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Pharmaceutical Research Transparency Act of 2023
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 5,649 other S bills in the 118th — cohort avg 33d
No CRS summary is available for this bill yet. The source title, actions, sponsors, and text versions below come from Congress.gov.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (4)
2024 · fourth_quarter · Medicare/Medicaid
MMM [House, Senate, HHS, CMS, FDA, Administration on Aging, EOP, DOC] Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act (Public Law No: 117-169). Medicare and Medicaid Prescription Drugs. (No bill): Joined comments with 19 other organizations urging HHS to use its existing authority to license competition in order to lower consumer and taxpayer costs for semaglutide drugs treating diabetes and weight management (e.g., Ozempic and Wegovy). Medicare Prescription Drugs. The PACE Part D Choice Act (H.R. 3549 and S. 1703): Proposal to increase the affordability of the Program of All-Inclusive Care for the Elderly (PACE) for Medicare beneficiaries by lowering the cost of Part D premiums substantially for Medicare-only enrollees, thus opening up the PACE program to this population. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Trustees Report (No bill). Review of the findings on economic, legislative and other developments affecting the actuarial soundness of the Medicare Part A (Hospital Insurance) Trust Fund and the Trust Funds for Parts B and D coverage. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Help Extend Auditory Relief Act of 2024 (H.R. 8064): Proposal to expand Medicare coverage to include hearing examinations and diagnoses, fittings and hearing aids. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home and Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes. The Building Americas Health Care Workforce Act (H.R. 9067): Proposal to allow time spent working in a nursing home (prior to any formal training, and permitted during the COVID-19 pandemic) to count toward a 75-hour minimum federal training standard that is required for certified nursing assistants. Medicare, Medicaid Nursing Homes. The Ensuring Seniors Access to Quality Care Act (H.R. 3227): Proposal to repeal regulations that prohibit certified nursing assistant training and competency evaluation programs in skilled nursing facilities that have a record of health and safety deficiencies and have incurred penalties (e.g., civil monetary penalties for substandard quality of care). Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposals to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposals to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities. Oversight of Health Care Industry Owned by Private Equity Firms. (No bill): Joined with other organizations in submitting comments (April 2024) to HHS, the Federal Trade Commission and the Department of Justice urging sustained, stepped up and rigorous oversight be extended to health care industry transactions that are financed by private equity company companies and other types of private investors. Medicaid Eligibility and Beneficiary Assets. Medicaid Estate Recovery Act (H.R. 7573): Proposals to provide financial protection to the families of Medicaid beneficiaries, including ending Medicaid estate claims and Medicaid liens, except in cases when benefits had been incorrectly paid, as determined by a court.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), SENATE
2024 · third_quarter · Medicare/Medicaid
Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act (Public Law No: 117-169). Medicare and Medicaid Prescription Drugs. (No bill): Joined comments with 19 other organizations urging HHS to use its existing authority to license competition in order to lower consumer and taxpayer costs for semaglutide drugs treating diabetes and weight management (e.g., Ozempic and Wegovy). Medicare Prescription Drugs. The PACE Part D Choice Act (H.R. 3549 and S. 1703): Proposal to increase the affordability of the Program of All-Inclusive Care for the Elderly (PACE) for Medicare beneficiaries by lowering the cost of Part D premiums substantially for Medicare-only enrollees, thus opening up the PACE program to this population. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Trustees Report (No bill). Review of the findings on economic, legislative and other developments affecting the actuarial soundness of the Medicare Part A (Hospital Insurance) Trust Fund and the Trust Funds for Parts B and D coverage. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Help Extend Auditory Relief Act of 2024 (H.R. 8064): Proposal to expand Medicare coverage to include hearing examinations and diagnoses, fittings and hearing aids. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home and Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes. The Building Americas Health Care Workforce Act (H.R. 9067): Proposal to allow time spent working in a nursing home (prior to any formal training, and permitted during the COVID-19 pandemic) to count toward a 75-hour minimum federal training standard that is required for certified nursing assistants. Medicare, Medicaid Nursing Homes. The Ensuring Seniors Access to Quality Care Act (H.R. 3227): Proposal to repeal regulations that prohibit certified nursing assistant training and competency evaluation programs in skilled nursing facilities that have a record of health and safety deficiencies and have incurred penalties (e.g., civil monetary penalties for substandard quality of care). Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposals to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposals to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities. Oversight of Health Care Industry Owned by Private Equity Firms. (No bill): Joined with other organizations in submitting comments (April 2024) to HHS, the Federal Trade Commission and the Department of Justice urging sustained, stepped up and rigorous oversight be extended to health care industry transactions that are financed by private equity company companies and other types of private investors.
