Prescription Drug Price Reporting Act

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1499: Protecting Consumer Access to Generic Drugs Act Cell, gene and radioligand therapies 340B Drug Discount Program Drug Importation Outcomes based Contracting/Value based arrangements Orphan Drugs Medicaid Payment Reform AMP Cap S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues PDUFA, BSUFA, GDUFA Drug vial size policy issues Pharmaceutical supply chain H.R. 4710 - Pharmaceutical Independence Long-Term Readiness Reform Act S. 3635 - Protecting our Pharmaceutical Supply Chain from China Act of 2020 S. 3538 - Strengthening Americas Supply Chain and Medical Security Act H.R. 6431 - Made in America Emergency Preparedness Act HR 6080 - Prevent Drug Shortages Act S. 3432 - Securing Americas Medicine Cabinet Act of 2020 H.R. 6670 - Prescription for American Drug Independence Act of 2020 H.R. 6930 - MADE in America Act HR 4439 - Creating Hope Reauthorization Act Pharmaceutical quality COVID 19 H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 3772 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 S. 3370 - Coronavirus Vaccine Act CARES Act, Pub. L. 116-136 H.R. 6080 - Preventing Drug Shortages Act Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Diversity in Clinical Trials FY 2021 Labor-HHS Appropriations Cures 2.0 Energy and Commerce RFI Part B Home Infusion Notice of Benefit Payment Parameters (NBPP) Priority Review Voucher (PRV) H.R. 4400 - The Advancing Education on Biosimilars Act of 2019 Vaccines Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Medicaid Generics Penalty fix HR 8337 - Continuing Appropriations Act, 2021 and Other Extensions Act H.R.2374 - Stop STALLING Act H.R. 5239 - Prescription Drug Price Reporting Act H.R. 6258 - Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 H.R. 6390 - To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak H.R. 6410 - To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 H.R. 6395/S. 4049 - National Defense Authorization Act for Fiscal Year 2021 HHS PREP Act declaration relating to COVID-19 Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues FDA modernization policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues FDA mandatory recall authority policy issues COVID-19 policy issues Transparency Issues Policy Issue H.R. 2477 - Beneficiary Enrollment Notification and the Eligibility Simplification (BENES) Act of 2019 H.R. 6800 - Heroes Act

Client expense: $660,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

1) Oppose eroding Section 230 speech protections - No specific legislation 2) Support ending duplicative government services that compete with private sector - H.R. 5239 and S. 2990. 3) Support severing government cooperation with companies censoring films for China. S. 3835

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 748 - CARES Act - Courtney - COVID-19 coverage H.R. 1418 - Competitive Health Insurance Reform Act of 2020 - DeFazio - antitrust laws, health insurance H.R. 3630 - No Surprises Act - Pallone - surprise medical billing H.R. 3784 - Air Ambulance Affordability Act of 2019 - Neguse - air ambulances H.R. 4223 - Protecting Patients from Surprise Medical Bills Act - Spano - surprise medical billing H.R. 5121 - Healthcare Cost Transparency Act - Beyer - provider price comparison tool H.R. 5239 - Prescription Drug Price Reporting Act - Joyce - reporting on drug expenditures and price changes under group health plans H.R. 5575 - Primary and Behavioral Health Care Access Act of 2020 -Underwood - coverage of primary care and behavioral health visits H.R. 6005 - Know the Price Act - Malinowski - health plan transparency H.R. 6173 - Covering Coronavirus Test Act of 2020 - DeGette - COVID-19 testing coverage H.R. 6193 - Medication Access in Emergencies Act of 2020 - Pappas - coverage of prescription drugs during emergency periods H.R. 6201 - Families First Coronavirus Response Act - Lowey - includes several provisions related to COVID-19 testing coverage H.R. 6213 - No Cost for COVID-19 Testing Act - Wilson - COVID-19 testing coverage H.R. 6214 - To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program - Kind - Medicare Advantage coverage of COVID-19 related visits and testing H.R. 6222 - Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Schakowsky - coverage of certain new preventative services related to COVID-19 H.R. 6231 - Ensuring Access to COVID-19 Preventive Care Act of 2020 - Bucshon - coverage of certain vaccines and testing