Medical Innovation Act of 2019

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)

Client expense: $6,450,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R.1897 MOMMA's Act - Federal efforts with respect to the prevention of maternal mortality S.340/H.R.965CREATES - facilitate the timely entry of lower-cost generic and biosimilar versions of drugs and biological products H.R. 938 the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 - eligibility for FDA approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval H.R. 1499, the Protecting Consumer Access to Generic Drugs Act of 2019 - pay for delay; prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products H.R.2113 Prescription Drug STAR Act - require drug manufacturer price transparency, to require certain manufacturers to report on product samples provided to certain health care providers H.R.2296, S.1391 FAIR Drug Pricing Act - Rx pricing transparency, require manufacturers to justify price increases S.1531STOP Surprise Medical Bills Act - provide protections for health insurance consumers from surprise billing H.R.861 - End Surprise Billing Act of 2019 - prevent surprise billing practices and require notification for consumers S.1895 Lower Health Care Costs Act - comprehensive legislation to end surprise medical bills, reduce prescription drug prices, improve health care transparency, improve public health, improve exchange of health information H.R. 3630 No Surprises Act - legislation to protect consumers from surprise medical bills, using median in network rate and an option to go to arbitration for bills above $1250. H.R. 3502 Protecting People From Surprise Medical Bills Act - legislation to protect consumers from surprise medical bills, arbitration as payment mechanism H.R.748, S. 684Middle Class Health Benefits Tax Repeal Act of 2019 - repeal the excise tax on high value employer-sponsored health care coverage, also known as the Cadillac Tax H.R.2411/S.1258 Tobacco to 21 Act - prohibit the sale of tobacco products to individuals under the age of 21 H.R.2339 Reversing the Youth Tobacco Epidemic Act - legislation to curb the rise of youth tobacco use H.R. 4548 Asthma Care and Prevention in Rural Communities Act -authorize CDC to award grants to eligible counties for the use of mobile clinics and distance learning and telemedicine to diagnose and treat children with asthma in rural areas and medically underserved communities, H.R.4575 - Improving Provider Directories Act - require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers H.R.1983 Community Health Investment, Modernization, and Excellence Act of 2019 - reauthorize and extend funding for community health centers and the National Health Service Corp H.R.5230 - Elijah E. Cummings Family Asthma Act - create programs to better educate families on asthma management and prevention, and would improve asthma research and data collection to help target asthma interventions more effectively S.2492STANDUP Act - provide best practices on student suicide awareness and prevention training and condition H.R.5031 Medical Innovation Act - authorize the collection of supplemental payments to increase congressional investments in medical research S.3162 Affordable Drug Manufacturing Act - establish an Office of Drug Manufacturing. Legislation requiring NAS to do a study on SUD treatment for minorities and underserved communities Kids Access to Primary Care Act - expanding kids access to primary care by aligning Medicaid reimbursement rates with Medicare payments No Surprise Bills for New Moms Act - Require all health plans and insurers to cover newborns under their mothers coverage for 14 days after birth Legislation around gathering research around projects that work to positively alter outcomes for children at risk of experiencing ACEs HEAA - comprehensive legislation to address health inequities and ensure that health and health care disparities elimination are prioritized Legislation to prevent air ambulances from balance billing patients Legislation to require health care facilities and providers to give patients a list of services received upon discharge Legislation to reauthorize the Patient-Centered Outcomes Research Institute (PCORI)

Client expense: $20,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE