Legislation

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 2009 approximately 21,550 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.

• Legislation (H.R. 2941/S. XXXX) to reauthorize Johanna’s Law: The Gynecologic Cancer Education and Awareness Act.

• 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.

Appropriations

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.  In FY2010, the Ovarian Cancer National Alliance calls for the following ovarian cancer-specific funding:

• $10 million in FY 2010 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;

• $10 million in FY 2010 for the 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;

• $30 million in FY 2010 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. The House and Senate both submitted letters in support of this request.  Members of Congress also submitted a letter to fight a proposed cut in funding for this program in FY2010.

Regulation

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.

Drug Approvals

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 test that mearure 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.

Reimbursement Policies

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).