services during the COVID-19 emergency H.R. 6299 - Rapid Coverage of COVID-19 Vaccine Act of 2020 - Courtney - COVID-19 coverage H.R. 6317 - To provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Doggett - special enrollment periods in public health emergency H.R. 6338 - To waive high deductible health plan requirements for health savings accounts -Budd - HDHP coverage during COVID H.R. 6486 - Care for COVID-19 Act 2.0 -Ruiz - COVID H.R. 6514 - Worker Health Coverage Protection Act - Scott - COVID H.R. 6518 - Stop Health Premium Spikes Act of 2020 - Peters - risk corridors H.R. 6532 - COVID Special Enrollment Act of 2020 - Doggett - COVID H.R. 6568 - Coverage for COVID-19 Treatment Act of 2020 - Rochester - COVID H.R. 6644 - To require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for services furnished via telehealth if such services would be covered if furnished in-person during the COVID-19 emergency. -Schrier - COVID H.R. 6674 - Medicare Crisis Program Act of 2020 -Jayapal - COVID H.R. 6712 - American Healthshare Plans Act of 2020 - Curtis - health share pools H.R. 6810 - Health Care Protection Act -Davis - COVID H.R. 7006 - Improving Care in Home Health Agencies Act - Velazquez - home health services H.R. 7267 - To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to prohibit a group health plan and a health insurance issuer offering group or individual health insurance coverage from reducing contracted rates, or terminating contracts, with health care providers during a public health emergency. - Porter - ERISA H.R. 7475 - Ensuring FEHBP Coverage During Pandemic Act - Vela - special enrollment period H.R. 7539 - Strengthening Behavioral Health Parity Act - Kennedy - strengthen mental health and SUD benefits H.R. 7647 - To provide for a COVID-19-related delay regarding annual limitation on cost-sharing for group health plans and individual and small group health insurance coverage - McEachin - drug manufacturer support applied to patient out-of-pocket limit H.R. 7659 - Ensuring Parity in MA for Audio-Only Telehealth Act of 2020 - Sewell - inclusion of certain audio-only diagnoses in the determination of risk adjustment for MA plans H.R. 7676 - Health Care Prices Revealed and Information to Consumers Explained Transparency Act - Flores - hospital and insurer price transparency H.R. 7722 - Matts Act - Fortenberry - limit price of insulin drugs accessible for those enrolled in group or indiv. health insurance coverage, group health plans, uninsured H.R. 7921 - Connecting Communities to Grant Opportunities Act of 2020 - Velazquez - navigator programs H.R. 7942 - Public Health Emergency COBRA Extension Act -Sanchez - COBRA extension H.R. 8060 - Tele-Mental Health Improvement Act - Trone - parity in mental health and SUD service under private insurance H.R. 8181 - Jack Reynolds Memory MediGap Expansion - Axne - Medigap coverage for Medicare ESRD H.R. 8308 - Telehealth Coverage and Payment Parity Act - Phillips - coverage for services furnished through telehealth H.R. 8330 - No Surprise Bills for New Moms Act - Porter - health coverage of newborns S. 1531 - STOP Surprise Medical Bills Act - Cassidy-Bennet - surprise medical billing S. 1948 - Chronic Disease Management Act - Thune - pre-deductible coverage of chronic disease prevention services S. 2546 - Safe Step Act - Murkowski - Step therapy exceptions S. 3200 - Chronic Disease Management Act of 2020 - Thune - coverage of chronic disease prevention services S. 3383 - Continuing Coverage for Preexisting Conditions Act of 2020 -Kennedy - preexisting conditions S. 3499 - A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Smith - COVID-19 cost -sharing S. 3505 - A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Jones - rapid COVID-19 coverage S. 3536 - A bill to provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Casey - COVID-19 coverage S. 3610 - American Healthshare Plans Act of 2020 - Paul - health share pools S. 3631 - Relief for Rural Providers During Emergencies Act - Sasse - COVID S. 3741 - Health Care at Home Act of 2020 - Smith - COVID S. 3792 - Tele-Mental Health Improvement Act - Smith - parity S. 3821 - Affordable Health Care Options Act of 2020 - Loeffler - affordability S. 3991 - Coronavirus 2019 Special Enrollment Period Act - Duckworth - SEP S. 4106 - A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency - Braun - price transparency S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - Wicker - establish an IDR for air ambulance S. 4198 - Affordable Coronavirus Testing Act - Scott - coverage for COVID serology testing S. 4255 - Katherines Lung Cancer Early Detection and Survival Act of 2020 - Smith - group health plans, group and indiv coverage benefits for lung cancer screenings S. 4329 - Continuous Health Coverage for Workers Act - McSally - COBRA continuation coverage S. 4469 - COVID-19 Treatment Coverage Act - Smith - COVID treatment Medicaid/MA/Private/Medicare coverage S. 4506 - Pre-Existing Conditions Protection Act of 2020 - Gardner - coverage of pre-ex conditions under private insurance S. 4521 - Health Care Improvement Act of 2020 - Warner - expand ACA coverage S. 4557 - COVid Enrollment Response Act - Baldwin - assistance enrolling in health care coverage S. 4609 - Vaccine And Coverage Certainty Act - Wyden - coverage of COVID vaccine under Medicare/Medicaid, CHIP S. 4653 - A bill to prevent efforts of the Department of Justice to advocate courts to strike down the Patient Protection and Affordable Care Act - Schumer - ACA S. 4761 - A bill to amend the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide for 3 primary care visits and 3 behavioral health care visits without application of any cost-sharing requirement - King - coverage and cost-sharing Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19, including testing, vaccines and therapeutics; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

1) Oppose eroding Section 230 speech protections - No specific legislation 2) Support ending duplicative government services that compete with private sector - H.R. 5239 and S. 2990.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 748, CARES Act H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R.1730, Cancer Drug Parity Act of 2019 H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S1872/HR5076, Protecting Seniors Through Immunization Act H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing HR6711, Medical Supply Transparency and Delivery Act, DPA impact on Rx manufacturers H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID-19, and for other purposes - Provisions related to prescription drug research and development and transparency H.R. 7296: To require any COVID-19 drug developed in whole or in part with Federal support to be affordable and accessible by prohibiting monopolies and price gouging, and for other purposes - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S3780, HOME Act S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: A bill to amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases - Provisions related to priority review vouchers H.R. 7288: Taxpayer Research and Coronavirus Knowledge (TRACK) Act of 2020 - Provisions related to database of federal biomedical investment information for COVID-19 H.R. 7296: Make Medicines Affordable by Preventing Pandemic Pricegouging (MMAPPP) Act of 2020 Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors FDA modernization policy issues PDUFA 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 Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients CARES ACT-Monograph Reform Support for Arthritis Caucus

H.R. 748 - CARES Act -Courtney - COVID-19 coverage H.R. 3630 - No Surprises Act - Pallone - surprise medical billing H.R. 3784 - Air Ambulance Affordability Act of 2019 - Neguse - air ambulances H.R. 4223 - Protecting Patients from Surprise Medical Bills Act - Spano - surprise medical billing H.R. 5121 - Healthcare Cost Transparency Act - Beyer - provider price comparison tool H.R. 5239 - Prescription Drug Price Reporting Act - Joyce - reporting on drug expenditures and price changes under group health plans H.R. 5575 - Primary and Behavioral Health Care Access Act of 2020 -Underwood - coverage of primary care and behavioral health visits H.R. 6005 - Know the Price Act - Malinowski - health plan transparency H.R. 6173 - Covering Coronavirus Test Act of 2020 - DeGette - COVID-19 testing coverage H.R. 6193 - Medication Access in Emergencies Act of 2020 - Pappas - coverage of prescription drugs during emergency periods H.R. 6201 - Families First Coronavirus Response Act - Lowey - includes several provisions related to COVID-19 testing coverage H.R. 6213 - No Cost for COVID-19 Testing Act - Wilson - COVID-19 testing coverage H.R. 6214 - To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program - Kind - Medicare Advantage coverage of COVID-19 related visits and testing H.R. 6222 - Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Schakowsky - coverage of certain new preventative services related to COVID-19 H.R. 6231 - Ensuring Access to COVID-19 Preventive Care Act of 2020 - Bucshon - coverage of certain vaccines and testing services during the COVID-19 emergency H.R. 6299 - Rapid Coverage of COVID-19 Vaccine Act of 2020 - Courtney - COVID-19 coverage H.R. 6317 - To provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Doggett - special enrollment periods in public health emergency H.R. 6338 - To waive high deductible health plan requirements for health savings accounts -Budd - HDHP coverage during COVID H.R. 6486 - Care for COVID-19 Act 2.0 -Ruiz - COVID H.R. 6514 - Worker Health Coverage Protection Act - Scott - COVID H.R. 6518 - Stop Health Premium Spikes Act of 2020 - Peters - risk corridors H.R. 6532 - COVID Special Enrollment Act of 2020 - Doggett - COVID H.R. 6568 - Coverage for COVID-19 Treatment Act of 2020 - Rochester - COVID H.R. 6644 - To require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for services furnished via telehealth if such services would be covered if furnished in-person during the COVID-19 emergency. -Schrier - COVID H.R. 6674 - Medicare Crisis Program Act of 2020 -Jayapal - COVID H.R. 6712 - American Healthshare Plans Act of 2020 - Curtis - health share pools H.R. 6810 - Health Care Protection Act -Davis - COVID H.R. 7006 - Improving Care in Home Health Agencies Act - Velazquez - home health services H.R. 7267 - To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to prohibit a group health plan and a health insurance issuer offering group or individual health insurance coverage from reducing contracted rates, or terminating contracts, with health care providers during a public health emergency. - Porter - ERISA S. 1531 - STOP Surprise Medical Bills Act - Cassidy-Bennet - surprise medical billing S. 1948 - Chronic Disease Management Act - Thune - pre-deductible coverage of chronic disease prevention services S. 2546 - Safe Step Act - Murkowski - Step therapy exceptions S. 3200 - Chronic Disease Management Act of 2020 - Thune - coverage of chronic disease prevention services S. 3383 - Continuing Coverage for Preexisting Conditions Act of 2020 -Kennedy - preexisting conditions S. 3499 - A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Smith - COVID-19 cost -sharing S. 3505 - A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Jones - rapid COVID-19 coverage S. 3536 - A bill to provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Casey - COVID-19 coverage S. 3610 - American Healthshare Plans Act of 2020 - Paul - health share pools S. 3631 - Relief for Rural Providers During Emergencies Act - Sasse - COVID S. 3741 - Health Care at Home Act of 2020 - Smith - COVID S. 3792 - Tele-Mental Health Improvement Act - Smith - parity S. 3821 - Affordable Health Care Options Act of 2020 - Loeffler - affordability S. 3991 - Coronavirus 2019 Special Enrollment Period Act - Duckworth - SEP S. 4106 - A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency - Braun - price transparency Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to COBRA continuation coverage; issues related to behavioral health benefits; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues relating to Medicaid best price; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6258: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: Medical Supply Chain Emergency Act of 2020 - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6457: Disaster and Emergency Pricing Abuse Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6472: COVID-19 Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7269: To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes - Provisions related to FDA provisional approval pathways H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 658: Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act - Provisions related to accelerated approval S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: TRICARE Retail Pharmacy Prescription Medication Expansion Act of 2020 - Provisions related to DoD TRICARE pharmacy benefits program S. 4010: Creating Hope Reauthorization Act - Provisions related to priority review vouchers Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues PDUFA 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 Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

1) Oppose eroding Section 230 speech protections - No specific legislation 2) Support ending duplicative government services that compete with private sector - H.R. 5239 and S. 2990.

Client expense: Not reported · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S1872/HR5076 Protecting Seniors Through Immunization Act S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance 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 Monograph Reform CDC Programmatic Funding Restoration of HSA/FSAs 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 748 - CARES Act -Courtney - COVID-19 coverage H.R. 3630 - No Surprises Act - Pallone - surprise medical billing H.R. 3784 - Air Ambulance Affordability Act of 2019 - Neguse - air ambulances H.R. 4223, Protecting Patients from Surprise Medical Bills Act - Spano - surprise medical billing H.R. 5121 - Healthcare Cost Transparency Act - Beyer - provider price comparison tool H.R. 5239 - Prescription Drug Price Reporting Act - Joyce - reporting on drug expenditures and price changes under group health plans H.R. 5575 - Primary and Behavioral Health Care Access Act of 2020 -Underwood - coverage of primary care and behavioral health visits H.R. 6005 - Know the Price Act - Malinowski - health plan transparency H.R. 6173 - Covering Coronavirus Test Act of 2020 - DeGette - COVID-19 testing coverage H.R. 6193 - Medication Access in Emergencies Act of 2020 - Pappas - coverage of prescription drugs during emergency periods H.R. 6201 - Families First Coronavirus Response Act - Lowey - includes several provisions related to COVID-19 testing coverage H.R. 6213 - No Cost for COVID-19 Testing Act - Wilson - COVID-19 testing coverage H.R. 6214 - To amend title XVIII of the Social Security Act to provide for coverage of testing for COVID-19 at no cost sharing under the Medicare Advantage program - Kind - Medicare Advantage coverage of COVID-19 related visits and testing H.R. 6222 - Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Schakowsky - coverage of certain new preventative services related to COVID-19 H.R. 6231 - Ensuring Access to COVID-19 Preventive Care Act of 2020 - Bucshon - coverage of certain vaccines and testing services during the COVID-19 emergency H.R. 6299 - Rapid Coverage of COVID-19 Vaccine Act of 2020 - Courtney - COVID-19 coverage H.R. 6317 - To provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Doggett - special enrollment periods in public health emergency H.R. 6338 - To waive high deductible health plan requirements for health savings accounts -Budd - HDHP coverage during COVID S. 1531 - STOP Surprise Medical Bills Act - Cassidy-Bennet - surprise medical billing S. 1948 - Chronic Disease Management Act - Thune - pre-deductible coverage of chronic disease prevention services S. 2546 - Safe Step Act - Murkowski - Step therapy exceptions S. 3200 - Chronic Disease Management Act of 2020 - Thune - coverage of chronic disease prevention services S. 3383 - Continuing Coverage for Preexisting Conditions Act of 2020 -Kennedy - preexisting conditions S. 3499 - A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Smith - COVID-19 cost -sharing S. 3505 - A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Jones - rapid COVID-19 coverage S. 3536 - A bill to provide for special enrollment periods during public health emergencies, coverage of services related to public health emergencies, and for other purposes - Casey - COVID-19 coverage Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to COVID-19; issues related to addressing the social determinants of health, including housing, transportation, nutrition, and educational opportunities; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices. - Provisions related to prescription drug pricing H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3468 Preventing Essential Medical Device Shortages Act of 2020 - Provisions related to medical device shortage reporting requirements S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3568: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Antimicrobial resistance 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 Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4244: MAGIC Act - Provisions related to FDA approval pathways H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 - Provisions related to designation of universities as centers of excellence supporting manufacturing H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes. - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Foreign manufacturing 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 Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Monograph Reform, HSA/FSAs S 2740 - Over-the-Counter Monograph Safety S1872/HR5076, Protecting Seniors Through Immunization Act S1654/HR1973, Vaccine Access Improvement Act