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), SENATE
2024 · second_quarter · Health Issues
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 766: Dr. Michael C. Burgess Preventive Health Savings Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1770: Equitable Community Access to Pharmacist Services Act H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program Bayh-Done march in rights policy issues H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7024: Tax Relief for American Families and Workers Act of 2024 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act H.R. 8333 BIOSECURE Act H.R.8818 American Privacy Rights Act of 2024; Provisions related to pharmaceutical industry S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs; Transparency provisions, Medicare Part D Delinking; Commerical Marketplace Delinking S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Vaccine provisions of the inflation reduction Act Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues
Client expense: $1,510,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2024 · second_quarter · Health Issues
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4818: Treat and Reduce Obesity Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 H.R. 7623: Telehealth Modernization Act of 2024 H.R. 7635: The 340B PATIENTS Act of 2024 H.R. 8574: 340B Affording Care for Communities and Ensuring a Strong Safety-net (ACCESS) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2474: Share the Savings with Seniors Act S. 2897: Give Kids a Chance Act of 2023 S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act BioCompete Act (draft) Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues
Client expense: $6,960,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
2024 · second_quarter · Medicare/Medicaid
Medicare Observation Stays. The Improving Access to Medicare Coverage Act of 2023 (H.R. 5138 and S. 4137): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. The Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. The Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. The Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. The Assuring Medicares Promise Act (H.R. 34) and The Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. The Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Medicare Part B. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. The HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Caregiving. The Alleviating Barriers to Caregiving Act (H.R. 8018 and S. 3109): Proposal to require the Secretaries of HHS and SSA to review and streamline enrollment in coverage and benefits for family caregivers in Medicare, Medicaid, CHIP and Social Security. Medicare and Medicaid Nursing Homes. The Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. The Protecting Americas Seniors Access to Care Act (H.R. 7513 and S. 3410): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes. (H.J. Res. 139 and S.J. Res. 91): Proposal to use the Congressional Review Act to disapprove the HHS Secretarys final rule promulgating national staffing standards in nursing homes Medicare, Medicaid Nursing Homes, Assisted Living and Other Long Term Care Services and Supports (LTSS) Settings. The Long-Term Care Workforce Support Act (H.R. 7994 and S. 4120): Proposal to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A proposed final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): Final regulations establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposal to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.
Client expense: $210,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), SENATE
2024 · first_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern__ Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues H.R.7024 - Tax Relief for American Families and Workers Act of 2024 Vaccine provisions of the Inflation Reduction Act
2024 · first_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4263: Allergen Disclosure in Non-food Articles Act (ADINA) H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act H.R. 6664: Innovation in Pediatric Drugs Act of 2023 H.R. 7174: Ensuring Pathways to Innovative Cures (EPIC) Act: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 7248: FDA Modernization Act 3.0 S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act Executive Order of February 28, 2024, Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future (SUSTAIN) 340B Act (draft) User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Artificial intelligence policy issues
2024 · first_quarter · Medicare/Medicaid
Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and to raise the income threshold for the Low-Income Subsidy program offering assistance in paying for drugs. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposals to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries. Medicare Prescription Drugs. (No bill): A regulatory proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill): An HHS regulatory proposal to ensure robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill): Proposal to increase funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R. 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Trust Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Medicare Part B. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage (MA). (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Advantage. (No bill): Proposals to apply a higher coding adjustment factor to fully account for intensive upcoding by MA plans and to exclude certain information for MA risk adjustment scores and payments; to use two years of traditional Medicare and MA diagnostic data for calculating MA risk-adjusted payments; and to promulgate more fundamental changes to the Hierarchical Condition Category (HCC) risk adjustment model. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762): Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177): Proposal to direct HHS to establish a national registry of medical directors. Medicare, Medicaid Nursing Homes. Protecting Americas Seniors Access to Care Act (H.R. 7513): Proposal to prohibit the HHS Secretary from promulgating national staffing standards in nursing homes. Medicare, Medicaid Nursing Homes, Assisted Living and Other LTSS Settings. Long-Term Care Workforce Support Act (No bill number): Proposal to increase the number of direct care professionals, including in rural communities; pathways to enter and be supported in the workforce for women, people of color, and people with disabilities; and to improve compensation for direct care professionals to reduce vacancies and turnover. Medicare and Medicaid Nursing Home Ownership. (No bill): A proposed final HHS regulation for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Rule calls for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill): A proposed CMS final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): Proposal to request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.
2023 · fourth_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2940/S. 1355: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. Inflation Reduction Act - provisions related to vaccines and pharmaceuticals. H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: Increasing Transparency in Generic Drug Applications Act H.R. 4115: The Lower Drug Costs for Families Act H.R. 4370: PREVAIL Act - Provisions related to the PTAB H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging (DRUG) Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - 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, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Real world evidence policy issues Clinical trial diversity policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Anticounterfeiting policy issues Artificial intelligence policy issues H.R.5143 - Vaccine Access Improvement Act - reform the vaccine injury compensation program H.R. 5142 - Vaccine Injury Compensation Modernization Act -- reform the vaccine injury compensation program S.1542/H.R.6283 - Delinking Revenue from Unfair Gouging Act - commercial delinking of PBM prices Labor HHS Appropriations Inflation Reduction Act of 2022, provisions related to Part D redesign and Medicare negotiation; 340B reform proposals
2023 · fourth_quarter · Health Issues
H.R. 167: Patient Access to Urgent-Use Pharmacy Compounding Act of 2023 H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program H.R. 456: Fairness in Orphan Drug Exclusivity Act H.R. 830: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes H.R. 885: TRACK Act of 2023 H.R. 1503: Prescription Information Modernization Act of 2023 H.R. 1613: Drug Price Transparency in Medicaid Act of 2023 H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes H.R. 2408: Access to Innovative Treatments Act of 2023 H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023 H.R. 2534: PROTECT 340B Act of 2023 - Provisions related to the 340B program H.R. 2679: Pharmacy Benefits Manager Accountability Act H.R. 2707: MADE in America Act H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act H.R. 2880: Protecting Patients Against PBM Abuses Act H.R. 2893: Seniors Securing Access to Vital and Essential Prescription Drugs Act H.R. 2959: Health Savings Act of 2023 H.R. 3008: Drug Shortage Prevention Act of 2023 H.R. 3093: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 H.R. 3134: Emergency Access to Insulin Act of 2023 H.R. 3160: Pharmaceutical Research Transparency Act of 2023 H.R. 3281: Transparent PRICE Act H.R. 3284: Providers and Payers COMPETE Act H.R. 3285: Fairness for Patient Medications Act H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program H.R. 3433: Give Kids a Chance Act of 2023 H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023 H.R. 3791: Improving DATA in Public Health Act H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023 H.R. 3810: Drug Origin Transparency Act of 2023 H.R. 3839: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications H.R. 4115: Lower Drug Costs for Families Act H.R. 4421: Preparing for All Hazards and Pathogens Reauthorization Act H.R. 4507: Transparency in Coverage Act of 2023 H.R. 4508: Hidden Fee Disclosure Act of 2023 H.R. 4822: Health Care Price Transparency Act of 2023 H.R. 4882: Clinical Laboratory Price Transparency Act of 2023 H.R. 4895: Lowering Drug Costs for American Families Act - Provisions related to drug pricing H.R. 4988: Modern Authentication of Pharmaceuticals Act of 2023 H.R. 5376: Share the Savings with Seniors Act H.R. 5378: Lower Costs, More Transparency Act H.R. 5391: Protecting Patient Access to Cancer and Complex Therapies Act H.R. 5539: ORPHAN Cures Act H.R. 5547: Maintaining Investments in New Innovation Act H.R. 6283: Delinking Revenue from Unfair Gouging or DRUG Act S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs S. 148: Stop STALLING Act - Provisions related to citizen petitions S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - 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, and for other purposes S. 476: Maintaining Investments in New Innovation Act S. 775: Increasing Transparency in Generic Drug Applications Act S. 935: Fair Accountability and Innovative Research Drug Pricing Act of 2023 - Provisions related to drug pricing S. 954: Affordable Insulin Now Act of 2023 S. 1067: Ensuring Timely Access to Generics Act of 2023 S. 1114: Expanding Access to Low-Cost Generics Act 2023 S. 1130: Health Care PRICE Transparency Act S. 1128: Ensuring Access to Generic Medications Act S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions S. 1217: Prescription Drug Impact Act of 2023 S. 1250: Drug-price Transparency for Consumers Act of 2023 S. 1264: SMART Prices Act - Provisions related to drug pricing reform S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues S. 1374: Patient Right to Shop Act S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes S. 1476: Pharmaceutical Research Transparency Act of 2023 S. 1497: Emergency Access to Insulin Act of 2023 S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs S. 1589: Safeguarding Patients and Taxpayers Act S. 1906: Promising Pathway Act - Approval pathway policy issues S. 1967: PBM Act S. 2305: Biosimilar Red Tape Elimination Act S. 2333: Pandemic and All-Hazards Preparedness and Response Act S. 2456: Protecting Seniors from High Drug Costs Act S. 2474: Share the Savings with Seniors Act S. 2840: Bipartisan Primary Care and Health Workforce Act S. 2973: Modernizing and Ensuring PBM Accountability Act (MEPA) S. 3393: SUPPORT for Patients and Communities Reauthorization Act S. 4953: Protect Drug Innovation Act User fee policy issues Inflation Reduction Act of 2022 (P.L. 117-169) Nomination of Dr. Monica Bertagnolli as NIH director Pharmacy Benefit Manager reform and policy issues Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) Cancer Moonshot Initiative 21st Century Cures 2.0 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Accelerated approval policy issues FDA regulatory approval authority policy issues Competition policy issues Orphan Drug Act policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain policy issues Mental health policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Cybersecurity policy issues Anticounterfeiting policy issues Artificial intelligence policy issues
2023 · fourth_quarter · Medicare/Medicaid
Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Prescription Drugs. (No bill) Supported an administrative proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. (No bill) Supported HHS promulgating robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. (No bill) Supported increased funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health Emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans using prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the final HHS regulations for comprehensive ownership disclosure in the nursing home sector issued on November 17th, 2023. Calling for strengthened cost reporting requirements, together with ongoing national analyses and monitoring of the performance of the nursing home sector that uses ownership, staffing, cost report data and inspection data. Medicare and Medicaid Nursing Home Staffing. (No bill) Support for CMS to promulgate improved final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.
2023 · third_quarter · Pharmacy
S.1476 Pharmaceutical Research Transparency Act, S.954 Affordable Insulin Now Act, Medicare drug price negotiation implementation; Bayh-Dole royalty-free rights and contractual reasonable pricing conditions, NDAA government owned medical invention licensing, research and development transparency, and other transactions authority justification, pay for delay reform; product hopping reform; citizen petition abuse reform; FDA prescription drug transparency, S.2220 PREVAIL Act; S. 79 Interagency Patent Coordination and Improvement Act; S.142 Preserve Access to Affordable Generics and Biosimilars Act; S.148 Stop STALLING Act; S.150 Affordable Prescriptions for Patients Act, We PAID Act
Client expense: $75,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2023 · second_quarter · Pharmacy
Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).
Client expense: $72,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · third_quarter · Medicare/Medicaid
Medicare Observation Stays. Improving Access to Medicare Coverage Act of 2023 (H.R. 5138): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3093): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Prescription Drugs. Supported an administrative proposal encouraging the Secretaries of the Departments of Health and Human Services (HHS) and Commerce to exercise march in rights that would aim to better control the pricing of prescription drugs. Medicare Prescription Drugs. Supported HHS promulgating robust negotiation rules and processes that aim to curtail the cost of certain prescription drugs, as authorized by the Inflation Reduction Act. Medicare Low-Income Subsidy (LIS) Program. Supported increased funding for LIS outreach and enrollment, so that low-income beneficiaries can more readily access needed medications at prices they can afford. Medicare Reform. Assuring Medicares Promise Act (H.R. 34) and Medicare and Social Security Fair Share Act (S. 1174 and H.R 4535): Proposals to close the loophole for wealthy individuals who bypass paying net investment income tax (NIIT) and directing the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals, and to the Social Security Trust Funds. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012 and H.R. 4146): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans use of prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the strengthening of proposed HHS regulations for comprehensive ownership disclosure in the nursing home sector, and for national safe staffing standards. Medicare and Medicaid Nursing Home Staffing. Support for CMS to promulgate improved final regulations for establishing national staffing standards in nursing homes that would safeguard the health and safety of all elderly and disabled residents. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.
2023 · third_quarter · Pharmacy
S.1476 Pharmaceutical Research Transparency Act, S.954 Affordable Insulin Now Act, Medicare drug price negotiation implementation; Bayh-Dole royalty-free rights and contractual reasonable pricing conditions, NDAA government owned medical invention licensing, research and development transparency, and other transactions authority justification, pay for delay reform; product hopping reform; citizen petition abuse reform; FDA prescription drug transparency, S.2220 PREVAIL Act; S. 79 Interagency Patent Coordination and Improvement Act; S.142 Preserve Access to Affordable Generics and Biosimilars Act; S.148 Stop STALLING Act; S.150 Affordable Prescriptions for Patients Act, We PAID Act
Client expense: $75,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2023 · second_quarter · Pharmacy
Bayh-Dole march-in & royalty-free rights; IRA drug price negotiation implementation; Affordable Insulin Now Act (S.954); Insulin for All Act (S.727, H.R.1485); S. 1246 SMART Prices Act; Lowering Drug Costs for Families Act (S. 1139), IRA drug price negotiation implementation, NDAA biomedical R&D transparency, licensing, and pricing; access to U.S. government funded medicines and vaccines; Bayh-Dole march-in & royalty-free rights, U.S. government support for the mRNA Hub program, H.R. 1613 (Drug Price Transparency in Medicaid Act), S.1269 INSULIN Act, S.1067 Ensuring Timely Access to Generics Act; S. 1114 Expanding Access to Low-Cost Generics Act; S.1214 RARE Act; S.1339, Pharmacy Benefit Manager Reform Act, S.150; S.148; S.142; S.113; S.79; S.727; S.954; H.R.1488; S.1269; S.1067; S.1114; S.1339; S.775; S.1128; S.574; S.935; S.127, H.R. 2666 (MVP Act); Bayh-Dole march-in & royalty-free rights; government use patent licensing; NIH nomination; Affordable Drug Manufacturing Act; S.1476 (Pharmaceutical Research Transparency Act).
Client expense: $72,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2023 · second_quarter · Medicare/Medicaid
Medicare Observation Stays. (No bill): Proposals to count time spent in observation status toward the three-day prior inpatient stay required under Medicare for coverage of a subsequent stay in a skilled nursing facility. Medicare Drug Prices (No bill): Proposal to have the Biden Administration lower the price of the prostate cancer drug Xtandi through executive action by using so-called march-in rights under the Bayh-Dole Act; to amend the Federal Food, Drug, and Cosmetic Act to grant eligible researchers access to drugs or biologic products for research purposes at a price no higher than the cost to the manufacturer; to block so-called Dispense-As-Written campaigns where drug manufacturers incentivize health care providers to specify a brand drug on a prescription to block generic substitution at the pharmacy. These campaigns increase drug spending by encouraging overuse of brand drugs when cheaper, equally effective generic alternative is available; and to reduce the period after Food and Drug Administration approval where a brand manufacturer could exclusively market their drug in the United States from 12 years to five years. This reduced exclusivity period would hasten the introduction of lower cost biosimilars to the market, helping bring down cost for consumers. Medicare Drug Costs. Pharmaceutical Research Transparency Act of 2023 (S. 1476 and H.R. 3160): Proposal to amend the Public Health Service Act and the Security Exchange Act to require pharmaceutical manufacturers to report their costs related to clinical trials and research and development. Medicare Drug Savings. Seniors Securing Access to Vital and Essential Prescription Drugs Act (H.R. 2893): Proposals to discount the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost sharing subsidies under Part D of the Medicare program. (No bills): Proposals to eliminate the Medicare Part D low-income subsidy programs asset test and raise the income eligibility levels to 200 percent of the federal poverty level. Medicare Prescription Drugs. Drug Costs. Inflation Reduction Act (Public Law No: 117-169): Proposal 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, eliminate cost-sharing for vaccines, eliminate cost-sharing in the catastrophic phase of Part D, and raise the income threshold for the low-income subsidy. Medicare Prescription Drugs. Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023 (H.R. 3039): Proposes to require companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service and authorize to determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes. Medicare Reform. Assuring Medicares Promise Act (H.R. 34): Proposal to close the loophole for wealthy individuals to bypass paying net investment income tax (NIIT) and would direct the revenue to the Hospital Insurance Fund, which pays for Medicare Part A that covers inpatient care in hospitals. Medicare Dental Coverage. Medicare Dental Benefit Act (S. 2012): Proposal to add a dental benefit to Medicare. Medicare Hearing Coverage. The Medicare Hearing Aid Coverage Act of 2021 (H.R. 244): Proposal to expand Medicare coverage to include hearing aids and services for seniors under Part B of the Medicare program. Medicare call center (No bill): Proposal to address the poor working conditions of the call center workers employed by Maximus, a federal contractor with the Department of Health and Humans Services/Center for Medicare and Medicaid Services) HHS/CMS. Public Health emergency (No bill): Proposals to ensure the transition out of the public health emergency doesnt create enrollment or coverage gaps for Medicare eligible individuals. Medicare Advantage. (No bill): Proposals to create transparency around Medicare Advantage plans use of prior authorization and supplemental benefits that are not offered under traditional Medicare. Medicare Privatization (No bill): Proposals to create reimbursement policies in traditional Medicare that mimic those used by private health insurance plans. Medicaid Home And Community-Based Services. Inflation Reduction Act (Public Law No: 117-169): Proposals to expand Medicaid home and community-based services and the Medicare savings programs. Medicaid Home And Community-Based Services. HCBS Access Act (H.R. 1493 and S. 762). Proposals to make home and community-based services (HCBS) a mandatory benefit within Medicaid, and to ensure eligible older adults and people with disabilities have the option to choose between home care and institutional care. Medicare and Medicaid Nursing Homes. Nursing Home Disclosure Act (H.R. 177). Proposal to direct HHS to establish a national registry of medical directors. Medicare and Medicaid Nursing Home Ownership. (No bill) Supporting the strengthening of proposed HHS regulations for comprehensive ownership disclosure in the nursing home sector, and for national safe staffing standards. Medicaid Long-Term Services and Supports (LTSS). (No bill): To request that CMS collect standardized LTSS expenditure data annually from every state and across all LTSS programs and for disaggregation of expenditure data by the delivery system and demographic characteristics in order to identify disparities in access and use of LTSS and help states and CMS deploy targeted strategies to meet the needs of older adults and people with disabilities.
Client expense: $820,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $9,600,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $200,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), SENATE
Client expense: $1,500,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Client expense: $6,430,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
Client expense: $160,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), SENATE
Client expense: $140,000 · Firm income: Not reported
Government targets: Administration on Aging, 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), 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), SENATE