LUNGevity ensures that the lung cancer community’s interests are represented in policy by leveraging our research, collaborations, and patients’ voices to inform legislative and regulatory policy priorities. LUNGevity submits letters to legislators and regulators, both as an individual organization and in coalitions of organizations to support the advancement of innovation and access to therapies and screening.
Innovations in early detection, diagnosis, treatment, and survivorship care offer hope to those living with or at risk of developing lung cancer. However, these advances are only meaningful if they are accessible to all who may benefit. We support policies that will improve access to care for everyone impacted by lung cancer, regardless of their insurance coverage.
Utilization Management
Insurers and pharmacy benefit managers (PBMs) use a variety of tools to manage care and contain costs. These may include prior authorization, step therapy, and formulary design. In some cases, these practices limit or delay patient access to guideline-recommended care. We support the removal of unnecessary barriers that hinder patient access to the best available care.
- Letters
Patient Group Letter to Humana on 2025 Step Strategy for Treatment of Non-Small Cell Lung Cancer (December 19, 2024)
Patient Group Letter to CMS on Humana 2025 Step Strategy for Treatment of Non-Small Cell Lung Cancer (December 19, 2024)
Safe Step Act Coalition Letter to House Education and Workforce Leadership on ERISA 50th Anniversary (May 17, 2024)
MAPRx Comments on Medicare Program Contract Year 2024 Proposed Rule (February 13, 2023)
Cancer Leadership Council Comments on Medicare Program Contract Year 2024 Proposed Rule (February 13, 2023)
Cancer Leadership Council Comments on CMS Request for Information on Essential Health Benefits (January 31, 2023)
Full Coverage for Services
Coverage policies can vary widely based on the type of insurance a patient has. LUNGevity advocates for full coverage of the range of services that people with lung cancer may need.
- Letters
Cancer Leadership Council Comments on CMS Notice of Payment and Benefit Parameters for 2025 (January 8, 2024)
All Copays Count Coalition Comments on CMS Notice of Benefit and Payment Parameters for 2025 (January 8, 2024)
MAPRx Comments on CY2025 Medicare Advantage and Part D Proposed Rule Comment Letter (January 5, 2024)
Cancer Leadership Council Letter on Physician Fee Scheduled CY 2024 Proposed Rule (September 11, 2023)
Stakeholder Letter on Transitional Coverage for Emerging Technologies (TCET) Proposed Pathway (August 28, 2023)
LUNGevity Statement in Support of the Comprehensive Cancer Survivorship Act (June 28, 2023)
Cancer Leadership Council Comments on CMS Notice of Benefit and Payment Parameters for 2024 (January 30, 2023)
Cancer Leadership Council Comments to CMS on Medicare Advantage (August 31, 2022)
Out-of-Pocket Costs for Patients
Depending on the type of insurance they hold, patients often face high out-of-pocket costs for services including diagnostics, treatment, and management of both cancer and treatment side effects. We advocate for policies that eliminate or significantly reduce out-of-pocket costs for these services so that the ability to pay is not a barrier to optimal care.
- Letters
All Copays Count Coalition Letter on Prospective Cost-Sharing Rule Revision (June 24, 2024)
LUNGevity Support Letter for California AB 2180 - Copay Accumulator Ban (April 8, 2024)
All Copays Count Coalition Letter on NBPP Court Decisions and Copay Accumulators (October 6, 2023)
All Copays Count Coalition Letter Supporting Inclusion of HELP Copays Act in PBM Reform Package (July 14, 2023)
All Copays Count Coalition Letter of Support for HELP Copays Act - Senate (May 10, 2023)
Provider Reimbursement
Lung cancer care involves a variety of providers, from primary care physicians and nurses to specialists such as oncologists, radiologists, and surgeons. We support adequate reimbursement for all of these professionals so that practices remain open and patients have access to the range of care needed as close as possible to their homes.
- Letters
Cancer Leadership Council Support Letter for the ROCR Act 2024 (July 23, 2024)
2023 Stakeholder Letter in Support of the SALSA Act (June 7, 2023)
Telehealth
During the COVID-19 pandemic, many patients benefited from new flexibilities that allowed them to utilize telehealth for the first time. Post-pandemic, we believe that telehealth should continue to be available to patients no matter where they live.
- Letters
To come.
Inflation Reduction Act Implementation
In 2022, Congress passed the Inflation Reduction Act, a large package that includes key patient-focused reforms in Medicare as well as a requirement for the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain drugs. LUNGevity is closely monitoring the implementation of this law to ensure that patients benefit from its provisions and that it does not have unintended consequences.
