Lower Insulin Costs Now Act

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; policies impacting Medicare coverage and reimbursement for prescription drugs; H.R.938, BLOCKING Act of 2019; H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019; H.R.5444, Lower Insulin Costs Now Act; Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.6482/S.3537/S.3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020; H.R.6431, Made in America Emergency Preparedness Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID H.R. 8190 - Biosimilar Insulin Access Act of 2020 - Grothman - insulin biosimilar S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency S. 4134 - Increasing Access to Biosimilars Act of 2020 - Cornyn - CMS demonstration project; provider payments for providing biosimilars S. 4199 - Prescription Drug Pricing Reduction Act of 2020 - Grassley - lower drug prices in Medicare and Medicaid/ transparency S. 4439 - Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020 - Smith - COVID-19 drug be affordable and accessible Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $200,000 · Firm income: Not reported

H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; pharmaceutical supply chain; H.R.938, BLOCKING Act of 2019; H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019; S.1895, Lower Health Care Costs Act of 2019; H.R.5444, Lower Insulin Costs Now Act; H.R.6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.116-123); H.R.6201, Families First Coronavirus Response Act (P.L.116-127); H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.6482/S.3537/S.3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020; H.R.6431, Made in America Emergency Preparedness Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $160,000 · Firm income: Not reported

H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6426 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines; Coronavirus impact and response; H.R.965, CREATES Act of 2019; H.R.938, BLOCKING Act of 2019; H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019; S.1895, Lower Health Care Costs Act of 2019; H.R.5444, Lower Insulin Costs Now Act; H.R.6074, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L.116-123); H.R.6201, Families First Coronavirus Response Act (P.L.116-127); H.R.748, CARES Act (P.L.116-136).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act S. 3052, Grassley, the US, Mexico and Canada Trade Agreement Implementation Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D HR 4378, Continuing Appropriations and Health Extenders Act S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $670,000 · Firm income: Not reported

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Risk Evaluation and Mitigation Strategies (REMS), H.R. 985 - FAST Generics Act of 2019, S. 340, H.R. 965 - CREATES Act of 2019 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics, S. 2103 - Affordable Insulin Approvals Now Act, H.R. 5444 - Lower Insulin Costs Now Act Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543, Prescription Drug Pricing Reduction Act S. 1416, Affordable Prescriptions for Patients Act S. 1895 Lower Health Care Costs Act of 2019 H.R. 3- Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act S. 64, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act

Client expense: $630,000 · Firm income: Not reported

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Legislation and regulations related to pharmaceuticals and medical products, and access to affordable medicines. H.R.965, CREATES Act of 2019. H.R.938, BLOCKING Act of 2019. H.R.1499, Protecting Consumer Access to Generic Drugs Act of 2019. S.1895, Lower Health Care Costs Act of 2019. H.R.5444, Lower Insulin Costs Now Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act S. 3052, Grassley, the US, Mexico and Canada Trade Agreement Implementation Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D HR 4378, Continuing Appropriations and Health Extenders Act S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $670,000 · Firm income: Not reported

Drug Pricing. H.R. 3, the Lower Drug Costs Now Act: Proposals authorizing the Secretary of Health and Human Services (HHS) to negotiate drug prices on behalf of Medicare with pharmaceutical manufacturers; creating a maximum price for any negotiated drug with an international price index (Average International Market price), requiring drug manufacturers that refuse to negotiation with HHS to pay a non-compliance fee of 65% of the gross sales of the drug in question; requiring drug companies that raised the price of a drug in Medicare above the rate of inflation since 2016 to either lower the price or pay the entire price above inflation in a rebate back to the Treasury; creating a $2,000 Medicare beneficiary annual out-of-pocket cost cap for prescription drugs. Drug Pricing. S. 2543, the Prescription Drug Pricing Reduction Act of 2019: Proposals to require pharmaceutical manufacturers to rebate Medicare if they raise prices for drugs covered by Medicare Parts B and D faster than inflation; to establish an out-of-pocket spending limit in which Medicare beneficiaries would pay no more than $3,100 a year on drug costs; to require Medicare Part D private insurers to pay 60% and, drug manufacturers 20%, of the costs incurred over the out-of-pocket spending cap; to increase transparency into pharmacy benefit manager practices and manufacturer drug pricing decisions; and to provide state Medicaid programs with increased authority to contain drug prices. Medicaid Home and Community-Based Services. H.R. 1865: Proposals to extend permanently the spousal impoverishment protections for Medicaid home and community-based services and to extend permanently Money Follows the Person which provides grants to states for initiatives for people requiring long term care to receive Medicaid services and supports in their homes. Medicare Prescription Drug Costs. (No bill): Proposal to require pharmacists to disclose to patients when the the patient copayment exceeds the total cost of the drug to their insurer or pharmacy benefits manager. Medicare Prescription Drug Costs. (No bill): Provisions of the United States-Mexico-Canada Agreement (formerly the North American Free Trade Agreement) addressing countries having expansive regulatory approval monopolies for biologic drugs and restricting the ability of Congress to reform patent laws that drive up drug costs for Medicare. Medicare Prescription Drug Costs, H.R. 1865: Proposal to reduce the threshold for entering the catastrophic phase of the Part D benefit to a point where seniors only pay five percent of their drug costs instead of 25%. Medicare Coverage Expansion. H.R 3, the Lower Drug Costs Now Act: Proposals to expand Medicare coverage to include, vision, dental and hearing benefits. Medicare Coverage Expansion. H.R. 3, the Lower Drug Costs Now Act: Proposals to expand eligibility for the Low-Income Subsidy and Medicare Savings Program. Medicare Open Enrollment. (No bill): Proposals to ensure the Centers for Medicare and Medicaid Services conducts open enrollment in a manner that is unbiased toward the traditional Medicare program. Medigap Reform. H.R. 3, the Lower Drug Costs Now Act: Proposal to improve quality of coverage and access to Medigap by extending guaranteed issue to disabled people and other beneficiaries. Medicare Enrollment. H.R. 1865: Proposal to improve beneficiary education tools and extend funding for state health insurance and assistance programs. Reducing Health Care Costs. S. 1895: Proposal to eliminate surprise medical billing including out-of-network charges in emergencies. Insulin Costs. H.R. 5444, The Lower Insulin Costs Now Act: Proposal to require the Food and Drug Administration (FDA) to continue reviewing generic insulin applications after the Agencys currently planned March 2020 cut-off date, i.e., ensuring that any existing generic insulin applications would continue to receive FDA review. Medicare Part B Penalty. H.R. 1788: Proposal to cap at two years the period for accrual of the penalty for delayed enrollment into Part B; to prevent individuals with Veterans or retiree coverage or who maintain COBRA coverage through a former employer from having to pay the Part B penalty for the remainder of the time they are covered under Part B. Medicare Savings Program. H.R. 4671: Proposal to reduce cost-sharing, align income and resource eligibility tests, simplify enrollment, and other program improvements for low-income Medicare beneficiaries. Medicaid restructuring. (No bill): Proposal by the state of Tennessee to block grant Medicaid.