Policy Letters Written or Signed by Children’s Cancer Cause
117th Congress (2021-2022)
October 2022
Accelerating Kids’ Access to Care Act: A community letter urging Congressional leadership to pass the Accelerating Kids’ Access to Care Act (H.R. 3089/S. 1544) in an end-of-year package this year.
This bill enjoys strong bipartisan support and is cosponsored by more than 90 House members and by more than 20 Senators. It has received technical assistance (TA) from CMS and the Department of Health and Human Services, and a modified version of the legislation to reflect the TA was included in the Senate Finance Committee’s youth mental health draft legislation. We are grateful for this progress and hope this legislation will be enacted this year. Our organizations advocate or directly care for children with complex health conditions, including children on Medicaid and CHIP. We understand the importance of having access to specialized care, including care that may be located in another state.
September 2022
Clinical Trial Coverage Act of 2022: An Alliance for Childhood Cancer letter to Reps. Jackie Speier and Michael McCaul endorsing H.R. 8546, the Clinical Trial Coverage Act of 2022.
For many childhood cancer patients, clinical trials provide the best or only treatment option available and appropriate for their condition. The Clinical Trial Coverage Act would reduce [a] financial barrier by requiring insurers to cover out-of-network routine care for a clinical trial if the provider operating the trial is not in-network. Reducing this barrier will increase access for children to participate in clinical trials, which will advance better treatments and outcomes for patients with childhood cancer.
August 2022
Kids First 2.0: A Coalition Against Childhood Cancer letter urging the Senate to adopt the House passed language of House Bill 623 and pass the Gabriella Miller Kids First Act 2.0.
The Gabriella Miller Kids First Act 2.0 authorizes continued resources to improve treatment of childhood cancer by advancing the research that brings us closer to finding a cure.
September as Childhood Cancer Awareness Month: An Alliance for Childhood Cancer letter thanking Senator Joe Manchin for introducing a resolution to designate September 2022 as “Childhood Cancer Awareness Month.”
Despite some progress, research in the pediatric cancer space has yet to meet the complex medical needs of children with cancer and their families, which is why we are heartened by your willingness to take action. By introducing a resolution commemorating Childhood Cancer Awareness Month, you and your colleagues are raising awareness and encouraging research into cures for pediatric cancers.
July 2022
Diversity in Clinical Trials: A joint letter signed by 71 organizations addressing the need for inclusion of clinical trial diversity policies in the final FDA User Fee Act package.
We are grateful for Congress’ affirmation of the importance of clinical trial diversity through provisions already included in the House-passed version of PDUFA as well as within the PREVENT Pandemics Act. Congress now has the opportunity to ensure these provisions become law by including them in the final PDUFA reauthorization.
June 2022
Retaining Access and Restoring Exclusivity (RARE) Act: A joint letter signed by 85 organizations to Senate HELP Committee leadership urging the incorporation of S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act, into the FDA Safety and Landmark Advancements Act (FDASLA).
Our organizations are deeply concerned that a decision from a recent court case, if not corrected by the enactment of the RARE Act, could hinder continued progress in rare disease drug development. The implications of this case could leave some rare disease patients, including children or those with less common variations of a rare disease, without access to an FDA approved treatment that has been proven to be safe and effective for their specific circumstances and/or condition.
May 2022
Medicare Multi-Cancer Early Detection Screening Coverage Act: A Prevent Cancer Foundation letter conveying support for the Medicare Multi-Cancer Early Detection Screening Coverage Act (S. 1873 and H.R. 1946), due to its enormous potential benefits, both human and economic.
Today, routine screening is reimbursed for only five types of cancer—breast, cervical, colorectal, prostate, and lung cancer (only in high-risk individuals for lung). That leaves the vast majority of cancers without available screening tests and those cases account for nearly three of every four cancer deaths in the United States each year. The data also show that cancer takes a disproportionate toll on communities of color and rural Americans. The imperative is clear: we must expand our ability to screen for and detect more cancers.
April 2022
Fiscal Year 2023 Appropriations: An Alliance for Childhood Cancer letter outlining community priorities for the FY2023 appropriations cycle, including full funding for the Childhood Cancer STAR Act and the Childhood Cancer Data Initiative.
We join with the leading national cancer organizations in requesting at least $49.048 billion for National Institutes of Health (NIH) in FY23, including $7.766 billion for cancer research at the National Cancer Institute (NCI).
February 2022
Pediatricians Accelerate Childhood Therapies Act (PACT Act): An Alliance for Childhood Cancer letter endorsing the PACT Act (H.R.3773/S.1357).
The PACT Act recognizes the challenges associated with attracting and retaining early-career researchers, including physician-scientists, to careers in pediatric research. The PACT Act addresses these issues by creating a new Trans-NIH career development award focused on early-career pediatric researchers. This bipartisan legislation would also authorize a process to better coordinate and manage the pediatric research portfolio at the National Institutes of Health (NIH), including prioritizing research topic areas and working to align these efforts with the important research currently underway at NIH, including critical childhood cancer research.
