The Lymphoma Research Foundation (LRF) supports policy measures that will increase federal funding for lymphoma research and education and ensure access to high quality lymphoma care. Through its public policy efforts and the LRF Advocacy Program, the Foundation works to ensure that these important policy issues are brought to the attention of federal lawmakers, the officials in Congress who have the ability to prioritize these issues.

Protect Patient Access to Radioimmunotherapy

This summer, the Centers for Medicare & Medicaid Services (CMS) – the federal agency which administers Medicare, Medicaid, and the Children's Health Insurance Program – released the proposed 2012 Hospital Outpatient Prospective Payment System (HOPPS). This proposal included policies that could impact the resources the federal government will pay for, or reimburse, to hospitals and medical centers in the coming year.

The proposed HOPPS, also called a rule, for 2012 could affect lymphoma patients in a number of ways. The rule would make adjustments to cancer hospital outpatient payments and also increase the number of measures that hospitals need to report on each year, to help determine the payment rates that CMS uses. Most urgently, the proposed rule would impact the payment system for an important treatment option for many lymphoma patients, called radioimmunotherapy (RIT). RIT may be used alone or in combination with chemotherapy to treat relapsed or refractory follicular lymphoma. RIT involves the attachment of a radioactive compound to a monoclonal antibody. This therapy delivers radiation directly to lymphoma cells that have a specific protein (CD20 antigen) on their surface. Hence, the tumor cell is killed by both the body's own immune system and radiation. Currently, two radioimmunotherapy drugs are commercially available: Iodine 131 tositumomab (Bexxar) and Y90 ibritumomab tiuxetan (Zevalin).

Unfortunately, the proposed payment system for RIT under the new rule would result in inadequate reimbursement rates. If reimbursement rates for RIT are insufficient, hospitals and physicians may be unable to make this treatment readily available to lymphoma patients. That is why LRF submitted a letter to CMS, urging them to reconsider this proposed rule. LRF advocates and members of the lymphoma community also weighed in on this critical issue, asking CMS to protect patient access to RIT.

CMS is expected to announce the proposed rule in the coming weeks; check back on the LRF website often for related updates.

The Preserving Access to Life-Saving Medications Act (S.296)

Shortages of prescription drugs cost the United States more than $200 million. In addition, shortages force doctors to delay or cancel treatment, including the treatment of cancer. Patient safety is compromised when doctors have to use different or unfamiliar drugs when they do not have access to the appropriate therapies.

In the six months from July to December of 2010, 240 drugs were either in short supply or completely unavailable, and most of the medicines with shortages are necessary for emergency care, sedation, or chemotherapy. In response to this problem, Senators Amy Klobuchar (D-MN) and Robert Casey (D-PA) introduced the Preserving Access to Life-Saving Medications Act on February 7, 2011. A companion bill has been introduced in the House of Representatives (H.R.2245) by sponsored by Reps. Tom Rooney (R., Fla.) and Diana DeGette (D., Colo.).

The legislation (S.296) would require the following:

- Manufacturers would have to notify the FDA if they anticipate changes in supplies or production that may lead to shortages.
- If a company plans to discontinue making a drug, they have to inform the FDA at least 6 months in advance.
- The FDA must develop penalties for manufacturers not complying with notifications and publish information about manufacturing problems and actual drug shortages on its website.
- The FDA must develop evidence-based criteria for drugs that are vulnerable to shortage and publish that information on their website. Factors that would make drugs vulnerable to shortages include the number of manufacturers, supply of raw materials, characteristics of the supply chain, and availability of other treatments.

"Physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available – that's not right," said Senator Klobuchar. "This common-sense solution will help set up an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible. As we move forward, it is important that we have better coordination between the pharmaceutical industry, the FDA and health care providers so patients don't lose access to the medications they depend on."

The Lymphoma Research Foundation actively endorses this legislation and applauds both Senators Klobuchar and Casey and RepresentativesDeGette and Rooney for their leadership on this important issue.

LRF Advocates Make Their Voices Heard

This spring, LRF advocates and chapter members from across the country will make their voices heard in support of these issues by attending local meetings with their federal legislators. The meetings, arranged by LRF and led by local Advocacy Chairs, will provide an opportunity to educate lawmakers about lymphoma and discuss public policies that are most important to the lymphoma community, including advocating for federal blood cancer education programming and protecting the nation's investment in cancer research.

Interested members of the lymphoma community are encouraged to consider participating in these legislative visits – no experience is required and you will participate alongside local LRF chapter leaders. To participate in this important advocacy activity, contact your local LRF Advocacy Chair or send an email with your name and contact information to advocacy@lymphoma.org.

Cancer Leadership Council Sends Letter to Congress

The Cancer Leadership Council, a patient-centered forum of national advocacy organizations addressing public policy issues in cancer, has submitted a letter to congress urging the preservation of funding for the National Institutes of Health and the National Cancer Institute for the remainder of Fiscal Year 2011. The Cancer Leadership Council includes over 20 organizations, including the Lymphoma Research Foundation. A portion of the letter reads:

"If funding for NIH and NCI is cut, the effects will be felt in homes, schools, workplaces, laboratories, and hospitals across the nation. We ask for your support of NIH and NCI to prevent:

• Interruption of dozens of clinical trials that are testing new treatments for cancer.
• Discontinuation of research studies undertaken in institutions in every state of the nation, studies that are yielding information about cancer and strategies for developing new treatments.
• Abandonment of efforts to develop interventions to help cancer survivors live with the long-term effects of their treatment.
• Economic dislocation in institutions, laboratories, and communities across the country, as investigators dedicated to the fight against cancer and their research support teams lose their jobs."

Please click here to download the .pdf of the entire letter.

Centers on Medicare and Medicaid Services Innovation Center

This month, the Centers on Medicare and Medicaid Services launched a new web tool designed to seek input from the public. Submitted ideas will be reviewed by staff, and the most promising ideas will be incorporated into the payment and care deliver models tested by the Innovation Center.

"We are seeking your ideas, both to help build the Innovation Center and to help identify innovative ideas about how care can be delivered and paid for in ways that will save money while improving health and healthcare," says Richard J. Gilfillan, MD, Acting Director of the Innovation Center.

Lymphoma Research Foundation advocates and partner health care professionals are encouraged to explore the site and use their experience as an important part of the healthcare delivery system to contribute in meaningful ways.

Visit www.innovations.cms.gov for more information.

Foundation Releases 2011 Public Policy Agenda

The Lymphoma Research Foundation (LRF) announced the release of its 2011 public policy agenda on February 17. Approved by the Foundation's Board of Directors, the public policy agenda highlights those public policies and policy initiatives that the Foundation and its network of over 5,000 advocates will support in the coming year. LRF volunteers and supporters are encouraged to learn more about the LRF Advocacy Program, as well as the Foundation's legislative and policy priorities, which include preserving the federal government's investment in lymphoma research and ensuring that every lymphoma patient has access to quality cancer care.

"The LRF Advocacy Program brings together members of the lymphoma community who are interested in making their voices heard," says Meghan Gutierrez, LRF Chief Communications Officer. "By joining LRF's nation-wide network of advocates, they can work with the Foundation to ensure that our federal lawmakers pay attention to the needs of people with lymphoma."

The Foundation's national public policy and advocacy priorities reflect the LRF mission, to eradicate lymphoma and serve those touched by this disease. Specifically, LRF supports policy measures that will increase federal funding for lymphoma research and education and ensure access to high quality lymphoma care. LRF is committed to advocating on behalf of the entire lymphoma community, working collaboratively with policymakers, the medical community, patient advocates and other stakeholders at the state and federal levels to advance legislative, regulatory and programmatic efforts that will improve the lives of lymphoma patients and survivors. To view the public policy agenda as a .pdf, please click here.

Advocacy Program Reaches 5,000 Members: Preview of 2011

The Lymphoma Research Foundation (LRF) Advocacy program is pleased to announce that it has recently reached over 5,000 members! This January marks the beginning of the 112th Congress and LRF is looking forward to building relationships with the new members, including a number of outspoken cancer research advocates. Republicans gained 63 seats in the House of Representatives in the midterm elections in November, giving them a 242-193 majority over the Democrats, while Democrats still hold a slight majority in the Senate, with 53 seats to Republicans' 47. In total, there are 93 new Representatives and 13 new Senators. LRF advocates look forward to sharing our public policy priorities with these new Members of Congress in the coming months.

Because of this shift in power, House Republicans now control critical committee chairmanships that will affect funding for lymphoma related research.

2011 will prove to be a very important year for advocates to engage in the national discussion around cancer research. This is a critical time to discuss investment in research with our lawmakers: recent advances in the study of lymphoma have provided new insight into the etiology of the disease. It is essential that the research community is secure in their efforts to develop effective cancer prevention and treatment strategies. A loss in momentum would be devastating to the hundreds of thousands patients around the country.

Greater federal support for biomedical research at the National Institutes of Health (NIH), including significant growth in funding for the National Cancer Institute (NCI), is necessary to provide investigators with the resources they require to accelerate the progress of research that will ultimately lead to new and innovative treatments for lymphoma and other cancer types. The federal government is also in a position to support the creation and distribution of education and support materials related to lymphoma. Please join us in advocating for these important issues.

If you have not yet become a part of LRF's Advocacy Program, please do so by registering on our website or emailing advocacy@lymphoma.org. In just minutes each month, you can make a difference in the lives of people with lymphoma.

