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Make Medications Affordable by Preventing Pandemic Price gouging Act of 2020 or the MMAPPP Act of 2020 This bill imposes licensing and price restrictions on federally supported drugs and other medicines intended to address COVID-19 (i.e., coronavirus disease 2019) or other public health emergencies. With respect to a COVID-19 drug patent developed using certain types of federal support, any license granted by the federal government shall be open and nonexclusive. Similarly, a licensee or assignee for such a patent shall grant open nonexclusive licenses for the patent. An entity that receives a license shall pay reasonable royalties to (1) the patent holder, or (2) the owner of marketing exclusivity rights granted by the Food and Drug Administration (FDA) that were terminated under this bill. The bill requires that such drugs be offered at a fair and reasonable price based on certain considerations, such as access. If the Department of Health and Human Services (HHS) finds that the price of any drug to address a public health emergency is excessive, HHS must void any FDA-granted exclusivity for the drug and grant open and nonexclusive licenses to other manufacturers. Such licenses are subject to reasonable royalty requirements.
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Filing registrants (8)
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Science, Space, and Technology, and Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · fourth_quarter · Copyright/Patent/Trademark
S. 1224, Stop STALLING Act S. 1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 3991-Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections
Client expense: $2,030,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Copyright/Patent/Trademark
S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act H.R. 4398 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues
Client expense: $2,750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Copyright/Patent/Trademark
S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues
Client expense: $1,930,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
-H.R. 748 - CARES ACT -H.R. 6800 - The Heroes Act, provisions related to private insurance coverage and federal funding of Medicaid -H.R.1425 - Patient Protection and Affordable Care Enhancement Act, provisions related to reinsurance programs and employer requirements for dependent health care coverage -H.R.7288 - Taxpayer Research and Coronavirus Knowledge Act, provisions related to required manufacturer reporting of funding for research and development of medicines -H.R.7296 - Make Medications Affordable by Preventing Pandemic Price gouging, provisions related to government negotiation of prices for medications to treat COVID-19 -urging for OSHA emergency temporary standard -Veterans Affairs health and Safety, Education (no bill number) -Defense Production Act used for PPE -Defense Production Act and on additional funding state Medicaid programs. -Medicaid waiver proposed by the State of Oklahoma -Section 1557 regulations (HHS)
Client expense: $760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Pharmacy
H.R. 7296 (MMAPPP Act); H.R. 7288 (TRACK Act); Patents for Humanity Program Improvement Act; transparency for federally support covid R&D; covid-19 medicine pricing and access, Drug pricing, Covid 19 Medicine pricing, manufacture and access,
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · third_quarter · Pharmacy
H.R. 7296 (MMAPPP Act); H.R. 7288 (TRACK Act); Patents for Humanity Program Improvement Act; transparency for federally support covid R&D; covid-19 medicine pricing and access, Drug pricing, Covid 19 Medicine pricing, manufacture and access,
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · fourth_quarter · Medicare/Medicaid
Additional Coronavirus Health Care Relief. S. 178, H.R. 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the Medicaid federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for Medicaid home and community-based services; improve nursing home oversight, provide funding for COVID testing; ensure tele-visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health Care Extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend the Medicaid Money Follows the Person Program which provides states money to keep seniors in their homes; and extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Enrollment. H.R. 2477, the BENES Act of 2020, changes the Medicare general enrollment period to October 15-December 31, and requires coverage to begin on the first day of the month following enrollment. (The general enrollment period has been January 1-March 31, and coverage begins July 1.) Medicare Enrollment. H.R. 2564, Medicare Enrollment Protection Act: Proposal to bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) -a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. Medicare Enrollment. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to extending funding for enrollment assistance to help low-income seniors access the Medicare Prescription Drug Program Part D Low-Income Subsidy. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic. Medical Expense Deduction. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to include a permanent extension of the 7.5 percent threshold for the medical expense deduction. Medicare Structure. Letter to Biden Transition team. Proposals to modify Medicare including changing to premium support model, lowering the eligibility age, furthering privatization of the program, adding hearing dental and vision coverage. Medicare Prescription Drugs: Letter to Biden transition team. Proposals to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Drug Pricing. Letter to Biden transition team. Proposals to allow generics to come to market earlier by limiting brand manufacturers ability to pay generics to delay entering the market. Short Term Care Coverage. H.R. 1682, Improving Access to Medicare Coverage Act of 2019: Proposal to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes.
