Vaccine Access Improvement Act of 2018

Health Insurance Coverage (general); Health Disparities (general); Breastfeeding (general); Assisted Reproductive Technology (general); Smoking Cessation (general); Substance Use Disorder (general); Gynecologic Cancer (general); Gynecologic Devices (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); E-Cigarettes (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Conscience Refusals (general); Child Welfare (general); Prematurity (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Contraception (general); National Health Service Corps (general); Abortion (general); Hyde Amendment (General); Indian Health (general); Teaching Health Centers (general); Teen Pregnancy Prevention Program (general); Personal Responsibility Education Program (general); Research in Pregnant and Breastfeeding Women (general); Health Care Reform (general); Title X (general); Womens Preventive Services (general); H.R. 5457/S. 2637, Quality Care for Moms and Babies Act; H.R. 1318/S 1112, Preventing Maternal Deaths Act/Maternal Health Accountability Act; H.R. 5977/S. 3776, MOMMAs Act; H.R.5761, Ending Maternal Mortality Act of 2018; S. 3392, MOMs Act; S. 3363, Maternal CARE Act; S.3494, MOMMIES Act; S. 3568, Rural MOMS Act; H.R. 1876/S. 781, Good Samaritan Health Professionals Act; S.2852/H.R. 6378 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; S. 783, Improving Access to Maternity Care Act; H.R. 3602/S. 1653, Real Education for Healthy Youth Act; H.R. 6085/S. 3029, the PREEMIE Reauthorization Act; H.R. 4993/S.3253, Vaccine Access Improvement Act of 2018; P.L. 115-271, SUPPORT for Patients and Communities Act; H.R. 6805, Pregnant Women in Custody Act; S. 756, First Step Act; S. 2960 Access to Infertility Treatment and Care Act; H.J.Res. 140/S.J.Res. 63, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Department of the Treasury, Department of Labor, and the Department of Health and Human Services relating to Short-Term, Limited Duration Insurance; Implementation of P.L. 114-91, Protecting Our Infants Act; Implementation of P.L. 114-198, Comprehensive Addiction and Recovery Act; Implementation of P.L. 114-255, 21st Century Cures Act; H.R. 6545, Violence Against Women Reauthorization Act.

Client expense: $202,071 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Indian Health Service, Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA), White House Office

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Tax extenders (second generation biofuel producer credit); issues related to innovative companies, including reform of NOL rules in Section 382 and reform of Section 1202 (QSBS Capital Gains); H.R.6756, American Innovation Act; simplification of excise tax for Vaccine Injury Compensation Program (HR 4993, S.3253).

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, White House Office

Health Insurance Coverage (general); Health Disparities (general); Breastfeeding (general); Assisted Reproductive Technology (general); Smoking Cessation (general); Substance Use Disorder (general); Gynecologic Cancer (general); Gynecologic Devices (general); Reproductive Health (general); Intimate Partner Violence (general); Gun Violence (general); Immunization (general); Breast Cancer (general); E-Cigarettes (general); Medical Liability Reform (general); Health IT (general); Patient-Physician Relationship (general); Conscience Refusals (general); Child Welfare (general); Prematurity (general); Health Disparities (general); Maternal Mortality and Morbidity (general); Graduate Medical Education (general); Lab Developed Tests (general); Contraception (general); Preeclampsia (general); Over the Counter Drugs (general); National Health Service Corps (general); Community Health Centers (general); Abortion (general); Hyde Amendment (General); Indian Health (general); Teaching Health Centers (general); Teen Pregnancy Prevention Program (general); Research in Pregnant and Breastfeeding Women (general); Healthy Start (general); Health Care Reform (general); Title X (general); Personal Responsibility Education Program (general); Womens Preventive Services (general); H.R. 5457/S. 2637, Quality Care for Moms and Babies Act; H.R. 1318/S 1112, Preventing Maternal Deaths Act/Maternal Health Accountability Act; H.R. 5977, MOMMAs Act; H.R.5761, Ending Maternal Mortality Act of 2018; S. 3392, MOMs Act; S. 3363, Maternal CARE Act; S.3494, MOMMIES Act; H.R. 1876/S. 781, Good Samaritan Health Professionals Act; S.2852/H.R. 6378 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; S. 783, Improving Access to Maternity Care Act; S.Res. 605, A resolution designating the first week in August as World Breastfeeding Week, and designating August as National Breastfeeding Month; H.R. 3602/S. 1653, Real Education for Healthy Youth Act; H.R. 421/S. 93, Allowing Greater Access to Safe and Effective Contraception Act; H.R. 6085/S. 3029, the PREEMIE Reauthorization Act; H.R. 3692, Addiction Treatment Access Improvement Act; S. 2680, Opioid Crisis Response Act; H.R. 5818/S. 2843, the Opioid Workforce Act of 2018; H.R. 2501/S. 1148, CRIB Act; H.R. 4993/ S.3253 - Vaccine Access Improvement Act of 2018; H.R. 6, SUPPORT for Patients and Communities Act; H.R. 6805, Pregnant Women in Custody Act; S. 2960 Access to Infertility Treatment and Care Act; H.J.Res. 140/S.J.Res. 63, Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the final rule of the Department of the Treasury, Department of Labor, and the Department of Health and Human Services relating to Short-Term, Limited Duration Insurance; Implementation of P.L. 114-91, Protecting Our Infants Act; Implementation of P.L. 114-198, Comprehensive Addiction and Recovery Act; Implementation of P.L. 114-255, 21st Century Cures Act; H.R. 6545/S.___, Violence Against Women Reauthorization Act.

H.R.4993, S.3253 Vaccine Access Improvement Act of 2018

Client expense: $10,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE