Advocacy News

Please note the important advocacy news items below that are of high priority to the cutaneous lymphoma community.  We encourage you to learn more about these issues and how, together, we can affect positive change and grow support for the issues that are most important to people affected by cutaneous lymphoma.

FDA Issues Final Guidance Documents for Expanded Access Program

June 2016 - The National Organization for Rare Disorders (NORD) published a press release applauding the Food and Drug Administration (FDA) for finalizing its efforts to streamline the process used by patients and their physicians seeking expanded access to investigational new drugs and biologics.

The FDA's release of the final Individual Patient Expanded Access Investigational New Drug Application - Form FDA 3926 - can be used by physicians to request expanded access, often referred to as “compassionate use,” for patients suffering from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available. The shortened form reduces the time to completion from hours to only 45 minutes; a drastic improvement in alleviating the burden on patients and their physicians.  To provide further clarity, step-by-step instructions have also been provided for completing the new form.  

In addition, the FDA also released two additional final guidance documents outlining what expanded access is, when and how to request it, and the type of information required to do so.  The other provides regulations on how patients may be charged for investigational new drugs.

NORD submitted comments to the FDA on the Individual Patient Expanded Access Application: Form FDA 3926 in April 2015 outlining its enthusiastic support for the creation of a unique form tailored specifically to individual patient expanded access requests.  You can review NORD's submission here.

The Cutaneous Lymphoma Foundation is a member of NORD and is included as a member in these responses.

CSC Comments on Proposed Medicare Part B Drug Payment Model

In June, the Cancer Support Community Cancer Policy Institute (CPI) submitted a comment letter in response to the Centers for Medicare and Medicaid Services (CMS) proposed Medicare Part B drug payment demonstration program. The CPI held a webinar in early April about the proposed changes and the impact to patients. To review the webinar on the Part B proposed rule, please click here.

This proposed change will have a direct impact on cancer patients. Medicare Part B covers outpatient chemotherapy treatments typically received in a clinic or in a doctor’s office. This proposal would modify the formula that determines how physicians are reimbursed for these treatments.  Currently, physicians are reimbursed under Medicare Part B for the average sale price (ASP) of the drug plus an additional percentage of the drug’s cost. Under the proposed change, physicians would be reimbursed the ASP plus a lower percentage rate and would also receive an additional flat fee.

Throughout their letter the CPI stressed the importance of including the patient voice and patient stakeholders in the development of all policies and proposals that impact patient care. They also asked CMS to consider the burdens that could be placed on patients as a result of this change.

View/Download CSC's Comment Letter: CMS Part B Proposed Rule CSC Comments.pdf

As the largest professionally led nonprofit network of cancer support worldwide, the Cancer Support Community (CSC) is dedicated to ensuring that all people impacted by cancer are empowered by knowledge, strengthened by action and sustained by community.

Action Alert: Stop Medicare from Getting Between Patients and Their Doctors!

The voice of the cutaneous lymphoma community and other patient stakeholders will be essential in urging Congress to stop Medicare from setting up a new reimbursement model that could significantly undermine the ability of patients and doctors to choose the most appropriate treatment method.

Click here to learn how you can help!

Medicare's Flawed Part B Drug Experiment Could Harm Patients - Editorial

April 2016 - Editorial by Rose Gerber concerning patients' need for flexibilty to change treatments when appropriate and how that flexibility is at risk.

Click here to read Ms. Gerber's article published on the Morning Consult (

Rose Gerber is the director of patient advocacy and education at the Community Oncology Alliance (COA) and leads the COA Patient Advocacy Network (CPAN), a national network representing all members of the cancer community and advocating for access to local, affordable cancer care.

FDA Regulation on Laboratory Developed Tests (LDTs)

April 2016 - The Cutaneous Lymphoma Foundation joined with other stakeholders to send letters to the Chairs and Ranking Members in the House and Senate on both Appropriations Committees and Agriculture/FDA Subcommittees encouraging them to support FDA regulations of LDTs.

FDA involvement in LDTs is important because:

  • The FDA has track record of exercising regulatory flexibility to bring new technologies to patients in a timely manner; and
  • The FDA can effectively fill current gaps in oversight that have led to uncertainty surround the quality of some tests

Click here to read the letter to the House Members.

One Voice Against Cancer Fact Sheets

One Voice Against Cancer (OVAC) is a collaboration of non-profit organizations whose purpose is to advocate as "one voice" on behalf of those affected by cancer to make Congress and the White House aware of issues related to a cancer diagnosis and the need for increased spending for cancer research. Click here to learn more about OVAC's purpose and current stance on cancer research.

Help FDA Help Patients Have A Bigger Voice: The New Patient Network Website

Want your voice heard concerning the FDA's regulation of medical products? Visit the FDA's new Patient Network website!

With their new website, the FDA welcomes the unique perspective of patients, family members, caregivers and patient advocates directly affected by serious disease, to the Agency’s decision-making processes. Get involved....your voice counts!

Advocacy - Why Are You Asked To Take Action So Many Times?

Ever wonder why you may be asked to frequently contact your congressional representative on the same bill? Truth is, Congress can vote on a bill five times before it becomes law. Why five times? And, why is it so important for you to act each time? Watch the American Cancer Society 90-second video to explain it all.

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