2020 · fourth_quarter · Health Issues
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. 2374: Stop STALLING Act - Provisions related to citizen petitions 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. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements 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: 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. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency 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 - Provisions related to accumulator adjustment programs H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development 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. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions 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. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing 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: 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 S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development 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 Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and 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 Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) 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, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26)
2020 · fourth_quarter · Copyright/Patent/Trademark
S. 1224, Stop STALLING Act S. 1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 3991-Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R. 5133--Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 1503 - the Orange Book Transparency Act; and H.R. 1520 - Orange Book Transparency Act of 2019; H.R. 3 - Lower Drug Costs Now Act of 2019 - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Domestic and international compulsory licensing issues - March-in Rights - Product hopping - Orange and purple book disclosures - Hatch Waxman litigation - Trade secret protections
Client expense: $2,020,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Health Issues
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. 2374: Stop STALLING Act - Provisions related to citizen petitions 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. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 a Provisions related to prescription drug pricing and access H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements 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. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency 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 - Provisions related to accumulator adjustment programs H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 8894: To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes - Provisions related to FDA authority and prescription drugs H.R. 8920: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to anti-microbial resistant and prescription drug development 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. 1169: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions S. 1224: Stop STALLING Act - Provisions related to citizen petitions 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. 1872/H.R. 5075: Protecting Seniors Through Immunization Act S. 4864/H.R. 8725: HAPI Act; Medicaid financial barriers S. 1619/H.R. 2862: VACCINES Act CMSS. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity CMS rule on Value Based Payment purchasing, 85 FR 37286, CMS-2482-P, provisions related to the definition of line-extension drugs. S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing CBD DSHEA 2.0 S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals 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 S. 4427: SAVE Act - Provisions related to the FDA drug approval process S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls S. 4760: The PASTEUR Act - Provisions related to anti-microbial resistant and prescription drug development 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 Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and 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 mandatoruy recall authority policy issues Pharmaceutical supply chain policy issues COVID-19 policy issues Final Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13950, Combating Race and Sex Stereotyping (September 22, 2020) 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, Combating Public Health Emergencies and Strengthening Na- tional Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Proposed Rule: Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation (RIN 0906-AB26) Amendments to HHS Covid-19 Declaration
2020 · fourth_quarter · Health Issues
COBRA support S.4653, A bill to protect the healthcare of hundreds of millions of people of the United States and prevent efforts of the Department of Justice to advocate courts to strike down the Patient Protection and Affordable Care Act, Entirety Monitor the following: Executive actions on An America-First Healthcare Plan Executive Order on Lowering Drug Prices by Putting America First Executive Order on Improving Rural Health and Telehealth Access Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Executive Order on Increasing Drug Importation to Lower Prices for American Patients Executive Order on Access to Affordable Life-saving Medications Healthcare extenders: continued delay of cuts to payments supporting disproportionate share hospitals and an extension of funding for Community Health Centers H.R.3, Lower Drug Costs Now Act, Entirety H.R. 1309/S.851, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues S.1357, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act, Entirety Surprise medical billing, generally Nurse Overtime and Patient Safety Act, Entirety H.R.5800, The Ban Surprise Billing Act, Entirety H.R.5826, Consumer Protections Against Surprise Medical Bills Act, Entirety S.696 the National Nurse Act, Entirety H.R. 1425, the Patient Protection and Affordable Care Enhancement Act, Entirety Health Equity Issues during COVID Pandemic S.3763, Pandemic Responder Service Award Act, Entirety H.R.7288, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety H.R.7113, COVID-19 Emergency Manufacturing Act, Entirety S.3799, HEAL for Immigrant Women and Families Act, Entirety National Infrastructure for Mitigating the Impact of COVID-19 within Racial and Ethnic Minority Communities grant program Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Nondiscrimination in Health and Health Education Programs and Activities, Final Rule (RIN 0945-AA11) Delivery of healthcare services to students during COVID pandemic Telehealth issues S.3599 Healthcare Workforce Resilience Act Political interference in work of experts H.R.6514, Worker Health Coverage Protection Act Emergency PPE Petition Department of Health and Human Services Regulations/Programs, Proposed Rule: Securing Updated and Necessary Statutory Evaluations Timely (Sunset Proposal)