- Letters
CSC Sign-On Letter - Medicare Prescription Payment Plan Model Documents (April 29, 2024)
MAPRx Comment Letter - Medicare Prescription Payment Plan Model Documents (April 29, 2024)
Group Letter to CMS on Comparative Effectiveness Considerations for Selected Oncology Drugs (October 2, 2023)
Community Letter to CMS on Medicare Part D Redesign Implementation (June 5, 2023)
Cancer Leadership Council Comments on CMS Initial Memorandum for Implementation of the Medicare Drug Price Negotiation Program (April 14, 2023)
MAPRx Comments on CMS Initial Memorandum for Implementation of the Medicare Drug Price Negotiation Program (April 14, 2023)
Rare Disease Patient Organization Sign-on Letter to CMS on Initial Memorandum for Implementation of the Medicare Drug Price Negotiation Program (April 14, 2023)
Partnership to Fight Chronic Disease Sign-on Letter to CMS on Initial Memorandum for Implementation of the Medicare Drug Price Negotiation Program (April 14, 2023)
Clinical Trials and Drug Approval Process
Clinical trials provide evidence to support the safety and efficacy of new therapies. We support ensuring that clinical trials are conducted in a safe and efficient manner, in populations that reflect the patients who will receive the drug, to support rapid delivery of new therapies to patients.
Representative Clinical Trials
The participants in a clinical trial should be representative of the population who will receive the treatment once approved. We support intentional clinical trial designs with appropriate eligibility criteria and ensuring financial neutrality to encourage representative participation.
- Letters
LUNGevity Comments on Multiregional Clinical Trials Draft Guidance (November 18, 2024)
LUNGevity Comments on Diversity Action Plans Draft Guidance (September 24, 2024)
Community Sign-on Letter to the Senate re: PDUFA and Diversity in Clinical Trials (June 8, 2022)
Community Letter in Support of Clinical Trial Diversity (May 11, 2022)
Sign-on letter in support of the Clinical Treatment Act (HR 913/ S 4742) (October 9, 2020)
LUNGevity Comments on FDA Draft Guidance to Enhance Diversity of Clinical Trial Populations (August 6, 2019)
Coalition Letter in Response to FDA Guidance Documents Concerning Cancer Clinical Trial Eligibility Criteria (May 13, 2019)
Innovative Clinical Trial Designs
We support innovative approaches to clinical trial design that encourage flexibility while maintaining rigor to help streamline research and encourage patient participation.
- Letters
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products (April 7, 2025)
LUNGevity Comments on Integrating Clinical Trials into Routine Clinical Practice Draft Guidance (December 17, 2024)
LUNGevity Comments on Enhancing Adoption of Innovative Clinical Trial Approaches (April 19, 2024)
LUNGevity Comments on Decentralized Clinical Trials Draft Guidance (July 31, 2023)
LUNGevity Comments on Externally Controlled Trials Draft Guidance (May 2, 2023)
LUNGevity Comments re: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (February 28, 2022)
LUNGevity Comments re: Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products (January 24, 2022)
Expedited FDA Pathways
Expedited programs include Accelerated Approval, Fast Track, Breakthrough Therapy, and Priority Review to efficiently develop and review therapies for unmet needs. We support the continued modernization of these programs to promote timely approvals for lung cancer therapies.
- Letters
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics (March 6, 2025)
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway (March 10, 2025)
LUNGevity Comments on Accelerated Approval of Oncology Therapeutics Draft Guidance (May 25, 2023)
Inclusion of reforms to the accelerated approval pathway in end-of-the-year PDUFA (prescription drug user fee act) legislation (September 20, 2022)
A4 Letter to Congress AA in PDUFA (August 1, 2022)
Accelerated Approval Action Alliance (A4) Sign-on Letter re: Accelerated Approval Consensus Themes (June 16, 2022)
Patient-Focused Drug Development
Patient-focused drug development is a systematic approach to ensure patients’ perspectives are incorporated across the entire drug development process. We support the incorporation of patients and their experiences, including through patient-reported outcomes, informed consent modifications, and enhanced engagement, in efforts to advance drug development.
