawley provided some statistics on the prevalence of breast cancer and discussed the need for adequate access to early screening for the disease: “This year in the United States, over 192,370 women will be diagnosed with breast cancer and approximately 40,170 women will die from the disease. If every woman in the United States had access to accurate information about the disease, early detection and quality, timely treatment, more women would survive breast cancer. Unfortunately, many women lack access to public health programs and adequate health coverage that provide these life saving services. The consequences are detrimental to their health and can be devastating in terms of their prognosis…Throughout the country, many women are forced to choose between preventive health care and more routine things, such as paying for food, housing, utilities, or even the health care of their kids and spouses, especially in hard economic times. ACS CAN [American Cancer Society Cancer Action Network] conducted a national survey in April 2009 to understand how Americans are dealing with health care costs in the current economic environment, whether they are delaying preventive cancer care, and how prepared they may be to deal with an illness like cancer in the future. One in five women surveyed said that they or a family member in their home put off getting a cancer screening test in the past year. Furthermore, nearly one-third of Americans with household incomes less than $35,000 said they put off potentially lifesaving screenings such as mammograms or colonoscopies.”

Jenny Luray, president of the Susan G. Komen for the Cure Advocacy Alliance, speaking on behalf of the Mammogram and MRI Availability Act, said, “The bill is consistent with guidelines recommended by Komen for the Cure, the American Cancer Society, and NCCN [National Comprehensive Care Network] that women at high risk receive annual mammograms and an MRI every year and that women at moderately increased risk should talk with their health care providers about the benefits and limitations of MRIs. About 80 to 90 percent of breast cancers in women without symptoms in the U.S. will be detected by mammography. Yet, only 51.2 percent of women 40 and older in the U.S. reported having a mammogram in the last year. Recent studies suggest that many women in the U.S. are getting their first mammogram later than recommended, not having mammograms at recommended intervals or not receiving appropriate and timely follow-up of positive screening results. This may lead to more advanced tumor size and stage at diagnosis. The Komen Advocacy Alliance believes all women should have access to recommended screenings. We have promoted this by seeking increased funding for programs that provide screening for underserved women like the NBCCEDP, advocating for patient protections in the House and Senate health care bills that will increase access to early detection services, and addressing other gaps that infringe on access to quality care. Further, the Komen Advocacy Alliance believes that women should have access to the appropriate diagnostic tests, including cancer survivors who need follow-up testing and surveillance.

Fran Visco, president of the National Breast Cancer Coalition (NBCC), stressed the importance of accurate evidence-based research and information, saying, “There are too many unfortunate examples of policy, messaging, and beliefs that have taken hold when there was in fact no real evidence behind them, and these actions resulted in harm to women. We are all familiar with the story of Autologous Bone Marrow Transplants (ABMT) in treating breast cancer. The community believed more chemotherapy would be better and that transplants worked in some cancers so why not breast cancer? While clinical trials were launched, too many women received the treatment outside of the trials, the trials did not accrue and it took many more years than it should have to get the real answer. Women died from the treatment itself…When we finally had the evidence, it was clear that ABMT was not better than conventional chemotherapy. And yet, laws were passed in various states mandating insurance coverage of this treatment, an example of misplaced advocacy when evidence did not exist.”

She continued, “We also know the story of hormone replacement therapy (HRT) becoming a widely used intervention for women based on the belief, without evidence, that it would help cardiac health among other benefits. Yet, when the clinical trials were completed, we found out that HRT increased a woman’s risk of breast cancer and other harms. Many many women took HRT when we had no evidence of its effectiveness and many women were harmed. Breast self examination (BSE) falls into this category also. BSE became gospel, yet there was no evidence at all that it saved lives or found breast cancer at an earlier stage. When we did have the evidence that, not only did it not save lives or find cancer earlier, it resulted in the harm of unnecessary biopsies and increased anxiety, the public would not believe it because the marketing of this approach had been so successful…NBCC has taken the position many times that we cannot afford to waste our limited resources and risk women’s lives on medical treatments and on public health interventions that have not been shown effective, particularly when there is evidence that the intervention may be causing harm. These resources would be better spent on funding more research studies to identify interventions that really do work, such as better ways to detect, treat, and prevent breast cancer. These resources would also be better spent on interventions that have already been shown to reduce breast cancer mortality, such as access to appropriate treatment for all. Let us be very careful not to make the same mistakes again. This holds true for the breast cancer bills currently pending before this committee and also holds true for health care reform. Currently, opponents of meaningful health care reform have begun to use incomplete, outdated and misleading statistics about breast cancer to support their arguments in opposition to these efforts. NBCC wants to set the record straight for the members of this committee and for anyone else who may have come across this misleading information.”

Dr. Marissa Weiss, president and founder of Breastcancer.org, explained why outreach to young women is critical in reducing breast cancer: “Breast cancer is a complex disease with multiple causes, some proven and others suspect. Most risks for breast cancer don’t begin at age 45. Rather, they accumulate over a lifetime, beginning at conception. There are periods when breast cells are hypersensitive to internal and external environmental insults and agents: the first trimester of pregnancy during initial organogenesis, the four to 10 main years of breast organogenesis between adolescence and the twenties, as well as the stretch of time leading up to a woman’s first full-term pregnancy, when breast cells are highly active and immature. So, the behaviors of women under age 45 impact not only their own breast health, but the future breast health of their daughters through pregnancy and modeled behaviors. As others have pointed out, not all risk factors are created equal. Some risks like being a woman, growing older, having a strong family history, and/or a specific breast cancer gene abnormality carry more significance than others, such as obesity, physical inactivity, alcohol consumption, smoking, and an unhealthy diet. Some risk factors are modifiable, some are not. But even tiny risks can combine and really add up. Concentrated exposures, combined exposures, regular exposures over time particularly during sensitive periods can accumulate and collectively increase risk. For example, besides being a woman, growing older is the biggest risk factor for breast cancer. And while you can’t control that you are aging, you can control how you age: how your inside environment interacts with the outside environment. We cannot undo past behaviors, but we can limit the damage by promoting a breast healthy lifestyle and behaviors starting as early as possible.”

Dr. Weiss added, “Contrary to the claim that proven breast cancer risk factors can’t be modified, our obesity epidemic is doing just that by accelerating the age of menarche. In the other direction, early education and behavior modification that increases athletic activity and healthy weight management can postpone the onset of puberty. Lessons learned from EARLY Act programs will benefit current and future generations, since women under the age of 45 are in the prime of their childbearing and parenting years.”

Rep. Nadler also testified.

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