The Alliance has
- submitted comments (with Bright Pink) regarding USPSTF BRCA testing guidelines
- joined 106 other organizations in a letter expressing concern about out of pockets costs for those enrolled in health plans through the marketplaces (exchanges)
- submitted comments regarding Medicare coverage of PET scans
- garnered support for House and Senate funding of the Ovarian Cancer Research Program
- submitted comments to the FDA regarding drug shortages
- testified in front of a House subcommittee regarding the need for ovarian cancer programs
- submitted comments to the FDA regarding an alternative pathway for drug approvals
- Educated Congressional staff regarding the need to maintain the OCRP in FY13
The Alliance has worked on
- federal appropriations for ovarian cancer related programs, especially the Department of Defense Ovarian Cancer Research Program
- provisions of PDUFA, especially those related to drug shortages
- provided comments to the United States Preventive Services Task Force regarding ovarian cancer screening recommendations
- created an action alert to tell Congress that sequestration should not include cuts to ovarian cancer programs
Through coalitions the Alliance has worked on
- legislation related to Track and Trace
- a letter regarding the standard for Essential Health Benefits
- PCORI’s research agenda
- tax credits for IVF that are similar to the adoption tax credit
- calling for the release of regulations that govern Laboratory Developed Tests
Legislation includes federal laws that authorize programs to help with the cost of cancer care, awareness of cancer, or create programs to aid patients in receiving quality care.
Ovarian Cancer has a Devastating Impact on Women, Families and the Nation.
In 2011, it is estimated that approximately 21,000 women will be diagnosed with ovarian cancer and approximately 15,000 women will die of the disease. Overall, the ten-year relative survival rate for ovarian cancer patients is 39 percent, while the five-year survival rate is 46 percent. Survival rates vary depending on the stage of ovarian cancer at diagnosis; women diagnosed at an early stage have a much higher five-year survival rate than those diagnosed at a late stage. Unfortunately, due to the lack of a reliable early detection test, less than 20 percent of ovarian cancer patients are diagnosed early.
- The Ovarian Cancer National Alliance has joined other cancer groups in supporting other cancer legislation including supporting cancer care planning, ensuring a steady stream of cancer research funding, supporting the education of cancer patients, and removing pre-existing condition barriers to health insurance, among others. See the most current list of the Alliance’s letters submitted to Congress, Dear Colleagues and testimony at the following link: http://www.ovariancancer.org/policydocuments/
Congress passes numerous appropriations bills every year that provide funding for programs like gynecologic cancer awareness and cancer research. Even if a bill is passed to authorize a program, Congress must allocate the money every year through this appropriations process. Every year, the Ovarian Cancer National Alliance works with Congress to ensure that critical ovarian cancer programs are funded, including funding for the Centers for Disease Control and Prevention, the Department of Defense Ovarian Cancer Research Program, the National Cancer Institute and the Food and Drug Administration. For FY2012, the Ovarian Cancer National Alliance calls for the following ovarian cancer-specific funding:
- Level-funding from FY 2010 for $6.8 million in FY 2012 to support implementation of Johanna’s Law: the Gynecologic Education and Awareness Act (P.L. 109-475), to educate women and health professionals about the signs and symptoms of ovarian and other gynecologic cancers so they can be detected at the earliest, and most treatable stage;
- Level-funding from FY 2011 for $4.9 in 2012 for the e Ovarian Cancer Control Initiative, housed at the Centers for Disease Control and Prevention, to continue and expand its efforts to answer questions regarding the provision of optimal care, patterns of diagnosis, and risk perception for women with ovarian cancer;
- Level-funding from FY 2011 for $20 million in FY 2012 for the Department of Defense Ovarian Cancer Research Program to allow it to maintain current research and expand innovative investigations into early detection and screening tools.
Both federal and state governments pass, enforce and interpret laws as well as regulations. Regulations have the force of law, but are made by an administrative body rather than an law-making body like Congress. The Regulatory section of the Alliance’s website will serve to keep you updated on federal agencies’ actions related to ovarian cancer.
The Ovarian Cancer National Alliance monitors regulations that are issued by the Food and Drug Administration (FDA),the Centers for Medicare and Medicaid Services (CMS) and the Social Security Administration (SSA).These policies may affect everything from the approval of a drug to its reimbursement by insurance companies, and can have an important effect on the lives of patients and caregivers.
Erythropoesis Stimulating Agents (ESAs)
Erythropoesis Stimulating Agents (ESAs) are drugs that help the body produce more red blood cells. The drugs have been used to help counteract chemotherapy-induced anemia, however, recent studies show that that the drugs may promote the growth of some tumors.
The Ovarian Cancer National Alliance submitted comments (MS Word) to the Centers for Medicare and Medicaid services regarding reimbursement of ESAs.
Medicare released a National Coverage Decision on reimbursement for ESA.
The Ovarian Cancer National Alliance submitted (PDF) comments to the FDA regarding the safety of ESAs. Speak to your doctor about the risks and benefits of ESAs before initiating therapy.
The Food and Drug Administration (FDA) approves drugs for specific indications, including ovarian cancer. Many drugs that are not approved for a specific use are used off-label, which means that the drugs are used for a different indication or in a different dose than approved by the FDA. The Ovarian Cancer National Alliance works with the FDA to ensure that drugs used to treat ovarian cancer are safe and effective, and brought to patients quickly.
Safety of Laboratory Tests:
In February 2007, the Alliance testified (MS Word) regarding new draft guidance on clinical laboratory tests. The FDA seeks to regulate a type of test called an In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs). IVDMIAs are laboratory tests that measure mulitple biomarkers. These complex laboratory tests were regulated by the Center for Medicare and Medicaid Services (CMS). The Alliance testified that the guidelines under which these tests are developed, tested and manufactured must be made clear so that the regulatory framework is predictable and will ensure safe and swift development of IVDMIAs. In July, the FDA released Draft Guidance (MS Word) addressing many of the issues the Alliance raised, including more clearly defining an IVDMIA. As of August 1, 2009, the FDA has not released final guidance on IVDMIAs.
Early Detection Tests
There is no single, reliable early detection test for ovarian cancer. The Ovarian Cancer National Alliance has worked with the FDA to approve more reliable early detection tests, and keep unreliable tests off the market.
- The Ovarian Cancer National Alliance presented (MS Word) oral testimony to the FDA regarding the use of the HE4 biomarker with the CA125 for early detection of ovarian cancer. Currently the test is approved by the FDA in conjunction with the CA-125 blood test for monitoring ovarian cancer.
Whether or not a drug or intervention is approved by the FDA, it can only be utilized by patients if there is way to pay for it. For most patients, access is limited by insurance reimbursement policies, many of which look to Medicare as a leader.
- The Ovarian Cancer National Alliance successfully worked with Medicare to provide reimbursement for PET scans for women with ovarian cancer by presenting (PowerPoint) evidence that PET scans were medically necessary for some of these women, submitting (MS Word) written comments on the subject. On April 3, 2009, CMS agreed(MS Word), and now reimburses for the cost of PET scans performed on women with ovarian cancer for whom the scan is medically necessary.
- The Ovarian Cancer National Alliance continues to work with Members of Congress and patients to ensure Medicare coverage for bevacizumab (Avastin). In July 2009, Senator Bennet (D-CO) sent a letter to The Centers for Medicare and Medicaid Services expressing concern over this issue. In October, more than 30 Members of Congress from affected states (Colorado, New Mexico, Oklahoma and Texas) signed a similar letter, led by Representative Markey (D-CO).