2020 · fourth_quarter · Medicare/Medicaid
Additional Coronavirus Health Care Relief. S. 178, H.R. 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the Medicaid federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for Medicaid home and community-based services; improve nursing home oversight, provide funding for COVID testing; ensure tele-visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health Care Extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend the Medicaid Money Follows the Person Program which provides states money to keep seniors in their homes; and extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Enrollment. H.R. 2477, the BENES Act of 2020, changes the Medicare general enrollment period to October 15-December 31, and requires coverage to begin on the first day of the month following enrollment. (The general enrollment period has been January 1-March 31, and coverage begins July 1.) Medicare Enrollment. H.R. 2564, Medicare Enrollment Protection Act: Proposal to bill creates a special Medicare enrollment period for individuals enrolled in, or transitioning out of, continuation coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) -a federal law that allows an individual to maintain health coverage following loss of coverage due to termination of employment or another qualifying event. Medicare Enrollment. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to extending funding for enrollment assistance to help low-income seniors access the Medicare Prescription Drug Program Part D Low-Income Subsidy. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic. Medical Expense Deduction. The Consolidated Appropriations Act of 2021 (P.L. 116-260): Proposal to include a permanent extension of the 7.5 percent threshold for the medical expense deduction. Medicare Structure. Letter to Biden Transition team. Proposals to modify Medicare including changing to premium support model, lowering the eligibility age, furthering privatization of the program, adding hearing dental and vision coverage. Medicare Prescription Drugs: Letter to Biden transition team. Proposals to allow Medicare to negotiate prices with drug makers, cap prices at inflation in Part B and D, cap beneficiary out-of-pocket costs in Part D. Drug Pricing. Letter to Biden transition team. Proposals to allow generics to come to market earlier by limiting brand manufacturers ability to pay generics to delay entering the market. Short Term Care Coverage. H.R. 1682, Improving Access to Medicare Coverage Act of 2019: Proposal to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes.
2020 · fourth_quarter · Pharmacy
Medicare drug price regulation, HR 7296/S 4439 (MMAAPP Act), HR 7288/S 4539 (TRACK Act), transparency for federally support COVID R&D,COVID-19 Medicine pricing and access, HR 4663-Freedom from Price Gouging Act, HR 1093/S 378-Stop Price Gouging Act, S 3847/HR 7113 (COVID 19 Emergency Manufacturing Act, CARES 2.0-S.1712/HR4100-DISARM Act, S 4760-PASTEUR Act, Antibiotic drug development, Prescription drug transparency, S 1416/HR 5133, S-64,HR-2374,HR-3379-Pharma competition legislation, Medicare Part B drug reimbursement
Client expense: $130,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Copyright/Patent/Trademark
H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks 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 Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $1,210,000 · Firm income: Not reported
2020 · third_quarter · Health Issues
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. 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. 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. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing 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 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 - Provisions related to accumulator adjustment programs H.R. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 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. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls 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 Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) 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 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Executive Order 13937, Access to Affordable Life-saving Medications (July 24, 2020) Proposed Rule; Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2020 · third_quarter · Medicare/Medicaid
Additional Coronavirus Health Care Relief. S. 178, H.R 925, S. 4108, H.R. 6539 and H.R. 6800: Proposals to increase the federal medical assistance percentage (FMAP), expand Medicare coverage for COVID related services, increase FMAP funding specifically for home and community based services; improve nursing home oversight, provide funding for COVID testing; ensure tele visitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Drug Database. H.R. 7288 and S. 4539, the Taxpayer Research and Coronavirus Knowledge Act of 2020: Proposals to require a single user-friendly database of federal biomedical investments in COVID-19 vaccines, drugs, therapies, medical devices, or other products. COVID Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price-gouging Act: Proposals to prohibit pharmaceutical companies from exclusive licensing of drugs used to treat or prevent COVID-19. Health care extenders. H.R. 8337, the Continuing Appropriations Act, 2021: Proposals to extend Money Follows the Person Program which provides states money to keep seniors in their homes; extend spousal impoverishment protections in Medicaid to long term care services provided in the home. Infection Control in Nursing Homes. H.R. 6698 and S. 3644, the Quality Care for Nursing Home Residents and Workers During COVID-19 Act: Proposal to authorize $500 million for states to establish expert strike teams for resident and worker safety to be deployed within 72 hours of 3+ confirmed or suspected COVID-19 cases in a facility. Medicare Coverage of Vaccines. H.R. 5076 and S. 1872, the Protecting Seniors Through Immunization Act of 2019: Proposals to expand Medicare to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices without any cost-sharing for Part D. Medicare Part B premiums. The Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159). Proposal to freeze the Medicare Part B standard monthly premium to a fee equal to 25% percent of the difference between the 2020 amount and the preliminary monthly actuarial rate for 2021. Medicare Telehealth. Proposal to support efforts at Center for Medicare and Medicaid Services to continue access to telehealth during the COVID pandemic. Nursing Home Telehealth Visitation. H.R. 6487 and S. 3517, the ACCESS Act: Proposal requiring that residents have access to telehealth visitation during the pandemic.
-H.R. 6800 - The HEROES Act (subsidies for COBRA health coverage and the federal FMAP Medicaid funding) -H.R. 8406 - The HEROES Act (Information on ACA coverage; Subsidies for COBRA coverage and federal FMAP Medicaid funding) - S. 4714, Worker Health Coverage Protection Act (Subsidies for COBRA coverage) - H.R. 7296, Make Medications Affordable by Preventing Pandemic Price Gouging Act (Provisions relating to securing reasonable royalties for COVID-19 drug therapies)
Client expense: $640,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (H.R. 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Second Look at Drug Patents Act of 2019 (S. 1617); Recall Unsafe Drugs Act of 2020 (H.R. 5578); Executive Order 13944; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393); Drug recalls, registration and listing, inspections, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (H.R. 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Potential Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board; Executive Order 13948; Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts.
2020 · third_quarter · Health Issues
S.3599 Healthcare Workforce Resilience Act Political interference in work of experts H.R.6514, Worker Health Coverage Protection Act Emergency PPE Petition, AFT H.R.1603, Alan Reinstein Ban Asbestos Now Act of 2019, Entirety S.4653, A bill to protect the healthcare of hundreds of millions of people of the United States and prevent efforts of the Department of Justice to advocate courts to strike down the Patient Protection and Affordable Care Act, Entirety Monitor the following: Executive actions on An America-First Healthcare Plan Executive Order on Lowering Drug Prices by Putting America First Executive Order on Improving Rural Health and Telehealth Access Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen Executive Order on Increasing Drug Importation to Lower Prices for American Patients Executive Order on Access to Affordable Life-saving Medications Healthcare extenders: continued delay of cuts to payments supporting disproportionate share hospitals and an extension of funding for Community Health Centers H.R.3, Lower Drug Costs Now Act, Entirety H.R. 1309/S.851, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues S.1357, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act, Entirety Surprise medical billing, generally Nurse Overtime and Patient Safety Act, Entirety H.R.5800, The Ban Surprise Billing Act, Entirety H.R.5826, Consumer Protections Against Surprise Medical Bills Act, Entirety S.696 the National Nurse Act, Entirety H.R. 1425, the Patient Protection and Affordable Care Enhancement Act, Entirety Health Equity Issues during COVID Pandemic S.3763, Pandemic Responder Service Award Act, Entirety H.R.7288, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety H.R.7113, COVID-19 Emergency Manufacturing Act, Entirety S.3799, HEAL for Immigrant Women and Families Act, Entirety National Infrastructure for Mitigating the Impact of COVID-19 within Racial and Ethnic Minority Communities grant program Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Nondiscrimination in Health and Health Education Programs and Activities, Final Rule (RIN 0945-AA11) FDA/FTC Workshop on a Competitive Marketplace for Biosimilars Docket No. FDA-2019-N-6050, FDA Delivery of healthcare services to students during COVID pandemic Telehealth issues
2020 · third_quarter · Health Issues
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. 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. 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: 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. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing 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 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 - Provisions related to accumulator adjustment programs H.R. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage 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. 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. 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: 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. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls 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 Transparency policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) 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 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Executive Order 13937, Access to Affordable Life-saving Medications (July 24, 2020) Proposed Rule; Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
2020 · third_quarter · Copyright/Patent/Trademark
H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks 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 Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues
Client expense: $5,960,000 · Firm income: Not reported
2020 · third_quarter · Copyright/Patent/Trademark
S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act H.R. 4398 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 H.R. 1503, the Orange Book Transparency Act;consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues
Client expense: $2,710,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · third_quarter · Pharmacy
H.R. 7296 (MMAPPP Act); H.R. 7288 (TRACK Act); Patents for Humanity Program Improvement Act; transparency for federally support covid R&D; covid-19 medicine pricing and access, Drug pricing, Covid 19 Medicine pricing, manufacture and access,
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · second_quarter · Medicare/Medicaid
COVID-19 Relief. H.R. 6800, the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act: Proposals to increase the federal medical assistance percentage (FMAP), increase FMAP funding specifically for home and community based services; improve nursing home oversight, provide funding for COVID testing; ensure televisitation for nursing home residents, and eliminate cost sharing for COVID treatment. COVID Relief. H.R. 6514, the Worker Health Coverage Protection Act: Proposal to subsidize the Consolidated Omnibus Budget Reconciliation Act (COBRA) coverage premiums for individuals who lose employer coverage due to COVID-19. Drug Pricing. H.R. 7296, the Make Medications Affordable by Preventing Pandemic Price Gouging Act of 2020: Proposal to require that drugs developed with government funding have open and not exclusive license in order to promote more competition to bring drug prices down. Drug Pricing. H.R. 7288, the Taxpayer Research and Coronavirus Knowledge Act: Proposal to establish a database of all taxpayer investments in COVID-19 drugs. Long-Term Services and Supports During the COVID-19 Pandemic. H.R. 6698, the Quality of Care for Nursing Home Residents During COVID-19 Act of 2020: Proposals to require facilities to have a full-time infection interventionist on staff; regularly test residents and staff; provide enough personal protective equipment (PPE) for all employees and report PPE shortages at least 24 hours before shortage is expected to occur; offer at least two weeks of paid sick leave to each employee; and facilitate virtual visits for residents who cannot receive visitors to look in on them during lockdown. Long-Term Services and Supports Telehealth. H.R. 6487, the Advancing Connectivity during the Coronavirus to Ensure Support for Seniors (ACCESS) Act: Proposals to provide an emergency supplemental appropriation of $50 million to the Department of Health and Human Services to assist nursing homes expand their use of telehealth services and to establish a grant program to allow nursing home residents to participate in virtual visits. Medicare Enrollment. S. 1280 and H.R. 2477, the Beneficiary Enrollment Notification and Eligibility Simplification (BENES) Act: Proposals which would improve Medicare beneficiary notification of enrollment rules, align enrollment periods, and eliminate coverage gaps for those who miss their initial enrollment period and sign up during the general enrollment period. Medicare Savings Program and Medicaid Long-Term Services and Supports: S. 3544 and H.R. 6305, the Coronavirus Relief for Seniors and People with Disabilities Act: Proposals to increase funding for Medicaid home and community-based services including improving rates for homecare workers and funding sick leave; and to streamline processes so that more low-income beneficiaries would get assistance with their Medicare premiums and cost sharing through the Medicare Savings Program. Medicaid. (No bill): Proposal by the State of Oklahoma to obtain a waiver from the Centers for Medicare and Medicaid Services to turn their state Medicaid program into a block grant program. Medicaid. S. 4108, the Coronavirus Medicaid Response Act: Proposal to make FMAP increases automatic when there is an economic downturn. Drug Costs. H.R. 6649, the Lower Drug Costs for Seniors During COVID-19: Proposal to allow individuals to spread out the upfront costs for a 90-day refill during the COVID-19 emergency period.
2020 · second_quarter · Health Issues
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
2020 · second_quarter · Health Issues
H.R. 1425, the Patient Protection and Affordable Care Enhancement Act, Entirety Health Equity Issues during COVID Pandemic S.3763, Pandemic Responder Service Award Act, Entirety H.R.7288, Taxpayer Research and Coronavirus Knowledge Act, Entirety H.R.7296, Make Medications Affordable by Preventing Pandemic Pricegouging Act, Entirety H.R.7113, COVID-19 Emergency Manufacturing Act, Entirety S.3799, HEAL for Immigrant Women and Families Act, Entirety National Infrastructure for Mitigating the Impact of COVID-19 within Racial and Ethnic Minority Communities grant program Support Medicare/ACA enrollment H.R. 6637, Health Equity and Accountability Act, Entirety Nondiscrimination in Health and Health Education Programs and Activities, Final Rule (RIN 0945-AA11) FDA/FTC Workshop on a Competitive Marketplace for Biosimilars Docket No. FDA-2019-N-6050, FDA Delivery of healthcare services to students during COVID pandemic Monitor the following: H.R.3, Lower Drug Costs Now Act, Entirety H.R. 1309/S.851, Workplace Violence Prevention for Health Care and Social Service Workers Act, Entirety Affordability of pharmaceuticals, generally Treating gun violence as a public health epidemic related issues S.1357, Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act, Entirety Surprise medical billing, generally Nurse Overtime and Patient Safety Act, Entirety H.R.5800, The Ban Surprise Billing Act, Entirety H.R.5826, Consumer Protections Against Surprise Medical Bills Act, Entirety S.696 the National Nurse Act, Entirety