S. 350, Competitive Health Insurance Reform Act (Daines) - McCarran-Ferguson Act S. 455, Marketing and Outreach Restoration to Empower Health Education Act (Shaheen) - funding for outreach and education on ACA Exchanges S. 466, Protecting Americans with Preexisting Conditions Act (Warner) - blocking updated Section 1332 guidance S. 560, Ensuring Lasting Smiles Act (Baldwin) - coverage mandate for treatment of congenital anomaly or birth defect S. 741, Cancer Drug Parity Act (Smith) -- cost sharing for oral anticancer drugs S. 913, Disclosure of Price Information to Enrollees (Braun) S. 961, Improving Health Insurance Affordability Act (Shaheen) - premium tax credits S. 964, Marketplace Certainty Act (Shaheen) - cost-sharing subsidies S. 967, Reducing Costs for Out-of-Network Services Act (Shaheen) - caps on out-of-network charges S. 981, Medicare-X Choice Act (Bennet) - public option S. 1033, CHOICE Act (Whitehouse) - public option S. 1125, Protect Act (Tillis) - pre-existing condition protections S. 1129, Medicare for All Act (Sanders) - government health insurance system S. 1170, Association Health Plans Act (Enzi) - codifying final rule for expanding AHPs S. 1266, Protecting Patients from Surprise Medical Bills Act (Scott) - surprise medical billing S. 1531, STOP Surprise Medical Bills Act (Cassidy-Bennet) - surprise medical billing S. 1576, Behavioral Health Coverage Transparency Act (Warren) - mental health parity S. 1577, Know the Price Act (Cassidy-Bennet) - restrictions on provider contracts S. 1737, Mental Health Parity Compliance Act (Murphy) - mental health parity S. 1948, Chronic Disease Management Act (Thune) - pre-deductible coverage of chronic disease prevention services S. 2546, Safe Step Act (Murkowski)-Step therapy exceptions H.R. 692, Pre-existing Conditions Protection Act (Walden) - pre-existing condition protections H.R. 986, Protecting Americans with Preexisting Conditions Act (Kuster) - blocking updated Section 1332 guidance H.R. 987, Marketing and Outreach Restoration to Empower Health Education Act (Blunt Rochester) - funding for outreach and education on ACA Exchanges, Navigator program, and establishment of state-based Health Insurance Exchanges; drug pricing proposals H.R. 1010, Short-Term Plans (Castor) - blocking final rule that expands short-term plans H.R. 1143, Educating Consumers on the Risks of Short-Term Plans Act (Eshoo) - standardized disclosures for short-term plans H.R. 1379, Ensuring Lasting Smiles Act (Peterson) - coverage mandate for treatment of congenital anomaly or birth defect H.R. 1384, Medicare for All Act (Jayapal) - government health insurance system H.R. 1385, State Allowance for a Variety of Exchanges Act (Kim) - funding for establishment of state-based Health Insurance Exchanges H.R. 1386, Expand Navigators Resources for Outreach, Learning, and Longevity Act (Castor) - funding for Navigator Program H.R. 1418, Competitive Health Insurance Reform Act (DeFazio) - McCarran-Ferguson Act H.R. 1425, State Health Care Premium Reduction Act (Craig) - funding for state reinsurance programs H.R. 1510, Premium Relief Act (Burgess) -- Patient and State Stability Fund H.R. 1730, Cancer Drug Parity Act (Higgins) -- cost sharing for oral anticancer drugs H.R. 1884, Protecting Pre-Existing Conditions and Making Health Care More Affordable Act (Pallone) - reinsurance funding, stabilization and affordability proposals H.R. 2000, Medicare-X Choice Act (Delgado) - public option H.R. 2061, Pathway to Universal Coverage Act (Bera) - auto-enrollment H.R. 2085, CHOICE Act (Schakowsky) - public option H.R. 2183, State Flexibility and Patient Choice Act (Marshall) - flexibility in state innovation waivers H.R. 2848, Parity Enforcement Act (Norcross) - mental health parity H.R. 2874, Behavioral Health Coverage Transparency Act (Kennedy) - mental health parity H.R. 3165, Mental Health Parity Compliance Act (Porter) - mental health parity H.R. 3502, Protecting People From Surprise Medical Bills Act (Ruiz) - surprise medical billing H.R. 3630, No Surprises Act (Pallone)-surprise medical billing H.R. 3784, Air Ambulance Affordability Act of 