The National Insitutes of Health Town Hall Meeting

The United States Department of Health and Human Services National Insitutes of Health is presenting a National Cancer Insititue Town Hall meeting with Director Harold Varmus. On January 10th, 2011at 2:30pm EST, Dr. Varmus will report on progress since the July 2010 Town Hall meeting. The community is welcome to participate in-person or online at http://videocast.nih.gov. If you are unable to view the event live, the webcast will archived.

FDA's Oncologic Drug Advisory Committee calls for Applications

The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Oncologic Drugs Advisory Committee (ODAC) in the Center for Drug Evaluation and Research (CDER).The ODAC is a standing committee that reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and formulates recommendations to the FDA. LRF is interested in nominating a member of our Advocacy Program for the role of Consumer Representative. The role of the Consumer Representative is to represent the consumer perspective on issues and actions before the ODAC.

To qualify, a consumer representative must be able to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of products under review. It is also essential that the representative have an affiliation with and/or active participation LRF's Advocacy Program. Learn more about the ODAC here.

September 2010 Designated Blood Cancer Awareness Month

Because of the efforts of the Lymphoma Research Foundation (LRF) volunteer advocates, September 2010 was designated as Blood Cancer Awareness month by the United States House of Representatives. The resolution was passed unanimously by voice vote on September 22, 2010.

Introduced by Representatives Walter Jones (R-NC) and Betsy Markey (D-CO), the legislation (H. Res. 1433) marks the first time a federal resolution citing the needs of the blood cancer community has been passed into law. The resolution highlights the impact that the blood cancers, including lymphoma, have each year in the United States: more than 150,000 Americans are diagnosed with a blood cancer; more than 50,000 die from one of these diseases; and new cases of blood cancer comprise approximately 10 percent of all new cases of cancer.

In addition to recognizing the toll taken by this group of diseases, the resolution calls for greater support for blood cancer research and encourages studies of the cause and prevention of all types of blood cancer. The resolution states that "continued investment and innovation is critical to the early diagnosis and the more effective and safer treatment for blood cancers where research and treatment advances have to date been limited."

LRF advocates played a key role in ensuring the resolution garnered enough Congressional support to advance to the floor of the House of Representatives for a final vote, by sending hundreds of email messages to their federal lawmakers. "When I received the e-mail from the Lymphoma Research Foundation asking for help in getting the House of Representatives to designate September 2010 as Blood Cancer Awareness Month, I was happy to do my part by taking a few minutes to send a short e-mail to my Representative," shares Tom Lakritz, LRF San Francisco Chapter Advocacy Chair. "Because of my efforts and other advocates in my district, my Representative was one of the first co-sponsors of the Resolution."

The LRF Advocacy Program works with members of the lymphoma community throughout the year, into similarly urge members of Congress to increase federal funding for lymphoma research and education, and ensure access to high quality cancer care for every patient. To learn more about how you can help, register to become an advocate by visiting lymphoma.org/advocacy or e-mailing LRF staff at advocacy@lymphoma.org.

Problems with Pre-Existing Condition Coverage for Children

Because the Affordable Care Act requires insurance companies to enroll children in new plans regardless of whether they can be considered to have a pre-existing condition, a number of health insurance companies have either ended or announced their intent to discontinue providing child-only health policies. The Affordable Care Act does not have the authority to require a company to offer a specific type of policy.

However, in a letter sent on October 13th to the National Association of Insurance Commissioners, Secretary Sebelius outlined efforts by the U.S. Department of Health and Human Services (HHS), working with states, to ensure insurance companies keep their promise to "make pre-existing conditions exclusions a thing of the past" for children. Secretary Sebelius claims that the insurances companies are "reneging" on a previous commitment to continue coverage that they currently provide.

State governments that are worried about insurance companies limiting the coverage of children with pre-existing conditions have taken a number of proactive steps. Maine, Massachusetts, New Jersey, New York require that children be offered coverage regardless of status. California, Colorado, Ohio, Oregon, Washington, Michigan, and Pennsylvania either enroll children in a guaranteed issue basis (if high-risk) or establish uniform open enrollment periods when all children may request coverage regardless of status.

In addition to Secretary Sibelius's letter to insurance companies, the Obama administration said that they would allow insurers to charge higher rates for sick children than for healthy ones. Insurers "can adjust their rates based on health status until 2014, to the extent state law allows," said Jay Angoff, director of the Office of Consumer Information and Insurance Oversight at HHS.

On a country-wide level, the Pre-Existing Condition Insurance Plan (PCIP) established under the Affordable Care Act may also offer options to certain families. Details differ by state, but if children are left uninsured for six-months and have certain required documentation (such as a denial of coverage letter) they may be eligible for market-priced coverage provided under the PCIP.

The issue of child-only insurance policies will be continually debated and refined until 2014 when all children will be required to have insurance, and coverage should be easily available through non-profit or government run exchanges.

For more information, please visit http://www.healthcare.gov/law/provisions/ChildrensPCIP/childrenspcip.html.