Prescription Drug User Fee Act Agreement (PDUFA VII): An Alliance for Childhood Cancer letter providing analysis and policy recommendations for inclusion in the upcoming reauthorization of PDUFA, addressing fiscal years 2023-2027.
The pharmaceutical industry is market-driven, and as such, there is more incentive to develop drugs for certain diseases than others. Childhood cancer provides little market incentive for the pharmaceutical industry to develop pediatric oncology drugs because the population of those impacted is comparatively small. Therefore, current treatments for children were developed decades ago for adults and were not based on modern understanding of the biology of pediatric cancers. With these challenges in mind, the Alliance for Childhood Cancer puts forward the following policy recommendations:
Recommendation 1: Ensure the Successful Implementation of the RACE for Children Act Through Appropriate FDA Resourcing
Recommendation 2: Congress Must Ensure that RACE Studies are Completed on Time: Congress should address the problem of delinquent pediatric studies now to ensure that it does not later become a problem with RACE Act studies. FDA needs the authority to penalize companies that do not complete their required pediatric studies.
Recommendation 3: Authorize a New Public-Private Partnership to Develop Drugs for Rare Pediatric Cancers: The Alliance recommends that Congress create a PPP to assume responsibility for conducting pediatric oncology drug development programs that may not be commercially advantageous for industry to develop on its own, bringing precision oncology and hope to children with many rare types of cancer.
Fiscal Year 2022 Spending Bill: A One Voice Against Cancer (OVAC) coalition letter urging Appropriations leaders to pass a fiscal year 2022 spending package as soon as possible.
As you know, the fiscal year is already one-third over, and additional continuing resolutions (CRs) beyond February 18 will create even more uncertainty for cancer research, prevention, and treatment programs, which have already suffered throughout the COVID-19 pandemic.
January 2022
Accelerating Kids’ Access to Care Act: A community letter in support of the Accelerating Kids’ Access to Care Act (HR 3089 / S 1544), which aims to improve access to care for children with cancer that are enrolled in Medicaid. This bipartisan legislation recognizes that children may need to receive care from providers outside of their home state and simplifies the Medicaid out-of-state provider enrollment process.
Many times, the best treatment for children with cancer requires out-of-state travel coupled with substantial coordination between the child’s family and their care team. In such cases, the State Medicaid Agency and/or Medicaid Managed Care Organization works with the child’s health care provider to approve the child for treatment out-of-state. For the child to be approved for out-of-state care, the out-of-state provider—or sometimes an entire care team—must be screened and subsequently enrolled in the Medicaid program where the child resides. While states do have the ability to use provider screenings done by other states or by Medicare, there exists no formal process to facilitate a streamlined screening, meaning that providers regularly spend an immense amount of time to address enrollment requirements, which vary significantly by state. When this occurs, access to care is delayed and, in some cases, the child’s cancer can worsen.
December 2021
Cures 2.0: A Children’s Cancer Cause letter thanking Representatives Diana DeGette and Fred Upton for the introduction of H.R. 6000, The CURES 2.0 Act. We believe H.R. 6000 addresses many of the individual needs of the pediatric cancer community and are pleased to share our specific comments in this letter.
Of particular note, we are pleased that the bill included Section 407, Precision Medicine Answers for Kids Today. This provision specifically addresses the rare disease needs of children with cancer. Genomic tests used to make cancer treatment decisions for children are not covered by insurance. Additionally, tests used in determine germline sequencing are also not paid for unless they are part of a research study. H.R. 6000 addresses this problem through a 15-state demonstration program to evaluate new coverage in this area which specifies coverage of “hereditary cancer testing in the presence of a suspected or confirmed cancer diagnosis.”
We also support the inclusion of Section 501 which authorizes $6.5 billion to create the Advanced Research Projects Agency for Health within NIH. The mission of ARPA-H will be to transform and improve important areas of medicine and health by funding projects that could overcome market failures through critical solutions and complement NIH’s existing research portfolio and mission and the private sector’s research initiatives. We hope to work with you on the creation, within ARPA-H, of a new public private partnership that assumes responsibility for conducting pediatric oncology drug development programs when such programs are not pursued by industry. By including such a public-private partnership in its authorizing section, the partnership could rapidly advance the development of emerging pediatric oncology therapies.
September 2021
Accelerating Kids’ Access to Care Act: An Alliance for Childhood Cancer letter in support of the Accelerating Kids’ Access to Care Act (HR 3089 / S 1544), which aims to improve access to care for children with cancer that are enrolled in Medicaid. This bipartisan legislation recognizes that children may need to receive care from providers outside of their home state and simplifies the Medicaid out-of-state provider enrollment process.
For children with complex medical needs such as cancer, patients are routinely required to travel out of state to receive care from a specific specialist or care team. About 40 percent of children in the United States rely on Medicaid and CHIP as their central sources of health care coverage, but Medicaid and CHIP coverage is limited to providers in a child’s home state. Under current requirements, if a child’s medical condition requires them to obtain care from an out-of-state provider or an out-of-state care team, the provider must go through the screening and enrollment process in the child's home state Medicaid program. This process causes burdensome, unnecessary delays in providing time-sensitive care and can unfortunately cause a child's condition to worsen.
July 2021
Gabriella Miller Kids First Research Act 2.0: An Alliance for Childhood Cancer letter endorsing S. 1521, the Gabriella Miller Kids First Research Act 2.0.
Despite initial progress, research in the pediatric cancer space has yet to meet the complex medical needs of children and their families, which is why we are heartened by your willingness to take action. The Gabriella Miller Kids First Act 2.0 will build upon the initial successes of the original Gabriella Miller Kids First Act, enacted in 2014, which has invested $75 million in childhood cancer research and is expected to fund another $50 million before it sunsets in 2023. The updated legislation will expand the Kids First Program, which supports collaborative research to uncover the genetic etiology of childhood cancer and structural birth defects. The Kids First Program holds promise to facilitate more refined diagnostic capabilities and ultimately more targeted therapies or interventions.
June 2021
AHRQ Report on Models of Care: A Children’s Cancer Cause letter with comments and recommendations to the Agency for Healthcare Research and Quality, in response to the draft report Models of Care that Include Primary Care for Adult Survivors of Childhood Cancer: A Realist Review. The report supports a major goal of Children’s Cancer Cause - the authorization of a Center for Medicare and Medicaid (CMMI) demonstration program to develop standards of care based on COG guidelines for survivors of childhood cancer with a focus on scalable models across the United States. We submitted with our comments a proposal that we recommend as a strategy to overcome barriers to survivorship care: the Child and Adolescent Cancer Survivorship Transition (CAST) Model.
Accelerating Kids’ Access to Care Act: A Children’s Cancer Cause letter seeking support of bipartisan legislation that aims to improve access to care for children with cancer that are enrolled in Medicaid.
Currently, if a child enrolled in Medicaid needs to see a provider outside of their home state, the out-of-state provider must first be screened and enrolled in the child's home state Medicaid program, despite already being enrolled within their own state's Medicaid program. This process could delay a child's access to care - care that could not be met by an in-state provider. Children with cancer have encountered this situation sometimes after travelling to another state for time sensitive care.
The Accelerating Kids' Access to Care Act will create a national enrollment pathway to help alleviate the administrative burden on providers and ensure that children with cancer are able to receive out-of-state care when they need it.
April 2021
FY2022 Appropriations: An Alliance for Childhood Cancer letter to appropriations leaders expressing funding priorities for FY2022, joining with leading national cancer organizations in requesting at least $46.111 billion for the National Institutes of Health (NIH), including $7.609 billion for cancer research at the National Cancer Institute (NCI). The letter also seeks funding for specific programs related to childhood cancer, including the STAR Act and the Childhood Cancer Data Initiative.
Within these funds, we are committed to working with Congress and the NIH to ensure that childhood cancer becomes a higher priority. Each year in the U.S. an estimated 15,780 children are diagnosed with cancer. Approximately 1 in 264 children in the U.S. are diagnosed with cancer before their 20th birthday. Annually there are more than 300,000 children diagnosed with cancer worldwide. Unfortunately, cancer remains the most common cause of death by disease for children in America.
DoD Peer Reviewed Cancer Research Program: An Alliance for Childhood Cancer letter to the Chairman and Ranking Member of the House Appropriations Subcommittee on Defense expressing support for a $130 million increase for the Department of Defense’s Peer Reviewed Cancer Research Program (PRCRP) and the continued inclusion of pediatric, adolescent and young adult cancers, pediatric brain tumors, neuroblastoma, sarcomas, germ cell cancers, blood cancers, lymphomas, and thyroid cancer as eligible topics of funding in FY2022.
We firmly believe that an increase in the FY22 PRCRP budget will result in marked progress in understanding the nature and treatment of childhood cancers. The lives of many children, adolescents and young adults depend on vigorous and innovative research programs like PRCRP to combat these diseases.
March 2021
CURES 2.0: A Children’s Cancer Cause letter sent to Representatives DeGette and Upton applauding their leadership in the creation of 21st CENTURY CURES 2.0 and expressing support for its advancement. We offered comments on the sections of the draft framework that relate to pediatric cancer.
Americans are living longer with cancer, resulting in larger numbers of cancer survivors in the United States. The nation’s 500,000 pediatric cancer survivors are uniquely affected because of late effects of cancer treatment. Over 80% of childhood cancer survivors will have at least one severe, disabling, or life-threatening late effect of their disease or treatment by the time they reach 45 years of age. At the conclusion of active treatment, survivors should receive information that includes a summary of their treatment, potential risk for late effects that are associated with their treatment, and recommendations for follow up care. We believe attention to survivorship care, which is often not covered by insurance, is an essential component of improved health literacy. A recent AHRQ report likened impediments to getting survivorship care as a system inequity because childhood cancer survivors often lack literacy about their needs when they leave the active phase of cancer treatment.
RISE Act: An Alliance for Childhood Cancer letter to Members of Congress endorsing the Research Investment to Spark the Economy (RISE) Act (H.R.869/S.289).
The RISE Act provides $25 billion, including $10 billion for the National Institutes of Health, in needed relief to support independent research institutions, public laboratories, and universities throughout the country as well as provide needed regulatory flexibility so they can continue their work. The COVID-19 pandemic has caused severe disruptions to federally-backed research, including pediatric cancer research. Due to federal guidelines adherence, many laboratories have been forced to minimize operations beyond “essential” work, delay research already underway, and postpone planned projects. These disturbances have created additional expenses for research institutions and supplemental funding is needed to offset these costs.
We also signed a ResearchAmerica! coalition letter around the RISE Act, sent to President Biden.
Beyond the immediate damaging financial losses at the local, state, and federal levels, the long-term repercussions of interrupted research mean that future scientific innovations and discoveries will be squandered or severely delayed. Whether the measure is societal progress, our nation’s ability to preempt and respond to threats like COVID-19, potential lives saved, or U.S. economic competitiveness, failing to shore up our weakened research infrastructure contravenes the best interests of the American people.
Kids First 2.0: An Alliance for Childhood Cancer letter to Members of Congress expressing support for the Gabriella Miller Kids First Research Act 2.0 (H.R.623).
The Gabriella Miller Kids First Act 2.0 will build upon the successes of the original Gabriella Miller Kids First Act, enacted in 2014, which has invested $75 million in childhood cancer research and is expected to fund another $50 million before it sunsets in 2023. Further, the Act will expand the Kids First Program, which supports collaborative research to uncover the genetic etiology of childhood cancer and structural birth defects. The Kids First Program holds promise to facilitate more refined diagnostic capabilities and ultimately more targeted therapies or interventions.
February 2021
Medicare Part D Payment Modernization Models: An ACS-CAN coalition letter sent to staff members of HHS Designee Becerra, the White House, and Congressional committee staff about proposed policy changes made by the outgoing Trump Administration that could jeopardize beneficiary access to medically necessary prescription drugs and harm patients with serious illness.
Given the potential harm to the populations we serve, we urge the Department to not move forward with either of these new flexibilities and rescind the proposed policy change by the previous administration. These changes could result in cost-shifting to beneficiaries and could jeopardize vulnerable beneficiaries’ access to medically necessary prescription drugs for patients with serious illness such as cancer, HIV/AIDS, epilepsy, mental health issues, and transplant patients.
January 2021
COVID-19 Vaccine Prioritization: A Cancer Leadership Council Letter to the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention urging consideration of COVID-19 risks to cancer patients and survivors when issuing recommendations around vaccine prioritization.
Cancer patients, including not only those in active treatment but also those with a history of cancer, are at risk of poor outcomes from COVID-19. Cancer survivors, including those just beginning treatment, those with advanced metastatic disease, and those who are in long-term survivorship care, are eager to receive the protection of COVID-19 vaccines. We encourage you to review the emerging data related to the risks that COVID-19 poses to cancer survivors – from diagnosis through treatment and survivorship -- as you monitor and update the immunization schedule and evaluate the states’ flexible use of the schedule.
116th Congress (2019-2020)
November 2020
Childhood Cancer Funding: An Alliance for Childhood Cancer letter to Appropriations leadership urging strong support for the NIH, NCI, the Childhood Cancer STAR Act, and the Childhood Cancer Data Initiative in the final funding agreement for FY2021.
We are grateful at the strong support that both the House and Senate have provided for childhood cancer funding, especially funding for the Childhood Cancer STAR Act…
We are extremely pleased that both the Senate and House have provided significant increases in funding to the National Institutes of Health (NIH) and the National Cancer Institute (NCI). We join with the leading national cancer organizations in requesting that you provide the largest possible increase in the final appropriations agreement.
NIH Appropriations: An OVAC letter to Appropriations leadership requesting at least $43.68 billion for the National Institutes of Health (NIH) and $6.72 billion for the National Cancer Institute (NCI) in any final FY 2021 Labor, Health and Human Services, and Education, and Related Agencies (LHHS) Appropriations bill.
Additionally, we urge you to provide at least $559 million, OVAC’s recommended level for cancer programs at the Centers for Disease Control and Prevention. We also urge you to provide at least $15.5 billion in emergency supplemental funding to the NIH as suggested by NIH Director Dr. Francis Collins during recent Senate testimony. This emergency funding will be used to ensure that biomedical research and clinical trials impacted by the COVID-19 pandemic can be restarted when safe to do so and for research related to COVID-19.
October 2020
CLINICAL TREATMENT Act: An Alliance for Childhood Cancer letter endorsing H.R. 913/S. 4742, the CLINICAL TREATMENT Act.
The CLINICAL TREATMENT Act would ensure that all routine care costs of clinical trial participation are covered for Medicaid enrollees with life-threatening conditions, like cancer. Routine care costs include the non-experimental costs of treating a patient who is participating in a clinical trial, such as the cost of laboratory tests, supportive care, or physician office visits. These costs are part of the standard of care and would be incurred regardless of whether a patient participates in a clinical trial.
July 2020
COVID Relief Package and Access to Cancer Care: A community letter to Congressional leaders requesting that the next COVID legislative package addresses barriers to patient access to care and coverage during the current public health crisis, including oral chemo parity, prescription drug refills, health insurance coverage, clinical trials, and an adequate PPE supply for oncology providers.
Substantial costs have been incurred for the shut-down, and there will be significant costs for the eventual ramp-up of research activities. We therefore urge Congress to provide the National Institutes of Health (NIH) with at least $10 billion in the next emergency package to ensure that the research ecosystem is restored and we continue to make progress in the fight against cancer and other diseases. Once again, thank you for your continued leadership on issues important in the fight against cancer. We look forward to working with you to ensure that cancer patients and survivors are considered as you negotiate the next legislative package addressing COVID.
June 2020
Pandemic Preparedness, including Testing and Telehealth: A Cancer Leadership Council letter to Health Committee Chairman Lamar Alexander on recommendations related to uninterrupted cancer care during a pandemic, access to telehealth, and accurate public health communications about future infectious diseases. The letter also addresses racial disparities in the COVID pandemic.
The tale of cancer care during the COVID-19 pandemic is one of disruption, innovation, and restoration of care for many, but not for all. When providers were instructed to delay elective care, that triggered an evaluation of what cancer care could be safely delayed and what care should proceed even in the pandemic. The pandemic triggered evaluation and innovation regarding how to care for cancer patients safely and how to protect the cancer care workforce.
COVID-19 & Expanding Paid Leave: A Cancer Leadership Council letter commending the Centers for Medicare & Medicaid Services (CMS) for providing flexibilities to health care professionals, institutions, and patients during the COVID-19 pandemic and offering additional suggestions regarding telehealth and home care.
Although oncology practices of all sizes and types are adapting to the COVID-19 public health emergency to protect patient access to care, practices report significant practice, personal, and financial strains. Adapting to telehealth, even though a positive for protecting access to care, has created some strain on practices. Modifications of processes and procedures in practices result in seeing fewer patients, and of course some patients are being advised to delay care for reasons related to coronavirus. Oncology practices are already “different” than they were before the public health emergency, and those differences are creating stress for many. We appreciate CMS’ efforts to support oncology practices financially during this time of need and encourage the Agency to continue taking steps to shore up oncology clinics to preserve cancer patient access to care.
Many patients, providers, and health care reformers are looking for the silver lining in the public health emergency and see the opportunity for reform and rejuvenation of health care – including cancer care – as the COVID-19 emergency lessens in its urgency. CMS has shown its ability to move quickly and creatively in its regulatory actions to provide flexibility to health care providers and patients during the COVID-19 emergency. We urge you to bring that same attitude to reforms after COVID and to collaborate not only with providers but also with patients and patient advocates to strengthen our health care system after the coronavirus crisis.
April 2020
COVID-19 & Expanding Paid Leave: A community letter urging Congressional leaders to act swiftly to support people who are most vulnerable to adverse outcomes from COVID-19 by expanding paid family and medical leave for people with chronic health conditions and working members of their household. This policy is needed to allow those at highest risk of complications from COVID-19 to remain home for the duration of the pandemic.
Currently, paid family medical leave provides support only to those with children or adults with disabilities whose local school district or usual care providers are closed due to the pandemic. This policy does not go far enough. The hardworking Americans who have been advised by the CDC to remain home are only eligible for up to two weeks of financial support and job protection of expanded paid sick leave. This places individuals who live with significant health conditions such as cystic fibrosis, cancer, diabetes, heart disease, organ transplants, sickle cell and others with a devastating choice: place their health or their loved one’s health at risk by going back to work or lose their jobs altogether. Additionally, adults living with family members who are immunocompromised also need access to this support to help protect these vulnerable Americans.
COVID-19 & Cancer Care: A community letter to Congressional leaders regarding action Congress should take to ensure continuity of care for people with cancer and survivors. The letter asks Congress to consider, as part of the next COVIC-19 legislative package, incorporating patient priorities, including: adopting the Cancer Drug Parity Act; allowing a beneficiary to obtain a 90-day supply of prescription medication; creating a special enrollment period for healthcare.gov; increasing funding for state Medicaid programs; providing assistance to people who have lost employer-sponsored coverage; alleviating the PPE shortage; and providing NIH with additional funding and extra flexibility regarding clinical trials.
In addition to the real risks associated with COVID-19 for all people, those impacted by cancer may be at heightened risk due to their compromised immune systems as well as the potential delays in treatment and care. Many of these patients rely on a strong safety net in the best of times to ensure access to affordable and comprehensive cancer care. The need to reinforce and even build upon that safety net has never been more urgent. Our organizations greatly appreciate the policy changes made to date in response to the COVID crisis, and we look forward to working with you to further ensure that cancer patients and survivors have access to the treatment they need.
February 2020
CLINICAL TREATMENT Act: A community letter urging Congressional leaders to include the CLINICAL TREATMENT Act (H.R.913) among the healthcare priorities Congress addresses this spring as the expiration of some healthcare extenders approaches. H.R.913 would ensure states cover routine care costs of participation in an approved clinical trial for Medicaid enrollees with life-threatening conditions.
Medicaid insures nearly one-fifth of the US population and is the only major payer that is not required by federal law to cover routine costs associated with participation in clinical trials. This coverage is already assured for Medicare beneficiaries and for patients with private health insurance. Although eleven states require their Medicaid programs to cover these costs, there are still as many as 42.2 million Medicaid patients that are potentially without this needed coverage.
January 2020
Modern Labeling Act: A community letter to the House Energy and Commerce Committee in support of the MODERN Labeling Act, which addresses a discrepancy that can occur when new scientific information relevant to a drug’s indication is not incorporated into its label. This bill would ensure the FDA can update outdated labels and protect patients across the country.
Patients and their caregivers, physicians, and nurses, need high quality sources of information about the prescription drugs they use, and that means up-to-date drug labels. While many sources of information exist, none can deliver as strong assurances of reliability and scientific accuracy as FDA-approved product labels.
December 2019
Cures 2.0: A Children’s Cancer Cause letter seeking childhood cancer inclusion in Cures 2.0 provisions, including:
Survivorship: We recommend several improvements in digital technology and data collection;
Clinical Trials: We recommend that Cures 2.0 legislation include the CLINICAL TREATMENT Act, and we recommend the NCI be charged with testing models of family caregiver support in coordination with CMS.
Pediatric Cancer Drug Shortages: We support legislative action on drug shortages, including the Mitigating Emergency Drug Shortages (MEDS) Act.
Affordable Care Act (Texas v. United States): A Cancer Leadership Council letter regarding the Fifth Circuit Court of Appeals opinion (2-1) affirming a district court decision finding the individual mandate of the Affordable Care Act unconstitutional.
We are deeply concerned about the uncertainty that is created by the pending litigation and that has already affected the implementation and administration of the ACA. We will continue to express to lawmakers the need to affirm their support for the patient protections of the ACA, the subsidies that help many Americans purchase insurance, and access to Medicaid for many.
Cures 2.0: A Cancer Leadership Council letter offering comment on Cures 2.0, an effort to modernize coverage and access to life-saving cures.
Some of our organizations have the word “cures” in our names, and all of us share a dedication to finding and making cancer cures accessible to Americans. Until we have cures for all cancers, our mission must also include providing the best possible care to people with cancer, boosting the quality of care they receive and the quality of life they experience after a cancer diagnosis. In our comments, we embrace this expansive view of cures and quality care.
Oncology Care First Model: A Cancer Leadership Council letter offering comment on the CMS Oncology Care First model, stressing the need to ensure that the model includes adequate resources to protect the quality of cancer care.
Medical Expense Savings Act (S.110): A coalition letter requesting co-sponsorship for bipartisan legislation that would make permanent the 7.5 percent threshold for the medical expense deduction.
Without action, 4.4 million Americans with high medical costs will face an unexpected tax increase when they file their returns in the coming months.
FDA Commissioner Nomination: A Cancer Leadership Council letter expressing support for Dr. Stephen Hahn’s nomination as the next Commissioner of the Food and Drug Administration.
Some of us have worked with Dr. Hahn for years as a result of his volunteer leadership of cancer organizations, and others have more recently become acquainted with him. We all support him because of his focus on patients, commitment to public health, and pledge to honor science-based decision-making. His record in cancer clinical care, clinical research, and institutional leadership prepares him well to lead FDA. We are especially concerned about attracting and retaining a stellar FDA staff, and we believe that Dr. Hahn can provide leadership on FDA staffing matters.
November 2019
Next Generation Sequencing (NGS) for Medicare Beneficiaries: A Cancer Leadership Council letter commenting on a Proposed Decision Memo around proposed revisions to previously defined Next Generation Sequencing standards.
The language of the initial coverage memo referenced the use of NGS technology in patients with “recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer.” This system of staging is not appropriate for hematological malignancies, and as a result coverage for somatic or germline testing for these beneficiaries is unclear. We urge CMS to clarify the language of the decision memo so that there is no question about the utilization of NGS technology for beneficiaries with hematological malignancies.
We appreciate the willingness of CMS to consider and respond to input from cancer stakeholders regarding coverage of NGS technology. With the modifications of the coverage decision memo recommended above and by others in their comments to the agency, we believe that CMS can achieve an appropriate coverage standard for somatic and germline testing.
October 2019
Institute for Clinical and Economic Review (ICER) Value Framework: A Cancer Leadership Council letter commenting on the 2020 update to the ICER Value Framework, providing recommendations on changes to certain provisions to ensure meaningful patient input.
September 2019
Proposed Changes to Hospital Outpatient Prospective Payment: A Cancer Leadership Council letter commenting on the hospital outpatient prospective payment system proposed rule for calendar year 2020 and offering advice regarding provisions of the rule that may affect cancer patient access to quality health care.
Creating Hope Reauthorization Act of 2019: An Alliance for Childhood Cancer letter endorsing the Creating Hope Reauthorization Act of 2019 (H.R.4439).
The Creating Hope Act Reauthorization Act of 2019 would permanently reauthorize this important program that expands treatment options for children with cancer and their families and continues to advance the research that brings us closer to curing childhood cancers.
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Proposed Revisions to Physician Fee Schedule: A Cancer Leadership Council letter commenting on proposed revisions to the physician fee schedule for calendar year 2020.
FDA Commissioner: A community letter expressing support for Dr. Norman Sharpless to be the next Commissioner of the Food and Drug Administration.
Dr. Sharpless has been an extraordinarily strong and respected leader throughout his impressive career, including as the Director of the National Cancer Institute, Director of the UNC Lineberger Comprehensive Cancer Center, and as a practicing oncologist specializing in leukemia.
June 2019
Healthcare Cost Legislation: A Cancer Leadership Council letter to Senate HELP Committee leaders offering comment on bipartisan draft legislation to reduce health care costs. The CLC letter includes comments on surprise medical bills, lowering prescription drug costs, transparency in the health care market, and leading healthier lives.
Financial toxicity has been added to the list of serious side effects of cancer treatment, with patients all too often struggling to manage the cost-sharing for all elements of complex multi-disciplinary care. Among those responsibilities are cost-sharing amounts for expensive medicines that can improve quality of life, extend survival, and even prove life-saving. We are pleased that the bipartisan package that you have offered would take steps to encourage competition in drug markets.
Consumer Inflation Measure: A Cancer Leadership Council letter to the Office of Management and Budget expressing concerns about the initials steps taken by the OMB to adopt a new index for inflation adjustment in programs operating under current poverty guidelines.
Changing the inflation rate index may cause vulnerable cancer patients to face even greater challenges in affording their health care, addressing their food insecurity, and managing their households.
Patient Access to CAR-T Therapy: A Cancer Leadership Council letter to the Centers for Medicare & Medicaid Services commenting on the hospital inpatient prospective payment system (IPPS) update for FY2020. The letter focuses on improvements in the payments for CAR-T therapy and its administration and offers advice aimed at improving patient access to CAR-T therapy.
We urge CMS to seek the input of patients who have received CAR T-cell therapy, in trials and after approval, regarding the administration of the therapy and management of side effects and for advice about how the treatment experience might be structured and financed.
We appreciate the opportunity to comment on the reimbursement for CAR T-cell therapy and its administration, and we look forward to ongoing discussion with CMS regarding innovative ways to pay for this groundbreaking therapy.
May 2019
VACCINES Act of 2019: A community letter led by the American Academy of Pediatrics urging Congress to sign on to the VACCINES Act of 2019, which would help track vaccination rates, combat vaccine hesitancy and misinformation, and authorize a public campaign to highlight the importance of vaccines.
The recent uptick in the number of unvaccinated children around the country is largely due to a rise in the spread of vaccine misinformation and vaccine hesitancy, which the World Health Organization (WHO) deemed one of the ten biggest threats to global health in 2019. The VACCINES Act of 2019 is a critical step in combatting vaccine hesitancy and misinformation and ensuring that there is continued public awareness of the importance of vaccinations.
Henrietta Lacks Legislation: A Cancer Leadership Council letter expressing support for the Henrietta Lacks Enhancing Cancer Research Act of 2019 (S.946/H.R.1966), which aims to better understand the reasons for unequal access to cancer trials by racial and ethnic minorities and Americans who live in rural areas, among others.
Our organizations have been engaged for some time in a wide range of efforts to improve the cancer clinical trial enterprise. We have pursued policies to guarantee payment for routine patient care costs for those enrolled in trials, improve enrollment criteria in order to foster greater trials participation, enhance the efficiency of clinical trials design, and strengthen the regulatory review of trials. Our fundamental goals have been to enhance patient care through clinical trials enrollment and speed the development of new treatments.
April 2019
Peer Reviewed Cancer Research Program: An Alliance for Childhood Cancer letter asking House Appropriations leaders for an increase to $120 million for the Peer Reviewed Cancer Research Program, part of the Congressionally Directed Medical Research Program administered by the Department of Defense.
We encourage Congress to once again extend PRCRP eligibility in FY20 to pediatric brain tumors, brain cancer and neuroblastoma, as well as increase funding for the program to $120 million. In addition, provided that funding and the aforementioned topics are maintained within the PRCRP, we also support the creation of a new program under the CDMRP for $30 million to fund research related to cancer in children, adolescents, and young adults.
We firmly believe that an increase in the FY20 PRCRP budget will result in marked progress in understanding the nature and treatment of childhood cancers. The lives of many children and young adults depend on vigorous and innovative research programs like PRCRP to combat these diseases.
FDA Exemption from Congressional Review Act: A community letter asking the Administration to exempt the FDA from a new review process that could delay scientific progress at the FDA.
The undersigned organizations, representing millions of patients, advocates, caregivers, and health care professionals strongly urge the administration to reconsider the enactment of the memorandum issued on April 11, 2019 regarding “Guidance on Compliance with the Congressional Review Act”. We strongly believe that if applied to the U.S. Food and Drug Administration (FDA), the public health, safety, and future well-being of the American people will be put at risk.
March 2019
Patient-Centered Care Strategies: A Cancer Leadership Council letter proposing recommendations to improve treatment decision-making from diagnosis through survivorship, including supporting the Cancer Care Planning and Communications Act:
We have two recommendations for Congressional action to foster cancer care planning and coordination and to ensure the efficient use of cancer care resources: 1) enactment of the Cancer Care Planning and Communications Act (HR 5160 in the 115th Congress and soon to be reintroduced in the 116th Congress) and 2) continuation of the Oncology Care Model demonstration model for its full five-year test. These efforts – one aimed at improving payment and delivery in the fee-for-service Medicare program and the other a test of an episode-of-care pilot that includes treatment planning services and core navigation services – hold promise of ensuring the delivery of high-quality to cancer patients.
NIH and STAR Act Funding: An Alliance for Childhood Cancer letter expressing support for the Administration’s efforts to boost childhood cancer research opportunities, and asking for funding to implement the Childhood Cancer STAR Act and to fully support NIH and NCI’s crucial ongoing work.
The Administration’s new childhood cancer research proposal has the potential to make meaningful progress for childhood cancer patients across the country, but this proposal cannot be implemented at the expense of NIH’s and NCI’s broader budget.
The Alliance for Childhood Cancer and the broader childhood cancer community also care deeply about the implementation of the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act, the most comprehensive childhood cancer legislation considered by Congress. This important legislation, which was fully funded for FY19, authorizes $30 million in new resources for the NIH and Centers for Disease Control (CDC) to expand opportunities for childhood cancer research, improve efforts to identify and track childhood cancer incidences and enhance the quality of life for childhood cancer survivors. This was a hard-fought victory for our community, and we strongly encourage the Administration to use its new childhood cancer research initiative to build on the work already underway by NIH and the CDC to implement the Childhood Cancer STAR Act.
Peer Reviewed Cancer Research Program: An Alliance for Childhood Cancer letter in support of an increase to $120 million for the Peer Reviewed Cancer Research Program and the continued inclusion of pediatric brain tumors and neuroblastoma as eligible topics of funding under the program.
In addition, we support the addition of a new line-item under the Congressionally Directed Medical Research Program to fund additional research for cancer in children, adolescents and young adults provided the PRCRP remains a key focus.
ACE Kids Act of 2019: A letter thanking Congressional leaders for incorporating the ACE Kids Act into the Medicaid Services Investment and Accountability Act of 2019.
Children with complex medical conditions have chronic life-limiting illnesses and disabilities, and often see six or more specialists and a dozen or more physicians. Under the current Medicaid system, parents of children with multiple, life-threatening disabilities struggle to coordinate the complex care of their kids, which often requires travelling to out-of-state providers. The ACE Kids Act works to create a patientcentered, pediatric-focused delivery system for this unique population of children. It is an important step in fixing the current fragmented system for children with complex medical conditions, ensuring ready access to care and reducing the burden on their families.
February 2019
HHS Notice of Benefit and Payment Parameters for 2020: A Cancer Leadership Council letter expressing concerns about provisions of the Notice of Benefit and Payment Parameters for 2020 that may threaten cancer patients’ access to quality care and urging reconsideration of certain provisions of the proposal.
CLINICAL TREATMENT Act: A community letter thanking Reps. Ben Ray Lujan and Gus Bilirakis for introducing H.R. 913, the CLINICAL TREATMENT Act and endorsing this legislation, which would ensure that states cover routine care costs of participating in approved clinical trials for Medicaid enrollees with life-threatening conditions.
Medicaid insures nearly one-fifth of the US population and is the only major payer that is not required by federal law to cover routine costs associated with participation in clinical trials. This coverage is already assured for Medicare beneficiaries and for patients with private health insurance. Although twelve states require their Medicaid programs to cover these costs, there are still as many as 42.2 million Medicaid patients that are potentially without this needed coverage.
January 2019
Medicaid and CHIP Managed Care: A Cancer Leadership Council letter sent to CMS Administrator Seema Verma, offering comment on the proposed rule changing certain standards for Medicaid and CHIP managed care.
We understand that the proposal is intended to increase the flexibility of states in implementing Medicaid and CHIP managed care programs. However, we have concerns that certain of the changes proposed will adversely affect patient access to quality care.
We urge that, instead of finalizing the proposed rule, CMS leave the 2016 final rule in place until its effects are understood and only then make a decision about revising the rule’s standards.
Government Shutdown’s Impact on FDA: A community letter sent to the President, Speaker Pelosi, and Leaders McConnell, McCarthy and Schumer regarding the ongoing partial shutdown of the government and its impact to the Food and Drug Administration (FDA), asking Congress to act immediately to bring the FDA back to full operating capacity.
On behalf of patients across this country, we are greatly concerned that the agency is currently not fully funded, and thousands of vital FDA employees are not working or able to operate at full capacity. While we applaud Commissioner Gottlieb, FDA leadership, and “essential staff” for truly heroic work to keep many aspects of its mission functioning, we fear that this continued shutdown not only puts the current health and safety of Americans at risk, but has begun to put future scientific discovery and innovation in jeopardy.
The ongoing government shutdown forces the FDA to make difficult choices regarding to which essential functions its greatly reduced resources are directed. These are decisions that never should have to be made— the health and safety of Americans today should never be weighed against the prospect of new life-saving therapies for patients. Tragically, that is what is happening.