NCI’s Bypass Budget: Join the Conversation

In two days, leaders of the nation’s cancer centers will convene in Washington, D.C. for the 2015 AACI/CCAF Annual Meeting. Cancer centers are the backbone of the country’s National Cancer Program, and as the head of communications for NCI, I’m honored to have this opportunity to blog about a very important topic affecting us all.

Peter F. Garrett, Director, NCI Office of Communications and Public Liaison

Peter F. Garrett, Director, NCI Office of Communications and Public Liaison

The Future of Funding for Cancer Research

On September 16, NCI delivered its Annual Plan and Budget Proposal for Fiscal Year 2017, or “Bypass budget,” to the President, Congress, the Office of Management and Budget (OMB), NCI’s advisory boards, the NIH and fellow HHS agencies. This year’s Bypass, also known as the Professional Judgment budget, differs from recent proposals in that acting NCI director Dr. Doug Lowy requests a seven percent funding increase, compared to 15 percent last year, and asks Congress to pledge to fund seven percent increases for each of the next ten years.

This strategic approach to double NCI’s budget by 2026 acknowledges the reality of today’s budgetary climate in Congress and the necessity of a sustained national commitment to restoring cancer research’s buying power so that we, as a nation, are able to meet the expectations of cancer patients — investing in cutting-edge research, facilitating advances across the continuum of scientific research, and supporting our most valuable resources – the cancer research community.

A New Approach to Engaging the Cancer Community 

I have also instituted a change in how the Bypass budget proposal for 2017 is presented to the community.  Rather than beginning with a printed version (still available by request), the information is being disseminated digitally, via emails and social media pointing to a web portal.  We want researchers, advocates, and others with a stake in cancer research to consider NCI’s proposals and engage in conversations—online and offline—about the strategies and opportunities we’ve outlined.

NCI wants your ideas to make this budget proposal come alive.  Discussion, debate, and engagement surrounding the topics in the Bypass Budget make it a meaningful, living proposal – the new, digital-first Bypass Budget should be more than just a page on a website, it should be the starting point for a meaningful conversation.

Your Voice is What Matters Most 

We want your input–through any communication channel (e.g. e-mail, Facebook, Twitter, etc.).  One way for you to share your ideas with us and the broader cancer community is to comment on Bypass-related blog posts that are appearing this fall (see full schedule below).

September 17: NCI Releases Budget Proposal for Fiscal Year 2017

September 24: Cancer Trends: Influencing Care and Research Priorities

October 8: Progress Against Cancer: The Role of Basic Science

October 22: Bringing Cancer Research to the Public: NCI’s Networks and Programs

November 5: A Holistic Approach to Reducing Cancer Health Disparities

November 19: Precision Medicine Part I: Understanding Precision Medicine

December 10: Precision Medicine Part II: Clinical Trials for Adults and Children

January 13: Cancer Prevention: The Best Defense

Each blog post offers a view from NCI leadership on the pivotal advances in cancer research that create key opportunities for progress.  The comment section accompanying each blog post allows you to open a dialogue with NCI and other thought leaders.

For those of you who actively participate in social media as a way of interacting with the public, we invite to join us in an upcoming Google Hangout.

Join the Conversation!

Make your voice heard. We have already engaged the community in conversations about cancer trends and the importance of basic science.  Starting today, you can comment on our Cancer Currents blog on how NCI networks, including the NCI-designated cancer centers, bring cancer research to the public. On November 2 we will host a Google Hangout about NCI networks and another one on November 10 about bioinformatics and expanding access to data. We would love for you and your colleagues to participate.

Once again, I appreciate this opportunity to write to you and I ask you to let me know if there are other ways we can facilitate better communication across the community and with the public we all serve.

Peter F. Garrett, Director, Office of Communications and Public Liaison 

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Three New Members Join AACI CRI Steering Committee

AACI congratulates the following new members of the AACI Clinical Research Initiative (CRI) Steering Committee. Each will serve a three-year term beginning September 1, 2015:

  • Rosemarie Gagliardi, Tisch Cancer Institute, Mount Sinai Medical Center
  • Jessica Moehle, BS, CCRP, Huntsman Cancer Institute, University of Utah
  • Steve Williamson, MD, University of Kansas Cancer Center
New CRI Steering Committee members (L-R) Gagliari, Moehle and Williamson.

New CRI Steering Committee Members (L-R) Gagliardi, Moehle and Williamson.