2019 (Neguse)- air ambulances H.R. 4223, Protecting Patients from Surprise Medical Bills Act (Spano)-surprise medical billing H.R. 4379, Under Performing Directories that Affect Treating Emergencies Act (Axne)-provider directories H.R. 4457, Chronic Condition Copay Elimination Act (Underwood)- Eliminating copays for services/drugs for chronic conditions H.R. 4484, Flexibility Through Lower Expenses Health Care Act (Budd)-STLDI plans H.R. 4530, Native American Health Savings Improvement Act (Moolenaar)-HSAs H.R. 4575, Improving Provider Directories Act (Schrier)-provider directories H.R. 5010, State-Based Universal Health Care Act of 2019 (Khanna) - universal health care systems H.R. 5121, Healthcare Cost Transparency Act (Beyer) - provider price comparison tool H.R. 5144, Insurance Accountability and Transparency Act (Davids) - insurance have publicly accessible self-audit information H.R. 5239 Prescription Drug Price Reporting Act (Joyce) - reporting on drug expenditures and price changes under group health plans H. Res. 271 (Allred) - resolution urging DOJ to reverse position in Texas v. United States litigation Regulatory Issues: Insurance regulatory reform; issues related to the coordination of private and public disability income benefits; disability risk management; disability income insurance enrollment and awareness; issues related to encouraging impaired workers to stay in/return to the workforce; issues related to expanding long-term care insurance coverage; issues relating to the coordination of benefits between private health insurance plans and Medicaid; Medigap claims processing and crossover fees; Medigap cross-over claim issues, Medigap coverage, implementation of Medigap standardized plan offerings; Medigap carrier recoveries related to CMS fraud and abuse enforcement activities, and issues related to Medigap educational materials, and other Medigap issues; fraud and abuse issues affecting public and private insurance coverage; issues relating to antitrust; implementation of the Mental Health Parity Act requirements; implementation of the 21st Century Cures Act requirements; summary of benefits and coverage disclosures; prior authorization; accountable care organizations; coverage of preventive services; preexisting condition exclusions; lifetime and annual dollar limits on benefits; patient protections; grandfathered health plan provisions; health reimbursement accounts; dependent coverage; treatment of expatriate plans; issues related to surprise medical bills; issues related to all payor claims databases; issues related to association health plans; issues related to substance abuse and provider treatment records (42 CFR Part 2); issues related to medical management; issues related to fraud, waste, abuse, Stark/Anti-Kickback laws and regulations, non-discriminatory wellness programs; issues related to supplemental products; issues relating to dental coverage; issues relating to proposals for single-payer and Medicare/Medicaid buy-in options; issues related to implementation of the Telephone Consumer Protection Act; issues relating to third party payment of premiums; issues related to cost-sharing reductions (CSRs); issues related to interoperability and price transparency; issues related to the employer market; issues relating to the individual market; and other issues relating to health care reform implementation.

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2732: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 - Provisions related to labeling of prescription drugs H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4010: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug access programs H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4814: Suspicious Order Identification Act of 2019 - Provisions related to reporting on distribution of controlled substances H.R. 4906: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices - Provisions related to prescription drug pricing H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Foreign manufacturing 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 Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)

S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.4633 - Investing in Safety and Innovation Act of 2019 H.R.5239 - Prescription Drug Price Reporting Act H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues