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Increasing Access to Biosimilars Act of 2020
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Increasing Access to Biosimilars Act of 2020 This bill requires the Centers for Medicare & Medicaid Services to establish a demonstration project to evaluate the benefits of providing additional payments to providers of biosimilars under Medicare. Specifically, under the demonstration project, participating providers receive an additional payment based on the difference between the costs to the provider of furnishing the biosimilar and the cost if the provider had furnished the underlying reference biological product instead.
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Filing registrants (12)
Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · fourth_quarter · Health Issues
H.R 856 - Physicians Pro Bono Care Act - charitable deduction for pro-bono health services H.R. 3796 - Health Savings for Seniors Act - This bill permits a Medicare beneficiary to participate in and contribute to health savings accounts. S. 1227 - Prescription Pricing for the People Act of 2019 - Thisbill requiresthe Federal Trade Commission (FTC) to report about anticompetitive practicesand other trendswithin the pharmaceuticalsupply chain that may impact the cost of prescriptionsdrugs. H.R. 5198 - Patients' Right to Know Their Medication Act of 2019 - Creates FDA approved standard method of sharing consumer information. S. 2441 - Health Savings Account Expansion Act of 2019 - Thisbill permitsindividualswho are not enrolled in a high deductible health plan to participate in healthsavingsaccounts. S. 2440 - Qualified Health Savings Account Distribution Act of 2019 - This bill amends the Internal Revenue Code, with respect to the requirements for tax-preferred health accounts, to modify the rules for using a conversion or termination of a flexible spending account or a health reimbursement arrangement to establish a health savings account. H.R. 603 - Health Savings Account Expansion Act of 2019 - This bill modifies the requirements for health savings accounts (HSAs) to: increase the maximum contribution amounts, permit the use of HSAs to pay health insurance premiums and for direct primary care service arrangements, repeal the restriction on using HSAs for over-the-counter medications, eliminate the requirement that a participant in an HSA be enrolled in a high deductible health care plan, and decrease the additional tax for HSA distributions not used for qualified medical expenses. H.R. 5596, S. 3112 - Personalized Care Act of 2020 - This bill revises provisions relating to health savings accounts (HSAs) H.R. 5566 - Patient Fairness Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 5076 - Protecting Seniors Through Immunization Act of 2019 - Seeks to eliminate out-of-pocket expenses for everyone covered by Medicare and spares seniors the decision to delay or not seek vaccines due to their share of the cost. S. 3537 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Requires Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States. S. 3432 - Securing America's Medicine Cabinet Act of 2020 - This bipartisan legislation would reduce American reliance on foreign manufacturing of active pharmaceutical ingredients (APIs). H.R. 6286 - Health Savings Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - This bill allows unapproved capital expenses that are made by health care facilities during the public health emergency declared on January 31, 2020, relating to COVID-19 (i.e., coronavirus disease 2019) to be included in federal payment determinations under Medicare and Medicaid. H.R. 3502 - Protecting People From Surprise Medical Bills Act - This bill makes a series of changes relating to health care costs and billing practices. S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Seeks to lower drug costs by establishing rebate programs for brandname drugs and biologics used for Part B and Part D with prices that increase faster than the rate of inflation. H.R.6663 - Truth in Healthcare Marketing - Strives to reduce confusion over professional licensure, education level, training, degrees obtained, and clinical expertise and makes it unlawful for providers to misrepresent these credentials. H.R. 6813, S. 3703 - Promoting Alzheimer's Awareness to Prevent Elder Abuse Act - Works toward providing this protection by requiring the development of training materials for anyone who responds, investigates, or prosecutes cases of elder abuse involving seniors afflicted with dementias H.R. 7233, S. 4216 - Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act - The expansion of telehealth would provide a convenient, cost-effective tool that complements traditional in-office medical visits. S. 4106 - Healthcare PRICE Transparency Act - Codifies two healthcare price transparency rules requiring hospitals and insurers to disclose their discounted cash rates and negotiated rates to consumers before they receive medical care. S. 3993 - Equal Access to Care Act - Expands access to telemedicine during the coronavirus emergency by allowing licensed health care providers to treat patients over the phone and online wherever the patient is located. H.R. 6930 - Manufacturing API, Drugs, and Excipients (MADE) in America Act - Addresses our drug supply chains dependence on foreign countries like China and works to mitigate drug shortages while incentivizing the domestic manufacturing of drugs, active pharmaceutical ingredients (API), personal protective equipment (PPE), and diagnostics. S. 4134 - Increasing Access to Biosimilars Act - TheIncreasing Access to Biosimilars Actwould direct the Department of Health and Human Services to create a shared savings demonstration program for biosimilar drugs in the Medicare program, which will help increase competition and expand access to biosimilars. H.R. 7008 - Family Savings Flexibility Act - This bill (1) increases to $2,750 the maximum amount of unused benefits or contributions remaining in a health flexible or dependent care spending arrangement that may be carried over from the 2020 to the 2021 plan year, (2) increases the maximum contribution amount for health savings accounts, and (3) increases the exclusion from employee gross income of employer-paid dependent care assistance. S. 3872 - Promising Pathway Act - Requires the US Food and Drug Administration to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic. S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - A bill to establish an independent dispute resolution process for surprise air ambulance bills, and for other purposes. S. 4198 - Affordable Coronavirus Testing Act - This bill requires health insurance plans to cover through 2021 without cost sharing COVID-19 (i.e., coronavirus disease 2019) serology testing, which looks for the presence of antibodies made in response to an infection. S. 4158 - PPE Supply Chain Transparency Act of 2020 - This bill requires the Federal Emergency Management Agency (FEMA) to issue, within 90 days, a public report on the security and resilience of the supply chain for personal protective equipment during the COVID-19 (i.e., coronavirus disease 2019) pandemic. S. 4151 & H.R. 4838 - The Sustaining Outpatient Services (SOS) Act - Prevents certain off-campus hospital outpatient services from receiving significant Medicare reimbursement cuts. S. 4367 and H.R. 8032 - Health Savings Accounts for All Act - Qualified medical expenses would include expenses incurred during the prior or current tax year before establishing the HSA and fees paid for personal patient care. H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act - Recognizes the important work done by CMMI and incorporates protections into the processes including, limiting the scope of models to only the size needed to realize a statistically valid sample; encouraging feedback from beneficiaries in developing CMMI models; and limiting the testing of new payment and delivery models to five years to shield beneficiaries from being subjected to potentially harmful models. H.R. 5741 also provides for key Congressional oversight for CMMI demonstrations that will improve transparency and patient safety. S. 4866 - updating standards for oversight of nursing homes S. 4796 & H.R. 7617 - proposing free market reforms to healthcare S. 4367 and H.R. 8032 - Expansion of health savings accounts.
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight 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 H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020
Client expense: $580,000 · Firm income: Not reported
2020 · fourth_quarter · Medicare/Medicaid
Formulary placement of generics and biosimilars in Part D, including H.R. 4913; issues related to access to biosimilar biological products in Medicare Part B, including S. 4134, Increasing Access to Biosimilars Act of 2020.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight 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 H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020
Client expense: $550,000 · Firm income: Not reported
2020 · fourth_quarter · Pharmacy
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 related to health care price transparency; 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.
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Client expense: $2,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Treasury, Dept of, White House Office
2020 · fourth_quarter · Health Issues
Senate Amendment to H.R. 133, Consolidated Appropriations Act, 2021 H.R. 8529, Protecting Access to Affordable Medicines Act of 2020: To amend title XIX of the Social Security Act to prohibit additional rebates under the Medicaid program for certain noninnovator multiple source drugs S. 2103, Affordable Insulin Approvals Now Act S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Health Care Issues, Issues Related to Drug Pricing, Issues Related to the FDA Buy America Provisions, Continuous Manufacturing Provisions & Medical Supply Chain
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Policy and oversight related to the generic pharmaceutical industry Issues related to the pharmaceutical supply chain Issues related to drug pricing Issues related to FDA generic drug approval process Issues related to Medicaid Generics Penalty Issues related to federal COVID-19 response S.4134 - A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Issues related to the consumer price index H.R. 6395/S. 4049 - FY 2021 National Defense Authorization Act H.R.133 - Consolidated Appropriations Act, 2021
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Medicare/Medicaid
The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P) H.R. 8624 - Protecting Access to Innovation During COVID-19 Act H.R. 8702 - Holding Providers Harmless From Medicare Cuts During COVID-19 Act of 2020 S. 1895 - Lower Health Care Costs Act S. 4199 - Prescription Drug Pricing Reduction Act of 2020 S. 4274 - Legalizing Drug Discounts for Seniors Act of 2020 Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Medicare prescription drug payments cards and related issues ASP reporting policy issues Non-covered drugs policy issues Drug wastage rebates policy issues
Client expense: $660,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.
Client expense: $1,260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. H.R. 133, Consolidating Appropriations Act, 2021. H.R. 925, HEROES Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. H.R. 133, Consolidating Appropriations Act, 2021. H.R. 925, HEROES Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Issues related to prescription drug pricing and value Issues related to ICD-10 diagnosis codes Prescription drug manufacturing and supply chains Issues regarding the ongoing COVID-19 public health emergency Biosimilars S. 3466/H.R. 4597, and H.R. 6179/S. 4134
Client expense: $790,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134
Client expense: $790,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Medicare/Medicaid
Issues related to Medicare Part D redesign, rebate reform, and international pricing index (no specific bills) 2021 Notice of Benefit and Payment Parameters and cost-sharing assistance Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134
Client expense: $790,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
Policy and oversight related to the generic pharmaceutical industry Issues related to the pharmaceutical supply chain Issues related to drug pricing Issues related to FDA generic drug approval process Issues related to Medicaid Generics Penalty Issues related to federal COVID-19 response S.4134 - A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Issues related to the consumer price index H.R. 6395/S. 4049 - FY 2021 National Defense Authorization Act H.R.133 - Consolidated Appropriations Act, 2021
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
Medicare related to biosimilars H.R. 4455 - The BIOSIM Act Passed the House as part of H.R. 3. Appropriations included in Committee report H.R. 2740; included also in FY 2021 Labor-H Committee report. H.R. 6179/S. 4134 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - The ACCESS Act H.R. 8624 - Protecting Access to Innovation during COVID-19 Act S. 4295 Public Health Emergency Pass-Through Payment Fairness Act Most Favored Nation Model for Medicare Part B Drugs and Biologicals Interim Final Rule
Client expense: $75,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S., White House Office
2020 · third_quarter · Health Issues
Medicare related to biosimilars H.R. 4455 - The BIOSIM Act Passed the House as part of H.R. 3. Appropriations included in Committee report H.R. 2740; included also in FY 2021 Labor-H Committee report. H.R. 6179/S. 4134 - Increasing Access to Biosimilars Act of 2020 H.R. 4597/S. 3466 - The ACCESS Act H.R. 8624 - Protecting Access to Innovation during COVID-19 Act S. 4295 Public Health Emergency Pass-Through Payment Fairness Act
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S., White House Office
2020 · third_quarter · Health Issues
H.R 856 - Physicians Pro Bono Care Act - charitable deduction for pro-bono health services H.R. 3796 - Health Savings for Seniors Act - This bill permits a Medicare beneficiary to participate in and contribute to health savings accounts. S. 1227 - Prescription Pricing for the People Act of 2019 - Thisbill requiresthe Federal Trade Commission (FTC) to report about anticompetitive practicesand other trendswithin the pharmaceuticalsupply chain that may impact the cost of prescriptionsdrugs. H.R. 5198 - Patients' Right to Know Their Medication Act of 2019 - Creates FDA approved standard method of sharing consumer information. S. 2441 - Health Savings Account Expansion Act of 2019 - Thisbill permitsindividualswho are not enrolled in a high deductible health plan to participate in healthsavingsaccounts. S. 2440 - Qualified Health Savings Account Distribution Act of 2019 - This bill amends the Internal Revenue Code, with respect to the requirements for tax-preferred health accounts, to modify the rules for using a conversion or termination of a flexible spending account or a health reimbursement arrangement to establish a health savings account. H.R. 603 - Health Savings Account Expansion Act of 2019 - This bill modifies the requirements for health savings accounts (HSAs) to: increase the maximum contribution amounts, permit the use of HSAs to pay health insurance premiums and for direct primary care service arrangements, repeal the restriction on using HSAs for over-the-counter medications, eliminate the requirement that a participant in an HSA be enrolled in a high deductible health care plan, and decrease the additional tax for HSA distributions not used for qualified medical expenses. H.R. 5596, S. 3112 - Personalized Care Act of 2020 - This bill revises provisions relating to health savings accounts (HSAs) H.R. 5566 - Patient Fairness Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 5076 - Protecting Seniors Through Immunization Act of 2019 - Seeks to eliminate out-of-pocket expenses for everyone covered by Medicare and spares seniors the decision to delay or not seek vaccines due to their share of the cost. S. 3537 - Protecting Our Pharmaceutical Supply Chain from China Act of 2020 - Requires Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States. S. 3432 - Securing America's Medicine Cabinet Act of 2020 - This bipartisan legislation would reduce American reliance on foreign manufacturing of active pharmaceutical ingredients (APIs). H.R. 6286 - Health Savings Act of 2020 - This bill revises requirements for health savings accounts (HSAs) H.R. 6336 - Increasing Hospital Capacity to Fight the Coronavirus Act of 2020 - This bill allows unapproved capital expenses that are made by health care facilities during the public health emergency declared on January 31, 2020, relating to COVID-19 (i.e., coronavirus disease 2019) to be included in federal payment determinations under Medicare and Medicaid. H.R. 3502 - Protecting People From Surprise Medical Bills Act - This bill makes a series of changes relating to health care costs and billing practices. S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Seeks to lower drug costs by establishing rebate programs for brandname drugs and biologics used for Part B and Part D with prices that increase faster than the rate of inflation. H.R.6663 - Truth in Healthcare Marketing - Strives to reduce confusion over professional licensure, education level, training, degrees obtained, and clinical expertise and makes it unlawful for providers to misrepresent these credentials. H.R. 6813, S. 3703 - Promoting Alzheimer's Awareness to Prevent Elder Abuse Act - Works toward providing this protection by requiring the development of training materials for anyone who responds, investigates, or prosecutes cases of elder abuse involving seniors afflicted with dementias H.R. 7233, S. 4216 - Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act - The expansion of telehealth would provide a convenient, cost-effective tool that complements traditional in-office medical visits. S. 4106 - Healthcare PRICE Transparency Act - Codifies two healthcare price transparency rules requiring hospitals and insurers to disclose their discounted cash rates and negotiated rates to consumers before they receive medical care. S. 3993 - Equal Access to Care Act - Expands access to telemedicine during the coronavirus emergency by allowing licensed health care providers to treat patients over the phone and online wherever the patient is located. H.R. 6930 - Manufacturing API, Drugs, and Excipients (MADE) in America Act - Addresses our drug supply chains dependence on foreign countries like China and works to mitigate drug shortages while incentivizing the domestic manufacturing of drugs, active pharmaceutical ingredients (API), personal protective equipment (PPE), and diagnostics. S. 4134 - Increasing Access to Biosimilars Act - TheIncreasing Access to Biosimilars Actwould direct the Department of Health and Human Services to create a shared savings demonstration program for biosimilar drugs in the Medicare program, which will help increase competition and expand access to biosimilars. H.R. 7008 - Family Savings Flexibility Act - This bill (1) increases to $2,750 the maximum amount of unused benefits or contributions remaining in a health flexible or dependent care spending arrangement that may be carried over from the 2020 to the 2021 plan year, (2) increases the maximum contribution amount for health savings accounts, and (3) increases the exclusion from employee gross income of employer-paid dependent care assistance. S. 3872 - Promising Pathway Act - Requires the US Food and Drug Administration to establish a rolling, real-time, priority review pathway to evaluate provisional approval applications for drugs intended to treat, prevent, or diagnose serious or life-threatening diseases or conditions, including those that pose a threat of epidemic or pandemic. S. 4185 - End Surprise Medical Bills for Air Ambulances Act of 2020 - A bill to establish an independent dispute resolution process for surprise air ambulance bills, and for other purposes. S. 4198 - Affordable Coronavirus Testing Act - This bill requires health insurance plans to cover through 2021 without cost sharing COVID-19 (i.e., coronavirus disease 2019) serology testing, which looks for the presence of antibodies made in response to an infection. S. 4158 - PPE Supply Chain Transparency Act of 2020 - This bill requires the Federal Emergency Management Agency (FEMA) to issue, within 90 days, a public report on the security and resilience of the supply chain for personal protective equipment during the COVID-19 (i.e., coronavirus disease 2019) pandemic. S. 4151 & H.R. 4838 - The Sustaining Outpatient Services (SOS) Act - Prevents certain off-campus hospital outpatient services from receiving significant Medicare reimbursement cuts. S. 4367 and H.R. 8032 - Health Savings Accounts for All Act - Qualified medical expenses would include expenses incurred during the prior or current tax year before establishing the HSA and fees paid for personal patient care. H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act - Recognizes the important work done by CMMI and incorporates protections into the processes including, limiting the scope of models to only the size needed to realize a statistically valid sample; encouraging feedback from beneficiaries in developing CMMI models; and limiting the testing of new payment and delivery models to five years to shield beneficiaries from being subjected to potentially harmful models. H.R. 5741 also provides for key Congressional oversight for CMMI demonstrations that will improve transparency and patient safety.
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight 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 H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134, Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs
Client expense: $590,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · third_quarter · Pharmacy
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
Client expense: $940,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Health Issues
S. 2103, Affordable Insulin Approvals Now Act S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program H.R. 8529, Protecting Access to Affordable Medicines Act of 2020: To amend title XIX of the Social Security Act to prohibit additional rebates under the Medicaid program for certain noninnovator multiple source drugs Health Care Issues, Issues Related to Drug Pricing, Issues Related to the FDA Buy America Provisions, Continuous Manufacturing Provisions & Medical Supply Chain
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Medicare/Medicaid
Formulary placement of generics and biosimilars in Part D, including H.R. 4913; issues related to access to biosimilar biological products in Medicare Part B, including S. 4134, Increasing Access to Biosimilars Act of 2020.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. The Cares Act (P.L. 116-136). H.R. 925, HEROES Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program. The Cares Act (P.L. 116-136). H.R. 925, HEROES Act.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Pharmacy
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.
Client expense: $2,230,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
2020 · third_quarter · Medicare/Medicaid
Issues related to Medicare Part D redesign, rebate reform, and international pricing index (no specific bills) 2021 Notice of Benefit and Payment Parameters and cost-sharing assistance Medicaid Drug Rebate Program (MDRP), including value-based purchasing (VBP) arrangements and line extensions Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134
Client expense: $610,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Issues related to prescription drug pricing and value Issues related to ICD-10 diagnosis codes Prescription drug manufacturing and supply chains Biosimilars S. 3466/H.R. 4597, and H.R. 6179/S. 4134
Client expense: $610,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Copyright/Patent/Trademark
Biosimilars S. 3466, H.R. 4597, and H.R. 6179, S. 4134
Client expense: $610,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Pharmacy
Policy and oversight related to the generic pharmaceutical industry Issues related to the pharmaceutical supply chain Issues related to drug pricing Issues related to FDA generic drug approval process Issues related to Medicaid Generics Penalty Issues related to federal COVID-19 response S.4134 - A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Issues related to the consumer price index H.R. 6395/S. 4049 - FY 2021 National Defense Authorization Act
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377 - Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772 - The Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129 - Lower Costs, More Cures Act of 2019 S. 3384 - Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457 - Preserving Patient Access to Home Infusion Act H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534 - Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134 - Increasing Access to Biosimilars Act of 2020 S. 102 - Prescription Drug Price Relief Act of 2019 CMS Proposed Rule: Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) or Drugs Covered in Medicaid, Revising Medicaid Rebate and Third Party Liability (TPL) Requirements (CMS-2482-P)
Client expense: $1,190,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Medicare/Medicaid
The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Medicare Part A, B and D AMP Cap H.R 3 S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Innovative pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics Drug Pricing Outcomes Based Contracts/value based arrangements Medicaid H.R.275 - Medicare Prescription Drug Price Negotiation Act of 2019 H.R.448 - Medicare Drug Price Negotiation Act H.R.19 - Lower Costs, More Cures Act of 2019 H.R.107 - To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R.4455 - BIOSIM Act H.R.4619 - Pharmaceutical Rebates for Excessive Pricing Above Inflation Act HR. 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 HR. 4597 - Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 S.3466 - ACCESS for Biosimilars Act of 2020 HR. 6179 - Increasing Access to Biosimilars Act of 2020 HR. 4629 - Star Rating for Biosimilars Act S. 3129: Lower Costs, More Cures Act of 2019 S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 S. 3457: Preserving Patient Access to Home Infusion Act - Provisions related to Medicare and prescription drug access H.R.5741 - Strengthening Innovation in Medicare and Medicaid Act Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Transparency policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Proposed Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans (CMS-9916-P) Reimbursement for cell therapy products S. 3353/H.R. 5534, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act Patient Cost-Sharing and Smoothing S. 4134, Increasing Access to Biosimilars Act of 2020 S. 102, Prescription Drug Price Relief Act of 2019
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2020 · second_quarter · Health Issues
Issues related to drug pricing Issues related to Medicaid Generics Penalty S.4134 - A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Consumer price index Issues related to workplace health and safety Issues related to the pharmaceutical supply chain H.R. 6395/S. 4049 - FY 2021 National Defense Authorization Act Issues related to federal COVID-19 response
Client expense: Not reported · Firm income: $40,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Health Issues
S. 2103 Affordable Insulin Approvals Now Act S. 4134 A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program Health Care Issues, Issues Related to Drug Pricing, Issues Related to the FDA Buy America Provisions, Continuous Manufacturing Provisions & Medical Supply Chain
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
Drug pricing legislation. S. 2543, Prescription Drug Pricing Reduction Act of 2019. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Medicare/Medicaid
Medicare reimbursement issues. FDA regulations of biosimilars. H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R. 4455, BIOSIM Act. H.R. 4629, Star Rating for Biosimilars Act. S. 1895, Lower Health Care Costs Act. S. 3466, ACCESS for Biosimilars Act of 2020. H.R. 6179, Increasing Access to Biosimilars Act of 2020. S. 4134, A bill to establish a demonstration project to increase access to biosimilar products under the Medicare program.
Client expense: Not reported · Firm income: $90,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Medicare/Medicaid
The BIOSIM Act (H.R. 4455); The Increasing Access to Biosimilars Act (H.R. 6179/S. 4134); Medicaids Consumer Price Index (CPI) penalty for generics; and Policies to incentivize biosimilars.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE