Drug Shortages Prevention and Quality Improvement Act

Communicate Wake EMSs support for S. 2586, Drug Shortages Prevention and Quality Improvement Act and H.R.2416, To amend the Public HealthService Act to reauthorize a military and civilian partnership for trauma readiness grant program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Access to Care Inflation Reduction Act (IRA). ACS CAN actively monitors implementation of the Inflation Reduction Acts Medicare Drug Price negotiation provisions to ensure cancer patients have access to costly prescription drugs. ACS CAN also supports the Medicare Prescription Payment Plan, which allows Part D enrollees to spread their out-of-pocket costs over the plan year. Enhanced Advanced Premium Tax Credits, H.R. 9774, Improving Health Insurance Affordability Act of 2023, S.5194. House and Senate bills would permanently extend the enhanced Affordable Care Act tax credits. Help CoPays Act S.1375; Help Ensure Lower Patient Copays Act, H.R.830. This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements. Safe Step Act, S.652, H.R. 2630. This bill requires a group health plan to establish an exception to medication step-therapy protocol in specified cases. A medication step-therapy protocol establishes a specific sequence in which prescription drugs are covered by a group health plan or a health insurance issuer. Creating Opportunities Now for Necessary and Effective Technologies (CONNECT) for Health Act of 2023 H.R.4189, S.2016. This bill expands coverage of telehealth services under Medicare. Telehealth Modernization Act of 2924, H.R. 7623. Modifies requirements relating to coverage of telehealth services under Medicare. Permanently expands telehealth flexibilities first authorized during the public health emergency. The Preserving Telehealth, Hospital, and Ambulance Access Act, H.R. 8261. This bill allows employers to offer stand-alone telehealth benefits to all employees. This includes employees who are eligible for enrollment in their employer's group health plan. Drug Shortage Prevention Act, H.R. 3008. This bill requires drug manufacturers to notify the Food and Drug Administration (FDA) if there is an increased demand for certain critical essential medicines that may result in a shortage. Protecting Americans from Unsafe Drugs Act of 2023, H.R. 2500. This bill expands the authority of the Secretary of the Department of Health and Human Services (HHS) to order the recall of controlled substances to cover all drugs. Ensuring Access to Lifesaving Drugs Act of 2023, H.R. 3793. This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.) Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties. Medical Device Shortage Reduction Act of 2023, H.R. 3807. This bill expands the scope of required notifications about medical device shortages beyond public health emergencies. Protecting PAHPA Action of 2023, H.R. 4697. ACS CAN is lobbying on all provisions related to drug shortages. This bill extends through FY2028 and modifies various programs and activities that support public health preparedness and response. The bill also addresses matters concerning shortages of drugs and medical devices and recalls of drugs. Essential Medicines Strategic Stockpile Act of 2023, H.R. 405. This bill requires the Department of Health and Human Services (HHS) to create a pilot program to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage. Alan Reinstein Ban Asbestos Now Act of 2023, H.R. 2402, S. 1069. This bill prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. RAPID Reserve Act, S. 2510. This bill improves supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies. Rolling Active Pharmaceutical Ingredient and Drug Reserve Act, H.R.6802. A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies Drug Shortage Prevention and Mitigation Act, S.2586. This legislation would address the ongoing drug shortage crisis. Access to Breast Cancer Diagnosis Act of 2023, H.R.3851, S.2464. To amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations. Health Disparities Nancy Gardner Sewell Multi-Cancer Early Detection Act, H.R. 2407. This bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. Medicare Multi-Cancer Early Detection Screening Coverage (MCED) Act, S.2085. Legislation to improve access to new and innovative cancer screenings for Medicare beneficiaries by creating a pathway to allow Medicare to initiate coverage of multi-cancer tests following FDA approval if a clinical benefit is shown. Screening for Communities to Receive Early and Equitable Needed Services (SCREENS for Cancer) Act, S.1840, H.R.3916. Reauthorization of the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) for fiscal years 2024 through 2028 to provide the program greater flexibility in providing access to lifesaving screening, diagnostic, and treatment services and continue its innovative work aimed to reduce disparities and advance health equity in breast and cervical cancer. Prostate-Specific Antigen Screening for High-Risk Insured Men (PSA Screening for HIM) Act, S.2821, H.R.1826. Legislation to remove cost sharing of PSA testing for those at the highest risk of being diagnosed with prostate cancer. Lung Cancer Screening and Prevention Act, H.R.6693. To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program. Health Equity and Accountability Act (HEAA), H.R. 9161, S. 4773. Legislation to eliminate racial and ethnic health disparities. We actively advocate for provisions (HEAA), which focuses on health inequalities, societal injustices, and their intersection with immigration status, age, disability, sex, gender, sexual orientation, and socioeconomic status. Increased Funding for the National Institute for Minority Health and Health Disparities. Reducing disparities in the use of recommended preventive services targeting three leading causes of death in the United States - cancer, heart disease, and diabetes. Cancer Drug Parity Act of 2023, S.2039, H.R.6301. Level the playing field for cancer patients by ensuring that the cost-sharing for oral anticancer drugs is on par with intravenous chemotherapy, thereby removing a significant financial obstacle to effective treatment. Henrietta Lacks Enhancing Cancer Research Act of 2019 Report. Request for Congress to urge the Government Accountability Office (GAO) to revisit the Henrietta Lacks Enhancing Cancer Research Act of 2019 report, with respect to promoting diverse participation in cancer clinical trials and addressing fully the request for insight into either implementation challenges for current federal activities or recommendations for additional activities and policy changes related to clinical trial diversity. Data Equity. Legislative and regulatory funding to support the collection of detailed demographic data toward reducing disparities in cancer prevention, detection, and treatment. Childhood Cancer Childhood Cancer Survivorship, Treatment, Access, and Research Reauthorization Act of 2022 (STAR) Act. Continued implementation and funding of the Childhood Cancer STAR Act to promote the development of new, safer therapies for children with cancer. Our appropriations request includes $30 million for the Childhood Cancer STAR Act and $50 million for the Childhood Cancer Data Initiative. Gabriella Miller Kids First Research Act 2.0, H.R. 623, S. 1523. This bill reauthorizes through FY2028 a pediatric disease research initiative within the National Institutes of Health (NIH) and requires the NIH to coordinate pediatric research activities to avoid duplicative efforts. Additionally, the Department of Health and Human Services must report to Congress about research funded through the initiative. Promoting Resources to Expand Vaccination, Education and New Treatments for HPV Cancers (PREVENT) Act, H.R.3633. Legislation that would help prevent cancer and save lives by raising awareness about HPV and HPV-related cancers through a national campaign to educate providers, parents, and the public about the life-saving HPV vaccine. It would also boost resources for a federal initiative to provide access to timely cervical cancer screening and diagnostic services for uninsured and underserved individuals. Accelerating Kids Access to Care Act, S.2372, H.R.4758. Legislation that alleviates these burdens for families and providers by facilitating coordination across state lines and clarifying the process by which state Medicaid programs can cover specialized treatment regardless of where the child lives and where their care is received. Creating Hope Reauthorization Act of 2024, H.R. 7384. This bill extends until FY2029 a Food and Drug Administration program that awards priority review vouchers to manufacturers of drugs that treat rare pediatric diseases. (A priority review voucher entitles the voucher holder to priority review of a single human drug application.) Quality of Life Palliative Care Palliative Care and Hospice Education and Training Act (PCHETA), S.2243. Legislation to facilitate access to palliative care and coordinated care management. Palliative Care Research Funding. Funding to focus and expand national research programs in palliative care at the National Institutes of Health. Specifically, ACS CAN is working to ensure the U.S. Congress appropriates specific money for palliative care research, upon enactment of the FY2024 LHHS Appropriations bill. Patient Navigation for People with Cancer. Legislation and policies to increase access to patient navigation for people with cancer, prioritizing policies that create sustainable funding to ensure access to patient navigation services across the cancer continuum. Patient Navigation Assistance Act, H.R. 9446. This bill would require state Medicaid programs to provide patient navigation services for enrollees. Cancer Survivorship Comprehensive Cancer Survivorship Act (CCSA), S.2213, H.R.4363. ACS CAN supports legislation that sets new standards for survivorship from diagnosis to end of life, ensuring the best and most seamless experience for survivors, and their families and caregivers throughout the journey. CCSA will address gaps in survivorship care and develop needed standards to improve the overall patient-centered quality of care and navigation needs that cancer survivors and their families experience. Federal Health Care Programs Increased Funding Levels for Cancer Research and Prevention. Ensure continued progress in the fight against cancer at the National Institutes of Health (NIH), the National Cancer Institute (NCI), the Advanced Research Projects Agency for Health (ARPA-H), and the Centers for Disease Control and Preventions (CDC) cancer programs. CDC Cancer Programs, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Regulatory issues related to healthy food and dietary guidelines PC CARE Act, H.R.1315. This bill establishes a committee to develop, implement, and periodically revise a plan to coordinate federal activities and programs concerning prostate cancer, including those related to research, screening, diagnosis, and treatment. Women and Lung Cancer Research and Preventive Services Act of 2023, H.R.4534, S.2245. This bill requires the Department of Health and Human Services to conduct an interagency review of the status of women and lung cancer. Department of Defense Appropriations Act, 2024 H.R.4365, S.2587. DOD Congressionally Directed Medical Research Program. Cancer Alan Reinstein Ban Asbestos Act, H.R.2402, S.1069. This bill generally prohibits the manufacture, process, use, and distribution in commerce of commercial asbestos or any mixture or article containing commercial asbestos. The President may, on application, grant exemptions from the prohibition in situations where it is necessary to protect national security interests. Nutrition Medical Nutrition Act H.R.6407, S.3297. A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program Farm, Food, and National Security Act of 2024, H.R.8467. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Rural Prosperity and Food Security Act, S.5335. To provide for the reform and continuation of agricultural and other programs of the Department of Agriculture through fiscal year 2029, and for other purposes. Clinical Trials Clinical Trial Modernization Act, H.R. 8412. Increase diversity in clinical trials and make it easier for all persons with cancer to participate by reducing barriers to enrollment. Barriers may include ancillary (non-medical) costs, such as transportation and lodging, and remote access to trials, particularly for people who are underrepresented, including certain racial and ethnic groups, older adults, rural residents, and those with limited incomes. NIH Clinical Trial Diversity Act, S.1701, H.R.3503. Legislation to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. Harley Jacobsen Clinical Trial Participant Income Exemption Act, H.R.7090, H.R. 7418. Legislation to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants.

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs H.R.5804-Mental Health Infrastructure Improvement Act of 2023, to provide loans and grants to improve mental health treatment and substance use disorder treatment facilities H.R.6960-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program H.R. 6992-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats H.R. 7153-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers H.R. 10545-American Relief Act, 2025, to provide appropriations for several federal departments and agencies and provide temporary extension of certain health care policies S. 1346-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act S. 2364-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats S.3679-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S.3765-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program

Communicate Wake EMSs support for S. 2586, Drug Shortages Prevention and Quality Improvement Act and H.R.2416, To amend the Public Health Service Act to reauthorize a military and civilian partnership for trauma readiness grant program.

Client expense: Not reported · Firm income: $31,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Communicate Wake EMSs support for S. 2586, Drug Shortages Prevention and Quality Improvement Act and H.R.2416, To amend the Public Health Service Act to reauthorize a military and civilian partnership for trauma readiness grant program.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs H.R.5804-Mental Health Infrastructure Improvement Act of 2023, to provide loans and grants to improve mental health treatment and substance use disorder treatment facilities H.R.6960-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program H.R. 6992-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats H.R. 7153-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S. 1346-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act S. 2364-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats S.3679-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S.3765-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs H.R.5804-Mental Health Infrastructure Improvement Act of 2023, to provide loans and grants to improve mental health treatment and substance use disorder treatment facilities H.R.6960-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program H.R. 6992-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats H.R. 7153-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S. 1346-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act S. 2364-Mapping Americas Pharmaceutical Supply Act, to map the U.S. pharmaceutical supply chain to identify vulnerabilities and other security threats S.3679-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S.3765-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs H.R.5804-Mental Health Infrastructure Improvement Act of 2023, to provide loans and grants to improve mental health treatment and substance use disorder treatment facilities H.R.6960-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program H.R. 7153-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S. 1346-Improving Mental Health Access from the Emergency Department Act, to establish grants for emergency departments and hospitals to help improve care and care coordination for patients with acute psychiatric care needs S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act S.3679-Dr. Lorna Breen Health Care Provider Protection Act, to reauthorize programs to improve mental health access for health care providers S.3765-Emergency Medical Services for Children Reauthorization Act of 2024, to reauthorize the EMSC program

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act H.R.5804-Mental Health Infrastructure Improvement Act of 2023, to provide loans and grants to improve mental health treatment and substance use disorder treatment facilities S. 1346-Improving Mental Health Access from the Emergency Department Act S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act

Client expense: $499,399 · Firm income: Not reported

Reproductive health, physician-patient relationship, and EMTALA issues Emergency department boarding Drug shortages Health care consolidation H.R.1694-Emergency Care Improvement Act, to permanently allow for coverage under Medicare and Medicaid of services that are provided by freestanding emergency centers. H.R.2412-Helping Kids Cope Act, to provide grants to improve mental health access for children and reduce pediatric emergency department boarding H.R. 2416-To reauthorize the MISSION ZERO military-civilian partnership for trauma readiness H.R. 2940-PASTEUR Act of 2023, to incentivize new antimicrobial development H.R.4941-Providing Access to Treatment and Housing Act H.R 5414-Improving Mental Health Access from the Emergency Department Act S. 1346-Improving Mental Health Access from the Emergency Department Act S. 1355- PASTEUR Act of 2023, to incentivize new antimicrobial development S. 1447-Bipartisan Solution to Cyclical Violence Act of 2023, to establish a grant program to support trauma center violence intervention and violence prevention programs S. 2586-Drug Shortages Prevention and Quality Improvement Act

Client expense: $352,268 · Firm income: Not reported