- Letters
Considerations for Including Tissue Biopsies in Clinical Trials; Draft Guidance for Industry, Investigators, Institutions, and Institutional Review Boards (March 10, 2025)
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices (February 28, 2025)
LUNGevity Comments on Assessment of Ovarian Toxicity During Drug Development Draft Guidance (January 27, 2025)
LUNGevity Comments on Facilitating Understanding in Informed Consent Draft Guidance (April 30, 2024)
LUNGevity Comments on Fourth PFDD Draft Guidance (July 1, 2023)
LUNGevity Comments on Dose Optimization Guidance (March 20, 2023)
LUNGevity Comments on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fitfor-Purpose Clinical Outcome Assessments (October 12, 2022)
Coalition sign-on response to ClinicalTrials.gov RFI (March 13, 2020)
LUNGevity Comments to FDA on Patient-Focused Drug Development Guidance (September 11, 2018)
Right to Try Coalition Letter (House) (March 12, 2018)
Right to Try (S.204 & H.R. 878) (February 6, 2018)
Enhancing Patient Engagement Efforts Across FDA (June 12, 2017)
Federal Agencies Recent Funding and Legislation
Legislation is introduced to provide funding and requirements for various agencies and programs in the federal government. We provide positions on the following.
Appropriations Legislation
Appropriations legislation designates federal funding for agencies, programs, and departments in the federal government, including the Department of Health and Human Services (HHS), which includes the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). We support robust funding for research into cancer treatment, screening, and prevention.
- Letters
OVAC Letter on Finalizing FY2024 Appropriations (January 30, 2024)
DHRC Letter to Congressional Leadership - Defense Appropriations and CDMRP (October 27, 2023)
Public Health Partners Response to House Budget RFI (October 15, 2023)
Lung Cancer Partners Letter on FY2024 Funding (July 26, 2023)
Partners Letter on FY2024 Public Health Funding (July 19, 2023)
FY2024 Defense Health Research Appropriations Letter - House (April 24, 2023)
FY2024 Defense Health Research Appropriations Letter - Senate (April 24, 2023)
FOVA FY2024 Appropriations Recommendation (March 27, 2023)
OVAC FY2024 Appropriations Request Letter (March 20, 2023)
Ad Hoc Group for Medical Research FY2024 Recommendation for NIH (March 14, 2023)
21st Century Cures Act
The 21st Century Cures Act was a patient-focused bill signed into law in 2016 to advance the discovery and development of innovative treatments and to strengthen the patient voice in the research and regulatory environment. Additional legislation has been proposed to build on these efforts, which we support.
- Letters
LUNGevity Comments on Cures 2.0 (November 12, 2021)
Cancer Leadership Council feedback on Cures 2.0 (December 16, 2019)
Letter to House and Senate (November 16, 2016)
PDUFA Legislation
The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect fees from drug and biologics sponsors with an agreement on predictable and efficient review procedures. We support enhancements to regulatory science and expediting drug development by promoting innovation and modernization of the drug review process.
- Letters
Community Sign-on Letter to the Senate re: PDUFA and Diversity in Clinical Trials (June 8, 2022)
LUNGevity PDUFA VII comments (August 23, 2020)
MODERN Labeling Act (November 15, 2018)
Lung Cancer Screening and Early Detection
Early detection of lung cancer saves lives, but only a fraction of those eligible receive screening. We support removing barriers to lung cancer screening and increasing access to early detection methods.
- Letters
Multigroup letter to USPSTF on Lung Cancer Screening Guidelines (July 17, 2024)
LUNGevity Statement in Support of the Increasing Access to Lung Cancer Screening Act (June 26, 2023)
Health Groups Applaud Stay on Braidwood v Becerra Lawsuit to Protect Coverage for Preventive Services (May 15, 2023)
Lung Cancer Screening Consensus Statement (October 21, 2022)
Treatment of lung cancer is at the leading edge of precision medicine, with several biomarker-driven treatment options. Access to accurate and reliable diagnostic tests for biomarker testing is of paramount importance.
Access to Biomarker Testing
We support consistent coverage for biomarker testing that keeps pace with scientific and clinical advances in treatment.
- Letters
Pennsylvania Biomarker Testing Coalition Support Letter for HB 1754 (May 31, 2024)
LUNGevity Comments on CLFS CY2024 Preliminary Determinations (October 27, 2023)
LUNGevity Comments for Proposed Local Coverage Determination: Novitas Solutions, Inc. (July 22, 2022)
Testimony on Washington State Prior Authorization for Cancer Biomarker Testing Bill (January 13, 2022)
LUNGevity on California Prior Authorization for Cancer Biomarker Testing Bill (September 8, 2021)
Coalition on California Prior Authorization for Cancer Biomarker Testing Bill (June 28, 2021)
Regulation of Diagnostic Devices
Patients undergoing biomarker testing should be confident in the accuracy of the results. We support an approach to oversight of laboratory-developed tests (LDTs) that balances the dual priorities of patient safety and continued innovation in test development.
- Letters
LUNGevity Response to Sen. Cassidy RFI on Regulation of Diagnostic Tests (April 1, 2024)
LUNGevity Comments on Proposed Rule on the Regulation of Laboratory-Developed Tests (December 1, 2023)
Multi-Stakeholder Concerns regarding IVDR and Patient Access to Clinical Trials (March 17, 2023)
LUNGevity Comments on VALID Act of 2022 (May 22, 2022)
LUNGevity Comments on FDA Technical Assistance for Diagnostics Accuracy and Innovation Act (August 20, 2018)
Diagnostic Reform Coalition Letter (August 8, 2018)
Diagnostic Reform Coalition Letter – May 2018 (May 9, 2018)
Letter to the House on Regulation of Lab-Developed Tests (January 24, 2017)
Letter to the Senate on Regulation of Lab-Developed Tests (January 24, 2017)
Letter to House on Regulation of Lab-Developed Tests (April 1, 2016)
Letter to Senate on Regulation of Lab-Developed Tests (April 1, 2016)
Understanding the determinants of health in the community and the possible and realized threats it faces is fundamental to prevent disease and promote health. We support actions to improve health in our communities as well as quick responses to public health threats that impact people with lung cancer.
COVID
We affirm our support of science and evidence-based health policy in response to public health emergencies, and support efforts to ensure access to quality care during such events, including use of telemedicine and access to treatments for high-risk populations.
- Letters
Sign-on Letter to the White House on the Importance of Additional COVID-19 Vaccine and Treatment Options (November 17, 2022)
Sign-on Letter to FDA on the Importance of Additional COVID-19 Vaccine and Treatment Options (July 20, 2022)
Sign-on letter to National Academies of Medicine re: COVID-19 Vaccine Allocation (September 4, 2020)
All Cancers Congress sign-on letter in response to Cancer Discrimination in Star County, Texas (August 17, 2020)
Sign-on letter to NCI on Telehealth Research Gaps (July 30, 2020)
Sign-on Cancer Community Letter to Congress on patient priorities for COVID negotiation package (July 28, 2020)
Sign-on Letter to Vice President Pence in Support of Science-Based Health Policy (July 15, 2020)
Sign-on letter to Chairman Alexander regarding pandemic preparedness (June 26, 2020)
Sign-on letter to Office of Civil Rights on emergency triage plans (May 20, 2020)
Cancer community anti-discrimination sign-on letter to governors (April 21, 2020)
Cancer community sign-on letter to Hill leadership regarding important policy changes for cancer patients during COVID crisis (April 15, 2020)
Cancer community sign-on letter to HHS regarding important policy changes for cancer patients during COVID crisis (April 15, 2020)
Joint Statement on COVID-19 Triage of Lung Cancer Patients (April 7, 2020)
HHS's Guidance on Avoiding Disability-Based Discrimination in Treatment Rationing (April 3, 2020)
Letter to Congress: Medications Access Must be Included in Third COVID-19 package (March 26, 2020)
Letter to Congress: Potential Aid for Patient Organizations Impacted by Coronavirus (March 26, 2020)
Letter to President Trump: Domestic manufacture of health care products (March 25, 2020)
The Charitable Sector: COVID-19 Relief and Economic Stimulus Package (March 23, 2020)
Letter to states to protect access to medications for high-risk populations during COVID-19 (March 20, 2020)
Smoking and Tobacco Use
Tobacco use is a leading cause of preventable death in the US and one of the primary preventable causes of cancer. We support evidence-based approaches to decreasing smoking and tobacco use, including cessation treatments, eliminating menthol, and regulation of e-cigarettes.
- Letters
Cancer Community Letter to Administration on Menthol Rule (March 19, 2024)
Cancer Community Letter to Administration on Menthol and Flavored Cigar Rules (December 13, 2023)
Partners Coalition Letter in Support of the Helping Tobacco Users Quit Act (September 28, 2023)
Coalition Letter Supporting FDA Proposed Rule on Menthol Cigarettes and Flavored Cigars (February 21, 2023)
Joint Statement: Remove Flavored E-Cigarettes from the Market (November 18, 2019)
Health Partners Letter Opposing the REINS Act (March 17, 2023)
2023 Sign-on Letter in Support of the PASTEUR Act to Combat Antimicrobial Resistance (March 8, 2023)
2022 Sign-on Letter in Support of the PASTEUR Act to Combat Antimicrobial Resistance (November 16, 2022)
LUNGevity has a long history of championing policies and initiatives that advance the lung cancer community’s interests. For past comments and letters supporting the above priorities, please explore our archive.
- Letters
To come.