Client expense: $440,000 · Firm income: Not reported
2020 · second_quarter · Copyright/Patent/Trademark
S.659 - Biologic Patent Transparency Act S. 1227, Prescription Pricing for the People Act of 2019 S. 1224, Stop STALLING Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R. 7296, Medications Affordable by Preventing Pandemic Price Gouging Act (MMAPPP) Act of 2020 H.R. 7288 Taxpayer Research and Coronavirus Knowledge (TRACK) Act - Intellectual property and process patent issues - Patent litigation reform - IPR process - Section 101 Reform - Compulsory licensing issues
Client expense: $1,910,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Health Issues
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
-H.R. 748 - CARES ACT -H.R. 6800 - The Heroes Act, provisions related to private insurance coverage and federal funding of Medicaid -H.R.1425 - Patient Protection and Affordable Care Enhancement Act, provisions related to reinsurance programs and employer requirements for dependent health care coverage -H.R.7288 - Taxpayer Research and Coronavirus Knowledge Act, provisions related to required manufacturer reporting of funding for research and development of medicines -H.R.7296 - Make Medications Affordable by Preventing Pandemic Price gouging, provisions related to government negotiation of prices for medications to treat COVID-19 -urging for OSHA emergency temporary standard -Veterans Affairs health and Safety, Education (no bill number) -Defense Production Act used for PPE -Defense Production Act and on additional funding state Medicaid programs. -Medicaid waiver proposed by the State of Oklahoma -Section 1557 regulations (HHS)
Client expense: $760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); National Defense Authorization Act for Fiscal Year 2020 (S.1790); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133/HR 4398); STOP GAMES Act of 2019 (HR 2387); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (HR 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Purple Book Continuity Act of 2019 (H.R. 1520); Biologic Patent Transparency Act (S. 659); Orange Book Transparency Act of 2019 (H.R. 1503); Prescription Drug Affordability and Access Act (S. 3166); Biosimilars user fees legislation; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Anticompetitive Exclusionary Conduct Prevention Act of 2020 (S. 3426); Second Look at Drug Patents Act of 2019 (S. 1617); Priority review vouchers; MODERN Labeling Act of 2020 (HR 5668); Recall Unsafe Drugs Act of 2020 (HR 5578); Buy American Executive Order; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Biosimilars user fee legislation; Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 (HR 6260/S.3545); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; Data Sharing; National Defense Authorization Act for Fiscal Year 2021 (HR 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (HR 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13922; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Protecting Americans with Preexisting Conditions Act of 2019 (H.R. 986); Bayh-Dole Act; TM Act of 2020 (S.3449 / HR 6196); Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (S.3537)
| Referred to |
| June 22, 2020 |
| Democratic |
| MN |
| Chellie Pingree | Democratic | ME |
| David E. Price | Democratic | NC |
| Dean Phillips | Democratic | MN |
| Dina Titus | Democratic | NV |
| Dwight Evans | Democratic | PA |
| Elaine G. Luria | Democratic | VA |
| Eleanor Holmes Norton | Democratic | DC |
| Francis Rooney | Republican | FL |
| Grace F. Napolitano | Democratic | CA |
| Jahana Hayes | Democratic | CT |
| Jamie Raskin | Democratic | MD |
| Jared Huffman | Democratic | CA |
| Judy Chu | Democratic | CA |
| Katie Porter | Democratic | CA |
| Lloyd Doggett | Democratic | TX |
| Mark DeSaulnier | Democratic | CA |
| Mark Pocan | Democratic | WI |
| Mary Gay Scanlon | Democratic | PA |
| Max Rose | Democratic | NY |
| Michael F. Q. San Nicolas | Democratic | GU |
| Nydia M. Velázquez | Democratic | NY |
| Peter A. DeFazio | Democratic | OR |
| Peter Welch | Democratic | VT |
| Pramila Jayapal | Democratic | WA |
| Raúl M. Grijalva | Democratic | AZ |
| Ro Khanna | Democratic | CA |
| Rosa L. DeLauro | Democratic | CT |
| Sanford D. Bishop, Jr. | Democratic | GA |
| Steve Cohen | Democratic | TN |
| Tulsi Gabbard | Democratic | HI |
Client expense: $180,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)
Client expense: $5,130,000 · 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), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $370,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $170,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $1,210,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of, U.S. Postal Service (USPS)
Client expense: Not reported · Firm income: $350,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE
Client expense: $5,960,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), Justice, Dept of (DOJ), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of
Client expense: $870,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $5,410,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
Client expense: Not reported · Firm income: $420,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)