The AACI CRI is a network of cancer center clinical research leaders that examines and shares best practices that promote the efficient operation of cancer center clinical research facilities, and leverages the ability of the AACI cancer center network to advocate for improvement in the national clinical trials enterprise.

Rosemarie Gagliardi is Associate Dean of Research Services, Icahn School of Medicine at Mount Sinai;  Operations Director, Cancer Clinical Trials Office (CCTO), Tisch Cancer Institute; and Assistant Professor, Department of Population Health Science and Policy. The primary mission of the Tisch Cancer Institute Clinical Protocol and Data Monitoring (CPDM) program is to assist investigators in the development, conduct, and reporting of clinical research in an efficient, compliant and scientifically sound manner. The CPDM provides regulatory, budgeting, study management, compliance, data management and reporting services to ensure clinical research uniformity and consistency. Ms. Gagliardi serves as the CCTO Operations Director, a role established in 2011 to provide direct management of CPDM operations.

Jessica Moehle is Associate Director of Operations, Clinical Trials Office, at Huntsman Cancer Institute. She has more than ten years of clinical research experience, including directing operations for the clinical trials office overseeing a staff of 109 FTEs. Prior to this time she served as the Clinical Trials Regulatory Department Manager and specialized in project management, operational leadership, protocol development, clinical trial portfolio management, IRB regulation, IND submissions, FDA regulation, NCI National Reporting criteria, principal investigator and pharmaceutical sponsor relations, clinical trial staff hiring and training. Ms. Moehle also spent several years in pre-clinical office administration at the National Institutes of Health, Division of AIDS, and Vaccine Research Program.

Stephen Williamson is Medical Director, Clinical Trials Research Unit, and Phase I Director, at University of Kansas Cancer Center. He has been involved in clinical trials research since his oncology fellowship, starting in 1984. Dr. Williamson has been involved in clinical trial development locally and nationally through the Southwest Oncology Group (now known as SWOG). Since 1986 he has been active in the Lung, GI and Head and Neck Committees of the Southwest Oncology Group. His first multi-institutional phase II trial through SWOG was initiated in 1986 and he has been the principal investigator on multiple investigator-initiated trials at the University of Kansas, including a phase I gene therapy clinical trial utilizing irradiated autologous melanoma cells adenovirally transduced with the human GM-CSF gene.

Recess Is A Time To Promote Research

Congress may be recessed, but dialogue surrounding important legislative issues continue in the cancer community. August presents a prime opportunity to meet with your senator(s) and representative to discuss issues impacting cancer centers. If your member of Congress has not yet visited your cancer center, invite them to do so while they are home. Items worth discussing include:

• NIH Funding
• (21st Century) Cures in the Senate
• Medicare Payment Proposals Impacting Hospital Outpatient Departments
• Oral Chemotherapy Parity Legislation

NIH Funding
NIH funding remains a top priority for AACI despite a recent victory in the House with the passage of H.R. 6, the 21st Century Cures Act in July. In June, House and Senate Appropriations Committees marked up Fiscal Year (FY) 2016 spending bills in their respective Labor, Health and Human Services, and Education subcommittees and aimed to significantly increase funding for the National Institutes of Health (NIH). Talks between Republicans and Democrats stalled as July came to a close and when Congress returns after Labor Day, they must move quickly toward a budget agreement in order to avoid another government shutdown. The Fiscal Year begins October 1. Therefore, it is important that you ask your legislators to collaborate with their colleagues in order to lift the caps imposed by the Budget Control Act and support increased funding for the NIH.

Cures in the Senate
You can expect Cures discussions to heat back up when the Senate returns after Labor Day. While several leaders in the senate are looking to the biomedical research community for direction of the bill, it is important that the cancer community maintains the need for sustainable and predictable, mandatory, funding for the NIH in order to make continued progress in cancer research.

Medicare Payment Proposals Impacting Hospital Outpatient Departments
Site-neutral policy recommendations have been made recently in regard to hospital outpatient departments and physician offices, with the suggestion to equalize Medicare payments. This recommendation is of concern to our nation’s cancer centers. National Cancer Institute-designated cancer centers and academic research institutions are the primary source of new discoveries into cancer’s causes, as well as the prevention, diagnosis, and treatment of cancer.

Our nation’s cancer centers treat some of the sickest and costliest patients. A recent study prepared for the American Hospital Association determined that relative to patients treated in physician offices, cancer patients receiving care in hospital outpatient departments are often more likely to be:

• Minority or underserved patients
• Uninsured, self-pay, charity care or Medicaid patients
• Residing in areas of poverty, with lower household income and lower educational attainment
• Burdened with more severe chronic conditions and comorbidities

H.R. 2895, the Medicare Patient Access to Treatment Act, has been introduced in the House and would equalize payments between community-based cancer clinics and hospital outpatient departments. AACI strongly objects to site-neutral reimbursement proposals performed in a budget neutral manner at the expense of cancer centers and other hospital-based programs.

Oral Chemotherapy Parity Legislation
Representatives Leonard Lance (R-NJ) and Brian Higgins (D-NY) have reintroduced oral chemotherapy parity legislation, H.R. 2739, the Cancer Drug Coverage Parity Act, to require health insurance plans which cover traditional, intravenous chemotherapy drugs provide equal coverage for prescribed, orally-administered anticancer medications. They have garnered 23 cosponsors and are hoping to add additional members of Congress to the bill. Senators Mark Kirk (R-IL) and Al Franken (D-MN) introduced S. 1566, the companion bill in the senate and are also looking to add cosponsors.

If your member of Congress has co-sponsored either bill, please thank them. There are several members of Congress who have expressed interest in cosponsoring the legislation but would like to hear from their constituents. If your representative or senator has not cosponsored H.R 2739 or S. 1566, please ask them to do so, because no patient should be forced to make difficult treatment decisions based on insurance coverage.

UV Safety Month Fuels Efforts to Ban Indoor Tanning

Summer is a time for visiting beaches and sunning yourself, but July provides the opportunity to remind us of the dangers of Ultra Violet (UV) rays as we promote UV Safety Month. There is clear and compelling scientific evidence linking tanning devices with increased incidence of skin cancer, including melanoma, basal cell cancer, and squamous cell cancer. UV radiation from tanning devices has been classified as carcinogenic to humans by the World Health Organization’s International Agency for Research on Cancer. However, the popularity of indoor tanning has grown, especially among teenage girls and young women. By the age of 17, more than 35 percent of white females use tanning beds. Of those, 62 percent use them at least ten times per year. A review of seven studies discovered a 75 percent increase in risk for melanoma in those exposed to UV radiation from indoor tanning before age 35, with the risk increasing with each use. Adolescents and young adults are at even higher risk for melanoma and other forms of skin cancer with tanning device use.
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Several countries, including Australia and Brazil, prohibit indoor tanning and numerous states in the U.S. have passed restrictive legislation and thirteen states prohibit indoor tanning for people under age 18. Considering the rising incidence of skin cancer in the U.S. and the dangers associated with tanning devices, AACI, along with the Alliance of Dedicated Cancer Centers, the American Association for Cancer Research, and many other organizations in the cancer community, came out in support of a joint position statement on indoor tanning. AACI is proud to support efforts spearheaded by Alan Geller, MPH, RN, Harvard School of Public Health, and Jeff Gershenwald, MD, University of Texas MD Anderson Cancer Center, who educated policymakers about the importance of prohibiting the use of indoor tanning by minors, promoting educational efforts to effectively communicate the risks of indoor tanning to teens and their parents, and recommending that states counter-advertise to debunk the perceived ‘beauty’ of tanned skin.

Last week, Rep. Rosa DeLauro (D-CT) called on the FDA to issue a nationwide ban on indoor tanning for minors. Her call to action was just the beginning of efforts to curb the use of tanning beds across the country. UV Safety Month is a great opportunity to advocate for the ban of indoor tanning and promote UV safety.

-Carly Luk, AACI Communications Intern

Victory for Biomedical Research Community

Today, by a vote of 344-77, the House passed H.R. 6, the 21st Century Cures Act, a bill championed by the cancer community and the biomedical research community at large. Yet, this victory was not achieved without challenges. This week, the House Rules Committee approved an amendment offered by freshman Representative Dave Brat (R-VA) to make the National Institutes of Health (NIH) Innovation Fund and Cures Innovation Fund in the bill discretionary funds, rather than mandatory. The amendment threatened to derail the bill and the advocacy community fought back. The Brat amendment failed by a vote of 141-281.

The bipartisan legislation, introduced by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO), which passed the House Energy and Commerce Committee unanimously in May, garnered 230 cosponsors and gained the support of 76 AACI cancer centers. H.R. 6 creates innovation funds for the NIH and FDA that would not be available through regular budgetary procedures over the next several years. The bill prescribes mandatory funding in the amount of $8.75 billion for the NIH and $550 million for the FDA over the next five years.

The final roll call vote can be found at http://clerk.house.gov/evs/2015/roll433.xml. Please thank your legislators for supporting the bill.

AACI Cancer Centers Voice Support for H.R. 6, the 21st Century Cures Act

upton degette

U.S. Representatives Fred Upton and Diana DeGette are leading the charge for passage of the 21st Century Cures Act. Photo: Office of Congressman Fred Upton.

In a strong show of support for H.R. 6, the 21st Century Cures Act, 67 AACI cancer centers signed a letter to House Energy and Commerce Committee Chairman Upton (R-MI) and Ranking Member Diana DeGette (D-CO), thanking them for their efforts on 21st Century Cures.  The cancer centers expressed their support for the bipartisan way that Upton and DeGette united to improve and expedite the discovery, development, and delivery of care.

The cancer community was encouraged to see that H.R. 6 authorizes $1.5 billion per year in increased funding for the National Institutes of Health (NIH) over the next three years, and also language to provide an additional $10 billion in mandatory funding for the NIH Innovation Fund through Fiscal Year 2021.  Cancer centers have struggled with flat funding from the NIH and National Cancer Institute (NCI) over the last several years.

Additionally, our nation’s cancer centers voiced their approval for language included in the bill to increase funding to the U.S. Food and Drug Administration (FDA) by $550 million over five years. Predictable and sustained growth in NIH and FDA funding remains a priority for the cancer community.

AACI’s cancer centers asked Chairman Upton and Ranking Member DeGette to ensure that the NIH Innovation Fund and the Cures Innovation Fund in the bill supplement, not supplant, the regular appropriations for the NIH and FDA.

The House Energy and Commerce Committee unanimously approved the bill 51-0 on May 21 and the bill has garnered 171 cosponsors.  H.R. 6 could be brought to the House floor for a vote as early as next week.

AACI cancer centers are encouraged to contact their legislators and convey the following message(s):

  • Please cosponsor H.R. 6, the 21st Century Cures Act
  • Please vote yes on H.R. 6, the 21st Century Cures Act, when it comes to the House floor

Read the full letter submitted to Chairman Upton and Ranking Member DeGette.

Jennifer W. Pegher, AACI Government Relations Manager

House Appropriators Release Fiscal Year 2016 Proposal

Today, the House Appropriations Subcommittee on Labor, Health and Human Services, and Education released its proposed Fiscal Year (FY) 2016 funding levels for the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

The proposal calls for approximately $31.2 billion for the NIH, a $1.1 billion increase above FY 2015 levels and $100 million above President Obama’s request for the Agency. The proposal calls for an appropriation of approximately $5.081 billion for the NCI, an increase of over $131 million.  Additionally, the President’s Precision Medicine Initiative would be funded fully at the requested $200 million.

While AACI maintains that a budget of at least $32 billion is necessary in order for the NIH to restore its lost purchasing power, the subcommittee is working with $3.7 billion less in FY 2016 discretionary funding than in FY 2015. AACI continues to advocate for a proportional increase for the NCI ($5.32 billion).

Since 2003, the NIH budget has dropped over 20 percent, when accounting for inflation in the cost of biomedical research. The outlook has been just as damaging for the NCI. With excitement mounting about the scientific opportunities ahead and the potential to leverage the resulting advances to improve patient care, now is not the time to retreat from fully funding the NIH and NCI.

The broad portfolio of research supported by the NIH and NCI is essential for improving the basic understanding of diseases and has considerably improved Americans’ health. A sound investment by the federal government in cancer research has led to advances in the understanding of cancer, and to new ideas that have the potential to accelerate progress faster than ever before.

Our nation’s cancer centers continue to make strides in biomedical research thanks to the support of the federal government. Without sustainable and predictable annual budget increases for the NIH, research projects with the potential to discover breakthrough therapies would not be possible.

The subcommittee will convene on Wednesday, June 17 at 9:00 a.m. ET to consider the proposal.  You may tune in by visiting:

http://appropriations.house.gov/calendar/eventsingle.aspx?EventID=394262

Jennifer W. Pegher, AACI Government Relations Manager